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目的:建立平胃舒胶囊的质量控制标准。方法:采用薄层色谱法对制剂中黄连和延胡索进行鉴别;采用高效液相色谱法测定制剂中盐酸小檗碱含量。结果:薄层色谱斑点清晰,分离度较好,专属性强。高效液相色谱法测定结果,盐酸小檗碱在0.368～3.680μg线性关系良好(r=0.999 8),平均加样回收率99.86%,RSD 1.46%。结论:该方法快速、灵敏、准确,可有效控制平胃舒胶囊的质量。
Objective: To establish the quality control standard of Pingweishu capsule. Methods: Chlortetracycline and Corydalis were identified by TLC. The content of berberine hydrochloride in the preparation was determined by high performance liquid chromatography. Results: Thin-layer chromatography spots clear, better resolution, specificity. The results of HPLC showed that the linearity of berberine was 0.368 ~ 3.680μg (r = 0.999 8), the average recovery was 99.86% and the RSD was 1.46%. Conclusion: The method is rapid, sensitive and accurate and can effectively control the quality of Pingweishu capsule.