摘要
目的根据国家评价性抽验任务,对2015年吉林省全省范围内市场中流通的复方丹参片进行质量分析研究。方法根据《中国药典》2010年版第一增补本及《药品补充检验方法和检验项目批件号2008010》对全省范围内抽检的46批复方丹参片进行了全项检验,并对检验结果进行了统计分析与比较。结果按照现行标准检验,样品合格率为97.8%,但是通过对片剂中樟脑成分的检测发现,各厂家中樟脑的含量差异参差不齐。结论吉林省内抽检的46批样品根据现行检验标准检验,只有1批样品不合格,根据检验依据和结果可以认为,当前吉林省内生产、经营、流通使用的复复方丹参片质量较好。但是发现了不少问题,建议有关部门加强对复方丹参片中冰片投料的监管,以保证产品质量。
Objective According to evaluation of the national drug sampling and testing tasks, circulating in the market Danshen tablets for quality analysis in Jilin Province in 2015. Methods According to Chinese Pharmacopoeia 2010 first supplement and Drug Testing Methods and Complementary Project Approval Document Number 2008010, a province-wide sampling of 46 batches of Salvia tablets were full term tested, and the test results were statistically analyzed and compared. Results Under the current standard test, the sample pass rate was 97.8%, but by the detection of camphor tablets ingredients found differences in the content of the manufac- turers of camphor mixed. Conclusion The 46 batches of samples within a sampling of Jilin Province under the existing test standard test, and only one batch of samples failed. According to test results, and based on the view that the current production of Jilin Province, management, compound Danshen tablets in circulation are of good quality. But we found a lot of problems, and recommend relevant departments to strengthen compound Danshen tablet borneol feeding regulation, to ensure product quality.
作者
杨建龙
韩晶
王辉
徐丹
蔡广知
贡济宇
YANG Jianlong HAN Jing WANG Hui XU Dan CAI Guangzhi GONG Jiyu(Chinese Medicine department Changchun Center for Food and Drug Control, Changchun 130012, China Jilin Institute for Food Control, Changchun 130103, China Drug analysis Laboratories, Changchun University of Chinese Medicine, Changchun 130117, China)
出处
《中国中医药现代远程教育》
2017年第1期139-141,共3页
Chinese Medicine Modern Distance Education of China
关键词
复方丹参片
国家评价性抽验
质量控制
药品管理
compound Danshen tablets
evaluation of national drug sample testing
quality analysis
drug management
