藏药安儿宁颗粒的质量标准研究

Study on Quality Standard of Tibetan Medicine AnErNing Granules

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0.099 9~0.4995 mg范围内线性关系良好,r=0.999 5;平均加样回收率为97.41%（n=9）;岩白菜素进样量在0.132 4~1.0592μg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 A nErNing granules. Methods： Qualitative identification methods ofcholalic acid, hyodesoxycholic acid, GanCao （Glycyrrhiza uralensis Fisch.） and bergenin in the preparations 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 A nErNing granules.