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Article in Chinese | WPRIM | ID: wpr-920652


@#An HPLC pre-column derivatization detection method was established to detect and analyze the formaldehyde and acetaldehyde in polysorbate 80 and polysorbate 20 from different manufacturers.The effects of aldehyde and acetaldehyde on the aggregation of adalimumab under different conditions were monitored.Based on the control of genotoxic impurities and the influence on the stability of monoclonal antibody preparations, the control limits of the two chemicals were preliminarily obtained.2, 4-dinitrophenylhydrazine (2, 4-DNPH) was applied as the derivatization reagent in HPLC pre-column derivatization; acetonitrile and water were used as mobile phase to perform a gradient elution on a C8 (4.6 mm × 150 mm, 5 μm) chromatographic column.The detection wavelength was 360 nm, and the external standard method was used for quantification.Verification results showed that the method was suitable for the quantitative analysis of trace formaldehyde and acetaldehyde in polysorbate 80 and polysorbate 20 . The detection and analysis of formaldehyde or acetaldehyde in different batches of polysorbate 80 and polysorbate 20 from different manufacturers showed that the content of formaldehyde and acetaldehyde were quite different. The content of formaldehyde and acetaldehyde in polysorbate 80 were significantly higher than those of polysorbate 20. After monitoring the changes of adalimumab aggregates treated by formaldehyde and acetaldehyde by size exclusion chromatography (SEC), it was found that the effect of formaldehyde on adalimumab aggregation was significantly higher than that of acetaldehyde.According to the requirements of ICH M7 (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk), the impurity limits of formaldehyde and acetaldehyde in polysorbate 80 and polysorbate 20 for monoclonal antibody preparations were calculated from the perspective of risk assessment.Combined with the influence on the aggregation stability of monoclonal antibodies, the preliminary limis for acetaldehyde and acetaldehyde were recommended to be ≤ 7 μg/g and ≤ 765 μg/g, respectively.

China Occupational Medicine ; (6): 180-185, 2022.
Article in Chinese | WPRIM | ID: wpr-942632


@#Objective To compare and analyze the occupational exposure limit(OEL)of hexavalent chromium compounds in China and foreign countries. Methods The OEL and background information of hexavalent chromium compounds released by nine official and unofficial organizations in seven countries/regions were collected and sorted. The classification,limit levels, formulation principles and compound characteristics labeling of OEL were compared. Results The OEL values published by nine organizations ranged from 0.000 02 to 0.050 00 mg/m3 . Among them,the limits of seven organizations(including China) did not clearly distinguish the soluble types of hexavalent chromium compounds;the limits of eight organizations(including China)were calculated in terms of chromium;seven organizations(including China)have only developed OEL for long-term exposure. The OEL of hexavalent chromium in China was 0.050 00 mg/m3 which is relatively loose. Its carcinogenicity label was consistent with international standards,its sensitization label was consistent with some countries,and its percutaneous absorption label had not been included in the characteristic labeling of limit values. Conclusion It is suggested that the OEL of hexavalent chromium in China should be revised timely,and the systemic adverse effects caused by percutaneous absorption of hexavalent chromium compounds should be focused on. At the same time,it is recommended to systematically adjust the management concepts and principles of all carcinogens.

Article in Chinese | WPRIM | ID: wpr-940056


ObjectiveTo establish microbial limit test methods for 44 pediatric drugs. MethodsAccording to the general guidelines in Chinese Pharmacopoeia (2015 and 2020 edition, volume Ⅳ),a suitability test of the methods for 44 drugs was carried out by pour-plate method, neutralization method or dilution method. ResultsTotal aerobic microbial count: chemical oral liquid samples can be tested by 1∶10 plate method;traditional Chinese medicine need to be neutralized firstly. Then oral liquids could be tested by 1∶10 plate method and 1∶100 plate method was used for granules. Total count of molds and yeasts: all the samples can be tested by the 1∶10 plate method. The recoveries of five test strains were between 0.5 and 2.0. The specified microorganisms were all detected in the test group, while not found in the negative control group. ConclusionThe microbial limit test methods for the 44 pediatric drugs are established and the results are reliable and can be used in the quality control.

