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Enrofloxacin injection and production method thereof

A technology of enrofloxacin and its manufacturing method, which is applied in the field of injections, can solve the problems of unqualified foreign matter, user returns, waste, etc., and achieve the effects of product stability, product quality assurance, and prolongation of storage time

Active Publication Date: 2017-11-21
BEIJING LISHIDA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0003] However, after this existing enrofloxacin injection product is stored for several months, there will be crystallization problems, and it can be seen that the foreign matter is unqualified, and finally the product is unqualified
The existence of this kind of problem will cause the user to return the product. For these returned products, it generally needs to be scrapped.
This not only causes a lot of waste, but also has a negative impact on customers, and the reputation of the manufacturer has been questioned

Method used

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  • Enrofloxacin injection and production method thereof
  • Enrofloxacin injection and production method thereof
  • Enrofloxacin injection and production method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0038] S1. Weigh 50g of enrofloxacin; 6g of sodium hydroxide; 200g of propylene glycol; 2g of anhydrous sodium sulfite.

[0039] S2. Add 200 ml of water for injection in the preparation container.

[0040] S3. Add the anhydrous sodium sulfite and sodium hydroxide in step S1 to the preparation container in step S2, and stir to fully dissolve the anhydrous sodium sulfite and sodium hydroxide.

[0041] S4. Heat the solution in the preparation container so that the temperature of the solution is kept at 30° C. to 40° C., add the enrofloxacin in step S1 under stirring, and stir until the enrofloxacin is completely dissolved.

[0042] S5. Add the propylene glycol in step S1 to the preparation container, and add water for injection to the second predetermined amount, so that the total volume of the solution is 995 ml.

[0043] S6. Adjust the pH value with hydrochloric acid or sodium hydroxide, the concentration of hydrochloric acid or sodium hydroxide is 0.1N, adjust the pH value at...

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Abstract

The present invention relates to an enrofloxacin injection and a production method thereof. The enrofloxacin injection comprises enrofloxacin with a concentration of 48-52 g / L, sodium hydroxide with a concentration of 5.5-6.5 g / L, propylene glycol with a concentration of 180-220 g / L, sodium sulfite with a concentration of 1.9-2.1 g / L, and a solvent, wherein the solvent is water for injection. According to the present invention, the use amount of the propylene glycol is increased in the formula or the production process of the enrofloxacin injection, such that the product is stable, and the quality of the product is ensured; specifically various detected indexes are qualified and especially the crystallization problem is effectively solved after the product is stored for more than 2 years; and the product meet the quality standard of the enrofloxacin injection in the new Veterinary Pharmacopoeia of the People's Republic of China, the storage time is prolonged, and it is ensured that various indexes are qualified within the validity period.

Description

technical field [0001] The invention relates to an injection in the pharmaceutical industry, in particular to an enrofloxacin injection and a manufacturing method thereof. Background technique [0002] Enrofloxacin injection is a product listed in the Veterinary Pharmacopoeia of the People's Republic of China and has been produced for many years. Traditional enrofloxacin injection mainly includes enrofloxacin and some other auxiliary materials. [0003] However, after several months of storage of this existing enrofloxacin injection product, there will be crystallization problems, and it can be seen that the foreign matter is unqualified, and finally the product is unqualified. The existence of this kind of problem will cause the user to return the product. For these returned products, it generally needs to be scrapped. This not only causes a lot of waste, but also has adverse effects on customers, and the reputation of manufacturers has been questioned. Contents of the ...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/496A61K47/10
CPCA61K9/0019A61K9/08A61K31/496A61K47/10
Inventor 徐海鸥张殿奎薛磊方泰云
Owner BEIJING LISHIDA PHARMA
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