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安体舒是什么(靶向)

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       刚看见这种药,是治疗肺癌乳腺癌的非小细胞类用药,介绍如下

  安体舒:国家级一类双靶向抗癌新药
  安体舒批准文号:国药准字H20030359 ,主要成份为7—氯—4—氧代—喹啉,分子式是C9H6CINO ,分子量是179.6。
  近日,从国家科技部传来消息,中国科学院、中国军事医学科学院、中国协和医科大学联合突破抗肿瘤核心技术,成功研制出世界上首个小分子双靶点抗癌新药——安体舒。该药物是我国科学家在世界范围内的全新发明和创造,具有极高的临床价值,获得了国际、国内的高度认可,同时拥有国际与国内两项发明专利权(国际专利主分类号:C07D215/233,国内专利号:ZL98 1 14407.1)。据悉,由于该药物在抗肿瘤领域的突出表现,现已被国家药品审评机构批准为“国家一类新药”(我国药品分类中的最高标准)。并获得国家“科学技术进步奖”与“国家重点新产品”证书!安体舒的问世,奠定了我国抗肿瘤药物在国际上的领先地位。
  我国著名药物学家、中国科学院上海药物研究所蔡俊超教授等科学家,在关于“安体舒”如何杀灭癌细胞的论文中,向全世界的科学家揭示了其中的奥秘。癌细胞的生物膜对自身有较强的保护作用,一般药物很难通过细胞膜进入细胞内。通常情况下,分子量越小、脂溶性越高,通过细胞膜就越容易。安体舒的主要成分7-氯-4-氧代-喹啉(简称氯氧喹)是安体舒研究机构在全世界首次合成的新型物质,分子量极小,仅为179.6,还不到一般药物分子团的十分之一,同时氯氧喹还是一个脂溶性很高的小分子,所以它通过细胞外膜和细胞核膜的速度与水通过的速度几乎一样快,顺利通过细胞膜的氯氧喹直捣癌细胞的“心脏”部位,癌细胞将被迫坏死和凋亡。能如此显著杀灭癌细胞的“安体舒”却对正常细胞没有伤害,让医学界人士也感到十分惊讶。原来安体舒与癌细胞表面独有的“酪氨酸激酶”有着很强的亲和性,它们结合后能使药物很快进入癌细胞;另一方面,正常细胞独有的“纤连蛋白”对却安体舒有着很强的排斥性,从而阻止安体舒接近正常细胞,使得安体舒在高效杀灭癌细胞的同时不伤害正常细胞。
  经卫生部指定的多家权威临床医疗机构近10年的三期(Ⅰ期、Ⅱ期、Ⅲ期)临床试验表明:安体舒单独使用的疗效是一般中成药物的3.1倍,控制和缩小肿瘤效果突出,安全性高。可见安体舒直接杀灭癌细胞、阻止肿瘤细胞的生长和增殖及其安全性超过目前上市的任何药物。国家食品药品监督管理局对安体舒杰出的治疗效果给予高度评价,认定完全达到国家级一类新药标准,特授予两项一类新药证书。于是,安体舒成为我国首个研究到分子水平的癌新药。许多肿瘤患者通过服用安体舒已完全康复的事实说明,安体舒是我国抗癌患者的首选治疗药,是医生首选临床一线用药,代表我国抗癌药物的研究迈向了新的里程碑!
  作用机理:该成分的cl离子与DNA上的鸟嘌呤有亲和作用,使药物嵌入DNA两股之间,从而形成DNA加合物,抑制DNA功能,达到阻止DNA复制、转录的目的,从而抑制癌细胞。适
  用于乳腺癌、肺癌、肝癌、肠癌、胃癌、胰腺癌、白血病、宫颈癌、卵巢癌、恶性淋巴瘤、骨肉瘤、膀胱癌、肾癌、鼻咽癌、脑肿瘤、胆囊癌等恶性肿瘤的治疗。
  安体舒是我国自主研发的靶向药物,达到了国际领先水平,是中国药物研究技术的代表,不仅为中国,也为世界的肿瘤患者带来了一种安全又高效的治疗手段。因此该药被列
  入国家“1035”工程和国家“九五”“十五”重大科技攻关项目;2002年4月,通过科技部生命科学技术发展中心验收;2002年9月,获得了国家知识产权局颁发的“发明专利证书
  ”。2003年4月23日获得国家药品监督管理局颁发的两个新药证书(原料药和胶囊剂)及两个药品注册批件。2004年国家科学部认定为“国家重点新产品”。
  药物安全性验证:(1)、生殖毒性:小鼠一般生殖毒性实验、大鼠致畸敏感期实验和围产期实验中,安体舒剂量(按体表面积折算)分别达人体临床用量的1.1 、2.7 、3.2
  倍,没有发生药物对生殖的毒性反应,而且生下来的小鼠并没有出现畸形。对雄性动物给人体用量的2.2倍安体舒,精子畸形率未见升高。:(2)、遗传毒性:鼠伤寒沙门氏菌回
  复突变实验、哺乳动物细胞染色体畸变试验、啮齿类动物显性致死试验和微核试验结果均为阴性。
  药代动力学:健康志愿者的药代动力学符合口服给药二室开放模型。胃肠道吸收快,1.25小时血药浓度达峰值;分布较快t 1/2a2.094±0.958小时,消除半衰期t 1/2为
  20.283±1.491小时。鼻咽癌患者药代动力学结果符合一级吸收、二室开放型。1.6小时血药浓度达峰值,t 1/2a1.91±0.07小时, t 1/2 16.93±1.29小时。 
  用法用量:口服,每次400毫克,每日3次;或以体重计每日每公斤体重20~30毫克,分3次服。细胞学实验表明,安体舒在体内抑杀癌细胞时间为120天-180天,正常治疗时间
  为120天-180天
  单独使用安体舒,可抑杀肿瘤细胞,缩小病灶,阻止转移与复发;联合放化疗使用,可提高放化疗疗效;康复期、放化疗、手术前后使用,可巩固疗效,提高治疗成功率。
  规格:0.25gX4瓶

