CN111214657A - Soft capsule containing phagostimulant for dogs and cats - Google Patents
Soft capsule containing phagostimulant for dogs and cats Download PDFInfo
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- CN111214657A CN111214657A CN201811403129.1A CN201811403129A CN111214657A CN 111214657 A CN111214657 A CN 111214657A CN 201811403129 A CN201811403129 A CN 201811403129A CN 111214657 A CN111214657 A CN 111214657A
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Abstract
The invention provides a soft capsule preparation for dogs and cats, which is characterized in that: (1) the capsule shell of the soft capsule contains food calling components; (2) mixing the active ingredients with adjuvants, making into drug-loaded granule (the shape of the drug-loaded granule includes spherical, nearly spherical, elliptical, flaky or irregular shape) by tablet press or extruder, kneading with film, and wrapping in capsule shell to form the soft capsule for dog and cat; or preparing the active ingredients into one of micro-capsules, microspheres, liposomes and solid dispersion particles, mixing the active ingredients with auxiliary materials, preparing the mixture into medicine-carrying particles (the shape of the medicine-carrying particles comprises a spherical shape, a nearly spherical shape, an oval shape, a sheet shape or an irregular shape) by a tablet press or an extruder, kneading the medicine-carrying particles and a film, and wrapping the mixture in a capsule shell to form the soft capsule for dogs and cats.
Description
Technical Field
The invention relates to a preparation technology of a veterinary drug preparation, in particular to a soft capsule containing a phagostimulant and treatment medicines (an anti-parasite medicine, an antibacterial medicine and a non-steroidal anti-inflammatory medicine), which is a preparation for dogs and cats with good food calling effect.
Background
The preparation for preventing and treating the diseases of the dogs and cats is commercially available as tablets, injections and external preparations (such as pour-on preparations, liniments and preparations for repelling and killing ectoparasites through medicated baths). The most commonly used dosage forms are mainly oral tablets. Because most drugs have certain odor, bitterness and are extremely sensitive to dog smell, the currently marketed oral tablets for dogs (such as praziquantel-containing tablets, ivermectin-containing tablets, albendazole-containing tablets, niclosamide-containing tablets and the like) have the problem of difficulty in administration because most tablets do not have a feeding attractant or do not have the expected effect of covering the odor and bitterness of the drugs such as praziquantel although a certain amount of the feeding attractant is added.
The application number is 201610423935.X discloses a soft capsule for dog and cat containing phagostimulant, which is characterized in that the soft capsule shell is added with ingredients with strong food calling effect for dog and cat, and the bad smell of the medicine is effectively covered by the isolation effect of the soft capsule shell. But the preparation method is basically consistent with the preparation of the common soft capsule.
The invention provides a new preparation method based on the preparation technology provided by the invention application, the preparation method provided by the invention can effectively cover the unpleasant odor of the medicine, and the preparation process is simpler, easy to control and lower in preparation cost.
Disclosure of Invention
The invention provides a soft capsule preparation for dogs and cats, which is characterized in that:
(1) the capsule shell of the soft capsule contains food calling components;
(2) mixing the active ingredients with adjuvants, making into drug-loaded granule (the shape of the drug-loaded granule includes spherical, nearly spherical, elliptical, flaky or irregular shape) by tablet press or extruder, kneading with film, and wrapping in capsule shell to form the soft capsule for dog and cat; or preparing the active ingredients into one of micro-capsules, microspheres, liposomes and solid dispersion particles, mixing the active ingredients with auxiliary materials, preparing the mixture into medicine-carrying particles (the shape of the medicine-carrying particles comprises a spherical shape, a nearly spherical shape, an oval shape, a sheet shape or an irregular shape) by a tablet press or an extruder, kneading the medicine-carrying particles and a film, and wrapping the mixture in a capsule shell to form the soft capsule for dogs and cats.
The invention provides an oral soft capsule preparation containing food calling components for dogs and cats, which is technically characterized by comprising the following components in part by weight:
(1) the oral soft capsule preparation comprises the following components: A. solid drug-loaded particles comprising an active ingredient; B. soft capsule shell containing food calling component;
(2) the preparation method of the oral soft capsule preparation comprises the following steps: the solid medicine carrying particles are encapsulated in a soft capsule film containing a food calling component to form the oral soft capsule preparation with the food calling function for the dogs and cats.
