藏药前列宁胶囊质量标准研究.docVIP

藏药前列宁胶囊质量标准研究 　　【摘要】目的：研究并提高藏药前列宁胶囊的质量标准。方法：采用薄层色谱法鉴别红花、诃子、菥蓂子、藏茜草；采用高效液相色谱法同时测定没食子酸和羟基红花黄色素A。结果：薄层色谱显色清晰，阴性对照无干扰。没食子酸在33.76~337.6 μg/ml浓度范围内线性关系良好，r=0.9996，平均加样回收率为98.35%，RSD为1.36%。羟基红花黄色素A在2.68~26.80 μg/ml浓度范围内线性关系良好，r=0.9998，平均加样回收率为99.03%，RSD为0.72%。结论：该方法简便、可行、可靠，可用于控制前列宁胶囊的质量。 　　【关键词】前列宁胶囊；红花；诃子；菥蓂子；藏茜草；没食子酸；羟基红花黄色素A 　　 　　Study on Quality Standard for Tibetan Medicine of Qianliening Capsule/Ma Hong-wei，SHAO Cheng-lei，WEI Yong-yi，et al.//Medical Innovation of China，2013，10（20）：129-132 　　【Abstract】Objective：To study and upgrade the quality standard of Tibetan Medicine Qianliening Capsule.Method：TLC method was used to identify Flos Carthami，Terminalia Chebula，Semen Thlaspi and Radix et Rhizoma Rubiae；Hplc was used for the determination of Gallic acid and Hydroxy Safflor yellow A.Result：Flos Carthami，Terminalia Chebula，Semen Thlaspi and Radix et Rhizoma Rubiae could be identified by TLC without the interference of negative control.Gallic acid and Hydroxy Safflor yellow A could be determined at the same time.Gallic acid was linear in the concentration range of 33.76-337.6μg/mL，r=0.9996.The average recovery rate was 98.35%，RSD=1.36%；Hydroxy Safflor yellow A had a good linear in the concentration range of 2.68-26.80 μg/ml，r=0.9998.The average recovery rate was 99.03%，RSD=0.72%.Conclusion：The method is simple，feasible，reliable，and can be effectively used for the quality control of Qianliening Capsule. 　　【Key words】Qianliening Capsule；Flos Carthami；Terminalia Chebula；Semen Thlaspi；Radix et Rhizoma Rubiae；Gallic acid；Hydroxy Safflor yellow A 　　First-author’s address：Shandong Arura Pharmaceutical Research Development.CO.，LTD.，Ji’nan 250101，China 　　doi：10.3969/j.issn.1674-4985.2013.20.064 　　藏药前列宁胶囊为金诃藏药股份有限公司独家产品，由菥蓂子、诃子、蒲公英、红花、菥蓂子等13味药材组成。主要功能清热解毒，化瘀通淋，用于热毒瘀阻所引起的尿???，尿急，尿痛属中医淋证者。现行前列宁胶囊标准只有紫草茸和蒲公英两味药材的薄层色谱鉴别和没食子酸的含量测定[1]，标准有待提高。为更好的控制其内在质量，参考中国药典[2]及相关文献，经反复试验，建立了红花[3-5]、诃子[6-7]、菥蓂子[8]、藏茜草[9-11]的薄层色谱鉴别方法，并实现了同一色谱条件下，通过变化检测波长，同时检测没食子酸[12-13]和羟基红花黄色素A[14-15]的含量。所