关闭
 
读者在线:用户名 密码
首页 期刊简介 投稿须知 期刊目录 专家风采 编委会 特邀顾问 联系我们 移动出版
  1. 1
  2. 2
  3. 3
  4. 4
  5. 5



刊物信息

期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nifdc.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237
 

访问统计
您是第  1 2 3 2 2 8 0 4 位浏览者
您当前的位置:首页 >> 正文

浅谈溶出度检查方法的分辨力

Studies onthe discriminatory power of dissolution test

作者: 王亚敏 
作者(英文):WANG Ya-min
分类号:
出版年·卷·期(页码):2012,32 (11):0-0
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

溶出度检查方法的分辨力是溶出度检查方法研究的重要内容,选择具有良好分辨力的溶出度检查方法是药品技术审评中关注的内容。本文参考相关文献,介绍溶出度检查方法分辨力的意义和一般方法,并以非布司他片为例探讨建立具有分辨力的溶出度检查方法。

-----英文摘要:---------------------------------------------------------------------------------------

Studies on the discriminatory power of dissolution test is important in the development of dissolution method.How to select a dissolution method with high discriminatory power is a major concern in pharmaceutical technology evaluation.This article is intended to introduce the importance of discriminatory power and the general method for dissolution test based on research articles.Febuxostat tablets were taken as the sample to investigate how to establish a dissolution method with high discriminatory power.

-----参考文献:---------------------------------------------------------------------------------------
1 State Food and Drug Administration(国家食品药品监督管理局).The Guidelines of Quality Research and Quality Standards Formulated for Chemical Medicine Preparation(Pilot) .2007
2 The Dissolution Procedure:Development and Validation.Pharmacopeial Forum,2004,30(1):351
3 FDA.Guidance for Industry:Dissolution testing of immediate release solid oral dosage forms [EB/OL].1997-08-25.http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070237.pdf
4 WANG Ya-min(王亚敏).Studies on dissolution test methods(浅谈溶出度检查方法的研究).Chin J Pharm Anal(药物分析杂志),2007,27(10):1667
5 XIE Mu-feng(谢沐风).Enhanced dissolution evaluation methods to improve the level of solid pharmaceutical preparations(改善溶出度评价方法,提高固体药物制剂水平).Chin J Pharm(中国医药工业杂志),2005,36(7):447
6 XIE Mu-feng(谢沐风).How to develop and validate the dissolution test on the quality criteria(如何科学、客观地制订溶出度试验质量标准).Chin J Pharm(中国医药工业杂志),2012,43(3):A23
7 XIE Mu-feng(谢沐风),CAO Hong-xin(操洪欣).Problems in the dissolution test(溶出度测定中的若干问题).Chin J Pharm(中国医药工业杂志),2006,37(12):859
8 HU Cheng-yao(胡程耀),HUANG Pei(黄培).Recent research and development on determination of solid solubility(固体溶解度测定方法的近期研究进展).Chin J Pharm Anal(药物分析杂志),2010,30(4):761
9 XU Ming-zhe(许明哲),HU Chang-qin(胡昌勤),JIN Shao-hong(金少鸿).Application of uncertainty evaluation in arbitration test of determination of dissolution rate of immediate release solid oral dosage forms(不确定度在速释型固体口服制剂溶出度复验中的应用).Chin J Pharm Anal(药物分析杂志),2010,30(6):1080
10 CHEN Wei-zhen(陈唯真),ZHAO Hui-fang(赵慧芳),YANG La-hu(杨腊虎).Symposia of dissolution testing of oral dosage forms(药物固体制剂的溶出度测定研讨会随笔).Chin J Pharm Anal(药物分析杂志),2007,27(10):1679
11 帝人株式会社.日本病院薬剤師会のIF記載要領 Feburic®Tablets 10mg,20mg,40mg [EB/OL].2012-04, [2012-06-01].http://www.info.pmda.go.jp//go/interview/1/470310_ 3949003F1023_1F
12 帝人株式会社.2-(3-氰基-4-异丁氧基苯基)-4-甲基-5-噻唑甲酸的多晶型体及其制备方法.CN1275126A,2000-11-29
13 帝人株式会社.含有单一晶型的固体制剂.CN1642546,2003-03-28
14 FDA.Guidance for Industry:SUPAC-IR/MR:Immediate Release and Modified Release Solid Oral Dosage Forms.Manufacturing Equipment Addendum[EB/OL]. 1999-02-26, [2012-06-01].www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070637.pdf

欢迎阅读《药物分析杂志》!您是该文第 2028位读者!

药物分析杂志 © 2009
地址:北京天坛西里2号 邮政编码:100050; 电子邮件:ywfx@nicpbp.org.cn