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Ornidazole injection

A technology of ornidazole injection and injection, which is applied in the direction of non-effective medical preparations, organic active ingredients, pharmaceutical formulas, etc., can solve problems such as easy to cause phlebitis, adverse reactions, and poor stability, and achieve The effect of low incidence of adverse reactions, high stability, and low impurity content

Active Publication Date: 2012-07-11
HEBEI RENHE YIKANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] 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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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1～20

[0016] Embodiment 1~20 ornidazole injection

[0017] According to the prescription in the table below and the preparation process of the patent of the present invention, ornidazole injection is prepared, wherein Examples 16-20 are comparative examples:

[0018]

[0019]

[0020]

[0021] Preparation process: Dissolve components such as ornidazole in the prescribed amount in ethanol (or a mixture of ethanol and propylene glycol), sterilize and filter, nitrogen-filled subpackage in Example 6-10, other direct subpackages, and sterilize (121° C. , 30 minutes), you can.

[0022]

[0023] Preparation process: Dissolve components such as ornidazole in the prescription amount in the mixed solution of propylene glycol and water, adjust pH, sterilize and filter, nitrogen-filled subpackage in Example 19, other direct subpackages, sterilization (121 ° C, 30 minutes), you can.

experiment example 1

[0024] Stability study of experimental example 1 ornidazole injection

[0025] According to Chinese Pharmacopoeia 2010 edition two appendices XIXC bulk drug and drug preparation stability test guiding principle, under high temperature condition (temperature is 40 ℃ ± 2 ℃, relative humidity is 75% RH ± 5% RH) carries out accelerated stability test ( 6 months), according to the method of Ornidazole Injection National Drug Standard (YBH00832004), the Ornidazole Injection that detection embodiment 1~20 makes is before sterilization, after sterilization 0 month, after sterilization 6 months. months of related substances and ornidazole content.

[0026] The result is as follows:

[0027]

[0028]

[0029]

[0030]

[0031]

[0032] To sum up, the average value of impurity content (0.14%) of the ornidazole injection (embodiment 1-15) of the present invention 0 months after sterilization is far lower than the ornidazole injection of the control example (embodiment 16-2...

experiment example 2

[0034] The pH value when experimental example 2 ornidazole injection compatibility

[0035] With the ornidazole injection that embodiment 1~20 makes, get the injection that contains principal agent ornidazole 1g, carry out compatibility with sodium chloride solution (0.9%) 200ml, glucose solution (5%) 200ml respectively, detect The pH value of the compatible solution, the results are as follows:

[0036]

[0037]

[0038]

[0039]

[0040] It can be seen that the pH value (4.5-5.7) of the ornidazole injection of the present invention after compatibility with 0.9% sodium chloride and 5.0% glucose is suitable for human infusion, and is significantly higher than that of the control example (2.7-3.7).

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PUM

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Abstract

The invention provides an ornidazole injection. The ornidazole injection has the advantages of high stability, low impurity content, pH value that is closer to the human physiological pH value, low incidence rate of infusion pain, infusion phlebitis and other adverse reactions, etc.

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 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] However, the existing ornidazole preparations easily cause infusion pain and adverse reactions such as phlebitis. The pH value of normal human blood is 7.35...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/4164A61K47/10A61P31/00
Inventor 何萍
Owner HEBEI RENHE YIKANG PHARMA
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