Veterinary apramycin sulfate soluble powder and preparation method thereof

Abstract

The invention belongs to the technical field of animal medicines, and provides veterinary apramycin sulfate soluble powder and a preparation method thereof, and the veterinary apramycin sulfate soluble powder comprises the following components in parts by weight: 25-35 parts of apramycin sulfate, 10-15 parts of baicalin, 8-12 parts of a suspending aid, 10-15 parts of a solubilizer and 4-6 parts of a stabilizer. According to the veterinary apramycin sulfate soluble powder, the treatment effect on piglet colibacillosis is remarkably better than that of apramycin sulfate and baicalin, and apramycin sulfate and baicalin play a remarkable synergistic effect in the aspect of treating the piglet colibacillosis. The veterinary apramycin sulfate soluble powder disclosed by the invention has a better treatment effect, and provides a better choice and a better treatment effect for livestock.

Description

Technical Field

[0001] This invention belongs to the field of animal medicine technology and relates to a soluble powder of veterinary ampicillin sulfate and its preparation method. Background Technology

[0002] Apramycin is an aminoglycoside antibiotic developed by Eli Lilly and Company in the 1960s. As a widely used veterinary antibacterial drug abroad, it is characterized by its broad spectrum, high efficacy, and low likelihood of inducing drug resistance. Because it effectively inhibits bacterial protein synthesis, it has a strong inhibitory effect on a variety of Gram-positive and Gram-negative bacteria, and is particularly sensitive to Escherichia coli and Salmonella. It is often used to treat various bacterial intestinal diseases in poultry and livestock, such as piglet diarrhea, fowl scours, and avian colibacillosis.

[0003] Scutellaria baicalensis, a traditional Chinese medicine, is the dried root of the plant Scutellaria baicalensis, belonging to the Lamiaceae family. Its main functions include clearing heat and dampness, purging fire and detoxifying. Baicalin is the main component of Scutellaria baicalensis, a flavonoid compound extracted and isolated from its root. Recent studies have found that it has strong biological activity, possessing anti-inflammatory, antibacterial, antiviral, anticancer, and antioxidant functions. Baicalin is insoluble in water but readily soluble in some organic solvents and alkaline solutions; however, it is unstable in alkaline solutions and its color tends to darken. Currently, baicalin on the market is mainly for human use, primarily in tablet and capsule forms. Veterinary formulations are mostly compound preparations of Scutellaria baicalensis, and there is a lack of baicalin formulations specifically for livestock and poultry.

[0004] Soluble powders have a simple manufacturing process, dissolve quickly in water, and the active ingredients are uniformly dispersed in water in a molecular state, which can better exert the drug's efficacy. Summary of the Invention

[0005] Therefore, the purpose of this invention is to provide a veterinary apramycin sulfate soluble powder and its preparation method. In the veterinary apramycin sulfate soluble powder finally prepared by this invention, apramycin sulfate and baicalin exert a significant synergistic effect.

[0006] The object of this invention is achieved in the following manner: A soluble powder of aspirin sulfate for veterinary use comprises the following components in parts by weight: 25-35 parts of aspirin sulfate, 10-15 parts of baicalin, 8-12 parts of suspending agent, 10-15 parts of solubilizer, and 4-6 parts of stabilizer. The method for preparing the veterinary apramycin sulfate soluble powder is as follows: weigh apramycin sulfate, baicalin, suspending agent, solubilizer and stabilizer according to the specified weight parts, mix them, pulverize or grind them into a fine powder, and pass them through a No. 5 sieve to obtain veterinary apramycin sulfate soluble powder.

[0007] Furthermore, the suspending agent is one or more of aluminum stearate, sodium carboxymethyl cellulose, and hydrogenated castor oil.

[0008] Furthermore, the solubilizer is one or more of Tween 40, polyoxyethylene castor oil, and poloxamer.

[0009] Furthermore, the stabilizer is one or more of sodium salicylate, tert-butylhydroxyanisole, xylitol, and propyl gallate.

[0010] In one embodiment of the present invention, the veterinary apramycin sulfate soluble powder comprises the following components in parts by weight: 30 parts apramycin sulfate, 12 parts baicalin, 10 parts suspending agent, 12 parts solubilizer, and 5 parts stabilizer; wherein the suspending agent is sodium carboxymethyl cellulose, the solubilizer is polyoxyethylene castor oil, and the stabilizer is propyl gallate.

