目的 通过原料勾兑来控制前列舒乐胶囊质量均一性。方法 采用药材勾兑计算器V2对原料药进行均一化勾兑,比较原料勾兑前后前列舒乐胶囊中朝藿定C、淫羊藿苷质量分数的差异。结果 原料勾兑前、后前列舒乐胶囊中朝藿定C质量分数的RSD分别为82.5%和11.2%,淫羊藿苷质量分数的RSD分别为35.3%和8.7%,指标成分质量分数差异减小,表明其质量均一性明显提高。结论 原料勾兑在控制中成药质量均一性中效果明显,适用于实际生产中。

Objective To develop a method for controlling the quality consistency of Qianlie Shule Capsule (QSC) by blending raw marerials. Methods Blending raw materials were blended by medicine calculator V2. The content differences of epimedin C and icariine in QSC made from raw materials and their mixtures were compared. Results The RSD of index component epimedin C from blended and raw materials were 11.2% and 82.5%, the RSD of icariine were 8.70% and 35.5%, the difference between index components decreased obviously, and it showed that the quality consistency in QSC was greatly increased. Conclusion Using the method to control the quality coherence of Chinese patent medicine has the obvious results, it is easy to operate and suitable for actual production.

2013年中医药行业科研专项项目(201307009);江西省赣鄱英才“555”工程领军人才培养计划资助