龙脉利缓释胶囊质量标准研究

Quality Standard of Longmaili Sustained-Release Capsules

目的 制定龙脉利缓释胶囊的质量标准。方法 用薄层色谱法对龙脉利缓释胶囊中穿山龙进行鉴别,用比色法对龙脉利缓释胶囊中穿山龙的薯蓣皂苷进行含量测定。结果 在薄层色谱中能检出穿山龙;比色法测得薯蓣皂苷在0.031~0.310mg范围内具有良好的线性关系（r=0.999 5）,平均回收率为99.73%（n=6）。结论 该方法准确、灵敏,重复性好,能有效地控制龙脉利缓释胶囊的质量。

Objective To establish the quality standard for Longmaili sustained-release capsules. MethodsDioscorea nipponica was identified by TLC.Colorimetric method was employed for the assay of dioscin.Results Dioscorea nipponica could be identified by TLC; The linear range of dioscin was within 0.031 40.310mg（r=0.999 5）.The average recovery of assay was 99.73%（n=6）. Conclusion The method is accurate, sensitivewith good repeatability.It could be used for quality control of Long Maili sustained-release capsules.