CN112107584A - Mizapine preparation composition for treating nausea, vomiting and anorexia of pets and process thereof - Google Patents

Mizapine preparation composition for treating nausea, vomiting and anorexia of pets and process thereof Download PDF

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Publication number
CN112107584A
CN112107584A CN202010692224.9A CN202010692224A CN112107584A CN 112107584 A CN112107584 A CN 112107584A CN 202010692224 A CN202010692224 A CN 202010692224A CN 112107584 A CN112107584 A CN 112107584A
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mirtazapine
anorexia
vomiting
composition
pets
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施军辉
施柔安
施并辉
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Shanghai Xinyuan Animal Pharmaceutical Co ltd
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Shanghai Xinyuan Animal Pharmaceutical Co ltd
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Priority to CN202010692224.9A priority Critical patent/CN112107584A/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • 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
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • 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
    • 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
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/08—Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys

Abstract

The invention provides a mirtazapine preparation for treating nausea, vomiting and anorexia of pets and a preparation process thereof; comprises mirtazapine and a matrix; the composition is in the form of topical liquid, ointment, cream, or gel; wherein the ointment matrix is an emulsified matrix and comprises the following components: oil phase, water phase, emulsifier, auxiliary agent I and auxiliary agent II. The invention also relates to a preparation method of the ointment composition; the composition prepared by the invention is used for 10 patients, and the disease condition is obviously relieved or cured after the composition related by the invention is used; the mirtazapine composition prepared by the invention has higher treatment effect on symptoms such as nausea, vomit, anorexia and the like of pets; the mirtazapine composition has good application prospect and good economic benefit value. The medicine is worthy of further research and popularization, and the medicine is uniformly smeared on the inner side of the pet ears; the administration dose is 0.3-0.9mg/kg once every 1-2 days for 14 consecutive days.

Description

Mizapine preparation composition for treating nausea, vomiting and anorexia of pets and process thereof
Technical Field
The invention belongs to the field of medicine; in particular to a mirtazapine preparation composition for treating nausea, vomiting and anorexia of pets and a process thereof.
Background
Mirtazapine is the commonly known drug from the European farmer company Remeron (mirtazapine). Mirtazapine is the first antidepressant drug worldwide with a dual inhibitory effect on the secondary uptake of norepinephrine and 5-hydroxytryptamine. Remeron obtained U.S. FDA approval in 1996 and has been used clinically in over 70 countries.
Chronic Kidney Disease (CKD) is common in senior cats. The kidneys of the gastrin are responsible for excretion, renal function deteriorates, and gastrin concentration may increase, resulting in uremic gastritis. Other factors may contribute to lethargy and anorexia, including metabolic acidosis, anemia, and secondary hyperparathyroidism in the kidney, due to which CKD cats often exhibit anorexia and vomiting. Loss of appetite can lead to negative energy balance, with consequent weight loss, muscle weakness and a reduction in quality of life. Furthermore, recent studies have demonstrated the value of specially formulated diets in the treatment of CKD. These diets usually contain limited amounts of high quality protein, sufficient non-protein calories, and limited phosphorus. The lack of consumption by patients negates the benefits of dietary management, and thus a key therapeutic goal for these patients is to maintain appetite and food intake. Current strategies for appetite enhancement include the use of h2 receptor antagonists or proton pump inhibitors to treat uremic gastritis, and the use of cyproheptadine as an appetite stimulant. Feeding tubes may also be used, but are not an acceptable option for many pet owners. Clearly, a need exists for a medicament that stimulates appetite in sick or geriatric cats.
Disclosure of Invention
The invention aims to provide an ointment composition for treating nausea, vomit and anorexia of pets and a preparation method thereof. Can be used for treating nausea, emesis and anorexia in pets. Is particularly useful for stimulating appetite in pets suffering from chronic kidney disease.
The invention is realized by the following technical scheme:
the invention relates to a mirtazapine preparation for treating nausea, vomiting and anorexia of pets, which consists of mirtazapine and a substrate; the amount of the mirtazapine added accounts for 5-8% of the total weight of the ointment composition; the substrate is an emulsion type substrate; wherein the composition of the emulsified matrix is as follows: oil phase, water phase, emulsifier, and adjuvant I and adjuvant II.
The oil phase comprises oils, waxes, hydrocarbons, fatty alcohols, fatty acids, esters and the like, and the oils comprise: vegetable oil, liquid paraffin, castor oil, cottonseed oil, groundnut oil, corn oil, rice bran oil, rice germ oil, olive oil, almond oil, palm oil, sesame oil and the like, and waxes including beeswax, spermaceti, lecithin, carnauba wax, candelilla wax, beeswax and the like, hydrocarbons include liquid paraffin, squalane, microcetyl, ceresin, paraffin, petrolatum, fatty alcohols including cetyl alcohol, stearyl alcohol, lauryl alcohol, decyl alcohol, myristyl alcohol, cholesterol, and like fatty acids including capric acid, myristic acid, palmitic acid, stearic acid, behenic acid, capric acid, linoleic acid, linolenic acid, lauric acid, myristic acid, oleic acid, and like esters including isopropyl myristate, isopropyl palmitate, stearyl myristate, stearyl oleate, cholesterol oleate, caprylic/capric glycerides, selected from one or a mixture of several thereof.
