药品检验中篮法和桨法溶出仪机械校验探讨

比较美国、日本、欧洲和中国药典对篮法和桨法溶出仪装置的技术要求,并介绍美国食品药品管理局、美国材料与试验协会、美国药典委员会等机构关于溶出装置机械校验的规范;分析我国溶出仪应用的现状,强调溶出度测定中溶出仪机械校验的重要性,并建议应建立适用于我国的溶出仪机械校验标准,确保溶出度测定结果的准确性。

To compare the technical requirements for basket and paddle dissolution apparatus in Chinese pharmacopoeia and overseas major pharmacopoeia,including U.S.Pharmacopeia, Japanese Pharmacopoeia, and European Pharmacopoeia, the latest literatures were summarized in this paper.The mechanical qualifications of basket and paddle dissolution apparatus were also introduced, which were developed by organizations such as Food and Drug Administration, American Society for Testing and Materials and The United States Pharmacopeial Convention.In addition, the status of dissolution apparatus marketed in China was reported, and the necessity for establishment of mechanical qualification standard in China was discussed, which guaranteed the accuracy of dissolution testing results.

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