中药对照制剂自身对照法用于桂枝茯苓胶囊的质量评价

Quality evaluation of Guizhi Fuling capsule using self-control method of reference Chinese medicine preparation

以桂枝茯苓胶囊（GZFL）为例,提出以中药对照制剂作为标准物质随行生成指纹图谱代替对照指纹图谱对中药复方制剂进行质量评价,消除因仪器和色谱柱等实验条件不同引入的误差,同时解决无对照指纹图谱不能拟合的问题。采用2010年版《中国药典》收录的GZFL质量标准（指纹图谱和多成分含量测定）对所制成的对照制剂进行质量合格性评价;在不同仪器、色谱柱等实验条件下,分别以对照制剂随行生成指纹图谱和对照指纹图谱为指标对多批出厂检验合格的GZFL样品进行质量评价对比研究,考察对照制剂评价复方药物的可行性;以稳定性试验考察结果为参考,确定GZFL对照制剂作为标准物质的包装和保质期。结果发现,以GZFL对照制剂随行生成指纹图谱评价样品较对照指纹图谱评价可消除因仪器和色谱柱等实验条件不同引入的误差;0~6月的加速和长期稳定性实验研究结果显示,对照制剂在双层铝塑包装条件下质量稳定,说明对照制剂可采用该包装条件进行储存。研究表明,GZFL对照制剂可以作为标准物质代替对照指纹图谱随行生成指纹图谱对GZFL进行质量评价。

Taking guizhi fuling capsule （GZFL） for instance, a new method about reference Chinese medicine preparation which was used as standard substance for the quality evaluation of complex Chinese medicine preparation by the fingerprint of reference preparation instead of standard fingerprint was proposed. It could eliminate the errors from different instruments, chromatographic columns and solve the problem of similarity matching in the absence of standard fingerprint. The qualification of reference GZFL was evaluated according to the quality control method of GZFL from Chinese Pharmacopoeia. Then multiple batches of GZFL were estimated, taking fingerprint of reference preparation and standard fingerprint as references, respectively, at different instruments and chromato- graphic columns. Finally, the packaging and expiration date for reference GZFL were confirmed according to the results of stability investigation. The results indicated that the fingerprint of reference GZFL could be used to assess the quality of GZFL better than standard fingerprint. The data of accelerated stability and long term stability test demonstrated that reference GZFL was stable in the conditions of double blister package. Therefore, reference GZFL can be used as standard substance in quality control of GZFL.