[0011] In one embodiment of the present invention, the veterinary apramycin sulfate soluble powder comprises the following components in parts by weight: 25 parts apramycin sulfate, 15 parts baicalin, 12 parts suspending agent, 10 parts solubilizer, and 4 parts stabilizer; wherein the suspending agent is aluminum stearate, the solubilizer is Tween 40, and the stabilizer is propyl gallate.

[0012] In one embodiment of the present invention, the veterinary apramycin sulfate soluble powder comprises the following components in parts by weight: 30 parts apramycin sulfate, 10 parts baicalin, 8 parts suspending agent, 15 parts solubilizer, and 6 parts stabilizer; wherein the suspending agent is sodium carboxymethyl cellulose, the solubilizer is poloxamer, and the stabilizer is xylitol.

[0013] In one embodiment of the present invention, the veterinary apramycin sulfate soluble powder comprises the following components in parts by weight: 35 parts apramycin sulfate, 15 parts baicalin, 10 parts suspending agent, 15 parts solubilizer, and 5 parts stabilizer; wherein the suspending agent is hydrogenated castor oil, the solubilizer is polyoxyethylene castor oil, and the stabilizer is sodium salicylate.

[0014] The present invention also provides the application of the aforementioned veterinary ampicillin sulfate soluble powder in the preparation of drugs for treating porcine colibacillosis.

[0015] Compared with the prior art, the present invention has the following beneficial effects: Animal experiments have shown that the veterinary ampicillin sulfate soluble powder of the present invention has a significantly better therapeutic effect on swine colibacillosis than ampicillin sulfate soluble powder, and is significantly better than baicalin soluble powder.

[0016] Animal experiments have shown that the veterinary ampramycin sulfate soluble powder of the present invention has a significantly better therapeutic effect on swine colibacillosis than ampramycin sulfate berberine soluble powder.

[0017] The veterinary ampicillin sulfate soluble powder of this invention has a significantly better therapeutic effect on swine colibacillosis than ampicillin sulfate and baicalin. Ampicillin sulfate and baicalin have a significant synergistic effect in the treatment of swine colibacillosis.

[0018] The veterinary ampicillin sulfate soluble powder of this invention has better therapeutic effects, providing a better choice and treatment effect for poultry and livestock. Attached Figure Description

[0019] Figure 1 For comparison of the efficacy of each group. Detailed Implementation

[0020] The following detailed description of specific embodiments further illustrates the content of the present invention, but it should not be construed as limiting the scope of the above-mentioned subject matter of the present invention to the following embodiments. The following embodiments are used to illustrate the technical solutions of the present invention and not to limit the scope of protection of the present invention. Modifications or equivalent substitutions made by those skilled in the art to the technical solutions of the present invention without departing from the essence and scope of the technical solutions of the present invention shall still fall within the scope of protection of the present invention.

[0021] Example 1 A soluble powder of veterinary ampicillin sulfate and its preparation method are as follows: The mixture contains 30 parts of apramycin sulfate, 12 parts of baicalin, 10 parts of suspending agent, 12 parts of solubilizer, and 5 parts of stabilizer; the suspending agent is sodium carboxymethyl cellulose, the solubilizer is polyoxyethylene castor oil, and the stabilizer is propyl gallate.

[0022] The preparation method includes the following steps: weigh apramycin sulfate, baicalin, suspending agent, solubilizer and stabilizer according to the stated weight parts, mix them, crush or grind them into a fine powder, pass them through a No. 5 sieve to obtain soluble powder of apramycin sulfate for veterinary use.

[0023] Example 2 A soluble powder of veterinary ampicillin sulfate and its preparation method are as follows: The mixture contains 25 parts of apramycin sulfate, 15 parts of baicalin, 12 parts of suspending agent, 10 parts of solubilizer, and 4 parts of stabilizer; the suspending agent is aluminum stearate, the solubilizer is Tween 40, and the stabilizer is propyl gallate.

[0024] The preparation method includes the following steps: weigh apramycin sulfate, baicalin, suspending agent, solubilizer and stabilizer according to the stated weight parts, mix them, crush or grind them into a fine powder, pass them through a No. 5 sieve to obtain soluble powder of apramycin sulfate for veterinary use.

