Study on Analytical Method of Leachable Substances of Allogeneic Products / 中国医疗器械杂志

Products made from allogeneic tissue are largely used in clinical treatment due to its wide source compared with autologous tissue, causing less secondary trauma of patients and the good biocompatibility. Various organic solvents and other substances introduced in the production process of allogeneic products will leach down into the human through clinical treatment, thus bringing varying degrees of harm to patients. Therefore, it is very necessary to detect and control the leachables in such products. Based on the classification and summary of leachable substances existing in the allogeneic products, the preparation of extract and the establishment of the detection techniques for known and unknown leachable are briefly introduced in this study, in order to provide research method for the study of leachable substances of allogeneic products.

Neurotoxicidad en trabajadores petroquímicos con bajos índices de exposición a disolventes orgánicos / Neurotoxicity among petrochemical workers with low exposure indexes to organic solvents

Resumen: Objetivo: Estimar el desempeño neuropsicológico y su asociación con la exposición a disolventes orgánicos (DO) en trabajadores petroquímicos en México. Material y métodos: Estudio transversal en 203 trabajadores: 102 expuestos a DO y 101 no expuestos. Se evaluó el desempeño neuropsicológico con Neurobehavioral Core Test Battery y la exposición a DO con la medición de metabolitos de exposición para tolueno, xilenos y benceno. Resultados: Los trabajadores expuestos presentaron un peor desempeño en todas las pruebas (p<0.05), excepto en la prueba de Santa Ana. Esto se corroboró con modelos de regresión; los trabajadores expuestos a DO tuvieron un mayor número de errores y realizaron las pruebas en mayor tiempo (p<0.05), además de presentar mayores probabilidades de padecer síntomas de neurotoxicidad (OR: 2.93; IC95%: 0.96, 8.96). Conclusiones: La exposición ocupacional a disolventes orgánicos, aun a niveles permitidos por la normatividad mexicana vigente, se relacionó con un menor desempeño neuropsicológico.

Abstract: Objective: To estimate the neuropsychological performance and its association with exposure to organic solvents (OS) among petrochemical workers in Mexico. Materials and methods: Cross-sectional study including 203 workers: 102 exposed to OS and 101 non-exposed. Neuropsychological performance was evaluated with Neurobehavioral Core Test Battery. Exposure to OS was evaluated with the metabolites from exposure to toluene, xylenes and benzene. Results: Exposed workers presented with a worse performance in all tests (p<0.05), except for Santa Ana test. This was corroborated with regression models; workers exposed to OS had a higher number of mistakes and performed the tests in longer time (p<0.05), together with having greater odds of neurotoxicity symptoms (OR: 2.93; 95%CI: 0.96, 8.96). Conclusions: Occupational exposure to organic solvents, even at levels allowed by current Mexican standards, was related to an impaired neuropsychological performance.

Intoxicación por tolueno / Toluene poisoning

Resumen El ser humano está inmerso en un entorno donde inhala, ingiere o absorbe muchas sustancias químicas, de las cuales toman relevancia las exposiciones en los lugares de trabajo y las que causan la muerte en la práctica médico forense. El tolueno es un inhibidor neuronal asociado con daño progresivo del sistema nervioso central y periférico, su toxicidad puede ocurrir por inhalación involuntaria o deliberada y puede llevar incluso a la muerte. Se realizó una revisión bibliográfica en diferentes bases de datos, de los artículos publicados referentes al tema de los últimos ocho años, con el objetivo de revisar las características del químico, el metabolismo, las intoxicaciones agudas y las crónicas, así como sus implicaciones letales. Se concluye que para mejorar la pericia médico legal, al valorar casos de intoxicacion por tolueno se deben de contemplar los criterios de causalidad en los casos de enfermedad laboral y en sospecha de causa de muerte es fundamentantal el resultado toxicológico ante la ausencia de hallazgos específicos en la autopsia.