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==== 汉译英 ====
Spironolactone: a class of pairs of state-level anti-cancer drug target
Spironolactone Approval Number: State medicine accurate H20030359, the main ingredient for 7 - chloro -4 - oxo - quinoline, formula is C9H6CINO, molecular weight is 179.6.
Recently, news came from the National Science and Technology, Chinese Academy of Sciences, China's Military Medical Sciences, Peking Union Medical University Joint breakthrough in anti-tumor core technology, successfully developed the world's first dual-target small molecule anti-cancer drug - spironolactone. The drug is Chinese scientists in the world of new inventions and creations, has a very high clinical value, access to the international and domestic high degree of recognition, two have both international and domestic patent for invention (international patent main words: C07D215 / 233, the domestic patent number: ZL98 1 14407.1). It is learned that, since the anti-tumor drug in the area of outstanding performance has now been approved by national drug review agency as "a class of new drugs countries" (China's drug classification the highest standard). And access to national "Science and Technology Progress Award" and the "National Key New Product" certificate! The advent of spironolactone laid the anticancer drug in China's leading position in the international arena.
Well-known pharmaceutical scientists, Shanghai Institute of Materia Medica Chinese Academy of Sciences Professor Cai Junchao and other scientists, on "Spironolactone" how to kill cancer cells in a paper to the world's scientists have revealed the mystery of them. The biofilm cells have a stronger protection of their own role, of generic drugs is difficult to pass through cell membranes to enter cells. Under normal circumstances, the smaller molecular weight, the higher the fat-soluble, through the cell membrane easier. Spironolactone the main component of 7 - chloro -4 - oxo - quinoline (referred to as oxygen and chlorine quinoline) is a spironolactone research institutions in the world for the first time the synthesis of new materials, molecular weight is extremely small, only 179.6, less than one-tenth of the general drug molecules, while oxygen and chlorine quinoline, or a high fat-soluble small molecules, so it is through the cell membrane and nuclear membrane by the speed and the speed of the water almost as fast and smoothly through the cell membrane of oxygen and chlorine quinoline destroy cancer cells, "heart" of parts will be forced to necrosis and apoptosis of cancer cells. Could be so significant to kill cancer cells, "Spironolactone" Quedui does no harm to normal cells, so that the medical profession is also very surprised. The original surface of cancer cells spironolactone unique "tyrosine kinase" has a strong affinity, they enable the combination of drugs to quickly enter the cell; the other hand, normal cells unique "fibronectin "For it Spironolactone has a strong rejection, thereby preventing spironolactone close to normal cells, making spironolactone kill cancer cells, while high-efficiency without harming normal cells.
The Ministry of Health the authority of the designated number of clinical medical institutions for nearly 10 years, three (Ⅰ period, Ⅱ period, Ⅲ period) clinical trials showed that: spironolactone alone the effect was 3.1 times that of Chinese patent medicines in general, control and reduce the tumor effect of prominent, high security. Spironolactone can be seen directly kill cancer cells, block tumor cell growth and proliferation and safety exceed the current listing of any drugs. State Food and Drug Administration of spironolactone treatment outstanding spoke highly identified a class of drugs fully meet the national standard, a special award category 2 new medicine certificate. As a result, spironolactone become China's first research to the molecular level of cancer drugs. Many cancer patients by taking Spironolactone has fully recovered facts show that spironolactone is China's first choice for the treatment of patients with cancer drugs, a doctor of clinical first-line drug of choice, the study on behalf of my anti-cancer drugs are reaching a new milestone!
