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目前,固体制剂含量均匀性已引起国内外药学界重视。中国药典1985年版已规定了片剂、胶囊、注射用无菌固体、注射液、膜剂等25种化学药物制剂的含量均匀度标准。USPX X 版规定对所有糖衣片和标示量为50mg及以下的素片进行含量均匀度试验。USPX X I 版扩大了范围,并将计量抽检与计数抽检相结合。除规定极限值外,另规定了相
At present, the uniform content of solid preparations has drawn the attention of the pharmaceutical community at home and abroad. Chinese Pharmacopoeia 1985 edition has provided tablet, capsule, sterile solid for injection, injection, film and other 25 kinds of chemical formulations of content uniformity standards. USPX X version of the provisions of all sugar-coated tablets and labeled amount of 50mg and below the content uniformity test. USPX X version I expands the scope and combines sampling and counting sampling. In addition to the provisions of the limit, the other provisions of the phase