The water phase is selected from purified water.
The emulsifier is selected from sorbitan monolaurate, sorbitan monooleate (span 80), sorbitan sesquioleate, sorbitan trioleate, sorbitan monolaurate (span 20), polyoxyethylene (20) sorbitan monolaurate (Tween 20), polyethylene glycol monooleate, polyethylene glycol alkanoate, polyoxyethylene alkyl ether, polyglycol diether, lauroyl diethanolamide, glyceryl monostearate, polyhydroxy fatty acid ether, alkylated polysaccharide, alkyl glucoside, saccharide ester and other nonionic surfactant, oleophilic type glycerol monostearate, self-emulsifying type glycerol monostearate, polyglycerol alkanoate, polysorbate 80 (Tween 80), polyethylene glycol monostearate, polyoxyethylene cetyl ether, polyoxyethylene sterol, polyoxyethylene ethoxylated adeps Caprae Seu Ovis, polyoxyethylene capryl caprae Seu Ovis oil, sorbitan monolaurate, Nonionic surfactants such as polyoxyethylated beeswax and polyoxyethylated hardened castor oil, anionic surfactants such as N-acyl monosodium glutamate, sodium palmitate, sodium laurate, potassium lauryl sulfate, triethanolamine alkyl sulfate ether, sulfated castor oil, linear dodecylbenzene sulfonic acid, polyoxyethylated hardened castor oil maleic acid and acyl methyl taurine, cationic surfactants such as stearyl dimethylbenzyl ammonium chloride, stearyl trimethyl ammonium chloride and lauryl amine oxide, amphoteric surfactants such as alkylamine ethyl glycinate hydrochloride and lecithin, and the like.
The auxiliary agent I is an antifreeze agent, a consistency regulator, a humectant and the like, and is mainly selected from one or more of polyethylene glycol, glycerol, propylene glycol, 1, 3-butanediol, erythritol, xylitol, sorbitol, maltitol, xanthan gum and Arabic gum.
The auxiliary agent II is antioxidant, pH regulator, antiseptic, chelating agent, etc. The antioxidant comprises acetate vitamin E, vitamin C, 2, 6-dibutylhydroxytoluene, butylhydroxyanisole, catechins, flavonoids and the like, the pH value regulator comprises disodium hydrogen phosphate, potassium phosphate, sodium hydroxide, potassium hydroxide, sodium citrate, citric acid and the like, and the preservative comprises parabens, p-hydroxy-propionate, gallic acid and other chelating agents comprising ethylene diamine tetraacetate, pyrophosphoric acid, hexametaphosphoric acid, citric acid, tartaric acid and the like.
Preferably, the oil phase is one or more of stearic acid, beeswax, paraffin, fatty alcohol, vaseline, vegetable oil and liquid paraffin.
Preferably, the aqueous phase is purified water.
Preferably, the emulsifier is one or a mixture of sodium dodecyl sulfate, span, tween, polysorbate and glycerin monostearate.
Preferably, the adjuvant I is one or a mixture of polyethylene glycol, glycerol and propylene glycol.
Preferably, the auxiliary agent II is acetate vitamin E, disodium hydrogen phosphate, sodium citrate, ethylene diamine tetraacetate, p-hydroxybenzoate ester and p-hydroxybenzoate propionate.
The invention also relates to a composition of the mirtazapine preparation for treating nausea, vomiting and anorexia of pets and a process thereof, which comprises the following steps:
step 1, heating the water phase to 90-95 ℃ for later use; adding an auxiliary agent II into the step 1 according to water solubility to be mixed and dissolved or adding the auxiliary agent II into the step 2 according to oil solubility to be mixed and dissolved;
step 2, mixing the oil phase, the emulsifier and the auxiliary agent I, heating to 80-90 ℃, pouring into the water phase, mixing and emulsifying, wherein the emulsifying temperature is 40-60 ℃;
and 3, stirring, and adding the ground mirtazapine powder to obtain the ointment composition.
Preferably, in step 1, the aqueous phase is heated to 90 ℃ and then kept warm for use.
Preferably, in step 3, the stirring time is 1 to 3 hours.
Mirtazapine acts as a central presynaptic alpha 2 receptor antagonist, enhancing adrenergic nerve conduction. Function to modulate 5-HT by interacting with central 5-hydroxytryptamine (5-HT2, 5-HT3) receptors. Both enantiomers of mirtazapine have antidepressant activity, the levorotatory isomer blocking the alpha 2 receptor and the 5-HT2 receptor and the dextrorotatory isomer blocking the 5-HT3 receptor. Mirtazapine has sedative effect, good tolerance, almost no anticholinergic effect, and no influence on cardiovascular system due to its therapeutic dose.
Mirtazapine has strong pharmacokinetics, is absorbed quickly after being smeared, has the bioavailability of about 50 percent, reaches the peak plasma concentration after about 2 hours and has the plasma protein binding rate of about 85 percent. The average half-life period is 20-40 h, the occasional time is as long as 65h, and the short half-life period is also occasional in young people. The blood concentration reaches a steady state 3-4 days after the medicine is taken, and then no in-vivo aggregation phenomenon occurs. The main metabolic modes are demethylation and oxidation reactions, and the demethylated metabolite still has pharmacological activity like the original compound. Mirtazapine is excreted in the body via urine and faeces within a few days after administration. Poor liver and kidney function can cause a decrease in mirtazapine clearance.
