如何科学、客观地评价口服固体制剂内在品质.pdfVIP

Evaluation and Guide 评价与指南 如何科学、客观地评价口服固体制剂内在品质 ——纵论我国固体制剂仿制药质量 谢沐风 上海市食品药品检验所，上海 201203 摘要:目的：通过剖析固体制剂质量标准中各检测指标，深入阐述如何科学、客观地评价固体制剂内在品质。方法：通过对比 各国药典检测方法、质量标准和技术指导原则，指出现行国内标准或技术法规中亟待解决之处。结果：由于现行国内标准和 技术法规制订得不够完善与科学，导致国产固体制剂内在品质与原研药的差距，进而导致临床疗效上的差距。结论： “标准 就是生产力”，唯有提高各类标准与完善检测方法，方能拉动国产制剂内在品质的切实提升！ 关键词：评价；口服固体制剂；内在品质；溶出度 [中图分类号]R943 [文献标识码]A [文章编号]1672-2809(2010)14-0019-05 How to Scientifically Evaluate the Inherent Quality of Oral Solid Dosage Form: Expatiate the quality of the Domestic Oral Solid Preparations XIE Mu-feng Shanghai Institute of Food and Drug Control, Shanghai 201203 Abstract: Obj ective: To illustrate how to evaluate the inherent quality of solid dosage form by analyzing the detection index. Methods: By comparing the quality standards of the products as well as various methods of pharmacopeias or guidelines of different countries, the aspects that need to be solved in the current standards and guidelines were pointed out. Results: There are large gaps between the products of domestic manufacturers and patent drugs which may be due to the defaults of current domestic quality standards or guidelines, further induce the different clinical effect. Conclusion: Standard is critical to the products. Only by enhancing the quality level or complete the detection methods, the inherent quality of products could be improved. Key Words ：Evaluation; Oral Solid dosage form; Inherent quality; Dissolution 用质量标准来评价 固体制剂的方法 ，主 (或装量) 。随后生产部门根据该数值调节填充量进 要有含量、含量均匀度、片重(装量)差 行压片或灌装。只要机器性能良好、生产过程中每 异、有关物质与溶出度/释放度等项 目，本文将对以 隔一段时间取样测定片重或装量，并将误差控制在 上各评价指标进行深入剖析与阐述。 一定范围内、含量就都不会出现问题。 从以上过程我们可知：该过程几乎不存在 “技 1 含量 术含量”，仅是将一物件彻底处理使之成均匀状后 按照GMP规定：固体制剂在造粒后、压片前， 按照一定规格制作即可。它与处方/制剂工艺的关联 应在盛装有中