Abstract The human being is immersed in an environment where he inhales, ingests or absorbs many chemical substances, in forensic medical practice the exposures in the workplace and those that cause death take on relevance. Toluene is a neuronal inhibitor associated with progressive damage of the central and peripheral nervous system, its toxicity can occur by involuntary or deliberate inhalation and can even lead to death. A bibliographic review was carried out in different databases, of the published articles referring to the subject of the last eight years, with the objective of reviewing the characteristics of the chemical, the metabolism, both acute and chronic poisoning and its lethal implications. It is concluded that to improve the legal medical expertise when assessing cases of toluene poisoning, causality criteria must be considered in cases of occupational disease and in suspected cases of death the toxicology result is fundamental in the absence of specific findings in the autopsy.

Systematic Review on Sanitary Pads and Female Health / 이화의대지

The majority of South Korean females use sanitary pads, which contain various organic solvents which could be excreted before and during their menstruation. However, they are not provided with findings from studies about the health effects of sanitary pads. Therefore, this study aims to establish a list of potential health hazards of sanitary pads and address the need for further extensive research by pointing out the limitations of the previous literature. A systematic review was adopted to conduct quantitative and qualitative reviews based on the PRISMA (preferred reporting items for systematic reviews and meta-analyses). Studies from electronic databases such as PubMed, RISS, and Google Scholar were retrieved for the final analyses. In accordance with our findings, we proposed a set of limitations of the previous studies. A systematic review revealed that there were effects of sanitary pads on vaginal or vulvar skin, endometriosis, and vaginal microflora. The review also revealed that organic solvents, which sanitary pads are composed of, bring potential harmful effects on pregnancy, autoimmune disease, cardiovascular disease, and neurological development. Social environments such as hygiene use or puberty education also turned out to affect female health. It was inferred that a lack of non-occupational and domestic studies reflecting the distinguishing features of sanitary pads with a reliable sample size remains as an important limitation. This study suggests that organic solvents in sanitary pads may increase some health risks bringing reproductive, autoimmune, cardiovascular, and neurological effects. Due to a lack of studies, a more extensive study can contribute to the public health of South Korean females.

Controlling Painters' Exposure to Volatile Organic Solvents in the Automotive Sector of Southern Colombia

BACKGROUND: Painters in the automotive sector are routinely exposed to volatile organic solvents, and the levels vary depending on the occupational health and safety controls enforced at the companies. This study investigates the levels of exposure to organic vapors and the existence of controls in the formal economy sector in southern Colombia. METHODS: This is an exploratory study of an observational and descriptive character. An analysis of solvents is conducted via the personal sampling of painters and the analysis of samples using the National Institute for Occupational Safety and Health 1501 method. The amount of solvents analyzed varied according to the budget allocated by the companies. The person in charge of the occupational safety and health management system was interviewed to learn about the exposure controls implemented at the companies. RESULTS: A medium exposure risk for toluene was found in one company. Another presented medium risk for carbon tetrachloride, xylene, ethylbenzene, and n-butanol. The others showed low risk of exposure and that the controls implemented were not sufficient or efficient. CONCLUSION: These results shed light on the working conditions of these tradespeople. The permissible limits established by Colombian regulations for the evaluated chemical contaminants were not exceeded. However, there were contaminants that exceeded the limits of action. The analysis of findings made it possible to propose improvements in occupational safety and health management systems to allow the optimization of working conditions for painters, prevent the occurrence of occupational diseases, and reduce costs to the country's health system.

Relação entre desempenho neurocognitivo e composição corporal de homens e mulheres expostos a solventes orgânicos / Relación entre desempeño neurocognitivo y composición corporal de hombres y mujeres expuestos a solventes orgánicos / Relationship between neurocognitive performance and body composition of men and women exposed to organic solvents

Resumo Investigou-se o efeito dos solventes orgânicos sobre o desempenho neurocognitivo de homens e mulheres com e sem exposição crônica a solventes orgânicos, e verificou correlações entre o desempenho neurocognitivo e índices de composição corporal. Participaram 14 homens e 14 mulheres expostos e 14 homens e 14 mulheres não expostos. Utilizou-se o Trail Making Test (TMT) A e B, Figura Complexa de Rey (FCR), Cópia e Memória, questionário sociodemográfico e avaliação de bioimpedância. A comparação entre mulheres expostas e não expostas mostrou diferença significativa em todos os testes. A comparação entre os homens expostos e não expostos mostrou diferença significativa no TMT-A, FCR-Cópia, FCR-Memória. Contudo, na comparação entre homens e mulheres expostos os resultados não mostraram diferenças significantes. Já na correlação entre o desempenho neurocognitivo com índices de composição corpórea, as mulheres expostas apresentaram correlação significante entre FCR-Cópia com água corporal, peso, massa gorda, massa magra corporal. Os homens expostos apresentaram correlação significante entre o TMT-B com a Relação Cintura-Quadril e gordura visceral. No geral, os solventes orgânicos podem afetar o desempenho neurocognitivo e os efeitos da exposição crônica dependem da precisão do teste neurocognitivo e do índice de composição corpórea.