(3) The active ingredients comprise: antiparasitic, antibacterial, non-steroidal anti-inflammatory, vitamin, Chinese medicinal materials or Chinese medicinal extract;
(4) the soft capsule shell comprises gelatin, glycerol, water extractive solution decocted with animal tissue, correctant and antiseptic; wherein the ratio of gelatin, glycerol and water extract decocted with animal tissue is 1: 0.35-0.5: 0.8-1.4;
(5) the solid drug-carrying particles consist of auxiliary materials and active ingredients, and the shape of the drug-carrying particles comprises a sphere, a nearly sphere, an ellipse, a sheet or an irregular shape; the active ingredients can be directly mixed with auxiliary materials and prepared into drug-loaded particles with a certain shape by pressing or extruding, or the active ingredients can be prepared into microspheres, microcapsules or liposome firstly, then the active ingredients are combined with the auxiliary materials and prepared into the drug-loaded particles with a certain shape by pressing or extruding.
The drug-loaded particles are drug-loaded solid particles prepared by a tablet press or an extruder.
The animal tissue comprises animal liver, muscle or pork liver powder, chicken liver powder, fish powder, beef powder, and meat floss powder prepared from the above animal liver and muscle.
The flavoring agent comprises at least one of chocolate flavoring agent, butter flavoring agent, beef flavor essence, chicken flavor essence, smoked meat flavor essence, sodium glutamate, oleum Menthae Dementholatum, saccharin sodium, orange oil, aspartame, stevioside, sodium cyclamate, acesulfame potassium, 1, 4, 6-trichlorosucrose, caramel flavor essence, and mint flavor essence.
The above food calling components also comprise adeps Caprae Seu Ovis, adeps medulla bovis Seu Bubali, adeps Caprae Seu Ovis residue, adeps medulla bovis Seu Bubali residue, butter, fish oil, and soybean oil or oleum Maydis or oleum Arachidis Hypogaeae or oleum Helianthi fried with animal tissue.
The antiseptic comprises at least one of potassium sorbate, sodium propionate, p-hydroxybenzoate, ethyl p-hydroxybenzoate, propyl p-hydroxybenzoate, butyl p-hydroxybenzoate, chlorhexidine gluconate, oleum Lavandula Angustifolia, thyme oil, thymol, chlorhexidine iodine, thimerosal, povidone iodine, and iodine.
The antiparasitic agent includes at least one acid salt selected from praziquantel, lufenuron, alforamide (Afoxolaner), fradanan (Fluralaner), Nitenpyram (Nitenpyram), emercepide (Emodepside), niclosamide, closantel, hydroxychlorosalicylanilide, closantaline, thiobischlorophenol, disulfotol, chloroiodonitrophenol, thiochlorophenol, butylnaphthylamidine hydrochloride, diiodonitrophenol, acetamidoamin/arecoline, pyramidine pamoate, piperazine, diethylcarbamazine, pyrantel, hexachloroparaxylene, clorsulone, febantel, thiabendazole, albendazole, oxoalbendazole, toludazole, fenbendazole, oxfenbendazole, triclabendazole, levamisole, abamectin, ivermectin, doramectin, cerin, tiazamide, emamectin benzoate, milbemycin, and imidyl acetate;
the antibacterial drug comprises at least one of β -lactams, aminoglycosides, tetracyclines, macrolides, sulfonamides, quinolones, chloramphenical, tiamulin fumarate, valnemulin hydrochloride, trimethoprim and dimetridazole;
the non-steroidal anti-inflammatory drug comprises at least one of flunixin meglumine, ketoprofen, ibuprofen, carprofen, naproxen, nimesulide, celecoxib, rofecoxib, indomethacin, aspirin, carbapilin calcium, diclofenac sodium, ganciclovir, meloxicam, aminopyrine, analgin, antadine and acetaminophen;
the above Chinese medicinal extracts include, but are not limited to, astragalus polysaccharides, its extract, epimedium extract, cordyceps powder, propolis, and yeast extract.
