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目的:建立乙肝清缓释片的质量标准。方法:采用薄层色谱法(TLC)对制剂中的贯叶连翘进行鉴别;采用高效液相色谱法(HPLC)测定制剂中的金丝桃素含量,Phenomenence Luna C18色谱柱(4.6 mm×250 mm,5μm),流动相乙腈-0.025mol.L-1 KH2 PO4水溶液(85∶15),检测波长588 nm。并对制剂进行释放度考察。结果:TLC图谱分离度好,检出斑点清晰;金丝桃素在0.076～0.76μg呈良好的线性关系,r=0.999 9,平均回收率98.66%,RSD 2.51%。结论:该法操作简便、可行,重复性好,可作为乙肝清缓释片的质量控制标准。
Objective: To establish the quality standard of Hepatitis B sustained release tablets. Methods: TLC was used to identify Hypericum perforatum L. The content of hypericin in the preparation was determined by high performance liquid chromatography (HPLC). Phenomenence Luna C18 column (4.6 mm × 250 mm, 5μm), mobile phase acetonitrile -0.025mol.L-1 KH2PO4 aqueous solution (85:15), detection wavelength 588 nm. And the release of the preparation investigated. Results: The TLC chromatogram was good and the spots were clear. Hypericin showed a good linear relationship between 0.076 ~ 0.76μg, r = 0.999 9, the average recovery was 98.66% and the RSD was 2.51%. Conclusion: The method is simple, feasible, reproducible, and can be used as a quality control standard for HDCP.