近红外光谱法对非洛地平缓释片一致性检验研究  

Uniformity Study of Felodipine Sustained-release Tablets by NIRS

作　　者：耿颖[1] 庾莉菊[1] 何积芬 何兰[1] 

机构地区：[1]中国食品药品检定研究院,北京100050 [2]佛山市顺德区药品检验所

出　　处：《中国药师》2015年第5期753-755,共3页China Pharmacist

基　　金：重大新药创制专项(编号:2011ZX09303-001)

摘　　要：目的：建立3个厂家的非洛地平缓释片近红外光谱法一致性检验模型，考察制剂工艺的差别，通过稳健、准确、代表性强的近红外一致性模型实现非洛地平缓释片的快速检验和筛查。方法：对评价性抽验抽取的6个厂家中的3个建立非洛地平缓释片近红外一致性检验模型，选取4000~9000 cm-1区段为建模区段、一阶导数＋矢量归一化法作为预处理方法。结果：建立了3个厂家非洛地平缓释片的近红外一致性模型，对抽样的6个企业样品进行了预测，对本厂产品和其他厂家产品的预测成功率均为100%。结论：近红外光谱法能够用于快速鉴别不同厂家的非洛地平缓释片，对制剂工艺进行考察。Objective：To develop the uniformity models for felodipine sustalned-release tablets from 3 manufacturers by NIRS in order to study the difference in the preparation technology and detect and screen the tablets quickly by the robust, accurate and repre-sentative models. Methods：The uniformity models for the tablets from 3 manufacturers among 6 manufacturers with evaluative casual inspection were established by NIRS. Region 4 000-9 000 cm-1 was chosen as the modeling section, and the first derivative plus vector normalization was used as the preprocessing method. Results：The uniformity models for the tablets from the three manufacturers was established and used to predict the samplings from the six manufacturers. The prediction success rate was 100%. Conclusion： NIRS can be used to identify felodipine sustalned-release tablets from different manufacturers quickly and study the preparation technology.

关 键 词：近红外光谱法 非洛地平缓释片 一致性检验模型 主成分分析 

分 类 号：R917[医药卫生—药物分析学]