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《医学研究与战创伤救治》（原医学研究生学报）[ISSN:1672-271X/CN:32-1713/R]

卷:

第11卷

期数:

2009年02期

页码:

134-138

栏目:

出版日期:

2009-03-20

文章信息/Info

Title:

Study on dissolution of famotidine tablets from different pharmaceutical factories

文章编号:

1672-271X(2009)02-0134-05

作者:

杭 娟; 古卓良; 周国华

南京军区联勤部药品仪器检验所，江苏南京 210002

Author(s):

HANG Juan;  GU Zhuo-liang; ZHOU Guo-hua

The Institute of Quality Control of Medical Material and Equipment under the Joint Logistic Department of Nanjing Military Command,Nanjing 210002,Jiangsu,China

关键词:

法莫替丁片; 光纤传感系统; 溶出度

Keywords:

Famotidine tablets; Fiber-optic sensor; Dissolution

分类号:

R917.7

DOI:

-

文献标志码:

A

摘要:

目的 对5个厂家法莫替丁片进行溶出度实时监测，考察各产品的质量。方法 设定波长266 nm,基准校正波长550 nm、温度37 ℃、转速100 r·min-1、数据采集间隔时间30 s、监测时间30 min，以900 ml的磷酸二氢钾缓冲液(pH4.5)为溶出介质，转篮法，用光程为5 mm的光纤探头监测法莫替丁片的溶出曲线。结果 5个不同厂家法莫替丁片的溶出度均符合《中国药典》规定，但是各溶出曲线存在差异。结论 光纤药物溶出度实时测定仪能准确、连续、定量地反映药物的溶出过程，获得的数据更加完整、真实，可比较出不同厂家之间同品种药物的溶出过程的差异。

Abstract:

Objective To study the quality of famotidine tablets from five different pharmaceutical factories with the new method for fiber-optic real time dissolution test system.Method Each famotidine tablets was dissolved in 900 ml of potassium dihydrogen phosphate buffer (pH 4.5) at 37 ℃, and the dissolution was monitored with 5mm fiber optic probe. The paddle method was used at the rate of 100 r·min-1, and signals were detected at 266 nm against the reference wavelength of 550 nm.Dissolution data were collected every 30 seconds during a 30-min run.Results The dissolution of famotidine tablets produced by all the five factories are qualified to the standards of Chinese pharmacopoeia, but a significant different was observed in their dissolution curves.Conclusion The fiber-optic sensor dissolution test system is capable of monitoring the real dissolution process of a drug and supplying more complete and accurate details of the dissolution process, so that the different in dissolution for the same drug among different manufactories can be detected in suit.

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备注/Memo:

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更新日期/Last Update: 2013-11-20