抗骨增生丸定性定量方法研究

Studies on Qualtative and Quantitative Methods of Kangguzengsheng Pills

摘要:

目的:建立抗骨增生丸质量标准。方法:采用TLC法对制剂中鸡血藤和骨碎补进行了鉴别;其中鸡血藤的薄层色谱鉴别采用鸡血藤为对照药材,以三氯甲烷-丙酮(15∶1)为展开剂;骨碎补的薄层色谱鉴别采用柚皮苷为对照品,以苯-醋酸乙酯-甲酸-水(1∶12∶2.5∶3)为展开剂。采用HPLC法测定制剂中淫羊藿苷和松果菊苷含量。流动相分别为乙腈-水(30∶70)和甲醇-0.1%甲酸(28.5∶71.5)。结果:淫羊藿苷平均回收率为97.7%,RSD为1.2%(n=5);松果菊苷平均回收率为97.9%,RSD为0.8%(n=5)。结论:鉴别方法专属性强,定量方法准确,稳定,重现性好,可作为抗骨增生丸的质量控制标准。

Abstract:

Objective:To develop the quality control standards for Kangguzengsheng Pills.Methods:Caulis Spatholobi and Rhizoma Drynariae in Pills were identified by TLC.Chloroform-acetone(15∶1) was used as developing solvent for Caulis Spatholobi with reference drug.Benzene-ehyl acetate-formic acid-water(1∶12∶2.5∶3) was used for Rhizoma Drynariae with naringin as chemical reference substance.The content of icariin and echinacoside were determined by HPLC with external standard method.The mobile phases were acetonitrile-water(30∶70) and methanol-0.1% formic acid(28.5∶71.5) respectively.Results:The average recovery of icariin 97.7% and RSD was 1.2%(n=5).The average recovery of echinacoside was 97.9% and RSD was 0.8%(n=5).Conclusion:These methods are simple,accurate and specific and can be used for the quality control of Kangguzengsheng Pills.