利咽颗粒剂质量标准的研究

Study on the quality standard for Liyan granule

目的 对利咽颗粒剂的质量标准进行研究。方法 用薄层色谱鉴别的方法对颗粒剂主要成分之一金银花进行定性分析 ,并用双波长紫外分光光度法对其主要成分绿原酸的含量进行测定。用小鼠进行急性毒性实验。结果 供试品溶液中检出了与绿原酸对照品溶液相一致的斑点。含量测定结果表明绿原酸溶液在 0 .46～ 46 .0 0 μg·mL-1之间有良好的线性关系 ,r =0 .9992 ,回收率 97.33% ,RSD为 1.49%。急性毒性实验结果表明 ,利咽颗粒剂毒性很小 ,小鼠一次最大耐受为临床人用剂量的85 0倍。结论 本法可为利咽颗粒剂的质量控制提供了科学的依据。

OBJECTIVE To establish a quality standard for Liyan granule.METHODS Honeysukle flower in the granule was identified by TLC.The developing agent was the upper solvent of butyl acetate formil acid water(7∶2.5∶2.5).The dual wavelength spectrophotometry was applied for the determination of chlorogenic acid in granule.And the acute toxicity test was accomplished.RESULT The TLC for the identification of Honeysule flower in the granule was accurate.The uv for chlorogenic acid was reliable.The linear range of chlorogenic acid was 0.46～46.00 μg·mL -1 ( r =0.9992),and the recovery was 97.33%, RSD =1.49%.The acute toxicity test showed that the maximal tolerable dose in rats was equivalent to 850 times of the clinical dosage in human.CONCLUSION This method could be used as the quality control during the production of Liyan granule.