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基于黄酮类水平评价不同厂家舒血宁注射液的质量
引用本文:陈翔宇,孙胜斌,冯玉康,丁艳谱,张岩岩,姜国志,陈钟. 基于黄酮类水平评价不同厂家舒血宁注射液的质量[J]. 世界科学技术-中医药现代化, 2016, 0(6): 1056-1061
作者姓名:陈翔宇  孙胜斌  冯玉康  丁艳谱  张岩岩  姜国志  陈钟
作者单位:神威药业集团有限公司 石家庄 051430,神威药业集团有限公司 石家庄 051430;河北省中药注射剂工程技术研究中心 石家庄 051430,神威药业集团有限公司 石家庄 051430,神威药业集团有限公司 石家庄 051430,神威药业集团有限公司 石家庄 051430,中药注射剂新药技术开发国家地方联合工程实验室 石家庄 051430,神威药业集团有限公司 石家庄 051430
基金项目:国家科学技术部国家重大新药创制专项(2014ZX09201022-004):中药大品种舒血宁注射液的技术改造及安全性评价,负责人:王正品。
摘    要:目的:根据黄酮类水平评价不同厂家舒血宁注射液的质量。方法:按舒血宁注射液质量标准指纹图谱方法测定黄酮类物质的峰面积,用因子分析法根据得分情况评价不同厂家产品质量。结果:厂家A的综合得分为0.059,厂家B的综合得分为-0.11,厂家C的综合得分为0.053。结论:因子分析法可用于复杂成分的中药注射液的质量评价,不同厂家黄酮类水平各有优劣,但从综合得分看,厂家B的整体质量水平最差,厂家A和C的质量水平相当。

关 键 词:舒血宁注射液 因子分析法 质量评价 黄酮
收稿时间:2016-03-03
修稿时间:2016-04-06

Quality Evaluation of Flavonoids in Shuxuening Injections from Different Pharmaceutical Manufacturers
Chen Xiangyu,Sun Shengbin,Feng Yukang,Ding Yanpu,Zhang Yanyan,Jiang Guozhi and Chen Zhong. Quality Evaluation of Flavonoids in Shuxuening Injections from Different Pharmaceutical Manufacturers[J]. World Science and Technology—Modernization of Traditional Chinese Medicine and Materia Medica, 2016, 0(6): 1056-1061
Authors:Chen Xiangyu  Sun Shengbin  Feng Yukang  Ding Yanpu  Zhang Yanyan  Jiang Guozhi  Chen Zhong
Affiliation:Shineway Pharmaceutical Group Co.,Ltd.,Shijiazhuang 051430,China,Shineway Pharmaceutical Group Co.,Ltd.,Shijiazhuang 051430,China;Hebei Province Engineering Research Center for TCM Injection,Shijiazhuang 051430,China,State-Local Joint Engineering Laboratory of New Drugs Development Technology for TCM Injection,Shijiazhuang 051430,China
Abstract:This study aimed to evaluate the qualities of Shuxuening injection(SXNI)from different manufacturers in regard to the content of flavonoids,determining the peak area of flavonoids in SXNI through fingerprint method conforming to the quality standard,and assessing the quality of products in line with factor analysis.It was found that the comprehensive score of pharmaceutical manufacturer A was 0.059,while that of manufacturer B -0.11,and that of manufacturer C 0.053.In conclusion,it was indicated that the factor analysis method can be used for the quality evaluation of the injection of traditional Chinese medicine with complex composition.The qualities of flavonoids in SXNI from different pharmaceutical manufacturers remained uneven according to their comprehensive scores.The overall quality of manufacturer A kept the same as that of manufacturer C,while that of manufacturer B presented much worse.
Keywords:Shuxuening injection  factor analysis method  quality evaluation  flavonoids
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