The selected soft capsule preparation A containing praziquantel comprises the following steps:
(1) preparing a microcapsule core: the praziquantel and the sucrose are combined to prepare a microcapsule core which can pass through a 24-mesh sieve, and the weight ratio of the praziquantel to the sucrose in the microcapsule core is 6: 4 to 9: 1;
(2) preparing the microcapsule: putting the microcapsule core into a coating pot, and coating with a coating solution to prepare a praziquantel microcapsule, wherein the content of praziquantel in the microcapsule is 30-70%; the microcapsule can completely pass through 20 mesh sieve, and 60 mesh sieve residue is less than 10%;
(3) preparing auxiliary material particles: granulating the auxiliary materials by a wet method to prepare auxiliary material granules which can completely pass through a 20-mesh sieve; the auxiliary material particles comprise a binder, a diluent and a disintegrant which are commonly used for preparing tablets;
(4) preparing medicine carrying particles: mixing the praziquantel microcapsule, the auxiliary material granules, the flow aid and the anti-sticking agent, and pressing by using a tablet press to prepare the medicine-carrying granules; the weight of each particle of the drug-loaded particles is 150-3500 mg; each drug-loaded particle contains 10-200mg of praziquantel;
(5) preparing capsule material liquid for preparing a soft capsule shell: mixing animal tissue with water at a weight-to-volume ratio of 1: 3 to 1: 20, decocting at 85-100 deg.C, cooling, grinding with colloid mill or grinder or high speed shearing machine, and sieving with 80 mesh sieve to obtain animal tissue extractive solution; adding medicinal gelatin, glycerol and antiseptic into the animal tissue extractive solution, heating to 40-80 deg.C, and stirring to obtain capsule wall material solution for preparing soft capsule shell;
(6) preparing rubber sheets: degassing the heated capsule wall material liquid, and pressing the capsule wall material liquid into a rubber sheet through a roller;
(7) and (3) placing the drug-loaded particles between two capsule shell films, and pressing the two capsule shell films through a steel plate die or a rotary die to close the capsule shell films so as to prepare the praziquantel-containing soft capsule preparation.
The selected soft capsule preparation B containing praziquantel comprises the following steps:
(1) preparing medicine carrying particles: uniformly mixing the praziquantel with auxiliary material components, then adding water, mixing, and extruding by an extruder to prepare medicine-carrying granules; the auxiliary material components comprise 10-35% of powder prepared from animal tissues, 10-30% of rice flour, 8-20% of corn flour, 6-15% of corn starch, 3-30% of powdered sugar, 0.3-0.9% of salt powder, 0.1-0.25% of calcium carbonate and 6-15% of water; the weight of each particle of the drug-loaded particles is 150-3500 mg; each drug-loaded particle contains 10-200mg of praziquantel;
(2) preparing capsule material liquid for preparing a soft capsule shell: mixing animal tissue with water at a weight-to-volume ratio of 1: 3 to 1: 20, decocting at 85-100 deg.C, cooling, grinding with colloid mill or grinder or high speed shearing machine, and sieving with 80 mesh sieve to obtain animal tissue extractive solution; adding medicinal gelatin, glycerol and antiseptic into the animal tissue extractive solution, heating to 40-80 deg.C, and stirring to obtain capsule wall material solution for preparing soft capsule shell;
(3) preparing rubber sheets: degassing the heated capsule wall material liquid, and pressing the capsule wall material liquid into a rubber sheet through a roller;
(4) and (3) placing the drug-loaded particles between two capsule shell films, and pressing the two capsule shell films through a steel plate die or a rotary die to close the capsule shell films so as to prepare the praziquantel-containing soft capsule preparation.
Detailed Description
Example 1 composition and preparation of Praziquantel-containing Soft Capsule preparations 1 to 3
(1) Formulation composition
(2) Preparation process
(a) Preparing a water extract containing a food calling component: adding pork liver powder and water into an extraction tank according to the ratio of 1: 20, boiling for 50-70 minutes at 90-100 ℃, standing overnight, filtering with a 100-mesh sieve the next day, reserving filtrate for later use, and using filter residue for preparing drug-loaded particles.
(b) Preparing a capsule shell film: putting gelatin, glycerol, water extract containing food calling components and potassium sorbate into a gelatin making barrel according to the weight ratio in the table, heating to 65-80 ℃, filtering through a 100-mesh sieve, and degassing to obtain capsule wall material liquid; the capsule shell rubber sheet with proper toughness, certain elasticity and even thickness is prepared from the capsule material liquid by an automatic rotary capsule pricking machine.
