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DORNER Tablets 20ug(beraprost 贝前列素片,ドルナー錠)
药店国别  
产地国家 日本 
处 方 药: 是 
所属类别 20微克/片 500片/盒 
包装规格 20微克/片 500片/盒 
计价单位: 盒 
生产厂家中文参考译名:
安斯泰来制药
生产厂家英文名:
Astellas Pharma Corporation
该药品相关信息网址1:
http://www.info.pmda.go.jp/go/pack/3399005F1021_1_19/
该药品相关信息网址2:
该药品相关信息网址3:
原产地英文商品名:
DORNER(ドルナー錠)20ug/Tablet 500Tablets/box
原产地英文药品名:
beraprost
中文参考商品译名:
DORNER(ドルナー錠)20微克/片 500片/盒
中文参考药品译名:
贝前列素
曾用名:
简介:

 

部分中文贝前列素处方资料(仅供参考)
英文名:beraprost
商标名:DORNER Tablets
中文名:贝前列素片
生产商:安斯泰来
ドルナー錠20μg
药效分类
口压缩环(PGI2)诱导体制剂
批准日期:1992年4月
欧文名
DORNER Tablets 20μg
一般名
ベラプロストナトリウム(JAN)beraprost(INN)
化学名
Monosodium(1RS,2RS,3aSR,8bSR)-2,3,3a,8b-tetrahydro-2-hydroxy-1-[(1E,3SR,4RS)-3-hydroxy-4-methyloct-1-en-6-yn-1-yl]-1H-cyclopenta[b]benzofuran-5-butanoate 
Monosodium(1RS,2RS,3aSR,8bSR)-2,3,3a,8b-tetrahydro-2-hydroxy-1-[(1E,3SR,4SR)-3-hydroxy-4-methyloct-1-en-6-yn-1-yl]-1H-cyclopenta[b]benzofuran-5-butanoate
構造式
分子式
C24H29NaO5
分子量
420.47
性状
这是白色的粉末。极易溶解甲醇,易溶于水或乙醇(99.5)。吸湿性。水溶液(1→200)不显示旋光性。
分配系数:(1-八醇/水系)
pH3 460
pH7 15
pH9 0.41
药理学
1.药理作用
(1)抗血小板作用
1)通过对末梢循环障碍患者及健康成人的经口服用,抑制血小板凝集能及血小板粘着能。
2)抑制由凝集诱发物质引起的人血小板凝集,具有人血小板凝集块解离作用(in vitro)。
(2)血管扩张和血流增加的作用
1)通过给健康成人的口服药可以增加皮肤血液流量。
2)通过对末梢循环障碍患者的经口给(对)给(对)末梢循环障碍患者的药物,脚背皮下的安静时组织氧分压的上升和驱动血复苏时间的缩短排列由于激光多普勒法的皮肤血流量的增加被认可。
3)对通过K+、PGF2α使之收缩了的狗的大腿动脉、肠间膜动脉等、各种摘出动脉及血清素、腓尼列宁使之收缩了的狗的摘出肺动脉,表示松弛作用(in vitro),使狗的各种内脏器官血管的血流增加。
(3) 血管平滑肌细胞增殖抑制作用
抑制由于血小板来历增殖因子刺激的人肺动脉血管平滑肌细胞的增殖(in vitro)。
(4) 对病态模型的作用
1)慢性动脉闭塞症
对拉乌林酸诱发老鼠后肢循环障碍、埃及生素诱发老鼠尾循环障碍及电刺激诱发兔动脉血栓,抑制缺血性病变的进展或血栓形成。
2)血栓症状
对老鼠动脉血栓症及老鼠静脉血栓症等具有抑制血栓形成的效果。
3)皮肤溃疡模型
对老鼠醋酸皮肤溃疡,表示治疗促进效果。
4)肺高血压症
在单色氨酸诱发老鼠肺高血压模型中,经口服用可抑制右室收缩期压的上升及肺血管中膜的肌性肥大。
在多伦多bokisanagonist诱发狗肺高血压模型中,通过静脉注射使肺动脉压及肺血管阻力下降。
阻塞诱发老鼠肺高血压模型抑制右室收缩期压上升。
2. 作用機序
与蛋白质相同,蛋白质通过血小板及血管平滑肌的蛋白质承受体,活性化腺苷酶,细胞内cAMP浓度上升,Ca2+流入抑制及多伦坡氧烷A2生成抑制等对抗血小板作用,血管扩张作用表示用等。
适应症
○慢性动脉闭塞症伴随的溃疡、疼痛及冷感的改善。
○原发性肺高血圧症
用法与用量
○慢性动脉闭塞症伴随的溃疡,疼痛及冷感的改善
通常,对成人,作为berapurosutorinumu,1天120μg分3次饭后经口服用。
○原发性肺高血圧症
通常,成人,作为berapurosutorinumu,从1日把60μg分成3次在饭后口服用开始,一边充分观察症状(副作用)一边逐渐增量。在增加量时,每天服用次数为3~4次,最高用量为180μg。
临床成绩
○慢性动脉闭塞症伴随的溃疡,疼痛及冷感的改善
通过对慢性动脉闭塞症的双重盲检比较试验,确认了本剂的有用性。在包含双盲检验比较考试的临床试验205例中,对溃疡、疼痛及冷感等虚血性各种症状的改善度,是中等度改善以上63.9%(131例),轻度改善以上82.9%(170例)。
○原发性肺高血圧症
在对肺高血压症的多设施开放试验中,核电站性肺高血压症21例中的全肺血管抵抗等的心血行动态指标及自他觉观察等综合的最终整体改善度,是中等度改善以上38.1%(8例),轻度改善以上61.9%(13例)。
包装
100錠(10錠×10)、500錠(10錠×50)、500錠(バラ)、1,050錠(21錠×50)、3,000錠(10錠×300)
厂家
安斯泰来制药
注:以上中文资料不够完整,使用者以原资料为准。
完整处方资料附件:http://www.info.pmda.go.jp/go/pack/3399005F1021_1_19/
DORNER Tablets 20mcg(Beraprost sodium ドルナー錠20μg)
Brand name:DORNER Tablets 20mcg
Active ingredient:Beraprost sodium
Dosage form:white to pale yellowish white tablet (diameter: 6.2mm, thickness:2.8mm)
Print on wrapping:(Face) ドルナー20μg, TR212, house-mark, (Back) ドルナー20μg, house-mark
Effects of this medicine
This medicine increases the blood flow by exerting potent effects on prostacyclin receptors on blood vessel andplatelets, thus vasodilating and inhibiting blood clotting.
It is usually used for the treatment of pain, cold feeling and skin sores of the hands and feet due to chronic arterialocclusion, as well as for the treatment of primary pulmonary hypertension.
Before using this medicine, be sure to tell your doctor and pharmacist