Resumen Se investigo el efecto de solventes orgánicos sobre el rendimiento neurocognitivo de hombres y mujeres con y sin exposición crónica a solventes orgánicos, además de verificar la correlación entre el rendimiento neurocognitivo y los índices de composición corporal. Participaron 14 hombres y 14 mujeres expuestas y 14 hombres y 14 mujeres no expuestas. Se utilizaron los siguientes tests: Trail Making Test (TMT) A y B, el test Figura Compleja de Rey (FCR; Copia y Memoria), cuestionario sociodemográfico y la evaluación de bioimpedancia. Hubo diferencia significativa entre las mujeres expuestas y las no expuestas, en todos los tests. La comparación de los hombres expuestos con los que no fueron expuestos mostró diferencia significativa en el TMT-A, FCR-Copia y FCR-Memoria. Sin embargo, no hubo diferencias significativas entre los sexos. Con relación a la comparación del rendimiento neurocognitivo con los índices de composición corporal, para las mujeres expuestas hubo correlación significativa entre la FCR-Copia y el agua, peso, masa corporal grasa y masa corporal magra. Para los hombres expuestos hubo correlación significativa entre la TMT-B y la relación cintura/cadera (RCC) y grasa visceral. En general, los solventes orgánicos pueden afectar el desempeño neurocognitivo y los efectos de la exposición crónica dependen de la precisión del test neurocognitivo y del índice de composición corporal.

Abstract It was investigate the effect of organic solvents on the neurocognitive performance of men and women with and without chronic exposure to organic solvents and verify correlations between neurocognitive performance and body composition indices. Participants included 14 men and 14 exposed women and 14 men and 14 unexposed women. The Trail Making Test (TMT) A and B, the Rey Complex Figure (RCF; Copy and Memory), sociodemographic questionnaire, and bioimpedance evaluation were used. There was a significant difference between exposed and non-exposed women in all tests. Comparison between exposed and non-exposed men showed a significant difference in TMT-A, RCF-Copy, and RCF-Memory. However, there was no significant difference between sexes. Regarding the comparison between neurocognitive performance and body composition indices, for exposed women, there was a significant correlation between RCF- Copy and water, body weight, fat mass, and lean mass. Regarding the exposed men, there was a significant correlation between TMT-B and WHR (waist-hip ratio) and visceral fat. In general, organic solvents can affect neurocognitive performance and the effects of chronic exposure depend on the accuracy of the neurocognitive test and the body composition index.

Fenómeno de Raynaud asociado a ácido nítrico: reporte de un caso / Raynaud's phenomenon associated with nitric acid: Case report

RESUMEN El fenómeno de Raynaud es un trastorno clínico, caracterizado por ataques episódicos de vasoespasmo de arterias y arteriolas periféricas, causando así isquemia tisular de porciones distales del cuerpo, como manos y pies, produciendo cambios en la coloración de la piel como: palidez, cianosis e hiperemia. Se ha asociado la aparición del fenómeno de Raynaud en personas que manipulan solventes orgánicos o herramientas vibratorias por un largo período, incluso se ha descrito que los solventes pueden ser gatilladores de algunas enfermedades inmunológicas como la esclerodermia, sin embargo, hasta donde conocemos no existen reportes de la exposición de compuestos químicos utilizados en la metalurgia, como el ácido nítrico y el desarrollo de enfermedades de espectro esclerodérmico. En el presente artículo se presenta un caso clínico relacionado con la aparición de fenómeno de Raynaud frente a la exposición a compuestos químicos utilizados en la metalurgia, en especial al ácido nítrico.

