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Article in Chinese | WPRIM | ID: wpr-928003


As a unique medical resource in China, Chinese herbal medicine plays a key role in the prevention and treatment of human diseases. With the gradual expansion of applications, the quality of Chinese herbal medicine has become the focus of attention. The quality of Chinese herbal medicines depends largely on their source authenticity. Tracing the origin of Chinese herbal medicines plays an important role in ensuring their quality and efficacy and reducing the mixing and adulteration of Chinese herbal medicines from different regions. Stable isotope technology, as a key technology for origin tracing of agricultural products and food, has been used in the research of Chinese herbal medicines from multiple sources and origins in recent years. This new technological means contributes to standardizing the origin of Chinese herbal medicines and controlling their quality from the source. Apart from introducing the basic principles of stable isotope technology and the characteristics of common stable isotopes, this study reviewed the application status of light and heavy stable isotopes in the origin tracing of Chinese herbal medicines and their correlation with ecological factors, and forecasted the application prospect of this technology in the authentication of Chinese herbal medicines, aiming to provide reference for the geographical origin tracing of Chinese herbal medicines and promote the sustainable development of traditional Chinese medicine.

Drug Contamination , Drugs, Chinese Herbal/analysis , Humans , Isotopes , Medicine, Chinese Traditional , Quality Control
Article in Chinese | WPRIM | ID: wpr-927944


This study aimed to establish a method for synchronous detection of 14 mycotoxins in Pseudostellariae Radix and investigate its contamination with mycotoxins, so as to provide technical guidance for monitoring the quality of Chinese medicinal materials and medication safety. The sample was extracted with 80% acetonitrile in an oscillator for 1 h, purified using the modified QuEChERS purifying agent(0.1 g PSA + 0.3 g C_(18) + 0.3 g MgSO_4), and separated on a Waters HSS T3 chromatographic column(2.1 mm×100 mm, 1.8 μm). The gradient elution was carried out with 0.1% formic acid in water and acetonitrile, followed by the scanning in the multi-reaction monitoring(MRM) mode and the analysis of mycotoxin contamination in 26 Pseudostellariae Radix samples. The recovery rates of the established method were within the range of 82.17%-113.6%, with the RSD values less than 7% and the limits of quantification(LOQ) being 0.019-0.976 μg·kg~(-1). The detection rate of 14 mycotoxins in 26 batches of medicinal materials was 53.85%. The detection rate of sterigmatocystin(ST) was the highest, followed by those of zearalenone(ZEN), aflatoxin G_2(AFG_2), fumonisin B_1(FB_1), HT-2 toxin, and nivalenol(NIV). Their respective detection rates were 38.46%, 26.92%, 23.08%, 11.54%, 11.54%, and 7.69%, with the pollution ranges being 1.48-69.65, 0.11-31.05, 0.11-0.66, 0.28-0.83, 20.86-42.56, and 0.46-1.84 μg·kg~(-1), respectively. The established method for the detection of 14 mycotoxins is accurate, fast and reliable. The research results have very important practical significance for guiding the monitoring and prevention and control of exogenous fungal contamination of Chinese medicinal materials.

Aflatoxins/analysis , Chromatography, High Pressure Liquid/methods , Drug Contamination , Food Contamination/analysis , Mycotoxins/analysis , Plant Roots/chemistry , Tandem Mass Spectrometry/methods
Medicina (B.Aires) ; 81(4): 555-558, ago. 2021. graf
Article in English | LILACS | ID: biblio-1346506


Abstract The aim of this study was to determine the incidence of preservation fluids (PF) bacterial positive cultures, identify the germs involved, determine their correlation with infections in recipients during the postoperative period and compare outcomes in terms of morbidity, hospital stay and both patient and graft survival. We describe incidence and etiology of germs developed in PF cultures in our series and evaluate its impact on recipients. A prospective study in deceased donor liver transplants (LT) recipients was carried out from January 2014 to December 2017. Back table PF cultures were analized considering positive the development of any germs and negative to no signs of growth after 5 days. PF were classified as contamination or pathogens. Targeted antibiotic therapy was administered in the last ones. Recipients were divided in: PF (-) and PF(+). Recipients infections related to positive PF were analyzed. These were identified as "direct correlation" when the same germ grew up in PF. Hospital stay and 30 days follow up were compared. Eighty-eight patients PFs were included, 38% (33) had positive cultures, 28 (85%) of these were considered contamination and only 5 as pathogens. We found no differences in postoperative infections (p 0.840), ICU and total hospital stay (p 0.374 and 0.427) between both groups. Postoperative infections and hospital stay seem not to be influenced by PF cultures positivity. Treatment of isolated pathogens could have prevented infections, therefore, those groups that perform PF cultures should consider treatment in these cases and conclude prophylaxis when PF is negative or contaminated.

Resumen Las infecciones bacterianas son frecuentes en pacientes sometidos a trasplante hepático. Describimos la incidencia y etiología de los cultivos de líquidos de preservación (LP) positivos en nuestra serie y analizamos su importancia clínica. Se trata de un trabajo prospectivo de pacientes trasplantados hepáticos, entre enero 2014 a diciembre 2017. Se analizaron muestras de LP tomadas al finalizar la mesa de banco, considerándose positivo el desarrollo de cualquier germen y negativo la ausencia del mismo luego de 5 días. Los LP positivos se clasificaron en: con contaminantes y con patógenos. Los pacientes con LP patógenos recibieron tratamiento antibiótico de acuerdo al antibiograma. Los pacientes fueron divididos en dos grupos: con LP + y LP-. Las infecciones relacionadas a los LP fueron analizadas. Se consideró "correlación directa" cuando el mismo germen desarrolló en el LP y en el recipiente. Se comparó estadía hospitalaria en ambos grupos. Se incluyeron 88 pacientes, 38% (33) presentaron LP+, de los que el 85% (28) fueron por contaminación y 5 por pa tógenos. No se hallaron diferencias significativas en infecciones postoperatorias (p 0.840) y estadía hospitalaria (p 0.427) entre ellos. No hubo casos de "correlación directa". Las infecciones postoperatorias y la estadía hospitalaria de los pacientes no parecen estar influidas por la positividad de los cultivos de LP. El tratamiento dirigido a los gérmenes aislados como patógenos pudo prevenir infecciones, por lo tanto, los grupos que realizan cultivos de rutina deberían considerar el tratamiento en estos casos y finalizar la profilaxis cuando el LP sea negativo o contaminado.

