CN111956612A - Oxytetracycline spray and preparation method thereof - Google Patents

Abstract

The invention belongs to the field of veterinary medicine, and provides a terramycin spray and a preparation method thereof. Every 1000g of the invention comprises 20-300g of main component, 10-500g of complexing agent, 900g of organic solvent, 10-100g of humectant, 10-200 g of film forming agent, 5-100g of pH regulator, 0.05-50g of colorant and the balance of purified water; the main component is selected from one or two of oxytetracycline and oxytetracycline hydrochloride. The sprayed medicine is uniformly and stably dispersed, safe to use, capable of being administered for multiple times, low in packaging cost and capable of effectively and conveniently treating animal trauma, and the preparation is an external medicine and sprayed on the body surface of an animal, so that veterinary medicine residues are avoided, and the withdrawal period is avoided.

Description

Oxytetracycline spray and preparation method thereof

Technical Field

The invention belongs to the field of veterinary medicine, and particularly relates to a terramycin spray and a preparation method thereof.

Background

Terramycin belongs to a broad-spectrum antibiotic of tetracycline, has strong effect on gram-positive bacteria such as staphylococcus, hemolytic streptococcus, bacillus anthracis, clostridium tetani and clostridium and is sensitive to gram-negative bacteria such as escherichia coli, salmonella, brucella and pasteurella. The product also has inhibitory effect on rickettsia, chlamydia, mycoplasma, spirochete, actinomycete and some protozoa.

Animal trauma, especially foot rot, is the most common, bacterial infection is often caused due to poor culture environment conditions and is not cured for a long time, and terramycin is a broad-spectrum antibiotic and has good treatment effect on animal trauma. Oxytetracycline and oxytetracycline hydrochloride are widely used for oral administration and injection in veterinarians, but an oxytetracycline spray and a preparation method thereof do not exist at present.

Disclosure of Invention

The invention aims to solve the problems in the prior art and provides the oxytetracycline spray and the preparation method thereof, the sprayed medicine is uniformly dispersed and stable, the use is safe, the medicine can be administered for multiple times, the packaging cost is low, the animal trauma can be effectively and conveniently treated, the oxytetracycline spray is an external medicine and sprayed on the surface of the animal body, and the oxytetracycline spray has no veterinary medicine residue and no withdrawal period.

The invention adopts the specific technical scheme that: the key point of the oxytetracycline spray is that every 1000g comprises 20-300g of main components, 10-500g of complexing agent, 900g of organic solvent, 10-100g of humectant, 10-200 g of film forming agent, 5-100g of pH regulator, 0.05-50g of colorant and the balance of purified water;

the main component is selected from one or two of oxytetracycline and oxytetracycline hydrochloride.

Preferably, the organic solvent is selected from one or at least two of methanol, ethanol, isopropanol, dimethylformamide, dimethylacetamide, 2-pyrrolidone and methylpyrrolidone.

Preferably, the complexing agent is selected from one or at least two of magnesium oxide, magnesium chloride, magnesium hydroxide and magnesium carbonate.

Preferably, the humectant is selected from one or at least two of propylene glycol, glycerin and polyethylene glycol.

Preferably, the film forming agent is one or at least two of povidone K12, povidone K17 and povidone K30.

Preferably, the pH regulator is one or at least two of hydrochloric acid, lactic acid, sodium hydroxide, ethanolamine, diethanolamine, triethanolamine and sodium citrate.

Preferably, the colorant is one or at least two of brilliant blue, patent blue, carmine, methyl violet and grape violet.

The preparation method of the oxytetracycline spray is characterized by comprising the following steps:

A. adding a complexing agent into 70-120 g of purified water, and uniformly mixing to obtain a stock solution;

B. adding an organic solvent and a humectant into the stock solution, and uniformly mixing;

C. adding the film forming agent into the solution obtained in the step B, and uniformly mixing until the film forming agent is dissolved;

D. c, adding oxytetracycline hydrochloride or oxytetracycline into the solution obtained in the step C, and uniformly mixing until the oxytetracycline hydrochloride or the oxytetracycline hydrochloride is dissolved

E. Adding a pH regulator into the solution obtained in the step D to regulate the pH to 8.0-9.0;

F. and E, adding a coloring agent into the solution obtained in the step E, adding purified water to 1000g, uniformly mixing until the coloring agent is dissolved, filtering, and filling into a special spraying agent bottle in an encapsulating manner to obtain the oxytetracycline spraying agent.

Preferably, the special bottle for the spraying agent is a plastic bottle with a spraying device or a glass bottle with a spraying device.

The invention has the beneficial effects that: the medicine sprayed by the oxytetracycline spray prepared by the invention is uniformly dispersed and stable, is safe to use, can be administered for multiple times, has low packaging cost, is used for treating animal trauma caused by multiple bacteria, shortens the time of pain and recovery, and relieves the pain of sick animals.

