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Gamithromycin microemulsion for injection and preparation method thereof

A technology of gamimycin and gamimycin salt, which is applied in the field of pharmacy, can solve the problems of high tissue irritation and slow release speed of active ingredients, and achieve the goal of small irritation, increased stability, and reduced difficulty and cost. Effect

Active Publication Date: 2021-12-21
FOSHAN NANHAI EASTERN ALONG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

If conventional oily solvents, such as glycerin, soybean oil and other oily solvents are used to prepare microemulsions for gamimycin injection, the release rate of active ingredients after administration will be reduced, and the irritation to tissues will be relatively greater

Method used

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  • Gamithromycin microemulsion for injection and preparation method thereof
  • Gamithromycin microemulsion for injection and preparation method thereof
  • Gamithromycin microemulsion for injection and preparation method thereof

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preparation example Construction

[0038] In order to solve the above-mentioned technical problems, the invention provides a kind of preparation method of gamimycin injection microemulsion, comprising the following steps:

[0039] S1. Add oil phase solvent and gaminomycin or gaminomycin salt to the reaction equipment at preset temperature, stir until dissolved, and then lower to room temperature;

[0040] S2. Add emulsifier, co-emulsion agent and water for injection into the reaction equipment until the preparation is homogeneously stable to obtain an intermediate;

[0041] S3. After the intermediate is sterilized, the finished product is obtained;

[0042] The microemulsion for gamimycin injection comprises, by mass percentage: 1-30% of gamimycin or its salts, 10-50% of an oil phase solvent, 1.5-10% of an emulsifier, and 1.5-10% of an emulsion assistant. %, water for injection 1-85%.

[0043] The microemulsion for gamimycin injection prepared by the preparation method of the microemulsion for gamimycin injec...

Embodiment 1

[0061] A preparation method of gamithromycin microemulsion for injection, comprising:

[0062] S1. Mix and stir 10% glycerol formal and 10% gaminomycin for pre-dissolving treatment to obtain the first mixture;

[0063] S2. Open the reaction kettle, heat up to 80°C, add 15% soybean oil for injection, then add the first mixture, and stir evenly;

[0064] S3. Add 2% glycerol oleate and 1% propylene glycol into the reaction kettle, mix evenly, cool down to room temperature, slowly add 60.7% water for injection while stirring, until the preparation is clear and transparent;

[0065] S4, adding 1% sodium metabisulfite and 0.3% glucose to the reaction kettle, and using sodium hydroxide solution to adjust the pH to the required range to obtain an intermediate;

[0066] S5. Using a microporous membrane to sterilize and filter the intermediate, subpackage after passing the test, and obtain a finished product.

Embodiment 2

[0068] A preparation method of gamithromycin microemulsion for injection, comprising:

[0069] S1. Open the reaction kettle, heat up to 70°C, add 10% ethyl oleate, then pour 5% gaminomycin, and stir evenly;

[0070] S2. Mix 3% Tween 80 and 2% Polyethylene Glycol 400 in the reaction kettle evenly, cool down to room temperature, slowly add 79.5% water for injection while stirring until the preparation is clear and transparent;

[0071] S3, adding 0.5% thioglycerol to the reaction kettle and using anhydrous citric acid solution to adjust the pH to the required range to obtain an intermediate;

[0072] S4. The intermediate is packaged and sterilized at high temperature to obtain a finished product.

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Abstract

The invention discloses a gamithromycin microemulsion for injection and a preparation method thereof. The preparation method comprises the following steps: adding an oil phase solvent and gamithromycin or gamithromycin salt into reaction equipment with a preset temperature, performing stirring until the mixture is dissolved, and then performing cooling to room temperature; adding an emulsifier, a co-emulsifier and water for injection into the reaction equipment until a preparation is homogeneous and stable to obtain an intermediate; and carrying out sterilization treatment on the intermediate to obtain a finished product. The gamithromycin microemulsion for injection comprises the following components in percentage by mass: 1%-30% of gamithromycin or salts thereof, 10%-50% of oil-phase solvent, 1.5%-10% of emulsifier, 1.5%-10% of co-emulsifier and 1%-85% of water for injection. The gamithromycin microemulsion for injection provided by the invention is simple in preparation process and relatively low in cost, the prepared finished product is high in stability, and the injection irritation is within a safe range.

Description

technical field [0001] The invention relates to the technical field of pharmacy, in particular to a microemulsion for gamimycin injection and a preparation method thereof. Background technique [0002] Gamimycin is a new macrolide veterinary antibiotic, white to beige powder, insoluble in water, hygroscopic, and insensitive to light. Gamimycin has a wide antibacterial spectrum, strong antibacterial activity, fast absorption, wide distribution in the body, low residue in the body, and high safety. Because it can be quickly absorbed and distributed in the lungs, it is mostly used for the prevention and treatment of Mannella hemolytica , Pasteurella multocida and Histophilia somalii and other related pathogens causing bovine respiratory disease, also can be used for Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis and bronchoseptic Boulder In addition, it is also involved in the systemic treatment of sheep infectious foot rot caused by pathogenic ba...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K31/7052A61K47/10A61K47/18A61K47/20A61P31/04
CPCA61K31/7052A61K9/1075A61K9/0019A61K47/10A61K47/20A61K47/18A61P31/04Y02A50/30
Inventor 辜质纯元晓琪周淑贞
Owner FOSHAN NANHAI EASTERN ALONG PHARMA CO LTD
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