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Ornidazole injection and preparation method thereof

A technology of ornidazole injection and ornidazole, which is applied in the direction of pharmaceutical formulations, medical preparations containing active ingredients, drug delivery, etc., can solve the problems of poor transportation stability, insoluble particles exceeding the standard, etc., and achieve the effect of good clarity

Inactive Publication Date: 2014-12-10
BEIJING LANDAN PHARMA TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In order to overcome the poor transport stability of ornidazole injection under low temperature conditions (-18°C to 4°C), and the defect that insoluble particles are prone to exceed the standard, after a large number of tests, the applicant found that using a new The preparation method can further reduce the amount of organic solvent, not only does not affect the clarity, but also improves the clarity

Method used

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  • Ornidazole injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Ornidazole 10g

[0045] Propylene glycol 15g

[0046] Anhydrous ethanol 25g

[0047] Preparation:

[0048] (1) Mix ornidazole with propylene glycol and absolute ethanol, and the temperature of the mixed materials is 20°C;

[0049] (2) The uniformly mixed materials are heated to 50°C for 15 minutes, maintained at 50°C for 5 minutes, and then cooled to 20°C for 15 minutes to complete the first heating and cooling cycle. The material that has completed the first heating and cooling cycle is heated to 50°C in 15 minutes, maintained at 50°C for 5 minutes, and then cooled to 20°C in 15 minutes, completing the second heating and cooling cycle.

[0050] (3) Filter the material after two heating and cooling cycles with a filter membrane with a pore size of 0.22 μm, and potting, with a specification of 5 ml, to prepare the ornidazole injection of this comparative example.

Embodiment 2

[0052] prescription:

[0053] Ornidazole 10g

[0054] Propylene glycol 15g

[0055] Anhydrous ethanol 25g

[0056] Preparation:

[0057] (1) Mix ornidazole with propylene glycol and absolute ethanol, and the temperature of the mixed materials is 20°C;

[0058] (2) The uniformly mixed materials are heated to 40°C for 20 minutes, maintained at 40°C for 10 minutes, and then cooled to 25°C for 20 minutes to complete the first heating and cooling cycle. The material that has completed the first heating and cooling cycle is heated to 40°C in 20 minutes, maintained at 40°C for 10 minutes, and then cooled to 18°C ​​in 20 minutes, completing the second heating and cooling cycle.

[0059] (3) Filter the material after two heating and cooling cycles with a filter membrane with a pore size of 0.22 μm, and potting, with a specification of 5 ml, to prepare the ornidazole injection of this comparative example.

Embodiment 3

[0061] prescription:

[0062] Ornidazole 10g

[0063] Propylene glycol 12.5g

[0064] Anhydrous ethanol 25g

[0065] Preparation:

[0066] (1) Mix ornidazole with propylene glycol and absolute ethanol, and the temperature of the mixed materials is 20°C;

[0067] (2) The uniformly mixed materials are heated to 45°C for 20 minutes, maintained at 45°C for 10 minutes, and then cooled to 23°C for 20 minutes to complete the first heating and cooling cycle. The material that has completed the first heating and cooling cycle is heated to 45°C in 20 minutes, maintained at 45°C for 10 minutes, and then cooled to 19°C in 20 minutes, completing the second heating and cooling cycle.

[0068] (3) Filter the material after two heating and cooling cycles with a filter membrane with a pore size of 0.22 μm, and potting, with a specification of 5 ml, to prepare the ornidazole injection of this comparative example.

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PUM

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Abstract

The invention discloses an ornidazole injection, which comprises 1g of ornidazole, 1-1.5g of propylene glycol and 2-2.5g of ethanol. The preparation method of the ornidazole injection comprises the following steps: (1) uniformly mixing ornidazole, propylene glycol and ethanol; (2) heating and cooling the uniformly mixed materials in a circulating manner at least twice, wherein the cycle of heating and cooling comprises steps of heating to 40-60 DEG C from 10-30 DEG C and cooling to 10-30 DEG C from 40-60 DEG C; and (3) filtering, filling and sealing, wherein specification of 2-5ml.

Description

Technical field [0001] The invention relates to the field of pharmacy, in particular to an ornidazole injection. Background technique [0002] Ornidazole, namely 1-(3-chloro-2-hydroxypropyl)-2-methyl-5-nitroimidazole, is a third-generation nitroimidazole drug. Ornidazole injection is the first choice for the treatment of anaerobic infections, and it also has a certain inhibitory effect on some aerobic bacteria. Unlike other nitroimidazole drugs, ornidazole does not inhibit acetaldehyde dehydrogenase and does not cause disulfiram reaction. [0003] CN201310028025.8 reported that ornidazole is difficult to dissolve in water, and its solubility increases under acidic conditions. According to the specifications of existing marketed products, 10ml:0.5g, the pH needs to be adjusted to 1.8-2.3 to dissolve ornidazole of this specification. The pH value is too acidic, leading to strong vascular irritation in clinical patients, and poor patient tolerance. To this end, propylene glycol mus...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/4164A61P31/04
Inventor 不公告发明人
Owner BEIJING LANDAN PHARMA TECH
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