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High-water-solubility tylvalosin premix

A technology of tivallosin and water-solubility, which is applied in the field of highly water-soluble tivallosin premixes, can solve the problems of poor formulation stability, easy agglomeration, and difficulty in reaching high concentrations of solubility, and achieves a simple preparation process. , The effect of low preparation cost

Pending Publication Date: 2022-01-07
江西成必信生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Tivalamectin tartrate can improve water solubility under acidic conditions; however, adding acidic excipients often leads to poor stability of the preparation and easy agglomeration
At present, the solubility of tivalamectin premix and soluble powder in the market is difficult to reach the high concentration required by the current large-scale breeding and drinking water dosing device

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] 1.1 Screening of the minimum addition amount of organic acid co-solvent

[0020] 1.1.1 There are three states after tyvalectin tartrate is dissolved in water: (1) completely clear and transparent, no visible precipitation at the bottom of the beaker after standing for 6 hours; (2) turbid and opaque, no visible precipitation at the bottom of the beaker after standing for 6 hours; (3) It is cloudy and opaque, and there is visible precipitation at the bottom of the beaker after standing for 6 hours.

[0021] 1.1.2 If the amount of organic acid co-solvent added is too high, it will affect the long-term stability of tyvanectin tartrate premix. Therefore, it is first necessary to test and verify the minimum addition amount of organic acid co-solvent.

[0022] According to preliminary tests, organic acids such as anhydrous DL-tartaric acid, succinic acid, anhydrous citric acid, DL-malic acid, etc., can significantly increase the solubility of tyvanectin tartrate. In the cour...

Embodiment 2

[0043] (1) Crush and sieve, crush anhydrous DL-tartaric acid and pass through an 80-mesh sieve, and set aside.

[0044] (2) The 20% tyvalactin tartrate premix formulation and specific consumption of the present embodiment are shown in Table 4 below

[0045] Table 4

[0046] Active ingredients Tivalamectin tartrate API 25.0kg Co-solvent Anhydrous DL-Tartrate 2.0kg pigment Caramel Coloring (Food Grade) 1.0kg filler Maltodextrin 72.0kg

[0047] (3) total mix

[0048] The four kinds of raw materials in the above-mentioned Table 4 were mixed, subpackaged and sealed to obtain 20% tivalamectin tartrate premix.

[0049] (4) Long-term stability accelerated test.

[0050] The subpackaged and sealed 20% tyvalactin tartrate premix was stored in a constant temperature and humidity chamber (40°C, 75% relative humidity) for 6 months, and the relevant components were tested once a month. The test results are shown in Table 5 below. According t...

Embodiment 3

[0054] (1) Crush and sieve: Crush anhydrous DL-tartaric acid and sucrose, pass through an 80-mesh sieve, and set aside.

[0055] (2) The 20% tyvalactin tartrate premix formulation and specific consumption of the present embodiment are shown in Table 6 below

[0056] Table 6

[0057] Active ingredients Tivalamectin tartrate API 25.0kg Co-solvent Anhydrous DL-Tartrate 2.0kg pigment Caramel Coloring (Food Grade) 1.0kg filler sucrose 72.0kg

[0058] (3) total mix

[0059] The four kinds of raw materials in the above-mentioned Table 6 were mixed, packaged and sealed to obtain 20% tyvalactin tartrate premix.

[0060](4) Long-term stability accelerated test.

[0061] The subpackaged and sealed 20% tyvalactin tartrate premix was stored in a constant temperature and humidity chamber (40°C, 75% relative humidity) for 6 months, and the relevant components were tested once a month. The test results are shown in Table 7 below. According to ...

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Abstract

The invention belongs to the related technical field of veterinary drug antibiotic products, and particularly relates to a high-water-solubility tylvalosin premix. An tartaric acid tylvalosin bulk drug, anhydrous DL-tartaric acid, caramel pigment (food grade) and maltodextrin are added for supplement; and uniformly mixing and sub-packaging to obtain the 20% tartaric acid tylvalosin premix. The water solubility of the tartaric acid tylvalosin premix is obviously improved, and meanwhile, the long-term storage stability can be ensured. The water solubility of the prepared tylvalosin premix is increased from 7000 to 8000 ppm to more than 20000 ppm on the basis of pure tartaric acid tylvalosin. In the accelerated test for long-term storage stability, the tylvalosin premix is sealed with a transparent plastic bag and stored in a constant temperature and humidity chamber (40 DEG C, relative humidity of 75%) for 6 months, and the tylvalosin premix is not caked and discolored and is detected to be qualified according to the national standard.

Description

technical field [0001] The invention belongs to the related technical field of veterinary drug antibiotic products, and in particular relates to a highly water-soluble tivalamectin premix. Background technique [0002] Tylvalerin is a macrolide antibiotic, which is the abbreviation of acetylisovaleryl tylosin tartrate. It has antibacterial activity against most Gram-positive bacteria and some Gram-negative bacteria, especially against Mycoplasma, and has unique curative effects against Mycoplasma gallisepticum, porcine epidemic pneumonia, and swine dysentery. [0003] Tivalamectin tartrate, under acidic conditions, can improve water solubility; but adding acidic auxiliary materials often leads to poor stability of the preparation and easy agglomeration. At present, the solubility of tivalamectin premix and soluble powder in the market is difficult to reach the high concentration required by the current large-scale breeding and drinking water dosing device. Contents of the...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K31/7048A61P31/04
CPCA61K31/7048A61K9/145A61P31/04
Inventor 刘志滨黄友辉任升柳罗建华
Owner 江西成必信生物科技有限公司
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