英文药名：Exal for Inj（Vinblastine Sulfate）

中文药名：硫酸长春碱注射剂

生产厂家：日本化药

エクザール注射用10mg

治疗类别名称
抗肿瘤药
商標名
Exal for Inj. 10mg
一般名
ビンブラスチン硫酸塩（Vinblastine Sulfate）
（初期にはVincaleukoblastineの名称で記載された。）
略号
VLB、VBL
化学名
Methyl(3aR,4R,5S,5aR,10bR,13aR)-4-acetoxy-3a-ethyl-9-[(5S,7S,9S)-5-ethyl-5-hydroxy-9-methoxycarbonyl-1,4,5,6,7,8,9,10-octahydro-3,7-methano-3-azacycloundecino[5,4-b]indol-9-yl]-5-hydroxy-8-methoxy-6-methyl-3a,4,5,5a,6,11,12,13a-octahydro-1H-indolizino[8,1-cd]carbazole-5-carboxylate monosulfate
分子式
C46H58N4O9・H2SO4
分子量
909.05
構造式

性状
硫酸长春碱为白色粉末至浅黄色。微溶于水，微溶于甲醇，和乙醇（99.5）几乎不溶。
它是吸湿性。
药效药理
1. 药理作用
(1) 对动物可移植性肿瘤的抗肿瘤作用
硫酸长春碱小鼠P-1534白血病，艾氏腹水瘤的类型，产生的显著存活天弗氏腹水肿瘤类型的延伸，S-180腹水肿瘤类型和B-82A白血病，另外，在小鼠乳腺肿瘤（DBA腺癌），即使对于步行者癌症和大鼠的横纹肌肉瘤，表现出明显的肿瘤生长抑制效果。
(2) 细胞学效应
硫酸长春碱为1.0mg/ kg的观察到在时间腹水肿瘤细胞的分裂图像施用到小鼠的腹腔内，在小鼠的肿瘤细胞（艾氏腹水肿瘤和L1210腹水肿瘤），与分裂的细胞的增加观察中期细胞的积累。
2. 作用机序
硫酸长春花碱的作用机制没有细节仍然明显，但通过在形成有丝分裂纺锤体微管结合至微管蛋白被认为导致细胞周期停滞在中期。
适应病
硫酸长春常规疗法
影响效能
的下列疾病的主观和TaSatoshi症状缓解
恶性淋巴瘤，滋养细胞疾病（绒毛膜癌，破坏葡萄胎，葡萄胎），复发或难治性生殖细胞瘤（睾丸肿瘤，卵巢肿瘤，性腺外肿瘤），朗格汉斯细胞增生症。
用法与用量
1. 恶性淋巴瘤，为滋养细胞疾病，白血细胞数为指标，如硫酸长春花碱，注入开始的成人每周为0.1mg/kg的静脉注射。
然后增加为0.05mg/kg时，注射，每周一次为0.3mg/kg静脉注射。
应当指出的是，增加或减少取决于患者的年龄和症状。
2. 复发性或难治性生殖细胞肿瘤，它执行与确定的标准其他抗肿瘤剂的组合疗法，硫酸长春碱，每日一次每日剂量0.11mg/kg的2天静脉内注射，随后停药19-26天。这是一个疗程，重复给药。
3. 对细胞组织细胞增生症，通常，一旦如硫酸长春碱为6mg/平方米（体表面积），一次在诱导治疗一周，每两至三周在维持治疗一次，静脉内注射。
应当指出的是，根据该状态的患者。
<注射法的制备>
将其溶解在每1毫升水硫酸长春碱为1mg用于注射或除了生理盐水的比例。
包装规格
10mg*1瓶

制造厂商
日本化药有限公司
完整处方资料附件：http://www.info.pmda.go.jp/go/pack/4240401D2031_2_08/
Efficacy and efficacy of "Langerhans cell histiocytosis (LCH)" of anticancer drug "Exal® for injection 10 mg"
On November 15, 2010, Nippon Kayaku Co., Ltd. (Headquarters: Tokyo, President: Akira Bandai) received a request from the Ministry of Health, Labor and Welfare on October 29, 2010 and on November 15, 2010, We have applied for partial change approval application for the indication of "Langerhans cell histiocytosis (LCH)" 1) for the use of 10 mg for general use (vinblastine sulfate for injection) 1) and for the manufacture and sale of pharmaceuticals related to addition of usage and dosage . We expect to approve around May 2011 by a half-year review from the application.
This drug is an antineoplastic agent derived from a plant extract and has been marketed in Japan in 1968 and is currently being treated for the treatment of "malignant lymphoma, villous disease, germ cell tumor of recurrence or refractory or urothelial carcinoma" It is used in.
This time, based on the "Langerhans cell histiocytosis (LCH)" from the academic society 1) Based on the indication for additional indication, in the "unconfirmed drug/medical examiner review meeting (2) , A report on the applicability to the publicly-known application 3) was prepared, and a preliminary evaluation that the publicly-known application 3) is appropriate at the Pharmaceutical Affairs Food Sanitation Council Pharmaceutical Subcommittee meeting held on October 29, 2010 We received this application.
In addition, we have continued efforts related to elimination of domestic and overseas drug lags (development of non-indication drugs), and on September 1, 2010, we established an ovary for anti-neoplastic agent "Hi camutine in injection" I am applying for cancer indication addition. We will continue to strive to develop new drugs that are useful for cancer treatment, and we will continue to contribute to medical care by addressing domestic and overseas drug lags for anticancer drugs that have approval for manufacturing and marketing.
1) Diseases occurring mainly in children who cause proliferation of malignant Langerhans cells (a kind of white blood cells related to immunity) in whole body organs
2) A meeting aimed at encouraging the development of unapproved drugs and non-applicable drugs by pharmaceutical companies composed of persons (experts) who have medical and pharmacological knowledge experience on drug therapy sponsored by the Ministry of Health, Labor and Welfare
3) Apply as medically known without doing a whole or a part of the clinical trial without new implementation
that's all