(c) Preparing a drug-containing microcapsule: uniformly mixing the praziquantel raw material and sucrose according to the ratio of 1: 1, then mixing a proper amount of sucrose aqueous solution containing 45% with the mixture to prepare a soft material, sieving the soft material with a 30-mesh sieve for granulation, rolling, drying and screening to prepare a drug-containing microcapsule core; placing the medicine-containing capsule core in a coating, coating with coating solution (1-1.4kg of acrylic resin IV, 0-0.4 kg of castor oil, 0-0.4 kg of Tween 80, 0.1-0.35kg of diethyl phthalate and 13-16kg of 95% ethanol), controlling the air inlet temperature at 60-70 ℃, the air outlet temperature at 50-55 ℃, controlling the liquid sprayed out by a spray gun to be completely atomized, controlling the liquid spraying amount per minute to be 0-0.5% (less first and more later) of the weight of the medicine-containing capsule core, and controlling the rotating speed of a coating pan at 50-60 rpm. The weight of the coating layer is controlled to be 10-20% of the weight of the microcapsule. The prepared drug-containing microcapsule can be used for preparing drug-carrying particles.
(d) and (3) granulating the auxiliary materials, namely measuring β -cyclodextrin, the starch, the pork liver powder and the residual sucrose according to the above table, uniformly mixing, adding a 20% polyvinylpyrrolidone ethanol solution, uniformly mixing, extruding and granulating, drying, and sieving by a 20-mesh sieve to obtain auxiliary material granules.
(e) Preparing medicine carrying particles: mixing the drug-containing microcapsule with adjuvant granule and magnesium stearate, and tabletting to obtain drug-loaded granule containing praziquantel 30mg, 50mg and 100mg respectively.
(f) The drug-loaded particles are placed between two capsule shell tablets, and the capsule shell tablets are pressed by a steel plate mould or a rotary mould to close the capsule shell tablets, so as to prepare the soft capsules with the specifications of 30mg praziquantel/tablet, 50mg praziquantel/tablet and 100mg praziquantel/tablet respectively.
Example 2 composition and preparation of Ivermectin-containing Soft Capsule preparations 4 to 6
(1) Formulation composition
(2) Preparation process
(a) Preparing a water extract containing a food calling component: adding beef powder and water at a ratio of 1: 20 into an extraction tank, decocting at 90-100 deg.C for 50-70 min, standing overnight, filtering with 100 mesh sieve the next day, and collecting the filtrate for use.
(b) Preparing a capsule shell film: putting gelatin, glycerol, water extract containing food calling components and potassium sorbate into a gelatin making barrel according to the weight ratio in the table, heating to 65-80 ℃, filtering through a 100-mesh sieve, and degassing to obtain capsule wall material liquid; the capsule shell rubber sheet with proper toughness, certain elasticity and even thickness is prepared from the capsule material liquid by an automatic rotary capsule pricking machine.
(c) the drug-loaded granules are prepared by measuring ivermectin according to the above table, dissolving the ivermectin in 95% ethanol which is 10 times of the amount of the ivermectin, mixing the solution with β -cyclodextrin and starch, adding beef powder and cane sugar, mixing the mixture evenly, adding a solution containing 1% sodium carboxymethyl starch, mixing the mixture evenly, granulating the mixture by using a granulator, drying the mixture, sieving the mixture by using a 20-mesh sieve, mixing the granules below the sieve with magnesium stearate, and pressing the mixture by using a tablet press to prepare the drug-loaded granules containing 0.2mg, 0.4mg and 1.0mg of the ivermectin respectively.
(d) The drug-loaded particles are placed between two capsule shell tablets and are pressed by a steel plate die or a rotary die, so that the capsule shell film is closed, and the soft capsule with the specification of 0.2mg of ivermectin/capsule, 0.4mg of ivermectin/capsule and 1.0mg of ivermectin/capsule is prepared.
Example 3 composition and preparation of Ivermectin-containing Soft Capsule preparations 7 to 9
(1) Formulation composition
(2) Preparation process
(a) Preparing a water extract containing a food calling component: adding beef powder and water at a ratio of 1: 20 into an extraction tank, decocting at 90-100 deg.C for 50-70 min, standing overnight, filtering with 100 mesh sieve the next day, and collecting the filtrate for use.
(b) Preparing a capsule shell film: putting gelatin, glycerol, water extract containing food calling components and potassium sorbate into a gelatin making barrel according to the weight ratio in the table, heating to 65-80 ℃, filtering through a 100-mesh sieve, and degassing to obtain capsule wall material liquid; the capsule shell rubber sheet with proper toughness, certain elasticity and even thickness is prepared from the capsule material liquid by an automatic rotary capsule pricking machine.
