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作 者:韩彬 徐艳梅 周玉岩 李佳蕊 高燕霞 Han Bin;Xu Yan-mei;Zhou Yu-yan;Li Jia-rui;Gao Yan-xia(Hebei Institute for Drag and Medical Device Control,Shijiazhuang 050021)
机构地区:[1]河北省药品医疗器械检验研究院,石家庄050021
出 处:《中国抗生素杂志》2023年第3期333-337,共5页Chinese Journal of Antibiotics
摘 要:目的建立顶空进样-气相色谱法测定盐酸平阳霉素原料及其制剂中有机溶剂残留量,同时对国产样品质量现状进行评价。方法采用气相色谱法,顶空进样;色谱柱为DB-624毛细管柱(60 m×0.53 mm,3.0μm),载气为高纯氮气,程序升温,氢火焰离子化检测器(FID),进样口温度为200℃,检测器温度为230℃,载气流速为5.0 mL/min,分流比为10:1,进样量1 mL。结果盐酸平阳霉素原料中可检出甲醇、丙酮、异丙醇3种溶剂;应用经验证的新方法对征集到的原料进行测定,其中一厂家的3批产品批间差异非常小,提示其生产工艺稳定,另一厂家的产品检出的丙酮含量超出国家限定值范围。注射用盐酸平阳霉素中有机溶剂残留量远低于限度要求。结论该方法操作简单、快速灵敏、结果准确,可通过对盐酸平阳霉素有机溶剂残留量的测定,对药品生产的工艺控制水平进行评估。建议我国药品生产企业在内控标准中增订残留溶剂检查项,并开展周期性地检验,及时发现生产中的质量波动情况;注射用盐酸平阳霉素采用冷冻干燥工艺生产,因而不需控制残留溶剂。Objective To establish a headspace sampling-gas chromatography method for the determination of residual organic solvents in bleomycin A5 hydrochloride,and to evaluate the quality status of domestic raw materials and powder for injections.Methods Gas chromatography and headspace injection were used.The chromatographic column was a DB-624 capillary column(60 m×0.53 mm,3.0μm)with high purity nitrogen as carrier gas,temperature programmed,hydrogen flame ionization detector(FID),injection port temperature of 200℃,detector temperature of 230℃,carrier gas flow rate of 5.0 mL/min.The shunt ratio was 10:1,and the injection volume was 1 mL.Results Three solvents,methanol,acetone and isopropanol,were detected in the raw material of Bleomycin A5 hydrochloride.The new verified method was used to determine the collected raw materials.The difference between the three batches of products from one manufacturer was very small,indicating that the production process was stable.The residual amount of organic solvent in bleomycin A5 hydrochloride for injection is far below the limit requirement.Conclusion The method is simple,rapid,sensitive,and accurate.It can be used to evaluate the process control level of drug production by determining the residual organic solvent of bleomycin A5 hydrochloride.It is suggested that Chinese drug manufacturers should add residual solvent inspection items in the internal control standards,and carry out periodic inspection to discover the quality fluctuation in production in time.It is not necessary to control the residual solvent of bleomycin A5 hydrochloride for injection,which is produced by freeze drying process.
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