Humans , Liver Transplantation/adverse effects , Organ Preservation Solutions , Drug Contamination , Prospective Studies , Retrospective Studies , Living Donors
Bol. latinoam. Caribe plantas med. aromát ; 20(4): 386-393, jul. 2021. ilus
Article in English | LILACS | ID: biblio-1352337


Leaves of Monteverdia ilicifolia ("espinheira-santa") are considered a medicinal tea by the Brazilian Sanitary Surveillance Agency (Anvisa), by their anti-dyspeptic, anti-acid and protective of the gastric mucosa properties. Their spiny margins are similar to those of other botanical species, which may lead to misidentifications. The aim of this work was to evaluate the authenticity of 32 samples of herbal drugs commercialized as "espinheira-santa" in the formal trade in Brazil, by macro and microscopic morphological studies of the leaves. The evaluation of the botanical authenticity was based on leaf venation patterns, shape and anatomy of the petiole and midrib region in cross section, vascular system arrangement and epidermal characters. Analysis of these characters compared to literature data suggests that 34% of the samples are M. ilicifolia and the remaining 66% are Sorocea bonplandii, a species with no clinical studies assuring its effective and safe use, representing thus a potential risk to public health.

Las hojas de Monteverdia ilicifolia ("espinheira-santa") son consideradas tés medicinales por la Agencia Nacional de Vigilancia Sanitaria (Anvisa), Brasil, por las indicaciones terapéuticas como antidispépticos, antiácidos y protectores de la mucosa gástrica. Sus márgenes foliares espinescentes se parecen a los de otras especies, conduciendo a identificaciones erróneas. El objetivo de este trabajo fue evaluar la autenticidad de 32 muestras de drogas vegetales vendidas como "espinheira-santa" en el comercio legal de Brasil, realizando un estudio morfológico de las hojas. Esta evaluación se ha basado en observar de la hoja, sus patrones de nerviación, su forma y anatomía (pecíolo y nervadura central en corte transversal), disposición del sistema vascular y caracteres epidérmicos. El análisis de la morfología, comparado con los datos de literatura, sugiere que el 34% de las muestras son M. ilicifoliay el 66% son Sorocea bonplandii, una especie que no cuenta con los estudios clínicos que garantizan su uso efectivo y seguro, representando un riesgo para la salud pública.

Plants, Medicinal , Maytenus/anatomy & histology , Fraud , Quality Control , Brazil , Drug Contamination , Plant Leaves/anatomy & histology , Celastraceae/anatomy & histology
Article in Chinese | WPRIM | ID: wpr-921742


In recent years, the quality and safety problems have been limiting the internationalization of Chinese medicine. The pollutants in Chinese medicine, particularly the exogenous harmful pollutants mainly including mycotoxins, pesticide residues, heavy metals, harmful elements, and sulfur dioxide, are of high risks for people. Therefore, the World Health Organization(WHO) and relevant national organizations have clearly defined the maximum residue limits(MRLs) of such pollutants. Chinese Pharmacopoeia(2020 edition, volume Ⅳ) also demonstrates the detection methods, MRLs and preliminary risk assessment methods for four typical exogenous harmful pollutants in Chinese medicine. Therefore, continuous optimization of the health risk assessment system can further help further raise the quality and safety of Chinese medicine. This paper reviews the research on the health risk assessment of four typical exogenous harmful pollutants in Chinese medicine and discusses the problems of and challenges for the assessment system, which is expected to lay a scientific basis for the establishment of the risk warning mode and response measures suitable for specific types of Chinese medicine.

Drug Contamination , Drugs, Chinese Herbal/analysis , Environmental Pollutants/analysis , Humans , Medicine, Chinese Traditional , Pesticide Residues/analysis , Risk Assessment
Article in Chinese | WPRIM | ID: wpr-828369


A highly sensitive monoclonal antibody against aflatoxin B_1(AFB_1) was prepared and an indirect competition enzyme-linked immunosorbent assay(ic-ELISA) was established based on the antibody which was used for high-throughput and rapid screening of AFB_1 contamination in Chinese herbal medicines to ensure the safety of medication. In this study, the structure of AFB_1 was modified by improved oxime method, and the carrier protein was coupled by EDC-NHS method to obtain the complete antigen of AFB_1, which was more convenient and environmental friendly. The Balb/c female mice were immunized using increasing the immunization dose and various ways of injection, and finally the AFB_1 monoclonal antibody was prepared. The AFB_1 monoclonal antibody belongs to IgG_(2 b) immunoglobulin by identifying its immunological characteristics, and its sensitivity(IC_(50)) can reach 0.15 μg·L~(-1), and the affi-nity is 2.81×10~8 L·mol~(-1). The cross-reaction rates of AFB_2, AFG_1, and AFG_2 were 35.07%, 8.75%, and 1.15%, respectively, and there was almost no cross-reactivity with other mycotoxins. Based on the high sensitivity and specificity of the antibody, an ic-ELISA method was established and applied to the determination of AFB_1 contamination in Ziziphi Spinosae Semen. According to the matrix matching standard curve, the linear concentration range for AFB_1 was 0.05-0.58 μg·L~(-1)(R~2=0.992), the recoveries were 88.00%-119.0%, and the detection limit was 1.69 μg·kg~(-1). The AFB_1 in 33 batches of Ziziphi Spinosae Semen samples was determined by ic-ELISA, and the contamination level was 3.62-206.58 μg·kg~(-1). The linear correlation coefficient between the detection results of ic-ELISA and UHPLC-MS/MS was 0.996, and there were no false positive and false negative cases. It indicates that the established ic-ELISA is accurate and reliable, and could provide a simple and effective technique for fast screening of AFB_1 contamination in Ziziphi Spinosae Semen, and also could be considered as the reference for the detection and monitoring of AFB_1 contamination in other Chinese herbal medicines.

