摘要
目的:制备注射用盐酸苯达莫司汀并建立其质量控制方法。方法:以冻干赋形剂甘露醇的不同用量为因素,以制剂的成形性等为指标筛选处方;确立制剂的制备工艺;采用高效液相色谱法测定制剂含量;根据2010年版《中国药典》相关要求考察制剂的鉴别、酸度、水分、有关物质和主药含量等质量控制指标。结果:选用2.25%甘露醇为辅料,制备时不采用脱炭工艺;成品各质量指标均符合《中国药典》相关要求。结论:所确定的制剂处方和制备工艺合理,所得产品质量可控。
OBJECTIVE： To prepare and control the quality of Bendamustine hydrochloride for injection. METHODS： The pre- scription was screened with the different amount of frozen-dried supporting agent mannitol as factor and compactibility of prepara- tion 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 in- vestigated 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.
出处
《中国药房》
CAS
CSCD
2012年第13期1201-1203,共3页
China Pharmacy
关键词
注射用盐酸苯达莫司汀
制备
质量控制
Bendamustine hydrochloride for injection
Preparation
Quality control
