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Preparation method and product of lincomycin-gentamicin compound injection

A technology of gentamicin and lincomycin, which is applied in the preparation of lincomycin-gentamycin compound injection and the field of injection preparation, can solve the problems of poor thermal stability, prone to hydrolysis or oxidation reaction, Substance failure and other issues

Inactive Publication Date: 2009-09-02
NORTHEAST AGRICULTURAL UNIVERSITY +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, since the lincomycin molecule contains amide groups and methylthio groups, these groups have poor thermal stability in aqueous solution, and lincomycin decomposes under heating conditions (higher than 60°C) and acidic conditions (pH lower than 4) The fastest, prone to hydrolysis or oxidation reactions, will degrade and lead to unqualified related substances

Method used

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  • Preparation method and product of lincomycin-gentamicin compound injection
  • Preparation method and product of lincomycin-gentamicin compound injection
  • Preparation method and product of lincomycin-gentamicin compound injection

Examples

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Comparison scheme
Effect test

Embodiment 1

[0054] Example 1 Preparation of Lincomycin-Gentamycin Compound Injection

[0055] Take 0.02% EDTA, add it to water for injection at 30°C, stir, and dissolve; respectively take gentamicin and lincomycin and add it into an appropriate amount of water for injection (30°C) and stir. Take 0.2% anhydrous sodium bisulfite and add it into the liquid medicine, and stir. Adjust the pH of the solution to 5.0 with hydrochloric acid solution, and fix the solution with water for injection. Add 0.1% needle-use activated carbon (25° C.) and stir for 20 minutes. Filter through 0.45um and 0.22um microporous membranes until clear. Fill it with nitrogen gas, and sterilize it by circulating steam at 115°C for 20 minutes.

Embodiment 2

[0056] Example 2 Preparation of Lincomycin-Gentamycin Compound Injection

[0057] Take 0.03% EDTA, add it to water for injection at 35°C, stir, and dissolve; respectively take gentamicin and lincomycin and add it into an appropriate amount of water for injection (35°C) and stir. Take 0.2% anhydrous sodium bisulfite and add it into the liquid medicine, and stir. Adjust the pH of the solution to 4.0 with hydrochloric acid solution, and fix the solution with water for injection. Add 0.2% needle-use activated carbon (25° C.) and stir for 20 minutes. Filter through 0.45um and 0.22um microporous membranes until clear. Nitrogen filling, steam sterilization at 115°C for 30 minutes.

Embodiment 3

[0058] Example 3 Preparation of Lincomycin-Gentamycin Compound Injection

[0059] Take 0.04% EDTA, add it to water for injection at 25°C, stir, and dissolve; respectively take gentamicin and lincomycin and add an appropriate amount of water for injection (25°C) and stir. Add 0.15% anhydrous sodium bisulfite into the liquid medicine, and stir. Adjust the pH of the solution to 6.0 with hydrochloric acid solution, and fix the solution with water for injection. Add 0.1% needle-use activated carbon (25° C.) and stir for 20 minutes. Filter through 0.45um and 0.22um microporous membranes until clear. Fill it with nitrogen gas, and sterilize it by circulating steam at 115°C for 20 minutes.

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Abstract

The invention discloses a preparation method of lincomycin-gentamicin compound injection, which comprises the following steps: (1) preparing an EDTA water solution; (2) adding lincomycin and gentamicin in tepid water for injection and mixing evenly, and obtaining liquid medicine after adding the EDTA and anhydrous sodium bisulfite into the mixture; (3) adjusting the pH value of the liquid medicine to 4.0 to 60; and (4) adding active carbon in the liquid medicine and performing filtration and live steam sterilization, wherein the pH value of the liquid medicine is adjusted to 4.0 to 60 in the step (3). The invention carries out optimization and filtration on the preparation method of lincomycin-gentamicin compound injection, respectively observes the influence to the stability and the safety of the lincomycin-gentamicin injection caused by the pH value, the preparation temperature, the concentration of the sodium bisulfite and EDTA, the addition of the active carbon and the sterilization temperature and time and finally determines the optimum preparation technology, thereby the prepared lincomycin-gentamicin compound injection has excellent stability and good safety.

Description

technical field [0001] The invention relates to a method for preparing an injection, in particular to a method for preparing a lincomycin-gentamycin compound injection and a product prepared by the method, belonging to the field of injection preparations. Background technique [0002] Gentamicin, also known as Chintamycin, is an aminoglycoside broad-spectrum antibiotic produced by Actinomycetes Micromonospora. Various serious infections caused by sensitive bacteria such as Staphylococcus aureus, Pseudomonas aeruginosa, Proteus, Escherichia coli, Streptococcus, etc., such as respiratory tract, intestinal tract, urinary tract, mastitis, skin, soft tissue infection and sepsis Treatment. Gentamicin from C 1 、C 2 、C 1a 、C 2a Composed of four components, its antibacterial activity and toxic and side effects are similar. The four components are all easily soluble in water, and the aqueous solution is stable to heat and stable under acid, alkali or heating conditions. [0003]...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/7056A61K31/7036A61K9/08A61P31/04
Inventor 李艳华刘永崔阳王敏边栋徐刚李明雁崔琳刘洋
Owner NORTHEAST AGRICULTURAL UNIVERSITY
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