CN1308965A - 降纤酶作为制备止血药的应用 - Google Patents

降纤酶作为制备止血药的应用 Download PDF

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CN1308965A
CN1308965A CN 01108025 CN01108025A CN1308965A CN 1308965 A CN1308965 A CN 1308965A CN 01108025 CN01108025 CN 01108025 CN 01108025 A CN01108025 A CN 01108025A CN 1308965 A CN1308965 A CN 1308965A
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hemorrhage
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CN1176719C (zh
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张行
陈波
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ANGE PHARMACEUTICAL Co LTD JIANGSU
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ANGE PHARMACEUTICAL Co LTD JIANGSU
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Abstract

本发明涉及一种药类,具体地讲涉及一种止血药。本发明采用从长白山白眉腹蛇或尖吻腹蛇毒中提取的蛋白水解酶,即降纤酶,利用少量降纤酶并不大量消耗血液中的纤维蛋白原,而是将纤维蛋白原降解,释放出纤维蛋白肽A,并聚合成纤维蛋白多聚体,促进血管破损处的血小板聚集,加速血小板止血栓的形成,起到止血作用的特性,转用于止血。本发明突破了降纤酶只用于治疗血栓药物的作用。本发明止血快速、效果好,工艺简单、成本低。

Description

降纤酶作为制备止血药的应用
本发明所涉及的是一种药类,具体地说涉及到的是一种止血药。
在本发明作出之前,降纤酶作为治疗脑梗塞、血栓闭塞性脉管炎、股动脉栓塞、肺栓塞等疾病的药物,每次注射5-10单位/次。通常是降纤酶给药5-10单位/次时,血液中的纤维蛋白原被大量消耗,血液粘度明显降低,因此降纤酶在临床上被广泛用于治疗血栓性疾病。降纤酶,曾用名蝮蛇抗栓酶、精制腹蛇抗栓酶、江浙腹蛇抗栓酶、去纤酶等,都是同一种药物。
本发明的目的在于从长白山白眉腹蛇Agkistrodon halys(ussriensis Eme-lianor)或尖吻腹蛇Agkistrodon acutus(Guenther)毒中提取的蛋白水解酶(平均分子量36000+5000),符合国家卫生部标准(试行)的注射用制剂,即降纤酶,利用其小剂量给药时并不大量消耗血液中的纤维蛋白原,而是将纤维蛋白原降解,释放出纤维蛋白肽A,并聚合成纤维蛋白多聚体,促进血管破损处的血小板聚集,加速血小板止血栓的形成,起到止血作用的这一特性,将降纤酶用于止血。
本发明的技术方案是:降纤酶,即从长白山白眉腹蛇或尖吻腹蛇毒中提取的蛋白水解酶,平均分子量36000+5000,以1-0.0005单位/次作止血药注射用制剂。
本发明的优点和效果在于开拓了降纤酶的另一用途,作止血药止血快速、效果好,而且制作工艺简单,成本低。
附图:
图1-本发明不同剂量降纤酶对小鼠出血时间的影响。
实施例1:注射用降纤酶冻干剂
称取降纤酶5mg,加赋形剂右旋糖酐或甘露醇等5000g,加注射水至50000ml,溶解,过滤后灌装于50000支西林瓶中,冻干。静脉、肌肉注射,每次注射1支。
实施例2:注射用降纤酶粉针剂
称取降纤酶5mg,加稀释剂右旋糖酐或甘露醇等5000g,混匀,等量分装于50000支西林瓶中。静脉、肌肉注射,每次1支。
实施例3:降纤酶注射液
称取降纤酶5mg,溶解于50000ml注射用水中,过滤,然后灌装于50000支安瓶中。静脉、肌肉注射,每次1支。
如图1所示:表明了不同剂量降纤酶对实验小鼠出血时间的影响。
降纤酶在0.0001-0.01单位/kg范围内可使小鼠的出血时间明显缩短,而当剂量增大到3.0单位/kg时,则明显延长了小鼠的出血时间。如表1。
在0.0004-0.0036单位/kg剂量范围内使家兔全血凝固时间明显缩短。如表2。
      表1  降纤酶对小鼠出血时间的影响(秒 X±SD,N=10)
组别  动物数 剂量(u/kg)     给药前 给药后0.5小时 给药后1小时 给药后3小时
对照组     1010101010101010     NS0.000010.00010.00030.0010.010.153.0  142.6±40.62138.7±17.71142.7±37.08137.4±41.44141.0±41.37143.6±34.82140.4±32.85146.2±41.50  144.9±50.76128.9±20.62126.3±49.0876.5±27.05**60.1±25.65**140.2±38.27176±114.56207.7±76.87  142.5±46.48138.8±52.2085.0±23.05**73.2±21.67**56.4±24.25**95.9±25.86*170.4±89.39377.3±258.9*  173.1±53.81175.6±49.0894.9±41.74**134.6±35.0293.3±33.28**94.2±33.5**292.7±247.46866.9±392.1**
给药组不同时相点与对照组相比*表示P<0.05,**表示P<0.01
      表2降纤酶对家兔全血凝固时间的影响(分钟,X±SD,N=6)
组别 剂量(u/kg) 给药前 给药后0.5小时 给药后1小时 给药后3小时
对照组小剂量组中剂量组大剂量组     NS0.00040.00120.0036  3.19±0.253.40±0.113.52±0.253.42±0.61     3.25±0.142.47±0.03**△△2.34±0.26**△△2.61±0.79     3.37±0.232.10±0.27**△△2.03±0.24**△△2.66±0.55**△     3.47±0.172.32±0.24**△△2.09±0.37**△△2.26±0.24**△△
各给药组给药前后各时相点全血凝固时间与对照组比较*表示P<0.05、**表示P<0.01各给药组给药后各时相点全血凝固时间与给药前比较△表示P<0.05、△△表示P<0.01

Claims (3)

1.降纤酶作为制备止血药的应用,其特征在于降纤酶,即从长白山白眉腹蛇或尖吻腹蛇毒中提取的蛋白水解酶,其平均分子量36000+5000,以1-0.0005单位/次作止血药注射用制剂。
2.根据权利要求1所述的降纤酶作为制备止血药的应用,其特征在于降纤酶是以0.2-0.02单位/次作止血药注射用制剂。
3.根据权利要求1或2所述的降纤酶作为制备止血药的应用,其特征在于可制成含降纤酶的复方注射用制剂。
CNB011080256A 2001-01-05 2001-01-05 降纤酶在制备体内止血药中的应用 Expired - Fee Related CN1176719C (zh)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101376022B (zh) * 2007-08-31 2011-11-30 上海医药工业研究院 含聚乙二醇降纤酶的药物组合物
CN1972706B (zh) * 2004-06-24 2012-03-21 东菱药品工业株式会社 含有去a肽纤维蛋白的恶性肿瘤抑制剂

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104083756B (zh) * 2014-07-22 2015-12-02 张庆宇 一种稳定药物组合物的辅剂及含有该辅剂的药物组合物

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1972706B (zh) * 2004-06-24 2012-03-21 东菱药品工业株式会社 含有去a肽纤维蛋白的恶性肿瘤抑制剂
CN101376022B (zh) * 2007-08-31 2011-11-30 上海医药工业研究院 含聚乙二醇降纤酶的药物组合物

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