CN106619497A - 一种肝素钠注射液的制备方法 - Google Patents

一种肝素钠注射液的制备方法 Download PDF

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CN106619497A
CN106619497A CN201611134817.3A CN201611134817A CN106619497A CN 106619497 A CN106619497 A CN 106619497A CN 201611134817 A CN201611134817 A CN 201611134817A CN 106619497 A CN106619497 A CN 106619497A
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heparin sodium
injection
preparation
sodium injection
value
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刘乃山
张明芳
陈娥功
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Qingdao Guanlong Biological Pharmaceutical Co Ltd
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Qingdao Guanlong Biological Pharmaceutical Co Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
    • A61K31/727—Heparin; Heparan
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
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  • Oil, Petroleum & Natural Gas (AREA)
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Abstract

本发明公开了一种肝素钠注射液的制备方法。本发明提供了一种规格为2ml：1000U的肝素钠注射液，每2000毫升该注射液中含有：肝素钠0.011亿单位、氯化钠18‑19g、苯酚2‑3ml和注射用水2150ml。本发明肝素钠注射液的pH值与渗透压与人体血液相接近，避免了局部凝血堵管现象，减少了封管注射液的出血等不良反应，稳定性和安仝性有显著提升。

Description

一种肝素钠注射液的制备方法
技术领域
本发明涉及化学制药工艺领域，具体地说涉及一种注射液的制备方法，尤其涉及肝素钠注射液的制备方法。
背景技术
肝素钠主要存在于哺乳动物的组织中。商品用的肝素钠主要是从猪的肠粘膜中提取的钠盐。肝素钠是一种酸性粘多糖，是需要迅速达到抗凝作用的首选药物。肝素钠可以与抗凝血酶的一些赖氨酸残基相结合，使抗凝血酶不能发挥作用而达到抗凝血的作用。临床广泛应用于治疗深层近端静脉血栓形成、肺栓塞、急性动脉闭塞或心肌梗死：也可用于外科预防血栓形成。肝素钠的另一重要临床应用是在心脏手术和肾脏透析时维持血液体外循环畅通。
目前，国内有30多家企业生产肝素钠注射液，规格为2ml：12500单位～1000单位。常规生产的肝素钠注射液有以下缺陷：1.高浓度的肝素钠注射液引易引起自发性出血。2.注射液的pH值与血液中的pH值相差较大，而且不是等渗溶液容易引起局部刺激与出血等。因此本发明的肝素钠封管注射液浓度体积合适。由于使用了氯化钠作为标准等渗液调节剂，能够使注射液与血液的等渗相符，使用了氢氧化钠作为pH值的调节剂，在药液中不增加其他物质或离子的情况下，保持了药液的pH值和渗透压与血液的pH值与渗透压基本相符，减少了局部刺激与出血的现象，且发明了检测肝素钠杂质不受氯化钠的干扰的检测方法。
发明内容
本发明提供了一种肝素钠注射液的制备方法，是为了能够有效生产出合格的肝素钠注射液。本发明肝素钠注射液的pH值与渗透压与人体血液相接近，避免了局部凝血堵管现象，减少了封管注射液的出血等不良反应，稳定性和安仝性有显著提升。
一种肝素钠注射液的制备方法，其发明的技术方案中，还具有以下特征：
1．一种肝素钠注射液的制备方法，其特征在于，规格为2ml：1000U的肝素钠注射液，每2000毫升该注射液中含有：肝素钠0.011亿单位、氯化钠18-19g、苯酚2-3ml和注射用水2150ml。
2．按照权利要求1所述的肝素钠注射液的制备方法，其特征在于：肝素钠注射液的渗透压为290～305mosmol/kg。
3．按照权利要求l所述的肝素钠注射液的制备方法，其特征在于：pH值为6.8～7.5。
4．按照权利要求l所述的肝素钠注射液的制备方法，该方法包括：
(1)按照所述用量取各组分：每2000毫升该注射液中含有：肝素钠0.011亿单位、氯化钠18-19g、苯酚2-3ml和注射用水2150ml；
(2)将上述各组分溶解至匀，用1mol/L的盐酸溶液和1mol/L氢氧化钠溶液来调节PH值为6.8-7.5；
(3)将配制好的溶液过滤，灌封，分装，灭菌，即得。
具体实施方式
下面结合具体实施例对本发明作进一步说明。
实施例1
(1)按照所述用量取各组分：每2000毫升该注射液中含有：肝素钠0.011亿单位、氯化钠18.4g、苯酚2.6ml和注射用水2150ml；
(2)将上述各组分溶解至匀，用1mol/L的盐酸溶液和1mol/L氢氧化钠溶液来调节PH值为6.9；
(3)将配制好的溶液过滤，灌封，分装，灭菌，即得。
所得肝素钠注射液PH值为7.1；渗透压为301mosmol/kg。
实施例2
(1)按照所述用量取各组分：每2000毫升该注射液中含有：肝素钠0.011亿单位、氯化钠18.5g、苯酚2.8ml和注射用水2150ml；
(2)将上述各组分溶解至匀，用1mol/L的盐酸溶液和1mol/L氢氧化钠溶液来调节PH值为7.0；
(3)将配制好的溶液过滤，灌封，分装，灭菌，即得。
所得肝素钠注射液PH值为7.2；渗透压为304mosmol/kg。
以上所述，仅是本发明的较佳实施例而已，并非是对本发明作其它形式的限制，任何熟悉本专业的技术人员可能利用上述揭示的技术内容加以变更或改型为等同变化的等效实施例。但是凡是未脱离本发明技术方案内容，依据本发明的技术实质对以上实施例所作的任何简单修改、等同变化与改型，仍属于本发明技术方案的保护范围。

Claims (4)

1.一种肝素钠注射液的制备方法，其特征在于，规格为2ml：1000U的肝素钠注射液，每2000毫升该注射液中含有：肝素钠0.011亿单位、氯化钠18-19g、苯酚2-3ml和注射用水2150ml。
2.按照权利要求1所述的肝素钠注射液的制备方法，其特征在于：肝素钠注射液的渗透压为290～305mosmol/kg。
3.按照权利要求l所述的肝素钠注射液的制备方法，其特征在于：pH值为6.8～7.5。
4.按照权利要求l所述的肝素钠注射液的制备方法，该方法包括：
(1)按照所述用量取各组分：每2000毫升该注射液中含有：肝素钠0.011亿单位、氯化钠18-19g、苯酚2-3ml和注射用水2150ml；
(2)将上述各组分溶解至匀，用1mol/L的盐酸溶液和1mol/L氢氧化钠溶液来调节PH值为6.8-7.5；
(3)将配制好的溶液过滤，灌封，分装，灭菌，即得。
CN201611134817.3A 2016-12-11 2016-12-11 一种肝素钠注射液的制备方法 Pending CN106619497A (zh)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115990296A (zh) * 2017-09-22 2023-04-21 贝克顿·迪金森公司 用作导管封管液的4%柠檬酸三钠溶液

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115990296A (zh) * 2017-09-22 2023-04-21 贝克顿·迪金森公司 用作导管封管液的4%柠檬酸三钠溶液

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