Aflatoxin B1 , Animals , Antibodies, Monoclonal , Drug Contamination , Enzyme-Linked Immunosorbent Assay , Female , Mice , Semen , Chemistry , Tandem Mass Spectrometry
Rev. SOBECC ; 24(3): 119-124, jul-.set.2019.
Article in Portuguese | LILACS, BDENF | ID: biblio-1021340


Objetivo: Comparar os resultados dos processos de limpeza e desinfecção manual e automatizado de Utensílios Sanitários (US). Método: Estudo experimental, descritivo, realizado por meio de culturas microbiológicas de US usados por pacientes acamados em uma unidade de internação de um hospital localizado no sul do Brasil. As amostras icrobiológicas foram coletadas após limpeza e desinfecção, sendo 11 amostras de cada um dos três processos testados: automatizado, manual sem supervisão e manual com supervisão. Resultados: No processo automatizado, não houve crescimento de microrganismos patogênicos de relevância epidemiológica. No manual, em ambos processamentos realizados, conforme protocolo estabelecido pela instituição com e sem supervisão, houve crescimento de microrganismos patogênicos. Conclusão: Com base nos resultados obtidos no estudo, o método automatizado demonstrou ser seguro para utilização dos US na assistência à saúde. Os resultados obtidos no método manual não conferem segurança. Sugere-se que sejam realizados estudos com conhecimento prévio do grau de contaminação controlada por meio de cepas de referência.

Objective: To compare the results of manual and automated cleaning and disinfection of Sanitary Appliance (US). Method: A descriptive experimental study, carried out by means of microbiological cultures of appliance used by patients bedridden in a hospitalization unit of a hospital located in the south of Brazil. Thirty three samples were collected after the cleaning and disinfection processes were carried out, eleven for each of the three methods available: automated, manual with and without supervision for microbiological evaluation. Results: In the automated process, pathogenic microorganisms of epidemiological relevance was now here to be found in the experiment. In the manual, in both processes performed, according to protocol established by the Institution with and without supervision, there was growth of pathogenic microorganisms. Conclusion: Therefore, in this study we conclude that the automated method for cleaning and disinfection has been shown to be safer for use in healthcare. The results obtained in the manual method do not confer safety. It is suggested that studies be carried out with references trains with controlled contamination.

Objectivo: Comparar los procesos de limpieza y desinfección manual y por médio de um equipo automático de Utensilios Sanitarios (US). Método: Estudio experimental descriptivo de medio de cultivos microbiológicos de US de los que hicieron uso enfermos en piso de internación de un hospital delsur de Brasil. Las muestras microbiológicas fueron recolectadas después de La limpieza y desinfección, de lãs cuales 11 muestras de cada uno de los tres procesos probados: automatico, manual sin supervisión y manual com supervisión. Resultados: Em El proceso com el equipo automatico, no hubo crecimiento de microorganismos patógenos de relevancia epidemiológica. Em los dos procesos manuales con y sin supervisión, conforme protocolo establecido por La institución, hubo crecimiento de microorganismos patógenos. Conclusión: Por los resultados obtenidos em ele studio, se concluye que el la limpeza e nel equipo automático ha demostrado seguridade para usar los US en cuidados a La salud. Se sugiere que se realicen estúdios conconocimiento prévio del grado de contaminación controlada por medio de cepas de referencia.

Humans , Disinfection , Equipment and Supplies , Household Work , Drug Contamination , Microbiological Techniques , Food Preservatives
Trends psychiatry psychother. (Impr.) ; 41(2): 186-190, Apr.-June 2019. tab, graf
Article in English | LILACS | ID: biblio-1043521


Abstract Introduction Brazil is the world's biggest consumer of crack cocaine, and dependence is a major public health issue. This is the first study to investigate the prevalence of potentially harmful adulterants present in hair samples from Brazilian patients with crack cocaine dependence. Method We evaluated adulterants in hair samples extracted by convenience from 100 patients admitted at the 48 hour-observation unit of Centro de Referência de Álcool, Tabaco e Outras Drogas (CRATOD), Brazil's largest center for addiction treatment. A cross-sectional analysis was performed with the data obtained. Results Adulterants were found in 97% of the analyzed hair samples. The most prevalent adulterant was lidocaine (92%), followed by phenacetin (69%) and levamisole (31%). Conclusion Adulterants were widely prevalent in hair samples from crack users treated at CRATOD: at least one adulterant was present in virtually all the hair samples collected. This points to a need to monitor adverse effects in the clinical setting in order to provide this high-risk group of patients with prompt and effective care related to the acute and chronic complications associated with these adulterants.

Resumo Introdução O Brasil é o maior consumidor mundial de crack, e a dependência é um grande problema de saúde pública. Este é o primeiro estudo a investigar a prevalência de adulterantes potencialmente nocivos presentes em amostras de cabelo de pacientes brasileiros com dependência de crack. Métodos Foram avaliados adulterantes em amostras de cabelos extraídos por conveniência de 100 pacientes internados na unidade de observação de 48 horas do Centro de Referência de Álcool, Tabaco e Outras Drogas (CRATOD), o maior centro de tratamento de dependência do Brasil. Uma análise transversal foi realizada com os dados obtidos. Resultados Foram encontrados adulterantes em 97% das amostras de cabelo analisadas. O adulterante mais prevalente foi a lidocaína (92%), seguida da fenacetina (69%) e levamisol (31%). Conclusão Os adulterantes foram amplamente prevalentes em amostras de cabelo de usuários de crack tratados no CRATOD: pelo menos um adulterante estava presente em praticamente todas as amostras de cabelo coletadas. Isso aponta para a necessidade de monitorar os efeitos adversos no ambiente clínico, a fim de proporcionar a esse grupo de pacientes de alto risco cuidados imediatos e efetivos relacionados às complicações agudas e crônicas associadas a esses adulterantes.