・If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.If you have bleeding due to haemophilia, capillary fragility, upper gastrointestinal ulcer, urinary tract haemorrhage,haemoptysis, bleeding of the ocular fundus, etc.
・If you are pregnant, possibly pregnant or breastfeeding.
・If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinaleffects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
・Your dosing schedule prescribed by your doctor is<< to be written by a healthcare professional>>
・For the improvement of ulcer, pain and cold feeling due to chronic arterial occlusion: In general, for adults, take 2tablets (40 mcg of the active ingredient) at a time, 3 times daily after meals.
For the treatment of primary pulmonary hypertension: In general, for adults, take 1 tablet (20 mcg of the activeingredient) at a time, 3 times daily after meals. The dosage may be increased gradually according to your symptoms.
If the dose is increased, it may be taken 3 to 4 times daily, and the maximum daily dose should not exceed 9 tablets(180 mcg).
In any case, strictly follow the instructions.
・If you miss a dose, skip the missed dose and continue your regular dosing schedule. You should never take twodoses at one time.
・If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
・Do not stop taking this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
・Since this medicine may cause disturbance of consciousness etc., pay close attention when you operate dangerous
machinery such as driving a car.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include headache, flushed face, hot flush, diarrhoea, queasy, malaise,bleeding tendency, subcutaneous haemorrhage, epistaxis, anaemia, rash, eczema, itching, urticaria and erythema. Ifany of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicatedin brackets. If any of these symptoms occur, stop taking this medicine and see your doctorimmediately.
・headache, queasy, visual impairment [cerebral haemorrhage, haemorrhage of the digestive tract, pulmonaryhaemorrhage, bleeding of the ocular fundus]
・facial pallor, cold sweat,dizziness on standing up, loss of consciousness [shock, syncope, loss of consciousness]
・fever, dry cough, breathing difficulty [interstitial pneumonia]
・general malaise, loss of appetite, yellowing of the skin and the whites of the eye [hepatic function disorder]
・chest pressure sensation, chest pain with strangled feeling, cold sweat [angina pectoris, myocardial infarction]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with yourdoctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
・Keep out of the reach of infants and children. Store away from direct sunlight, heat and moisture.
・Discard the remainder. Do not store them. Consult with your dispensing pharmacy or medical facility when you
discard the medicine.
For healthcare professi
Internal
Revised: 07/2015
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approvaldetails may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It isimportant to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response,patients should understand their medication and cooperate with the treatment. 

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