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A kind of injection preparation containing argatroban

A technology for argatroban and injection, applied in the field of medicine, can solve the problem of high disability rate

Inactive Publication Date: 2011-12-07
FUKANGREN BIO PHARMA
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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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  • A kind of injection preparation containing argatroban
  • A kind of injection preparation containing argatroban

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Example 1: Argatroban water injection

[0021] prescription:

[0022] components Dosage Argatroban 100g Absolute ethanol 400g D-sorbitol 300g Water for Injection q.s.1000ml Co-made 1000ml

[0023] Preparation:

[0024] Take 400g of absolute ethanol, add D-sorbitol and stir to dissolve, add argatroban, stir and 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 2

[0025] Example 2: Argatroban water injection

[0026] prescription:

[0027] components Dosage Argatroban 50g Absolute ethanol 400g D-sorbitol 300g Water for Injection q.s.1000ml Co-made 1000ml

[0028] Preparation:

[0029] Take 400g of absolute ethanol, add D-sorbitol and stir to dissolve, add argatroban, stir and 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

[0030] Example 3: Argatroban water injection

[0031] prescription:

[0032] components Dosage Argatroban 200g Absolute ethanol 400g D-sorbitol 300g Water for Injection q.s.1000ml Co-made 1000ml

[0033] Preparation:

[0034] Take 400g of absolute ethanol, add D-sorbitol and stir to dissolve, add argatroban, stir and 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.

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PUM

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Abstract

The invention relates to an injection preparation which uses argatroban as an active ingredient. It takes the single optical isomer of argatroban or its salt and hydrate as the medicinal active ingredient, adds some specific types and proportions of excipients, and prepares and develops it for intravenous injection according to the technical means described in this patent. preparations. Dosage forms include powder injection, small-volume injection or large-volume injection.

Description

technical field [0001] The invention relates to an injection preparation which takes a single optical isomer of argatroban or its salt and purified hydrate as active ingredients, 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 ...

Claims

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Application Information

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IPC IPC(8): A61K38/05A61K9/08A61K9/14A61P7/02A61P9/10
Inventor 不公告发明人
Owner FUKANGREN BIO PHARMA
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