CN111956612A - Oxytetracycline spray and preparation method thereof - Google Patents

Abstract

The invention belongs to the field of veterinary medicine and provides an oxytetracycline spray and a preparation method thereof. Every 1000g of the present invention includes 20-300g of main components, 10-500g of complexing agent, 200-900g of organic solvent, 10-100g of moisturizing agent, 10-200g of film-forming agent, 5-100g of pH adjusting agent, and 0.05-50g of colorant , the remainder is purified water; the main component is selected from one or both of oxytetracycline and oxytetracycline hydrochloride. The medicine sprayed by the invention is evenly dispersed and stable, safe to use, can be administered multiple times, has low packaging cost, and can effectively and conveniently treat animal trauma. drug period.

Description

A kind of oxytetracycline spray and preparation method thereof

technical field

The invention belongs to the field of veterinary medicine, in particular to an oxytetracycline spray and a preparation method thereof.

Background technique

Oxytetracycline belongs to tetracycline broad-spectrum antibiotics, and has strong effect on gram-positive bacteria such as Staphylococcus, hemolytic streptococcus, Bacillus anthracis, Clostridium tetani and Clostridium spp. Gram-negative bacteria such as L. brucei and Pasteurella are more susceptible. This product also has inhibitory effects on rickettsia, chlamydia, mycoplasma, spirochetes, actinomycetes and some protozoa.

Animal trauma, especially hoof rot, is the most common. Bacterial infection is often caused by poor breeding environment, which will not heal for a long time. Oxytetracycline is a broad-spectrum antibiotic, which has a good treatment for animal trauma. In veterinary medicine, oxytetracycline and oxytetracycline hydrochloride are widely used for oral administration and injection, but there is no oxytetracycline spray and its preparation method.

SUMMARY OF THE INVENTION

In order to solve the above-mentioned problems in the prior art, the present invention provides an oxytetracycline spray and a preparation method thereof. The sprayed medicine is uniform and stable, safe to use, can be administered multiple times, has low packaging cost, and can It is effective and convenient for the treatment of animal trauma. The preparation is an external drug, sprayed on the surface of the animal body, and has no veterinary drug residue and no drug withdrawal period.

The specific technical scheme adopted in the present invention is: an oxytetracycline spray, the key is that every 1000g includes 20-300g of main components, 10-500g of complexing agent, 200-900g of organic solvent, 10-100g of moisturizing agent, 10g-200g of film agent, 5-100g of pH adjuster, 0.05-50g of colorant, and the balance is purified water;

The main component is selected from one or both 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 adjusting agent is one or at least two selected from hydrochloric acid, lactic acid, sodium hydroxide, ethanolamine, diethanolamine, triethanolamine and sodium citrate.

Preferably, the colorant is one or at least two selected from brilliant blue, patent blue, blue, carmine, nail violet and grape violet.

A kind of preparation method of oxytetracycline spray, the key is, comprises the following steps:

A. The complexing agent is added into 70g～120g purified water and mixed to obtain a stock solution;

B. Add organic solvent and humectant to the original solution and mix well;

C, in the solution obtained in step B, add film-forming agent and mix to dissolve;

D, in the solution obtained in step C, add oxytetracycline hydrochloride or oxytetracycline and mix until dissolved

E, in the solution that step D obtains, add pH regulator to adjust pH to be 8.0～9.0;

F. Add a colorant to the solution obtained in step E, add purified water to 1000 g, mix to dissolve, filter, and fill in a special bottle for spray to obtain the oxytetracycline spray.

Preferably, the dedicated spray bottle is a plastic bottle with a spray device or a glass bottle with a spray device.

The beneficial effects of the invention are as follows: the oxytetracycline spray prepared by the invention has the advantages of uniform dispersion and stability, safe use, multiple administration, low packaging cost, and is used for treating animal trauma caused by various bacteria , shortens the time of pain and recovery, and relieves the suffering of sick animals.

