胃炎平颗粒剂质量标准研究

Study on the Quality Standard of Weiyanping Granules

目的：建立胃炎平颗粒剂质量控制标准。方法：采用TLC法对处方中黄芪、黄连、枳壳、元胡进行定性鉴别;用HPLC法测定盐酸小檗碱的含量。结果：在TLC法中均能检出黄芪、黄连、枳壳和元胡。盐酸小檗碱在5-30μg范围内有良好的线性关系,平均回收率为101.03%、RSD为1.0%。结论：所建立的方法简单、准确、可靠,可作为控制该制剂的质量。

Objective： To establish the quality standard of Weiyanping Granules. Method： The Radix Astragali, Rhizoma Coptidis ,Rhizoma corydalis and Fructus Aurantil were identified by TLC. The berberin hydrochlofide in the granules were determined by HPLC. Results： The Radix Astragali,Rhizoma Coptidis, Rhizoma corydalis and Fructus Aurantil could be identified with TLC chromatograms. The linear relationship was good when the adding quantity of berberin hydrochloride was in range of 5 - 30μg. Average rate of reovery was 101.03% ,RSD = 1.0%. Conclusion： The method is rapid, accurate and simple ,and can be used for quality control of Weiyanping granules.