部份中文醋酸格拉替雷处方资料（仅供参考）
英文名：Glatiramer acetate
商品名：COPAXONE S.C. Injection 20mg Syringe
中文名：醋酸格拉替雷注射剂
日文名：コパキソン皮下注20mgシリンジ
剂  型：注射器
生产商：武田制药有限公司
药品介绍
药物分类名称
治疗多发性硬化症的药物
批准日期：2015年11月
商標名
COPAXONE S.C. Injection 20mg Syringe
一般名
グラチラマー酢酸塩（Glatiramer Acetate）〔JAN〕
化学的性質
醋酸格拉替雷是由L-谷氨酸，L-丙氨酸，L-酪氨酸，L-赖氨酸组成的平均分子量为5,000至9,000的多肽混合物。 L-谷氨酸，L-丙氨酸，L-酪氨酸，L-赖氨酸的各氨基酸残基的摩尔比为0.129至0.153,0.392至0.462,0.086至0.100和0.300至0.374。
構造式
（Glu, Ala, Lys, Tyr）X・yCH3COOH（C5H9NO4・C3H7NO2・C6H14N2O2・C9H11NO3）X・yC2H4O2
分子式
ポリ［L-Glu13-15, L-Ala39-46, L-Tyr8.6-10, L-Lys30-37］X・yCH3COOH
x：聚合物链长
y：每100个氨基酸残基的乙酸分子数为15至24。
上标：表示构成醋酸格拉替雷中各种多肽的氨基酸残基的摩尔百分比范围，这些氨基酸残基的序列不同。
分子量
醋酸格拉替雷组合物的平均分子量为5,000至9,000，并且至少68％的分子具有2,500至20,000的分子量。
性状
醋酸格拉替雷是白色至微黄色的白色冻干产品。
处理注意事项
[注意]
（1）避免冷冻，存放在外箱中并在2-8℃下储存。
（2）打开后屏蔽和保护光线。
（3）使用时将其恢复到室温时使用，将其用于泡罩。
（4）如果溶液中存在不溶性颗粒，请勿使用。
（5）不要重新消毒或重复使用这种药物，因为它只需一次使用。适当地处理用过的预装注射器。
批准条件
1.制定药品风险管理计划并适当实施。
2.由于日本的临床试验数量非常有限，通过针对所有病例进行使用结果调查，直到制造和销售后累积某个病例的数据为止，除了掌握使用该药物的患者的背景信息外，还应尽快收集有关该药物安全性和有效性的数据，并采取必要措施正确使用该药物。
3.2上市后监测，四年后，每天的批准（以下简称“中期报告期”简称）编译的最高药品风险管理计划的基础上：1的数据，临时报告期内结果在过去一天之后的3个月内将其提交给监管机构。
药用药理学
醋酸格拉替雷（GA）与皮下给药后外周淋巴结中抗原呈递细胞（APC）表面上存在的主要组织相容性复合物（MHC）分子结合。 结果，GA通过与T细胞受体上的抗原 - 主要组织相容性复合物竞争，抑制多发性硬化的抗原特异性T细胞的活化。
此外，当GA结合APC表面上的MHC分子时，诱导GA反应性Th2细胞。 GA反应性Th2细胞通过血脑屏障，在中枢神经系统中积聚，并被髓鞘碱性蛋白自身抗原刺激，分泌抗炎细胞因子和神经营养因子。
此外，GA给药通过抗原非特异性机制改变APC功能，并且是一种抗炎II型，其特征在于IL-10和TGF-β的增加，以及IL-12和TNF的产生的减少。 促进单核细胞的形成。
适应症
预防多发性硬化复发
用法与用量
通常，成人每天一次皮下注射20mg醋酸格拉替雷。
包装
20毫克注射器
1个注射器×7
制造供应商
武田制药有限公司
提携
Teva Pharmaceutical Industries Ltd.
完整说明书附件：http://www.info.pmda.go.jp/go/pack/3999440G1024_1_05/
Manufacture and sale of Copaperon® subcutaneous injection 20 mg syringe in Japan in the treatment of multiple sclerosis
On September 28, 2015, the Company announced today that it has co - copaxone ® subcutaneous injection 20 mg syringe (generic name: glatiramer acetate, hereinafter referred to as "Copaxone"), a therapeutic agent for multiple sclerosis。
Copaxone is a once-daily subcutaneous injection that prevents recurrence of multiple sclerosis developed by Teva Pharmaceutical Industries Ltd. (Headquarters: Israel Petaha Tikuba, hereinafter "Teva"). This drug is one of the most frequently used drugs in the field of multiple sclerosis and has been approved in more than 50 countries around the world.
In Japan, the development of this drug has been requested by the Ministry of Health, Labor and Welfare as an unapproved drug with a high necessity for medical treatment Teva Pharmaceutical Corporation (a wholly owned subsidiary of Teva, head office: Minato-ku, Tokyo, Teba ") has been advancing. In March 2013, the Company entered into a licensing agreement concerning the commercialization of this drug in Japan with Teva, and in December 2014, the Company filed an application for manufacturing and marketing approval based on the contract.
This approval is based on open-label clinical trial results which examined the efficacy and safety of this drug when Teva Inc. administered this drug for 52 weeks in relapsing-remitting multiple sclerosis in Japan, and Teva is based on three clinical trial data conducted overseas for relapsing-remitting multiple sclerosis.
Acquisition of manufacturing and marketing approval in Japan is a very important milestone for our company and this drug, which is the first-line drug of recurrent multiple sclerosis overseas, is of great importance for patients in Japan with multiple sclerosis I hope to contribute as a new treatment option. We will continue to strive to deliver the medicines needed for patients and medical professionals.
Overview of Copaxon
Product name: Copaxone® subcutaneous injection 20 mg syringe
Common name: glatiramer acetate
Indication
Prevention of recurrence of multiple sclerosis
Dosage regimen
Usually, adults are administered subcutaneously once daily 20 mg as glatiramer acetate.
About glatiramer acetate
Overseas indication for this drug is recurrent multiple sclerosis. The most frequent side effects are injection site reactions (erythema, pain, mass, itching sensation and edema). Currently, this drug is approved in more than 50 countries including the United States Russia Canada Mexico Australia Israel European countries.
About Multiple Sclerosis
Multiple sclerosis is an autoimmune disease with an inflammatory demyelinating disorder of the central nervous system as its main feature, characterized by demyelinating plaques in the brain and spinal cord. Common symptoms include visual and ocular dyskinesia, paresthesia, muscle weakness, spasticity, urination failure, cognitive dysfunction, etc. The disease has a primary progressive type that follows a chronic progressive course from the early stage of onset, a relapsing remitting type that repeats relapsing remission, and a secondary progressive type that turns into progressive type after relapsing remission, and more than 80% of patients It is classified as relapsing-remitting type. The number of people suffering from this disease in Japan is about 18,000, and it is on the upward trend.