中国药房2012，Vol.23Issue(13)：1201-1203,3.DOI:10.6039/j.issn.1001-0408.2012.13.18
注射用盐酸苯达莫司汀的制备及质量控制
Preparation and Quality Control of Bendamustine Hydrochloride for Injection
陈祥峰 1杨奇珍 1魏佳1
作者信息
- 1. 江苏奥赛康药业有限公司,南京211112
- 折叠
摘要
Abstract
OBJECTIVE: To prepare and control the quality of Bendamustine hydrochloride for injection. METHODS: The prescription was screened with the different amount of frozen-dried supporting agent mannitol as factor and compactibility of preparation as index. The preparation technology was determined and HPLC method was adopted to determine the content of preparation. The identification, acid, moisture, the content of related substances and main components and other quality control index were investigated according to Chinese Pharmacopoeia (2010 edition). RESULTS: 2.25% mannitol was used as excipient, and decarbon-ization technology wasn't adopted. The quality index of products were all up to the requirements of Chinese Pharmacopoeia. CONCLUSION : The prescription and preparation technology is appropriate, and the quality of product is controllable.关键词
注射用盐酸苯达莫司汀/制备/质量控制Key words
Bendamustine hvdrochloride for injection/Preparation/Quality control分类
医药卫生引用本文复制引用
陈祥峰,杨奇珍,魏佳..注射用盐酸苯达莫司汀的制备及质量控制[J].中国药房,2012,23(13):1201-1203,3.
