Impact of parameter fluctuations on the performance of ethanol precipitation in production of Re Du Ning Injections, based on HPLC fingerprints and principal component analysis

作     者：SUN Li-Qiong WANG Shu-Yao LI Yan-Jing WANG Yong-Xiang WANG Zhen-Zhong HUANG Wen-Zhe WANG Yue-Sheng BI Yu-An DING Gang XIAO Wei 

作者机构：State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process Lianyungang 222001 China Jiangsu Kanion Pharmaceutical Co. Ltd. Lianyungang 222001 China 

出 版 物：《Chinese Journal of Natural Medicines》 (中国天然药物（英文版）)

年 卷 期：2016年第14卷第1期

页      面：73-80页

核心收录：

学科分类：0710[理学-生物学] 1007[医学-药学(可授医学、理学学位)] 1006[医学-中西医结合] 1005[医学-中医学] 1002[医学-临床医学] 0703[理学-化学] 10[医学] 100602[医学-中西医结合临床] 

基　　金：supported by 973 Project from the Ministry of Science and Technology of China(No.2010 CB735604) 

主　　题：Traditional Chinese Medicines Ethanol precipitation Re Du Ning Injections Process parameter Principal Component Analysis 

摘      要：The present study was designed to determine the relationships between the performance of ethanol precipitation and seven process parameters in the ethanol precipitation process of Re Du Ning Injections,including concentrate density,concentrate temperature,ethanol content,flow rate and stir rate in the addition of ethanol,precipitation time,and precipitation temperature.Under the experimental and simulated production conditions,a series of precipitated resultants were prepared by changing these variables one by one,and then examined by HPLC fingerprint analyses.Different from the traditional evaluation model based on single or a few constituents,the fingerprint data of every parameter fluctuation test was processed with Principal Component Analysis(PCA)to comprehensively assess the performance of ethanol precipitation.Our results showed that concentrate density,ethanol content,and precipitation time were the most important parameters that influence the recovery of active compounds in precipitation resultants.The present study would provide some reference for pharmaceutical scientists engaged in research on pharmaceutical process optimization and help pharmaceutical enterprises adapt a scientific and reasonable cost-effective approach to ensure the batch-to-batch quality consistency of the final products.