Veterinary compound amoxicillin soluble powder and preparation process thereof

Abstract

The invention belongs to the technical field of animal medicine, and particularly relates to veterinary compound amoxicillin soluble powder and a preparation process thereof.The veterinary compound amoxicillin soluble powder contains amoxicillin, potassium clavulanate, sargentgloryvine stem polysaccharide and other components, and through component optimization, it is found that the final soluble powder has the advantages that the content of amoxicillin, potassium clavulanate, sargentgloryvine stem polysaccharide and other components is increased through an acceleration test; the solubility of the product and the content of related substances meet the requirements of Chinese veterinary drug pharmacopoeia. Pharmacodynamic experiments show that the product provided by the invention is definite in curative effect, can significantly improve the economic benefits of chicken farms, and is suitable for further expanded production.

Description

Technical Field

[0001] The invention belongs to the technical field of animal medicine, and in particular relates to a veterinary compound amoxicillin soluble powder and a preparation process thereof. Background Art

[0002] Amoxicillin is a broad-spectrum antibiotic widely used in veterinary medicine. It belongs to the β-lactam antibiotic class and has the ability to kill both Gram-negative and Gram-positive bacteria. Amoxicillin is an organic compound with the chemical formula C 16 H 19 N3O5S is an antibiotic drug, also known as amoxicillin, belonging to the aminopenicillin class of the penicillin family. It is a white or off-white crystalline powder with a slightly specific odor and bitter taste. It is the main variety of the second-generation penicillin. It is a broad-spectrum semi-synthetic antibiotic that can inhibit the synthesis of bacterial cell walls. It has a highly effective broad-spectrum antibacterial effect and very little toxic side effects. It is often used to treat bacterial infections such as middle ear infections, streptococcal pharyngitis, pneumonia, skin infections and urinary tract infections. The World Health Organization recommends this product as the preferred β-lactam oral antibiotic, and it occupies an important position in oral antibiotics.

[0003] Amoxicillin preparations include capsules, tablets, granules, dispersible tablets, etc., but soluble powder is the main form of veterinary medicine, which is convenient for transportation and liquid preparation. The maximum solubility of standard amoxicillin is very limited (2g / l), and it is easy to react with ions (Ca2+) in water during use. 2+ Mg 2+ In addition, due to the β-lactam ring in the molecular structure of amoxicillin, its chemical properties are extremely unstable and it is easily degraded under acidic or alkaline conditions to form inactive molecules. However, the solubility and chemical stability of amoxicillin in water are contradictory: the solubility of amoxicillin increases in alkaline environments, but its stability is poor. In addition, amoxicillin is prone to discoloration when exposed to heat or stored for a long time, resulting in a decrease in the effective ingredients and thus a decrease in efficacy.

[0004] The Chinese patent with publication number CN104188914A discloses a compound amoxicillin powder and its production process. The weight percentage composition of the compound amoxicillin powder is: 15-18% amoxicillin-clavulanate potassium 4:1 mixed powder, 30-40% mannitol, 0.5-1% micro-powder silica gel, and the remainder anhydrous glucose. The production process is: control the production environment temperature below 25°C and the relative humidity below 20%, and perform the following operations: (1) crush mannitol, micro-powder silica gel and anhydrous glucose respectively, pass through an 80-mesh sieve, mix in a dry mixer at 80±5°C for 1-2h, and naturally cool to room temperature; (2) add the 4:1 mixed powder of amoxicillin-clavulanate potassium to the dry mixer and continue mixing for 20-30min; (3) vacuum pack in an aluminum foil bag, and then pack in a plastic-aluminum composite bag. However, it can be observed in the accelerated test that the content of amoxicillin therein shows a gradual downward trend, indicating that the active ingredient has decomposed under high temperature and high humidity conditions. Summary of the invention

[0005] In view of the deficiencies in the prior art, the present invention provides a veterinary compound amoxicillin soluble powder with high stability and strong efficacy. By optimizing the prescription and controlling the preparation process, the defects of amoxicillin being easy to decompose and difficult to dissolve are overcome, the solubility of amoxicillin is improved, the pH value of the final product is stable, and the effect of the compound amoxicillin soluble powder is definite.