Detailed ways

Below in conjunction with specific embodiment, the present invention will be further described:

Example 1

prescription

process

A, adding magnesium chloride to 70g～120g purified water and dissolving to obtain stock solution;

B. Add isopropanol and propylene glycol to the stock solution and mix;

C, then add povidone K17 and mix to dissolve;

D. Add oxytetracycline hydrochloride and mix until dissolved;

E, then add ethanolamine to adjust pH to 8.0～9.0;

F. Add bright blue again, add purified water to 1000g, mix to dissolve, filter, take 150g and fill it into a special bottle for spray to obtain the oxytetracycline spray.

Example 2

prescription

process

A, adding magnesium chloride to 70g～120g purified water and dissolving to obtain stock solution;

B. Add ethanol and propylene glycol to the stock solution and mix;

C, then add povidone K17 and mix to dissolve;

D. Add oxytetracycline hydrochloride and mix until dissolved;

E, then add ethanolamine to adjust pH to 8.0～9.0;

F. Add bright blue again, add purified water to 1000g, mix to dissolve, filter, take 150g and fill it into a special bottle for spray to obtain the oxytetracycline spray.

Example 3

prescription

process

A, adding magnesium chloride to 70g～120g purified water and dissolving to obtain stock solution;

B. Add dimethylacetamide and propylene glycol to the stock solution and mix;

C, then add povidone K12 and mix to dissolve;

D. Add oxytetracycline and mix until dissolved;

E, then add ethanolamine to adjust pH to 8.0～9.0;

F. Add bright blue again, add purified water to 1000g, mix to dissolve, filter, take 150g and fill it into a special bottle for spray to obtain the oxytetracycline spray.

Example 4

prescription

process

A, adding magnesium chloride to 70g～120g purified water and dissolving to obtain stock solution;

B. Add methylpyrrolidone and propylene glycol to the stock solution and mix;

C, then add Povidone K30 and mix to dissolve;

D. Add oxytetracycline and mix until dissolved;

E, then add ethanolamine to adjust pH to 8.0～9.0;

F. Add bright blue again, add purified water to 1000g, mix to dissolve, filter, take 150g and fill it into a special bottle for spray to obtain the oxytetracycline spray.

Test Example 1

The oxytetracycline spray prepared in Example 3 was divided into 3 batches, and the stability test was observed, including the influence factor test (high temperature, light), accelerated test (temperature 40±2°C, RH75±5%) for 6 months and Long-term test (25±2℃, RH60±10%) for 24 months, test conditions, inspection time and inspection items are shown in Table 1, and test results are shown in Table 1-4:

Table 1: Contents and investigation items of stability test of oxytetracycline spray

Table 2 Test results of influencing factors

Table 3 Accelerated test results

Table 4 Long-term test results

As can be seen from the table, the oxytetracycline spray prepared by the present invention has good stability, long shelf life, can be stored at a relatively high temperature, is not easily decomposed when exposed to light, and is resistant to light.

Test Example 2

Observation of the effect of the oxytetracycline spray prepared in Example 3 on cattle, sheep, and pig foot rot, selection: oxytetracycline spray (the batch number prepared in Example 3 is 20190401); 10% copper sulfate solution + rubbing anti-inflammatory Ointment (traditional therapy); iodine-rich (double-chain quaternary ammonium salt complexed with iodine, analgesic new) are administered to sick animals.

Test method: Select 60 cattle with typical hoof rot disease in the normal feeding process and divide them into I, II, III, IV groups, 15 heads in each group; 80 sheep, divided into I, II, III, IV groups, each There were 20 pigs in the group and 120 pigs, divided into I, II, III, IV groups, 30 pigs in each group, and the administration method was external spray.

Table 5 Test grouping and administration

Criteria for judging clinical efficacy:

Cure: After 3 days of medication, the appetite, body temperature and mental state of the test animals returned to normal, the diseased hoof completely touched the ground when standing, the normal weight-bearing state was maintained, there was no pain, the outer skin of the hoof and toes was normal, there was no erosion or swelling, and the phenomenon of carrion between the hoof and toes was complete. Disappeared, no recurrence within a week of drug withdrawal.

