英文药名：Somatuline（Lanreotide Acetate for s.c. Injection） 中文药名：醋酸兰瑞肽皮下注射剂 生产厂家：帝人制药 ソマチュリン皮下注60mg／ソマチュリン皮下注90mg／ソマチュリン皮下注120mg 药用类别名称 持续生长抑素缓释制剂 批准日期：2012年11月 商標名 Somatuline for s.c. Injection 一般名 ランレオチド酢酸塩（Lanreotide Acetate） 化学名 3-(2-Naphthyl)-D-alanyl-L-cysteinyl-L-tyrosyl-D-tryptophyl-L-lysyl-L-valyl-L-cysteinyl-L-threoninamide cyclic(2→7)-disulfide acetate 化学構造式 分子式 C54H69N11O10S2・xC2H4O2（x：1.0～2.0） 分子量 1096.32（遊離塩基として） 性状 本品是一种白色粉末。这种产品可溶于二甲基亚砜和乙醇（99.5），略溶于甲醇，微溶于水。 操作注意事项 1. 冷藏（2〜8℃），存储仍然层压包装。 2. 此剂是无菌，不打开层压包装，直到准备使用。另外，也可以立即除去后使用。 3. 如果层叠体的包装打开，或损坏，或者您当观察异常如裂缝或损坏注射器不使用。 4. 不放弃它，或受到强烈冲击。这可能会导致损坏或缺陷。 适应症 肢端肥大症:外科手术和/或放射治疗之后分泌异常时；类癌临床症状的治疗. 用法用量 最初每14天肌注1次,每次1支,如治疗反应不显著,可增至每10天注射1次 药效药理 1. 作用机序 生长抑素，经由结合于5人生长抑素受体（HSST）的子类型在垂体前叶（hsst2）和5型（hsst5），知识抑制生长激素分泌的两种主要类型是。生长抑素兰瑞肽（醋酸）的模拟显示出较高的结合亲和力hsst2和hsst5 2.血清生长激素（GH）的浓度降低作用 在大鼠中，血清GH浓度降低了兰瑞肽的单次皮下施用（乙） 包装规格： 皮下注 60毫克: 1 注射器 90毫克: 1 注射器 120毫克: 1 注射器 存储方法、到期日期等。 存储方法 2 ~ 8 ℃, 屏蔽密闭容器 (见处理注意事项) 制造商（进口商） 日本帝人制药有限公司 其他商標 ソマチュリン/Somatuline is the registered trademark of Ipsen Pharma, Paris, France. 完整资料附件：http://www.info.pmda.go.jp/go/pack/2499413G1025_1_04/ "Somaturin Subcutaneous 120mg" acquires additional approval for the efficacy and effects of pancreatic and gastrointestinal neuroendocrine tumors Teijin Pharma Co., Ltd. (Head Office: Chiyoda-ku, Tokyo, President: Nabeshima Akihisa) is introduced from Ibsen Inc. (Head office: France Paris, Euronext: IPN, ADR: Ipsey), advanced giant disease and pituitary gland therapeutics Somaturin Subcutaneous note 120mg (general name: Randall Acetate), today, the Ministry of Health and Welfare has obtained additional approval of the efficacy and effects of "pancreatic and gastrointestinal neuroendocrine tumors". 1．On the pancreatic and digestive tract neuroendocrine tumors (1) Pancreatic and gastrointestinal neuroendocrine tumors (neuroendocrine Tumor, hereinafter referred to as "NET") are malignant tumors arising from endocrine cells that secrete hormones. NET, which occurs in the digestive tract, such as the pancreas, small intestine, and rectum, is also a type that encourages excessive secretion of hormones, which can cause symptoms such as hypoglycemia, peptic ulcers, and severe diarrhea. (2) The percentage of Japanese people who are newly developed in one year is said to be about 1.3 people in the pancreas net, and about 3.5 people in the digestive tract net per 100,000 population. Although they are both relatively rare, the significance of their treatment is increasing since the number of patients is on an increasing trend every year. 2．Background and history of approval acquisition (1) For the treatment of pancreatic and digestive tract net, tumor resection is considered to be the first choice, but if surgery is difficult or the tumor remains after surgery, drug treatment is required. 2） The somatostatin formulation * 1 is the first choice for drug treatment of pancreatic and digestive tract net, where physical symptoms are found. However, in Japan domestic, there was no somatostatin formulation available for pancreatic net in the anti-tumor effect, and the digestive tract net had only one agent, and the choice of the drug was limited. 3）In this based on the results of the "clarinet" Test 2 conducted in 14 European countries, and the ⅱ phase of clinical trials since 2013, which Teijin Pharma conducted in Japan Japan, Ibsen has applied for additional efficacy and effects in July 2016. 4） By obtaining additional approval of this efficacy and effect, the "Somaturin subcutaneous note 120mg" is a somatostatin formulation that has the first pancreatic net indication in Japan. 1 "somatostatin formulation" Somatostatin similar compounds with the effect of inhibiting endocrine hormone secretion. 2 "Clarinet®Test" A placebo-controlled clinical trial by Ibsen, which examines the efficacy and safety of the Lancet, which is not resected or has remote metastasis to the pancreas and digestive tract net. 3．Future developments (1) Ibsen will continue its efforts to provide treatment options to patients around the world who are suffering from net symptoms in the wake of obtaining additional approval of the efficacy and efficacy of this drug in this Japan. (2) Teijin Pharma will continue to contribute to improving patient QOL (quality of Life) by focusing on new drug discovery research and providing new treatment options for high-unmet diseases. * "Somaturin" and "clarinet" are registered trademarks of Ibsen Corporation.