[0025] Example 3 A soluble powder of veterinary ampicillin sulfate and its preparation method are as follows: The mixture contains 30 parts of apramycin sulfate, 10 parts of baicalin, 8 parts of suspending agent, 15 parts of solubilizer, and 6 parts of stabilizer; the suspending agent is sodium carboxymethyl cellulose, the solubilizer is poloxamer, and the stabilizer is xylitol.

[0026] The preparation method includes the following steps: weigh apramycin sulfate, baicalin, suspending agent, solubilizer and stabilizer according to the stated weight parts, mix them, crush or grind them into a fine powder, pass them through a No. 5 sieve to obtain soluble powder of apramycin sulfate for veterinary use.

[0027] Example 4 A soluble powder of veterinary ampicillin sulfate and its preparation method are as follows: The mixture contains 35 parts of apramycin sulfate, 15 parts of baicalin, 10 parts of suspending agent, 15 parts of solubilizer, and 5 parts of stabilizer; the suspending agent is hydrogenated castor oil, the solubilizer is polyoxyethylene castor oil, and the stabilizer is sodium salicylate.

[0028] The preparation method includes the following steps: weigh apramycin sulfate, baicalin, suspending agent, solubilizer and stabilizer according to the stated weight parts, mix them, crush or grind them into a fine powder, pass them through a No. 5 sieve to obtain soluble powder of apramycin sulfate for veterinary use.

[0029] Example 5 A soluble powder of veterinary ampicillin sulfate and its preparation method are as follows: The mixture contains 30 parts of apramycin sulfate, 10 parts of baicalin, 8 parts of suspending agent, 12 parts of solubilizer, and 6 parts of stabilizer; the suspending agent is sodium carboxymethyl cellulose, the solubilizer is Tween 40, and the stabilizer is propyl gallate.

[0030] The preparation method includes the following steps: weigh apramycin sulfate, baicalin, suspending agent, solubilizer and stabilizer according to the stated weight parts, mix them, crush or grind them into a fine powder, pass them through a No. 5 sieve to obtain soluble powder of apramycin sulfate for veterinary use.

[0031] Example 6 A soluble powder of veterinary ampicillin sulfate and its preparation method are as follows: The mixture contains 25 parts of apramycin sulfate, 12 parts of baicalin, 12 parts of suspending agent, 10 parts of solubilizer, and 4 parts of stabilizer; the suspending agent is hydrogenated castor oil, the solubilizer is poloxamer, and the stabilizer is tert-butylhydroxyanisole.

[0032] The preparation method includes the following steps: weigh apramycin sulfate, baicalin, suspending agent, solubilizer and stabilizer according to the stated weight parts, mix them, crush or grind them into a fine powder, pass them through a No. 5 sieve to obtain soluble powder of apramycin sulfate for veterinary use.

[0033] Example 7 A soluble powder of veterinary ampicillin sulfate and its preparation method are as follows: The mixture contains 35 parts of apramycin sulfate, 10 parts of baicalin, 10 parts of suspending agent, 12 parts of solubilizer, and 5 parts of stabilizer; the suspending agent is sodium carboxymethyl cellulose, the solubilizer is polyoxyethylene castor oil, and the stabilizer is tert-butylhydroxyanisole.

[0034] The preparation method includes the following steps: weigh apramycin sulfate, baicalin, suspending agent, solubilizer and stabilizer according to the stated weight parts, mix them, crush or grind them into a fine powder, pass them through a No. 5 sieve to obtain soluble powder of apramycin sulfate for veterinary use.

[0035] Comparative Example 1 A soluble powder of apramycin sulfate is composed of the following raw materials in parts by weight: 42 parts of apramycin sulfate, 10 parts of suspending agent, 12 parts of solubilizer and 5 parts of stabilizer; wherein the suspending agent is sodium carboxymethyl cellulose, the solubilizer is polyoxyethylene castor oil and the stabilizer is propyl gallate.

[0036] The preparation method is the same as in Example 1.

[0037] Comparative Example 2 A soluble powder of baicalin comprises the following raw materials: 42 parts of baicalin, 10 parts of suspending agent, 12 parts of solubilizer and 5 parts of stabilizer; wherein the suspending agent is sodium carboxymethyl cellulose, the solubilizer is polyoxyethylene castor oil and the stabilizer is propyl gallate.

