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通脉复方微丸多元释药系统中丹参酮缓释单元的制备工艺
引用本文:陈斌,萧伟,贾晓斌,黄洋.通脉复方微丸多元释药系统中丹参酮缓释单元的制备工艺[J].中国实验方剂学杂志,2012,18(4):39-42.
作者姓名:陈斌  萧伟  贾晓斌  黄洋
作者单位:江苏省中医药研究院中药新型给药系统重点实验室,国家中医药管理局中药释药系统重点研究室,南京210028;中国制药过程新技术国家重点实验室,江苏康缘药业股份有限公司,连云港222001
基金项目:江苏省中医药局中医药科技技术研究专项(LZ09061);国家中医药管理局中药释药系统重点研究室开放基金课题(2011NDDCM01002);中药制药过程新技术国家重点实验室开放课题(SKL2010Z0303)
摘    要:目的:优选丹参酮缓释微丸制备工艺.方法:将丹参酮组分制备成缓释固体分散体,考察乙基纤维素、羟丙甲基纤维素对其溶出度的影响;以丹参酮固体分散体作为主药制备微丸,考察处方中润湿剂、载药量、辅料、乳糖、润湿剂等因素对丹参酮微丸收率、圆整度的影响;采用正交试验设计筛选出丹参酮缓释微丸的最佳制备工艺.结果:丹参酮组分制备成缓释固体分散体,处方为乙基纤维素-丹参酮组分-羟丙甲基纤维素(3∶1∶0.5);以固体分散体为主药制备成微丸,处方为丹参酮固体分散体20 g,乳糖6 g,微晶纤维素24 g,润湿剂为水33 mL,最佳工艺条件为挤出频率25 Hz,滚圆频率50 Hz,滚圆时间6min.结论:本工艺科学合理,制剂稳定,为通脉复方微丸多元释药系统的制备奠定了基础.

关 键 词:通脉复方微丸多元释药系统  丹参酮缓释单元  固体分散体  挤出滚圆  正交设计

Preparation Technology of Tanshinone Release Unit in Multi-drug Delivery System of Tongmai Compound Pellets
CHEN Bin,XIAO Wei,JIA Xiao-bin and HUANG Yang.Preparation Technology of Tanshinone Release Unit in Multi-drug Delivery System of Tongmai Compound Pellets[J].China Journal of Experimental Traditional Medical Formulae,2012,18(4):39-42.
Authors:CHEN Bin  XIAO Wei  JIA Xiao-bin and HUANG Yang
Institution:Key Laboratory of New Drug Delivery System of Chinese Meteria Medica, Jiangsu Provincial Academy of Chinese Medicine; Key Laboratory of Chinese Medicine Delivery System of State Administration of Traditional Chinese Medicine, Nanjing 210028, China; State Key Laboratory of Newtech Chinese Medicine Pharmacentical Process, Jiangsu Kanion Pharmacent Co. Ltd, Lianyungang 222001, China;Key Laboratory of New Drug Delivery System of Chinese Meteria Medica, Jiangsu Provincial Academy of Chinese Medicine; Key Laboratory of Chinese Medicine Delivery System of State Administration of Traditional Chinese Medicine, Nanjing 210028, China; State Key Laboratory of Newtech Chinese Medicine Pharmacentical Process, Jiangsu Kanion Pharmacent Co. Ltd, Lianyungang 222001, China;Key Laboratory of New Drug Delivery System of Chinese Meteria Medica, Jiangsu Provincial Academy of Chinese Medicine; Key Laboratory of Chinese Medicine Delivery System of State Administration of Traditional Chinese Medicine, Nanjing 210028, China; State Key Laboratory of Newtech Chinese Medicine Pharmacentical Process, Jiangsu Kanion Pharmacent Co. Ltd, Lianyungang 222001, China;Key Laboratory of New Drug Delivery System of Chinese Meteria Medica, Jiangsu Provincial Academy of Chinese Medicine; Key Laboratory of Chinese Medicine Delivery System of State Administration of Traditional Chinese Medicine, Nanjing 210028, China; State Key Laboratory of Newtech Chinese Medicine Pharmacentical Process, Jiangsu Kanion Pharmacent Co. Ltd, Lianyungang 222001, China
Abstract:
Keywords:multi-drug delivery system of Tongmai compound pellets  tanshinone release unit  solid dispersion  extrusion spheronization  orhogonal design
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