(c) Preparing medicine carrying particles: taking ivermectin according to the above table, dissolving the ivermectin in 95% ethanol which is 10 times of the amount of the ivermectin, uniformly mixing the solution with the rest components, adding water which is 3% of the total amount, uniformly mixing, performing extrusion granulation (the temperature is controlled to be not more than 120 ℃) by using a double-screw extruder (MT65-II type), and drying to obtain medicine-carrying granules with ivermectin content of 0.2mg, 0.4mg and 1.0mg respectively.
(d) The drug-loaded particles are placed between two capsule shell tablets and are pressed by a steel plate die or a rotary die, so that the capsule shell film is closed, and the soft capsule with the specification of 0.2mg of ivermectin/capsule, 0.4mg of ivermectin/capsule and 1.0mg of ivermectin/capsule is prepared.
Example 4 composition and preparation of Soft Capsule formulations 10 to 12 containing Praziquantel
(1) Formulation composition
(2) Preparation process
(a) Preparing a water extract containing a food calling component: adding beef powder and water at a ratio of 1: 20 into an extraction tank, decocting at 90-100 deg.C for 50-70 min, standing overnight, filtering with 100 mesh sieve the next day, and collecting the filtrate for use.
(b) Preparing a capsule shell film: putting gelatin, glycerol, water extract containing food calling components and potassium sorbate into a gelatin making barrel according to the weight ratio in the table, heating to 65-80 ℃, filtering through a 100-mesh sieve, and degassing to obtain capsule wall material liquid; the capsule shell rubber sheet with proper toughness, certain elasticity and even thickness is prepared from the capsule material liquid by an automatic rotary capsule pricking machine.
(c) Preparing medicine carrying particles: the components are weighed according to the above table and put into a powder mixer, the mixture is uniformly mixed, the mixture is extruded and granulated by a double-screw extruder (MT65-II type) (the temperature is controlled not to exceed 120 ℃), the dried mixture is dried, oil immersion treatment is carried out (the dried granules are immersed for 5-7 minutes by soybean oil/beef tallow which is fried with beef powder, and then filtering is carried out by a screen mesh), and medicine-carrying granules with 30mg, 60mg and 100mg of praziquantel in each granule are respectively prepared.
(d) The drug-loaded particles are placed between two capsule shell tablets, and the capsule shell tablets are pressed by a steel plate mould or a rotary mould to close the capsule shell tablets, so as to prepare the soft capsules with the specifications of 30mg praziquantel/tablet, 60mg praziquantel/tablet and 100mg praziquantel/tablet respectively.
Example 5 composition and preparation of Soft Capsule preparation 13 to 15 containing Aforamide and Miraboxim
(1) Formulation composition
(2) Preparation process
(a) Preparing a water extract containing a food calling component: adding beef powder and water at a ratio of 1: 20 into an extraction tank, decocting at 90-100 deg.C for 50-70 min, standing overnight, filtering with 100 mesh sieve the next day, and collecting the filtrate for use.
(b) Preparing a capsule shell film: putting gelatin, glycerol, water extract containing food calling components and potassium sorbate into a gelatin making barrel according to the weight ratio in the table, heating to 65-80 ℃, filtering through a 100-mesh sieve, and degassing to obtain capsule wall material liquid; the capsule shell rubber sheet with proper toughness, certain elasticity and even thickness is prepared from the capsule material liquid by an automatic rotary capsule pricking machine.
(c) Preparing medicine carrying particles: the alfilana and milbemycin oxime are measured according to the above table, dissolved in 95% ethanol which is 10 times of the milbemycin oxime, then evenly mixed with the rest components, added with water which is 3% of the total amount, evenly mixed, extruded and granulated (the temperature is controlled not to exceed 100 ℃) by a double-screw extruder (MT65-II type), and dried to prepare the drug-loaded granules of which the alfilana and the milbemycin oxime are respectively 1.0mg +0.2mg, 2.0mg +0.4mg and 5.0mg +1.0 mg.
(d) The drug-loaded particles are placed between two capsule shell tablets and are pressed by a steel plate die or a rotary die, so that the capsule shell film is closed, and the soft capsules with the specifications of 1.0mg of alfilamide and 0.2mg of milbemycin oxime/tablet, 2.0mg of alfilamide and 0.4mg of milbemycin oxime/tablet and 5.0mg of alfilamide and 1.0mg of milbemycin oxime/tablet are prepared.