The matrix involved in the invention plays a decisive role in the quality, drug release and absorption of the product; the matrix selected by the invention has high stability, and the matrix and mirtazapine do not generate compatibility change;
the common mirtazapine is used as one of the raw materials, and is mixed with the emulsified substrate to prepare the ointment composition for treating nausea, vomiting and anorexia of pets, the method is simple, large-scale equipment is not needed, and only simple mixing is needed; the ointment composition prepared by the invention has very remarkable effect on treating nausea, vomit and anorexia of pets, and is particularly remarkable for stimulating the appetite of pets suffering from chronic kidney diseases; the preparation method is simple, low in cost, environment-friendly, free of side effect and good in application prospect.
The ointment composition prepared by the invention has the following characteristics: uniform, fine and non-irritant; good stability, good safety, sterility, etc.
The method of the invention has the following advantages:
(1) the product of the invention can be used as the first choice drug of appetite promoter.
(2) The product of the invention is used for treating nausea, vomiting and anorexia in pets.
(3) The product of the invention is particularly useful for stimulating appetite in pets suffering from chronic kidney disease.
(4) The preparation method is simple, low in cost, environment-friendly, free of side effect and good in application prospect.
Detailed Description
The present invention will be described in detail with reference to specific examples. It should be noted that the following examples are only illustrative of the present invention, but the scope of the present invention is not limited to the following examples.
Example 1
The embodiment relates to a mirtazapine preparation for treating nausea, vomiting and anorexia of pets, which consists of mirtazapine and a substrate; the addition amount of the mirtazapine accounts for 5% of the total weight of the ointment composition; the substrate is an emulsion type substrate; wherein the composition of the emulsified matrix is as follows: oil phase, water phase, emulsifier, adjuvant I and adjuvant II; the oil phase, the water phase, the emulsifier, the adjuvant I and the adjuvant II are mixed according to the mass ratio of 5:3:1:0.5: 0.05.
The oil phase is formed by mixing stearic acid and octadecanol according to the mass ratio of 1: 1.
The water phase is purified water.
The emulsifier is sodium dodecyl sulfate.
The adjuvant I is polyethylene glycol.
The auxiliary agent II is disodium hydrogen phosphate.
Also relates to a process for preparing the mirtazapine preparation for treating nausea, vomiting and anorexia of pets, which comprises the following steps:
step 1, heating and stirring the water phase and the auxiliary agent II to 90 ℃ for later use;
step 2, mixing the oil phase, the emulsifier and the auxiliary agent, heating to 80 ℃, pouring the mixture into the water phase, mixing and emulsifying, wherein the emulsifying temperature is 40 ℃;
and 3, emulsifying and stirring, and adding the ground mirtazapine powder to obtain the ointment composition.
Preferably, in step 3, the stirring time is 1 to 3 hours.
The matrix involved in this example plays a decisive role in the quality, drug release and absorption of the product in the present invention; the matrix selected by the invention has high stability, and the matrix and mirtazapine do not generate compatibility change;
in the embodiment, the ointment composition is prepared by mixing common mirtazapine serving as one of raw materials with a W/O type emulsified base, and is used for treating nausea, vomiting and anorexia of pets, and the method is simple, does not need large-scale equipment and only needs simple mixing; the ointment composition prepared by the invention has very remarkable effect on treating nausea, vomit and anorexia of pets, and is particularly remarkable for stimulating the appetite of cats suffering from chronic kidney diseases; the preparation method is simple, low in cost, environment-friendly, free of side effect and good in application prospect.
The ointment composition prepared in this example had the following characteristics: uniform, fine and non-irritant; good stability, good safety, sterility, etc.
Example 2
The embodiment relates to a mirtazapine preparation for treating nausea, vomiting and anorexia of pets, which consists of mirtazapine and a substrate; the addition amount of the mirtazapine accounts for 8 percent of the total mass of the ointment composition; the substrate is an emulsion type substrate; wherein the composition of the emulsified matrix is as follows: oil phase, water phase, emulsifier, adjuvant I and adjuvant II; the oil phase, the water phase, the emulsifier, the adjuvant I and the adjuvant II are mixed according to the mass ratio of 5:3:1:0.5: 0.05.
The oil phase is formed by mixing stearic acid, beeswax and hexadecanol according to the mass ratio of 1:1: 1.
The water phase is purified water.
The emulsifier is formed by mixing sodium dodecyl sulfate and span according to the mass ratio of 1: 1.
The auxiliary agent I is formed by mixing glycerol and polyethylene glycol according to the mass ratio of 1: 1.
The auxiliary agent II is formed by mixing p-hydroxybenzoate and p-hydroxybenzoate propionate according to the mass ratio of 4: 1.
Also relates to a preparation method of the mirtazapine preparation for treating nausea, vomiting and anorexia of pets, which comprises the following steps:
step 1, heating the water phase to 90-95 ℃ for later use;
step 2, mixing the oil phase, the emulsifier, the adjuvant I and the adjuvant II, heating to 80-90 ℃, pouring into the water phase, mixing and emulsifying, wherein the emulsifying temperature is 40-60 ℃;
and 3, emulsifying and stirring, and adding the ground mirtazapine powder to obtain the ointment composition. The stirring time was 1 hour.
