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目的:建立参木肠溶胶囊的质量控制方法。方法:采用薄层色谱法(TLC)对制剂中木香、白芍、茯苓进行定性鉴别;采用高效液相色谱法(HPLC)测定制剂中盐酸小檗碱的含量。结果:TLC法可专属性地鉴别木香、白芍、茯苓,且特征斑点清晰,阴性对照无干扰。含量测定结果显示,盐酸小檗碱在0.028~0.28μg范围内线性关系良好,r=0.9995;平均加样回收率为100.81%,RSD为1.65%。结论:所建立的方法简便可行、重复性好,可有效控制参木肠溶胶囊的质量。
Objective: To establish the quality control method of Shenmu enteric-coated capsules. Methods: TLC, TLC and HPLC were used to identify the contents of berberine hydrochloride in the preparations. The content of berberine hydrochloride was determined by TLC. Results: The TLC method could identify woody, white peony root and tuckahoe exclusively, and the characteristic spots were clear. The negative control had no interference. The content of berberine hydrochloride showed good linearity in the range of 0.028-0.28μg, r = 0.9995. The average recovery was 100.81% and the RSD was 1.65%. Conclusion: The established method is simple and feasible, good repeatability, which can effectively control the quality of Shenmu enteric-coated capsules.