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Injection preparation containing argatroban

A technology for argatroban and injection, which is applied in the field of medicine, can solve the problems of high disability rate and achieve the effect of stable quality and low pharmacological toxicity

Inactive Publication Date: 2011-11-16
BEIJING RUNDEKANG MEDICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The disability rate is as high as 75%

Method used

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  • Injection preparation containing argatroban
  • Injection preparation containing argatroban
  • Injection preparation containing argatroban

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Embodiment 1: Argatroban sterile powder injection

[0041] prescription:

[0042]

[0043] Preparation:

[0044] 1. Take 400g of absolute ethanol, add D-sorbitol and stir to dissolve to form a solution.

[0045] 2. Take the aseptic powder of argatroban, quantitatively fill it into 3ml vials, stopper 0.25g per bottle, and crimp the cap.

[0046] 3. When in use, use the solution obtained in step 1 to dissolve the sterile powder obtained in step 2, and dilute it with 0.9% NaCl injection, or 5% glucose injection, or Lactated Ringer's injection to a concentration of 1 mg / ml. The dilution is Argatroban may crystallize out, but repeated shaking can dissolve it.

Embodiment 2

[0047] Embodiment 2: Argatroban small volume injection

[0048] prescription:

[0049]

[0050]

[0051] Preparation:

[0052] Take 400g of absolute ethanol, add D-sorbitol and stir to dissolve, add argatroban, stir to dissolve, add 0.1% activated carbon for needles according to the prepared amount, heat the liquid to about 60°C, stir for 20min, filter and decarbonize, Add water for injection to the total amount, and detect intermediates. After passing the test of the intermediate, fine filter with a 0.22 μm microporous membrane, fill in vials, 2.5 ml per vial, stopper, and cap. Moist heat sterilization, you can.

Embodiment 3

[0053] Embodiment 3: Argatroban small volume injection

[0054] prescription:

[0055]

[0056] Preparation:

[0057] Take water for injection accounting for about 80% of the total volume, add sodium chloride, stir to dissolve, add argatroban, stir to dissolve, add 0.1% activated carbon for needles according to the prepared amount, heat the liquid medicine to about 60°C, stir for 20 minutes, After filtering and decarbonizing, add physiological saline to the total amount, and detect intermediates. After passing the test of the intermediate, fine filter with a 0.22 μm microporous membrane, fill in vials, 2.5 ml per vial, stopper, and cap. Moist heat sterilization, you can.

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Abstract

The invention relates to an injection preparation which adopts argatroban as an active component. The injection preparation is characterized by: adopting a single optical isomer of the argatroban or a salt of the argatroban or a hydrate of the argatroban as the medicinal active component and adding a plurality of auxiliary materials with specific types and specific ratios to prepare and develop the preparation for the intravenous injection according to a technical means described in the present patent specification. The formulations of the injection preparation comprise powder injection, small volume parenteral solution or large volume parenteral solution.

Description

technical field [0001] The invention relates to an injection preparation which takes the conformation of argatroban or its salt and purified hydrate as active components, including powder injection, small-volume injection or large-volume injection. It belongs to the field of medical technology. Background technique [0002] Stroke is the scientific name of cerebral apoplexy, which is a sudden onset of cerebral blood circulation disorders. The clinical manifestations are mainly characterized by sudden coma, unconsciousness or sudden crooked mouth and eyes, hemiplegia, strong tongue, and mental retardation. Cerebral stroke includes ischemic stroke (transient ischemic attack, atherosclerotic thrombotic cerebral infarction, lacunar infarction, cerebral embolism), hemorrhagic stroke (cerebral hemorrhage, subarachnoid hemorrhage), high Blood pressure encephalopathy and vascular dementia four categories. According to statistics, there are 2 million stroke patients in my country ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/05A61K9/00A61P9/10
Inventor 不公告发明人
Owner BEIJING RUNDEKANG MEDICAL TECH CO LTD
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