蒙药益智温肾十味丸质量标准

Research on Quality Standard of Traditional Mongolian Patent Medicine Sugmul-10 Pills

目的:建立蒙药益智温肾十味丸的显微、薄层、理化鉴别方法和高效液相含量测定方法,提高其质量控制水平。方法:在显微镜下观察本品粉末,以种皮厚壁细胞、石细胞群和体壁碎片为指标,鉴别本品中益智、苦石莲、冬葵果和方海;提取挥发油,点样于硅胶GF254薄层板上,环己烷-乙酸乙酯(9∶1)展开,以标准药材为对照,鉴别本品中的益智;理化方法鉴别白硇砂中氯化铵和方海中碳酸钙。对荜茇中胡椒碱进行含量监控,用ODS填充的色谱柱,甲醇-水(77∶23)为流动相,343 nm波长下测定。结果:方法可有效鉴别本品中益智、苦石莲、冬葵果、方海和白硇砂5味药材,高效液相含量测定方法在0.040 4～0.282 8μg线性良好(r=0.999 9),胡椒碱的平均回收率为98.1%,RSD 0.62%,含量限度为不得少于1.4 mg.g-1。结论:该方法可有效控制本品质量。

Objective： To improve the quality standard of the traditional Mongolian patent medicine Sugmul-10 pills by the establishing of microscopic,TLC,physiochemical identification,and HPLC content assay methods.Method： Alpiniae oxyphyllae fructus,Caesalpinia fructus,Malva fructus and Eriocheir sinensis were identifred by microscopical analysis of episperm sclerenchymatous cells,scleroticnests and body wall debris in the sample powder.TLC identification of Alpiniae oxyphyllae fructus was performed on a silica gel plate GF254,with cyclohexane-ethyl acetate（9∶1） as developing solvent and standard medicinal materials as controls.Physiochemical methods were used to identify ammonium chloride in Sal Ammoniacus and calcium carbonate in Eriocheir sinensis.Piperine from Piperis longi fructus was selected for content supervision.HPLC method was performed on a ODS column,eluted with methol-H2O（77 ∶ 23）,and detected at 343 nm.Result： Five medicinal materials from Sugmul-10 pills can be identified by the methods,including Alpiniae oxyphyllae fructus,Caesalpinia fructus,Malva fructus,Sal Ammoniacus and Eriocheir sinensis.HPLC content determination method showed good linearity（r = 0.999 9） in the range of 0.040 4-0.282 8 μg.The average recovery rate of piperine was 98.1% with RSD 0.62%,and the content limitation is not less than 1.4 mg.g-1.Conclusion： This methods can effectively control the product quality.