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目的:对国内不同厂家生产的司他夫定胶囊进行质量分析和研究。方法:采用法定标准对样品进行检验,参照国外标准及文献探索性研究了旋光度、薄层色谱行为、水分、制剂均一性、α-异构体、有关物质、溶出度、邻苯二甲酸酯类物质。结果:按法定标准检验的结果均符合规定。旋光度、薄层色谱行为、α-异构体、有关物质及制剂均一性结果均能符合《美国药典》(USP)规定,水分测定结果远高于USP限度。一个厂家的样品溶出曲线与参比制剂有差异。一个厂家的胶囊壳及内容物中均检出邻苯二甲酸二(乙-乙基己)酯(DEHP)或邻苯二甲酸二异丁酯(DIBP)两种邻苯二甲酸酯。结论:现行法定质量标准对控制产品质量基本可行,但与USP有一定差距;个别厂家需改进生产工艺。
OBJECTIVE: To analyze the quality of stavudine capsules produced by different domestic manufacturers. Methods: The samples were tested according to the statutory standards. The optical rotation, TLC behavior, water content, homogeneity of preparations, α-isomer, related substances, dissolution rate, phthalates Substances. Results: According to statutory standards test results are in line with the provisions. Optical rotation, TLC behavior, α-isomer, related substances and formulation homogeneity were in accordance with the United States Pharmacopeia (USP), and the moisture content was much higher than the USP limit. A manufacturer’s sample dissolution curve and reference formulations are different. Two phthalates, di- (di-ethylhexyl) phthalate (DEHP) and diisobutyl phthalate (DIBP), were detected in the capsule shell and contents of one manufacturer. Conclusion: The current statutory quality standards are basically feasible to control the quality of products, but there is a certain gap between them and USP. Individual manufacturers need to improve the production process.