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目的:建立消渴灵片的质量标准。方法:使用显微特征法对茯苓、石膏进行鉴别,采用TLC法对牡丹皮、黄芪、红参和黄连进行鉴别。用HPLC法测定消渴灵片中盐酸小檗碱的含量,使用Discovery C_(18)为色谱柱(150 mm×4.6 mm,5μm),流动相:乙腈-0.1%磷酸溶液(50:50)(每100 ml加十二烷基磺酸钠0.1 g),检测波长:265 nm;流速:1.0 ml.min~(-1);柱温为室温(27℃),进样量:10μl。结果:显微特征明显;薄层色谱斑点清晰;HPLC法中盐酸小檗碱对照品在0.16~16.20μg·ml~(-1)浓度范围内线性关系良好(r=0.999 9,n=5),回收率为98.99%(RSD=0.86%,n=6)。结论:该质量控制方法简便、可靠、准确,可用于消渴灵片的质量控制。
Objective: To establish the quality standard of Xiaokeling tablets. Methods: Tuckahoe and gypsum were identified by microscopic characteristic method. The contents of Cortex Moutan, Radix Astragali, Radix Ginseng and Coptis Chinensis were identified by TLC. The content of berberine hydrochloride in Xiaokeling tablets was determined by HPLC. The mobile phase consisted of acetonitrile-0.1% phosphoric acid solution (50:50) with Discovery C 18 column (150 mm × 4.6 mm, 5 μm) Per 100 ml sodium dodecyl sulfate 0.1 g), detection wavelength: 265 nm; flow rate: 1.0 ml.min -1; column temperature was room temperature (27 ° C), injection volume: 10 μl. Results: The microscopic features were obvious and the TLC spots were clear. The HPLC method showed good linearity (r = 0.999 9, n = 5) in the range of 0.16 ~ 16.20μg · ml ~ , The recovery was 98.99% (RSD = 0.86%, n = 6). Conclusion: The quality control method is simple, reliable and accurate and can be used for the quality control of Xiaokeling tablets.