Humans , Male , Female , Adolescent , Adult , Young Adult , Phenacetin/analysis , Levamisole/analysis , Drug Contamination , Crack Cocaine/analysis , Cocaine-Related Disorders , Hair/chemistry , Lidocaine/analysis , Brazil
Article in English | WPRIM | ID: wpr-762256


BACKGROUND: Infection, one of the complications associated with procedures, can cause fatal outcomes for patients. Although the local anesthetic agent we use is less susceptible to infection due to its antibacterial action, we performed this study to check the change in the antibacterial effect of lidocaine in various clinical conditions. METHODS: After exposing lidocaine to five contaminated environments, we checked on whether the bacteria could be cultured in blood agar plate (BAP) media. In each contaminated environment, lidocaine was exposed for 4 h (n = 9) and 8 h (n = 9), and the results were compared. Lidocaine was swabbed with chlorhexidine (group A), brought into contact with saliva (group B), skin (group C), an operating room floor and an outpatient room floor (group D), operating room air for 24 h (group A-a), and outpatient room air for 24 h (group A-b). After exposure, the culture was initiated. RESULTS: In 2 of 9 BAP media where lidocaine was exposed to saliva (group B) for 8 h, growth of a colony was observed. In gram staining, it was found to be Streptococcus viridans. No bacteria were found in any other groups. CONCLUSIONS: Though lidocaine has strong antibacterial activity, it has been found that long-term exposure to a contaminated environment reduces its antibacterial activity and that drug contamination can be heavily affected not only by environmental but also human effects. Therefore, the use of aseptic drugs is necessary, and stopping the reuse of the drug is a way to prevent complications, including infection.

Agar , Bacteria , Chlorhexidine , Drug Contamination , Fatal Outcome , Humans , Lidocaine , Operating Rooms , Outpatients , Saliva , Skin , Viridans Streptococci
São Paulo; s.n; s.n; 2019. 192 p. ilus, graf, tab.
Thesis in Portuguese, French | LILACS | ID: biblio-1025282


A adulteração de suplementos alimentares pela adição de substâncias farmacologicamente ativas e um problema que vem se agravando nos últimos anos. Essas substâncias são adicionadas intencionalmente nos produtos, com objetivo de melhorar a sua eficácia, sem que essa adição seja devidamente informada nos rótulos. O consumo de suplementos adicionados de substâncias farmacologicamente ativas nao declaras nos rótulos e, alem de um problema de saúde pública, um risco a carreira de atletas profissionais, quando se trata de doping no esporte. Neste trabalho foram desenvolvidos métodos analíticos baseados em cromatografia líquida para detecção de 19 substâncias farmacologicamente ativas em amostras de suplementos alimentares, nos niveis de contaminação cruzada e adulteração. Para tal, empregou-se a cromatografia líquida de alta eficiência acoplada a detector de arranjo de diodos (HPLC-DAD) e a cromatografia líquida acoplada a espectrometria de massas sequencial (LC-MS/MS). As substâncias investigadas apresentam ação androgênica e anabólica (i.e. testosterona, metiltestostetona, propionato de testosterona, decanoato de testosterona, trembolona, estanozolol, dehidroepiandrosterona, androstenediona, decanoato de nandrolona, oxandrolona e metasterona), estimulante (i.e. cafeína), anorexigena (i.e. sibutramina), diurética (i.e. amilorida, bumetanida, furosemida, hidroclorotiazida e clortalidona) e laxante (i.e. fenolftaleina). Entre os métodos de preparo de amostra avaliados (Quechers e extração sólido-líquido seguida de uma etapa de precipitação de proteína), a extração sólido-líquido empregando metanol como solvente extrator e ZnSO4 como agente precipitante apresentou-recuperação acima de 80% para todas as substâncias avaliadas, sendo selecionado para o fim deste estudo. Os métodos analíticos propostos apresentaram limites de detecção e de quantificação na faixa de contaminação, foram seletivos e lineares com r2 superior a 0,99 na faixa de concentração de interesse para todas as substâncias e valores de recuperação, precisão e exatidão dentro dos valores aceitáveis. Um conjunto amostral representativo dos suplementos alimentares comercializados no Brasil, constituído por 230 amostras, foi analisado sendo que mais de 25% do conjunto amostra foram positivos para cafeína (48), sibutramina (14), fenolftaleína (2) e furosemida (3), isoladas ou associadas entre si. Os métodos desenvolvidos utilizaram um preparo de amostra simples e apresentaram resultados satisfatórios para a investigação de possível adulteração ou contaminação com 19 das substâncias de interesse. Dos 58 suplementos alimentares adulterados, apenas 11 podem ser considerados adulterados por contaminação cruzada. Os demais, são consideradas adições dolosas por parte dos fabricantes com objetivo de melhorar a eficiência dos seus produtos. Os resultados aqui apresentados indicam a necessidade de ações mais efetivas por parte das autoridades sanitárias no sentido de fiscalizar com mais eficiência a produção e a comercialização desses produtos e alertar a população para que fiquem atentos a possível adulteração de suplementos alimentares e aos riscos associados ao consumo desses produtos