[0006] Specifically, the technical solution of the present invention is achieved as follows: The first object of the present invention is to provide a veterinary compound amoxicillin soluble powder. Calculated by weight, the veterinary compound amoxicillin soluble powder is composed of: 11.5 parts of amoxicillin, 2.5 parts of potassium clavulanate, 1.5-4.5 parts of red vine polysaccharide, 0.5-2.5 parts of stabilizer, and 1.0-4.5 parts of promoter, wherein the promoter is L-theanine, sodium deoxycholate, and ethylenediaminetetraacetic acid, and the weight ratio is 5:3:2 respectively, and the stabilizer is glyceryl monostearate and cholesterol, and the weight ratio is 5:1.

[0007] Furthermore, calculated by weight ratio, the composition of the veterinary compound amoxicillin soluble powder is: 11.5 parts of amoxicillin, 2.5 parts of potassium clavulanate, 2.5 parts of red vine polysaccharide, 1.5 parts of stabilizer, and 2.3 parts of promoter, wherein the promoter is L-theanine, sodium deoxycholate, and ethylenediaminetetraacetic acid, and the weight ratio is 5:3:2 respectively, and the stabilizer is glyceryl monostearate and cholesterol, and the weight ratio is 5:1.

[0008] Furthermore, calculated by weight ratio, the composition of the veterinary compound amoxicillin soluble powder is: 11.5 parts of amoxicillin, 2.5 parts of potassium clavulanate, 4.5 parts of red vine polysaccharide, 2.5 parts of stabilizer, and 4.5 parts of promoter, wherein the promoter is L-theanine, sodium deoxycholate, and ethylenediaminetetraacetic acid, and the weight ratio is 5:3:2 respectively, and the stabilizer is glyceryl monostearate and cholesterol, and the weight ratio is 5:1.

[0009] Furthermore, the veterinary compound amoxicillin soluble powder is calculated by weight as follows: 11.5 parts of amoxicillin, 2.5 parts of potassium clavulanate, 1.5 parts of red vine polysaccharide, 0.5 parts of stabilizer, and 1.0 parts of promoter, wherein the promoter is L-theanine, sodium deoxycholate, and ethylenediaminetetraacetic acid, and the weight ratio is 5:3:2 respectively, and the stabilizer is glyceryl monostearate and cholesterol, and the weight ratio is 5:1.

[0010] The second object of the present invention is to provide a method for preparing compound amoxicillin soluble powder, which specifically comprises the following steps: 1) Place potassium clavulanate and stabilizer in a three-dimensional motion mixer and mix; 2) Mix amoxicillin and Sargentodoxan polysaccharide evenly, add an accelerator, and mix in a three-dimensional motion mixer to obtain a mixture A; 3) adding mixture A to step 1) to obtain mixture B; 4) Transferring the mixture B to a vacuum drying oven; 5) After testing, package according to dosage and seal to obtain compound amoxicillin soluble powder.

[0011] The above method is further optimized, and the method comprises the following steps: 1) Place potassium clavulanate, glyceryl monostearate and cholesterol in a three-dimensional motion mixer and mix for 30-40 minutes; 2) Mix amoxicillin and red safflower polysaccharide evenly, add L-theanine, sodium deoxycholate and ethylenediaminetetraacetic acid, and mix in a three-dimensional motion mixer for 10-20 minutes to obtain mixture A; 3) Adding mixture A in step 1) into the three-dimensional motion mixer twice, with each addition amount being 50% of mixture A, and mixing for 15-30 minutes after each addition to finally obtain mixture B; 4) Transfer mixture B to a vacuum drying oven, dry it at 85-95°C and 0.09 MPa until the moisture content is 0.2%-0.5%, and grind it through an 80-mesh sieve; 5) After testing, package according to dosage and seal to obtain compound amoxicillin soluble powder.

[0012] The third object of the present invention is to provide the use of the above-mentioned veterinary compound amoxicillin soluble powder in the preparation of antibiotic drugs.

[0013] Compared with the prior art, the present invention has the following beneficial effects: The advantage of the present invention is that red vine polysaccharide is added to the prescription of amoxicillin tablets, and the combined use thereof improves the efficacy and stability of amoxicillin soluble powder, and improves the ability to prevent Escherichia coli in chicken farms. Animal experiments have confirmed that the survival rate of chicks in amoxicillin soluble powder with added red vine polysaccharide is significantly improved.