The matrix involved in this example plays a decisive role in the quality, drug release and absorption of the product in the present invention; the matrix selected by the invention has high stability, and the matrix and mirtazapine do not generate compatibility change;
in the embodiment, the ointment composition is prepared by mixing common mirtazapine serving as one of raw materials with a W/O type emulsified base, and is used for treating nausea, vomiting and anorexia of pets, and the method is simple, does not need large-scale equipment and only needs simple mixing; the ointment composition prepared by the invention has very remarkable effect on treating nausea, vomit and anorexia of pets, and is particularly remarkable for stimulating the appetite of cats suffering from chronic kidney diseases; the preparation method is simple, low in cost, environment-friendly, free of side effect and good in application prospect.
The ointment composition prepared in this example had the following characteristics: uniform, fine and non-irritant; good stability, good safety, sterility, etc.
Example 3
The embodiment relates to a mirtazapine preparation for treating nausea, vomiting and anorexia of pets, which consists of mirtazapine and a substrate; the addition amount of the mirtazapine accounts for 7 percent of the total mass of the ointment composition, and the matrix is an emulsified matrix; wherein the composition of the emulsified matrix is as follows: oil phase, water phase, emulsifier, adjuvant I and adjuvant II; the oil phase, the water phase, the emulsifier, the adjuvant I and the adjuvant II are mixed according to the mass ratio of 5:3:1:0.5: 0.05.
The oil phase is formed by mixing stearic acid, beeswax and paraffin according to the mass ratio of 1:1: 1.
The water phase is purified water.
The emulsifier is sodium dodecyl sulfate, span 20 and tween 20, and the mass ratio of the emulsifier to the emulsifier is 1:1 are mixed.
The auxiliary agent I is formed by mixing glycerol and propylene glycol according to the mass ratio of 1: 1.
The auxiliary agent II is formed by mixing p-hydroxybenzoate and p-hydroxybenzoate propionate according to the mass ratio of 4: 1.
Also relates to a preparation method of the mirtazapine preparation for treating nausea, vomiting and anorexia of pets, which comprises the following steps:
step 1, heating the water phase to 90-95 ℃ for later use;
step 2, mixing the oil phase, the emulsifier, the adjuvant I and the adjuvant II, heating and stirring to 80-90 ℃, pouring into the water phase, mixing and emulsifying, wherein the emulsifying temperature is 40-60 ℃;
and 3, stirring, and adding the ground mirtazapine powder to obtain the ointment composition.
Preferably, in step 3, the stirring time is 3 hours.
The matrix involved in this example plays a decisive role in the quality, drug release and absorption of the product in the present invention; the matrix selected by the invention has high stability, and the matrix and mirtazapine do not generate compatibility change;
in the embodiment, the ointment composition is prepared by mixing common mirtazapine serving as one of raw materials with a W/O type emulsified base, and is used for treating nausea, vomiting and anorexia of pets, and the method is simple, does not need large-scale equipment and only needs simple mixing; the ointment composition prepared by the invention has very remarkable effect on treating nausea, vomit and anorexia of pets, and is particularly remarkable for stimulating the appetite of cats suffering from chronic kidney diseases; the preparation method is simple, low in cost, environment-friendly, free of side effect and good in application prospect.
The ointment composition prepared in this example had the following characteristics: uniform, fine and non-irritant; good stability, good safety, sterility, etc.
Example 4
The embodiment relates to a mirtazapine preparation for treating nausea, vomiting and anorexia of pets, which consists of mirtazapine and a substrate; the addition amount of the mirtazapine accounts for 20 percent of the total mass of the ointment composition; the substrate is an emulsion type substrate; wherein the composition of the emulsified matrix is as follows: oil phase, water phase, emulsifier, adjuvant I and adjuvant II; the oil phase, the water phase, the emulsifier, the adjuvant I and the adjuvant II are mixed according to the mass ratio of 5:3:1:0.5: 0.05.
The oil phase is stearic acid, beeswax, paraffin and octadecanol according to a mass ratio of 1:1:1 are mixed.
The water phase is purified water.
The emulsifier is formed by mixing sodium dodecyl sulfate, span 20 and polysorbate 80 according to the mass ratio of 1: 11.
The auxiliary agent I is formed by mixing polyethylene glycol and glycerol according to the mass ratio of 1: 1.
The auxiliary agent II is formed by mixing disodium hydrogen phosphate, sodium citrate and ethylene diamine tetraacetic acid according to the mass ratio of 2:1: 0.5.
Also relates to a preparation method of the mirtazapine preparation for treating nausea, vomiting and anorexia of pets, which comprises the following steps:
step 1, stirring and heating the water phase and the auxiliary agent II to 90-95 ℃ for later use;
step 2, mixing the oil phase, the emulsifier and the auxiliary agent I, heating to 80-90 ℃, pouring into the water phase, mixing and emulsifying, wherein the emulsifying temperature is 40-60 ℃;
and 3, stirring, and adding the ground mirtazapine powder to obtain the ointment composition.