The adulteration of dietary supplements by the addition of pharmacologically active substances is a serious issue, which is aggravating steadily. These substances are added intentionally in various products, with the aim of improving their effectiveness, but without proper labeling stating so. In addition to a public health problem, the consumption ofsupplements added with undeclared pharmacologically active substances also represents a career risk for professional athletes when it comes to doping in sport. In the present work, analytical methods based on liquid chromatography were developed for the detection of 19 pharmacologically active substances in dietary supplement samples at the levels of crosscontamination and adulteration. For this purpose, high performance liquid chromatography/diode array detector (HPLC-DAD) and liquid chromatography/tandem mass spectrometry (LC-MS/MS) were used. The investigated substances comprise of androgenic and anabolic effects (ie testosterone, testosterone propionate, testosterone decanoate, trenbolone, stanozolol, dehydroepiandrosterone, androstenedione, nandrolone decanoate, oxandrolone and metasterone), stimulant (ie caffeine), anorexigenic (ie sibutramine), diuretic (ie amiloride, bumetanide, furosemide, hydrochlorothiazide and chlorthalidone) and laxative (ie phenolphthalein). Among the sample preparation methods evaluated (Quechers and solidliquid extraction followed by a protein precipitation step), solid-liquid extraction using methanol as extraction solvent and ZnSO4 as the precipitating agent has been chosen as it has shown recovery values above 80% for all evaluated substances. The proposed analytical methods had limits of detection and quantification within the contamination range, they were also selective and linear showing r2 values higher than 0.99 in the concentration range of interest for all substances and accuracy within acceptable values. A representative sampling of dietary supplements marketed in Brazil, consisting of 230 samples, was analyzed and more than 25% have shown to be positive for caffeine (48), sibutramine (14), phenolphthalein (2) and furosemide (3), isolated or associated with each other. The methods developed used a simple sample preparation and presented satisfactory results for the investigation of possible adulteration or cross-contamination for the 19 of the substances of interest. From a total of 58 adulterated dietary supplements, only 11 could be considered adulterated by crosscontamination. The remaining are considered to be intentional additions by manufacturers in order to improve the efficiency of their products. The results presented in this study indicate the need for more effective measures by the health authorities towards the production and marketing of these products so that the general public is aware of their potential adulteration and the risks associated with their consumption

Mass Spectrometry/instrumentation , Drug Contamination/prevention & control , Chromatography, Liquid/instrumentation , Dietary Supplements/analysis , Caffeine , Testosterone Congeners/adverse effects , Diuretics/adverse effects
Article in Chinese | WPRIM | ID: wpr-773720


To evaluate the pesticide residue risk of Jinyinhua Formula Granules( made from Lonicerae Japonicae Flos) used in the market preliminarily,20 samples of Jinyinhua Formula Granules from 5 manufactures were collected randomly through the national evaluative sampling test program. Totally 262 pesticides( involving 270 chemical monomers) with monitoring significance to traditional Chinese medicinal materials were detected. Samples were extracted by high speed homogenate with acetonitrile as solvent. And their residues were analyzed by GC-MS/MS and LC-MS/MS in MRM mode. No less than 2 groups of characteristic ion pairs were adopted for qualitative detection,and the calibration curve method was used for quantitative detection. The results showed that 20 pesticides were detected in 20 batches of Jinyinhua Formula Granules,with an average of about 9 pesticides detected in every batch,but no restricted pesticide was detected. The detected pesticides were all at the trace level,which was far lower than the limit of the general food standard. Therefore,the safety risk was low in Jinyinhua Formula Granules. In this study,a screening method for pesticide residues in Jinyinhua Formula Granules was established for the first time. The method was accurate and rapid,and the detection indicators were highly targeted. The results could provide theoretical reference for the prevention and control of pesticide safety risks in Jinyinhua Formula Granules and even traditional Chinese medicine formula granules.

Chromatography, Gas , Chromatography, Liquid , Drug Contamination , Drugs, Chinese Herbal , Pesticide Residues , Quality Control , Tandem Mass Spectrometry
Article in Chinese | WPRIM | ID: wpr-773185


To evaluate the safety of heavy metals contaminated Astragalus membranaceus,an appropriate protocol was established to study the heavy metals pollution level by health risk assessment. This study provided a detailed procedure to assess the medicinal herbs in quality control and safety evaluation,and expected to create awareness among the public on the safety of consuming of A. membranaceus or any other kinds of medicinal herbs. The heavy metals content of Cu,As,Cd,Pb and Hg in a total of 45 batches of A. membranaceus were carefully analyzed with a developed inductively coupled plasma mass spectrometry( ICP-MS). Besides,the heavy metal contamination level was further evaluated through 4 main assessment parameters,including maximum residue limit( MRL) set by International Standard Organization,estimated daily intake( EDI) set by IUPAC,target hazard quotients( THQ) and Total THQ set by USEPA and total THQs in raw herbs of A. membranaceus. In addition,the recommended MRLs of 5 main heavy metals aimed to A. membranaceus were calculated based on the regulated consumption quantity. The result showed that,under the ISO international standard of Chinese medicine-Chinese herbal medicine heavy metals,the unqualified rate was 8. 89% for A. membranaceus,which including 4 batches of A. membranaceus exceeded the MRL of As. Here,the standard THQ value of A. membranaceus was firstly proposed as 0. 02 and 0. 011 25 for adults and children,respectively,which were calculated with the recommended consumption quantity of 30 g and 9 g for adults and children. Furthermore,the values of THQ for As and total THQs in adults and children were exceeded the standard THQ in A. membranaceus,and the recommended MRLs of Pb,Cd,Hg and Cu in above medicinal materials that calculated based on health risk assessment model were higher than the regulated MRLs that set by ISO and Chinese Pharmacopeia. The research showed that the contents of heavy metals in A. membranaceus were not in the safe range and the certain non-carcinogenic risks to human body cannot be neglected. Based on above investigation result,it is easily known that the common evaluation method for raw herbs based on the comparison of MRL of heavy metals was not precise enough,and the international model of health risk assessment should be built for each medicinal herb. Above all,this study provided a more realistic research approach for safety evaluation of any other kinds of heavy metals contaminated medicinal herbs,including the establishment of heavy metals standard limit in a specified medicinal herb under recommended consumption quantity,and it is expected to create awareness among the public on the safety of consuming any other medicinal herbs.

Astragalus propinquus , Chemistry , Drug Contamination , Drugs, Chinese Herbal , Reference Standards , Humans , Metals, Heavy , Plants, Medicinal , Chemistry , Risk Assessment
Article in Chinese | WPRIM | ID: wpr-771519


The residue of the pesticides is closely related to the quality and safety of traditional Chinese medicines(TCMs) and has attracted widespread attention at home and abroad.This article analyzed the current status of pesticide residues in TCMs by summarizing the research results of recent years.At the same time,the methods for the detection of pesticide residues in TCMs were summarized,and the domestic and foreign pesticide residue limit standards for TCMs were compared,intending to provide reference and basis for the detection and control of pesticide residues in TCMs.

