参柏妇炎宁栓质量标准

摘要

Objective To establish a method for quality control of Shenbo Fuyanning suppositories. Methods Sophorae flavescentis Radix, Rhizoma dioscoreae Hypoglaucae, and Cnidii fructus were identified by thin layer chromatography ( TLC) , and the content of berberine hydrochloride was determined by HPLC. Results The TLC spots were clear and the negative control had no interference.Berberine hydrochloride had a linear relationship in the range of 0.079-0.790 μg, and the average recovery was 99.3%(RSD=0.70%,n=6). Conclusion The method is accurate, reliable and feasible, and can be used in the quality control of the Shenbo Fuyanning suppository effectively.%目的 建立参柏妇炎宁栓的质量标准. 方法 采用薄层色谱法对制剂中苦参、粉萆薢、蛇床子进行定性鉴别;采用高效液相色谱法测定制剂中盐酸小檗碱含量. 结果 薄层斑点清晰,阴性对照无干扰;盐酸小檗碱进样量在0.079~0.790 μg范围内线性关系良好(r=0.999 9),平均回收率为99.3%,RSD值为0.70%(n=6). 结论 该方法准确、可靠,可行及重复性良好,能有效控制参柏妇炎宁栓的质量.