黄芪复方制剂供试品溶液制备方法优化

Optimization of the Preparation for the Test Solution of Huangqi Compound Preparation

目的优化黄芪复方制剂供试品溶液的制备方法。方法以提取溶剂为影响因素,以扶正强筋片样品中黄芪甲苷含量为考察指标,优选供试品溶液制备方法。并以此方法对4种市售黄芪复方制剂(前列通片、复方石韦片、芪明颗粒、复方血栓通胶囊)进行验证。结果优选方法为在药典方法基础上,用氨试液-水-水饱和的正丁醇(10∶30∶50,V/V/V)混合溶剂进行加热回流提取(含量测定结果为1.09 mg/g,RSD为1.93%)。4种复方制剂测得黄芪甲苷含量为药典方法的1.8~2.6倍,RSD介于1.61%~4.73%。结论该方法快捷高效,专属性、重复性良好,降低了系统误差,结果准确,可用于黄芪复方制剂供试品溶液的制备。

Objective To optimize the preparation method of the test solution of Huangqi Compound Preparation.Methods The preparation method of the test solution was optimized with the extraction solvent as the influencing factor and the content of astragalosideⅣin the Fuzheng Qiangjin Tablets as the investigation indicator.The above optimal method was verified with four commercial Huangqi Compound Preparations(Qianlietong Tablets,Compound Shiwei Tablets,Qiming Granules,Compound Xueshuantong Capsules)as the test subjects.Results The optimal method was that the ammonia test solution-water-water saturated n-butanol(10∶30∶50,V/V/V)was used for heating reflux extraction based on the method of Chinese Pharmacopoeia;the content of astragalosideⅣdetermined by the above method was 1.09 mg/g with an RSD of 1.93%.The content of astragalosideⅣin four compound preparations determined by the above optimal method was in the range of 1.8 to 2.6 times higher than that determined by the method of Chinese Pharmacopoeia,with an RSD in the range of 1.61%to 4.73%.Conclusion This method is fast,efficient,specific,repeatable,accurate and has low systematical error,which can be used for the preparation of the test solution of Huangqi Compound Preparation.