CN112022809A - Oxytetracycline aerosol and preparation method thereof - Google Patents

Oxytetracycline aerosol and preparation method thereof Download PDF

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Publication number
CN112022809A
CN112022809A CN202010819847.8A CN202010819847A CN112022809A CN 112022809 A CN112022809 A CN 112022809A CN 202010819847 A CN202010819847 A CN 202010819847A CN 112022809 A CN112022809 A CN 112022809A
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oxytetracycline
aerosol
uniformly mixing
purified water
propellant
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Inventor
魏占勇
宋婷婷
刘静
刘欣
魏丽娟
李金明
刘毅
耿智霞
瞿红颖
贾兴
郭李珉
王德功
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Hebei Yuanzheng Pharmaceutical Co ltd
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • A61K9/0017—Non-human animal skin, e.g. pour-on, spot-on
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/12—Aerosols; Foams
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents

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  • General Chemical & Material Sciences (AREA)
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  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
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  • Inorganic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
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  • Proteomics, Peptides & Aminoacids (AREA)
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Abstract

The invention belongs to the field of veterinary medicine, and particularly relates to a terramycin aerosol and a preparation method thereof. Every 1000g of the invention 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, 50-300g of propellant and the balance of purified water; the main component is selected from one or two of oxytetracycline and oxytetracycline hydrochloride. The aerosol provided by the invention has fine and uniform droplets or fog particles, accurate dose, contains a propellant, is suitable for single administration, and can effectively and conveniently treat animal trauma; the preparation is thrown on animal body surface, is used as topical medicine, has no veterinary drug residue, and has no withdrawal period.

Description

Oxytetracycline aerosol and preparation method thereof
Technical Field
The invention belongs to the field of veterinary medicine, and particularly relates to a terramycin aerosol 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, particularly foot rot, is most common. The bacterial infection is often caused due to poor culture environmental conditions and is not cured for a long time. 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 aerosol and a preparation method thereof do not exist at present.
Disclosure of Invention
The invention provides the oxytetracycline aerosol and the preparation method thereof in order to solve the problems in the prior art, wherein the aerosol is fine and uniform in droplets or fog particles ejected by the aerosol, accurate in dosage, contains a propellant, is suitable for single administration, and can effectively and conveniently treat animal trauma; the preparation is thrown on animal body surface, is used as topical medicine, has no veterinary drug residue, and has no withdrawal period.
The invention adopts the specific technical scheme that: the key point of the oxytetracycline aerosol 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, 50-300g of propellant 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; the humectant is selected from one or at least two of propylene glycol, glycerol and polyethylene glycol; 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.
Preferably, the propellant is one or at least two of nitrogen, air, hydrofluorocarbon, propane butane and dimethyl ether.
The preparation method of the oxytetracycline aerosol 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, and uniformly mixing until the oxytetracycline hydrochloride or oxytetracycline is dissolved;
E. adding a pH regulator into the mixture obtained in the step D to regulate the pH to 8.0-9.0;
F. and E, adding a coloring agent into the obtained product in the step E, adding purified water to 1000g, uniformly mixing until the purified water is dissolved, filtering, filling and sealing into a metal can, and injecting a propellant to obtain the oxytetracycline aerosol.
Preferably, the metal can is an aluminum can or an iron can, and the metal can is plated with a lining layer or is provided with a bag
The invention has the beneficial effects that: the oxytetracycline aerosol for animals prepared by the invention has fine and uniform fog drops or fog particles ejected by the aerosol, accurate dose, contains a propellant, is suitable for single administration, is used for treating animal trauma caused by various 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
Figure BDA0002634076640000031
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 uniformly mixing;
(C) then adding the povidone K17 and mixing evenly until the povidone K17 is dissolved;
(D) then adding oxytetracycline hydrochloride and mixing evenly until dissolving;
(E) adding ethanolamine to adjust the pH to 8.0-9.0;
(F) and then adding brilliant blue, adding purified water to 1000g, uniformly mixing until the purified water is dissolved, filtering, taking 150g, filling and sealing into a 200g coated iron tank, and injecting 50g of propane and butane to obtain the oxytetracycline aerosol.
Example 2
Prescription
Figure BDA0002634076640000041
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) then adding the povidone K17 and mixing evenly until the povidone K17 is dissolved;
(D) then adding oxytetracycline hydrochloride and mixing evenly until dissolving;
(E) adding ethanolamine to adjust the pH to 8.0-9.0;
(F) and then adding brilliant blue, adding purified water to 1000g, uniformly mixing until the mixture is dissolved, filtering, taking 150g, filling and sealing into a 200g coated aluminum can, and injecting 50g of propane and butane to obtain the oxytetracycline aerosol.
Example 3
Prescription
Figure BDA0002634076640000042
Process for producing a metal oxide
(A) Adding magnesium oxide 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 uniformly;
(C) then adding the povidone K12 and mixing evenly until the povidone K12 is dissolved;
(D) then adding oxytetracycline and mixing evenly until dissolving;
(E) and then adding ethanolamine with the pH of 8.0-9.0.
(F) And then adding brilliant blue, adding purified water to 1000g, uniformly mixing until the purified water is dissolved, filtering, taking 150g, filling and sealing into a 200g coated aluminum can, and injecting 50g of dimethyl ether to obtain the oxytetracycline aerosol.
Example 4
Prescription
Figure BDA0002634076640000051
Process for producing a metal oxide
(A) Adding magnesium oxide 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 uniformly mixing;
(C) then adding the povidone K30 and mixing evenly until the povidone K30 is dissolved;
(D) then adding oxytetracycline and mixing evenly until dissolving;
(E) then adding ethanolamine with the pH of 8.0-9.0;
(F) and then adding brilliant blue, adding purified water to 1000g, uniformly mixing until the purified water is dissolved, filtering, taking 150g, filling and sealing into a 200g coated aluminum can with a bag, and injecting 50g of nitrogen to obtain the oxytetracycline aerosol.
Test example 1
The oxytetracycline aerosol 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 to 4:
table 1: test content and investigation project of oxytetracycline aerosol stability
Figure BDA0002634076640000061
TABLE 2 influence factor test results
Figure BDA0002634076640000062
TABLE 3 accelerated test results
Figure BDA0002634076640000063
Figure BDA0002634076640000071
TABLE 4 Long-term test results
Figure BDA0002634076640000072
The table shows that the oxytetracycline aerosol 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 aerosol prepared according to the example 3 is used for observing the effect of foot rot of cattle, sheep and pigs, and is selected from the following components: oxytetracycline aerosol (batch No. 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
Figure BDA0002634076640000081
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 aerosols 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 aerosols on foot rot in 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 aerosols 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 aerosol can obviously relieve various clinical symptoms of the sick animals and improve the treatment effect, is superior to 10 percent of copper sulfate solution, smearing anti-inflammatory cream (traditional therapy) and iodine-rich (double-chain quaternary ammonium salt complex iodine and acesodyne), and shows that the oxytetracycline aerosol can effectively treat the trauma of the sick animals, and especially has a certain treatment effect on the foot rot. The administration method is spraying for external use, shaking before application, spraying for several seconds or until the lesion is completely covered, and should not be administered many times, and the treated livestock should stand on dry ground for one hour before returning to the pasture.

