日本橙皮书数据库(Japanese Orange Book)
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再评价结果通知号及日期12
2002/3/6
药效分类396
Antidiabetic agents
商品名Buformin Hydrochloride Tab. 50mg 「MITA」
活性成分Buformin Hydrochloride
活性成分(日文)塩酸ブホルミン
剂型Tablets
规格50mg
特性Enteric-coated
转速Paddle Method,50rpm
溶出液基准液:1.2  6.8
其他:6  water  
溶出规格120minutes(pH1.2): Not more than 5%; 90minutes(pH6.8):Not less than 80%(HPLC method)
溶出曲线测定例
成分名称:塩酸ブホルミン   英文名:Buformin Hydrochloride   含量:50mg
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