论文部分内容阅读
继美、英、日本等国药典之后,中国药典1985年版增设了含量均匀度检查法,其内容是“取供试品10片(个),照各该药品项下规定的方法,分别测定含量,并求其平均值。每片(个)的含量与平均含量相比较,除另有规定外,含量差异大于±15%的不得多于1片(个),并不得超过±20%。”它与英国药典1980年版的含量均匀度检查法基本相同。我国药物分析界对这个检查法的某些规定,在其颁布实施前即已存在意见分歧,一直持续至今,已发表的文章。反映了这个
Following the United States, Britain, Japan and other countries Pharmacopoeia, the Chinese Pharmacopoeia 1985 edition of the content uniformity test method, which is “for the test 10 (a), according to the drug under the provisions of the method were measured Content, and average the value of each piece (content) compared with the average content, unless otherwise specified, the content of more than ± 15% of not more than 1, and shall not exceed ± 20%. ”It and the British Pharmacopoeia 1980 version of the content uniformity method is basically the same. China’s pharmaceutical analysis of some of the provisions of the inspection method, before its promulgation and implementation already exist differences of opinion, has been so far, published articles. Reflected this