小儿氨酚黄那敏颗粒全组分色谱分析

Chromatographic Analysis of Total Components in Pedicatric Anfenhuang Namin Granules

目的:完善小儿氨酚黄那敏颗粒质量标准。方法:采用薄层色谱法(TLC)对主成分对乙酰氨基酚、马来酸氯苯那敏和人工牛黄中的胆酸和猪去氧胆酸同时进行鉴别;采用高效液相色谱(HPLC)双波长法同时测定对乙酰氨基酚和马来酸氯苯那敏的含量,色谱柱为DiamonsilC18,流动相为乙腈-1‰三乙胺的水溶液[用磷酸调pH(3.7±0.5)],梯度洗脱,检测波长分别为280、210nm。结果:薄层色谱法可同时鉴别4种主要成分;含量测定方法学考察中线性关系r≥0.9992,平均回收率≥99.3%,RSD≤0.8%(n=3)。结论:建立的方法可准确、快速地对小儿氨酚黄那敏颗粒进行定性、定量分析,可更全面地控制该制剂的质量。

OBJECTIVE：To improve the quality standard for Pediatric Anfenhuang Namin granules.METHODS：Paracetamol,chlorphenamine maleate,cholic acid and hyodeoxycholic in artificial cow-bezoar were identified by TLC simultaneously.The contents of paracetamol and chlorphenamine maleate were determined by HPLC with gradient elution and dual wavelength detection.The determination was performed on Diamonsil C 18 column with mobile phase consisted of acetonitrile-1‰ triethylamine [pH value adjusted to（3.7±0.5）using phosphoric acid].The detection wavelengths were 280 nm and 210 nm.RESULTS：TLC method can be used to determine 4 main components,in the methodology test of content determination,linearity r≥0.999 2,average recoveries were ≥99.3%,RSD≤0.8%（n=3）.CONCLUSIONS：The method is accurate and rapid for qualitative and quantity analysis of the granules,and quality control of the preparation completely.