CN110613698B - Microencapsulated animal medicine and preparation method thereof - Google Patents
Microencapsulated animal medicine and preparation method thereof Download PDFInfo
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- 239000003814 drug Substances 0.000 title claims abstract description 103
- 238000002360 preparation method Methods 0.000 title claims abstract description 67
- 239000002245 particle Substances 0.000 claims abstract description 69
- 239000000463 material Substances 0.000 claims abstract description 67
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- 239000008108 microcrystalline cellulose Substances 0.000 claims abstract description 35
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- 229940016286 microcrystalline cellulose Drugs 0.000 claims abstract description 35
- 108010010803 Gelatin Proteins 0.000 claims abstract description 26
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- 239000008273 gelatin Substances 0.000 claims abstract description 26
- 235000019322 gelatine Nutrition 0.000 claims abstract description 26
- 235000011852 gelatine desserts Nutrition 0.000 claims abstract description 26
- 229920002261 Corn starch Polymers 0.000 claims abstract description 24
- 239000008120 corn starch Substances 0.000 claims abstract description 24
- 229940079593 drug Drugs 0.000 claims abstract description 24
- 239000000945 filler Substances 0.000 claims abstract description 21
- 239000002775 capsule Substances 0.000 claims abstract description 16
- 239000002994 raw material Substances 0.000 claims abstract description 15
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- 239000007921 spray Substances 0.000 claims description 50
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- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 10
- 229930006000 Sucrose Natural products 0.000 claims description 10
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- 239000008103 glucose Substances 0.000 claims description 10
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims description 10
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- 229960000223 tilmicosin Drugs 0.000 claims description 10
- JTSDBFGMPLKDCD-XVFHVFLVSA-N tilmicosin Chemical compound O([C@@H]1[C@@H](C)[C@H](O)CC(=O)O[C@@H]([C@H](/C=C(\C)/C=C/C(=O)[C@H](C)C[C@@H]1CCN1C[C@H](C)C[C@H](C)C1)CO[C@H]1[C@@H]([C@H](OC)[C@H](O)[C@@H](C)O1)OC)CC)[C@@H]1O[C@H](C)[C@@H](O)[C@H](N(C)C)[C@H]1O JTSDBFGMPLKDCD-XVFHVFLVSA-N 0.000 claims description 10
- 239000003995 emulsifying agent Substances 0.000 claims description 7
- 150000003839 salts Chemical class 0.000 claims description 6
- 239000005720 sucrose Substances 0.000 claims description 6
- SPFYMRJSYKOXGV-UHFFFAOYSA-N Baytril Chemical compound C1CN(CC)CCN1C(C(=C1)F)=CC2=C1C(=O)C(C(O)=O)=CN2C1CC1 SPFYMRJSYKOXGV-UHFFFAOYSA-N 0.000 claims description 2
- 229960000740 enrofloxacin Drugs 0.000 claims description 2
- 125000002791 glucosyl group Chemical group C1([C@H](O)[C@@H](O)[C@H](O)[C@H](O1)CO)* 0.000 claims description 2
- UURAUHCOJAIIRQ-QGLSALSOSA-N tiamulin Chemical compound CCN(CC)CCSCC(=O)O[C@@H]1C[C@@](C)(C=C)[C@@H](O)[C@H](C)[C@@]23CC[C@@H](C)[C@]1(C)[C@@H]2C(=O)CC3 UURAUHCOJAIIRQ-QGLSALSOSA-N 0.000 claims description 2
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- 235000019640 taste Nutrition 0.000 abstract description 4
- 239000011248 coating agent Substances 0.000 abstract description 3
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- 230000000052 comparative effect Effects 0.000 description 17
- 238000004519 manufacturing process Methods 0.000 description 12
- YXQXDXAHCSEVSD-GCYNEOGWSA-N dynamutilin Chemical compound OC(=O)\C=C\C(O)=O.CCN(CC)CCSCC(=O)O[C@@H]1C[C@@](C)(C=C)[C@@H](O)[C@H](C)[C@@]23CC[C@@H](C)[C@]1(C)[C@@H]2C(=O)CC3 YXQXDXAHCSEVSD-GCYNEOGWSA-N 0.000 description 10
- 229940092292 tiamulin fumarate Drugs 0.000 description 10
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- 238000001514 detection method Methods 0.000 description 8
- CQCIBVPASWGWAZ-UHFFFAOYSA-M sodium;1-cyclopropyl-7-(4-ethylpiperazin-1-yl)-6-fluoro-4-oxoquinoline-2-carboxylate Chemical compound [Na+].C1CN(CC)CCN1C(C(=C1)F)=CC2=C1C(=O)C=C(C([O-])=O)N2C1CC1 CQCIBVPASWGWAZ-UHFFFAOYSA-M 0.000 description 8
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- WHGYBXFWUBPSRW-FOUAGVGXSA-N beta-cyclodextrin Chemical compound OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO WHGYBXFWUBPSRW-FOUAGVGXSA-N 0.000 description 2
- 235000011175 beta-cyclodextrine Nutrition 0.000 description 2
- 229960004853 betadex Drugs 0.000 description 2
- 235000019438 castor oil Nutrition 0.000 description 2
- 239000004359 castor oil Substances 0.000 description 2
- 239000011162 core material Substances 0.000 description 2
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 description 2
- 235000001727 glucose Nutrition 0.000 description 2
- 150000004676 glycans Chemical class 0.000 description 2
- ZEMPKEQAKRGZGQ-XOQCFJPHSA-N glycerol triricinoleate Natural products CCCCCC[C@@H](O)CC=CCCCCCCCC(=O)OC[C@@H](COC(=O)CCCCCCCC=CC[C@@H](O)CCCCCC)OC(=O)CCCCCCCC=CC[C@H](O)CCCCCC ZEMPKEQAKRGZGQ-XOQCFJPHSA-N 0.000 description 2
- 230000006872 improvement Effects 0.000 description 2
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- 230000001070 adhesive effect Effects 0.000 description 1
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 description 1
- 238000010923 batch production Methods 0.000 description 1
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- 238000009835 boiling Methods 0.000 description 1
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- 150000002016 disaccharides Chemical class 0.000 description 1
- 229940126534 drug product Drugs 0.000 description 1
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- 229910052623 talc Inorganic materials 0.000 description 1