Article in Chinese | WPRIM | ID: wpr-928866


Bacterial endotoxin is considered as one of the critical risk factors in medical devices, especially implanted devices that directly or indirectly contact with blood circulating system. In that case, endotoxin limits for implanted medical devices is important in determine the safety of medical devices. According to GB/T 14233.2-2005, the requirements of endotoxin index for intrathoracic medical devices is 2.15 EU per device. However, the definition of "intrathoracic medical devices" is vague. Specifically, "for cardiovascular system application" instead of "intrathoracic application" is more reasonable. With the deeper understanding of the risk of endotoxin in medical devices and considering the internationally accepted standards, the limits of endotoxin in medical devices for cardiovascular system application is acceptable at 20 EU per device.

Article in Chinese | WPRIM | ID: wpr-923509


@#Objective To analyze the characteristics of static balance and limits of stability (LOS) in patients with cervical vertigo (CV). Methods From January, 2020 to August, 2021, 30 CV patients in our hospital (vertigo group) and 30 healthy people (control group) were selected and tested with PRO-KIN system, under the conditions of eyes open and closed. The standard deviation of the vertical and horizontal amplitude, the mean of vertical and horizontal sway velocities, the area of the movement, the length of the movement, and LOS at eight directions, The Romberg ratios of the area and the length were caculated. Results All the indicators of the static balance were higher under eyes closed than under eyes open in both groups (|Z| > 2.138, P < 0.05); whether under the eyes open or closed, the static balance indicators were higher in the vertigo group than in the control group (|Z| > 2.004, P < 0.05), except for the mean of horizontal sway velocities (|Z| < 1.026, P > 0.05). The LOS and total LOS completion percentage in the front (upper right, right above, upper left) were lower in the vertigo group than in the control group (|Z| > 2.240, P < 0.05). Conclusion The static balance abilities decrease for CV patients, and the balance control depends on visual compensation. The range of LOS reduces, means a higher risk of falling.

Estud. Interdiscip. Psicol ; 12(3): 91-118, set-dez.2021.
Article in Portuguese | LILACS | ID: biblio-1359085


Este artigo discorre sobre adolescentes que foram alfabetizados em prazos bastante curtos, quando internados para cumprimento de medida socioeducativa, após terem fracassado recorrentemente no curso regular de escolarização. A investigação buscou compreender os sentidos do êxito tardio em ambiente de privação de liberdade. Participaram do estudo 15 adolescentes de quatro unidades da Fundação CASA, que não possuíam competência de leitura e escrita quando de sua internação. Para tanto, os adolescentes foram entrevistados; alguns produziram desenhos, que foram examinados. O trabalho amparou-se na psicanálise, centralmente em Donald W. Winnicott. Conclui-se que há necessidade de o ambiente educativo se apresentar como espaço continente para as dificuldades e para processos identificatórios, podendo apresentar-se como um "alojamento" em que o "paradoxo limite e espaço" e as ressignificações ganham o sentido de amparo psíquico que, dentre outras coisas, interfere na aprendizagem e pode ou não chegar a ser curativo (Au).

This article discusses adolescents who were taught to read and write within a very short time when interned in compliance with a socio-educational measure, after recurrent failures on regular school courses. The investigation seeks to understand the meanings of late success in an environment of freedom deprivation. 15 adolescents from four Fundação Casa units participated, who were unable to read and write on their internment. To this end, the adolescents were interviewed and some produced drawings, which were examined. The work was supported by psychoanalysis, especially Donald W. Winnicott. It was concluded that there is a need for the educational environment to present itself as a containing space for difficulties and for identificatory processes, able to show itself as "lodging" where the "limit and space paradox" and resignifications gain the meaning of psychic support which, among other things, affects learning and may or may not be ultimately curative (AU).

