瑶药止痛散质量标准研究

Quality Standard of Yaoyaozhitong Powder

目的建立瑶药止痛散的质量标准。方法采用薄层色谱(TLC)法对瑶药止痛散中毛两面针、洋金花、草乌进行定性鉴别;采用高效液相色谱(HPLC)法测定瑶药止痛散中氯化两面针碱的含量,色谱柱为Waters XBridge Phengl C18柱(150 mm×2.1 mm,3.5μm),流动相为乙腈-0.2%磷酸溶液-三乙胺(20∶80∶1,V/V/V),流速为1.0 m L/min,检测波长为271 nm,柱温为30℃,进样量为10μL。结果瑶药止痛散中毛两面针、洋金花、草乌的TLC图斑点清晰,分离度好,阴性对照无干扰。氯化两面针碱质量浓度在1.25~12.50μg/m L范围内与峰面积线性关系良好;精密度、重复性、稳定性试验结果的RSD均小于2.0%;平均加样回收率为100.28%,RSD为1.75%(n=9)。结论该研究所建立的标准可用于瑶药止痛散的质量控制。

Objective To establish the quality standard of Yaoyaozhitong Powder.Methods The thin layer chromatography(TLC)method was used to identify Zanthoxylum nitidum,Datura metel and Radix Aconiti kusnezoffii in Yaoyaozhitong Powder,and the high-performance liquid chromatography(HPLC)method was used to determine the content of nitidine chloride in Yaoyaozhitong Powder,the chromatographic column was Waters XBridge Phengl C18 column(150 mm×2.1 mm,3.5μm),the mobile phase was acetonitrile-0.2%phosphoric acid triethylamine(20∶80∶1,V/V/V),the flow rate was 1.0 m L/min,the detection wavelength was 271 nm,the column temperature was 30℃,and the injection volume was 10μL.Results The TLC spots of Zanthoxylum nitidum,Datura metel and Radix Aconiti kusnezoffii in Yaoyaozhitong Powder were clear and well separated,and the negative control had no interference.The linear range of nitidine chloride was 1.25-12.50μg/m L.The RSDs of precision,repeatability and stability tests were less than 2.0%.The average recovery of nitidine chloride was 100.28%with RSD of 1.75%(n=9).Conclusion The established standard can be used for the quality control of Yaoyaozhitong Powder.