妇舒保凝胶的质量标准研究

Quality standard for Fushubao Gel

目的建立妇舒保凝胶的质量标准。方法 TLC法用于鉴别黄柏、苦参、大黄;采用HPLC法测定处方中大黄的主要成分大黄酸、大黄素甲醚和黄柏的主要成分盐酸小檗碱的含量。结果黄柏、苦参、大黄的薄层斑点清晰,阴性无干扰;大黄酸、大黄素甲醚、盐酸小檗碱分别在5~30、4.19~25.14、14.58~174.99μg/mL范围内线性关系良好,含量分别为0.0277、0.0249、8.709 mg/g,方法加样回收率分别为98.37%、98.1%、97.9%。结论本试验结果可靠,方法可行,可作为妇舒保凝胶的质量控制方法。

Objective To establish the quality standard of Fushubao Gel. Methods Phellodendri Chinensis Cortex, Sophorae Flaveseentis Radix, Rhei Radix et Rhizome were identified by. TLC. The contents of Hydrochloric acid Berberine, Rhein and physcion were determined by HPLC. Results The TLC spots were clear and the blank test showed no interference. The linear ranges of Hydrochloric acid Berberine, Rhein and physcion were 5-30, 4.19-25.14, 14.58-174.99μg/mL respectively. The content were 0.0277, 0.0249, 8.709 mg/g. The recoveries were 98.37%, 98.1%, 97.9% respectively. Conclusion The method is reliable and accurate,and can be applied as the quan]ity control method for Fushubao Gel.