摘要
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 develop a method for the quality control of Xiaokeling pills. Method ： Microscopic characteristics were employed to qualitatively identify Poria, C, ypsum fibrosum and Moutan cortex, Astragali radix, Ginseng radix et rhizome rubra and Copti- dis rhizome were identified by TLC. An HPLC with a Discovery Cls column （ 150 mm x4.6 ram,5 μm） was applied in the determina- tion of berberine hydrochloride with the mobile phase of acetonitrile-0.1% phosphoric acid solution （50： 50） （ containing 0.1 g/100 ml sodium lauryl sulfate） , the flow rate of 1.0 ml min- 1 , the detection wavelength of 265 nm, the column temperature of room tempera- ture（ 27~C ） and the injection volume of 10 pd. Result： The microscopic characteristics were obvious and the TLC spots were quite clear. The tested samples and the reference substance showed the same chromatographic spots. The linear range of berberine hydrochlo- ride was 0.16-16.20 μg m1-1 （ r =0.999 9 ,n =5）, and the average recovery was 98.9% （RSD =0.86, n = 6）. Conclusion： The method is sensitive, accurate and rapid, and the quality standard can be used in the quality control of Xiaokeling pills.
出处
《中国药师》
CAS
2013年第11期1641-1644,共4页
China Pharmacist
