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Ornidazole injection liquid

A technology of ornidazole injection and ornidazole, which is applied in the directions of drug delivery, antibacterial drugs, organic active ingredients, etc., can solve the problems of excessive insoluble particles and poor storage stability, and achieves less irritation and improved storage stability. Effect

Inactive Publication Date: 2014-11-05
BEIJING JINGKE TAILAI TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In order to overcome the poor storage stability of ornidazole injection under low temperature conditions (-10°C to 20°C), the defect that insoluble particles are prone to exceed the standard, the invention provides a kind of ornidazole injection Preparation

Method used

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preparation example Construction

[0013] The invention provides a preparation method of ornidazole injection, the preparation method comprising: (1) uniformly mixing ornidazole and an organic solvent; wherein, the organic solvent is ethanol, or the organic solvent is ethanol and A mixture of propylene glycol; (2) subjecting the homogeneously mixed material to at least two heating and cooling cycles; wherein, the heating and cooling cycles include: first heating from a temperature of 10-30°C to a temperature of 40-60°C, and then from 40 A temperature of -60°C is cooled to a temperature of 10-30°C.

[0014] Wherein, ornidazole refers to a substance whose chemical name is 1-(3-chloro-2-hydroxypropyl)-2-methyl-5-nitroimidazole.

[0015] Wherein, when the organic solvent is ethanol, the amount of ornidazole and ethanol can be the conventional amount in the field of preparation of ornidazole injection, for example, relative to 1g of ornidazole, the amount of ethanol can be 3.5- 5.5 mL; preferably, relative to 1 g o...

Embodiment 1

[0026] Mix 1 g of ornidazole and 4.5 mL of ethanol uniformly, and the temperature of the uniformly mixed material is 20° C. The uniformly mixed material was heated to 50°C in 15 minutes, maintained at 50°C for 300s, and then cooled to 20°C in 15 minutes to complete the first heating and cooling cycle. The material that completed the first heating and cooling cycle was heated to 50°C in 15 minutes, maintained at 50°C for 300s, and then cooled to 20°C in 15 minutes to complete the second heating and cooling cycle.

[0027] The ornidazole injection of this example was prepared by filtering and sterilizing the material after two heating and cooling cycles with a filter membrane with a pore size of 0.22 μm.

Embodiment 2

[0029] Mix 1 g of ornidazole with 4 mL of ethanol uniformly, and the temperature of the uniformly mixed material is 15° C. The uniformly mixed material was heated to 45°C for 10 minutes, maintained at 45°C for 600s, and then cooled to 11°C for 10 minutes to complete the first heating and cooling cycle. The material that completed the first heating and cooling cycle was heated to 45°C in 10 minutes, maintained at 45°C for 480s, and then cooled to 28°C in 10 minutes to complete the second heating and cooling cycle.

[0030] The ornidazole injection of this example was prepared by filtering and sterilizing the material after two heating and cooling cycles with a filter membrane with a pore size of 0.22 μm.

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Abstract

The invention provides a preparation method of an ornidazole injection liquid. The preparation method comprises the steps: (1) mixing evenly ornidazole and an organic solvent, wherein the organic solvent is ethanol or is a mixture of ethanol and propylene glycol; (2) carrying out at least two times of heating cooling circulation on the evenly-mixed material, wherein the heating cooling circulation comprises the steps of firstly heating from the temperature of 10-30 DEG C to the temperature of 40-60 DEG C, and then cooling from the temperature of 40-60 DEG C to the temperature of 10-30 DEG C. The invention also provides the ornidazole injection liquid, wherein the ornidazole injection liquid is prepared according to the above method. Through the technical scheme, the storage stability of the ornidazole injection liquid under a condition of relatively low temperatures (-10 DEG C to 20 DEG C) is significantly improved, and irritation is relatively small after injection.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a preparation method of ornidazole injection and the ornidazole injection prepared by the preparation method. Background technique [0002] Ornidazole injection is an antibacterial drug. The mechanism of action is that the nitro group in its molecule is reduced to an amino group in an oxygen-free environment or through the formation of free radicals, and interacts with cell components, resulting in the death of microorganisms. It has a strong therapeutic effect on diseases caused by oxygen bacteria, trichomonas, amoeba, etc. [0003] Ornidazole injection is widely used clinically and is the drug of choice for the treatment of anaerobic infection. It can be used to prevent infection before surgery and treat anaerobic infection after surgery. Amoebic dysentery, amoebic liver abscess. But ornidazole water-solubility is not good, and existing technology adjusts pH value t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/4164A61P31/04A61P33/02
Inventor 梅运红赵静
Owner BEIJING JINGKE TAILAI TECH
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