[0014] The stabilizer and the accelerator are preferably selected in the prescription of the veterinary compound amoxicillin soluble powder of the present invention, which not only makes the effective ingredients dissolve quickly and guarantees the efficacy to the greatest extent, but also finds through accelerated tests that the pH value and solubility are relatively stable, thereby further ensuring the quality of the product and avoiding the burden on the chicken farm caused by the increase of harmful substances or the loss of efficacy due to long-term storage. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1 : Comparison chart of the dissolution time of Examples 1-3 and Comparative Examples 1-9 in 0-6 months.

[0016] Figure 2 : A comparison chart of pH values ​​of Examples 1-3 and Comparative Examples 1-9 at 0-6 months; a: a comparison chart of pH values ​​of Examples 1-3 and Comparative Examples 1-9 at month 0; b: Comparison of pH values ​​of Examples 1-3 and Comparative Examples 1-9 at the second month; c: Comparison of pH values ​​of Examples 1-3 and Comparative Examples 1-9 at the third month; d: Comparison of pH values ​​of Examples 1-3 and Comparative Examples 1-9 at the 6th month.

[0017] Figure 3 : Comparison of body weights of the positive control group, negative control group, Example 1 and Comparative Examples 1-3.

[0018] Figure 4 : Comparison of survival curves of the positive control group, negative control group, Example 1 and Comparative Examples 1-3 after infection with Escherichia coli. DETAILED DESCRIPTION

[0019] In order to make the purpose and technical solution of the present invention clearer, the present invention is further described below in conjunction with embodiments, but the protection scope of the present invention is not limited to these embodiments, and the embodiments are only used to explain the present invention. It should be understood by those skilled in the art that any changes or equivalent substitutions that do not deviate from the concept of the present invention are included in the protection scope of the present invention.

[0020] Embodiment: Compound amoxicillin soluble powder and its preparation process are as follows: The dosage of accelerator and stabilizer is as follows: The specific preparation process is: 1) Place potassium clavulanate, glyceryl monostearate and cholesterol in a three-dimensional motion mixer and mix for 30-40 minutes; 2) Mix amoxicillin and red safflower polysaccharide evenly, add L-theanine, sodium deoxycholate and ethylenediaminetetraacetic acid, and mix in a three-dimensional motion mixer for 10-20 minutes to obtain mixture A; 3) Adding the mixture A in step 1) into the three-dimensional motion mixer twice, with each addition amount being 50% of the mixture A, and mixing for 15-30 minutes after each addition to obtain a mixture B; 4) Transfer mixture B to a vacuum drying oven, dry it at 85-95°C and 0.09 MPa until the moisture content is 0.2%-0.5%, and grind it through an 80-mesh sieve; 5) After testing, package according to dosage and seal to obtain compound amoxicillin soluble powder.

[0021] Comparative Example 1: A compound amoxicillin soluble powder and its preparation process It does not contain red croton polysaccharide, and the other ingredients and dosages are the same as those in Example 1. The specific preparation process is as follows: 1) Place potassium clavulanate, glyceryl monostearate and cholesterol in a three-dimensional motion mixer and mix for 30-40 minutes; 2) mixing amoxicillin, L-theanine, sodium deoxycholate and ethylenediaminetetraacetic acid in a three-dimensional motion mixer for 10-20 minutes to obtain a mixture A; 3) Adding the mixture A in step 1) into the three-dimensional motion mixer twice, with each addition amount being 50% of the mixture A, and mixing for 15-30 minutes after each addition to obtain a mixture B; 4) Transfer mixture B to a vacuum drying oven, dry it at 85-95°C and 0.09 MPa until the moisture content is 0.2%-0.5%, and grind it through an 80-mesh sieve; 5) After testing, package according to dosage and seal to obtain compound amoxicillin soluble powder.

