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目的建立骨痹颗粒的质量标准。方法采用薄层色谱(TLC)法对该制剂中桑寄生、续断、骨碎补进行定性鉴别;采用高效液相色谱法测定该制剂中续断的有效成分川续断皂苷Ⅵ的含量。结果桑寄生、续断、骨碎补的TLC别专属性强;川续断皂苷Ⅵ在0.24~15.33滋g范围内呈良好的线性关系,平均回收率为98.36%,RSD为1.09%(n=9)。结论该定性、定量检测方法简便可行、专属性强、重现性好、灵敏度高,可作为骨痹颗粒的质量控制标准。
Objective To establish the quality standard of Gubi granule. Methods TLC method was used to qualitatively identify the parasiticus, dipsacus and drynaria of this preparation. The content of the continuous active ingredient Dictyosaponin Ⅵ in this preparation was determined by high performance liquid chromatography (HPLC). Results TLC of Sanguisheng, Dipsacus and Rhizoma Drynariae was strong. The linear relationship was found between 0.24 and 15.33 μg in the range of 0.24-15.33 g, with the average recovery of 98.36% and RSD of 1.09% (n = 9). Conclusion The qualitative and quantitative detection method is simple and feasible, with strong specificity, good reproducibility and high sensitivity, which can be used as the quality control standard of Gubi granule.