丹参舒心胶囊检验结果与质量评价  

Test Results and Quality Evaluation of Danshen Shuxin Capsules

作　　者：黄丽丹[1] 张亚中[1] 王鼎[1] 刘军玲[1] 袁杰[1] 程世云[1] 蒲婧哲 翟宏焱[1] 班永生[1] 王理民 

机构地区：[1]安徽省食品药品检验所,合肥230051

出　　处：《中国药事》2011年第6期584-586,共3页Chinese Pharmaceutical Affairs

基　　金：2009年全国药品抽验品种

摘　　要：目的对全国药品流通领域中丹参舒心胶囊的质量现状进行全面评价。方法按丹参舒心胶囊的现行标准进行检验,同时开展探索性研究,并进行统计分析。结果按现行标准检验,96.9%的样品符合规定;探索性研究发现,丹参舒心胶囊原料工艺参数不明确,产品质量参差不齐,含量差异悬殊;个别企业未按工艺规定生产。结论丹参舒心胶囊的现行标准不能有效控制产品质量,工艺参数需研究明确,质量标准亟待修订提高。Objective Comprehensively evaluate the quality status of Dansheng Shuxin Capsules in nationwide circulation of medicine.Methods Test Dansheng Shuxin Capsules on the basis of current standards,carry on with exploratory research and statistical analysis.Results Based on the current standards,96.9% of the samples met the standards.By the detection of exploratory research,the technology parameter of raw materials of Dansheng Shuxin Capsule was not clear,product qualities were not uniform and the medicine content in different samples were varied a lot.Very few companies did not produce following the standards.Conclusion The current standards of Dansheng Shuxin Capsules can not control the quality of the product effectively.The technology parameter should be definite and the quality standard must be improved.

关 键 词：丹参舒心胶囊 探索性研究 质量评价 

分 类 号：R288[医药卫生—中药学] R943.3[医药卫生—中医学]