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Double-ingredient sodium ozagrel freeze-dried powder injection solution for injection

A technology for sodium ozagrel and freeze-dried powder injection, which is applied in the field of pharmaceutical preparations and preparations, can solve the problems of low qualification rate of finished product clarity and solution color, long freeze-drying time and high drying temperature, and achieves the finished product clarity and solution. The effect of improving the color qualification rate, excellent product quality, and reducing the drying temperature

Inactive Publication Date: 2018-02-23
刘兴付
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] Since the commercially available ozagrel sodium freeze-dried powder for injection is produced with a single auxiliary material, mannitol, it has long freeze-drying time during production, high drying temperature, high energy consumption, and low pass rate of product clarity and solution color. Shortcomings

Method used

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  • Double-ingredient sodium ozagrel freeze-dried powder injection solution for injection
  • Double-ingredient sodium ozagrel freeze-dried powder injection solution for injection
  • Double-ingredient sodium ozagrel freeze-dried powder injection solution for injection

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Experimental program
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Effect test

Embodiment 1

[0025] Embodiment 1, ozagrel sodium freeze-dried powder injection for injection, calculated in 1000 bottles

[0026] Prescription (specification: 40mg / bottle):

[0027]

[0028] Preparation Process:

[0029] a) Dissolve the prescribed amount of mannitol in water for injection, and stir in a constant temperature water bath magnetic stirrer at a temperature of 60°C until it is completely dissolved, then add the prescribed amount of hydroxyethyl starch 130 / 0.4 and the prescribed amount respectively Keep the temperature of 60° C. and continue to stir until it is completely dissolved, and use water for injection to make the volume to 2000 ml, and adjust the pH value of the solution to 8.5.

[0030] b) The above solution is circulated and filtered successively through 0.45 μm and 0.22 μm filter membranes for 30 minutes;

[0031] c) Sampling inspection, determine the filling volume and pour it into a cleaned and sterilized vial, put it into a vacuum freeze dryer after half-tight...

Embodiment 2

[0032] Embodiment two, ozagrel sodium freeze-dried powder for injection, in 1000 bottles

[0033] Prescription (specification: 40mg / bottle):

[0034]

[0035] Preparation Process:

[0036] a) Dissolve the prescribed amount of mannitol in water for injection, and stir in a constant temperature water bath magnetic stirrer at a temperature of 60°C until it is completely dissolved, then add the prescribed amount of hydroxyethyl starch 130 / 0.4 and the prescribed amount respectively Keep the temperature of 60° C. and continue to stir until it is completely dissolved, and use water for injection to make the volume to 2000 ml, and adjust the pH value of the solution to 8.5.

[0037] b) The above solution is circulated and filtered successively through 0.45 μm and 0.22 μm membranes for 30 minutes.

[0038] c) Sampling inspection, after the main drug content meets the requirements, determine the filling volume and pour it into a cleaned and sterilized vial, put it into a vacuum fre...

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Abstract

The invention provides a ozagrel sodium freeze-dried powder for injection with double auxiliary materials, relates to the field of pharmaceutical preparations and preparation methods, and mainly solves the problem of existing production of excipients in the production formula of ozagrel sodium freeze-dried powder for injection in the prior art The disadvantages of long freeze-drying time, high drying temperature and high energy consumption. The ozagrel sodium freeze-dried powder for injection uses double excipients, the excipients include mannitol and hydroxyethyl starch 130 / 0.4, the main drug is ozagrel sodium, and the weight ratio of the main drug to the excipients is 100:100‑100:140 , the weight ratio between mannitol and hydroxyethyl starch 130 / 0.4 is 100:30‑100:50. The ozagrel sodium freeze-dried powder for injection is prepared by using the above-mentioned main drug and auxiliary materials. The ozagrel sodium freeze-dried powder for injection provided by the invention is stable in quality, safe and effective, simple in production process, short in freeze-drying time during production, low in drying temperature and low in energy consumption.

Description

Technical field: [0001] The invention relates to the field of pharmaceutical preparations and preparation methods, in particular to a ozagrel sodium freeze-dried powder for injection with double auxiliary materials and a preparation method thereof. Background technique: [0002] Ozagrel sodium freeze-dried powder for injection is a thromboxane (TX) synthase inhibitor, which can prevent prostate H2 (PGH2) from generating thromboxane A2 (TXA2), and promote platelet-derived PGH2 to turn to endothelial cells. Endothelial cells are used to synthesize PGI2, thereby improving the abnormal balance of TXA2 and prostaglandin PGI2. Play the role of inhibiting platelet aggregation and dilating blood vessels. [0003] This product can improve the movement disorder in the acute stage of cerebral thrombosis, improve the circulation disorder in the acute stage of cerebral ischemia and improve the abnormal energy metabolism in cerebral ischemia. Intravenous administration can reduce plasma...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K47/26A61K47/36A61K31/4174A61P9/10
CPCA61K9/19A61K9/0019A61K31/4174A61K47/26A61K47/36
Inventor 刘兴付
Owner 刘兴付
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