复方大黄软膏质量标准研究

Study on Quality Standard of Compound Rhubarb Ointment

目的:建立复方大黄乳膏的质量标准,为其质量控制提供参考依据。方法:采用薄层色谱法(TLC)对复方大黄乳膏制剂中的大黄、黄柏、枳壳、乌梅进行定性研究;采用高效液相色谱法(HPLC)测定复方大黄乳膏中芦荟大黄素、大黄酚、大黄素甲醚和盐酸小檗碱含量。结果:薄层色谱斑点清晰,阴性对照无干扰。芦荟大黄素在0.022～0.443μg(r=0.999 9)、大黄酚在0.022～0.442μg(r=0.999 9)、大黄素甲醚在0.013～0.268μg(r=0.999 9)、盐酸小檗碱在0.10～2.00μg(r=0.999 9)进样量范围内与其峰面积积分线性关系良好,平均回收率分别为99.93%,100.24%,99.51%和100.08%,RSD分别为1.433%(n=6)、1.425%(n=6)、1.226%(n=6)、0.648%(n=6)。结论:该方法简便、灵敏度高、重复性好,可用于复方大黄乳膏的质量控制。

Objective. To establish the quality for Compound Rhubarb Ointment. To provide the methods and basis for the quality control of Compound Rhubarb Ointment. Methods：Rhubarb, Cortex phellodendri, fructus aurantii, dark plum were identified by TLC. The content of aloe-emodin, chrysophanol, physcion and berberine hydrochloride was determined by HPLC. Results. TLC spots were clear without interference in negative control. The aloe-emodin showed good linear relationship at a range of 0. 022 0. 443b-g（r：0. 999 9） ,the chrysophanol showed good linear relationship at a range of 0. 022-0. 442μg（r=0. 999 9） ,the physcion showed good linear relationship at a range of 0.013 - 0. 268μg（r = 0.999 9）, the b erberine hydrochloride showed good linear relation-ship at a range of 0.15-2. 00μg（r=0. 999 9）. The average recovery（n= 6） was 99.86% ,99.92%,99.53%,99.86%,with RSD was 2.42 %, 2.51%, 2.39%, 2.48%. Conclusion This method is ease, high accuracy and good stability reproducibility, so it can be used for the quality control of Compound Rhubarb Ointment .