Este artículo discurre sobre los adolescentes que han sido alfabetizados en plazos bastante cortos cuando fueron internados para el cumplimiento de una medida socioeducativa, después de que hubiesen fracasado recurrentemente en el recorrido normal de la escolarización. La investigación trató de comprender los sentidos del éxito tardío en un entorno de privación de la libertad. Participaron del estudio quince adolescentes de cuatro unidades de la Fundação CASA ("Fundación CASA"), los cuales no poseían competencia de lectura y escritura cuando fueron internados. Para ello, se entrevistaron a los adolescentes; algunos produjeron dibujos, los cuales fueron examinados. El trabajo se amparó en el psicoanálisis, sobre todo en Donald W. Winnicott. Se concluyó que hay la necesidad de que el entorno educativo se presente como un espacio continente para las dificultades y para los procesos identificatorios, apareciendo como un "alojamiento" en que la "paradoja límite y espacio" y las resignificaciones ganan el sentido de auxilio psíquico. Eso, entre otras cosas, interfiere en el aprendizaje y puede o no llegar a ser curativo (AU).

Humans , Psychoanalysis , Sheltering , Freedom , Learning , Antisocial Personality Disorder , Psychology, Educational , Environment
Rev. bras. psicanál ; 55(2): 61-72, abr.-jun. 2021. ilus
Article in Portuguese | LILACS-Express | LILACS, INDEXPSI | ID: biblio-1288979


O artigo apresenta a captura no circuito da dor como um modelo para a escuta e o manejo de situações clínicas em que o enquadre analítico esbarra na tendência imperiosa à redução de tensão própria da fuga da dor, num esforço de inativar o traumático. A busca de fundamentos metapsicológicos resgata o conceito de dor e de masoquismo erógeno primário, a fim de interrogar as condições analíticas para favorecer uma mínima ligação capaz de propiciar a suportabilidade da inevitável tensão da existência psíquica.

The article presents the capture in the pain circuit as a model for listening and handling clinical situations in which the analytical setting comes up against the imperative tendency to reduce tension inherent in the escape of pain, in an effort to inactivate the traumatic one. The search for metapsychological foundations rescues the concept of pain and primary erogenous masochism, to interrogate the analytical conditions to favor a minimal connection capable of supporting the inevitable tension of the psychic existence.

El artículo presenta la captura en el circuito del dolor como modelo metasicológico de escucha y manejo de situaciones clínicas en las que el marco analítico choca con la tendencia imperativa para reducir la tensión inherente al escape del dolor, en un esfuerzo por inactivar lo traumático. La búsqueda de fundamentos metasicológicos rescata el concepto de dolor y masoquismo erógeno primario, para cuestionar las condiciones analíticas y así favorecer una relación mínima capaz de favorecer la soportabilidad de la inevitable tensión de la existencia psíquica.

L'article présente la capture dans le circuit de la douleur en tant qu'un modèle d'écoute et de gestion de situations cliniques dans lesquelles le cadre analytique se heurte à la tendance impérative à réduire la tension propre à la fuite de la douleur, dans un effort pour inactiver le traumatisant. La recherche de fondements de métapsychologie récupère le concept de douleur et de masochisme érogène primaire, afin d'interroger les conditions analytiques de manière à favoriser une liaison minimale susceptible de favoriser la capacité de supporter l'inévitable tension de l'existence psychique.

China Pharmacy ; (12): 2377-2382, 2021.
Article in Chinese | WPRIM | ID: wpr-886920


OBJECTIVE:To investigate the contents of 5 kinds of heavy metal as copper (Cu),arsenic(As),cadmium (Cd),mercury(Hg)and lead (Pb)in Yougui pills ,and to evaluate its safety risk. METHODS :Using yttrium (89Y),indium (115In)and bismuth (209bi)as internal standard ,the contents of each element were determined by ICP-MS. ICP-MS condition included that atomization gas flow rate was 0.95 L/min,auxiliary gas flow rate was 1.2 L/min,plasma gas (argon)flow rate was 18 L/min,pump speed was 30 r/min. RF power of inductively coupled plasma was 1 200 W,the voltage in simulation stage was 1 750 V,the voltage in pulse stage was 1 300 V,the voltage of deflection device was -12 V,and the detector was in analog and pulse dual-mode. The determination methods of various elements were investigated ,and 45 batches of marketed Yougui pills were determined. Hazard index (HI)was used to analyze the non-carcinogenic risk of each element and calculate the maximum residual limit(MRL)of each element. RESULTS :The linear range of Cu ,As,Cd,Hg and Pb ranged from 10-200,1-50,0.4-30,0.2-6 and 2-100 μg/L(all r>0.999 0),respectively. The limits of quantitation were 0.67,0.23,0.20,0.07,0.27 μg/L. The limits of detection were 0.20,0.07,0.06,0.02,0.08 μg/L. RSDs of precision,stability and reproducibility tests were all lower than 3.5% (n=6 or n=5). Average recoveries were 92.96%-100.89%(RSD=2.23%-3.62%,n=3). Average contents of Cu ,As,Cd,Hg and Pb in 45 batches of Yougui pills were 2.72,0.28,0.07,0.05,0.62 mg/kg,and superimposed HI of each element was less than 1. The contents of 5 kinds of heavy metals in Yougui pills were lower than the proposed MRL (MRL of Cu ,As,Cd,Hg and Pb were 20,2,1,0.2,5 mg/kg or 111.11,4.44,2.22,1.48,8.89 mg/kg respectively ). CONCLUSIONS :Established method can be used for the determination of content of 5 kinds of heavy metal in Yougui pills ;the heavy metal pollution rate of marketed Yougui pills is low and the safety risk is small.