Preferably, in step 1, the aqueous phase is heated to 90 ℃ and then kept warm for use.
Preferably, in step 3, the stirring time is 3 hours.
The matrix involved in this example plays a decisive role in the quality, drug release and absorption of the product in the present invention; the matrix selected by the invention has high stability, and the matrix and mirtazapine do not generate compatibility change;
in the embodiment, the ointment composition is prepared by mixing common mirtazapine serving as one of raw materials with a W/O type emulsified base, and is used for treating nausea, vomiting and anorexia of pets, and the method is simple, does not need large-scale equipment and only needs simple mixing; the ointment composition prepared by the invention has very remarkable effect on treating nausea, vomit and anorexia of pets, and is particularly remarkable for stimulating the appetite of cats suffering from chronic kidney diseases; the preparation method is simple, low in cost, environment-friendly, free of side effect and good in application prospect.
The ointment composition prepared in this example had the following characteristics: uniform, fine and non-irritant; good stability, good safety, sterility, etc.
Example 5
The embodiment relates to a mirtazapine preparation for treating nausea, vomiting and anorexia of pets, which consists of mirtazapine and a substrate; the addition amount of the mirtazapine accounts for 5% of the total weight of the ointment composition; the substrate is an emulsion type substrate; wherein the composition of the emulsified matrix is as follows: oil phase, water phase, emulsifier, adjuvant I and adjuvant II; the oil phase, the water phase, the emulsifier, the adjuvant I and the adjuvant II are mixed according to the mass ratio of 5:3:1:0.5: 0.05.
The oil phase is stearic acid, beeswax, paraffin and octadecanol according to a mass ratio of 1:1:1 are mixed.
The water phase is purified water.
The emulsifier is sodium dodecyl sulfate, span 20, tween 20 and polysorbate 80 in a mass ratio of 1:1:1 are mixed.
The auxiliary agent I is formed by mixing polyethylene glycol and glycerol according to the mass ratio of 1: 1.
The auxiliary agent II is formed by mixing sodium citrate and ethylene diamine tetraacetic acid according to the mass ratio of 2: 0.5.
Also relates to a preparation method of the mirtazapine preparation for treating nausea, vomiting and anorexia of pets, which comprises the following steps:
step 1, stirring and heating the water phase and the auxiliary agent II to 90-95 ℃ for later use;
step 2, mixing the oil phase, the emulsifier and the auxiliary agent I, heating to 80-90 ℃, pouring into the water phase, mixing and emulsifying, wherein the emulsifying temperature is 40-60 ℃;
and 3, stirring, and adding the ground mirtazapine powder to obtain the ointment composition.
Preferably, in step 1, the aqueous phase is heated to 90 ℃ and then kept warm for use.
Preferably, in step 3, the stirring time is 2 hours.
The matrix involved in this example plays a decisive role in the quality, drug release and absorption of the product in the present invention; the matrix selected by the invention has high stability, and the matrix and mirtazapine do not generate compatibility change;
in the embodiment, the ointment composition is prepared by mixing common mirtazapine serving as one of raw materials with a W/O type emulsified base, and is used for treating nausea, vomiting and anorexia of pets, and the method is simple, does not need large-scale equipment and only needs simple mixing; the ointment composition prepared by the invention has very remarkable effect on treating nausea, vomit and anorexia of pets, and is particularly remarkable for stimulating the appetite of cats suffering from chronic kidney diseases; the preparation method is simple, low in cost, environment-friendly, free of side effect and good in application prospect.
The ointment composition prepared in this example had the following characteristics: uniform, fine and non-irritant; good stability, good safety, sterility, etc.
Example 6
The embodiment relates to a mirtazapine preparation for treating nausea, vomiting and anorexia of pets, which consists of mirtazapine and a substrate; the addition amount of the mirtazapine accounts for 30 percent of the total mass of the ointment composition; the substrate is an emulsion type substrate; wherein the composition of the emulsified matrix is as follows: oil phase, water phase, emulsifier, adjuvant I and adjuvant II; the oil phase, the water phase, the emulsifier, the adjuvant I and the adjuvant II are mixed according to the mass ratio of 5:3:1:0.5: 0.05: and (4) mixing.
The oil phase is stearic acid, beeswax, paraffin and octadecanol according to a mass ratio of 1:1:1 are mixed.
The water phase is purified water.
The emulsifier is sodium dodecyl sulfate, span 20, tween 20 and polysorbate 80 in a mass ratio of 1:1:1 are mixed.
The auxiliary agent I is formed by mixing polyethylene glycol and glycerol according to the mass ratio of 1: 1.
The auxiliary agent II is formed by mixing disodium hydrogen phosphate, sodium citrate and ethylene diamine tetraacetic acid according to the mass ratio of 1:2: 0.5.
Also relates to a preparation method of the mirtazapine preparation for treating nausea, vomiting and anorexia of pets, which comprises the following steps:
step 1, stirring and heating the water phase and the auxiliary agent II to 90-95 ℃ for later use;
step 2, mixing the oil phase, the emulsifier and the auxiliary agent I, heating to 80-90 ℃, pouring into the water phase, mixing and emulsifying, wherein the emulsifying temperature is 40-60 ℃;
and 3, stirring, and adding the ground mirtazapine powder to obtain the ointment composition.
