英文药名:VONOSAP Pack(Vonoprazan Fumarate/Amoxicillin Hydrate/Clarithromycin)
中文药名:复合维莫那唑富马酸盐/阿莫西林水合物/克拉霉素(片+胶囊)
生产厂家:武田薬品
ボノサップパック400/ボノサップパック800
新型抗幽门螺杆菌口服药的释放制剂 批准上市日期:2016年6月 商標名 VONOSAP Pack 400 VONOSAP Pack 800 维莫那唑富马酸盐
化学構造式 一般名 ボノプラザンフマル酸塩(Vonoprazan Fumarate)〔JAN〕 化学名 1-[5-(2-Fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl]-N-methylmethanamine monofumarate 分子式 C17H16FN3O2S・C4H4O4 分子量 461.46 融点 194.8℃ 性状 富马酸下是一种白色或类白色结晶或结晶性粉末。它往往在二甲基亚砜,N,微溶于N-二甲基乙酰胺,甲醇和微溶于水,易溶于2-丙醇和乙腈很差微溶。 阿莫西林水合物
化学構造式 一般名 アモキシシリン水和物(Amoxicillin Hydrate)〔JAN〕 略号 AMPC 化学名 (2S,5R,6R)-6-[(2R)-2-Amino-2-(4-hydroxyphenyl)acetylamino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate 分子式 C16H19N3O5S・3H2O 分子量 419.45 融点 約195℃(分解) 性状 阿莫西林水合物是白色晶体或结晶性粉末,以淡黄白色。微溶于水或甲醇,乙醇(95)非常微溶。 克拉霉素
化学構造式
一般名 クラリスロマイシン(Clarithromycin)〔JAN〕 略号 CAM 化学名 (2R,3S,4S,5R,6R,8R,10R,11R,12S,13R)-5-(3,4,6-Trideoxy-3-dimethylamino-β-D-xylo-hexopyranosyloxy)-3-(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyloxy)-11,12-dihydroxy-6-methoxy-2,4,6,8,10,12-hexamethyl-9-oxopentadecan-13-olide 分子式 C38H69NO13 分子量 747.95 融点 220~227℃ 性状 克拉霉素作为一种白色结晶粉末,味微苦。微溶于丙酮或氯仿,甲醇,乙醇(95)或在乙醚中微溶,并且几乎不溶于水。 药效药理 1.抗菌作用 (1) 阿莫西林水合物和克拉霉素显示对幽门螺杆菌消毒的抗菌作用。 (2) pH值的影响,该酸性衰减相比中性作为下克拉霉素的抗菌。另一方面,使用克拉霉素相比pH值的阿莫西林水合物效果小。 (3) 与阿莫西林水合物和克拉霉素,协同或相加效应组合的抗菌力被观察到的,对抗中的任何菌株是不允许。 2.作用机制 阿莫西林水合物是通过抑制细菌细胞壁合成有效,另外,克拉霉素显示出通过抑制结合蛋白质合成与细菌70S核糖体50S亚单位的效果。 Bonopurazan不需要通过酸活化,H+在有竞争力的方式可逆地钾离子,抑制K+-ATP酶。Bonopurazan抑制由剩余的时间在胃壁细胞强碱性的酸生产现场长期产生胃酸。Bonopurazan抗幽门螺杆菌活性和幽门螺杆菌脲酶抑制活性未示出。通过增加胃内pH在三种药物治疗与阿莫西林水合物和克拉霉素Bonopurazan的作用,被认为是加强阿莫西林水合物和克拉霉素的抗微生物活性。 适应病症 <适应的物种> 阿莫西林,幽门螺杆菌感性克拉霉素 <适应症> 胃溃疡和十二指肠溃疡,胃MALT淋巴瘤,特发性血小板减少性紫癜,幽门螺杆菌感染的内镜治疗胃早期胃癌后,幽门螺杆菌感染性胃炎。 用法与用量 一般,20毫克1次作为Bonopurazan对于成年人来说,一旦将750mg(效价),为阿莫西林水合物,一次作为三种药物同时克拉霉素200毫克(效价),一天两次,口服给药7天。顺便说一下,克拉霉素如果需要可以增加。然而,一旦两次400毫克,每天(效价)和上限。 包装规格 ボノサップパック 400毫克(20mg+250+200) 包含7片(1片×7),35张PTP(1张×7×5)
800毫克(20mg+250+250) 包含7片(1片×7),35张PTP(1张×7×5)
制造厂商 武田化学工业有限公司[联盟]大冢制药有限公司 注:以上中文资料仅供参考,使用以原处方为准:http://www.info.pmda.go.jp/go/pack/6199104X1023_1_02/ Acquired approval for manufacturing and marketing packing formulation for sterilization of Helicobacter pylori including Take cab tablets - Takeda Pharmaceutical and Otsuka Pharmaceutical Co.Ltd. Manufacture and market approval of "Bonosappak 400, 800" and "Bonopion pack" Takeda Pharmaceutical Co.Ltd. and Otsuka Pharmaceutical Co., Ltd. on February 26 announced that Take Cab (R) tablets (generic name: Bono Plaza fumarate) for acid related diseases, Announced that it acquired production and marketing approval from the Ministry of Health, Labor and Welfare for Helicobacter pylori primary sterilization pack formulation containing the product. This time approval was obtained for packs for eradication of Helicobacter pylori "Bonosap (R) pack 400, 800" and "Bonopion (R) pack". BONO SUPP is a combination of "TAKE CAB tablet" which is an acid secretion inhibitor of action mechanism also called Potassium-Competitive Acid Blocker (P-CAB) created by Takeda Pharmaceutical and "Amorin (R) capsule" (Generic name: amoxicillin hydrate), and "Clarris (R) tablet" (generic name: clarithromycin) are combined to form a single package for primary sterilization. On the other hand, Bonopion is a packaging preparation for secondary sterilization combining Take Cab and Amorin, and "Flagier (R) internal tablet" (generic name: Metronidazole). Expect to improve patient adherence and improve the convenience of medical staff The same pack formulation in which two antibacterial drugs used for eradication of Helicobacter pylori and a powerful and sustained inhibitory effect on acid secretion are combined into one sheet for each daily dosage is compatible with the patient's medication adherence Through improvement, it was developed with the aim of ensuring that each drug is taken. We are also expecting improvement of convenience of medical staff, we believe that both companies can contribute even more to domestic eradication therapy. Takeda Pharmaceutical's Takekabu tablet's domestic joint promotion agreement concluded at the end of March 2014 is that Takeda Pharmaceutical receives a contract lump sum of 20 billion yen from Otsuka Pharmaceutical with a milestone at the time of approval, Otsuka Pharmaceutical Co.Ltd. from Takeda Pharmaceutical Co.Ltd. It is announced that it will receive certain consideration according to sales.
|