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阿莫西林(羟氨苄青霉素)为半合成青霉素,用于敏感菌引起的呼吸道、泌尿道、胆道及伤寒等感染。《中国药典》1990年版、1995年版均已收载,并被列为国家基本药物。 1997年,我们对12个药厂生产,总计35批次样品的阿莫西林胶囊(规格为0.25g/粒)进行了质量考查,按《中国药典》1995年版全项检验。检验结果:35批样品中有12批不符合规定,合格率为65.7％。现分析如下: 1.水分和装量差异 《中国药典》1995年版规定,阿莫西林胶囊按费休氏法测定,水分不得超过16.0％。经对35批次阿莫西林胶
Amoxicillin (amoxicillin) is a semi-synthetic penicillin, used for sensitive bacteria caused by the respiratory tract, urinary tract, biliary and typhoid and other infections. “Chinese Pharmacopoeia” 1990 edition, 1995 edition have been included, and was listed as national essential medicines. In 1997, we conducted quality tests on amoxicillin capsules (specifications: 0.25g / tablet) produced by a total of 35 batches of pharmaceutical companies at 12 pharmaceutical companies. The test was conducted according to the 1995 edition of the Chinese Pharmacopoeia. Test results: 35 batches of samples 12 batches do not meet the requirements, with a pass rate of 65.7%. The analysis is as follows: 1. Differences in water content and loading “Chinese Pharmacopoeia” 1995 edition provides that amoxicillin capsules determined by the Fisher method, the moisture content of not more than 16.0%. After 35 batches of amoxicillin