英文药名：MIRIPLA suspension vehicle（Miriplatin Hydrate） 中文药名：米铂混悬液 生产厂家：住友制药 治疗类别名称 肝癌的治疗剂 批准上市日期：2010年1月 商標名 MIRIPLA suspension vehicle 一般名 ヨード化ケシ油脂肪酸エチルエステル Iodine addition products of the ethylesters of the fatty acids obtained from poppyseed oil 本質 ケシ油脂肪酸エチルエステルにヨウ素を結合させたもので、定量するとき、ヨウ素（I：126.90）36.0～41.0％を含む。 结构式： 性状 它是粘性浅黄色的油溶液至黄棕色清晰。余混溶（95），以及氯仿或乙醚乙醇。它不溶于水。它由光或空气变成暗褐色逐渐。 粘度 27〜54毫米2 /秒（20℃） 比重 D20201.270〜1.292 操作注意事项 有相似性和在色调略微不同批次差异，但它不是一个重标记，只要它是在一个范围内的浅黄色至黄褐色 适应症： 用于肝细胞癌（HCC）的治疗 用法用量： 将70mg 本品溶于3.5mL 本品专用混悬液中，通过插入肝动脉内的导管注射进肝脏，直至药液充满肿瘤血管内时结束。给药上限为每次6 mL（含本品120mg），且需重复给药时要设4 周以上的观察期。 药效药理 1. 药理作用 (1) 抑制细胞活性 对人肝癌Kangankabu，李-7和鼠Kangankabu AH109A，这表明细胞的生长抑制作用。 (2) 抗肿瘤作用 对大鼠Kangankabu AH109A和人类Kangankabu锂7在大鼠肝植入表明在肝动脉通过单次给药剂量依赖性的抗肿瘤作用。 2. 作用机序 Miriplatin被转化为二氯1,2-二氨基环己烷铂和在生物体内等，认为形成交联共价结合到在癌细胞中的DNA链的铂-DNA。 制造厂商 大日本住友制药 Miriplatin Hydrate是“大日本住友制药株式会社”开发的脂溶性铂复合物抗癌药，于2009年10 月16日获得日本厚生劳动省批准，用于治疗肝细胞癌。本品专用混悬液已于同年8月20日获得批准。2010年1月20日，Miriplatin Hydrate及其专用混悬液同时上市。而miriplatin的批准将是世界范围内的第一次。Miripla solution 4ml需在2- 10度冷藏。 该药品完整处方资料附件： 1.ミリプラ用懸濁用液：http://www.info.pmda.go.jp/go/pack/7990401A1040_1_05/ 2.ミリプラ動注用： http://www.info.pmda.go.jp/go/pack/4291416D1022_1_06/ October 16, 2009 -- Dainippon Sumitomo Pharma Co., Ltd. (Head Office: Osaka, ; President: Masayo Tada) announces that the Company has obtained a manufacturing and marketing approval for “MIRIPLA® for intra-arterial injection 70 mg” (generic name: miriplatin hydrate), a therapeutic agent for hepatocellular carcinoma in as of October 16, 2009 from Ministry of Health, Labor and Welfare. “MIRIPLA®” is first suspended in an oily lymphographic agent and then administered through hepatic artery into hepatocellular carcinoma. As such an oily lymphographic agent, the Company has “MIRIPLA® suspension vehicle 4 mL” (generic name: iodine addition products of the ethylesters of the fatty acids obtained from  poppyseed oil), which is approved for suspending  MIRIPLA®. The manufacturing and marketing approval for this suspension vehicle was obtained on August 20, 2009 from the competent Ministry. “Lipiodolization” or “Chemo-lipiodlization” is one of the standard methods for treating hepatocellular carcinoma , where an anticancer drug is suspended in an oily lymphographic agent (iodine addition products of the ethylesters of the fatty acids obtained from  poppyseed oil,  Lipiodol) and then administered into hepatic artery. The Company has carried out a research program to discover an anticancer drug suitable for this treatment and succeeded in development of a lipophilic platinum complex, miriplatin which has high affinity to  Lipiodol. MIRIPLA®has a high suspensibility in “MIRIPLA® suspension vehicle 4 mL “. Some of the characteristics of MIRIPLA®are: it accumulates and stays in a tumor after the administration into hepatic artery, platinum component is released gradually over a long duration and yet exposure to entire body is minor. In clinical tests on hepatocellular carcinoma, satisfactory anti-tumor effects were confirmed not only on patients of initial treatment but also on patients who relapsed after treatment such as hepatic resection. Some side effects were observed, but they were regarded as those generally observed under chemo-lipiodolization therapy, and they were thought to be tolerable at medical institutions familiarized with this treatment. There was no adverse event on vessel disorder in hepatic artery related to this drug. The Company has an intention to launch both “MIRIPLA® for intra-arterial injection 70 mg” and “MIRIPLA® suspension vehicle 4 mL” after they are listed on the national health insurance drug price standard. As a result of launching of MIRIPLA®, the Company expects to increase the line-up of products for the liver diseases, which includes Sumiferon®, a natural interferon-alpha product, and to further contribute to the total care of liver diseases. ------------------------------------------------- 产地国家：日本 原产地英文商品名： Miripla suspension(ミリプラ用懸濁用液) 4ml/vial 原产地英文药品名： miriplatin 中文参考商品译名： Miripla混悬液(ミリプラ用懸濁用液)4毫升/瓶 中文参考药品译名： 米铂 生产厂家英文名： Dainihon Sumitomo 生产厂家中文参考译名： 大日本住友製薬 ------------------------------------------------- 产地国家：日本 原产地英文商品名： MIRIPLA(ミリプラ動注用)70mg/vial 原产地英文药品名： miriplatin 中文参考商品译名： MIRIPLA注射用(ミリプラ動注用)70毫克/瓶 中文参考药品译名： 米铂 生产厂家中文参考译名： 大日本住友製薬 生产厂家英文名： Dainihon Sumitomo