ABSTRACT The Raynaud phenomenon is a clinical disorder, characterized by episodic attacks of vasospasm of peripheral arteries and arterioles, causing tissue ischemia of distal portions of the body, such as hands and feet, causing changes in skin color such as pallor, cyanosis and hyperemia. The occurrence of the Raynaud phenomenon in people who handle organic sol vents or vibratory tools has been associated for a long time, and it has even been described that the solvents may be triggering some immune diseases such as scleroderma, however, as far as we know there are reports of exposure of chemical compounds used in metallurgy, such as nitric acid and the development of scleroderma-spectrum diseases. This article presents a clinical case related to the appearance of Raynaud s phenomenon against exposure to chemical compounds used in metallurgy, especially nitric acid.

Determination of Four Kinds of Organic Residual Solvents in Imatinib Mesylate by Capillary Gas Chromatography / 医药导报

Objective To establish a method for simultaneous determination of petroleum ether (60-90 ℃),ethyl acetate,ethanol and pyridineas residual organic solvents in imatinib mesylate API. Methods Capillary gas chromatography was adopted.The determination was performed on DB-WAX capillary column with FID detector.The injector temperature was 180 ℃and the temperature of FID was 200 ℃ by temperature programming with nitrogen serving as carrier gas at a flow rate of 5 mL·min-1.The injection volume was 1 μL.With N,N-dimethylformamide(DMF) serving as solvent,four kinds of organic solvent residues in the samples were calculated by external standard method. Results The four kinds of organic solvent were completely separated under the established chromatographic condition.A good linearity was obtained in the concentration ranges of them (r=0.999 8-0.999 9).The sampling precisions (RSDs) were less than 2.0%(n=5).The average recovery rates of ethyl acetate,ethanol and pyridine were 97%-101%and that of petroleum ether was 88.7%(RSD<2.0%,n=5).The limits of detection for them were 0.58,0.42,0.18 and 0.61 ng respectively(S/N=3:1).The limits of quantification for them were 1.8,2.1,0.5 and 2.5 ng,respectively (S/N=10:1). Conclusion The method is simple,sensitive,accurate and reliable.

Simultaneous Determination of 5 Organic Solvents in Favipiravir by Headspace GC / 中国药房

OBJECTIVE:To establish a method for simultaneous determination of 5 kinds residual ethanol,acetone,ethylacetate,N,N-diisopropylethylamine and toluene in favipiravir.METHODS:Headspace GC was adopted.The determination was performed on DB-624 capillary column,temperature programmed.The inlet temperature was 220 ℃,and detector was flame ionization detector with temperature of 250 ℃.Nitrogen was used as carrier gas at flow rate of 2.0 mL/min,split ratio was 10 ∶ 1,headspace equilibrium temperature was 80 ℃,equilibrium time was 20 min and headspace sample size was 1 mL.RESULTS:The linear range was 10.0-501.4 μg/mL for ethanol(r=0.999 9),10.0-501.4 μg/mL for acetone (r=0.999 9),10.1-502.6 μg/mL for ethylacetate (r=0.999 9),0.2-11.4 μg/mL for N,N-diisopropylethylamine (r=0.999 9)and 1.8-89.4 μg/mL for acetone(r=0.999 7).The limits of quantification were 5.3,3.4,5.2,6.1 and 20.4 μg/mL,and the limits of detection were 1.4,1.1,1.3,1.6,5.9 μg/mL.RSD of precision test was lower than 4.0％,and RSDs of acetone in stability and reproducibility tests were both lower than 4.0％.The recoveries were 96.61％-99.70％ (RSD=1.01％,n=9),95.81％-99.50％ (RSD=1.29％,n=9),96.42％-99.76％ (RSD=1.24％,n=9),96.36％-99.30％ (RSD=1.19％,n=9),97.00％-99.51％ (RSD=0.82％,n=9).CONCLUSIONS:The method is simple,accurate,reproducible and can be used for simultaneous determination of 5 organic solvents in favipiravir.