Article in Chinese | WPRIM | ID: wpr-912084


Objective:To establish and evaluate a rapid nucleic acid detection method for SARS-CoV-2 based on COYOTE ? Flash20 real-time fluorescent quantitative PCR instrument. Methods:A rapid reaction system was constructed by using specific primer and probe sets targeting ORF1ab and N gene of SARS-CoV-2, and the sensitivity and specificity of the system were verified. At the same time, 108 clinical samples of COVID-19 were used to evaluate the application of this method.Results:The detection method did not require nucleic acid extraction, and the manual operation time was only one minute. After the sample was sent to the system, the test could be completed in 30 minutes. The detection limit of this method was 4×10 2 copies/ml. It had no cross-reactivity with other human coronaviruses (including HCoV-229E, HCoV-NL63, HCoV-OC43, HCoV-HKU1, SARS-CoV and MERS-CoV) and other respiratory viruses. The evaluation of clinical sample application showed that the total coincidence rate with the conventional RT-qPCR which required nucleic acid extraction was 98.15%. Conclusions:Through the application evaluation of the rapid fluorescent quantitative PCR method of SARS-CoV-2, it was found that the method was simple, fast, specific and sensitive, and it was suitable for real-time and rapid detection needs in varieties of situations.

Chinese Journal of Geriatrics ; (12): 1323-1327, 2021.
Article in Chinese | WPRIM | ID: wpr-911011


The main objectives of antihypertensive therapy for elderly patients with hypertension are to reduce the disability rate and mortality caused by hypertension and to improve the life expectancy of elderly patients.It is of great clinical significance to establish the target value and lower target value of antihypertensive treatment for elderly patients with hypertension, but there is still no consensus on the definition of the target value and the lower value.In this article, the literature about the target value and lower target value of antihypertensive therapy for elderly patients with hypertension is reviewed.

Article in Chinese | WPRIM | ID: wpr-910474


Objective:Based on the AAPM-TG218 report, the dose verification of intensity-modulated radiotherapy (IMRT) plans were classified to understand the current status, establish the process and determine the limits of dose verification in our hospital.Methods:Different combinations of tumor locations, accelerators, treatment planning systems and verification devices in our hospital were verified and compared to determine the tolerance limits and action limits of each combination. The measurement requirement was adopted according to the AAPM-TG218 report, and 80 cases were selected for each measurement. The measurement procedures were implemented based upon the AAPM-TG218 report and clinical experience of our hospital.Results:The clinical action limits of IMRT plans in our hospital could meet the recommended range of the AAPM-TG218 report, and the tolerance limits were slightly lower than the AAPM-TG218 report′s recommendation (93.94% for 3%/2 mm). The measurement of verification devices was related to the sensitivity. The tolerance limits measured by EPID were higher than ArcCHECK, especially when the dose/distance requirements were more stringent (94.12% and 92.03% for 3%/2 mm, P=0.074; 86.82% and 74.61% for 2%/2 mm, P=0.017). Conclusion:Through the AAPM-TG218 report, the work flow of IMRT dose verification and the limit range are established in our hospital, providing guidance for subsequent clinical dosimetric measurement.