[0022] Comparative Example 2: A compound amoxicillin soluble powder and its preparation process Lactose replaces Sargentodoxan polysaccharide and is mixed with amoxicillin. Other ingredients and dosages are the same as those in Example 1. The specific preparation process is as follows: 1) Place potassium clavulanate, glyceryl monostearate and cholesterol in a three-dimensional motion mixer and mix for 30-40 minutes; 2) Mix amoxicillin and lactose evenly, add L-theanine, sodium deoxycholate and ethylenediaminetetraacetic acid, and mix in a three-dimensional motion mixer for 10-20 minutes to obtain mixture A; 3) Adding the mixture A in step 1) into the three-dimensional motion mixer twice, with each addition amount being 50% of the mixture A, and mixing for 15-30 minutes after each addition to obtain a mixture B; 4) Transfer mixture B to a vacuum drying oven, dry it at 85-95°C and 0.09 MPa until the moisture content is 0.2%-0.5%, and grind it through an 80-mesh sieve; 5) After testing, package according to dosage and seal to obtain compound amoxicillin soluble powder.

[0023] Comparative Example 3: A compound amoxicillin soluble powder and its preparation process Astragalus polysaccharide replaces Sargentodoxan polysaccharide and is mixed with amoxicillin. Other ingredients and dosages are the same as those in Example 1. The specific preparation process is as follows: 1) Place potassium clavulanate, glyceryl monostearate and cholesterol in a three-dimensional motion mixer and mix for 30-40 minutes; 2) Mix amoxicillin and astragalus polysaccharide evenly, add L-theanine, sodium deoxycholate and ethylenediaminetetraacetic acid, and mix in a three-dimensional motion mixer for 10-20 minutes to obtain mixture A; 3) Adding the mixture A in step 1) into the three-dimensional motion mixer twice, with each addition amount being 50% of the mixture A, and mixing for 15-30 minutes after each addition to obtain a mixture B; 4) Transfer mixture B to a vacuum drying oven, dry it at 85-95°C and 0.09 MPa until the moisture content is 0.2%-0.5%, and grind it through an 80-mesh sieve; 5) After testing, package according to dosage and seal to obtain compound amoxicillin soluble powder.

[0024] Comparative Example 4: A compound amoxicillin soluble powder and its preparation process The ingredients of the accelerator are different from those in the example, and the other ingredients and amounts are the same as those in Example 1. The specific preparation process is as follows: 1) Place potassium clavulanate, glyceryl monostearate and cholesterol in a three-dimensional motion mixer and mix for 30-40 minutes; 2) Mix amoxicillin and clary strychnine polysaccharide evenly, add sodium hexametaphosphate, lysine and sodium acetate (the weight ratio of sodium hexametaphosphate, lysine and sodium acetate is 5:3:2), place in a three-dimensional motion mixer and mix for 10-20 minutes to obtain mixture A; 3) Adding the mixture A in step 1) into the three-dimensional motion mixer twice, with each addition amount being 50% of the mixture A, and mixing for 15-30 minutes after each addition to obtain a mixture B; 4) Transfer mixture B to a vacuum drying oven, dry it at 85-95°C and 0.09 MPa until the moisture content is 0.2%-0.5%, and grind it through an 80-mesh sieve; 5) After testing, package according to dosage and seal to obtain compound amoxicillin soluble powder.

[0025] Comparative Example 5: A compound amoxicillin soluble powder and its preparation process The composition of the stabilizer is different from that in the example, and the other components and amounts are the same as in Example 1. The specific preparation process is as follows: 1) Place potassium clavulanate, hydroxyethylcellulose and hydroxypropyl beta-cyclodextrin (1:4) in a three-dimensional motion mixer and mix for 30-40 minutes; 2) Mix amoxicillin and red safflower polysaccharide evenly, add L-theanine, sodium deoxycholate and ethylenediaminetetraacetic acid, and mix in a three-dimensional motion mixer for 10-20 minutes to obtain mixture A; 3) Adding the mixture A in step 1) into the three-dimensional motion mixer twice, with each addition amount being 50% of the mixture A, and mixing for 15-30 minutes after each addition to obtain a mixture B; 4) Transfer mixture B to a vacuum drying oven, dry it at 85-95°C and 0.09 MPa until the moisture content is 0.2%-0.5%, and grind it through an 80-mesh sieve; 5) After testing, package according to dosage and seal to obtain compound amoxicillin soluble powder.

[0026] Comparative Example 6: A compound amoxicillin soluble powder and its preparation process The dosage of accelerator and stabilizer is as follows: The preparation process is the same as that of Example 1.

