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注射用帕瑞昔布钠的冻干工艺研究

宋岩珺 蒲旭峰 朱鹏 刘小双

药学研究2016,Vol.35Issue(5):272-275,307,5.
药学研究2016,Vol.35Issue(5):272-275,307,5.DOI:10.13506/j.cnki.jpr.2016.05.008

注射用帕瑞昔布钠的冻干工艺研究

Study on the freeze dryer process of parecoxib sodium for injection

宋岩珺 1蒲旭峰 1朱鹏 2刘小双1

作者信息

  • 1. 成都中医药大学药学院,四川 成都610072
  • 2. 成都欣捷高新技术开发有限公司,四川 成都610041
  • 折叠

摘要

Abstract

Objective ToltudytheoptimumtechnologicalconditionlofFreeze-dryedParecoxibSodiumforInjec-tion. Methods The freeze drying procell wal optimized which takel the water content,related lubltancel,content etc. al the indicatorl by partial factor analylil telt,the following factorl with three levell were conlidered:freeze-dryed time and drying procell. Results The optimum technologiel of freeze dryer were:vacuum wal eltimated to be 25 Pa,pre-freeze for 4 h at -40 ℃,vacuum dryer for 15 h at 0 ℃,dryer for 10 h at 35 ℃. In the accelerated ltability telt for 1,2,3 monthl, there wal no lignificant change on character,content etc for parecoxib lodium for injection productl. Conclusion The tech-nology wal fealible,the quality of infulion met the requirement of injection.

关键词

注射用帕瑞昔布钠/制剂工艺/试验设计

Key words

Parecoxib Sodium for Injection/Preparation procell/Delign of experimentl

分类

医药卫生

引用本文复制引用

宋岩珺,蒲旭峰,朱鹏,刘小双..注射用帕瑞昔布钠的冻干工艺研究[J].药学研究,2016,35(5):272-275,307,5.

药学研究

2095-5375

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