复方附子口服液中黄芪甲苷含量测定和乌头碱限量检查方法研究

目的建立复方附子口服液中黄芪甲苷含量测定和乌头碱限量检测方法。方法采用HPLC法对黄芪甲苷含量、乌头碱限量进行检测。结果黄芪甲苷在0.047 12⁰.471 2 mg·mL-1与峰面积线性关系良好(r=0.999 7),高、中、低浓度平均加样回收率分别为99.9%、99.9%、97.6%,RSD分别为4.4%、1.9%、2.2%;乌头碱在0.005 970.471 2 mg·mL-1与峰面积线性关系良好(r=0.999 7),高、中、低浓度平均加样回收率分别为99.9%、99.9%、97.6%,RSD分别为4.4%、1.9%、2.2%;乌头碱在0.005 97⁰.597 0 mg·mL-1与峰面积线性关系良好(r=0.999 9);高、中、低浓度平均加样回收率分别为101.3%、98.3%、98.7%,RSD分别为2.1%、1.0%、1.6%。结论该方法专属性强,灵敏度高,重现性好,可用于复方附子口服液中黄芪甲苷含量和乌头碱限量的检测。

Determination of astragaloside and aconitine in compound aconite oral solution

Objective To determine the content of astragaloside and the limit detection of aconitine in compound aconite oral solution. Methods HPLC method was used to detect astragaloside and aconitine. Results Astragaloside showed a good linearity at 0.047 12 - 0.471 2 mg · mL^- 1 （r = 0.999 7）, the average recoveries of high, middle and low concentration were 99.9%, 99.9% and 97.6%, and RSDs were 4.4%, 1.9% and 2.2%. The aconitine showed a good linearity at 0.005 97 - 0.597 mg· mL^- 1 （r = 0.999 9）, the average recoveries of high, middle and low concen- tration were 101.3%, 98.3% and 98.7%, and RSDs were 2.1%, 1.0% and 1.6%. Conclusion The method is specific, highly sensitive, good reproducible and can be used to detect the astragaloside and aconitine in the compound aconite oral solution.