目的：建立安儿宁颗粒的质量标准。方法：采用TLC法建立制剂中胆酸及猪去氧胆酸、甘草、岩白菜素的定性鉴别方法及乌头碱的限量检查方法；采用HPLC法建立样品中乌头碱总碱及岩白菜素的含量测定方法。结果：样品中定性鉴别薄层色谱特征明显，专属性强，阴性对照无干扰；HPLC测定中乌头总生物碱在0.0999～0.4995 mg范围内线性关系良好，r=0.9995；平均加样回收率为97.41%(n=9)；岩白菜素进样量在0.1324～1.0592μg范围内线性关系良好，r=0.9998；平均加样回收率为98.90%(n=9)。结论：建立的检测方法操作简便、准确、稳定、专属性强，可作为安儿宁颗粒的质量方法控制。%Objective: To set up quality standard of AnErNing granules. Methods: Qualitative identification methods of cholalic acid, hyodesoxycholic acid, GanCao (Glycyrrhiza uralensis Fisch.) and bergenin in the prepara-tions were established, and limit examination method for aconitine by TLC;content determination methods for total alkaloids of aconitine and bergenin were founded by HPLC. Results: TLC presented distinguishing features with strong specificity and the blank test showed no intereference of negative control;total alkaloids of WuTou indicated good linear relationship in the range between 0.099 9 and 0.499 5 mg by HPLC, r=0.999 5;average recovery rate was 97.41%(n=9);bergenin of sample size presented good linear relationship in the range between 0.132 4 and 1.059 2μg, r=0.999 8;average recovery rate was 98.90% (n=9). Conclusion:The determination method is simple, accurate, sta-ble and specific, and it could be used for quality control of AnErNing granules.
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