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21 (R) argatroban intravenous injection containing acid as solubiliser

A technology for intravenous injection and solubilizer, applied in the field of medicine, can solve the problems of extreme instability of light and heat, and achieve the effect of avoiding hydrolysis degradation and other chemical reactions and enhancing infusion characteristics.

Inactive Publication Date: 2011-11-02
TIANJIN WEIJIE TECH
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0005] However, since the solubility of 21(R) Argatroban in water is less than 0.04mg / mL, it is very slightly soluble according to the solute classification of the United States Pharmacopoeia, and it is extremely unstable to light and heat. Therefore, the study of 21(R) Argatroban Addatroban preparations, and its successful clinical use is of great significance

Method used

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  • 21 (R) argatroban intravenous injection containing acid as solubiliser
  • 21 (R) argatroban intravenous injection containing acid as solubiliser
  • 21 (R) argatroban intravenous injection containing acid as solubiliser

Examples

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Embodiment 1

[0014] Embodiment 1: 21 (R) argatroban intravenous injection

[0015]

Embodiment 2

[0016] Embodiment 2: 21 (R) argatroban intravenous injection

[0017]

Embodiment 3

[0018] Embodiment 3: 21 (R) argatroban intravenous injection

[0019]

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Abstract

The invention discloses a 21 (R) argatroban intravenous injection containing at least one acid as a solubiliser. The intravenous injection is characterized in that at least one acid is utilized for improving the dissolvability of 21 (R) argatroban; at least one buffering agent is utilized for maintaining pH; and at least one penetration regulator is utilized for enhancing transfusion characteristics. A test result shows that the intravenous injection can avoid effectively hydrolysis and other chemical reactions, can be stored stably under light and heat conditions, and can be preserved at room temperature for at least 24 month.

Description

technical field [0001] The invention belongs to the field of medicine, in particular to a thrombin inhibitor using acid as a solubilizing agent. Background technique [0002] Argatroban has been widely used clinically as a thrombin inhibitor, and its chemical name is (2R,4R)-4-methyl-1-[N2-((R,S)-3-methyl-1 , 2,3,4-Tetrahydro-8-quinolinesulfonyl)-L-arginyl]-2-piperidinecarboxylic acid-hydrate [141396-28-3]. The clinically used argatroban is a mixture of two diastereoisomers, 21 (S) and 21 (R), and the drug standard stipulates that the ratio of the two is 65: 35 ± 2. The chemical structural formula of the drug is as follows: [0003] [0004] The chemical name of 21(R) argatroban is (2R, 4R)-4-methyl-1-[N 2 -[(R)-3-Methyl-1,2,3,4-tetrahydro-8-quinolinesulfonyl]-L-arginyl]-2-piperidinecarboxylic acid [121785-72-6]. Preliminary animal experiments have proved that the activity of 21(R) argatroban in inhibiting thrombin is higher than that of the blank control group, so 21(...

Claims

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Application Information

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IPC IPC(8): A61K38/05A61K47/04A61K47/12A61K47/16A61K47/26A61P7/02
Inventor 宋洪海张冉高巨孙致远孔霞
Owner TIANJIN WEIJIE TECH
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