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Sarafloxacin hydrochloride injection solution and preparation method thereof

A technology of salafloxacin hydrochloride and injection, which is applied in pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc., can solve the problems of easy oxidation and discoloration, poor stability, etc., and achieve good stability , Easy to operate, reasonable effect

Active Publication Date: 2016-03-16
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 solution and preparation method thereof
  • Sarafloxacin hydrochloride injection solution and preparation method thereof
  • Sarafloxacin hydrochloride injection solution and preparation method thereof

Examples

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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-2Na0.05g

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

[0025] The balance of water for injection

[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-2Na0.05g

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

[0034] The balance of water for injection

[0035] 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 α-pyrrolidone, and stir to obtain solution A; add 2.5g 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-2Na0.05g

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

[0043] The balance of water for injection

[0044] 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 dimethylformamide, stir and mix to obtain solution A; add 2.5g 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 solution and a preparation method thereof. Every 100 ml of the injection solution is prepared from 1-5 g of sarafloxacin hydrochloride, 5-10 g of a stabilizing agent, 15-50 g of organic solvent, 0.01-0.05 g of a metal ionic chelating agent, a pH regulating agent of which the using amount is enough to control the pH value of a system to be 9.5-10.5 and the balance water for injection; one or more of ethyl alcohol, sodium acetate and sodium glycinate is / are selected as the stabilizing agent, and one or more of PEG-400, propylene glycol, alpha-pyrrolidone and dimethylformamide is / are selected as the organic solvent. According to the sarafloxacin hydrochloride injection solution and the preparation method thereof, by adding the stabilizing agent and the organic solvent, the problems that the sarafloxacin hydrochloride is unstable, prone to oxidizing discoloration under the condition of the higher temperature, small in solubility in water and prone to separation under the low-temperature condition are solved; by adding the metal ionic chelating agent, a trace number of metal ions existing in equipment and the water for injection are prevented from catalyzing medicine to be oxidized, and then the oxidation resistance is achieved; the obtained sarafloxacin hydrochloride injection solution is good in stability, the preparation technology is simple, and industrialization is easy to achieve.

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. Currently, it is mainly used for the digestive system, respiratory system, Treatment of urinary tract infections and mycoplasmosis. [0003] Sarafloxacin hydrochloride has low solubility in water, poor chemical stability, hygroscopicity, and gradually darkens color when exposed to light or heat. Among the currently commerci...

Claims

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Application Information

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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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