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作 者:曲佳 陈卓 刘小瑞 王杰 Qu Jia;Chen Zhuo;Liu Xiaorui;Wang Jie(Tianjin Institute for Drug Control,Tianjin 300070;Tianjin Wuqing District Cuihuangkou Hospital,Tianjin 301702)
机构地区:[1]天津市药品检验研究院,天津300070 [2]天津市武清区崔黄口医院,天津301702
出 处:《天津药学》2018年第3期11-16,共6页Tianjin Pharmacy
摘 要:目的:建立补肾强身片的近红外一致性模型,为鉴别不同厂家产品提供依据。方法:使用MPA型近红外光谱仪(1.5 m光纤探头)、OPUS 5.5软件,采用一阶导数+矢量归一化法对原始光谱进行预处理。结果:北京同仁堂科技发展股份有限公司制药厂补肾强身片一致性指数(CI值)设为7,湖北诺得胜制药有限公司补肾强身片CI值设为4.3,景忠山国药(唐山)有限公司补肾强身片CI值设为4.2,葵花药业集团(佳木斯)有限公司补肾强身片CI值设为4.4,洛阳天生药业有限责任公司补肾强身片CI值设为7,三门峡莘原制药有限公司补肾强身片CI值设为6.5,太极集团四川绵阳制药有限公司补肾强身片CI值设为4.6时,所建模型能将以上不同厂家的补肾强身片快速鉴别,且各模型经验证均可行。结论:此方法简便、快捷、环保,建立该品种近红外一致性检验模型,以用于建立快筛方法鉴别不同厂家补肾强身片。Objective: To establish a consistency test model by near-infrared spectroscopic method for the comparison of the consistency of Bushenqiangshen Tablet from various manufacturers. Methods: The MPA near-infrared spetrometer(1. 5 m optical fiber probe) and OPUS 5. 5 software were used. The original spectra were pretreated by the first derivative + vector normalization method. Results: CI(consistency index) was 7. 4 for the products of Beijing Tongrentang Technology Co Ltd was 7,4. 3 for Hubei Nodse Pharmaceutical Co Ltd,4. 2 for Jingzhongshan sinopharm(Tangshan) Co Ltd,4. 4 for Sunflower Group(Jiamusi) Co Ltd,7 for Luoyang natural pharmaceutical Co Ltd,6. 5 for Sanmenxia Shenyuan Pharmaceutical Co Ltd and 4. 6 for Sichuan Mianyang Pharmaceutical Co Ltd affiliated to Taiji Group. The model could be used to identify Bushenqiangshen Tablet from different manufacturers quickly. Conclusions: This approach is convenient,rapid and environment-friendly,and can be applied to the classification of the products from different manufacturers rapidly.
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