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Unilateral mequindox injection and preparation method thereof

A technology of acemetquine and injection, applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problems of non-compliance with regulations, failure to detect maximum absorption, companies and operators Economic loss and other issues to achieve the effect of ensuring product quality

Active Publication Date: 2020-03-20
BEIJING LISHIDA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, as the Bureau of Veterinary Medicine of the Ministry of Agriculture and Rural Affairs requires random inspection of products, it is not allowed to add substances with medicinal effects to the products. Sodium salicylate is the best co-solvent for acemethaquine injection, but Sodium salicylate has medicinal effects, and according to the identification requirements of acemethaquine injection, there are maximum absorptions at wavelengths of 242, 254, and 371nm. After sodium salicylate is added to the product, no maximum absorption can be detected at 242nm wavelengths, which does not meet the requirements. Regulation
After discovery, the manufacturers and distributors should be punished, causing economic losses to the company and operators

Method used

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  • Unilateral mequindox injection and preparation method thereof
  • Unilateral mequindox injection and preparation method thereof
  • Unilateral mequindox injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] A unilateral acemethaquine injection, which comprises the raw material components of the following mass concentrations:

[0029]

[0030]

[0031] The solvent is water for injection.

[0032] The preparation method of this unilateral Acetyl Mequin injection comprises the following steps:

[0033] S1: Add 280g of α-pyrrolidone into the preparation container, start stirring, and raise the temperature to 30°C;

[0034] S2: Add 18g of acetylmethaquine to the preparation container to dissolve completely;

[0035] S3: Add 90g of propylene glycol into the preparation container, and cool down to below 30°C while stirring;

[0036] S4: Take 180g of ethanol and add it into the preparation container;

[0037] S5: Add water for injection to 995ml in the preparation container, and continue stirring for a certain period of time; adjust the pH value of the liquid in the preparation container to 5.5 with sodium hydroxide solution, and finally add water for injection until the ...

Embodiment 2

[0048] A unilateral acemethaquine injection, which comprises the raw material components of the following mass concentrations:

[0049]

[0050] The solvent is water for injection.

[0051] The preparation method of this unilateral Acetyl Mequin injection comprises the following steps:

[0052] S1: Add 300g of α-pyrrolidone into the preparation container, start stirring, and raise the temperature to 35°C;

[0053] S2: Add 20g of acetylmethaquine to the preparation container to dissolve completely;

[0054] S3: Add 100g of propylene glycol into the preparation container, and cool down to below 30°C while stirring;

[0055] S4: Add 200g of ethanol to the preparation container;

[0056] S5: Add water for injection to 995 ml in the preparation container, and continue stirring for a certain period of time; adjust the pH value of the liquid in the preparation container to 5.0 with sodium hydroxide solution, and finally add water for injection until the total volume of the solu...

Embodiment 3

[0064] A unilateral acemethaquine injection, which comprises the raw material components of the following mass concentrations:

[0065]

[0066] The solvent is water for injection.

[0067] The preparation method of this unilateral Acetyl Mequin injection comprises the following steps:

[0068] S1: Add 320g of α-pyrrolidone into the preparation container, start stirring, and raise the temperature to 30°C;

[0069] S2: Add 22g of acetylmethaquine to the preparation container to dissolve completely;

[0070] S3: Add 95g of propylene glycol into the preparation container, and cool down to below 30°C while stirring;

[0071] S4: Take 210g of ethanol and add it into the preparation container;

[0072] S5: Add water for injection to 995ml in the preparation container, and continue stirring for a certain period of time; adjust the pH value of the liquid in the preparation container to 6.0 with sodium hydroxide solution, and finally add water for injection until the total volume...

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Abstract

The present invention relates to the technical field of veterinary pharmaceuticals, and specifically relates to an unilateral mequindox injection and a preparation method thereof. The unilateral mequindox injection comprises the following feed compositions in mass concentrations: mequindox 18-22g / L; ethanol 180-220g / L; propylene glycol 90-110g / L; alpha-pyrrolidone 280-320g / L; and water for injection as a solvent. Compared to the prior art, sodium salicylate is removed from production process of the unilateral mequindox injection in the present invention, so as to obtain an injection product with stability comparable to an original injection, and maximum absorption can be detected at 242, 254 and 371 nm of wavelength, thereby ensuring quality of the product and meeting provisions in mequindox injection identification (2) section in Quality Standards for Veterinary Medicines, 2017 Edition, Chemicals Volume.

Description

technical field [0001] The application relates to the technical field of veterinary medicine, in particular, to a unilateral acemethaquine injection and a preparation method thereof. Background technique [0002] Acetylmequine is 3-methyl-2-acetylquinoxaline-1,4-dioxide, which is a broad-spectrum antibacterial drug, mainly inhibiting the synthesis of deoxyribonucleic acid (DNA) of bacteria, and is effective for most bacteria Especially Gram-negative bacteria have a strong inhibitory effect. Whether it is administered orally or injected, it is well absorbed, metabolized quickly in the body, and most of it is excreted in the form of metabolites. [0003] Acetylmethaquine injection is a product of the 2017 edition of the Chemical Drug Volume of the "Quality Standards for Veterinary Drugs" and has been produced for many years. The traditional acemetaquine injection mainly includes acemetaquine active ingredient and auxiliary materials such as sodium salicylate. The unilateral...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/498A61K47/10A61K47/22A61P31/04
CPCA61K9/0019A61K9/08A61K31/498A61K47/10A61K47/22A61P31/04
Inventor 张殿奎徐海鸥方太云薛磊
Owner BEIJING LISHIDA PHARMA
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