养血护肝颗粒质量标准的提高

Improvement of the quality standards of Yangxue Hugan granules

目的:建立养血护肝颗粒的质量控制新方法,以提高其质量标准。方法:采用薄层色谱法(TLC)对养血护肝颗粒中的丹参、大黄和重楼进行定性鉴别;用HPLC法测定该制剂中丹参酮ⅡA的含量,色谱柱为Hypersil C18柱(250 mm×4.6mm,5μm),流动相为甲醇∶水(78∶22),检测波长为270nm,柱温为室温,流速为1ml/min。结果:丹参、大黄和重楼的TLC谱图中斑点清晰,分离度好,且阴性对照无干扰。丹参酮ⅡA在0.5~40.0μg/ml范围内,峰面积与浓度呈良好的线性关系(r=0.999 8),精密度、稳定性、重复性实验的RSD<2%;平均加样回收率为(100.07±2.44)%(n=9)。测得3批养血护肝颗粒中丹参酮ⅡA的含量分别为(52.25±0.50)、(57.63±0.60)、(56.31±0.48)μg/ml(n=3)。结论:本研究建立的方法准确、灵敏、重现性好,有利于提高养血护肝颗粒的质量控制标准。

Objective：To establish a new method for the improvement of the quality standards of Yangxue Hugan granules.Methods：The main ingredients of Salviae Miltiorrhizae Radix Et Rhizoma,Rhei Radix Et Rhizoma and Paridis Rhizoma were indentified by thin layer chromatography（TLC）.The contents of tanshinoneⅡA were determined by HPLC method.Separation was performed on Hypersil C18column（250mm×4.6mm,5μm）with methanol-water（78∶22）as mobile phase at a flow rate of 1 ml/min.The detection wavelength was set at 270 nm,and the column temperature was room temperature.Results：The three herbs could be identified by TLC method.Spots were well separated without interference from negative control in the TLC chromatograms.TanshinoneⅡA was in good linearity within the ranges of 0.5-40.0μg/ml（r=0.999 8）.RSDs of precision test,stability test and repeatability test were all less than 2%,and the average recovery was（100.07±2.44）%（n=9）.Contents of tanshinoneⅡAin three batches of samples were（52.25±0.50）,（57.63±0.60）and（56.31±0.48）μg/ml（n=3）,respectively.Conclusion：The detection method established through this study is accurate,sensitive,reproducible and could be used for the quality control of Yangxue Hugan granules.