抗骨增生片质量标准研究

Study on Quality Standards for Kangguzengsheng Tablets

目的制订抗骨增生片质量标准。方法采用薄层色谱法对制剂中的骨碎补、鸡血藤进行定性鉴别;采用高效液相色谱法对制剂中淫羊藿进行了含量测定。结果抗骨增生片中淫羊藿苷含量约为0.25 mg/片;平均回收率为99.0%,RSD为0.38%。结论方法简便,专属性强,重复性好,可作为该制剂的质量控制指标。

Objective To establish the quality standards for Fengdshiding Tablets. Method Rhizoma Drynariae and Caulis Spatholobi were identified by TLC, and Icariin was determined by HPLC. Result Icariin content in Kangguzengsheng Tablets was about 0. 25 mg/tablet. The average recovery was 99.0% and RSD was 0.38%. Conclusion These methods are simple with strong specificity and good reproducibility, and can be used as the quality control of this preparation.