在线检测复方消化酶胶囊肠溶层包衣过程  

On-line Detection of Enteric Coating Process of Compound Digestive Enzyme Capsules

作　　者：程妍 梅魏鹏 顾峥嵘 刘旻虹 付金凤 汪嘉丽 邵铖祎 CHENG Yan;MEI Wei-Peng;GU Zheng-Rong;LIU Min-Hong;FU Jin-Feng;WANG Jia-Li;SHAO Cheng-Yi(Changzhou Institute for Food,Drug and Fiber Control,Changzhou 213000,China;Chanse Technology(Jiangsu)Inc.,Changzhou 213000,China;Changzhou Qianhong Biopharma Co.,Ltd.,Changzhou 213000,China)

机构地区：[1]常州市食品药品纤维质量监督检验中心,江苏常州213000 [2]创志科技(江苏)股份有限公司,江苏常州213000 [3]常州千红生化制药股份有限公司,江苏常州213000

出　　处：《中国药物经济学》2023年第6期96-101,共6页China Journal of Pharmaceutical Economics

摘　　要：目的 利用近红外光谱分析技术、微波快速水分检测技术及粒径分析技术实现生产过程中对复方消化酶胶囊肠溶层包衣情况的在线检测。方法 建立近红外光谱数据与理论增重模型,微波水分测量值与真实水分模型,粒径(包衣膜厚)与理论增重、紫外吸光度模型,并利用模型对包衣过程进行预测。结果 所建模型及根据模型预测结果的相关度均大于97,标准偏差均小于5%。结论 实验所建模型快速、无损、可靠,可应用于复方消化酶胶囊肠溶层包衣过程的在线检测。Objective To realize on-line detection of Enteric coating of Compound digestive enzyme capsules by near infrared spectroscopy,microwave rapid moisture detection and particle size analysis.Methods Near infrared spectroscopy data and theoretical weight gain model,microwave moisture measurement data and real moisture model,particle size(coating thickness) and theoretical weight gain model,UV absorption model were established,the coating process was predicted by the model.Results The correlation degree of the model and the prediction result based on the model were more than 97,and the standard deviation was less than 5%.Conclusion The prediction results show that the model is rapid,non-destructive and reliable,which can be used for on-line detection of Enteric coating process of Eompound digestive enzyme capsules.

关 键 词：复方消化酶胶囊 肠溶层包衣 在线检测 近红外分析 微波水分分析 粒径分析 

分 类 号：R975[医药卫生—药品] R917[医药卫生—药学]