Example 6, summary of the phagostimulant Effect tests of formulation 1 to formulation 15
The results of feeding test dogs with formulations 1-15 show that the active food intake rate of the dogs is above 90% after 16 hours of food restriction. The active feeding rate of dogs who do not eat food is more than 86%. The product of the invention has good food calling effect.
Claims (9)
1. An oral soft capsule preparation containing food calling components for dogs and cats, which is characterized in that:
(1) the oral soft capsule preparation comprises the following components: A. solid drug-loaded particles comprising an active ingredient; B. soft capsule shell containing food calling component;
(2) the preparation method of the oral soft capsule preparation comprises the following steps: the solid medicine-carrying particles are encapsulated in soft capsule shells containing food calling components to form the oral soft capsule preparation with the food calling function for dogs and cats.
(3) The active ingredients comprise: antiparasitic, antibacterial, non-steroidal anti-inflammatory, vitamin, Chinese medicinal materials or Chinese medicinal extract;
(4) the soft capsule shell comprises gelatin, glycerol, water extractive solution decocted with animal tissue, correctant and antiseptic; wherein the ratio of gelatin, glycerol and water extract decocted with animal tissue is 1: 0.35-0.5: 0.8-1.4;
(5) the solid drug-carrying particles consist of auxiliary materials and active ingredients, and the shape of the drug-carrying particles comprises a sphere, a nearly sphere, an ellipse, a sheet or an irregular shape; the active ingredients can be directly mixed with auxiliary materials and prepared into drug-loaded particles with a certain shape by pressing or extruding, or the active ingredients can be prepared into microspheres, microcapsules or liposome firstly, then the active ingredients are combined with the auxiliary materials and prepared into the drug-loaded particles with a certain shape by pressing or extruding.
2. The soft capsule formulation of claim 1, wherein the drug-loaded particles are drug-loaded solid particles prepared using a tablet press or an extruder.
3. The soft capsule formulation of claim 1, wherein said animal tissue comprises animal liver, muscle or pork liver powder, chicken liver powder, fish meal, beef meal, meat floss meal prepared therefrom.
4. The soft capsule preparation of claim 1, wherein said flavoring agent comprises at least one of chocolate-type flavoring agent, cream flavoring agent, beef flavor, chicken flavor, smoked meat flavor, sodium glutamate, peppermint oil, saccharin sodium, orange oil, aspartame, stevioside, sodium cyclamate, acesulfame potassium, 1, 4, 6-sucralose, caramel flavor, and mint flavor.
5. The soft capsule formulation of claim 1, wherein said food calling ingredient comprises mutton fat, beef tallow, mutton fat pomace, beef tallow fat pomace, butter oil, fish oil, soybean oil or corn oil or peanut oil or sunflower oil that has been fried to animal tissue.
6. The soft capsule formulation of claim 1, wherein the preservative comprises at least one of potassium sorbate, sodium propionate, parabens, ethyl paraben, propyl paraben, butyl paraben, chlorhexidine gluconate, lavender oil, thyme oil, thymol, chlorhexidine iodine, thimerosal, povidone iodine, and iodine.
7. The soft capsule formulation of claim 1, wherein:
a. the antiparasitic agent comprises at least one acid salt of praziquantel, lufenuron, alforamide (Afoxolaner), frasnarin (Fluralaner), Nitenpyram (Nitenpyram), emercepside (Emodepside), niclosamide, closantel, hydroxychlorosalicylanilide, closantaline, thiobischlorophenol, disulfotol, chloroiodonitrophenol, thiochlorophenol, butylnaphthylamidine hydrochloride, diiodonitrophenol, acetamidine/arecoline, pyramidine pamoate, piperazine, diethylcarbamazine, pyrantel, hexachlorop-xylene, clorsulon, febantel, thiabendazole, albendazole, oxybenzdazole, toludazole, fenbendazole, oxfenbendazole, triclabendazole, levamisole, abamectin, ivermectin, doramectin, moxidectin, selamectin, emamectin benzoate, milbemycin, or imidocarb;
b. the antibacterial drug comprises at least one of β -lactams, aminoglycosides, tetracyclines, macrolides, sulfonamides, quinolones, chloramphenical, tiamulin fumarate, valnemulin hydrochloride, trimethoprim and dimetridazole;
c. the non-steroidal anti-inflammatory drug comprises at least one of flunixin meglumine, ketoprofen, ibuprofen, carprofen, naproxen, nimesulide, celecoxib, rofecoxib, indomethacin, aspirin, carbapirine calcium, diclofenac sodium, ganciclovir, meloxicam, aminopyrine, analgin, antadine and acetaminophen;
d. the traditional Chinese medicine extract comprises but is not limited to astragalus polysaccharide, astragalus root extract, epimedium extract, cordyceps sinensis powder, propolis and yeast extract.
