小儿咽扁分散片的质量标准研究

Quality Standard Study of Pediatric Throat Tonsil Dispersible Tablets

目的:建立小儿咽扁分散片的质量控制方法。方法:用高效液相法测定小儿咽扁分散片中金银花的有效成分绿原酸的含量,对处方中金银花、射干、麦冬进行了薄层鉴别[1][2]。结果:绿原酸进样量在0-0.2814μg范围内与峰面积线性关系良好,r=0.9997,回收率为99.68%,RSD为0.99%。金银花、射干和麦冬的薄层色谱重现性好;结论:HPLC法准确可靠、重现性好,可用于该制剂的质量控制。

Objective：To establish the quantity control method of Pediatric Tharoat Tonsil Dispersible Tablets.Methods：To determine the contents of caffeotanic acid of flost lonicerae＇s active components in Pediatric Tharoat Tonsil Dispersible Tablets.Treat the lost lonicaerae belamcandae,ophiopogonis with lamellar detect.Results：The sample size of caffeotannic acid between 0-0.2814μg has a good linear correlation with peak area,r=0.9997,the recovery rate is 99.68%,RSD is 0.99%.The color spectrum reproducibility of flost lonicerae belamcandae,ophiopogonis is good.Conclusion：HPLC is accurate and reiable and the reproducibility is good.It can be used in the quantity control of this preparation.