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A kind of tiamulin colloid injection and preparation method thereof

A technology of tiamulin and tiamulin fumarate, which is applied in the direction of antibacterial drugs, pharmaceutical formulas, medical preparations of non-active ingredients, etc., and can solve the problem of difficult preparation of long-acting injections containing tiamulin fumarate, etc. problem, to achieve the effect of low adhesion rate, good needle passability and good fluidity

Active Publication Date: 2017-09-15
中农华威制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

We have carried out repeated experiments to the disclosed patented technology, and the results show that even with oil or other non-aqueous solvents as the medium, it is not easy to prepare long-acting tiamulin fumarate containing injection

Method used

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  • A kind of tiamulin colloid injection and preparation method thereof
  • A kind of tiamulin colloid injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Embodiment 1, preparation formula screening test

[0033] Table 1 shows the representative compositions screened and the test results.

[0034] Table 1. Formula screening test and results

[0035]

[0036] From the above test results, it can be seen that: (1) The formation of latex is the result of the interaction between glycerol monooleate and tiamulin fumarate. (2) Only by adding carnauba wax in the preparation can a stable and uniform emulsion be formed.

Embodiment 2

[0037] Embodiment 2, prepare the tiamulin fumarate injection containing Brazilian wax

[0038] Take 183g of tiamulin fumarate with a purity of 99.5%, 9.0g of Brazilian wax, and 0.2g of TBHQ, put them in a 2-liter Erlenmeyer flask, add 300ml of formalin glycerol and 300ml of benzyl benzoate, and stir in a water bath at 85-92°C After the tiamulin fumarate and carnauba wax are completely dissolved, remove it from the water bath, lower the temperature of the material to room temperature while stirring, pass through a high-shear homogenizer, and shear for 10 minutes to obtain the product.

Embodiment 3

[0039] Embodiment 3, prepare the tiamulin fumarate injection containing Brazilian wax and glyceryl monooleate

[0040] Take 183g of tiamulin fumarate with a purity of 99.5%, 6.5g of Brazilian wax, and 0.2g of BHTQ, put them in a 2-liter conical flask, add 300ml of formalin glycerol and 300ml of benzyl benzoate, stir in a water bath at 90°C, and wait until the solid After the substance is completely dissolved, add 60ml of glyceryl monooleate, continue to stir for 3 minutes, remove from the water bath, make the temperature of the substance drop to room temperature under the condition of stirring, and process it with a high-shear emulsifying homogenizer for 10 minutes to obtain the preparation .

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PUM

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Abstract

The invention relates to a colloid injection containing tiamulin, which contains 150-220 g of tiamulin fumarate and 1.5-11 g of Brazilian wax in every liter of the injection, and the dispersion medium is added to 1 liter. Described dispersing medium is: glycerol / benzyl benzoate with a volume ratio of 1:1 or glycerol triacetate / glycerol / 1,2-propylene glycol / benzene with a volume ratio of 3:3:1:1 Benzyl formate. Each liter of injection also contains 60-300ml monoolein. In the process of preparing the above injections, sodium carbonate decahydrate (Na2CO3 10H2O) can be added, and in every 1 liter of injection prepared, the addition of sodium carbonate decarbahydrate is 38.0-63.3g, and these Na2CO3 added will combine with fumarate The reaction of myocin causes tiamulin fumarate to be converted into tiamulin base, and the preparation thus prepared contains two active components of tiamulin base and unreacted tiamulin fumarate. The preparation has both quick-acting and long-acting effects.

Description

technical field [0001] The invention belongs to the technical field of preparation of veterinary medicine preparations, and in particular relates to an emulsion injection containing tiamulin fumarate or tiamulin fumarate and tiamulin base and a preparation method thereof. Background technique [0002] Tiamulin fumarate is an acid salt formed by tiamulin base (free base form of tiamulin) and fumaric acid. It is a semi-synthetic antibiotic for animals, mainly used for the prevention and treatment of gram-positive bacteria and Infectious diseases caused by mycoplasma. Currently commercially available products are only soluble powders and premixes prepared with tiamulin fumarate, and there is no commercialized tiamulin fumarate injection on the market. Patent CN 103006551A discloses a cosolvent (ethanol, 1,2-propylene glycol or benzyl alcohol) and sesame oil as a solvent to prepare an oily injection containing 10% tiamulin. Patent CN101703776A discloses in the "preparation met...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/44A61K31/22A61K9/107A61K47/14A61K47/10A61P31/04
Inventor 王玉万戴晓曦李蕾任雅楠李莹翁志飞沈力
Owner 中农华威制药股份有限公司
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