摘要
2.5%恩诺沙星注射液常温储存6个月以上,就会出现析晶现象,造成产品质量下降,影响正常使用。为解决2.5%恩诺沙星注射液的析晶问题,筛选不同的稳定剂乙醇、丙二醇并在不同pH值条件下,考察对析晶的影响。改良了2.5%恩诺沙星注射液的工艺处方,确定适宜的稳定剂为丙二醇,最佳配比为30%（质量分数）,控制溶液的pH值为10.2~10.4,使2.5%恩诺沙星注射液的稳定性得到了提高。经过常温储存6个月以上及冷藏（4~8℃）保存,无析晶现象出现。所得样品指标符合兽药质量标准,采用该处方工艺能解决恩诺沙星的析晶问题,提高产品稳定性。
2.5% enrofloxacin injection has the situation of devitrification when reserved at normal temperature for more than six months,which may cause the product deteriorating in quality and affect the normal use.In order to solve the problem,screening of different stabilizer ethanol,propylene glycol and pH condition are implemented,and the influence is examined.The preparation of 2.5% enrofloxacin injection is prometed.The appropriate stabilizer is determined to be propylene glycol,the best ratio is of 30%（mass ratio）,and pH value is controlled between 10.2and 10.4.The stability of the 2.5% enrofloxacin injection is improved.After storage at room temperature for more than six months and refrigeration（4~8 ℃）,no devitrification phenomenon appears.It meets the quality standards for veterinary drugs,and the formulation and technology can solve the problem of devitrification of enrofloxacin,improving the stability of the product.
出处
《河北工业科技》
CAS
2015年第5期413-416,共4页
Hebei Journal of Industrial Science and Technology
关键词
药物化学
恩诺沙星
析晶
稳定剂
PH值
pharmaceutical chemistry
enrofloxacin
devitrification
stabilizer
pH value
