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目的:建立四妙颗粒的质量标准。方法:用TLC法对四妙颗粒中苍术、黄柏、黄连进行鉴别;用HPLC法对制剂中的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;盐酸小檗碱的含量测定线性范围为0.15～0.90μg(r=0.999 4,n=6),平均回收率为99.65%(RSD=3.04%,n=6)。结论:所建立方法准确可靠,灵敏度高,专属性强,能有效控制四妙颗粒的质量。
Objective: To establish the quality standard of Simiao granules. Methods: The TLC method was used to identify Atractylodes, Cortex Phellodendri and Coptidis Rhizoma in Simiao granule. The content of berberine hydrochloride in the preparation was determined by HPLC. Results: The results of qualitative identification were better and the specificity was better. The linear range of determination of berberine hydrochloride was 0.15-0.90μg (r = 0.999 4, n = 6), the average recovery was 99.65% (RSD = 3.04% n = 6). Conclusion: The established method is accurate and reliable, high sensitivity, specificity, and can effectively control the quality of Si Miao granules.