Drug Contamination , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Pesticide Residues , Research
Article in Chinese | WPRIM | ID: wpr-771514


To achieve a comprehensive understanding of heavy metals and harmful elements residues in Niuhuang Qingwei Pills,49 samples from 18 manufactures were collected from 31 provinces in China.Risk assessment and control preparations were applied innovatively in evaluation of exogenous pollution in traditional Chinese Medicine.Determination methods for Pb,Cd,As,Hg and Cu were established by inductively coupled plasma mass spectrometry(ICP-MS).Based on the procedures including hazard identification,hazard characterization,exposure assessment and risk characterization,risk assessment was performed and residual limits for Pb,Cd,As,Hg and Cu in the drug were formulated.The results showed that the hazardous quotients(HQ) of the elements were decreased in the following order:Pb>As>Cu>Hg>Cd,and the total hazardous index(HI) of heavy metals and harmful elements in Niuhuang Qingwei Pills was above 1,implying health risk of the drug.Under the proposed limits,5 elements in the control preparation as well as Cd and Cu in the samples were within the limits range,but the excess rates of Pb,As and Hg in the samples were 12%,12% and 14%,respectively.For the first time,basic steps for risk assessment of Chinese patent medicine were established,which provided model and reference for risk assessment and limit formulation of other drugs.

China , Drug Contamination , Drugs, Chinese Herbal , Reference Standards , Metals, Heavy , Risk Assessment
Article in Chinese | WPRIM | ID: wpr-774553


Through market investigation, the adulteration of Zaocys dhumnades on markets was found out, and samples of authentic and adulterated Z. dhumnades on markets were collected. The origin and properties of the adulterated Z. dhumnades were studied in order to provide reference for the identification of Z. dhumnades. The counterfeit Z. dhumnades sold on markets were as follows: Ptyas korros, P. mucosus, Najanaja atra, Sinonatrix annularis, Dinodon septentrionalis, etc. It is found that there existed a obvious difference between the traits of the Z. dhumnades and counterfeits. Genuine Z. dhumnades with "sword ridge" "iron tail", strongly ribbed scales and other features, is the key point to identify the difference from adulterants.

Animals , Drug Contamination , Materia Medica , Reference Standards , Snakes
Rev. bras. oftalmol ; 77(6): 320-323, nov.-dez. 2018. graf
Article in Portuguese | LILACS | ID: biblio-985314


Resumo Objetivos: Avaliar o grau de contaminação por fungos e bactérias e o modo de conservação destes colírios hipotensores por parte dos pacientes no ambulatório de Glaucoma da Santa Casa de Ribeirão Preto. Métodos: Foram selecionados aleatoriamente cinquenta e cinco pacientes, em seguimento no ambulatório, e após consentimento dos mesmos os colírios eram coletados e enviados via correio para análise por microbiologista e patologista em até 72 horas. Foi analisado 0,5ml aproximadamente das medicações e os pacientes respondiam a um questionário simples sobre o método de conservação e se consideravam estes adequados. Resultados: Dos 55 colírios analisados, cinco (9,01%) estavam com seu conteúdo líquido contaminado. Entre os microrganismos isolados haviam 4 bactérias Gram negativas, sendo 1 (1,8%) por Serratia marcescens, 1 (1,8%) Pseudomonas aeruginosa e 2 (3,6%) Stenotrophomas maltophilia. Um colírio estava contaminado pelo fungo Cândida ssp Todos pacientes do estudo julgam seus métodos de armazenamento e instilação adequados. Os pacientes que tiveram os colírios positivados eram convocados para exame clínico e passavam por novo questionário pelo investigador. Conclusão: O tempo de abertura dos frascos e os métodos de conservação influenciam na contaminação dos medicamentos, todos os colírios com crescimento de microrganismos no presente estudo estavam abertos entre 30 e 90 dias. O fato de que a maioria dos pacientes levam seus colírios em tarefas cotidianas, aumenta a exposição dos frascos e podem ser um fator relevante para determinar a contaminação destas medicações.

Abstract Objetives: To assess the degree of fungal and bacterial contamination of hypotensive eye drops and the way these are preserved by the patients at the Glaucoma outpatient clinic of Santa Casa Hospital in Ribeirão Preto. Methods: Fifty-five patients were randomly assigned to follow-up in the outpatient clinic and, after their consent, an eye drop was collected per patient and later sent by mail for analysis by microbiologist and pathologist in up to 72 hours. Approximately 0.5ml of the medications were analyzed and the patients were asked to answer a simple questionnaire on the method of drug conservation and whether they considered it adequate. Results: Of the 55 analysed eye drops, five (9.01%) had their liquid contents contaminated. Among the microorganisms isolated there were 4 Gram negative bacteria, 1 (1.8%) by Serratia marcenses, 1 (1.8%) Pseudomonas aeruginosa and 2 (3.6%) Stenotrophomas maltophilia. An eye drop was contaminated by the fungus Candida ssp. All the patients in the study judged their methods of storage and instillation appropriate. The patients who had the positive coliria were summoned for clinical examination and passed through a new questionnaire by the investigator. Conclusion: The time and methods of preservation influence the contamination of medicinal products. All the eye drops that presented growth of microorganisms in the present study were open between 30 and 90 days. The fact that most patients take their eye drops on daily tasks increases the exposure of the bottles and can be a relevant fact to determine the contamination of these medications.