[0038] The preparation method is the same as in Example 1.

[0039] Comparative Example 3 A soluble powder of apramycin sulfate and berberine comprises the following raw materials: 30 parts apramycin sulfate, 12 parts berberine, 10 parts suspending agent, 12 parts solubilizer, and 5 parts stabilizer; wherein the suspending agent is sodium carboxymethyl cellulose, the solubilizer is polyoxyethylene castor oil, and the stabilizer is propyl gallate.

[0040] The preparation method is the same as in Example 1.

[0041] Example 1: Efficacy study of veterinary ampicillin sulfate soluble powder against Escherichia coli infection in piglets. 180 piglets were selected and randomly divided into 6 groups: drug administration group 1, drug administration group 2, drug administration group 3, drug administration group 4, challenge control group, and blank control group, with 30 piglets in each group. The feeding methods and environments of each group were the same.

[0042] Groups 1, 2, 3, and 4 were administered medication, with each piglet receiving 2.0 × 10⁻⁶ ppm via gavage. 8 One mL of *E. coli* bacterial suspension was used for challenge. The challenge control group underwent challenge. The blank control group did not undergo challenge.

[0043] About 20 hours after infection with E. coli, piglets in each challenge group began to show symptoms. The affected piglets had poor appetite, were lethargic, and excreted yellow or grayish-white watery feces, with severe diarrhea.

[0044] Administer the medication according to the prescribed dosage and administration method for each experimental group and control group. All piglets were given the medication continuously for 3 days (one course of treatment), and were observed for another 3 days after the medication was stopped.

[0045] Group 1: The soluble powder of apramycin sulfate prepared in Comparative Example 1 was dissolved in 5 mL of drinking water at a dosage of 200 mg / mL and administered orally twice daily.

[0046] Group 2: The baicalin soluble powder prepared in Comparative Example 2 was dissolved in 5 mL of drinking water at a dosage of 200 mg / mL and administered orally twice daily.

[0047] Group 3: The soluble powder of amprolium berberine sulfate prepared in Comparative Example 3 was dissolved in 5 mL of drinking water at a dosage of 200 mg / mL and administered orally twice daily.

[0048] Four groups were administered the following medications: the veterinary ampicillin sulfate soluble powder prepared in Example 1 was dissolved in 5 mL of drinking water at a dosage of 200 mg / mL and administered orally twice daily.

[0049] The challenge control group was given 5 mL of drinking water orally. The blank control group was given 5 mL of drinking water orally.

[0050] During the administration period, clinical symptoms of each group were observed and recorded daily. The cause of death was determined through clinical symptoms, pathological autopsy changes, and bacterial culture identification.

[0051] Criteria for judging therapeutic efficacy Recovery: Symptoms disappear after treatment, and body temperature, appetite, movement, bowel movements, and mental activity return to normal.

[0052] Effective: Symptoms are significantly reduced after treatment, and bowel movements, mental state, and appetite all improve. However, if symptoms do not completely disappear within one course of treatment, continued treatment may lead to further improvement, recovery, or the use of other medications to assist in the cure.

[0053] Ineffective: If there is no significant change in symptoms after one course of treatment, or if typical E. coli diarrhea symptoms appear, or if symptoms worsen or even lead to death, the treatment can be considered ineffective or result in death.

[0054] Cure rate = (cured) / (cured + effective + ineffective) × 100%.

[0055] Effectiveness rate = (cured + effective) / (cured + effective + ineffective) × 100%.

[0056] Results Analysis The experimental results are shown in Table 1. Figure 1 After medication, the piglets in groups 1, 2, and 3 showed improved mental condition, reduced mortality, decreased frequency of diarrhea, and their fecal color gradually returned to normal. Most piglets increased their appetite, and after the medication was administered, the piglets basically returned to normal.

[0057] Five piglets died in the virus-challenged control group. No piglets died in the blank control group.

[0058] After administration of drugs to groups 1, 2, 3 and 4, the condition of piglets in each group improved significantly. The effective rates of groups 1, 2, 3 and 4 were 86.67%, 83.33%, 90.00% and 96.67%, respectively.

[0059] The cure rates for treatment group 1, treatment group 2, treatment group 3, and treatment group 4 were 40.00%, 50.00%, 56.67%, and 70.00%, respectively.

