| 过程控制技术对桂枝茯苓胶囊质量的影响 |
| |
| 引用本文： | 李家春,王金玲,伍静玲,黄文哲,王振中,萧伟.过程控制技术对桂枝茯苓胶囊质量的影响[J].中国中药杂志,2015,40(6):1017-1022. |
| |
| 作者姓名： | 李家春 王金玲 伍静玲 黄文哲 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;中国药科大学, 江苏 南京 210009,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,江苏康缘药业股份有限公司, 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,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,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 |
| |
| 基金项目： | 国家"重大新药创制"科技重大专项(2013ZX09402203) |
| |
| 摘 要： | 通过应用过程控制技术前后内控指标波动情况,评价过程质量控制对桂枝茯苓胶囊内在质量的影响。采用统计分析的方法,对应用过程控制技术前(2009—2011年)96批样品及应用过程控制技术后(2012—2014年)96批样品中主要质控指标进行统计分析。依据桂枝茯苓胶囊内控质量标准,对192批药品进行分析,结果显示所有批次内控指标均符合规定,应用过程控制技术后内控指标与应用过程控制技术前质量均一性存在较为显著地差异。应用过程控制技术可提高桂枝茯苓胶囊批间质量的一致性。
|
| 关 键 词： | 桂枝茯苓胶囊 过程控制 质量 均一性 |
| 收稿时间： | 2015/2/10 0:00:00 |
Quality analysis of Guizhi Fuling capsule before and after application of in-process quality control in pharmaceutical production |
| |
| LI Jia-chun,WANG Jin-ling,WU Jing-ling,HUANG Wen-zhe,WANG Zhen-zhong and XIAO Wei.Quality analysis of Guizhi Fuling capsule before and after application of in-process quality control in pharmaceutical production[J].China Journal of Chinese Materia Medica,2015,40(6):1017-1022. |
| |
| Authors: | LI Jia-chun WANG Jin-ling WU Jing-ling HUANG Wen-zhe WANG Zhen-zhong and XIAO Wei |
| |
| Institution: | Jangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China;China Pharmaceutical University, Nanjing 210009, China,Jangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China;State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Lianyungang 222001, China,Jangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China,Jangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China;State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Lianyungang 222001, China,Jangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China;State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Lianyungang 222001, China and Jangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China;State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Lianyungang 222001, China |
| |
| Abstract: | The effects of application of in-process quality control in Guizhi Fuling capsule production were evaluated by 192 batches data analysis. Using a statistical analysis method, each batch of data were to be counted to research for the difference between 96 samples adopting the technologies of in-process control or not. According to quality standards of Guizhi Fuling capsule, all measurements of the 192 batches of the drugs before and after the application of process control technology were analyzed, and they were within the rules. There was a significant difference between adopting the technologies of process control or not. Application of in-process control technology can improve the uniformity of lot-to-lot for Guizhi Fuling capsule. |
| |
| Keywords: | Guizhi Fuling capsule in-process control quality uniformity |
| 本文献已被 CNKI 等数据库收录！ |
|