Detailed Description

The invention will be further illustrated with reference to specific examples:

example 1

Prescription

Process for producing a metal oxide

A. Adding magnesium chloride into 70-120 g of purified water to dissolve to obtain a stock solution;

B. adding isopropanol and propylene glycol into the stock solution, and mixing uniformly;

C. adding polyvidone K17, and mixing to dissolve;

D. adding oxytetracycline hydrochloride, and mixing to dissolve;

E. adding ethanolamine to adjust the pH to 8.0-9.0;

F. and adding brilliant blue, adding purified water to 1000g, uniformly mixing until the purified water is dissolved, filtering, taking 150g, and filling and sealing into a special bottle for the oxytetracycline spray to obtain the oxytetracycline spray.

Example 2

Prescription

Process for producing a metal oxide

A. Adding magnesium chloride into 70-120 g of purified water to dissolve to obtain a stock solution;

B. adding ethanol and propylene glycol into the stock solution, and mixing;

C. adding polyvidone K17, and mixing to dissolve;

D. adding oxytetracycline hydrochloride, and mixing to dissolve;

E. adding ethanolamine to adjust the pH to 8.0-9.0;

F. and adding brilliant blue, adding purified water to 1000g, uniformly mixing until the purified water is dissolved, filtering, taking 150g, and filling and sealing into a special bottle for the oxytetracycline spray to obtain the oxytetracycline spray.

Example 3

Prescription

Process for producing a metal oxide

A. Adding magnesium chloride into 70-120 g of purified water to dissolve to obtain a stock solution;

B. adding dimethylacetamide and propylene glycol into the stock solution, and mixing;

C. adding polyvidone K12, and mixing to dissolve;

D. adding oxytetracycline and mixing to dissolve;

E. adding ethanolamine to adjust the pH to 8.0-9.0;

F. and adding brilliant blue, adding purified water to 1000g, uniformly mixing until the purified water is dissolved, filtering, taking 150g, and filling and sealing into a special bottle for the oxytetracycline spray to obtain the oxytetracycline spray.

Example 4

Prescription

Process for producing a metal oxide

A. Adding magnesium chloride into 70-120 g of purified water to dissolve to obtain a stock solution;

B. adding methyl pyrrolidone and propylene glycol into the stock solution, and mixing uniformly;

C. adding polyvidone K30, and mixing to dissolve;

D. adding oxytetracycline and mixing to dissolve;

E. adding ethanolamine to adjust the pH to 8.0-9.0;

F. and adding brilliant blue, adding purified water to 1000g, uniformly mixing until the purified water is dissolved, filtering, taking 150g, and filling and sealing into a special bottle for the oxytetracycline spray to obtain the oxytetracycline spray.

Test example 1

The oxytetracycline spray prepared in example 3 was divided into 3 batches and subjected to stability test observations including influencing factor tests (high temperature, light), accelerated tests (temperature 40 + -2 deg.C, RH75 + -5%) for 6 months and long-term tests (25 + -2 deg.C, RH60 + -10%) for 24 months, wherein the test conditions, examination times and examination items are shown in Table 1, and the test results are shown in tables 1-4:

table 1: test content and investigation project of stability of terramycin spray

TABLE 2 influence factor test results

TABLE 3 accelerated test results

TABLE 4 Long-term test results

The table shows that the oxytetracycline spray prepared by the invention has good stability and long shelf life, can be stored at higher temperature, is not easy to decompose when exposed to light, and is resistant to light.

Test example 2

The terramycin spray prepared according to the example 3 is used for observing the effect of foot rot of cattle, sheep and pigs, and the following are selected: oxytetracycline spray (batch 20190401, prepared in example 3); 10% copper sulfate solution + rub anti-inflammatory cream (traditional therapy); iodine-enriched (double-chain quaternary ammonium salt complexed iodine, analgesic) is used for animals with diseases.

The test method comprises the following steps: selecting 60 cattle with typical foot rot in normal breeding process, and dividing into groups I, II, III, and IV, each group having 15 cattle heads; 80 sheep heads divided into groups I, II, III, IV, 20 each, 120 pigs divided into groups I, II, III, IV, 30 each, administration mode is topical injection, and specific test groups and administration conditions are shown in Table 5

TABLE 5 test grouping and dosing

The clinical curative effect judgment standard is as follows:

and (3) curing: after the medicine is taken for 3 days, the appetite, the body temperature and the mental state of the tested animals are recovered to be normal, the sick hoofs completely touch the ground when standing, the sick hoofs keep the load state normally, the pain is avoided, the skin of the hoofs and toes is normal, the erosion and swelling characteristics are avoided, the rotten flesh hyperplasia phenomenon between the hoofs and toes completely disappears, and the sick hoofs and toes do not relapse within one week after the medicine is stopped.

