A method for preparing a soluble powder of tylosin tartrate

Abstract

The application provides a preparation method of soluble powder of tylosin tartrate. The preparation is composed of the following components: tylosin tartrate 10%-20%, yellow dextrin 2.5%-5%, ethylenediaminetetraacetic acid disodium 5%-10%, acidifying agent 5%-10%, acacia 5%-10%, and anhydrous glucose as an auxiliary material. The preparation is prepared through the processes of liquid preparation, high-speed shearing and spray drying. The preparation prepared by the method has the advantages of high solubility, about 65,000 PPM, good water-solubility, clear solution, and good water solution stability.

Description

TECHNICAL FIELD

[0001] The present application belongs to the field of veterinary medicine in the field of biological medicine, and particularly relates to a preparation method of soluble tylosin tartrate powder. BACKGROUND

[0002] Tylosin tartrate is a new generation of macrolide antibiotics, and is the most active antibiotic for killing mycoplasma at present. Metabolic products thereof not only have strong killing activity on pathogenic bacteria such as mycoplasma pneumoniae, but also can activate macrophages, increase the number of macrophages, enhance phagocytosis, promote the secretion of lysozyme, and enhance the non-specific immune function of the body.

[0003] Tylosin tartrate is dissolved in water, and its water solubility is about 50,000 ppm according to different raw material sources. In clinical application, because tylosin tartrate is obtained by biological fermentation, the high-concentration aqueous solution of the preparation will appear flocculation, and needs to be stirred for a long time to be completely dissolved. The most commonly used administration method in large-scale breeding farms is through water administration, and the flocculation of the preparation will greatly limit the application of the product in clinical application.

[0004] Therefore, we consider to find a method which has good water solubility and can eliminate the flocculation of tylosin soluble powder in aqueous solution to solve the phenomenon of easy blockage of waterway in clinical use.

[0005] In the research process, it is found that adding a certain proportion of yellow dextrin can increase the water solubility of tylosin tartrate, the aqueous solution of tylosin tartrate is more stable at acidic pH, and adding disodium ethylenediaminetetraacetate can form a chelate with tylosin tartrate to completely eliminate the flocculation formed in water. Gum arabic can play a thickening role to ensure the uniformity of the material in the processing process and the uniformity of the aqueous solution in the clinical use, and also can play a certain protective role in the process of spray drying. SUMMARY

[0006] The present application adopts the following technical scheme:

[0007] The present application aims to provide a preparation method of soluble tylosin tartrate powder. It contains the following weight components: 10%-20% of tylosin tartrate, 2.5%-5% of yellow dextrin, 5%-10% of disodium ethylenediaminetetraacetate, 5%-10% of acidifying agent, 5%-10% of gum arabic, and anhydrous glucose.

[0008] The preparation method of soluble tylosin tartrate powder provided by the present application is characterized in that the acidifying agent is aspartic acid or glutamic acid.

[0009] The ratio of tylosin tartrate to yellow dextrin is 1:0.25

[0010] The ratio of the said tylosin tartrate and the disodium EDTA is 1:0.5

[0011] The ratio of the said tylosin tartrate and the acidifying agent is 1:0.5

[0012] The ratio of the said tylosin tartrate and the gum arabic is 1:0.5

[0013] A preparation method of tylosin tartrate soluble powder, comprising the following steps:

[0014] Step 1: tylosin tartrate, yellow dextrin and EDTA-2NA are preliminarily mixed, water is added to dissolve, and after dissolution, an acidifying agent is added to stir and completely dissolve for standby.

[0015] Step 2: gum arabic is added to water to form a gum paste solution for standby.

[0016] Step 3: the solutions obtained in steps 1 and 2 are mixed, and an appropriate amount of anhydrous glucose is added to form a uniform suspension liquid.

[0017] Step 4: the suspension liquid in step 3 is placed in a high-speed shearing emulsifying pot for shearing for standby.

[0018] Step 5: the liquid obtained in step 4 is spray dried and packed in aluminum foil bags.