[0027] Comparative Example 7: A compound amoxicillin soluble powder and its preparation process The dosage of accelerator and stabilizer is as follows: The preparation process is the same as that of Example 1.

[0028] Comparative Example 8: A compound amoxicillin soluble powder and its preparation process The types and contents of accelerators are as follows: The rest is the same as in Example 1.

[0029] Comparative Example 9: A compound amoxicillin soluble powder and its preparation process The types and contents of stabilizers are as follows: The rest is the same as in Example 1.

[0030] 1. Solubility test Experimental method and condition requirements: Common dosage is based on the amoxicillin soluble powder in the Chinese Veterinary Pharmacopoeia. The dissolution and pH value of the amoxicillin soluble powder of Examples 1-3 and Comparative Examples 1-9 in tap water were mainly investigated.

[0031] Specific method: Weigh the soluble powder of Examples 1-3 and Comparative Examples 1-9, add water to make a solution containing 2 mg (in terms of amoxicillin) per 1 ml, determine the pH value according to the law, and record the dissolution time. Perform the above parallel test 5 times and take the average value.

[0032] Results: The dissolution and pH value of the amoxicillin soluble powder of Examples 1-3 and Comparative Examples 1-9 in tap water were investigated at 0, 2, 3, and 6 months. Acceleration conditions: The accelerated test was conducted at a temperature of 40°C ± 2°C and a relative humidity of 75% RH ± 5% RH to observe the dissolution of the samples and measure the pH value. The experimental results are shown in Figure 1-2 .

[0033] Figure 1 It can be seen that the dissolution time of Examples 1-3, Comparative Examples 1-3, Comparative Examples 6 and 9 is within 50 seconds, and the dissolution time of other comparative examples is about 1 minute, especially 6 months after the accelerated test, the dissolution time has exceeded 1 minute. It can be seen that different promoters, different stabilizers, and the same promoters and stabilizers but in different proportions can significantly affect the dissolution time of amoxicillin. At the same time, it was found in the test that insoluble particles were found in Comparative Examples 4-5 at the 6th month.

[0034] Figure 2 It can be seen that the pH values ​​of Comparative Examples 4-5, Comparative Example 7 and Comparative Example 9 exceeded 5.5 at the 6th month, indicating that the degradation rate was significantly increased, which can be explained that the stability of amoxicillin is significantly reduced without the stabilizer or promoter of the present invention.

[0035] 2. Relevant substances are determined by high performance liquid chromatography in accordance with the Chinese Pharmacopoeia (General Chapter 0512).

[0036] Mobile phase A: 0.05 mol / L phosphate buffer (take 0.05 mol / L potassium dihydrogen phosphate solution and adjust the pH value to 5.0 with 2 mol / L potassium hydroxide solution)-acetonitrile (99:1).

[0037] Mobile phase B: 0.05 mol / L phosphate buffer (pH 5.0)-acetonitrile (80:20).

[0038] Test solution: Take an appropriate amount of the soluble mixed powder of each embodiment of the present invention, accurately weigh it, add mobile phase A to dissolve it and quantitatively dilute it to make a solution containing about 1 ml of amoxicillin (according to C 16 H 19 N3O5S) 2.0 mg solution.

[0039] Reference solution: Take an appropriate amount of amoxicillin reference substance, weigh it accurately, add mobile phase A to dissolve it and quantitatively dilute it to make a solution containing about 1 ml of amoxicillin (according to C 16 H 19 N3O5S) 20μg solution.

[0040] System suitability solution: Take an appropriate amount of amoxicillin system suitability reference substance, dissolve it in mobile phase A and dilute it to make a solution containing approximately 2.0 mg per 1 ml.

[0041] Chromatographic conditions: octadecylsilane bonded silica gel was used as filler; 0.05 mol / L phosphate buffer (take 0.05 mol / L potassium dihydrogen phosphate solution, adjust the pH value to 5.0 with 2 mol / L potassium hydroxide solution)-acetonitrile (99:1) was used as mobile phase A, and 0.05 mol / L phosphate buffer (pH5.0)-acetonitrile (80:20) was used as mobile phase B; firstly, isocratic elution was performed with mobile phase A-mobile phase B (92:8), and after the elution of amoxicillin peak was completed, linear gradient elution was performed immediately according to the table below; the detection wavelength was 254 nm; the injection volume was 20 μl.

