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目的:建立舒经克痛软胶囊的质量标准。方法:对制剂中当归和香附成分做薄层鉴别(TLC),然后采用高效液相色谱法(HPLC)对舒经克痛软胶囊中α-香附酮的定量研究及留样观察试验和加速试验的研究进行测定。结果:α-香附酮在0.02746～0.54920μg范围内线性关系良好,相关系数r=0.9999,加样回收率99.8%,确定本品每粒以香附中的α-香附酮计,不得少于2.2 mg。结论:本法操作简便,灵敏度高,重现性好,可作为该制剂的质量控制标准。
Objective: To establish the quality standard of Shu Jing Ke Tong Soft Capsule. Methods: TLC (TLC) was applied to the constituents of Angelica sinensis and Cyperus rotundus. Quantitative study of α-ketoconazole in Shu Jing Ke Tong soft capsules by HPLC and observation of retention test and acceleration Experimental studies were performed. Results: The calibration curve of α-ketones showed a good linearity in the range of 0.02746 ~ 0.54920 μg with a correlation coefficient of 0.9999 and a recovery rate of 99.8%. It was confirmed that the product should be less than 2.2 mg. Conclusion: This method is simple, sensitive, reproducible, and can be used as the quality control standard of this preparation.