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Ilaprazole freeze-dried powder injection and preparation method thereof

A technology of freeze-dried powder injection and powder injection, which is applied in the field of medicine, can solve the problems of increasing the risk of vascular irritation, and achieve the effects of facilitating large-scale production operations, improving solubility, and increasing safety

Active Publication Date: 2014-04-09
HARBIN SANLIAN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the addition of sodium thiosulfate to the prescription of the invention patent increases the risk of drug irritation to blood vessels

Method used

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  • Ilaprazole freeze-dried powder injection and preparation method thereof
  • Ilaprazole freeze-dried powder injection and preparation method thereof
  • Ilaprazole freeze-dried powder injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Prescription composition:

[0041]

[0042] Preparation:

[0043] (1) Weigh the prescribed amount of dextran 20 into 80% of the total amount of water for injection, stir magnetically until the dextran 20 is completely dissolved, add the prescribed amount of meglumine, add sodium hydroxide after dissolving, and adjust the pH value to 9.0-12.0;

[0044] (2) Dissolve the prescribed amount of ilaprazole in the solution obtained in step (1), adjust the pH value to 9.0-12.0 after dissolving, and add water for injection to the full amount;

[0045] (3) Add 0.1% medicinal activated carbon to the prepared medicinal liquid, stir at room temperature, filter with a 0.22 μm filter membrane, and take the fine filtrate for filling;

[0046] (4) freeze-drying the filled medicinal liquid;

[0047] (5) After the freeze-drying is completed, the sample is corked and taken out of the box, and the cap is rolled, and the product is obtained.

Embodiment 2

[0049] Prescription composition:

[0050]

[0051] Preparation:

[0052](1) Weigh the prescribed amount of dextran 20 into 80% of the total amount of water for injection, stir magnetically until the dextran 20 is completely dissolved, add the prescribed amount of meglumine, add sodium hydroxide after dissolving, and adjust the pH value to 9.0-12.0;

[0053] (2) Dissolve the prescribed amount of ilaprazole in the solution obtained in step (1), adjust the pH value to 9.0-12.0 after dissolving, and add water for injection to the full amount;

[0054] (3) Add 0.1% medicinal activated carbon to the prepared medicinal liquid, stir at room temperature for 15 minutes, filter twice with a 0.22 μm filter membrane, and take the fine filtrate for filling;

[0055] (4) freeze-drying the filled medicinal liquid;

[0056] (5) After the freeze-drying is completed, the sample is corked and taken out of the box, and the cap is rolled, and the product is obtained.

Embodiment 3

[0058] Prescription composition:

[0059]

[0060] Preparation:

[0061] (1) Weigh the prescribed amount of dextran 40 into 80% of the total amount of water for injection, magnetically stir until completely dissolved, add the prescribed amount of meglumine, add sodium hydroxide after dissolving, and adjust the pH value to 9.0-12.0;

[0062] (2) Dissolve the prescribed amount of ilaprazole in the solution obtained in step (1), adjust the pH value to 9.0-12.0 after dissolving, and add water for injection to the full amount;

[0063] (3) Add 0.1% medicinal activated carbon to the prepared medicinal liquid, stir at room temperature for 15 minutes, filter twice with a 0.22 μm filter membrane, and take the fine filtrate for filling;

[0064] (4) freeze-drying the filled medicinal liquid;

[0065] (5) After the freeze-drying is completed, the sample is corked and taken out of the box, and the cap is rolled, and the product is obtained.

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Abstract

The invention relates to an ilaprazole freeze-dried powder injection and a preparation method thereof. The ilaprazole freeze-dried powder injection provided by the invention comprises an active ingredient consisting of ilaprazole or a pharmaceutically acceptable salt thereof, a stabilizer, a solubilizer and / or an excipient, wherein the solubilizer is an inorganic base, and the inorganic base is one or two or a composition of more than two of sodium hydroxide, potassium hydroxide, sodium bicarbonate and potassium bicarbonate; the stabilizer is one or two or a combination of meglumine and hydroxypropyl-beta-cyclodextrin. According to the ilaprazole freeze-dried powder injection provided by the invention, through adding the stabilizer and the solubilizer, the problem of poor stability of ilaprazole is solved, the solubility of ilaprazole is increased, and the ilaprazole freeze-dried powder injection is stable in quality and high in effect taking speed.

Description

technical field [0001] The invention relates to an ilaprazole freeze-dried powder injection and a preparation method thereof, in particular to the preparation, prescription composition and preparation method of the ilaprazole freeze-dried powder injection, and belongs to the field of medicine. Background technique [0002] Ilaprazole (Ilaprazole), chemical name: 5-(1 hydrogen-pyrrol-1-yl)-2-[[(4-methoxy-3-methyl)-2-pyridyl]-methyl ]-sulfinyl-1 hydrogen-benzimidazole. Ilaprazole (Ilaprazole, IY~81149, Oprazole, Eriprazole) is a drug for the treatment of gastric ulcer jointly developed and sold by Korea Ilyang Co., Ltd. and TAP Pharmaceutical Company. Worldwide development license rights outside Korea and China. Compared with similar prazoles, ilaprazole has obvious advantages in terms of safety and drug efficacy. The curative effects are 4 times that of omeprazole, 6 times that of lansoprazole, and 6 times that of pantoprazole. 8 times that of rabeprazole, and 4 times that...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4439A61K47/04A61K47/18A61K47/40A61P1/04A61P7/04
Inventor 杨亚军魏茹娟
Owner HARBIN SANLIAN PHARMA CO LTD
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