China Occupational Medicine ; (6): 33-38, 2021.
Article in Chinese | WPRIM | ID: wpr-881966


OBJECTIVE: To establish the occupational exposure limit for trimethyltin chloride(TMT) in workplace air. METHODS:According to the GBZ/T 210.1-2008 Guide for Establishing Occupational Health Standards--Part 1: Occupational Exposure Limits for Airborne Chemicals in the Workplace, the relevant literatures on toxicology, population epidemiology and foreign occupational exposure limit of TMT were collected and analyzed. A total of 276 workers with TMT occupational exposure were selected as the exposure group and 25 workers without TMT occupational exposure were selected as the control group.Worksite survey of occupational health and occupational medical examination were carried out. Combined with the literature data, the occupational exposure limit of TMT in the workplace air was calculated by using the 90% medical reference level(internal exposure limit) of the urine TMT level of workers who exposed to TMT without moderate hypokalemia. RESULTS: The time-weighted average of TMT in the workplace air is 0.100 mg/m~3 and the short-term exposure limit is 0.200 mg/m~3 in the United States based on total organic tin. The highest concentration of TMT in the workplace air in Germany is 0.005 mg/m~3. The literature data analysis results showed that the incubation period of TMT poisoning is mostly 3-6 days, and the main symptoms of TMT poisoning are hypokalemia in the early stage, followed by neuropsychiatric symptoms such as headache, memory loss and aggressive behavior. The median(M) and the 0-100 th percentile(P_0-P_(100)) of exposure to TMT were 8.35(< 0.20-91.40) μg/m~3 in the exposure group. The individual TMT exposure level of workers in different positions from high to low were crushing, granulation, withdrawal and assembly positions. The M(P_0-P_(100)) of urinary TMT level in the exposure group was 16.94(<0.50-591.14) μg/L. There was a positive correlation between the individual TMT exposure level and urine TMT level in the exposure group(Spearman correlation coefficient=0.62, P<0.01). The detection rate of hypokalemia in the exposure group was higher than that in the control group(26.1% vs 4.0%, P < 0.05). However, there was no significant difference in the detection rate of moderate hypokalemia between the two groups(3.3% vs 0.0%, P>0.05). The 90% medical reference value of urine TMT was 89.90 μg/L in workers exposed to TMT without moderate hypokalemia. CONCLUSION: In order to prevent acute hypokalemia damage caused by TMT, we recommended that the occupational exposure limit of TMT in the workplace air should be set at 0.025 mg/m~3 in China, and this limit should be the maximum allowable concentration.

Article in English | LILACS, BBO | ID: biblio-1280608


ABSTRACT OBJECTIVE To estimate the maximum theoretical daily intake of pesticides potentially consumed, chronically, by the Brazilian population. METHOD By using data from the food consumption section of the 2008-2009 Household Budget Survey to characterize the population diet, a database was built to group the foods based on the NOVA classification. Considering the maximum residue limit values of each pesticide authorized in the country until 2016, the limits of all consumed foods were added and multiplied by the amount consumed, resulting in the maximum theoretical intake index, which was compared with the acceptable daily intake. RESULTS The results show that, of the 283 pesticides considered in the database, 71 (25%) compounds had estimates of zero intake, 144 compounds (50.8%) reached acceptable daily intake values and 68 compounds (24%) showed median intake that exceeded the acceptable daily value. The pesticide intake estimation according to the different regions of the country showed a variation in the amount of compounds that exceeded the acceptable daily intake (48 to 69 substances) due to the different consumption patterns. The categories of products that most exceeded the limits were the insecticides, herbicides and fungicides. CONCLUSION The application of this methodology is valid for the first step in risk assessment, but the resulting values may be different from the actual exposure since they do not include other factors, such as the combined use of pesticides or unauthorized products. The importance of developing research on specific national food consumption data in a systematic way is emphasized, which generates data and analyses that allow a detailed risk assessment.

