中药制剂平肝胶囊的生产工艺及质量标准研究

 目的 研究中药复方制剂平肝胶囊的生产工艺及质量控制标准。方法 用高效液相色谱法定量及化学成分的特征反应定性。结果 提出平肝胶囊的生产工艺，建立了HPLC法测定平肝胶囊中齐墩果酸含量的方法及特征成分理化反应鉴别方法。结论 平肝胶囊中齐墩果酸含量应控制为4.23%～9.65%，一些特征成分的检识反应可作为该制剂的定性检查标准。

Study on quality criteria of compound preparation Pinggan capsules

OBJECTIVE To study the production technology and quality control criteria of Pinggan capsules.METHODS A HPLC was adopted as the quantitative assay and chemical reactions were used for identification.RESULTS The appropriate production technology was proposed.The HPLC method was established to determine the content of oleanolic acid in Pinggan capsules.The specific physiochemical identification was also reported.CONCLUSION The level of oleanolic acid in Pinggan capsules should be controlled in the range between 4.23% to 9.65%,and certain distinguished reactions of some special compositions may be used as the identification criteria.