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Arbekacin sulphate injection and preparation method thereof

A technology of arbekacin and injection, which is applied in the field of antibiotic drug preparation, can solve the problems of product heat-labile, elevated, and no preparation method of arbekacin sulfate injection, etc., so as to solve product instability and production problems. Simple process and good stability

Inactive Publication Date: 2017-02-01
WUXI FORTUNE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because the structure of arbekacin sulfate contains glycosidic bonds, the product is not heat-resistant, and after high-temperature sterilization, the product is prone to discoloration and related substances increase, so it cannot meet the requirements of the Pharmacopoeia
In the existing patents and documents, there is no relevant report on arbekacin sulfate injection and its preparation method, and the product has not yet been launched in China

Method used

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  • Arbekacin sulphate injection and preparation method thereof
  • Arbekacin sulphate injection and preparation method thereof
  • Arbekacin sulphate injection and preparation method thereof

Examples

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Comparison scheme
Effect test

Embodiment 1

[0025] An arbekacin sulfate injection, comprising the following components:

[0026]

[0027]

[0028] The pH of the arbekacin sulfate injection is 6.0-8.0.

[0029] The antioxidant is one of sodium sulfite, sodium bisulfite, sodium pyrosulfite or sodium thiosulfate, or a mixture of two or more in any proportion, and most preferably sodium bisulfite. The isotonicity adjusting agent is sodium chloride or dextrose, and most preferably sodium chloride. The oxygen content in deoxygenated water for injection is less than 0.1ppm. The pH regulator is sulfuric acid solution or sodium hydroxide solution.

Embodiment 2

[0031] A preparation method for arbekacin sulfate injection, comprising the following steps:

[0032] Step (1), put 1000ml of deoxygenated water for injection into the liquid preparation tank, cool to room temperature, and pass protective gas into the liquid preparation tank until saturated. The protective gas is selected from nitrogen, argon or helium, and is most preferably nitrogen.

[0033] Step (2), put 30-200 g of arbekacin sulfate, 0.2-1.5 g of antioxidant, and 3.0-9.0 g of isotonic regulator into the liquid mixing tank, and fully dissolve them. Specifically, the antioxidant is one of sodium sulfite, sodium bisulfite, sodium pyrosulfite or sodium thiosulfate or a mixture of two or more in any proportion, and sodium bisulfite is most preferred. The isotonicity adjusting agent is sodium chloride or dextrose, and most preferably sodium chloride.

[0034] Step (3), put 1-1.5g of medicinal activated carbon into the liquid mixing tank to decarburize under the protection of ...

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Abstract

The invention provides Arbekacin sulphate injection and a preparation method thereof. The Arbekacin sulphate injection comprises the following components: 30 to 200 g of Arbekacin sulphate, 0.2 to 1.5 g of an anti-oxidant, 3.0 to 9.0 g of an isoosmotic adjusting agent, a suitable amount of a pH regulator, and 1,000 ml of deoxidized injection water; the pH of the Arbekacin sulphate injection is 6.0 to 8.0. The Arbekacin sulphate injection and the preparation method thereof disclosed by the invention have the advantages of simple production process and low cost; the problem that the Arbekacin sulphate injection cannot meet the requirement of terminal sterilization is solved; the stability in a period of validity is good; the problems that a product is instable and impurities are increased caused by the terminal sterilization adopted in the current production process are solved; the Arbekacin sulphate injection and the preparation method thereof are applicable to industrial production.

Description

technical field [0001] The invention relates to the technical field of preparation of antibiotic drugs, in particular to an arbekacin sulfate injection and a preparation method thereof. Background technique [0002] Arbekacin sulfate is a newly developed aminoglycoside antibiotic. It is a derivative of (S)-4-amino-2-hydroxybutyryl introduced into the 1-amino group of dibekacin. Its molecular structure is shown below. [0003] [0004] Compared with other aminoglycosides, arbekacin sulfate is extremely stable to various non-activating enzymes derived from staphylococci, and it is also effective against methicillin-resistant and cephalosporins that lack clinically effective therapeutic drugs. Staphylococcus aureus (MRSA) has strong antibacterial activity. Its antibacterial effect is the best among aminoglycoside drugs, and compared with minocycline, imipenem (imipenem), cefuzonam (cefazonam), its antibacterial activity is not inferior. The general toxicity of this product...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/7036A61K47/02A61K47/26A61P31/04
CPCA61K31/7036A61K9/0019A61K9/08A61K47/02A61K47/26
Inventor 米靖宇徐建国李晓明秦玉荣虞佳媛孙益林蒋逸云
Owner WUXI FORTUNE PHARMA