RESUMO OBJETIVO Estimar a ingestão diária máxima teórica dos agrotóxicos potencialmente consumidos, de forma crônica, pela população brasileira. MÉTODO Utilizando os dados do bloco de consumo alimentar da Pesquisa de Orçamentos Familiares de 2008-2009 para caracterização da dieta da população, foi construído um banco de dados agrupando os alimentos com base na classificação NOVA. Considerando os valores de limite máximo de resíduos de cada agrotóxico autorizado no país até o ano de 2016, foram somados os limites de todos os alimentos consumidos, multiplicados pela quantidade consumida, gerando o índice de ingestão teórica máxima, que foi comparado com a ingestão diária aceitável. RESULTADOS Os resultados mostram que dos 283 agrotóxicos considerados no banco de dados, 71 compostos tiveram estimativas de ingestão zero (25%), 144 compostos (50,8%) atingiram aos valores de ingestão diária aceitável e 68 compostos (24%) apresentaram mediana de ingestão que excedeu o valor diário aceitável. Quando realizada a estimativa de ingestão de agrotóxicos discriminando as distintas regiões do país, houve variação (entre 48 e 69 substâncias) na quantidade de compostos que excederam a ingestão diária aceitável devido aos diferentes padrões de consumo da população. As categorias dos produtos que mais excederam as estimativas são inseticidas, herbicidas e fungicidas. CONCLUSÃO A aplicação dessa metodologia é válida para o primeiro passo na avaliação de risco, porém os valores resultantes podem ser diferentes da exposição real por não englobar outros fatores, como o uso combinado de agrotóxicos ou de produtos de uso não autorizado. É ressaltada a importância do desenvolvimento de pesquisas de dados específicos de consumo de alimentos nacionais de forma sistemática, gerando dados e análises que viabilizem uma avaliação pormenorizada sobre riscos.

Humans , Pesticides , Pesticide Residues/analysis , Brazil , Food Contamination/analysis , Risk Assessment , Eating
Chinese Critical Care Medicine ; (12): 1511-1513, 2021.
Article in Chinese | WPRIM | ID: wpr-931808


Thoracentesis is common in daily medical practice. During the operation, it is easy to cause complications such as re-expansion pulmonary edema, pulmonary hypotension, liver and spleen injury, pleural reaction, intercostal artery injury, pneumothorax, and so on. If the operator does not master procedures properly, it is easy to damage the thoracic organs. Therefore, the department of the general practice of the First Hospital of Jiaxing improved the puncture needle device based on thoracic puncture cannula, developed a new type of disposable thoracic puncture cannula, and obtained the National Utility Model Patent of China (patent number: ZL 2019 2 2112955.7). New type of disposable thoracic puncture cannula comprises a flexible puncture cannula, a steel needle, a limit structure, and a second bolt. In the process of puncture, the length of the puncture is limited by the limit structure. If the puncture force is too strong, the limit structure will prevent further penetration of the needle. The device is easy to use, flexible to operate, easy to master, and can reduce the risk of thoracentesis, which is worth of clinical promotion.

Article | IMSEAR | ID: sea-215282


Upper Gastro-Intestinal Bleeding (UGIB) is one of the common complaints with which patients present to casualty. It is associated with significant morbidity and mortality. The aetiological spectrum of UGIB is variable in different geographical regions. Our study aimed to analyse the aetiology, endoscopic profile, mortality, Rockall score and predictors of mortality in patients with UGIB, in North East India. METHODSThis cross-sectional study was conducted at Assam Medical College and Hospital in North East India. We enrolled patients with age 12 years and above, who were admitted between July 2019 and January 2020 with a history suggestive of UGIB. Demographic data of the patients was collected, after which they underwent clinical examination, and upper GI endoscopy. Mean ± standard deviation was used to express continuous variables. Frequency and percentage were used to express categorical variables. Test of significance for qualitative data was assessed by Chi-square test (for 2 x 2 tables). P value less than 0.05 was taken as statistically significant. RESULTSWe analysed 117 patients diagnosed with UGIB [80.34 % male, 19.60 % female], ratio of male to female of [4.08:1] was seen. The most common symptom was melena 87 patients (74.15 %), endoscopy finding showed that 48.71 % had oesophageal and / or gastric varices, 26.49 % had peptic ulcers, 17.94 % had gastric erosions / duodenal erosions / erosive gastritis, 1.7 % had Mallory-Weiss tear, 1.7 % had gastric malignancy, 1.7 % had GJ stoma bleed, 1.7 % had both oesophageal varices and peptic ulcer disease. Partial gastric outlet obstruction was observed in peptic ulcer disease in 2 patients (6.45 % of total peptic ulcer disease patients). 73.75 % patients had Rockall score < 5 and 26.49 % patients had Rockall score > 6. H. pylori infection (assessed by RUT) was an independent predictor of upper GI bleed in both variceal and non-variceal bleed [p < 0.001]. The mortality in our study was 7.69 %. Predictors of mortality in the study population were, patients with variceal bleed [p = < 0.001], Rockall score > 6 [p = 0.013], and chronic liver disease [p < 0.001]. The average duration of hospital admission of the study population is about 4.6 + / - 0.4 days. CONCLUSIONSThe study reported oesophageal varices was the most common cause of UGIB, followed by peptic ulcer in North East India. H. pylori was an independent predictor of both variceal and non-variceal bleed. Partial gastric outlet obstruction (GOO) was one of the common benign complication of peptic ulcer disease. Variceal bleed, Rockall score > 6, chronic liver disease were predictors of mortality.

