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Tiamulin colloid injection and preparation method thereof

A technology of tiamulin base and tiamulin fumarate, which is applied in the directions of antibacterial drugs, pharmaceutical formulations, medical preparations with inactive ingredients, etc., can solve the problem of difficulty in preparing long-acting injections containing tiamulin fumarate and other problems, to achieve the effect of low adhesion rate, good fluidity and good slow release effect

Active Publication Date: 2015-09-16
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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  • Tiamulin colloid injection and preparation method thereof
  • Tiamulin colloid injection and preparation method thereof

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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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Abstract

The invention relates to a tiamulin colloid injection. Each liter of the injection includes 150-220g of tiamulin fumarate, 1.5-11g of carnauba wax, and the balance of a dispersion medium. The dispersion medium is a formal glycerine / benzyl benzoate mixture with the volume ratio of 1:1, or a glyceryl triacetate / formal glycerine / 1,2-propylene glycol / benzyl benzoate mixture with the volume ratio of 3:3:1:1. Each of the injection also comprises 60-300ml of glyceryl monooleate. In the preparation process of the injection, 38.0-63.3g of sodium carbonate decahydrate (Na2CO3.10H2O) is added to 1L of the injection, and the added sodium carbonate decahydrate reacts with tiamulin fumarate to make tiamulin fumarate converted into tiamulin alkali, so the active components of the injection prepared in the invention contain the tiamulin alkali and unreacted tiamulin, thereby the injection has quick 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 CN 101703776A discloses in the "preparation me...

Claims

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Application Information

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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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