| 复方苦参注射液醇沉工艺优化及醇沉颗粒沉降过程研究 |
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| 引用本文： | 刘晓谦,仝燕,王锦玉,王瑞珍,张彦霞,王智民.复方苦参注射液醇沉工艺优化及醇沉颗粒沉降过程研究[J].中国中药杂志,2011,36(22):3108-3113. |
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| 作者姓名： | 刘晓谦 仝燕 王锦玉 王瑞珍 张彦霞 王智民 |
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| 作者单位： | 1. 中国中医科学院中药研究所,北京100700;中药质量控制技术国家工程实验室,北京100700;
2. 山西振东制药股份有限公司,山西长治,047100 |
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| 基金项目： | 国家"重大新药创制"科技重大专项(2009ZX09308-003,2009ZX09301-005,2008ZX09202-009);国家发改委项目(发改办高技[2009]406号) |
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| 摘 要： | 目的:以复方苦参注射液为模型药物,对其醇沉工艺进行优化,并对醇沉过程中颗粒沉降过程及其特点进行研究,掌握其沉降机制和过程变化规律,探讨过程控制模式在中药生产中的可行性.方法:以复方苦参注射液为研究对象,以生物碱及大泽米苷成分的保留量为评价指标,优化醇沉工艺,同时结合对醇沉过程中形成的沉淀颗粒的数量、密度、沉降速度等参数的测定确定醇沉时间,理解工艺过程.结果:优选出的醇沉工艺为醇沉2次,乙醇浓度依次为60％,80％～90％.该过程随着沉降时间的延长,生物碱类成分有一定的下降,一次醇沉36 h,二次醇沉6h即可满足生产要求.10 μm及25μm颗粒在第1次醇沉过程中完全沉降所需时间分别为157.7,25.2 h;在第2次醇沉过程中完全沉降所需时间分别为84.2,13.5 h.结论:优化后的醇沉工艺能够更好地保留指标成分,节约时间,减少能耗.同时也证实了中药注射剂的生产质量是可以控制和把握的,但过程控制模式应在充分理解过程的变化规律的基础上制定.
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| 关 键 词： | 复方苦参注射液 醇沉工艺 颗粒沉降过程 生物碱 大泽米苷 过程控制 |
| 收稿时间： | 2011/6/27 0:00:00 |
Alcohol-purification technology and its particle sedimentation process in manufactory of Fufang Kushen injection |
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| LIU Xiaoqian,TONG Yan,WANG Jinyu,WANG Ruizhen,ZHANG Yanxia and WANG Zhimin.Alcohol-purification technology and its particle sedimentation process in manufactory of Fufang Kushen injection[J].China Journal of Chinese Materia Medica,2011,36(22):3108-3113. |
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| Authors: | LIU Xiaoqian TONG Yan WANG Jinyu WANG Ruizhen ZHANG Yanxia and WANG Zhimin |
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| Institution: | LIU Xiaoqian 1,2,TONG Yan1,WANG Jinyu 1,WANG Ruizhen 3,ZHANG Yanxia 3,WANG Zhimin1,2(1.Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences,Beijing 100700,China,2.National Engineering Laboratory for Quality Control Technology of Chinese Herbal Medicines,3.Zhendong Pharmaceutical Co.,Ltd.,Changzhi 047100,China) |
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| Abstract: | Objective: Fufang Kushen injection was selected as the model drug,to optimize its alcohol-purification process and understand the characteristics of particle sedimentation process,and to investigate the feasibility of using process analytical technology(PAT) on traditional Chinese medicine(TCM) manufacturing.Method:Total alkaloids(calculated by matrine,oxymatrine,sophoridine and oxysophoridine) and macrozamin were selected as quality evaluation markers to optimize the process of Fufang Kushen injection puri... |
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| Keywords: | Fufang Kushen injection alcohol precipitation process particle settling alkaloids macrozamin process analytical technology(PAT) |
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