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氟比洛芬干混悬剂的制备及其质量控制

陈莹 王硕 刘雅静 冯婉玉

中国药房2011,Vol.22Issue(21):1976-1978,3.
中国药房2011,Vol.22Issue(21):1976-1978,3.

氟比洛芬干混悬剂的制备及其质量控制

Preparation and Quality Control of Flubiprofen Dry Suspension

陈莹 1王硕 2刘雅静 1冯婉玉1

作者信息

  • 1. 中国医科大学附属第一医院药学部,沈阳市,110001
  • 2. 齐鲁制药有限公司药物研究院,济南市,250100
  • 折叠

摘要

Abstract

OBJECTIVE: To prepare Flubiprofen dry suspension and to establish quality control method.METHODS: Flurbiprofen dry suspension was prepared using hydroxypropyl methyl cellulose as suspending agent.The sedimentation ratio, redispersibility, morphology, particle size distribution and suspension viscosity were investigated.HPLC method was used to determine the content of main components in formulations.The stability of suspension kept at 40 ℃ and 75% humidity condition for 6 months was studied.RESULTS: Average sedimentation ratio of Flurbiprofen dry suspension was no less than 0.90 with good redispersibility.Flurbiprofen dry suspension was granular and uniform.Particle size of Flubiprofen dry suspension mainly ranged 3~5 μm (more than 75%).The viscosity of Flurbiprofen dry suspension was 59 mPa·s with good liquidity.The average labelled amount of 6 batches of samples was 99.66%.Flurbiprofen dry suspension showed no significant change in each index after 6 months.CONCLUSION: Prepared Flubiprofen dry suspension is simple and feasible in preparation technology and reproducible, stable and controllable in property.

关键词

氟比洛芬/干混悬剂/制备/质量控制/高效液相色谱法/稳定性

Key words

Flubiprofen/ Dry suspension/Preparation/ Quality control/ HPLC/ Stability

分类

医药卫生

引用本文复制引用

陈莹,王硕,刘雅静,冯婉玉..氟比洛芬干混悬剂的制备及其质量控制[J].中国药房,2011,22(21):1976-1978,3.

中国药房

OACSCDCSTPCD

1001-0408

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