骨筋丸胶囊质量控制方法研究

目的：研究骨筋丸胶囊的质量控制方法。方法：采用TLC法对其中三七、蛇床子进行了鉴别,采用HPLC法对其中的士的宁进行了含量测定,色谱柱为HypersilC18（4.6×200mm,5μm）,流动相为甲醇-水-冰醋酸-三乙胺（20∶80∶0.5∶0.15）,流速为1.0ml/min,柱温为30℃,测定波长为254nm。结果：TLC法鉴别专属性强,重复性好,含量测定实验结果显示,士的宁在0.2196～0.8784μg之间呈良好的线性关系r=0.9999,平均回收率为99.91%,RSD%=1.96%。结论：此方法专属性强,精确度高,重复性好,可以有效控制骨筋丸胶囊的质量。

The quality control method study of Gujinwan capsule

Objective： To study the quality control method of Gujinwan capsule. Methods： TLC was used for the identification of Radix Notoginseng and Fructus Cnidii. HPLC was applied for the determination of Strychnine by which Hypersil C18 （4.6×200 mm, 5 μm） chromatographic column was used and the mobile phase was methanol-water-glacial acetic acid-triethylborane （20∶80∶0.5∶0.15） with a flow rate of 1.0 ml/min. The column temperature was maintained at 30℃ and the detection wavelength was set at 254 nm. Results： TLC method was proved to be sepecific and reproducible, and free from the interference of the negative control substance. The linear range of the Strychnine was 0.219 6 to 0.878 4 μg （r=0.999 9）, and the average recovery was 99.91% （RSD=1.96%, n=6）. Conclusion： This method is proved to be simple, rapid, accurate and exclusive, and it can be used as a new method to control the quality of Gujinwan capsule.