补正续骨丸质量标准研究

Quality Standard Study on Buzheng Xugu Pill

目的：建立并完善军规制剂补正续骨丸的质量标准。方法：采用显微鉴别法对处方中5味具有显微鉴别特征的药味进行鉴别;对方中续断、何首乌、骨碎补、鸡血藤、菟丝子运用薄层色谱法进行定性鉴别;样品中柚皮苷的含量测定则运用专属性较强的HPLC法进行定量测定。色谱条件：色谱柱为Welchrom C_（18）柱（200 mm×4.6 mm,5μm）;流动相：乙腈-水（20∶80）;流速为1.0 m L/min;检测波长：283 nm;柱温：25℃。结果：显微鉴别特征明显,薄层定性鉴别的斑点清晰,分离效果良好;柚皮苷在2.5~80μg/m L浓度范围内线性关系良好（r=1.0000）,平均加样回收率为96.06%,RSD为1.63%（n=6）。结论：本次研究所建立和完善的标准在方法上专属性强,重现性好;在操作上简便易行,省时省力。符合军队质量标准提升的要求,可作为该制剂列入新版军规的质量标准。

Objective：To establish a quality standard for Buzheng Xugu pill.Methods：Five crude drugs in the prescription were identified by microscope,including Duanxu（ Radix Dipsaci）,Heshouwu（ Polygonum multiflorum）,Gusuibu（ Rhizoma Drynariae）,Jixueteng（ Caulis Spatholobi） and Tusizi（ Semen Cuscutae） were identified by TLC method.Also,the content of Naringin in Buzheng Xugu pill was determined by HPLC.The Welchrom C_（18）（ 200 mm × 4.6 mm,5 μm） column was used.The mobile phase consisted of acetonitrile-water（ 20：80） was at a flow rate of 1.0 m L / min,and the detection wavelength was at 283 nm under 25℃.Results：The microscopic features were easy to identify：the spots in the thin layer chromatography were clear.The Naringin showed a good linear relationship within the range of 2.5 ~ 80 μg / m L（ r = 1.0000）.The average recovery was 96.06%,and the RSD was 1.63%（ n = 6）.Conclusion：This method is simple,reliable,reproducible and can be used in the quality control of the preparation of the drug.