Humans , Male , Female , Aged , Ophthalmic Solutions/analysis , Ophthalmic Solutions/therapeutic use , Glaucoma/drug therapy , Drug Contamination , Pseudomonas aeruginosa/isolation & purification , Serratia marcescens/growth & development , Bacteria/isolation & purification , Candida/growth & development , Cross-Sectional Studies , Surveys and Questionnaires , Stenotrophomonas maltophilia/growth & development , Drug Storage , Slit Lamp Microscopy , Fungi/isolation & purification
Rev. bras. oftalmol ; 77(4): 194-196, jul.-ago. 2018. tab
Article in Portuguese | LILACS | ID: biblio-959104


RESUMO Objetivos: Analisar a prevalência da microbiota nos tonômetros de aplanação de Goldmann nos consultórios do SUS e definir o grau de contaminação dos tonômetros e a eficácia da assepsia do cone do tonômetro de aplanação. Métodos: Estudo transversal em que foi realizado a coleta de 60 "swabs", divididos nos três tonômetros de aplanação dos ambulatórios do SUS em dois momentos distintos. No primeiro realizou-se a coleta no início dos atendimentos e no segundo momento, a coleta foi realizada ao final de todos os atendimentos. Todos "swabs" foram colhidos no meio Stuart e foi realizada a cultura em meio de bactérias. Resultados: Das 60 amostras, apenas uma apresentou crescimento de agente patogênico, a Escherichia coli. Conclusão: Independente dos vários métodos que o oftalmologista escolher para realizar a assepsia, a mesma é imprescindível para a manutenção de uma boa saúde ocular do paciente, evitando assim a transmissão e propagação de patógenos por meio do exame oftalmológico e concluímos também que o método utilizado pelo nosso serviço parece ser eficaz nesta profilaxia.

ABSTRACT Objective: Analyze the microbiota prevalence in the Goldmann applanation tonometers in the clinic of the SUS to define the contamination of the tonometers and the efficacy of asepsis of the applanation tonometer cone. Methods: A cross-sectional study was carried out to collect 60 "swabs" divided into the three aplanation tonometers of SUS clinics at two different times. In the first one, the collection will be performed at the beginning of the visits and at the second moment, the collection will be performed at the end of all the visits. All swabs will be harvested in the Stuart medium and culture was carried to sow bacteria. Results: Of the 60 samples, only one showed pathogen growth, Escherichia coli. Conclusion: Regardless of the various ways the ophthalmologist chooses to perform asepsis, it is essential for the maintenance of good patient eye health, thus avoiding the transmission and propagation of pathogens through ophthalmologic examination, and we also conclude that the method used by our patient seems to be effective in this prophylaxis.

Bacteria/isolation & purification , Bacteria/growth & development , Tonometry, Ocular/instrumentation , Equipment Contamination , Escherichia coli/isolation & purification , Escherichia coli/growth & development , Tonometry, Ocular/adverse effects , Asepsis/methods , Glaucoma/diagnosis , Drug Contamination/statistics & numerical data , Cross-Sectional Studies , Bacteriological Techniques , Equipment Reuse , Fluorescein/adverse effects , Culture Media , Fomites/microbiology , Intraocular Pressure
Rev. chil. infectol ; 35(4): 363-370, ago. 2018. tab, graf
Article in Spanish | LILACS | ID: biblio-978046


Resumen Introducción: Sarocladium kiliense es un hongo saprófito que puede generar infecciones oportunistas asociadas a procedimientos invasores. Se informa un brote multicéntrico nosocomial de fungemias de fuente común por este agente. Luego del reporte de cinco casos en pacientes en tres hospitales al Programa de Control de Infecciones del Ministerio de Salud de Chile en julio de 2013, se estudiaron a nivel nacional todos los pacientes con hemocultivo positivo para este agente. Se trató de cuadros clínicos leves a moderados, sin muertes atribuibles. El estudio identificó 65 casos en 8 hospitales, en su mayoría pacientes pediátricos en quimioterapia. Estudios iniciales de 94 muestras de cuatro fármacos y dispositivos usados en todos los casos resultaron negativas hasta que, en un segundo análisis de lotes seleccionados por criterios epidemiológicos y su matriz farmacéutica, se identificó la contaminación intrínseca de ampollas de ondansetrón de un productor específico, que se usó en todos los casos. Se realizó un retiro nacional de las ampollas de los tres lotes contaminados del fármaco, después de lo cual se contuvo el brote. La vigilancia de infecciones en los hospitales y el programa nacional coordinado con los laboratorios de microbiología fueron claves para identificar un brote multicéntrico de fuente común por contaminación de un fármaco por un hongo inusual.

Sarocladium kiliense is a saprophyte fungus that can cause opportunistic infections associated to invasive procedures. We report a multi-hospital nosocomial outbreak of fungemias due to this agent. Patients with positive blood culture to this agent were studied after six bloodstream infections identified in three Chilean hospitals in July 2013 were reported to Ministry of Health National Infection and Prevention Control Program. In general, there were mild clinical manifestations, without deaths attributable to the infection. Epidemiological and micro-biological study identified 65 cases in 8 hospitals, mostly pediatric patients in chemotherapy. Initial studies of 94 different drugs and medical devices had negative results, until a second analysis of specific blisters and their pharmaceutical matrix selected by epidemiological criteria identified an intrinsic contamination of ondansetron blisters from a specific producer used in all the patients. A recall of contaminated ondansetron blisters was performed in all the country, after which the outbreak was contained. Surveillance and response of local and national infection prevention and control programs and laboratory support were key to control of a national multi-hospital common source outbreak due to contamination of a drug by an unusual fungus.