- 230000008542 thermal sensitivity Effects 0.000 description 1
- 125000000647 trehalose group Chemical group 0.000 description 1
Classifications
-
- 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
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
-
- 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
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
-
- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
-
- 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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
- A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5015—Organic compounds, e.g. fats, sugars
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5052—Proteins, e.g. albumin
- A61K9/5057—Gelatin
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Epidemiology (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Molecular Biology (AREA)
- Emergency Medicine (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention relates to the technical field of veterinary drugs, in particular to a microencapsulated animal drug and a preparation method thereof. The microencapsulated animal medicine comprises raw material medicines, wall materials and external fillers; the wall material comprises the following preparation raw materials in parts by weight: 30-40 parts of gelatin and 30-50 parts of saccharides; the external filler comprises the following preparation raw materials in parts by weight: 30-40 parts of corn starch or rice bran and 3-8 parts of microcrystalline cellulose. The microencapsulated animal medicine has the characteristics of round particles, good capsule material coating effect and good free-flowing property, and the effective medicinal ingredients are isolated from the outside, so that the purposes of masking taste, preventing moisture, improving the stability of the medicine and improving the utilization rate of the medicine are achieved.
Description
Technical Field
The invention relates to the technical field of veterinary drugs, in particular to a microencapsulated animal drug and a preparation method thereof.
Background
The microcapsule technology is a technology for embedding liquid or solid drugs (capsule wall materials) into tiny capsule particles with the diameter of 100-500 mu m by utilizing natural or synthetic polymer film-forming materials (wall materials), and the process for preparing the microcapsule particles is called microencapsulation for short. The drug microencapsulation has the advantages of covering up the bitter taste or the peculiar smell of the drug, improving the fluidity and the hygroscopicity of the drug, improving the stability of the drug, controlling the release of the drug, reducing the stimulation of the gastrointestinal tract and the like, so the preparation method of the microencapsulated drug is very popular at present and is widely applied to various industries.
There are three main methods for preparing microencapsulated drugs: firstly, the boiling granulation method, with in the powdery material drops into airtight container, because the effect of hot-blast air current, make powdery material suspension be the fluidization state in the container, spout into adhesive and atomizing simultaneously, make the powder agglomerate into the tiny particle, but the production facility of this method is mostly batch production, can not satisfy the requirement of assembly line, and its product granule is irregular, is not suitable for the material of easy oxidation and thermal sensitivity. The other is a fluidized bed coating method, which is a main method for forming the powdery and crystalline drugs into microcapsules based on the physical and mechanical principle, but the coated drugs have larger specific surface area, the phenomena of particle adhesion and electrostatic adsorption frequently occur in the preparation process, and the coating process needs longer time, has large energy consumption, high production cost and low production efficiency. Thirdly, a spray drying method, which has the basic principle that a core material substance is dispersed in a wall material solution, is uniformly mixed and is sprayed and atomized in hot air flow, so that a solvent for dissolving the core material is quickly evaporated, and a microencapsulated product is finally obtained; the method has the characteristics of simple production process, flexible operation, convenient control, high efficiency, low cost, low material temperature, high product purity and suitability for continuous production, so that the technology for preparing the microcapsule by using the spray drying method is more and more widely applied in recent years, and the research work is also continuously and deeply carried out.
For example, in the research on the preparation of tiamulin fumarate taste-masking microcapsules and the properties thereof (the first author: Hanjing), tiamulin fumarate microcapsules prepared by a spray drying method are disclosed, wherein gelatin, β -cyclodextrin and castor oil are used as auxiliary materials, so that the unpleasant smell of a raw material drug is effectively masked, and the hygroscopicity and the fluidity of the microcapsules are improved, but the process also indicates that the wall adhesion phenomenon is easy to occur in the spray drying process, and for example, in patent document CN105287433A, a preparation method of microencapsulated animal drugs is disclosed, wherein gelatin, saccharides, β -cyclodextrin and castor oil are used as auxiliary materials, so that the purposes of masking taste, preventing moisture and improving the bioavailability of the drugs can be achieved, but the microemulsion contains more saccharides, has relatively strong material adhesion, and therefore the wall adhesion problem is easy to occur in the spray drying process.
