评价国产利福平胶囊与参比制剂体外溶出一致性研究
Consistency evaluation of domestic generic rifampicin capsules and reference drug in vitro
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摘要: 评价国产利福平胶囊与参比制剂质量的一致性。参照《中华人民共和国药典》(2015版)对国产利福平胶囊与参比制剂的含量和有关物质进行考察，同时通过预实验与方法学验证确立溶出曲线测定基本方案，分别在pH 1.2盐酸溶液、pH 4.0磷酸盐缓冲液、pH 6.8磷酸盐缓冲液与纯水4种溶出介质中比较国产利福平胶囊与参比制剂间溶出曲线的相似性。结果显示，国产利福平胶囊与参比制剂的含量和有关物质均符合《中华人民共和国药典》(2015版)标准规定，但杂质谱结果显示国产利福平胶囊的杂质较少，特别是醌式利福平的含量远小于参比制剂；国产利福平胶囊与参比制剂体外溶出行为不一致，建议采用生物等效性试验对国产利福平胶囊与参比制剂的一致性进行进一步评价。Abstract: This study was to evaluate quality consistency of domestic generic and reference preparations. Content and related substances of domestic generic preparations and reference preparation were inspected according to Chinese Pharmacopeia 2015. Then the basic solution for determining dissolution curve was established through preliminary experiment and validation for determination. The dissolution curves of domestic rifampicin capsules and reference preparation were compared in four dissolution mediums: HCl(pH 1. 2), PBS(pH 4. 0), PBS(pH 6. 8)and pure water, respectively. Results showed that the content and related substances of domestic generic and reference preparations complied with the quality standard, but impurity profile displayed that impurities in domestic generic preparations were less than those in the reference preparation, with the content of rifampin quinine being especially less. Furthermore, dissolution of domestic generic and reference preparations were compared, and their dissolution curves were not similar. It is suggested that consistency between domestic rifampicin capsules and reference preparation should be evaluated by bioequivalence test.
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Keywords:
- rifampicin capsules /
- reference drug /
- dissolution /
- consistency evaluation
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