Preferably, in step 1, the aqueous phase is heated to 90 ℃ and then kept warm for use.
Preferably, in step 3, the stirring time is 1 to 3 hours.
The matrix involved in this example plays a decisive role in the quality, drug release and absorption of the product in the present invention; the matrix selected by the invention has high stability, and the matrix and mirtazapine do not generate compatibility change;
in the embodiment, the ointment composition is prepared by mixing common mirtazapine serving as one of raw materials with a W/O type emulsified base, and is used for treating nausea, vomiting and anorexia of pets, and the method is simple, does not need large-scale equipment and only needs simple mixing; the ointment composition prepared by the invention has very remarkable effect on treating nausea, vomit and anorexia of pets, and is particularly remarkable for stimulating the appetite of cats suffering from chronic kidney diseases; the preparation method is simple, low in cost, environment-friendly, free of side effect and good in application prospect.
The ointment composition prepared in this example had the following characteristics: uniform, fine and non-irritant; good stability, good safety, sterility, etc.
Example 7
The embodiment relates to a mirtazapine preparation for treating nausea, vomiting and anorexia of pets, which consists of mirtazapine and a substrate; the addition amount of the mirtazapine accounts for 7 percent of the total mass of the ointment composition; the substrate is an emulsion type substrate; wherein the composition of the emulsified matrix is as follows: oil phase, water phase, emulsifier, adjuvant I and adjuvant II; the oil phase, the water phase, the emulsifier, the adjuvant I and the adjuvant II are mixed according to the mass ratio of 5:3:1:0.5: 0.05.
The oil phase is fatty alcohol.
The water phase is purified water.
The emulsifier is prepared by mixing span 20, glyceryl stearate and sodium dodecyl sulfate according to the mass ratio of 1:1: 1.
The auxiliary agent I is formed by mixing polyethylene glycol and glycerol according to the mass ratio of 1: 1.
The auxiliary agent II is formed by mixing p-hydroxybenzoate and p-hydroxybenzoate propionate according to the mass ratio of 4: 1.
Also relates to a preparation method of the mirtazapine preparation for treating nausea, vomiting and anorexia of pets, which comprises the following steps:
step 1, heating the water phase to 90-95 ℃ for later use;
step 2, mixing the oil phase, the emulsifier, the adjuvant I and the adjuvant II, heating to 80-90 ℃, pouring into the water phase, mixing and emulsifying, wherein the emulsifying temperature is 40-60 ℃;
and 3, stirring, and adding the ground mirtazapine powder to obtain the ointment composition.
Preferably, in step 1, the aqueous phase is heated to 90 ℃ and then kept warm for use.
Preferably, in step 3, the stirring time is 3 hours.
The matrix involved in this example plays a decisive role in the quality, drug release and absorption of the product in the present invention; the matrix selected by the invention has high stability, and the matrix and mirtazapine do not generate compatibility change;
in the embodiment, the common mirtazapine is used as one of the raw materials, and the emulsified matrixes of the mirtazapine are mixed to prepare the ointment composition for treating nausea, vomiting and anorexia of pets, wherein the method is simple, large-scale equipment is not needed, and only simple mixing is needed; the ointment composition prepared by the invention has very remarkable effect on treating nausea, vomit and anorexia of pets, and particularly has remarkable effect on stimulating the appetite of pets with chronic kidney diseases; the preparation method is simple, low in cost, environment-friendly, free of side effect and good in application prospect.
The ointment composition prepared in this example had the following characteristics: uniform, fine and non-irritant; good stability, good safety, sterility, etc.
Example 8
The embodiment relates to a mirtazapine preparation for treating nausea, vomiting and anorexia of pets, which consists of mirtazapine and a substrate; the addition amount of the mirtazapine accounts for 5% of the total mass of the cream composition; the substrate is an emulsion type substrate; wherein the composition of the emulsified matrix is as follows: oil phase, water phase, emulsifier, adjuvant I and adjuvant II; the oil phase, the water phase, the emulsifier, the adjuvant I and the adjuvant II are mixed according to the mass ratio of 5:3:1:0.5: 0.05.
The oil phase is formed by mixing olive oil and triglyceride according to the mass ratio of 1: 1. .
The water phase is purified water.
The emulsifier is formed by mixing Tween 80 and span 20 according to the mass ratio of 1: 1. .
The auxiliary agent I is formed by mixing glycerol and propylene glycol according to the mass ratio of 1: 1.
The auxiliary agent II is formed by mixing p-hydroxybenzoate and p-hydroxybenzoate propionate according to the mass ratio of 4: 1.
Also relates to a preparation method of the mirtazapine preparation for treating nausea, vomiting and anorexia of pets, which comprises the following steps:
step 1, heating the water phase to 90-95 ℃ for later use;
step 2, mixing the oil phase, the emulsifier, the adjuvant I and the adjuvant II, adding the ground mirtazapine powder, stirring and heating to 80-90 ℃, pouring the mixture into the water phase, mixing and emulsifying, wherein the emulsifying temperature is 40-60 ℃;
and 3, stirring to obtain the cream composition.
Preferably, in step 1, the aqueous phase is heated to 90 ℃ and then kept warm for use.
