益气散聚颗粒质量标准研究

Quality Standard for Yiqi Sanju Granules

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 for Yiqi Sanju granules. Method： Astragalus membranaceus （Fisch.） Bge. and Artemisia capillaries Thunb. in Yiqi Sanju granules were identified by TLC. The polysaccharides were determined using DNS colorimetric method. Berberine hydrochloride was determined by HPLC. Result： The characteristic identification by TLC was distinct and highly specific. The absorptions of the processed samples were tested at the wavelength of 480nm. The linear range of glucose was 4. 168-29.176 mg · L- 1 （ r = 0. 999 8 ）, and the average recovery was 97.13 % （ RSD -- 1.77 % , n = 6 ）. The linear range of berberine hydroehloride was 0.09-1.74μg（ r = 1. 000 0 ）, and the average recovery was 99.07% （ RSD = 1.05% , n = 6 ）. Conclusion ： The method is reliable, accurate and specific. It ean be used in the quality control of Yiqi Sanju granules.