清胃胶囊质控标准的研究

Studies on Quality Standard of Qingwei Capsules

目的建立清胃胶囊的质控标准。方法采用薄层色谱法鉴别清胃胶囊中的黄连、黄芩;采用高效液相色谱法定量检测清胃胶囊中的盐酸小檗碱含量。结果黄连、黄芩的薄层色谱鉴别效果好、专属性强,分离度高,且阴性样品无干扰;盐酸小檗碱在0.1185∽1.1850μg范围内与峰面积呈良好的线性关系（r=1）;平均加样回收率为：98.40%,RSD为0.79%。结论本文建立的方法不仅操作简便、结果准确、重现性好,而且能够对清胃胶囊进行定性和定量质控,符合中成药的质控要求。

OBJECTIVE To establish the quality control standard of Qingwei Capsules.METHODS The TLC method was used to identify Rhizoma Coptidis, Radix Scutellariae in Qingwei Capsules, the content of berberine hydrochloride was determined quantitatively by HPLC RESULTS The TLC identification of Rhizoma Coptidis,Ra-dix Scutellariae was fairly exclusive, specialty, well-seperated without interference from negative control, the linear range of berberine hydrochloride was 0.1185∽1.1850μg range（r=1）;the average recovery rate was 98.40%,with RSD of 0.79%.CONCLUSION The established qualitative and quantitative method is simple,accurate,well re-producible and can be used for the quality control of Qingwei Capsules.