Sarafloxacin hydrochloride injection and preparation method thereof

A technology for salafloxacin hydrochloride and injection, which is applied in pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc., can solve problems such as poor stability, easy oxidation and discoloration, and achieve good stability. , the composition is reasonable, the preparation process is simple effect

Active Publication Date: 2018-04-13
CHONGQING FANGTONG ANIMAL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In view of this, one of the purposes of the present invention is to solve the problems of poor stability and easy oxidative discoloration of the currently commercially available sarafloxacin hydrochloride injection, and provide a kind of sarafloxacin hydrochloride injection with good stability; the second purpose is to provide A method for preparing the sarafloxacin hydrochloride injection, the process is simple, the operation is convenient, and it is easy to realize industrialization

Method used

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  • Sarafloxacin hydrochloride injection and preparation method thereof
  • Sarafloxacin hydrochloride injection and preparation method thereof
  • Sarafloxacin hydrochloride injection and preparation method thereof

Examples

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Effect test

preparation example 1

[0019] Sarafloxacin hydrochloride injection, each 100ml consists of the following components:

[0020] Sarafloxacin Hydrochloride 5g

[0021] Sodium glycinate 7g

[0022] Propylene glycol 35g

[0023] EDTA-2Na 0.05g

[0024] Hydrochloric acid or sodium hydroxide to adjust the pH value of the system to 9.5~10.5

[0025] water for injection balance

[0026] Preparation method: Dissolve 7g of sodium glycinate and 0.05g of EDTA-2Na in an appropriate amount of water for injection, then add 35g of propylene glycol, and stir to obtain solution A; add 5g of sarafloxacin hydrochloride to solution A, stir to dissolve, and use hydrochloric acid or Adjust the pH value to 9.5~10.5 with sodium hydroxide solution, then dilute to 100ml with water for injection, filter with an organic filter membrane, fill the filtrate with nitrogen, subpackage, and steam sterilize for 15~30 minutes to obtain sarafloxacin hydrochloride injection 1.

preparation example 2

[0028] Sarafloxacin hydrochloride injection, each 100ml consists of the following components:

[0029] Sarafloxacin Hydrochloride 2.5g

[0030] Sodium glycinate 7g

[0031] α-Pyrrolidone 35g

[0032] EDTA-2Na 0.05g

[0033] Hydrochloric acid or sodium hydroxide to adjust the pH value of the system to 9.5~10.5

[0034] water for injection balance

[0035] Preparation method: Dissolve 7 g of sodium glycinate and 0.05 g of EDTA-2Na in an appropriate amount of water for injection, then add 35 g of α-pyrrolidone, and stir to obtain solution A; add 2.5 g of sarafloxacin hydrochloride to solution A, stir to dissolve, Use hydrochloric acid or sodium hydroxide solution to adjust the pH value to 9.5~10.5, then dilute to 100ml with water for injection, filter with an organic filter, fill the filtrate with nitrogen, and steam sterilize for 15~30 minutes to obtain sarafloxacin hydrochloride injection 2.

preparation example 3

[0037] Sarafloxacin hydrochloride injection, each 100ml consists of the following components:

[0038] Sarafloxacin Hydrochloride 2.5g

[0039] Sodium glycinate 7g

[0040] Dimethylformamide 35g

[0041] EDTA-2Na 0.05g

[0042] Hydrochloric acid or sodium hydroxide to adjust the pH value of the system to 9.5~10.5

[0043] water for injection balance

[0044] Preparation method: Dissolve 7 g of sodium glycinate and 0.05 g of EDTA-2Na in an appropriate amount of water for injection, then add 35 g of dimethylformamide, and stir to obtain solution A; add 2.5 g of sarafloxacin hydrochloride to solution A, and stir to make Dissolve, adjust the pH value to 9.5~10.5 with hydrochloric acid or sodium hydroxide solution, then dilute to 100ml with water for injection, filter with an organic filter membrane, fill the filtrate with nitrogen, and steam sterilize for 15~30 minutes to obtain sarafloxacin hydrochloride Injection 3.

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Abstract

The invention discloses a sarafloxacin hydrochloride injection and a preparation method thereof. Each 100ml injection consists of the following components: 1-5g of sarafloxacin hydrochloride, 5-10g of a stabilizer, 15-50g of an organic solvent, and a metal ion chelate Mixture 0.01~0.05g, the dosage is enough to control the pH of the system as a pH regulator of 9.5~10.5, and the balance is water for injection; the stabilizer is one or more of ethanol, sodium acetate and sodium glycinate; the organic solvent is PEG- 400, one or more of propylene glycol, α-pyrrolidone and dimethylformamide. The present invention solves the problems that sarafloxacin hydrochloride is unstable, easily oxidized and discolored under high temperature conditions, has low solubility in water, and easily precipitates under low temperature conditions by adding a stabilizer and an organic solvent; and the trace amount of metal ions present in the water for injection catalyze the oxidation of the drug and play an anti-oxidation effect; the obtained sarafloxacin hydrochloride injection has good stability, simple preparation process and easy industrialization.

Description

technical field [0001] The invention belongs to the technical field of veterinary drug preparations, and relates to a veterinary sarafloxacin hydrochloride preparation and a preparation method thereof. Background technique [0002] Sarafloxacin Hydrochloride is a third-generation fluoroquinolone broad-spectrum antibacterial drug specially used for animals. It has strong antibacterial activity and has antibacterial effects on Gram-negative bacteria, Gram-positive bacteria and mycoplasma, especially It has good antibacterial properties against Escherichia coli, Salmonella, Klebsiella, Proteus, Pasteurella multocida, Campylobacter and other enterobacteria. At present, it is mainly used for the digestive system and respiratory system of livestock and poultry caused by sensitive bacteria. , urinary tract infection and mycoplasma treatment. [0003] Sarafloxacin hydrochloride has low solubility in water, poor chemical stability, hygroscopicity, and gradually darkens color when ex...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/496A61K47/10A61K47/12A61K47/18A61P31/04
Inventor 唐建华龚聪袁启峰宋小红
Owner CHONGQING FANGTONG ANIMAL PHARMA
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