Preferably, in step 3, the stirring time is 1 to 3 hours.
The matrix involved in this example plays a decisive role in the quality, drug release and absorption of the product in the present invention; the matrix selected by the invention has high stability, and the matrix and mirtazapine do not generate compatibility change;
in the embodiment, common mirtazapine is used as one of raw materials, and the emulsion type matrixes are mixed to prepare the cream composition, so that the cream composition is used for treating nausea, vomiting and anorexia of pets, the method is simple, large-scale equipment is not needed, and only simple mixing is needed; the cream composition prepared by the invention has very remarkable effect on treating nausea, vomit and anorexia of pets, and is particularly remarkable for stimulating the appetite of cats suffering from chronic kidney diseases; the preparation method is simple, low in cost, environment-friendly, free of side effect and good in application prospect.
The cream composition prepared in this example had the following characteristics: uniform, fine and non-irritant; good stability, good safety, sterility, etc.
Example 9
The embodiment relates to a mirtazapine preparation for treating nausea, vomiting and anorexia of pets, which consists of mirtazapine and a substrate; the addition amount of the mirtazapine accounts for 8% of the total weight of the external liquid composition; the matrix is an oily matrix; wherein the composition of the emulsified matrix is as follows: oil phase, water phase, emulsifier, adjuvant I and adjuvant II; the oil phase, the water phase, the emulsifier, the adjuvant I and the adjuvant II are mixed according to the mass ratio of 5:3:1:0.5: 0.05.
The oil phase is sunflower seed oil.
The emulsifier is Tween 20.
The adjuvant I is glycerol.
The auxiliary agent II is formed by mixing p-hydroxybenzoate and p-hydroxybenzoate propionate according to the mass ratio of 4: 1.
Also relates to a preparation method of the mirtazapine preparation for treating nausea, vomiting and anorexia of pets, which comprises the following steps:
step 1, mixing the oil phase, the emulsifier, the adjuvant I and the adjuvant II, adding the ground mirtazapine powder, heating and stirring to 50-90 ℃, and stirring for 1-3 hours.
Step 2, stirring until cooling, and obtaining the external liquid composition.
The matrix involved in this example plays a decisive role in the quality, drug release and absorption of the product in the present invention; the matrix selected by the invention has high stability, and the matrix and mirtazapine do not generate compatibility change;
in the embodiment, the externally-applied liquid composition is prepared by mixing common mirtazapine serving as one of raw materials with an oily matrix, and is used for treating nausea, vomiting and anorexia of pets, and the method is simple, does not need large-scale equipment and only needs simple mixing; the external liquid composition prepared by the invention has very remarkable effect on treating nausea, vomit and anorexia of pets, and is particularly remarkable for stimulating appetite of cats suffering from chronic kidney diseases; the preparation method is simple, low in cost, environment-friendly, free of side effect and good in application prospect.
The external liquid composition prepared in this example has the following characteristics: uniform, fine and non-irritant; good stability, good safety, sterility, etc.
Example 10
The embodiment relates to a mirtazapine preparation for treating nausea, vomiting and anorexia of pets, which consists of mirtazapine and a substrate; the addition amount of the mirtazapine accounts for 7% of the total mass of the gel composition; the substrate is an emulsion type substrate; wherein the composition of the emulsified matrix is as follows: oil phase, water phase, emulsifier, adjuvant I and adjuvant II; the oil phase, the water phase, the emulsifier, the adjuvant I and the adjuvant II are mixed according to the mass ratio of 5:3:1:0.5: 0.05.
The oil phase is sunflower seed oil.
The water phase is purified water.
The emulsifier is sodium dodecyl sulfate.
The auxiliary agent I is prepared by mixing xanthan gum and Arabic gum according to the mass ratio of 1: 1.
The adjuvant II is gallic acid.
Also relates to a preparation method of the mirtazapine preparation for treating nausea, vomiting and anorexia of pets, which comprises the following steps:
step 1, heating the water phase and the adjuvant II to 90-95 ℃ for later use;
step 2, mixing the oil phase, the emulsifier and the adjuvant I with the ground mirtazapine powder, heating to 80-90 ℃, pouring into the water phase, mixing and emulsifying, wherein the emulsifying temperature is 40-60 DEG C
And 3, stirring to obtain the gel composition.
Preferably, in step 1, the aqueous phase is heated to 90 ℃ and then kept warm for use.
Preferably, in step 3, the stirring time is 1 hour.
The matrix involved in this example plays a decisive role in the quality, drug release and absorption of the product in the present invention; the matrix selected by the invention has high stability, and the matrix and mirtazapine do not generate compatibility change;
in the embodiment, the gel composition is prepared by mixing common mirtazapine serving as one of raw materials with a matrix, and is used for treating nausea, vomiting and anorexia of pets, and the method is simple, does not need large-scale equipment and only needs simple mixing; the gel composition prepared by the invention has very remarkable effect on treating nausea, vomit and anorexia of pets, and is particularly remarkable for stimulating appetite of cats suffering from chronic kidney diseases; the preparation method is simple, low in cost, environment-friendly, free of side effect and good in application prospect.