[0060] Among them, group 4 showed the most significant improvement. In group 4, one piglet died, 21 piglets were completely cured, and 8 piglets showed effective cure. The effective rate of veterinary ampicillin sulfate soluble powder in group 4 for treating E. coli infection in piglets reached 96.67%. The cure rate of group 4 was better than that of groups 1, 2, and 3.

[0061] After oral administration of the veterinary ampicillin sulfate soluble powder prepared in Example 1, the treatment effect on swine colibacillosis in the four groups was significantly better than that in the four groups (Group 1, Group 2, and Group 3).

[0062] It is evident that apramycin sulfate and baicalin have a significant synergistic effect in the treatment of Escherichia coli infection in piglets.

[0063] Table 1 Comparison of therapeutic effects among groups This invention relates to a soluble powder of veterinary ampicillin sulfate, which has a good therapeutic effect on Escherichia coli infection in piglets and can be used to treat Escherichia coli infection in piglets.

[0064] The above embodiments are not intended to limit the present invention in any way. For those skilled in the art, any modifications or substitutions made within the scope of the present invention based on its technical essence shall still fall within the protection scope of the present invention.

Claims

1. A soluble powder of aspirin sulfate for veterinary use, characterized in that, The veterinary apramycin sulfate soluble powder comprises the following components in parts by weight: 25-35 parts apramycin sulfate, 10-15 parts baicalin, 8-12 parts suspending agent, 10-15 parts solubilizer, and 4-6 parts stabilizer. The preparation method of the veterinary apramycin sulfate soluble powder is as follows: weigh apramycin sulfate, baicalin, suspending agent, solubilizer and stabilizer according to the specified weight parts, mix them, crush or grind them into fine powder, and pass them through a No. 5 sieve to obtain veterinary apramycin sulfate soluble powder.

2. The veterinary ampicillin sulfate soluble powder according to claim 1, characterized in that, The suspending agent is one or more of aluminum stearate, sodium carboxymethyl cellulose, and hydrogenated castor oil.

3. The veterinary ampicillin sulfate soluble powder according to claim 1, characterized in that, The solubilizer is one or more of Tween 40, polyoxyethylene castor oil, and poloxamer.

4. The veterinary ampicillin sulfate soluble powder according to claim 1, characterized in that, The stabilizer is one or more of sodium salicylate, tert-butylhydroxyanisole, xylitol, and propyl gallate.

5. The veterinary ampicillin sulfate soluble powder according to claim 1, characterized in that, The veterinary apramycin sulfate soluble powder comprises the following components in parts by weight: 30 parts apramycin sulfate, 12 parts baicalin, 10 parts suspending agent, 12 parts solubilizer, and 5 parts stabilizer; wherein the suspending agent is sodium carboxymethyl cellulose, the solubilizer is polyoxyethylene castor oil, and the stabilizer is propyl gallate.

6. The veterinary ampicillin sulfate soluble powder according to claim 1, characterized in that, The veterinary apramycin sulfate soluble powder comprises the following components in parts by weight: 25 parts apramycin sulfate, 15 parts baicalin, 12 parts suspending agent, 10 parts solubilizer, and 4 parts stabilizer; the suspending agent is aluminum stearate, the solubilizer is Tween 40, and the stabilizer is propyl gallate.

7. The veterinary ampicillin sulfate soluble powder according to claim 1, characterized in that, The veterinary apramycin sulfate soluble powder comprises the following components in parts by weight: 30 parts apramycin sulfate, 10 parts baicalin, 8 parts suspending agent, 15 parts solubilizer, and 6 parts stabilizer; wherein the suspending agent is sodium carboxymethyl cellulose, the solubilizer is poloxamer, and the stabilizer is xylitol.

8. The veterinary ampicillin sulfate soluble powder according to claim 1, characterized in that, The veterinary apramycin sulfate soluble powder comprises the following components in parts by weight: 35 parts apramycin sulfate, 15 parts baicalin, 10 parts suspending agent, 15 parts solubilizer, and 5 parts stabilizer; the suspending agent is hydrogenated castor oil, the solubilizer is polyoxyethylene castor oil, and the stabilizer is sodium salicylate.

9. The veterinary ampicillin sulfate soluble powder according to claim 1, characterized in that, The application of the veterinary ampicillin sulfate soluble powder in the preparation of drugs for treating porcine colibacillosis.

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