国内外溶出度试验用标准片的研究及应用
Overview and application of reference standard tablets for dissolution tester qualification
分类号：
出版年·卷·期（页码）：2012,32 (8):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----摘要：-------------------------------------------------------------------------------------------
回顾了国内外溶出度试验用标准片的研究、建立情况及各种标准片的历史数据,介绍了我国水杨酸标准片的溶出特性,对溶出度标准片的作用及面临的挑战,以及国际上对溶出度标准片的观点进行了论述。
-----英文摘要：---------------------------------------------------------------------------------------
Overview the history of investigation,establishment of different kinds of reference standard tablets(granules) for dissolution tester’s qualification,provides the historical data of reference standard tablets official dissolution range.Describe the characteristics of Chinese salicylic acid reference standard tablets,discuss the application and challenges of reference standard tablets,summarize the different perspective on reference standard tablets from industry,manufacturer and regulatory authority.
-----参考文献：---------------------------------------------------------------------------------------
1 Data Sheet for USP Dissolution Calibrator,Non-disintegrating Type,for Apparatus Suitability Test,Salicylic Acid Tablets,Lot F,Approximately 300 mg
2 The USP performance test and the dissolution procedure statement..http://www.usp.org/usp-nf/notices/usp-performance-test-and-dissolution-procedure-statement
3.http://www.usp.org/reference-standards/use-and-storage/dissolution-pvt-ranges
4 Certificate of USP prednisone tablets Lot P1I300..http://www.usp.org/pdf/EN/referenceStandards/certificates/1559505-P1I300.pdf
5 ISO.ISO 5725-6:1994,Accuracy (Trueness and Precision) of Measurement Methods and Results-Part 6:Use in Practice of Accuracy Values.Geneva,Switzerland:ISO,1994
6 Aiache JM,Aoyagi N,Blume H,et al.FIP,1997-Joint Report of the Section for Official Laboratories and Medicines Control Services and the Section of Industrial Pharmacists of the FIP,"FIP Guidelines for Dissolution Testing of Solid Oral Products".Dissolut Technol,1997,4(4):5
7 Hamilton JF,Moore TW,Kerner CM.Reproducibility of Dissolution Test Results.Pharm Forum,1995,21:1383
8 Oates M,Brune S,Gray V,et al.PhRMA Subcommittee on Dissolution calibration:dissolution calibrator:recommendations for reduced chemical testing and enhanced mechanical calibration.Pharm Forum,2000,26(4):1149
9 Konieczny J,Cohen E,Thomas A,et al.Validation Technique of Dissolution Test for Control of Drug Quality and Bioequivalence,1980,Presented at the Interphex USA Technical Conference
欢迎阅读《药物分析杂志》！您是该文第 1809位读者！