Determination of residual organic solvents in Apixaban bulks drug by headspace gas chromatography / 药物评价研究

Objective To establish a method for determination of the twelve residual organic solvents,including methanol,ethanol,acetone,isopropanol,tert-Butyl methyl ether,dichloromethane,aceticether,tetrahydrofuran,triethylamine,trimethylorthofor-Mate,morpholine,N,N-Dimethylformamide in Apixaban bulks drug.Methods Gas head-space chromatography was applied to this study.The column was DB-624 silica capillary column (30.0 m × 0.53 mm × 3.00 μm) and the carrier gas was high purity nitrogen;The vial temperature was 100 ℃,and the vial time was 20 min.The Column temperature was kept at 40 ℃ for 6 min,then the temperature was raised to 220 ℃ at the rate of 20 ℃/min and subsequently sustained for 10 min.FID detector temperature and injection temperature were both 250 ℃.The N2 flow rate was 2.8 mL/min.Split ratio was 5∶1.Results Twelve kinds of solvents were completely separated and determined with a good linearity (r =0.9994-0.9999).The RSD values of precision experiments and the average recovery was in line with the requirements.Conclusion Theanalytical method is simple,accurate and sensitive,which could be used for determination of residual organic solvents in Apixaban bulks drug.

Perda auditiva associada à exposição ocupacional a solventes orgânicos: uma revisão sistemática / Hearing loss associated with organic solvent exposure: a systematic review

Resumo Introdução: evidências apontam produtos químicos como agentes potencialmente otoneurotóxicos, todavia, ainda não há consenso quanto às associações entre as características das exposições e a ototoxicidade das diversas substâncias químicas presentes em ambientes laborais. Objetivo: revisar a literatura científica disponível, a fim de identificar estudos que apontem evidências de associação, ou não associação, entre dano auditivo e a exposição a solventes orgânicos. Método: revisão sistemática da literatura a partir da consulta a bases de dados eletrônicas, considerando artigos originais, publicados de janeiro de 1987 a fevereiro de 2013. Resultados: trinta e um estudos foram incluídos na revisão sistemática. Discussão: os estudos confirmaram a exposição a determinados solventes como fator de risco para perda auditiva de origem ocupacional, sobretudo na presença do ruído. Foram utilizados métodos variados de avaliação e classificação do desfecho coclear e/ou central, que contribuíram para a compreensão da extensão da perda auditiva induzida quimicamente, bem como com a identificação dos grupos populacionais susceptíveis. Contudo, dados sobre procedimentos diagnósticos adequados, níveis seguros e efeito dose-resposta da exposição química ainda não foram totalmente elucidados.

Abstract Introduction: evidences indicate chemicals as potentially otoneurotoxic agents; however, there is no consensus as to the associations between exposure characteristics and the ototoxicity of different chemicals present in industrial environments. Objective: to review the available scientific literature in order to identify studies that point to evidence of association, or non-association, between hearing impairment and occupational exposure to organic solvents. Method: systematic review of the literature, through query on electronic databases, considering only original articles, published from January 1987 to February 2013. Results: thirty-one studies were included in the systematic review. Discussion: studies have confirmed exposure to certain solvents as a risk factor for occupational hearing loss, especially in the presence of noise. Various assessment and classification methods were used regarding cochlear and/or central hearing impairment, contributing to the understanding of the extent of chemical-induced hearing loss as well as to the identification of populations at risk. However, data on appropriate diagnostic procedures, safe levels of chemical exposure and dose-response effect have not yet been fully elucidated.

Determination of Residual Organic Solvents in Imported Lidocaine Patches by GC / 中国药师

Objective:To establish a GC method for the determination of residual organic solvents in lidocaine patches. Methods:GC was carried out on a DB-WAX capillary column (30 m × 0. 25 mm, 0. 5 μm). The detector was FID and the carrier gas was He. The initial temperature was 50℃, maintained for 8 min, and then raised to 250℃ with a rate of 50℃ per min. The inlet temperature and the detector temperature were 280℃. The separation was 50 ∶1. Results:The linear range of acetone, ethyl acetate and methanol was 15. 0-600. 0 μg·ml-1. The average recovery was 97. 4% (RSD =3. 2%, n=9), 95. 6% (RSD=1. 9%, n=9) and 112. 0%(RSD =4. 5%, n=9), respectively. Conclusion:The method is simple and accurate,which can be used for the determination of re-sidual organic solvents in lidocaine patches.

