英文药名:BASEN Tablets(Voglibose)
中文药名:伏格列波糖片
生产厂家:武田药品
ベイスン錠0.2/ベイスン錠0.3
药物分类名称 餐后高血糖改善剂 批准日期:1994年9月 商標名 BASEN Tablets 0.2 BASEN Tablets 0.3 化学構造式
一般名 ボグリボース(Voglibose)〔JAN〕 化学名 3,4-Dideoxy-4-[2-hydroxy-1-(hydroxymethyl)ethylamino]-2-C-(hydroxymethyl)-D-epi-inositol 分子式 C10H21NO7 分子量 267.28 融点 163~168℃ 性状 伏格列波糖是一种白色结晶或结晶粉末。 它易溶于水,易溶于乙酸(100),难溶于甲醇,极难溶于乙醇(99.5)。 溶于0.1mol/L盐酸试剂溶液。 药效药理 此药物抑制负责从肠道中的二糖(α-葡糖苷酶)降解为单糖二糖水解酶,提高了通过延迟糖类的消化和吸收的餐后高血糖。 (1)作用机制 1)分别表示大约20倍和大约270倍和190倍的阿卡波糖,30倍抗猪肠道麦芽糖酶和蔗糖酶,大鼠肠麦芽糖酶和蔗糖酶的抑制活性阿卡波糖更强的抑制作用(体外) 。抗猪和大鼠胰α-淀粉同时抑制作用为约阿卡波糖的1/3000,它显示了对β-葡糖苷酶没有抑制活性(体外)。 2)从大鼠小肠蔗糖酶 - 反对二糖水解酶复合物异麦芽糖酶抑制方式是竞争性的拮抗(体外)。 (2)血糖升高抑制作用 当口服给药时,以正常大鼠,淀粉,抑制血糖值升高之后麦芽糖和蔗糖负荷是无效的葡萄糖,果糖和乳糖负载(体内)后葡萄糖增加。 测量呼吸氢气进行蔗糖负荷健康的成年人,在临床剂量本发明的药剂和基于碳水化合物的二糖部分分解抑制的轻微吸收抑制的血糖升高抑制作用,其结果的吸收据推测是由于延误。 适应病症 ○改善糖尿病餐后高血糖症 (但是,如果饮食疗法和运动疗法的患者没有足够的效果,或者使用口服降糖药或胰岛素制剂的患者除了饮食疗法和锻炼疗法之外是足够有效的 只有当它不能被获得) ○2型糖尿病的葡萄糖耐量降低发病的抑制(仅0.2片剂) (但是,即使饮食疗法/运动疗法充分进行也不会改善) 用法与用量 ○餐后高血糖症的改善 通常,成人在每顿饭之前每天口服一次0.2mg,每天一次伏格列波糖三次。 如果效果不够,一次观察到足够的剂量可以增加到0.3毫克。 ○抑制葡萄糖耐量异常2型糖尿病的发病的情况(仅限于片剂0.2) 通常,成人在每顿饭之前每天口服一次0.2mg,每天一次伏格列波糖三次。 包装规格 片剂 0.2毫克:100片(10片×10),500片(瓶装,10片×50),1000片(10片×100),2100片(21片×100) 0.3毫克:100片(10片×10),500片(瓶装,10片×50),1000片(10片×100),2,100片(21片×100) 制造商 武田特瓦制药有限公司 注:以上中文资料不够完整,使用者以原处方为准。 完整说明书附件:http://www.info.pmda.go.jp/go/pack/3969004F1020_2_03/ "Basin ® tablets" for postprandial hyperglycaemia About obtaining additional approval for the indication for suppressing onset of type 2 diabetes in impaired glucose tolerance We are pleased to announce that the Ministry of Health, Labor and Welfare has announced the first time in Japan that "Basin ® Tablet 0.2, OD Tablet 0.2" (common name: Voglibose, hereinafter "Basin") " We are pleased to announce that we have obtained approval for additional indication for suppression. Basin is a drug that improves postprandial hyperglycemia by delaying carbohydrate digestion and absorption in the small intestine and has been used as a therapeutic agent for diabetes since 1994 in Japan. The effect of inhibiting the onset of type 2 diabetes by administering this drug to patients with impaired glucose tolerance was confirmed in clinical trials published in the world-renowned medical journal "The Lancet" in April this year It is clear from the results of the exam. Impaired glucose tolerance is a condition in which the ability to metabolize sugars in the body is impaired, and it is said that the rate of transition to diabetes and the risk of developing cardiovascular disease will be high. Therefore, patients are instructed about lifestyle habits, mainly diet therapy and exercise therapy, but there are cases where sufficient effect can not be obtained by them alone, so through the new treatment option of baseline medication therapy , It can be expected to suppress the onset of diabetes. We have three types of diabetes drugs with different mechanisms of action, Actos, Basin, and Glufast, and we propose optimal treatments suitable for each patient's condition to healthcare professionals. We believe that our products can contribute to the treatment of more patients by adding new indications of Basin's "suppression of the onset of type 2 diabetes in impaired glucose tolerance". |