Effective: After 3 days of medication, the appetite, body temperature and mental state of the test animals improved, the diseased hoof could land on the ground when standing, and the weight-bearing state was basically maintained, with a slight pain, the skin outside the hoof and toes was obviously improved, the erosion and swelling did not completely disappear, and the slough between the hoof and toes was proliferated. The phenomenon improved significantly, and the symptoms no longer aggravated during the observation period of drug withdrawal.

Ineffective: The appetite, body temperature and mental state of the test animals did not improve or even continued to deteriorate after 3 days of treatment, or recurred during the observation period of drug withdrawal.

Table 6 The therapeutic effect of oxytetracycline spray on cattle foot rot

grouping Number of cases heal (head) Cure rate (%) Efficient(%) no efficiency(%) 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 The therapeutic effect of oxytetracycline spray on sheep foot rot

grouping Number of cases heal (head) Cure rate (%) Efficient(%) no efficiency(%) 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 The therapeutic effect of oxytetracycline spray on pig foot rot

grouping Number of cases heal (head) Cure rate (%) Efficient(%) no efficiency(%) Group I 30 30 100 100 0 Group II 30 twenty four 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, oxytetracycline spray can obviously relieve various clinical symptoms of sick animals and improve the therapeutic effect, which is better than 10% copper sulfate solution + Tumo anti-inflammatory cream (traditional therapy), iodine rich ( Double-chain quaternary ammonium salt complexed with iodine, analgesic new), indicating that oxytetracycline spray can effectively treat the trauma of sick animals, especially to play a certain therapeutic effect on foot rot. Shake and spray several times until the lesions are completely covered. It is safe to use and can be administered multiple times. Treated animals should stand on dry ground for one hour before returning to pasture.

Claims (9)

1. an oxytetracycline spray, is characterized in that, every 1000g, comprises main component 20-300g, complexing agent 10-500g, organic solvent 200-900g, moisturizing agent 10-100g, film-forming agent 10g-200g, pH adjuster 5-100g, colorant 0.05-50g, and the balance is purified water; The main component is selected from one or both of oxytetracycline and oxytetracycline hydrochloride. 2. a kind of oxytetracycline spray according to claim 1 is characterized in that, described organic solvent is selected from methanol, ethanol, isopropanol, dimethylformamide, dimethylacetamide, 2-pyrrolidone and one or at least two of methylpyrrolidone. 3. a kind of oxytetracycline spray according to claim 1 is characterized in that, described complexing agent is selected from one or at least two in magnesium oxide, magnesium chloride, magnesium hydroxide, magnesium carbonate. 4. a kind of oxytetracycline spray according to claim 1, is characterized in that, described moisturizing agent is selected from one or at least two in propylene glycol, glycerol, polyethylene glycol. 5. a kind of oxytetracycline spray according to claim 1 is characterized in that, described film-forming agent is one or at least two of povidone K12, povidone K17 and povidone K30. 6. a kind of oxytetracycline spray according to claim 1, is characterized in that, described pH regulator is one in hydrochloric acid, lactic acid, sodium hydroxide, ethanolamine, diethanolamine, triethanolamine and sodium citrate one or at least two. 7. a kind of oxytetracycline spray according to claim 1, is characterized in that, described colorant is a kind of or at least in bright blue, patent blue, blue, carmine, nail violet and grape violet two kinds. 8. the preparation method of any one oxytetracycline spray according to claim 1 to 7, is characterized in that, comprises the following steps: A. The complexing agent is added into 70g～120g purified water and mixed to obtain a stock solution; B. Add organic solvent and humectant to the original solution and mix well; C, in the solution obtained in step B, add film-forming agent and mix to dissolve; D, in the solution obtained in step C, add oxytetracycline hydrochloride or oxytetracycline and mix until dissolved E, in the solution that step D obtains, add pH regulator to adjust pH to be 8.0～9.0; F. Add a colorant to the solution obtained in step E, add purified water to 1000 g, mix to dissolve, filter, and fill in a special bottle for spray to obtain the oxytetracycline spray. 9. the preparation method of a kind of oxytetracycline spray according to claim 8, is characterized in that, in described spray special bottle is the plastic bottle with spray device or the glass bottle with spray device.