注射用尼可地尔的冻干工艺研究  

Freeze-drying Technology for the Preparation of Injection-nicorandil

作　　者：刘玺 邢建峰[1] LIU Xi;XING Jian-feng(School of Pharmacy,Xi'an Jiaotong University,Xi'an 710061,China)

机构地区：[1]西安交通大学药学院,陕西西安710061

出　　处：《精细化工中间体》2021年第4期13-16,共4页Fine Chemical Intermediates

基　　金：国家自然科学基金项目(81973253,81773663)。

摘　　要：研究了注射用尼可地尔的处方及冻干生产工艺。采用单因素实验方法,以冻干粉针剂的性状、pH、含量及有关物质等为考察指标,对处方中赋形剂的类型、用量、 pH范围及冻干工艺参数进行筛选及优化。获得了优化处方及冻干工艺:制备规格为12 mg的注射用尼可地尔,甘露醇作为赋形剂,加入量为18 mg, pH范围为6.5~7.5,选择2次退火,退火温度为-15℃,退火保持时间为2 h,制备的冻干粉针剂成型性好、易复溶。该制剂处方工艺设计合理,工艺路线可行,为注射用尼可地尔的处方及工艺筛选提供借鉴。The formulation and freeze-drying process of nicorandil used for injection were studied. Single factor experiment was used to optimize the excipient type, dosage, pH range and parameters for freeze-drying process.The optimal formulation and freeze-drying process were as followings: in 12 mg of nicorandil for injection, 18 mg of mannitol was used with a pH range between 6.5 and 7.5;a second annealing method was selected with a temperature of-15 ℃ and an annealing holding time of 2 h. The freeze-dried powder for injection has good formability and is easy to redissolve. The formulation process of the preparation is reasonable and feasible. This study provides a basis for the prescription and process screening of nicorandil for injection.

关 键 词：注射用尼可地尔 处方 工艺研究 冻干 稳定性 

分 类 号：O657[理学—分析化学]