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Argatroban injection and preparing method thereof

A technology of argatroban and injection, which is applied in the field of pharmaceutical preparations, can solve the problems of complex preparation process and unsuitability for industrial production, and achieve the effects of simple preparation process, convenient storage and good solubility

Active Publication Date: 2019-11-22
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

CN101516370A discloses a water-based preparation of argatroban, using lactobionic acid and methionine as solubilizers, supplemented with stabilizers to make injections, its preparation process is complex, not suitable for industrial production

Method used

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  • Argatroban injection and preparing method thereof
  • Argatroban injection and preparing method thereof
  • Argatroban injection and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Embodiment 1 Argatroban injection

[0021] 1) Prescription

[0022] Argatroban 10g

[0023] Sorbitol 20g

[0024] Water for injection Add water to 20L.

[0025] 2) Preparation process

[0026] Add the prescribed amount of argatroban and sorbitol into 40ml of methanol, stir at 40°C to dissolve, remove the methanol under reduced pressure to obtain the argatroban-sorbitol complex, then add the prescribed amount of water for injection, and stir to obtain a clear solution. Fill it, and sterilize it at 115°C for 30 minutes.

Embodiment 2

[0027] Embodiment 2 Argatroban injection

[0028] 1) Prescription

[0029] Argatroban 10g

[0030] Sorbitol 3.5g

[0031] Water for injection Add water to 20L.

[0032] 2) Preparation process

[0033] Add the prescribed amount of argatroban and sorbitol to 20ml of ethanol, stir at 50°C to dissolve, remove the ethanol under reduced pressure to obtain the argatroban-sorbitol complex, then add the prescribed amount of water for injection, and stir to obtain a clear solution. Fill it, and sterilize it at 115°C for 30 minutes.

Embodiment 3

[0034] Embodiment 3 argatroban injection

[0035] 1) Prescription

[0036] Argatroban 10g

[0037] Sorbitol 100g

[0038] Water for injection Add water to 20L.

[0039] 2) Preparation process

[0040] Add the prescribed amount of argatroban and sorbitol into 60ml of isopropanol, ultrasonically dissolve at 40°C, remove the isopropanol under reduced pressure to obtain the argatroban-sorbitol complex, then add the prescribed amount of water for injection, and stir to obtain Clarify the solution, fill it, and sterilize it at 115°C for 30 minutes.

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PUM

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to an argatroban injection and a preparing method thereof. The argatroban injection comprises an argatroban-sorbitol compound and water for injection. By preparing argatroban into the compound, the dissolubility of the argatroban is improved, meanwhile the consumption of sorbitol is greatly reduced, the safety of drug use is higher, the target patient population range is wider, stability is high, the preparing process is simple, and the argatroban injection is suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to an argatroban injection and a preparation method thereof. Background technique [0002] Argatroban (Argatroban), the chemical name is (2R,4R)-4-methyl-1-[N-[(3-methyl-1,2,3,4-tetrahydro-8-quinolinyl) )sulfonyl]-L-arginyl]-2-piperidinecarboxylic acid, the molecular formula is C 23 h 36 N 6 o 5 S, the molecular weight is 508.6. Argatroban is a synthetic monovalent small molecule direct thrombin inhibitor that selectively binds reversibly to the catalytically active site (serine-histidine-arginine) of thrombin to exert competitive inhibition. Unlike heparin and other direct thrombin inhibitors, argatroban inhibits thrombin in blood clots, and the antithrombotic effect of argatroban does not require the cofactor antithrombin III, which catalyzes Or the induced response, including the formation of fibrin, the activation of coagulation factors V, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/05A61K9/08A61K47/26A61P7/02
CPCA61K9/0019A61K9/08A61K38/05A61K47/26A61P7/02
Inventor 张贵民郝贵周王苗苗
Owner LUNAN PHARMA GROUP CORPORATION
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