大黄碳酸氢钠片评价性抽验结果及质量评价  

Sampling Test Results and Quality Evaluation of Rhubarb Sodium Bicarbonate Tablets

作　　者：金鹏[1] 吴旭[1] 

机构地区：[1]淮安市食品药品检验所,江苏淮安223300

出　　处：《中国药物评价》2017年第4期300-304,共5页Chinese Journal of Drug Evaluation

摘　　要：目的:评价大黄碳酸氢钠片的质量现状及存在问题。方法:按现行标准结合探索性研究进行样品检验,统计分析检验结果。结果:按现行标准检验,100批大黄碳酸氢钠片中不合格批数为6批,不合格率为6%;经探索性试验,部分样品中大黄素和大黄酚的含量很低,有16批样品检出土大黄苷相似物。结论:本次抽验的大黄碳酸氢钠片总体质量评价一般,现行质量标准还需进一步完善。Objective： To evaluate the quality status and exsisting problems of rhubarb sodium bicarbonate tablets. Methods： Using statutory testing methods combined with the exploratory research to examine samples, the results were statistically analyzed. Results：Ac- cording to the results of the current quality standard,among the 100 batches of Rhubarb Sodium Bicarbonate Tablets, 19 batches of them are unqualified, accounting for 6% ; According to the results of exploratory test, the content of emodin and chrysophanol was low in some sample, the similarity of rhaponticin was detected in 16 batches of samples. Conclusion：The quality of rhubarb sodium bicarbonate tablets is average, the current quality standards need to be further improved.

关 键 词：大黄碳酸氢钠片 评价性抽验 质量评价 

分 类 号：R927.1[医药卫生—药学]