近红外光谱技术测定复方丹参脉冲片衣膜厚度及其与体外释药时滞相关性的研究  

Determination of Coating Film Thickness of Compound Danshen Pulsatile Release Tablets by Near Infrared Spectroscopy and Research of the Correlation between Coating Film Thickness and Drug Release Lag Time

作　　者：潘德城[1] 罗晓健[2,3] 宋小玲[1] 龚明 胡锦芳[1] 任翔 Pan Decheng;Luo Xiaojian;Song Xiaoling;Gong Ming;Hu Jinfang;Ren Xiang(Department of Pharmacy,First Affiliated Hospital of Nanchang University,Nanchang 330006,China;Jiangxi University of Traditional Chinese Medicine;National Pharma-ceutical Engineering Center for Solid Preparations of Chinese Herbal Medicine;Jiangxi Pharmaceutical Price and Procurement Serv-ice Center)

机构地区：[1]南昌大学第一附属医院药学部,南昌330006 [2]江西中医药大学 [3]中药固体制剂制造技术国家工程研究中心 [4]江西省医药价格和采购服务中心

出　　处：《中国药师》2022年第5期898-904,共7页China Pharmacist

基　　金：江西省科技厅应用研究培育计划项目(编号:20181BBG78051);江西省卫生计生委中医药科研项目(编号:2017A302)。

摘　　要：目的:采用近红外漫反射光谱分析技术,建立快速、无损测定复方丹参脉冲片包衣膜厚度的方法,并进一步对衣膜厚度与体外释药时滞的相关性进行研究。方法:采集不同厚度脉冲片样品的近红外光谱,对光谱的预处理方法、建模波段、主因子数进行优选,采用偏最小二乘回归方法(PLSR)建立包衣膜厚度的近红外光谱定量校正模型,并对所建模型进行方法学考察。采用不同的方程拟合释药时滞及衣膜破裂时间与衣膜厚度的相关关系。结果:所建包衣膜厚度的近红外光谱定量校正模型相关系数r为0.9927,内部交叉验证均方根误差(RMSECV)为3.35μm,预测均方根误差(RMSEP)为4.15μm。释药时滞及衣膜破裂时间与衣膜厚度的相关性以二项式拟合效果最优。结论:本试验所建中药脉冲片包衣膜厚度测定方法快速、无损、可靠,可进一步应用于评价及指导脉冲制剂的体内外释药行为研究和中药生产包衣过程的在线检测。Objective:To establish a rapid and nondestructive method to measure the coating film thickness of compound Danshen pulsatile release tablets(CDPRT)by using the near infrared spectroscopy(NIRS)technology,and to research the correlation between coating film thickness and lag time of CDPRT by using the same samples for the dissolution test in vitro.Methods:NIRS spectrographs of CDPRT samples with different coating film thickness were obtained,and the spectral pretreating methods,wavenumber selection and main factor number of NIRS were optimized.Partial least squares regression(PLSR)was used for building the NIRS quantitative calibration models for the coating film thickness,and the methodology of models were investigated.Different modeling methods were used to research the correlation between coating film thickness and rupture time,drug release lag time.Results:Correlation coefficients(r),root-mean-squares error of cross-validation(RMSECV)and root mean square error of prediction(RMSEP)obtained by PLSR model were 0.9927,3.35μm and 4.15μm,respectively.The binomial fitting between drug release lag time,coating rupture duration and coating thickness was optimal.Conclusion:Predicted results show that the established method is rapid,nondestructive and reliable,which can be applied to evaluating and guiding the studies on pulsed preparation release effects in vivo and in vitro,and the online monitoring of coating process of Chinese medicine tablets.

关 键 词：近红外光谱 包衣膜厚度 复方丹参脉冲片 偏最小二乘回归法 释药行为 

分 类 号：R917[医药卫生—药物分析学]