Article in Chinese | WPRIM | ID: wpr-843209


Objective : To establish a practical data-driven method that helps predict the evolutionary trend of the coronavirus disease 2019 (COVID-19) epidemic, track and prejudge the current risk classification of the epidemic area, and provide a quantitative evidence for precision prevention and control strategies. Methods ¡¤ A moving average prediction limit (MAPL) method was established based on the moving average method. The previous severe acute respiratory syndrome (SARS) epidemic data was used to verify the practicability of the MAPL method for predicting epidemic trends and quantitative risk. By tracking the COVID-19 outbreak epidemic data publicly reported since January 16, 2020, the MAPL method was used for timely epidemic trend prediction and the risk classification. Results ¡¤ According to the MAPL analysis, the na-tional epidemic of COVID-19 peaked in early February 2020. After active prevention and control in early stages, the overall epidemic situation in the country showed a downward trend from mid-February to mid-March. Compared with Hubei Province, the number of new cases in non-Hubei region declined rapidly in mid-February, but then increased slightly. The analysis of imported cases since March showed that there was a medium to high level of epidemic import risk in the near future. It is recommended to take corresponding prevention and control measures to prevent the epidemic from spreading again. Conclusion ¡¤ The MAPL method can assist in judging the epidemic trend of emerging infectious diseases and predicting the risk levels in a timely manner. Each epidemic district may implement a differentiated precision prevention and control strategies according to the local classification of epidemic risk. Since March, attention should be paid to the prevention and control of imported risks.

Acta Pharmaceutica Sinica ; (12): 2695-2701, 2020.
Article in Chinese | WPRIM | ID: wpr-837522


Heavy metals and other harmful elements in traditional Chinese medicines inflict serious damage on public health. Therefore, risk assessment of Chinese raw materials has gained increasing attention. To date, few reports have been published on the health risk assessment of heavy metals and harmful elements in Chinese patent medicines. To gain a comprehensive understanding of heavy metals and other harmful elements in Chinese patent medicines and to establish proper limits, residual Pb, Cd, As, Hg, Cu and Cr in 15 054 samples of 295 drugs was analyzed with regard to distribution and variation between elements and dosage forms. In addition, in accord with procedures including hazard identification, hazard characterization, exposure assessment and risk characterization, basic procedures and specific parameters for risk assessment of heavy metals and harmful elements in Chinese patent medicines were clarified based on the health risk assessment of 14 787 samples and 276 drugs. A method and equation for establishing residual limits is proposed. The results show that content and target hazard quotients (THQs) of the investigated elements in all samples showed a skewed distribution approaching 0. Content of Pb, As, Cu, Hg, Cd or Cr in the samples exceeded 100 mg·kg-1 and the content of Pb, As, or Cu in individual samples exceeded 1 000 mg·kg-1. THQs of 586 samples and four drugs were above 1. We believe that the health risk of Hg, Pb and As in Chinese patent medicines with dosage forms of pill, capsule, tablet and powder, especially those in raw powder preparations, warrant concern.

