title: 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.
abstract: 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.
authors: State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Lianyungang 222001, China; Jiangsu Kanion Pharmaceutical Co. Ltd., Lianyungang 222001, China.
authors: Li-Qiong
authors: LQ
authors: Sun
authors: State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Lianyungang 222001, China; Jiangsu Kanion Pharmaceutical Co. Ltd., Lianyungang 222001, China.
authors: Shu-Yao
authors: SY
authors: Wang
authors: State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Lianyungang 222001, China; Jiangsu Kanion Pharmaceutical Co. Ltd., Lianyungang 222001, China.
authors: Yan-Jing
authors: YJ
authors: Li
authors: State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Lianyungang 222001, China; Jiangsu Kanion Pharmaceutical Co. Ltd., Lianyungang 222001, China.
authors: Yong-Xiang
authors: YX
authors: Wang
authors: State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Lianyungang 222001, China; Jiangsu Kanion Pharmaceutical Co. Ltd., Lianyungang 222001, China.
authors: Zhen-Zhong
authors: ZZ
authors: Wang
authors: State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Lianyungang 222001, China; Jiangsu Kanion Pharmaceutical Co. Ltd., Lianyungang 222001, China.
authors: Wen-Zhe
authors: WZ
authors: Huang
authors: State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Lianyungang 222001, China; Jiangsu Kanion Pharmaceutical Co. Ltd., Lianyungang 222001, China.
authors: Yue-Sheng
authors: YS
authors: Wang
authors: State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Lianyungang 222001, China; Jiangsu Kanion Pharmaceutical Co. Ltd., Lianyungang 222001, China.
authors: Yu-An
authors: YA
authors: Bi
authors: State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Lianyungang 222001, China; Jiangsu Kanion Pharmaceutical Co. Ltd., Lianyungang 222001, China.
authors: Gang
authors: G
authors: Ding
authors: State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Lianyungang 222001, China; Jiangsu Kanion Pharmaceutical Co. Ltd., Lianyungang 222001, China. Electronic address: kanionxw2010@126.com.
authors: Wei
authors: W
authors: Xiao
mesh_terms: D011232:Chemical Precipitation; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004365:Drugs, Chinese Herbal / Q000032:analysis / Q000737:chemistry*; D000431:Ethanol; D007267:Injections; D025341:Principal Component Analysis
chemical_list: D004365:Drugs, Chinese Herbal; C000596355:reduning; D000431:Ethanol
keywords: Ethanol precipitation; Principal Component Analysis; Process parameter; Re Du Ning Injections; Traditional Chinese Medicines