The method has the following advantages: after the medicine is taken for 3 days, the appetite, the body temperature and the mental state of animals are improved, the sick hoofs can be landed when the animals stand, the state of load bearing is basically kept, the animals feel slightly painful, the outer skin of the hoofs and toes is obviously improved, erosion and swelling are not completely disappeared, the rotten meat hyperplasia phenomenon between the hoofs and toes is obviously improved, and the symptoms are not aggravated any more in the observation period of stopping the medicine.

And (4) invalidation: after 3 days of administration, the appetite, body temperature and mental state of the test animals are not improved or even continuously worsened, or the test animals are repeatedly sent in the observation period of drug withdrawal.

TABLE 6 therapeutic Effect of oxytetracycline spray on bovine foot rot

Grouping	Number of cases	Cure (head)	Cure rate (%)	Effective rate (%)	Inefficiency (%)
						Group I	15	15	100	100	0
Group II	15	10	66.7	100	0
						Group III	15	12	80.0	100	0
Group IV	15	0	0	0	100

TABLE 7 therapeutic Effect of oxytetracycline spray on foot rot of sheep

Grouping	Number of cases	Cure (head)	Cure rate (%)	Effective rate (%)	Inefficiency (%)
						Group I	20	20	100	100	0
Group II	20	13	65.0	100	0
						Group III	20	16	80.0	100	0
Group IV	20	0	0	0	100

TABLE 8 therapeutic Effect of oxytetracycline spray on porcine foot rot

Grouping	Number of cases	Cure (head)	Cure rate (%)	Effective rate (%)	Inefficiency (%)
						Group I	30	30	100	100	0
Group II	30	24	80.0	100	0
						Group III	30	26	86.7	100	0
Group IV	30	0	0	0	100

As can be seen from tables 6, 7 and 8, the oxytetracycline spray can obviously relieve various clinical symptoms of the sick animals and improve the treatment effect, is superior to 10 percent copper sulfate solution, daubing anti-inflammatory cream (traditional therapy) and iodine rich (double-chain quaternary ammonium salt complex iodine and acesodyne), shows that the oxytetracycline spray can effectively treat the trauma of the sick animals, and especially has a certain treatment effect on the foot rot disease.

Claims (9)

1. The oxytetracycline spray is characterized by comprising, per 1000g, 20-300g of main components, 10-500g of complexing agents, 900g of organic solvents, 10-100g of humectants, 10-200 g of film forming agents, 5-100g of pH regulators, 0.05-50g of coloring agents and the balance of purified water;

the main component is selected from one or two of oxytetracycline and oxytetracycline hydrochloride.

2. The oxytetracycline spray of claim 1, wherein said organic solvent is selected from one or at least two of methanol, ethanol, isopropanol, dimethylformamide, dimethylacetamide, 2-pyrrolidone and methylpyrrolidone.

3. The oxytetracycline spray of claim 1, wherein the complexing agent is selected from one or at least two of magnesium oxide, magnesium chloride, magnesium hydroxide, and magnesium carbonate.

4. The oxytetracycline spray of claim 1, wherein said humectant is selected from one or at least two of propylene glycol, glycerin, polyethylene glycol.

5. The oxytetracycline spray of claim 1, wherein the film forming agent is one or at least two of povidone K12, povidone K17, and povidone K30.

6. The oxytetracycline spray of claim 1, wherein the pH modifying agent is one or at least two of hydrochloric acid, lactic acid, sodium hydroxide, ethanolamine, diethanolamine, triethanolamine and sodium citrate.

7. The oxytetracycline spray of claim 1, wherein the coloring agent is one or at least two of brilliant blue, patent blue, carmine, methyl violet, and grape violet.

8. The method for preparing the oxytetracycline spray of any one of claims 1 to 7, comprising the steps of:

A. adding a complexing agent into 70-120 g of purified water, and uniformly mixing to obtain a stock solution;

B. adding an organic solvent and a humectant into the stock solution, and uniformly mixing;

C. adding the film forming agent into the solution obtained in the step B, and uniformly mixing until the film forming agent is dissolved;

D. c, adding oxytetracycline hydrochloride or oxytetracycline into the solution obtained in the step C, and uniformly mixing until the oxytetracycline hydrochloride or the oxytetracycline hydrochloride is dissolved

E. Adding a pH regulator into the solution obtained in the step D to regulate the pH to 8.0-9.0;

F. and E, adding a coloring agent into the solution obtained in the step E, adding purified water to 1000g, uniformly mixing until the coloring agent is dissolved, filtering, and filling into a special spraying agent bottle in an encapsulating manner to obtain the oxytetracycline spraying agent.

9. The method for preparing the oxytetracycline spray according to claim 8, wherein the special spray bottle is a plastic bottle with a spraying device or a glass bottle with a spraying device.