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Ornidazole injection liquid

A technology of ornidazole injection and ornidazole, which is applied in drug delivery, antibacterial drugs, organic active ingredients, etc., can solve the problems of poor storage stability and excessive insoluble particles, achieve less irritation and improve 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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  • Ornidazole injection liquid

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preparation example Construction

[0013] The invention provides a preparation method of ornidazole injection, the preparation method comprising: uniformly mixing ornidazole with a solvent, the solvent is a mixture of propylene glycol and at least part of water for injection, or the solvent is propylene glycol, ethanol and at least part of water for injection, and the resulting mixture is adjusted to a pH value of 3-6 with acetic acid; then the material after the adjusted pH value is subjected to at least two heating and cooling cycles; wherein, the heating and cooling cycle includes: first starting from 10 Heat from a temperature of -30°C to a temperature of 75-85°C, then cool from a temperature of 75-85°C 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 solvent is a mixture of propylene glycol and at least part of water for injection, the amount of ornidazole, propylene glyc...

Embodiment 1

[0031] Heat 1.3g of propylene glycol to 80°C, add 1g of ornidazole under stirring to completely dissolve the ornidazole, then mix it with 15mL of water for injection, and adjust the pH value to 4.5 with acetic acid. The temperature of the adjusted pH value of the material is 20 ℃. The material whose pH value was adjusted was heated to 80°C in 20 minutes, maintained at 80°C for 300s, and then cooled to 20°C in 40 minutes to complete the first heating and cooling cycle. The material that completed the first heating and cooling cycle was heated to 80°C in 20 minutes, maintained at 80°C for 300s, and then cooled to 20°C in 40 minutes to complete the second heating and cooling cycle.

[0032] The material after two heating and cooling cycles was mixed with 0.06 g of activated carbon for 900 s, and then filtered to remove the activated carbon. Then add water for injection to a volume of 20 mL and sterilize by filtration to prepare the 0.05 g / mL ornidazole injection of this embodime...

Embodiment 2

[0034] Heat 1.2g of propylene glycol to 76°C, add 1g of ornidazole under stirring to completely dissolve the ornidazole, then mix evenly with 19.5mL of water for injection, and adjust the pH value to 4.9 with acetic acid. The temperature of the adjusted pH value of the material is 15°C. The material with adjusted pH value was heated to 76°C in 15 minutes, maintained at 76°C for 600s, and then cooled to 11°C in 30 minutes to complete the first heating and cooling cycle. The material that completed the first heating and cooling cycle was heated to 83°C in 15 minutes, maintained at 83°C for 600s, and then cooled to 28°C in 30 minutes to complete the second heating and cooling cycle.

[0035] The material after two heating and cooling cycles was mixed with 0.03 g of activated carbon for 600 s, and then filtered to remove the activated carbon. Then add water for injection to a volume of 25 mL and sterilize by filtration to prepare the 0.04 g / mL ornidazole injection of this embodim...

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Abstract

The invention provides a preparation method of an ornidazole injection liquid. The preparation method comprises the steps: evenly mixing ornidazole and a solvent, wherein the solvent is a mixture of propylene glycol and at least a part of injection water, or the solvent is a mixture of propylene glycol, ethanol and at least a part of injection water; adjusting the pH value of the obtained mixture to 3-6 with acetic acid; and then carrying out at least two times of heating cooling circulation on the material after the pH value is adjusted. 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): A61K31/4164A61K9/08A61P31/04
Inventor 李中丽梅运红李娇
Owner BEIJING JINGKE TAILAI TECH
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