Chinese Pharmaceutical Journal ; (24): 228-232, 2020.
Article in Chinese | WPRIM | ID: wpr-857789


OBJECTIVE: To establish a method to determine the genotoxic impurity, N-nitroso-N-methyl-4-aminobytyric acid, in losartan potassium using high performance liquid chromatography triple quadrupole mass spectrometry (HPLC-MS/MS). METHODS: The method was developed by using Shimadzu Shim-pack XR-ODS II column (2.0 mm×150 mm, 2.2 μm). Time program was conducted with mobile phase consisting of water (0.1% formic acid, A) and methanol (B). The flow rate was 0.3 mL•min-1, and the column oven temperature was maintained at 40 ℃. The samples were ionized by electrospray ionization (ESI) with multi reaction monitoring (MRM) data acquisition mode. The collision energies were -11, -13, and -13 V, CID gas was argon with pressure of 270 kPa.3 pairs of precursor, and product ions (m/z) of NMBA were 147.15→117.10, 147.15→87.10, and 147.15→44.10, respectively. RESULTS: The genotoxic impurity NMBA showed linearity between 1 and 100 ng•mL-1 with correlation coefficient of 0.999 9. The intra-day and inter-day repeatability was examined by relative standard deviations (RSDs) of retention time and peak area (RSD<1.10%, n=6 for intra-day repeatability and n=18 for inter-day repeatability). The accuracy was examined by percent recovery at three concentration levels, and the average percent recovery was between 94.40% and 98.04%. CONCLUSION: The established LC-MS/MS method is efficient for limit test and quantitation of NMBA in losartan potassium bulk drug.

Chinese Pharmacological Bulletin ; (12): 727-731, 2020.
Article in Chinese | WPRIM | ID: wpr-856981


Aim To establish a method for determining the antithrombotic biological activity of Honghua injection, which can be used to evaluate and control its quality. Methods Collagen-adrenalin was used to induce mouse acute cerebral thrombosis model and hemiplegic protection rate of Honghua injection in mice as an index to investigate the antithrombotic activity of Honghua injection. The experimental conditions of the administration dosage, inducer dosage, and different strains of mice were investigated, and the experimental conditions were optimized by orthogonal design. Results Honghua injection which was made by 5. 0 g crude drug · kg-1and continuously ip for 3 d, had obvious protective effect on collagen-adrenalin-induced acute cerebral thrombosis in mice. The established biological activity limit method showed a good repeatability, intermediate precision, and reproducibility. Each sample showed different degrees of differences in biological activity. Conclusions The thrombus test in mice can be used as a method for measuring the biological activity of Honghua injection. It is recommended to use 5. 0 g crude drug · kg-1dose as the limit for bioactive process optimization and product quality controlment of Honghua injection.

Braz. arch. biol. technol ; 63(spe): e20190536, 2020. tab, graf
Article in English | LILACS | ID: biblio-1142500


Abstract Swine manure is applied in agricultural fields as a source of nutrients for plant growth, however, excessive application over the years can promote soil phosphorus (P) accumulation. The objective of this study was to establish the environmental soil P threshold based on the degree of P saturation (DPS), as well, to evaluate the soil P storage capacity. The experiment was carried out in an Oxisol (sandy clay loam texture), under no-tillage and crop rotation. Treatments consisted of four annual doses of liquid swine manure (0, 100, 200, and 300 m3 ha-1 year-1), and three doses of mineral fertilizer (0, 50, and 100% of the crop nutrients requirement), in a randomized block with split-plot design (four replications). Soil P content was analyzed by PMehlich-1, PCaCl2, water-soluble P (WSP) and total P. The application of swine manure and mineral fertilizer increased soil P contents mainly at 0-10 cm depth. The DPS corresponding to the change point was 14.9% at depth 0-10 and 8.6% at depth 0-20 cm with WSP and 18.7% at 0-10 cm and 8.9% at 0-20 cm depth with PCaCl2. The lowest change point value was DPS 8.6% which corresponds to 43 mg kg-1 of PMehlich-1, so, in practical terms, we suggest this value as the environmental soil P threshold. The soil P storage capacity indicated negative values with the higher doses of swine manure and mineral fertilizer which increases the vulnerability of P loss by surface and subsurface hydrological transfer pathway.

Animals , Phosphorus/analysis , Soil/chemistry , Fertilizers/analysis , Manure/analysis , Potassium/analysis , Swine , Sustainable Agriculture , Models, Theoretical , Nitrogen/analysis