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.
journal_name
Chin J Nat Medjournal_title
Chinese journal of natural medicinesauthors
Sun LQ,Wang SY,Li YJ,Wang YX,Wang ZZ,Huang WZ,Wang YS,Bi YA,Ding G,Xiao Wdoi
10.3724/SP.J.1009.2015.00073subject
Has Abstractpub_date
2016-01-01 00:00:00pages
73-80issue
1eissn
2095-6975issn
1875-5364pii
S1875-5364(16)30012-7journal_volume
14pub_type
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journal_title:Chinese journal of natural medicines
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