Argatroban injection for resisting thrombus and preparation method thereof

A technology of argatroban and injection, which is applied in the field of western medicine injection preparation, can solve the problems of unsuitability for industrial production and complex preparation process, etc., and achieve inhibition of arterial-venous bypass thrombosis in rats, increase curative effect, and reduce bleeding The effect of adverse reactions

Active Publication Date: 2013-07-10
NANJING CHIA TAI TIANQING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

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

Method used

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  • Argatroban injection for resisting thrombus and preparation method thereof
  • Argatroban injection for resisting thrombus and preparation method thereof
  • Argatroban injection for resisting thrombus and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-4

[0018] The prescription content of table 1 embodiment 1-4 argatroban injection

[0019] Component content

[0020] Preparation process: Add D-sorbitol and nitroglycerin to part of the water for injection, stir until dissolved, add 0.1% (W / V) activated carbon for needles, stir well, filter for decarbonization, add argatroban to the filtrate, and Heating while stirring, maintaining the temperature of the liquid medicine at 55-60°C, stirring until the argatroban is completely dissolved, adjusting the pH of the liquid medicine to 5.5-6.0 with 0.1mol / L hydrochloric acid solution or 0.1mol / L sodium hydroxide solution, Add the remaining amount of water for injection to constant volume, sterilize and filter with a 0.22 μm microporous membrane, fill, and sterilize with moist heat to obtain a clear solution.

Embodiment 5

[0021] Embodiment 5 Stability investigation test of argatroban injection of the present invention

[0022] Take the argatroban injection prepared in Examples 1-4 of the present invention respectively, place them under the conditions of 40°C±2°C and RH75% to carry out the accelerated test, and take samples at the 1st, 2nd, 3rd, and 6th months respectively. The changes in appearance, pH value, visible foreign matter, and related substances were investigated respectively. The test results are shown in Table 2.

[0023] Table 2 each embodiment sample accelerated investigation result

[0024]

[0025]

[0026] As can be seen from the accelerated test results in Table 2, the argatroban injection prepared by the present invention is under accelerated conditions, and its appearance, pH value, visible foreign matter, and related substances all meet the requirements, and the content of related substances is low and increases over time. The change is not obvious, which shows that ...

Embodiment 6

[0027] Example 6 Inhibitory Effect of Argatroban Injection on Experimental Rat Carotid Artery-Venous Bypass Thrombosis

[0028] 60 rats, male, weighing 200-220 g, were randomly divided into 4 groups, 15 rats in each group, and raised for one week in advance. A model control group, a nitroglycerin group, a Noblast group and a group of the present invention were established. Each group was administered in the manner shown in Table 3:

[0029] Table 3 Grouping and administration of experimental animals

[0030]

[0031] Note: Nuobaositai is argatroban injection produced by Japan Mitsubishi Pharmaceutical Co., Ltd., specification 20mL: 10mg; nitroglycerin injection is produced by Sihuan Pharmaceutical Co., Ltd., specification 1ml: 5mg.

[0032] Rats were weighed, and 1 hour after administration, anesthetized by intraperitoneal injection of urethane, the left external jugular vein and the right common carotid artery were separated, and a cannula composed of three polyethylene ...

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Abstract

The invention discloses argatroban injection for resisting thrombus. The argatroban injection contains 0.5mg / mL of argatroban, 0.1-0.4mg / mL of nitroglycerin and 30-80mg / mL of D-sorbierite. The argatroban injection is good in stability, has obvious effect in resisting thrombopoiesis, simultaneously reduces bleeding danger of the argatroban and obviously reduces the bleeding rate.

Description

technical field [0001] The invention belongs to the field of preparation of western medicine injections, and relates to an argatroban injection, in particular to an antithrombotic argatroban injection and a preparation method thereof. Background technique [0002] Thrombosis is a variety of diseases that cause dysfunction of major organs due to narrowing and occlusion of blood vessel lumen caused by thrombus. It belongs to cardiovascular and cerebrovascular diseases. Cerebral thrombosis, cerebral infarction, myocardial infarction, coronary heart disease, arteriosclerosis and other cardiovascular and cerebrovascular diseases take the lives of 12 million people every year, which is close to 1 / 4 of the total death toll in the world. enemy number one. In China, more than 2.6 million people die from cardiovascular and cerebrovascular diseases every year, and 75% of the surviving patients are disabled, and more than 40% of them are seriously disabled. [0003] At present, antith...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K38/05A61K47/14A61P7/02A61P9/10A61K31/21
Inventor 张蓓顾兴安
Owner NANJING CHIA TAI TIANQING PHARMA
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