三黄栓质量标准研究

目的建立三黄栓的质量控制方法。方法采用薄层色谱法鉴别三黄栓中的黄连、黄芩、黄柏。采用高效液相色谱法测定制剂中黄芩苷、盐酸小檗碱的含量,色谱柱为Aglient ZORBAXSB-C18(4.6 mm×250 mm,0.45μm),甲醇-水-磷酸(47∶53∶0.2)为流动相,流速为1.0 mL/min,检测波长黄芩苷为280 nm、盐酸小檗碱为365 nm,柱温30℃。结果定性鉴别色谱特征明显。黄芩苷在0.248~2.48μg线性关系良好(r=0.999 9),平均回收率为99.77%,RSD=1.05%;盐酸小檗碱在0.336~1.68μg线性关系良好(r=0.999 9),平均回收率为97.74%,RSD=1.48%。结论该定性定量检测方法简便可行,可有效控制该制剂质量。

Quality Standard Study of Sanhuang Suppository

Objective To establish the quality control method for Sanhuang Suppository. Methods Coptidis rhizoma, Scutellariae radix and Phellodendri chinensis cortex in Sanhuang Suppository were identified by TLC. The contents of baicalin and berberine hydrocholride were determined by HPLC which was performed on an Agilent Zorbaxsb C18 column （4.6 mm×250 mm, 0.45 μm） with a mobile phase of methanol-water-phosphoric acid （47∶53∶0.2）, with flow rate of 1.0 mL/min. The wavelength of detector was set at 280 nm for baicalin and 365 nm for berberine hydrochloride, with column temperature of 30℃.Results Chromatographic characteristics of qualitative identification were evident. The linear range of baicalin was 0.248-2.48 μg （r=0.999 9） and the average recovery rate was 99.77% （RSD=1.05%）. The linear range of berberine hydrocholride was 0.336-1.68 μg （r=0.999 9） and the average recovery rate was 97.74% （RSD=1.48%）.Conclusion The method of qualitative and quantitative analysis is accurate, feasible and suitable for effective quality control of Sanhuang Suppository.