消石胶囊的质量标准研究

Study of Quality Standard for Xiaoshi Capsule

目的建立消石胶囊的质量标准。方法用显微鉴别的方法鉴别制剂中的金钱草、大黄、郁金,用薄层色谱法鉴别制剂中的金钱草、大黄、延胡索;用高效液相色谱法测定大黄中大黄素、大黄酚的含量。结果显微鉴别可观察到金钱草中孔沟及梯纹导管、大黄中草酸钙簇晶及纹状导管、郁金中油细胞类不规则团块;金钱草、大黄、延胡索的薄层色谱特征斑点分离清晰,阴性无干扰;大黄素及大黄酚分别在0.840~4.20μg/ml、5.136~25.68μg/ml范围内与峰面积的线性关系良好(r=0.999 9),平均回收率为98.97%、102.8%,平均含量分别为0.438 5 mg/g、2.521 mg/g。结论该方法全面、简便、准确,为消石胶囊质量控制提供可靠标准。

Objective To establish the quality standard for Xiaoshi capsule. Methods The microscopic identification of the Lysimachia christinae Hance, Rheum officinale Baill and Radix Curcumae in the preparation. Three major components, Lysimachia christinae Hance, Rheum officinale Baill and Corydalis yanhusuo W.T.Wang, are identified by TLC. The content of emodin and chrysophanol are determined by HPLC. Results The microscopical identification can be observed in the obvious pore trench and echelon catheter in the Lysimachia christinae Hance, the crystal of calcium oxalate in the Rheum officinale Baill and the irregular lumps of oil cells in Radix Curcumae, the spots of TLC of Lysimachia christinae Hance, Rheum officinale Baill and Corydalis yanhusuo W.T.Wang are distinctive and there has no interfere with the negative references. The linear range of emodin and chrysophanol are 0.840 ~ 4.20 μg/ml, 5.136 ~ 25.68 μg/ml（r = 0.999 9）, which indicated the linearity of this method is all right. The average recovery of them are 98.97 %, 100.2 %, The average content of them are 0.438 5 mg/g, 2.521 mg/g. Conclusion The method is simple and accurate, which can provide reliable basis for the formulation and improvement of the quality standard of Xiaoshi capsules.