[0019] The preparation method of tylosin tartrate soluble powder provided by the application has good water solubility and does not produce flocculation. The amino acid is not only used as an acidifying agent but also has a buffering effect in the aqueous solution, so that the aqueous solution of the preparation is more stable, and the amino acid can also provide necessary nutrients for animals. DETAILED DESCRIPTION

[0020] The application will be further described in combination with specific examples, and the advantages and characteristics of the application will be clearer with the description. However, these examples are only exemplary and do not constitute any limitation on the scope of the application. Those skilled in the art should understand that the details and forms of the technical solutions of the application can be modified or replaced without departing from the spirit and scope of the application, and these modifications and replacements all fall within the protection scope of the application.

[0021] Example 1: tylosin tartrate soluble powder prepared by the method

[0022] Step 1: tylosin tartrate 20g (dry product), yellow dextrin 5g and EDTA-2NA 10g are preliminarily mixed, 200ml of water is added to dissolve, and after dissolution, aspartic acid 10g is added to stir and completely dissolve for standby.

[0023] Step 2: Take 10g of gum arabic and add 30ml of water to make a gum paste solution. Stir well and set aside.

[0024] Step 3: Mix the solutions obtained in Step 1 and Step 2, stir well, add 36g of anhydrous glucose, and stir to form a uniform suspension.

[0025] Step 4: Place the suspension from Step 3 into a high-speed shear emulsification pot and shear for 20 minutes at a temperature below 45°C.

[0026] Step 5: Spray dry the liquid obtained in Step 4. Set the drying stability to 170℃ and the high-pressure pump pressure to 16-20 MPa. Collect the spray-dried powder and seal it in aluminum foil bags to obtain Sample 1.

[0027] Example 2: Tartrate soluble powder prepared by conventional methods

[0028] Take 20g of tylosin tartrate (calculated as a dry product) and add anhydrous glucose to 100g. Crush and mix evenly, then pack in an aluminum foil bag to obtain sample 2.

[0029] Example 3: Tartrate soluble powder prepared by adding common acidifier

[0030] Take 20g of tylosin tartrate (calculated on a dry basis) and 10g of tartaric acid, add anhydrous glucose to 100g, grind and mix evenly, and then put it in an aluminum foil bag to obtain sample 3.

[0031] Example 4: Tartrate soluble powder prepared by adding common acidifier and disodium EDTA.

[0032] Take 20g of tylosin tartrate (calculated as a dry product), 10g of tartaric acid, 10g of EDTA-2NA, and add anhydrous glucose to 100g. Crush and mix evenly, then put it in an aluminum foil bag to obtain sample 4.

[0033] Example 5:

[0034] Take 20g of each and add 100ml of water. Stir for 1 minute and observe the water solubility.

[0035]

[0036]

[0037] Experiments show that the water solubility of tartrate tartrate soluble powder prepared by this method is better than that prepared by the ordinary method. In terms of stability, the aqueous solution is more stable when aspartic acid is used as an acidifying agent. The use of disodium ethylenediaminetetraacetate can completely eliminate the flocculent phenomenon in the aqueous solution. The formulation without disodium ethylenediaminetetraacetate needs to be left for a long time to eliminate the flocculent phenomenon.

[0038] Example 6:

[0039] Take 20g of tylosin tartrate raw material and 5g of dextrin, mix them evenly and set aside. This will serve as sample 1.

[0040] Take 20g of tylosin tartrate raw material for later use as sample 2.

[0041] Slowly add each of the above two items to 100ml of water while stirring until insoluble matter appears, and record the amount added.

[0042]

[0043]

[0044] Experiments show that the solubility and water solubility of tartrate tivacin with added dextrin are superior to those of ordinary tivacin.

Claims

1. A method for preparing tartrate soluble powder, wherein the tartrate soluble powder comprises: Tylenol tartrate, dextrin, disodium EDTA, acidifier, gum arabic; The acidifying agent is aspartic acid; The ratio of tartrate tylosin to xanthodextrin is 1:0.25; The ratio of tartrate tylosin to acidifying agent is 1:0.5; The ratio of tartrate tylosin to gum arabic is 1:0.

5.

2. The method for preparing tartrate soluble powder according to claim 1, characterized in that, The ratio of tartrate tylosin to disodium EDTA is 1:1.

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