Mechanism: This component cl ions and guanine on the DNA pro-and the role of drug embedded in DNA between the two stocks to form DNA adducts, inhibit DNA function, to prevent DNA replication, transcription, and consequently inhibit cancer cells. Fitness
For breast cancer, lung cancer, liver cancer, colon cancer, stomach cancer, pancreatic cancer, leukemia, cervical cancer, ovarian cancer, malignant lymphoma, osteosarcoma, bladder cancer, kidney cancer, nasopharyngeal cancer, brain cancer, gallbladder cancer and other malignant cancer treatment.
Spironolactone is China's own R & D targeted drug reached the international advanced level, is representative of the Chinese drug research technology, not only for China but also for the world's cancer patients to bring a safe and effective treatment. Therefore, the drug was listed
Into the national "1035" project and the state "95" "15" major scientific and technological research projects; in April 2002, through the Ministry of Science and Life Science and Technology Development Center of acceptance; in September 2002, won the State Intellectual Property Office issued " Patent
. "April 23, 2003 won the State Drug Administration issued two new drug certificate (bulk drugs and capsules) and two drug registration approval documents. In 2004 the Ministry of National Science recognized as" National Key New Product. "
Drug safety validation: (1), reproductive toxicity: Mice general reproductive toxicity, rat teratogenicity experiments and perinatal sensitive period experiments, spironolactone dose (converted by the body surface area) were human clinical dosage of up to 1.1 , 2.7, 3.2
Times, no drugs on reproductive toxicity, but also born mice did not appear abnormal. Pairs of male animals to the human body of 2.2 times the amount of spironolactone, no increase in the rate of sperm deformity. : (2), genetic toxicity: Salmonella typhimurium Back
Complex mutation test, mammalian cell chromosome aberration test, rodent dominant lethal test and micronucleus test were negative.
Pharmacokinetics: The pharmacokinetics in healthy volunteers after oral administration in line with a two-compartment open model. Gastrointestinal tract absorption of fast, 1.25 hours peak plasma concentration; distribution faster t 1/2a2.094 ± 0.958 hours, elimination half-life t 1 / 2 for the
20.283 ± 1.491 Xiao Shi. Pharmacokinetic results of patients with nasopharyngeal carcinoma consistent with an absorbed, two-compartment open. 1.6 hours peak plasma concentration, t 1/2a1.91 ± 0.07 Xiao Shi, t 1 / 2 16.93 ± 1.29 Xiaoshi.
Usage and dosage: oral, 400 mg per day, three times; or total body weight per day per kg of body weight 20 to 30 mg divided 3 times service. Cytological experiments show that spironolactone killing cancer cells in the body and suppression time of 120 days -180 days, the normal treatment time
120 days -180 days
Spironolactone used alone can kill tumor cells, suppression, narrow lesions to prevent metastasis and recurrence; combined use of radiotherapy and chemotherapy can improve the efficacy of radiotherapy and chemotherapy; recovery period, radiotherapy and chemotherapy, surgery before and after use, it can consolidate the curative effect, improve the treatment success rate.
Specifications: 0.25gX4 bottle

Tags: 安体舒是什么(靶向)

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更新日期: 2010-01-28 15:04
作者: : mcyclub
修订: 1.0

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