长春七滴丸制备及质量控制研究

Preparation and Quality Control of Radix Sesali Dropping Pills

目的：制备长春七滴丸并建立其质量控制方法。方法：常规方法制备滴丸,薄层色谱法定性鉴别,HPLC法测定蛇床子素含量。结果：制得的滴丸大小均匀、圆整光滑、硬度适中。薄层色谱斑点清晰,阴性对照无干扰;高效液相色谱中,蛇床子素含量在0.202~2.424μg范围内线性关系良好（r=0.9997）,平均回收率为100.22%（RSD=1.33%）。结论：该制备工艺合理可行;所建立的质量控制方法简便、易行、重现性好,可用于本制剂的质量控制。

Objective：To prepare Radix Sesali dropping pills and establish their quality control methods.Methods：The dropping pills were prepared by a conventional method,TLC was used to qualitatively identify osthole in the dropping pills,the HPLC method was used to determine the content of osthole.Results：The dropping pills were well distributed in size,smooth and glossy in appearance,mild in hardness.The TLC spots were fairly clear and the negative control showed no interference.The linear range of osthole was 0.202～2.424μg,with a correlation coefficient of 0.9997.The average recovery and the RSD were 100.22% and 1.31% respectively.Conclusion：The preparing technology is rational and available.The method is sample and reproducible for the quality control of Radix Sesali dropping pills.