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目的:建立益气散聚颗粒质量标准。方法:采用TLC法对益气散聚颗粒中黄芪、茵陈进行定性鉴别;用3,5-二硝基水杨酸(DNS)法对制剂中多糖进行含量测定;用HPLC法对制剂中盐酸小檗碱进行含量测定。结果:定性鉴别分离度较好,专属性强;样品经DNS试剂显色后于480 nn处测定吸光度,多糖含量测定线性范围为4.168~29.176 mg·L~(-1),r=0.999 8,平均加样回收率为97.13%,RSD为1.77%(n=6);盐酸小檗碱的含量测定线性范围为0.09~1.74μg(r=1.000 0),平均回收率为97.06%(RSD=1.05%,n=6)。结论:所建立方法准确可靠,灵敏度高,专属性强,能有效控制益气散聚颗粒的质量。
Objective: To establish the quality standard of Yiqi Sanju granule. Methods: The contents of polysaccharides in Radix Astragali, Radix Angelicae Sinensis were identified qualitatively by TLC and the content of polysaccharides in Radix Astragali, Berberine content determination. Results: The results of qualitative identification were better and the specificity was better. The absorbance was measured at 480 nn after DNS reagent was developed. The linear range of polysaccharide was 4.168-29.176 mg · L -1, r = 0.999 8. The average recovery was 97.13% and the RSD was 1.77% (n = 6). The linear range of determination of berberine hydrochloride was 0.09-1.74μg (r = 1.000 0) and the average recovery was 97.06% (RSD = 1.05 %, n = 6). Conclusion: The established method is accurate and reliable, high sensitivity and specificity, and can effectively control the quality of Yiqi Sanju granule.