The mirtazapine composition obtained from the above examples 1-10 can be used for treating nausea, emesis and anorexia of pets with remarkable effect; the administration mode of the invention is that the medicine is evenly smeared at the inner side of the pet ear; the administration dose is 0.3-0.9mg/kg once every 1-2 days for 14 consecutive days.
To illustrate the mirtazapine compositions obtained in examples 1-10 according to the present invention for the treatment of pets suffering from nausea, vomiting and anorexia, the following treatment data are now provided:
more than 1000 cases of dogs and cats are successfully treated since 11 months in 2014 by using the mirtazapine composition prepared by the method, the curative effect is exact, and the diseases are not serious and are cured once; for severe cases requiring multiple treatments, the clinical effective rate is over 95 percent, and the cure rate is over 80 percent.
The mirtazapine compositions obtained in examples 1-10 are used for the treatment of nausea, vomiting and anorexia in companion animals in the following cases: table 1 shows the therapeutic effect of mirtazapine after use according to the invention;
TABLE 1
Figure BDA0002589702310000141
Figure BDA0002589702310000151
As can be seen from the data in the table 1, the mirtazapine composition prepared by the invention is applied to 10 patients, and the disease is obviously relieved or cured after the mirtazapine composition related to the invention is used; the mirtazapine composition prepared by the invention has higher treatment effect on symptoms such as nausea, vomit, anorexia and the like of pets; the mirtazapine composition has good application prospect and good economic benefit value. By the early 2020, effect tests show that 1000 pets using mirtazapine to treat nausea, vomiting and anorexia have an effective rate of over 95 percent through preliminary statistics. Is worthy of further research and popularization.
The method of the invention has the following advantages:
(1) the product of the invention can be used as the first choice drug of appetite promoter.
(2) The product of the invention is used for treating nausea, vomiting and anorexia in pets.
(3) The product of the invention is particularly useful for stimulating appetite in pets suffering from chronic kidney disease.
(4) The preparation method is simple, low in cost, environment-friendly, free of side effect and good in application prospect.
The foregoing description of specific embodiments of the present invention has been presented. It is to be understood that the present invention is not limited to the specific embodiments described above, and that various changes or modifications may be made by one skilled in the art within the scope of the appended claims without departing from the spirit of the invention.

Claims (11)

1. A mirtazapine preparation for treating nausea, vomiting and anorexia of pets is characterized by comprising mirtazapine and a substrate.
2. The formulation of mirtazapine for the treatment of nausea, vomiting, anorexia in companion animals as defined in claim 1 wherein the formulation is a topical liquid, ointment, cream, gel.
3. The formulation of mirtazapine for treating nausea vomiting, anorexia, and loss of appetite in companion animals as claimed in claim 1 wherein said base is an emulsified base; wherein the composition of the emulsified matrix is as follows: oil phase, water phase, emulsifier, and adjuvant I and adjuvant II.
4. The formulation of mirtazapine for treating nausea, vomiting and anorexia in companion animals as claimed in claim 1, wherein said mirtazapine is added in an amount of 5% to 20% by weight of the total composition.
5. The formulation of mirtazapine for treating nausea, vomiting and anorexia in companion animals as claimed in claim 1, wherein said mirtazapine is added in an amount of 5% to 8% by weight of the total composition.
6. The mirtazapine formulation for treating nausea, vomiting and anorexia in pets according to claim 3, wherein the oil phase is one or more of stearic acid, beeswax, paraffin, fatty alcohol, vaseline, vegetable oil and liquid paraffin, and the oil phase accounts for 15-50% by weight of the total composition.
7. The mirtazapine formulation for the treatment of nausea, vomiting, anorexia in pets according to claim 3, wherein the aqueous phase is purified water and the amount of the aqueous phase is 10-40% by weight of the total composition.
8. The mirtazapine formulation for treating nausea, vomiting and anorexia in pets according to claim 3, wherein the emulsifier is one or a mixture of several of sodium dodecyl sulfate, span, tween, polysorbate and glyceryl stearate, and the emulsifier accounts for 5-20% of the total weight of the composition.
9. The composition for treating nausea, vomiting and anorexia in pets according to claim 3, wherein the auxiliary agent I is one or more of antifreeze, consistency regulator and humectant, in particular propylene glycol, polyethylene glycol and glycerol, and accounts for 4-20% by weight of the total composition.
10. The mirtazapine formulation for treating nausea, vomiting and anorexia in pets according to claim 3, wherein said adjuvant II comprises antioxidants, pH regulators, preservatives, colorants in an amount of 0.1-5% by weight of the total composition.
11. A process of forming a mirtazapine formulation for treating nausea, vomiting and anorexia in companion animals as defined in claim 3, comprising the steps of:
step 1, stirring and heating the water phase to 90-95 ℃ for later use; the auxiliary agent II is dissolved according to the water-soluble addition step 1 or the oil-soluble addition step 2;
step 2, mixing the oil phase, the emulsifier and the adjuvant I, stirring and heating to 80-90 ℃, pouring the mixture into the water phase, mixing and emulsifying, wherein the emulsifying temperature is 40-60 ℃;
and 3, stirring, and adding the ground mirtazapine powder to obtain the ointment composition.
CN202010692224.9A 2020-07-17 2020-07-17 Mizapine preparation composition for treating nausea, vomiting and anorexia of pets and process thereof Pending CN112107584A (en)

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