Determination of Residual Organic Solvents in Erlotinib Hydrochloride by Headspace Gas Chromatography / 中国药师

Objective:To establish a headspace capillary gas chromatography method for the determination of residual solvents in erlotinib hydrochloride .Methods:A DB-624 capillary column (30 m ×0.53 mm, 3.0 μm) was used and the carrier gas was nitro-gen.The flow rate was 2.0 ml· min-1 and the inlet temperature was 190℃.The FID detector temperature was 230 ℃.The column temperature program was with the initial temperature of 35℃( maitaining 8 min) , risen to 170℃with the rate of 28℃· min-1 ( main-taining 8 min) , and then risen to 200℃with the rate of 32℃· min-1 ( maintaining 7 min) .The headspace vial temperature was 100℃and the time was 30 min.Results:Ethanol, isopropanol, methylene chloride and n-butanol had a good linear relationship within the range of 0.68-409.14 μg· ml-1 (r=0.999 8),0.67-404.88 μg· ml-1 (r=0.999 8),1.71-51.31μg· ml-1 (r=0.999 7) and 0.72-431.12 μg· ml-1(r=0.999 8), respectively.The average recovery was 99.0% (RSD=0.41%, n=9), 100.2%(RSD=0.52%, n=9),97.1%(RSD=1.75%, n =9) and 102.5% (RSD=1.08%, n=9), respectively.Conclusion: The method is simple and accurate , which can be used for the determination of four residual organic solvents in erlotinib hydrochloride .

Residual Determination of 7 Organic Solvents in PicrosideⅡRaw Material by Head-space GC / 中国药房

OBJECTIVE:To establish the method for the residual determination of 7 organic solvents in picrosideⅡraw materi-als. METHODS:Head-space GC was performed on the capillary column of 6% cyanopropyl phenyl-94% dimethyl polysiloxane (DB-624) by temperature programming,the temperature of injector was 200 ℃,temperature of flame ionization detector was 250 ℃,the flow rate of N2 was 35 ml/min,and split ration was 10∶1,headspace sampling was adopted with the volume of 1 ml, the heating temperature of headspace sampling was 85 ℃,heating time was 45 min. RESULTS:The good linear relationship of methanol,ethanol,ethylacetate,methylbenzene,benzene,phenylethylene and divinglbenzene had been obtained(r=0.999 6-0.999 9);RSDs of precision stability test were less than 3%;average recoveries was in the range of 78.0%-104.9%(RSDs were 0.65%-2.47%,n=6)respectively. CONCLUSIONS:The method is specific,rapid,simple and accurate,and can be used for the determination of residual organic solvents in picrosideⅡraw materials.

Determination of Residual Organic Solvents in Flupirtine Maleate by Headspace Gas Chromatography / 中国药师

Objective:To determine the content of methanol, alcohol and isopropanol in flupirtine maleat by headspace gas chro-matography. Methods:The capillary gas chromatography with programming temperature was established with an FID detector and a DB-624(30 m × 0. 53 mm,3. 0 μm) capillary column. The temperature of the injector and the detector was 200℃ and 250℃, respec-tively. The residual organic solvents were determined by an external standard method. Results: Methanol, alcohol and isopropanol showed good linearity within the range of 2. 182~152. 74(r=0. 999 1), 3. 546-248. 22(r=0. 9998)and 4. 082-285. 74 μg·ml-1(r=0. 999 7) with the average recovery of 97. 7%(RSD=1. 5%),99. 0%(RSD=1. 1%)and 98. 8%(RSD=1. 1%)(n=5), respec-tively. Conclusion:The method is simple, sensitive and accurate, and can be used in the residual solvents detection for flupirtine mal-eat.

Determination of Residual Toluene in Diclofenac Sodium Raw Material by GC / 中国药师

Objective:To establish a detection method for residual toluene in diclofenac sodium raw material by GC. Methods:An HP-5 column (0. 53 mm × 30 m, 2. 65 μm) with nitrogen as the carrier gas was employed for the separation. The temperature of the column, injection port and FID detector was set at 50℃, 200℃ and 250℃, respectively. An internal standard method with isooctane as the internal standard was used to assay the residual amount after the sample was dissolved in DMSO. Results:The linear calibration curve was obtained over the range of 9. 27-111. 19μg·ml-1(r=0. 999 4). The mean recovery was 97. 27%(RSD=2. 80%,n=9). The LOD and LOQ was 0. 59μg·ml-1 and 1. 46μg·ml-1 , respectively. The residual contents of toluene in 3 batches of the products all met the relevant regulations. Conclusion:The established method is reliable and accurate, and can be used in the quality control of diclofenac sodium.

