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目的:制备戊已胶囊剂,并建立其质量控制方法。方法:采用乙醇加热回流法与水煎煮法提取药液。采用薄层色谱(TLC)法对黄连、吴茱萸、白芍进行定性鉴别,采用高效液相色谱(HPLC)法测定黄连中小檗碱的含量。结果:TLC图谱斑点清晰,专属性强;小檗碱的线性范围在10.5～105.0mg.L-1(r=0.9999),平均回收率为100.19%(RSD为0.76%,n=6)。结论:本品制备方法合理,质量标准可行,可用于戊已胶囊剂的质量控制。
OBJECTIVE: To prepare pentobarbitone capsules and to establish its quality control method. Methods: Ethanol heating reflux method and decoction method to extract liquid. TLC and HPLC were used to identify the contents of berberine in Coptis chinensis Franch, Fructus Evodiae and Radix Paeoniae Alba, respectively. The content of berberine in Coptis Chinensis was determined by high performance liquid chromatography (HPLC). Results: The spots of TLC were clear and specific. The linear range of berberine ranged from 10.5 to 105.0 mg.L-1 (r = 0.9999). The average recovery was 100.19% (RSD 0.76%, n = 6). Conclusion: The preparation method is reasonable and the quality standard is feasible. It can be used for the quality control of Pei Capsules.