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响应面法优选妇科IV颗粒一步制粒工艺
引用本文:刘丹,何凤军,刘长龙,刘俊超,吴云,王振中,萧伟.响应面法优选妇科IV颗粒一步制粒工艺[J].中国中药杂志,2016,41(1):75-82.
作者姓名:刘丹  何凤军  刘长龙  刘俊超  吴云  王振中  萧伟
作者单位:江苏康缘药业股份有限公司, 江苏连云港 222001;中药制药过程新技术国家重点实验室, 江苏连云港 222001;中药提取精制新技术重点研究室, 江苏连云港 222001,江苏康缘药业股份有限公司, 江苏连云港 222001;中药制药过程新技术国家重点实验室, 江苏连云港 222001;中药提取精制新技术重点研究室, 江苏连云港 222001,江苏康缘药业股份有限公司, 江苏连云港 222001;中药制药过程新技术国家重点实验室, 江苏连云港 222001;中药提取精制新技术重点研究室, 江苏连云港 222001,江苏康缘药业股份有限公司, 江苏连云港 222001;中药制药过程新技术国家重点实验室, 江苏连云港 222001;中药提取精制新技术重点研究室, 江苏连云港 222001,江苏康缘药业股份有限公司, 江苏连云港 222001;中药制药过程新技术国家重点实验室, 江苏连云港 222001;中药提取精制新技术重点研究室, 江苏连云港 222001,江苏康缘药业股份有限公司, 江苏连云港 222001;中药制药过程新技术国家重点实验室, 江苏连云港 222001;中药提取精制新技术重点研究室, 江苏连云港 222001,江苏康缘药业股份有限公司, 江苏连云港 222001;中药制药过程新技术国家重点实验室, 江苏连云港 222001;中药提取精制新技术重点研究室, 江苏连云港 222001
基金项目:国家"重大新药创制"科技重大专项(2013ZX09402203)
摘    要:利用响应面法优选妇科IV(FKIV)颗粒一步制粒的工艺条件。以颗粒合格率为指标,利用Plackett-Burman设计实验,对影响一步制粒的6个因素进行考察,评价各因素显著水平并确定主要影响因素。在此基础上,以颗粒合格率、含水量、休止角为指标,建立3因素3水平的Box-Behnken设计,对模型进行全二次回归拟合,并利用Response Optimizer优化实验结果。确定最佳一步制粒工艺条件:浸膏相对密度1.20,进风温度88℃,雾化压力0.28 MPa。利用该优化方案制备妇科IV颗粒,测得的颗粒合格率93.65%,含水量3.76%,休止角23.19°,与模型预测值基本一致,说明优化的工艺条件符合生产要求。

关 键 词:妇科IV颗粒  响应面法  一步制粒  Plackett-Burman  设计  Box-Behnken设计
收稿时间:2015/6/16 0:00:00

Optimization of one-step pelletization technology of Fuke IV granules with response surface methodology
LIU Dan,HE Feng-jun,LIU Chang-long,LIU Jun-chao,WU Yun,WANG Zhen-zhong and XIAO Wei.Optimization of one-step pelletization technology of Fuke IV granules with response surface methodology[J].China Journal of Chinese Materia Medica,2016,41(1):75-82.
Authors:LIU Dan  HE Feng-jun  LIU Chang-long  LIU Jun-chao  WU Yun  WANG Zhen-zhong and XIAO Wei
Institution:Jiangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China;State Key Laboratory of Pharmaceutical Process New-teach for Chinese Medicine, Lianyungang 222001, China;Key Laboratory for New Technique Research of Traditional Chinese Medicine Extraction and Purification, Lianyungang 222001, China,Jiangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China;State Key Laboratory of Pharmaceutical Process New-teach for Chinese Medicine, Lianyungang 222001, China;Key Laboratory for New Technique Research of Traditional Chinese Medicine Extraction and Purification, Lianyungang 222001, China,Jiangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China;State Key Laboratory of Pharmaceutical Process New-teach for Chinese Medicine, Lianyungang 222001, China;Key Laboratory for New Technique Research of Traditional Chinese Medicine Extraction and Purification, Lianyungang 222001, China,Jiangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China;State Key Laboratory of Pharmaceutical Process New-teach for Chinese Medicine, Lianyungang 222001, China;Key Laboratory for New Technique Research of Traditional Chinese Medicine Extraction and Purification, Lianyungang 222001, China,Jiangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China;State Key Laboratory of Pharmaceutical Process New-teach for Chinese Medicine, Lianyungang 222001, China;Key Laboratory for New Technique Research of Traditional Chinese Medicine Extraction and Purification, Lianyungang 222001, China,Jiangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China;State Key Laboratory of Pharmaceutical Process New-teach for Chinese Medicine, Lianyungang 222001, China;Key Laboratory for New Technique Research of Traditional Chinese Medicine Extraction and Purification, Lianyungang 222001, China and Jiangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China;State Key Laboratory of Pharmaceutical Process New-teach for Chinese Medicine, Lianyungang 222001, China;Key Laboratory for New Technique Research of Traditional Chinese Medicine Extraction and Purification, Lianyungang 222001, China
Abstract:
Keywords:Fuke IV granules  response surface methodology  one-step pelletization  Plackett-Burman design  Box-Behnken design
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