国家药品评价性抽验通滞苏润江制剂质量分析及建议  

Quality Analysis and Suggestion for Tongzhisurunjiang Preparations of National Drug Evaluation Sampling Test

作　　者：于新兰 王雪 冯春蕾 于睿 徐鸿 陈媛媛 周洋 孙磊 Yu Xinlan;Wang Xue;Feng Chunlei;Yu Rui;Xu Hong;Chen Yuanyuan;Zhou Yang;Sun Lei(Xinjiang Institute for Food and Drug Control,Urumqi 830004,China;National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]新疆维吾尔自治区食品药品检验所,乌鲁木齐830004 [2]中国食品药品检定研究院,北京100050

出　　处：《中国药事》2019年第3期275-282,共8页Chinese Pharmaceutical Affairs

基　　金：中国食品药品检定研究院中青年发展研究基金(编号2013WA8)

摘　　要：目的:通过对通滞苏润江制剂的评价性抽验结果进行分析,以评价其质量现状。方法:先依据现行质量标准进行检验。再采用高效液相色谱法、气相色谱法和化学计量学等分析技术,从安全性、有效性和整体质量控制角度开展探索性研究。结果:标准检验合格率为100%。探索性研究结果表明,部分样品存在辐照问题;部分样品存在黄曲霉毒素检出的情况;毒性成分秋水仙碱的检测方法和限度存在不一致的情况;贵细药西红花普遍投料不足;部分样品番泻叶成分含量低;诃子肉含量差异过大;质量标准检测项目不够全面、不统一等。结论:通滞苏润江制剂总体质量较差,质量标准有待进一步提高。Objective: To evaluate the quality status of Tonzhisurunjiang preparations by analyzing the national evaluation sampling test results. Methods: Samples were tested according to current quality standards.Exploratory study were carried out for the following perspectives, such as safety, effectiveness and quality control,by using HPLC, GC, chemomertics and other analytical techniques. Results: The qualified rate of inspection was 100%. The results of exploratory study showed that some samples had radiation problems and aflatoxin contamination. There were inconsistencies in the detection method and limitation of colchicine, shortage of saffron and sennae folium, too many differences in content of chebulae fructus, as well as incomprehensive and ununiform quality standards. Conclusion: The overall quality of Tonzhisurunjiang preparations was poor and the quality standard needed to be further improved.

关 键 词：通滞苏润江胶囊 通滞苏润江片 质量评价 化学计量学分析 

分 类 号：R917[医药卫生—药物分析学] R95[医药卫生—药学]