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Tylvalosin tartrate soluble powder and preparation method thereof

A technology of tivalamectin and tartaric acid, which is applied in the fields of pharmaceutical formulation, powder delivery, antibacterial drugs, etc., can solve the problems that soluble powder cannot be directly applied, and achieve good inclusion effect, strong operability, and high solubility

Active Publication Date: 2020-05-19
CHINANIMAL NANJING VETERINARY DRUGS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this technical solution is aimed at tyvalactin tartrate premix and does not need to improve the solubility, so it cannot be directly applied to soluble powder

Method used

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  • Tylvalosin tartrate soluble powder and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Embodiment 1, preparation tyvalactin tartrate soluble powder

[0029] The preparation method of the tyvalactin tartrate soluble powder of the present embodiment comprises:

[0030] The first step is to mix hydroxypropyl-β-cyclodextrin with water and stir until dissolved to obtain the first liquid; the weight ratio of hydroxypropyl-β-cyclodextrin to water is (0.8-1.2):(16 -twenty four);

[0031] Wherein, the process of preparing the first liquid is carried out in a water bath with a temperature lower than or equal to 15°C. The weight ratio of hydroxypropyl-β-cyclodextrin to water is preferably 1:(20-24).

[0032] In the second step, in a water bath with a temperature less than or equal to 15°C, mix the first liquid, the raw material of tyvanectin tartrate, and the pH regulator tartaric acid, and stir for at least 0.75 hours until a clear liquid is obtained; The weight ratio of medicine and pH regulator tartaric acid is 1:(0.015-0.025); The weight ratio of hydroxypropy...

Embodiment 2

[0038] Embodiment 2, solubility detection

[0039] The finished product of the test case of Example 1, the bulk drug of tyvalomectin tartrate, and the soluble powder of tyvalomectin tartrate in the market were used as samples. At 25°C, the solubility of the above samples in water was tested.

[0040] The results are shown in the table below:

[0041] Test case finished product API commercially available Solubility at 25°C 50000ppm 5000ppm 8000ppm

[0042] It can be seen that the solubility of the finished product of the test case of Example 1 is much higher than that of the tyvalomectin tartrate bulk drug and the commercially available tyvalomectin tartrate soluble powder.

Embodiment 3

[0043] Embodiment 3, stability monitoring

[0044] The finished product of the test case of Example 1, the bulk drug of tyvalomectin tartrate, and the soluble powder of tyvalomectin tartrate in the market were used as samples.

[0045] Each sample was placed under the conditions of 40°C and RH75% for 6 months, and its A component was monitored (A component not lower than 80% is qualified). Note: According to the first volume of the national standard for veterinary drugs "Tyvalamicin Tartrate Premix", and the imported veterinary drug standard "Tyvalamicin Tartrate Soluble Powder" approved and issued by the Ministry of Agriculture Announcement No. 1680, when investigating stability, the The main monitoring index is the content of component A (ie tylvanicin A), and no less than 80% of component A is qualified.

[0046] The results are shown in the table below:

[0047] API Test case finished product commercially available 0 months 88.34％ 88.21％ 86.31％ ...

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Abstract

The invention relates to a tylvalosin tartrate soluble powder and a preparation method thereof. The method comprises the steps of mixing hydroxypropyl-beta-cyclodextrin and water and stirring until dissolved to obtain a first liquid; mixing the first liquid, a tylvalosin tartrate crude drug and a pH regulator in a low-temperature water bath and stirring until a clear liquid is obtained; and carrying out spray drying on the obtained clear liquid through a spray drying tower to obtain powder, namely a finished product of tylvalosin tartrate soluble powder. The prepared tylvalosin tartrate soluble powder is capable of masking the drug odor, and is high in solubility and high in stability. The preparation method is high in operability, high in drug loading capacity and good in inclusion effect.

Description

technical field [0001] The invention relates to a tylvalosin tartrate soluble powder and a preparation method thereof, belonging to the technical field of veterinary drug preparations. Background technique [0002] Tyvanectin, formerly known as acetylisovaleryl tylosin, is a macrolide antibiotic. Developed by the British Eco Animal Health Products Co., Ltd., its tartrate is often used. At present, tyvanectin tartrate premix and soluble powder have been approved in China for the treatment of mycoplasma infection, Brachyspira hyodysenteriae and other sensitive bacteria in pigs and chickens. Tivalamectin has the advantages of high efficiency, low toxicity, and low residue, and will not produce cross-resistance between macrolide antibiotics. It is a good macrolide for the treatment of respiratory and digestive tract infections. antibiotic. However, the solubility of tyvanectin tartrate raw material in water is difficult to reach the high concentration required by the dosing d...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/69A61K31/7048A61K9/14A61P31/04
CPCA61K9/146A61K31/7048
Inventor 马小平徐瑞华戴银娣
Owner CHINANIMAL NANJING VETERINARY DRUGS
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