Humans , Male , Child, Preschool , Child , Adolescent , Cross Infection/microbiology , Drug Contamination , Disease Outbreaks , Fungemia/microbiology , Fungemia/epidemiology , Ondansetron , Hypocreales/isolation & purification , Chile/epidemiology , Equipment Contamination , Hospitals, Public
Rev. cuba. enferm ; 34(2): e1621, abr.-jun. 2018. tab, graf
Article in Spanish | LILACS, BDENF, CUMED | ID: biblio-1099048


RESUMEN Introducción: Dentro de la unidad de salud las principales adversidades relacionadas a la contaminación se direccionan al paciente, existiendo fallas de las técnicas que pueden poner en riesgo la vida de las personas. Objetivo: identificar los principales problemas relacionados a la contaminación de medicamentos por el equipo de enfermería en el ambiente hospitalario. Métodos: Revisión integradora como forma de inclusión de los estudios relevantes sobre el tema en estudio. Las bases de datos seleccionadas fueron SCOPUS, PubMed Central: PMC, Web of Science/ Colección Principal, Scielo, Lilacs y CINAHL (EBSCO). Después de aplicar los criterios propuestos en el estudio, fueron identificados 123 artículos. De estos, solo siete cumplieron los criterios de inclusión y exclusión para el análisis: siendo dos trabajos de SciELO, dos de PubMed, un trabajo de Web of Science, uno de Lilacs y un trabajo de CINAHL. Conclusiones: Los resultados mostraron que la contaminación de medicamentos está relacionada con el equipo de enfermería y el local para la preparación del medicamento. Dentro de los errores encontrados se destacan: la manipulación y la falta de cuidados de asepsia. Estos factores aumentan los riesgos de contaminación y colocan en peligro la seguridad del paciente, lo que hace evidente la necesidad de adoptar las medidas efectivas y continuadas de educación farmacológica para el equipo de enfermería(AU)

ABSTRACT Introduction: Within the health unit, the main adversities associated with contamination affect the patient, and there are flaws in the techniques that can put people's lives at risk. Objective: To identify the main problems associated with the contamination of medicines by the nursing team in the hospital environment. Methods: Integrative review as a way to include relevant studies on the subject under analysis. The selected databases were SCOPUS, PubMed Central: PMC, Web of Science/Main Collection, Scielo, Lilacs, and CINAHL (EBSCO). After applying the criteria proposed in the study, 123 articles were identified, out of which number only seven met the inclusion and exclusion criteria for the analysis: two SciELO papers, two from PubMed, one from Web of Science, one from Lilacs, and one from CINAHL. Conclusions: The results showed that contamination of medications is associated with the nursing team and the local area for the medication preparation. The most representative errors include: manipulation and lack of aseptic care. These factors increase the risk for contamination and put patient safety at risk, which makes evident the need to adopt effective and continuous pharmacological education measures among the nursing team(AU)

Humans , Drug Contamination/prevention & control , Nursing Care/methods , Review Literature as Topic , Databases, Bibliographic
São Paulo; s.n; s.n; 2018. 88 p. graf, tab.
Thesis in Portuguese | LILACS | ID: biblio-996316


A adição fraudulenta de ativos farmacêuticos em suplementos nutricionais é um problema mundial. É comum encontrar mensagens sobre perda de peso, aumento da capacidade intelectual e/ou física, e estímulo sexual na embalagem de suplementos adulterados com fármacos sintéticos ocultos em formulações aparentemente inofensivas para os usuários. No Brasil, a disponibilidade de dados sobre a adulteração de suplementos nutricionais é escassa. No presente trabalho, foi desenvolvido e aplicado um método analítico empregando cromatografia gasosa com detector de nitrogênio fósforo (GC-NPD) para a detecção, identificação e quantificação de estimulantes/anorexígenos não declarados nos rótulos de suplementos alimentares, tais como: cafeína, femproporex, anfepramona, fenfluramina, sibutramina, fentermina, efedrina, fenilpropanolamina, pseudoefedrina e 4- metilhexan-2-amina. A técnica de extração/solubilização com metanol foi utilizada, ressaltando a utilização de baixa quantidade de amostra, solvente e padrões de estimulantes. Após o desenvolvimento e validação do método, as análises foram aplicadas em amostras de suplementos nutricionais obtidos em lojas especializadas em suplementos, de diversas partes do estado de São Paulo (n=125). Das 125 amostras de suplemento nutricional analisadas, 38 delas (30%) apresentaram resultado positivo para alguma das substâncias de interesse, dentre elas, sibutramina, cafeína e efedrina mediante a metodologia escolhida. As amostras positivas foram posteriormente analisadas qualitativamente por LC-MS/MS, no propósito de confirmar o resultado positivo obtido. A técnica analítica empregada proporciona seletividade, linearidade, precisão, exatidão, recuperação e limites em conformidade ao objetivo que foram destinadas. Os métodos de preparo de amostra desenvolvidos e validados demonstraram ser simples, práticos, eficientes e diferenciados pelo baixo uso de amostra e solvente

The fraudulent addition of active pharmaceutical compounds in nutritional supplements is, indeed, a worldwide problem. Often, it can be found several advertisements on various supplement packaging assuring weight loss, increased intellectual and/or physical capacity and sexual stimulation. These products may have been 'spiked' with synthetic drugs containing formulations which are apparently harmless to users. In Brazil, the availability of data about adulteration of nutritional supplements is scarce. In the present work, an analytical method using gas chromatography coupled with a nitrogen-phosphorus detector (GC-NPD) was developed and applied for the detection, identification and quantification of undeclared stimulants and/or anorectic agents in food supplement labels, such as: caffeine, fenproporex, amfepramone, fenfluramine, sibutramine, phentermine, ephedrine, phenylpropanolamine, pseudoephedrine e 4- metilhexan -2- amine. The extraction/solubilization with methanol presented satisfactory results, emphasizing the use of low amount of sample, solvent and standards of analytes. After the development and validation, the method was applied in samples of nutritional supplements obtained from specialty stores in various parts of the state of São Paulo (n = 125). From the 125 nutritional supplement samples analyzed, 38 of them (30%) presented positive results for some of the substances of interest, among them sibutramine, caffeine and ephedrine according to the chosen methodology. The positive samples were subsequently analyzed qualitatively by LCMS / MS, in order to confirm the positive result obtained. The analytical technique employed provides selectivity, linearity, precision, accuracy, recovery and limits in accordance with the intended purpose. The sample preparation methods developed and validated to be simple, practical, efficient and differentiated by the low sample and solvent usage

Laboratory and Fieldwork Analytical Methods/methods , Dietary Supplements/analysis , Appetite Depressants/administration & dosage , Drug Contamination