8. The soft capsule preparation according to claim 7, wherein the composition and the preparation process of the soft capsule preparation containing praziquantel comprise the steps of:
a. preparing a microcapsule core: the praziquantel and the sucrose are combined to prepare a microcapsule core which can pass through a 24-mesh sieve, and the weight ratio of the praziquantel to the sucrose in the microcapsule core is 6: 4 to 9: 1;
b. preparing the microcapsule: putting the microcapsule core into a coating pot, and coating with a coating solution to prepare a praziquantel microcapsule, wherein the content of praziquantel in the microcapsule is 30-70%; the microcapsule can completely pass through 20 mesh sieve, and 60 mesh sieve residue is less than 10%;
c. preparing auxiliary material particles: granulating the auxiliary materials by a wet method to prepare auxiliary material granules which can completely pass through a 20-mesh sieve; the auxiliary material particles comprise a binder, a diluent and a disintegrant which are commonly used for preparing tablets;
d. preparing medicine carrying particles: mixing the praziquantel microcapsule, the auxiliary material granules, the flow aid and the anti-sticking agent, and pressing by using a tablet press to prepare the medicine-carrying granules; the weight of each particle of the drug-loaded particles is 150-3500 mg; each drug-loaded particle contains 10-200mg of praziquantel;
e. preparing capsule material liquid for preparing a soft capsule shell: mixing animal tissue with water at a weight-to-volume ratio of 1: 3 to 1: 20, decocting at 85-100 deg.C, cooling, grinding with colloid mill or grinder or high speed shearing machine, and sieving with 80 mesh sieve to obtain animal tissue extractive solution; adding medicinal gelatin, glycerol and antiseptic into the animal tissue extractive solution, heating to 40-80 deg.C, and stirring to obtain capsule wall material solution for preparing soft capsule shell;
f. preparing rubber sheets: degassing the heated capsule wall material liquid, and pressing the capsule wall material liquid into a rubber sheet through a roller;
g. and (3) placing the drug-loaded particles between two capsule shell films, and pressing the two capsule shell films through a steel plate die or a rotary die to close the capsule shell films so as to prepare the praziquantel-containing soft capsule preparation.
9. The soft capsule preparation according to claim 7, wherein the composition and the preparation process of the soft capsule preparation containing praziquantel comprise the steps of:
a. preparing medicine carrying particles: uniformly mixing the praziquantel with auxiliary material components, then adding water, mixing, and extruding by an extruder to prepare medicine-carrying granules; the auxiliary material components comprise 10-35% of powder prepared from animal tissues, 10-30% of rice flour, 8-20% of corn flour, 6-15% of corn starch, 3-30% of powdered sugar, 0.3-0.9% of salt powder, 0.1-0.25% of calcium carbonate and 6-15% of water; the weight of each particle of the drug-loaded particles is 150-3500 mg; each drug-loaded particle contains 10-200mg of praziquantel;
b. preparing capsule material liquid for preparing a soft capsule shell: mixing animal tissue with water at a weight-to-volume ratio of 1: 3 to 1: 20, decocting at 85-100 deg.C, cooling, grinding with colloid mill or grinder or high speed shearing machine, and sieving with 80 mesh sieve to obtain animal tissue extractive solution; adding medicinal gelatin, glycerol and antiseptic into the animal tissue extractive solution, heating to 40-80 deg.C, and stirring to obtain capsule wall material solution for preparing soft capsule shell;
c. preparing rubber sheets: degassing the heated capsule wall material liquid, and pressing the capsule wall material liquid into a rubber sheet through a roller;
d. and (3) placing the drug-loaded particles between two capsule shell films, and pressing the two capsule shell films through a steel plate die or a rotary die to close the capsule shell films so as to prepare the praziquantel-containing soft capsule preparation.
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WO2022069922A1 (en) * | 2020-09-30 | 2022-04-07 | Procaps S.A. | Formulation of ivermectin in soft gelatin capsules |
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