复方白术健脾合剂的制备及质量控制

Preparation and quality control of Fufangbaizhujianpi mixture

目的制备复方白术健脾合剂,建立质量控制方法,并考察其稳定性。方法确定处方组成,拟定生产工艺流程,采用薄层色谱法对其中有效成分进行鉴别,并通过长期试验考察其稳定性。结果薄层色谱定性鉴别分离度好,专属性强,稳定性试验考察结果表明,法制剂的各项指标无明显变化。结论该制剂生产工艺流程合理,质量稳定可控。

OBJECTIVE To prepare Fufangbaizhujianpi mixture,establish its quality and study its stability.METHODS Definite the composion of prescription,draw up the technical process of the preparation,carry on the identification of its effective component by TLC,and investigate its stability by long test.RESULTS The identification by TLC was special,and resolution was good.The parameters of the preparation were proved to be of no marked change.CONCLUSION The production technical process of the preparation is reasonable and its quality is stable and controllable.