骨松停胶囊质量控制方法的研究

Quality Control of Gusongting Capsules

目的：建立骨松停胶囊的质量标准。方法：采用薄层色谱法（TLC）进行本方中的骨碎补、杜仲、淫羊藿、女贞子、狗脊的定性鉴别;采用高效液相色谱法（HPLC）进行骨碎补中主要有效成分柚皮苷的含量测定。结果：在TLC色谱中,样品斑点清晰,与其他成分分离度好;HPLC色谱中,柚皮苷峰可与其他成分峰有效分离,在0.286~2.288μg范围内与色谱峰面积呈现良好的线性关系,相关系数0.9998,平均回收率99.2%。结论：所建立的方法可以准确地进行定性、定量检测,可用于该制剂的质量控制。

Objective： To establish the quality standard of Gusongting capsules. Methods： Drynariae Rhizoma,Eucommiae Cortex,Epimedii Folium,Ligustri Lucidi Fructus,Cibotii Rhizoma were identified by TLC; the contents of Naringin were determined by HPLC. Results： The TLC sample spots were clear and separate; the HPLC method showed that the peak of Naringin could be effective for the separation of other component peaks,with chromatographic peak area in the range of 0. 286 ~ 2. 288 μg,which presented a good linear relationship,with a correlative coefficiency of 0. 9998. The average recovery rate was 99. 2%. Conclusion： The method is accurate and can be used for the quality control.