[0042] Table 1 Chromatographic conditions Limits: If there are impurity peaks in the chromatogram of the test solution, the peak area shall be calculated by the main component external standard method. The single impurity shall not exceed 1.0%, and the total amount of impurities shall not exceed 3.0%. Peaks less than 0.05 times the main peak area of ​​the reference solution shall be ignored.

[0043] Test results: The contents of related substances under accelerated conditions of the amoxicillin soluble powder of Example 1 and Comparative Examples 4-5 and Comparative Examples 8-9 were investigated at 0, 1, 2, 3 and 6 months, as shown in Table 2.

[0044] Table 2 Test results of relevant substances in relevant examples under accelerated test conditions 3. Drug efficacy experiment (1) Experimental animals: White-feathered broiler chicks aged 25 days old, weighing 1260±30 g, were randomly selected from a chicken farm of a certain enterprise in Weifang and were clinically diagnosed to be infected with Escherichia coli.

[0045] (2) Experimental grouping and administration method: 50 sick chickens infected with E. coli were selected and randomly divided into five groups, each with 10 chickens, namely: Example 1 group and Comparative Example 1-3 groups, positive control group; and 10 healthy chicks were taken as negative control group. There was no significant difference in body weight among the groups ( P>0.05 ); Administration method: Group 1 of Example 1 of the present invention (amoxicillin soluble powder prepared in Example 1), the positive control group (veterinary drug number 162061199) and Comparative Examples 1-3 (amoxicillin soluble powder prepared in Comparative Examples 1-3) were administered 10 mg of compound amoxicillin soluble powder (calculated according to the amoxicillin content) per 1 kg of body weight, once a day; the negative control group was given an equal dose of normal saline by gavage, once a day.

[0046] (3) Evaluation indicators: After the start of treatment, the weight changes of sick chickens and the distribution of dead animals were recorded daily. After 10 days of treatment, the treatment effect was statistically analyzed, including: Ineffective: refers to the situation that after 10 days, there is no obvious change in the symptoms of the diseased chickens, and they still maintain the symptoms before treatment or die.

[0047] Effective: It means that after 10 days, the symptoms of the diseased chickens have changed and are better than before treatment.

[0048] Cure: It means that after 10 days, the symptoms disappear and the sick chickens recover.

[0049] (4) The results showed that, as time went by, the sick chickens in Comparative Examples 1-3 became increasingly ill, ate less, and died on the second day. They died one after another within the next 10 days. Finally, on the 10th day, all the chickens in Comparative Example 1 died, 3 chickens were left in Comparative Example 2, and 5 chickens were left in Comparative Example 3. Among the 10 sick chickens in Example 1 group, the condition improved within 24 hours after the first administration, and the food intake increased. On the 10th day, no chicks were injured or killed. All the chicks in the positive control group died within 48 hours, and all the 10 chickens in the negative control group survived intact. Figure 4The body weights of the chicks in the above five groups were measured at the end of death / 10th day.

[0050] (5) Results analysis The analysis results were analyzed and counted using spss17.0. The specific statistical results are shown in Figure 3 and Figure 4 .

[0051] Figure 3 , Figure 4 It can be seen that there is no significant difference in body weight (g) between Example 1 group and negative control group ( p>0.05 ), the negative control group has significant difference compared with the positive control group, indicating the rationality of this experiment, and the Example 1 group has significant difference with the Comparative Examples 1-3 groups ( p<0.05 The combined use of amoxicillin and scutellaria tatarinowii polysaccharide improves the antibacterial effect of amoxicillin, and has significant differences compared with ingredients without scutellaria tatarinowii polysaccharide or containing other polysaccharides ( P<0.01 ), the inventors believe that the stability of amoxicillin is increased by red vine polysaccharide during storage, or that the antibacterial effect of amoxicillin is better exerted under the synergistic effect of red vine polysaccharide.