Claims (8)

1. The oxytetracycline aerosol is characterized by comprising, per 1000g, 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, 50-300g of propellant and the balance of purified water;
the main component is selected from one or two of oxytetracycline and oxytetracycline hydrochloride.
2. The oxytetracycline aerosol of claim 1, wherein the organic solvent is selected from one or at least two of methanol, ethanol, isopropanol, dimethylformamide, dimethylacetamide, 2-pyrrolidone and methylpyrrolidone.
3. The oxytetracycline aerosol of claim 1, wherein the complexing agent is selected from one or at least two of magnesium oxide, magnesium chloride, magnesium hydroxide, magnesium carbonate; the humectant is selected from one or at least two of propylene glycol, glycerol and polyethylene glycol; the film forming agent is one or at least two of povidone K12, povidone K17 and povidone K30.
4. The oxytetracycline aerosol of claim 1, wherein the pH regulator is one or at least two of hydrochloric acid, lactic acid, sodium hydroxide, ethanolamine, diethanolamine, triethanolamine and sodium citrate.
5. The oxytetracycline aerosol of claim 1, wherein the coloring agent is one or at least two of brilliant blue, patent blue, carmine, methyl violet, and grape violet.
6. The oxytetracycline aerosol of claim 1, wherein the propellant is one or at least two of nitrogen, air, hydrofluorocarbons, propane and dimethyl ether.
7. The method for preparing the oxytetracycline aerosol of any one of claims 1 to 6, 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, and uniformly mixing until the oxytetracycline hydrochloride or oxytetracycline 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, filling and sealing into a metal can, and injecting a propellant to obtain the oxytetracycline aerosol.
8. The method for preparing oxytetracycline aerosol of claim 7, wherein the metal can is an aluminum can or an iron can, and the metal can is coated with a lining or has a pouch.
CN202010819847.8A 2020-08-14 2020-08-14 Oxytetracycline aerosol and preparation method thereof Pending CN112022809A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117695225A (en) * 2023-12-26 2024-03-15 石家庄石牧药业有限公司 Aureomycin spray and preparation method thereof

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117695225A (en) * 2023-12-26 2024-03-15 石家庄石牧药业有限公司 Aureomycin spray and preparation method thereof

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