香连胶囊的制备与质量标准研究

Preparation and Quality Control of Xianglian Capsule

目的制备香连胶囊并建立其质量标准。方法采用煎煮和蒸馏法提取药液,以薄层色谱法进行定性鉴别,以高效液相色谱法对制剂中盐酸小檗碱进行含量测定。结果薄层色谱法可检出黄连、木香的特征斑点,阴性对照无干扰;盐酸小檗碱进样质量浓度线性范围为2.0～80.0μg/mL(r=0.999 9),平均回收率为100.07%,RSD=0.41%(n=9)。结论该制剂制备工艺合理,质量标准可行、可靠,可用于该胶囊剂的质量控制。

Objective To study the preparation and quality control method of Xianglian Capsule.Methods Physic liquor were extracted by decoction and boil water method,and TLC was used for identification.HPLC was used to determine content of berberine hydrochloride.Results It can been checked the characteristic spot of Coptis chinensis and Radix Aucklandiae in the TLC,negative control have no interference.The calibration curves of berberine hydrochloride were linear within the range of 2.0-80.0 μg/mL（r=0.999 9）;the average recovery rate was 100.07%,RSD=0.41%（n=9）.Conclusion The preparation technology is reasonable,quality control method is feasible and reliable,the standard can provide a reference for the quality control of Xianglian Capsule.