Claims

1. A veterinary compound amoxicillin soluble powder, characterized in that: Calculated by weight ratio, the composition of the veterinary compound amoxicillin soluble powder is: 11.5 parts of amoxicillin, 2.5 parts of potassium clavulanate, 1.5-4.5 parts of red vine polysaccharide, 0.5-2.5 parts of stabilizer, 1.0-4.5 parts of promoter, wherein the promoter is L-theanine, sodium deoxycholate, and ethylenediaminetetraacetic acid, and the weight ratio is 5:3:2, respectively, and the stabilizer is glyceryl monostearate and cholesterol, and the weight ratio is 5:1; The preparation process of the veterinary compound amoxicillin soluble powder comprises the following steps: 1) Place potassium clavulanate, glyceryl monostearate and cholesterol in a three-dimensional motion mixer and mix for 30-40 minutes; 2) Mix amoxicillin and red safflower polysaccharide evenly, add L-theanine, sodium deoxycholate and ethylenediaminetetraacetic acid, and mix in a three-dimensional motion mixer for 10-20 minutes to obtain mixture A; 3) Adding the mixture A in step 1) into the three-dimensional motion mixer twice, with the amount added each time being 50% of the mixture A, and mixing for 15-30 minutes after each addition to finally obtain a mixture B; 4) Transfer mixture B to a vacuum drying oven, dry it at 85-95°C and 0.09 MPa until the moisture content is 0.2%-0.5%, and grind it through an 80-mesh sieve; 5) After testing, package according to dosage and seal to obtain veterinary compound amoxicillin soluble powder.

2. The veterinary compound amoxicillin soluble powder according to claim 1, characterized in that: Calculated by weight ratio, the composition of the veterinary compound amoxicillin soluble powder is: 11.5 parts of amoxicillin, 2.5 parts of potassium clavulanate, 2.5 parts of red vine polysaccharide, 1.5 parts of stabilizer, and 2.3 parts of promoter, wherein the promoter is L-theanine, sodium deoxycholate, and ethylenediaminetetraacetic acid, and the weight ratio is 5:3:2 respectively, and the stabilizer is glyceryl monostearate and cholesterol, and the weight ratio is 5:

1.

3. The veterinary compound amoxicillin soluble powder according to claim 1, characterized in that: Calculated by weight ratio, the composition of the veterinary compound amoxicillin soluble powder is: 11.5 parts of amoxicillin, 2.5 parts of potassium clavulanate, 4.5 parts of red vine polysaccharide, 2.5 parts of stabilizer, and 4.5 parts of promoter, wherein the promoter is L-theanine, sodium deoxycholate, and ethylenediaminetetraacetic acid, and the weight ratio is 5:3:2 respectively, and the stabilizer is glyceryl monostearate and cholesterol, and the weight ratio is 5:

1.

4. The veterinary compound amoxicillin soluble powder according to claim 1, characterized in that: Calculated by weight ratio, the composition of the veterinary compound amoxicillin soluble powder is: 11.5 parts of amoxicillin, 2.5 parts of potassium clavulanate, 1.5 parts of red vine polysaccharide, 0.5 parts of stabilizer, and 1.0 parts of promoter, wherein the promoter is L-theanine, sodium deoxycholate, and ethylenediaminetetraacetic acid, and the weight ratio is 5:3:2 respectively, and the stabilizer is glyceryl monostearate and cholesterol, and the weight ratio is 5:

1.

5. A process for preparing the veterinary compound amoxicillin soluble powder according to any one of claims 1 to 4, characterized in that: The preparation process comprises the following steps: 1) Place potassium clavulanate, glyceryl monostearate and cholesterol in a three-dimensional motion mixer and mix for 30-40 minutes; 2) Mix amoxicillin and Sargentodoxane polysaccharide evenly, add L-theanine, sodium deoxycholate and ethylenediaminetetraacetic acid, and mix in a three-dimensional motion mixer for 10-20 minutes to obtain mixture A; 3) Adding the mixture A in step 1) into the three-dimensional motion mixer twice, with the amount added each time being 50% of the mixture A, and mixing for 15-30 minutes after each addition, to finally obtain a mixture B; 4) Transfer mixture B to a vacuum drying oven, dry it at 85-95°C and 0.09 MPa until the moisture content is 0.2%-0.5%, and grind it through an 80-mesh sieve; 5) After testing, package according to dosage and seal to obtain veterinary compound amoxicillin soluble powder.

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