新一代血液凝固剂Recomodulin已获日本批准，用于阻止血栓形成。 本品也是首个治疗遗传基因重组型凝血调节蛋白制剂 リコモジュリン点滴静注用12800 治疗类别名称 抗凝剂 商標名 Recomodulin lnj.12800 一般名 トロンボモデュリン アルファ（遺伝子組換え）（JAN） 本質 ヒトトロンボモデュリンの1-498番目のアミノ酸残基をコードするcDNAの発現により、チャイニーズハムスター卵巣細胞で産生される498個のアミノ酸残基（C2230H3357N633O718S50；分子量：52,124.58）からなる糖タンパク質（分子量：約64,000） 组成 成分含量（1瓶） 血栓调节蛋白α-DU磷12,800 UA（基因改造）） 添加剂（1瓶） L-精氨酸盐酸盐40毫克，pH调节剂 血栓调节素杜磷α是使用这种药物的活性成分（转基因），中国仓鼠卵巢细胞，牛血清，抗血栓调节素杜磷α鼠单克隆抗体（在澳大利亚或新西兰的产品）在制造过程中是。 使用1个单位的活动，是统一由旭化成制药一）国家健康科学研究所） 性状 剂型 注射溶液 适应病症 汎発性血管内血液凝固症（DIC） 用法及び用量 通常情况下，成人，血栓调节一次380U/公斤级每天超过一段约30分钟的磷阿尔法静脉输注。应当指出的是，根据症状减肥适当。 *注射法的制备 溶解在每天站2mL的生理盐水或天站一个小瓶（12,800U）葡萄糖注射液（5％），并以相同的溶液100毫升采取了根据患者的体重所需量从该溶液稀释，静脉滴注。 药效药理 1. 作用机理 这种药物，凝血酶促进蛋白C的活化。所得活化的蛋白C，因子V和通过灭活，抑制凝血系统的活化抑制凝血酶的形成活化的因子VIII活性。这种药物的基础上，凝血酶的产生抑制作用，抑制DIC的发病的抗凝作用。 2. 薬理作用 (1) 蛋白C激活促进作用 和促进蛋白C凝血酶（体外）的活化。 (2) 凝血酶生成抑制作用 1) 正常人血浆中，它抑制因子V和凝血酶原酶的活性的诱导活化的组织因子，抑制凝血酶的产生（体外）。 2) 在蛋白C，人血浆蛋白S或抗凝血酶活性被降低由组织因子诱导，抑制凝血酶原酶的活性（体外）。 (3) 凝血酶的凝血活性抑制作用 它延伸在正常人血浆中的凝血酶凝血时间（体外）。 (4) 血栓成長阻害作用 1) 它抑制由人血小板凝血酶凝集反应（体外）。 2) 又延长了各种凝血时间（体外）。 (5) 实验DIC模型效果 1) 在组织因子诱导的DIC模型（鼠，猴），提高了血块组织学检查的价值。 2) 内毒素诱发DIC模型（大鼠），和改进的血液凝块的组织学检查值。 3) 在组织因子诱导的DIC模型，从而降低了抗凝血酶活性（鼠），改善凝血组织学检查值。 4) 在组织因子诱导的DIC模型（鼠），抑制出血时间的延长。 5) 在大鼠内毒素诱发DIC模型中，抑制炎性细胞因子的生成和器官损伤的发生，并提高了存活。 ＜参考＞ 滴度单位 所引用的文件，血栓调节蛋白α的滴度显示在基于内部滴定法的单位。单元“1U”是基于公司滴定法，对应于电流测量方法的“0.10U”，这剂1小瓶的内容12,800U，一个128,000U是在内部滴定法。 对于剂量 引文：在血栓调节蛋白α（或一组密度）的剂量是由重量显示指示（毫克等）。对应于“1mg的”是“6,400U”，该试剂1小瓶，一个为2mg内容12,800U。 包装 リコモジュリン点滴静注用12800：１バイアル リコモジュリン点滴静注用12800：10バイアル 制造厂商 旭化成制药株式会社 完整资料附件：http://www.info.pmda.go.jp/go/pack/3339401D1027_1_09/ Thrombomodulin formulation "Ricomodulin for intravenous drip infusion 12800" Asahi Kasei Pharma Corporation (Head office: Chiyoda-ku, Tokyo; President: Toshio Asano) and Pfizer Inc. (Headquarters: Shibuya-ku, Tokyo; President: Ichiro Umeda) are currently manufacturing and selling in Japan by Asahi Kasei Pharma We announce you that we have signed a co-promotion (co-promotion) contract in Japan for thrombomodulin preparation "Ricomodulin 1) Intravenous drip injection 12800" (common name: thrombomodulin alpha (genetical recombination)). In the case of Based on this agreement, Asahi Kasei Pharma and Pfizer will begin promotion activities of "Ricomodulin" jointly on 1 November this year. In Pfizer, the Infectious Disease Domain Business Division takes charge of this promotion. As for manufacturing and sales, Asahi Kasei Pharma will do as usual, and sales will be recorded in Asahi Kasei Pharma. "Ricomodulin" is a blood coagulation inhibitor that was launched in Japan as "indolent intravascular coagulation disorder (DIC) 2" "created by Asahi Kasei Pharma in 2008 and released in Japan, and a new blood coagulation regulatory mechanism DIC symptoms are improved by. DIC is known as a serious disease that frequently complicates infectious diseases. Currently, Asahi Kasei Pharma is conducting international joint Phase III clinical trials for severe sepsis 4) with "coagulation abnormality 3) worldwide" 4). Pfizer, who has experience and proven experience in the field of DIC therapy and has strengths in information provision activities in Asahi Kasei Pharma and infectious diseases, has established close cooperative relationships through this co-promotion activity, thereby improving the product value of "Ricomodulin" We expect to maximize it and further contribute to the treatment of DIC. <Glossary explanation> 1) "Ricomodulin" Human thrombomodulin preparation produced using gene recombination technology. Thrombomodulin exerts anticoagulant action by suppressing the production of thrombin which is the causative substance of blood coagulation. 2) disseminated intravascular coagulation (DIC) Due to excessive activation of the blood clotting system, disseminated thrombus formation occurs in the microvessels, and organ damage is caused by vascular endothelial cell disorders due to ischemia and the like, and reduction in consumption of hemostatic factor and secondary A syndrome that causes pronounced bleeding tendency due to fibrinolysis. Malignant tumor, infectious disease, etc. It develops with frequent complications. It is known that prognosis deteriorates markedly by developing DIC. "Disseminated intravascular coagulation", "disseminated intravascular coagulation syndrome" sometimes. 3) abnormality of coagulation Generally refers to a state in which there is abnormally elevated systemic blood coagulation. Coagulopathy in sepsis is caused by excessive activation of the coagulation system via activation of inflammatory cytokine networks such as endotoxin. 4) sepsis It is a systemic inflammatory response syndrome caused by infection. Pathogenic microorganisms have spread throughout the body and are in a very serious condition, with no treatment there is an early death from shock, DIC, multiple organ dysfunction etc. Often the background is based on the original physical strength, the outcome is also not good at all. (※ "From Japan Sepsis Clinical Practice Guidelines/Japan Intensive Care Medical Society Sepsis Registry Committee (Daily Intensive Medical Journal 2013; 20: 124-73)".