Determination of Organic Solvent Residues in Testosterone Cypionate / 医药导报

Objective To establish a headspace GC method for the determination of residual organic solvents in testosterone cypionate. Methods The residual organic solvents were determined by GC with DB-WAX capillary colum(30 m× 0. 32 mm,0. 25 μm)and FID detector at 230℃,using high purity nitrogen as the carrier gas by headspace sampling. The flow rate was 1. 5 mL·min-1 ,the split ratio was 20:1,the temperature of injection port was 220℃,the headspace heating temperature was 70 ℃,and the headspace balance time was 40 mins. The content of residues was calculated by using n-propanol as the internal standard. Results Four residual solvents were completely separated. There were good linearity for m-ethanol,ethanol,benzene and pyridinein in the ranges of 4. 17-2. 50×103 μg·g-1(R=0. 999 9),4. 18-2. 51×103 μg·g-1(r=0. 999 6),0. 84-172 μg·g-1 (r=0. 998 1),and 2. 95-1. 77×103μg·g-1(r=0. 999 9),respectively. The detection limit was 2.08,1. 23,0.28,and 0. 87 μg·g-1,respectively. The average recovery of methanol,ethanol,benzene and pyridinein was 102. 2%(RSD=4. 0%),99. 6%(RSD=1. 9%),112. 6(RSD=5. 6%),and 98. 9%(RSD=1. 6%),respectively. Conclusion This method is reliable,sensitive, accurate and can be used for the determination of residual organic solvents in testosterone cypionate.

Determination of Residual Organic Solvents in Dimemorfan Phosphate by GC / 中国药师

Objective:To determine the content of chloroform, ethyl acetate and DMF in dimemorfan phosphate by gas chromatog-raphy (GC). Methods:The capillary gas chromatography was used with a PEG-20M column, programmed temperature, water as the solvent and FID as the detector. Results:The three organic solvents were separated and showed good linear relationship (r>0. 999 0). The detection limit of chloroform, ethyl acetate and DMF was 0. 63,0. 60 and 8. 92μg·ml-1 , respectively. The residues of the organ-ic solvents in three batches of the samples all met with the requirements of ICH. Conclusion: The method is sensitive, accurate and reliable, and can be used in the quality control of dimemorfan phosphate.

Determination of Residual Organic Solvents in Paclitaxel by Capillary GC / 中国药师

Objective:To establish a capillary GC method for the determination of residual organic solvents in paclitaxel. Meth-ods:The standard solution and test solution was respectively injected into an HP-INNOWAX sillica capillary column by headspace in-jection. The chromatograms were recorded with an FID. The injection port and detector temperature was 250℃ and 300℃, respective-ly, the initial column temperature was kept at 35℃ for 5 min, and then was risen to 260℃ at the rate of 25℃/min. Results:The four residual organic solvents could be separated completely. The resolution and sensitivity were acceptable. Conclusion: The method is proved to be simple, rapid, sensitive and reliable, and can be used in the determination of residual organic solvents in paclitaxel.

Screening of eclipta alba extracts for anticancer activity.

Cancer is the second largest cause of death which killed 7.6 million people worldwide in 2005 (Danaei et al., 2005). The number is believed to become 9 million in 2015 and 11.5 million in 2030 (World Health Organization, 2007). There is an increasing interest to research and develop on new anticancer drugs, from both synthetic and natural sources (Mukherjee et al., 2001). Half of the drugs which have been approved recently are from natural sources. Plants have been extensively used as natural sources to develop anticancer drugs because of their active constituents. Medicinal plants in Asian countries play an important role in cancer treatment and indeed, their chemical constituents and derivatives have been utilized for combating cancers over the last half-century. Presently in the study Eclipta alba ethanolic plant extract has been used for screening the anti-cancer activity in-vitro and the results obtained, gives the evidence that the ethanolic extract inhibit the growth of colon cancer cells at concentrations that showed no apparent toxicity effect against normal cells.