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化验人员在进行释放度试验时,不论其目的是为了开发一个新药,或是控制产品的质量或是检查其是否符合法定要求,在安装释放仪之前,一定要查阅最新一版的药典或制剂规范,包括最新的修订或增补版。USP/NF、英国、欧洲和加拿大药典以及日本药局方所规定的释放度测定方法,都有一些不同的细节。基本方法之一——转篮法(USP/NF中的第一法) 这是第一个被采纳作为药典的法定方法(1970年USPXVIII/NFXIII)。它的基本组成部分是一个大约1英寸直径×1(3/8)英寸高的40目不锈钢转篮,转速约在25～150rpm之间,和一个装有900毫升溶媒的
When performing a release test, the laboratory technician, regardless of whether the intention is to develop a new drug, to control the quality of the product or to check that it meets the statutory requirements, be sure to consult the latest edition of the Pharmacopoeia or Formulation Specification , Including the latest revision or supplement. There are a few different details about the method of determination of release prescribed by the USP / NF, the United Kingdom, the European and Canadian Pharmacopoeias, and the Japanese Pharmacopoeia. One of the basic methods - basket method (first method in USP / NF) This is the first statutory method adopted as a pharmacopoeia (USPXVIII / NFXIII 1970). Its basic component is a 40-mesh stainless steel rotating basket about 1 inch in diameter × 1 (3/8 inch) high with a speed of between 25 and 150 rpm, and a 900-ml