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A kind of pharmaceutical composition containing ornidazole and its preparation

The technology of ornidazole and composition is applied in the field of pharmaceutical compositions containing ornidazole and preparations thereof, which can solve the problems of adverse reactions, easy to cause phlebitis, poor stability and the like, and achieves low impurity content and adverse reactions. Low incidence and high stability

Active Publication Date: 2017-09-12
长春海悦药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Therefore, there are following contradictions that are difficult to solve in the prior art: reduce the pH value of ornidazole injection on the one hand, though can improve its stability, easily cause adverse reactions such as phlebitis; Improve the pH value of ornidazole injection on the other hand pH reduces the incidence of phlebitis but leads to increased impurities and poorer stability

Method used

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  • A kind of pharmaceutical composition containing ornidazole and its preparation
  • A kind of pharmaceutical composition containing ornidazole and its preparation
  • A kind of pharmaceutical composition containing ornidazole and its preparation

Examples

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preparation example Construction

[0035] Prepare ornidazole injection according to the prescription in the table and the preparation process of the patent of the present invention:

[0036] Table 1 Prescription Screening Scheme

[0037]

[0038] Prepare ornidazole injection according to the method of the present invention: mix 1 / 2 amount of water for injection with propylene glycol; dissolve linoleic acid (not added in Example 1) in the above mixed solution; add ornidazole to the above obtained solution azole, stir, dissolve and make up to the total volume with water for injection; add 0.1% activated carbon for needles to the above obtained solution, stir for adsorption, and filter to remove carbon; fill the above obtained solution with ampoules; autoclave sterilization for injection , temperature 121 ℃, time 30min; light inspection, that is, 200 bottles.

[0039] Under the packaging conditions of marketed drugs, they were stored for 3 months at a temperature of (25±2)°C and a relative humidity of 60%±10%,...

Embodiment 1

[0061] 1) Mix 1000ml water for injection with 10g propylene glycol;

[0062] 2) Dissolving 5g of linoleic acid in the above mixed solution;

[0063] 3) Add 100 g of ornidazole to the solution obtained above, stir, dissolve and dilute to 2000 ml with water for injection;

[0064] 4) Add 0.1% activated carbon for needles to the solution obtained above, stir for adsorption, and filter to remove carbon;

[0065] 5) Fill 400 bottles of the above-mentioned gained solution with ampoules;

[0066] 6) The injection is autoclaved at 121°C for 30 minutes;

[0067] 7) Light inspection, that is to say.

Embodiment 2

[0069] 1) Mix 1000ml water for injection with 20g propylene glycol;

[0070] 2) Dissolving 35g of linoleic acid in the above mixed solution;

[0071] 3) Add 200g of ornidazole to the solution obtained above, stir, dissolve and dilute to 2000ml with water for injection;

[0072] 4) Add 0.1% activated carbon for needles to the solution obtained above, stir for adsorption, and filter to remove carbon;

[0073] 5) Fill the above-mentioned gained solution with ampoules, totally 400 bottles;

[0074] 6) The injection is autoclaved at 121°C for 30 minutes;

[0075] 7) Light inspection, that is to say.

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Abstract

The invention belongs to the technical field of medicine, and provides a pharmaceutical composition containing ornidazole and a preparation thereof, comprising ornidazole, propylene glycol and linoleic acid. The injection prepared from the composition of the invention has good solubility and good stability; the injection prepared from the composition is convenient to use, convenient for storage and transportation, has a simple preparation method, is easy to industrialized production, and has low production cost.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a pharmaceutical composition containing ornidazole and a preparation thereof. Background technique [0002] Ornidazole, namely 1-(3-chloro-2-hydroxypropyl)-2-methyl-5-nitroimidazole, is the third generation of nitroimidazole drugs. Ornidazole injection is the drug of choice for the treatment of anaerobic bacterial infections, and it also has a certain inhibitory effect on some aerobic bacteria. The mechanism of its antimicrobial effect may be through the nitro group in its molecule, which is reduced to amino in an oxygen-free environment or through the formation of free radicals, interacting with cell components, resulting in the death of microorganisms. Unlike other nitroimidazoles, ornidazole does not inhibit aldehyde dehydrogenase and does not cause a disulfiram reaction. [0003] Compatibility studies and reports of existing ornidazole preparations and commonly...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/4164A61K47/12A61P31/04
Inventor 张春苗王小雪徐璐郝昕王梅董伟
Owner 长春海悦药业股份有限公司
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