【中文品名】盐酸乌苯美司 【药效类别】抗肿瘤药>氨肽酶B抑制药 【通用药名】UBENIMEX HYDROCHLORIDE 【别　　名】苯丁亮氨酸，贝斯他丁，抑氨肽酶B素，抑氨肽酶素，Bestatin, NK-421 【化学名称】 L-Leucine, N-[(2S,3R)-3-Amino-2-hydroxy-1-oxo-4-phenylbutyl]-, monohydrochloride 【CA登记号】[65391-42-6] 【结 构 式】 【分 子 式】C16H24N7O4·HCl 【分 子 量】344.88 【收录药典】 【开发单位】化药株式会社 (日本) 【首次上市】1987年，日本 【性　　状】白色结晶。易溶于水，不溶于乙酸乙酯、苯、三氯甲烷。[α]D25-14.3℃(C =0.5，1mol/L HCl)。 【用　　途】免疫调节剂类抗肿瘤药。用于治疗成人急性非淋巴细胞白血病。以及成人急性淋巴性白血病完全缓解后与药物强化维持疗法并用，可延长生存期。 【药物剂型】胶囊：10mg，30mg/粒。 【药理作用】本品是从橄榄网状链球菌培养液中提取的亮氨酸氨肽酶和氨肽酶β的抑制物，它是一种低分子免疫激活剂。实验证明它可激活巨噬细胞对多种小鼠肿瘤的细胞毒性，调节T淋巴细胞亚群的平衡，使肿瘤患者TH/TS比值上升，并促进其白细胞介素IL-1和IL-2产生。本品通过T淋巴细胞介导和NK细胞数量及其活性的提高而呈现抗肿瘤作用。由于它能促进骨髓干细胞的增殖和分化，故能减轻抗癌药物或其他因素(如放射线)对骨髓造血功能的抑制作用，并促进抗癌治疗后外周血细胞的回复。 【药动学】成人口服本品30mg单剂量后血药浓度在1～2h内达峰值，以后呈双相性下降。半衰期为0.98～1.5h。体内分布以肝、肾药浓度较高，其次为脾、肠系膜、肾门淋巴结、肾上腺等。24h内本品原形及其代谢物自尿中排泄的量约90%。 【不良反应】 少数病人服药后出现皮疹、肝功能异常、恶心、呕吐、腹痛、腹泻等副作用，停药后便逐渐消失。 【用法用量】 口服：成人每天30mg，可顿服或分2～3次 完整处方资料附件：http://www.info.pmda.go.jp/go/pack/4299002M1034_1_03/ The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse effects (risks) as well as efficacies (benefits). It is important to minimize adverse effects and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment. Brand name : Bestatin Cap. 10 mg  30mg 　Active ingredient: Ubenimex 　Dosage form: Size 3 capsules with white caps and bodies 　Print on wrapping: ベスタチンカプセル10mg, 30mg Bestatin Cap. 10mg, 30mg NK742110 Effects of this medicine This medicine exerts anti-tumor effects by enhancing immune function of the body. It is usually used in the treatment of adult acute non-lymphatic leukemia. Before using this medicine, be sure to tell your doctor and pharmacist •If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines. •If you are pregnant or breastfeeding. •If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.) Dosing schedule (How to take this medicine) •Your dosing schedule prescribed by your doctor is <<        to be written by a healthcare professional>> •In general, for adults, take 3 capsules at a time (30 mg of the active ingredient) once a day, to be adjusted according to your age or symptoms. Strictly follow the instructions. •If you miss a dose, take the missed dose as soon as possible. You should never take two doses at one time. •If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist. •Do not stop taking this medicine unless your doctor instructs you to do so. Precautions while taking this medicine • Possible adverse effects of this medicine The most commonly reported adverse reactions include rash/redness, itching, nausea/vomiting, and loss of appetite. If any of these symptoms occur, consult with your doctor or pharmacist. The symptoms described below are rarely seen as initial symptoms of the adverse effects indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately. No pertinent entries. The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above. Storage conditions and other information •Keep out of the reach of children. Store away from direct sunlight, heat and moisture. •Discard the remainder. Do not store them. --------------------------------------------------- 产地国家: 日本 原产地英文商品名: Bestatin 30mg/capsule 100caps 原产地英文药品名: Ubenimex 中文参考商品译名: 倍司他定 30毫克／胶囊 100胶囊／盒 中文参考药品译名: 乌苯美司 生产厂家英文名: Nippon Kayaku --------------------------------------------------- 产地国家: 日本 原产地英文商品名: Bestatin 30mg/capsule 30caps 原产地英文药品名: Ubenimex 中文参考商品译名: 倍司他定 30毫克／胶囊 30胶囊／盒 中文参考药品译名: 乌苯美司 生产厂家英文名: Nippon Kayaku --------------------------------------------------- 产地国家: 日本 原产地英文商品名: Bestatin 10mg/capsule 100caps 原产地英文药品名: Ubenimex 中文参考商品译名: 倍司他定 10毫克／胶囊 100胶囊／盒 中文参考药品译名: 乌苯美司 生产厂家英文名: Nippon Kayaku