Therefore, there is a need for improvement of the prior art to overcome the problem of wall sticking during the preparation of veterinary microcapsules by spray drying.
Disclosure of Invention
Aiming at the defects of the prior art, one of the purposes of the invention is to provide a microencapsulated animal medicine, which effectively solves the problem of wall adhesion in the spray drying process by applying external auxiliary materials, has the characteristics of round particles, good capsule material coating effect and good flowing and dispersing property, and can isolate effective medicinal components from the outside, thereby achieving the purposes of masking taste, preventing moisture, improving the stability of the medicine and improving the utilization rate of the medicine.
In order to achieve the purpose, the invention adopts the following technical scheme:
a microencapsulated animal medicine comprises raw materials, wall materials and external filler;
the wall material comprises the following preparation raw materials in parts by weight: 30-40 parts of gelatin and 30-50 parts of saccharides;
the external filler comprises the following preparation raw materials in parts by weight: 30-40 parts of corn starch or rice bran and 3-8 parts of microcrystalline cellulose.
Further, the wall material also comprises 2-7 parts by weight of pullulan polysaccharide.
Further, the raw material medicine is one of tilmicosin or a salt thereof, tiamulin or a salt thereof, enrofloxacin or a salt thereof and florfenicol.
Further, the saccharide is glucose or sucrose.
Further, the microencapsulated animal medicine further contains an emulsifier.
Still further, the emulsifier is tween-80.
Another object of the present invention is to provide a process for preparing microencapsulated animal medicine, which improves the wall adhesion problem during spray drying, increases production efficiency, reduces product loss, lowers production cost, and is suitable for industrial flow line production of microencapsulated medicine.
In order to achieve the purpose, the invention adopts the following technical scheme:
a preparation method of a microencapsulated animal medicine specifically comprises the following steps:
s1, preparation of wall materials: dissolving gelatin and saccharides in a formula amount in water to obtain a water phase A;
s2, preparation of capsule wall materials: dissolving the raw material medicine in a solvent to obtain an oil phase B;
s3, preparation of a dispersion system: adding the oil phase B into the water phase A under the conditions that the shearing power is 50-80 kW and the stirring speed is 5000-10000 r/min, and then removing the solvent under the conditions that the stirring time is 15-20 min and the temperature is 50 ℃ to form a microemulsion;
s4, spray granulation and drying: adding an external filler with a formula amount into a spray granulation tower, enabling the external filler to circularly flow in the tower, pumping the microemulsion into the spray granulation tower for spray granulation and drying to obtain microencapsulated animal medicine particles and powder, collecting the microencapsulated animal medicine particles, and sieving the microencapsulated animal medicine particles by a sieve with 30-120 meshes to obtain the microencapsulated animal medicine.
Further, the solvent is ethanol or water.
Further, the step S1 further comprises adding 2-7 parts by weight of pullulan into water.
Further, step S2 includes adding an emulsifier to the solvent.
Further onAnd step S4, implementing granulation and drying simultaneously by using a conventional spray granulation dryer, wherein the conditions of spray granulation and drying are as follows: the upper air inlet temperature is 120 ℃, and the air inlet volume is 1400-1500 m3The lower air inlet temperature is 100 ℃, and the air inlet volume is 1000-1200 m3The rotating speed of the spray head is 2000-3000 r/min, and the liquid inlet amount is 20-30L/h.
In summary, the inventive concept of the present invention is as follows: in order to improve the wall sticking problem in the process of preparing veterinary drug microcapsules by a spray drying method, from the viewpoint of enhancing the material flowability and reducing the material caking property, the inventor introduces microcrystalline cellulose on the basis of the prior art, and finds that due to the structural characteristics of the microcrystalline cellulose, compared with substances with anti-caking and lubricating effects such as talcum powder, silicon dioxide and the like, the microcrystalline cellulose can better improve the wall sticking phenomenon caused by more saccharides, so that the microcrystalline cellulose is selected and mixed with corn starch or rice bran to be used as an external filler, and is combined with microemulsion in the spray drying process to be used as an external filler of a wall material, so that the material flowability is improved, the material caking property is reduced, and the wall sticking phenomenon is effectively improved.
However, although the wall sticking phenomenon is improved by the introduction of microcrystalline cellulose, it is presumed that the introduction of microcrystalline cellulose also causes a decrease in drug stability because the network structure formed by gelatin is broken to some extent by a large amount of disaccharide or monosaccharide in the wall material, and microcrystalline cellulose easily bonds with the wall material, causing cracks in the wall film and a decrease in drug stability. Therefore, in order to solve the problem, the pharmaceutical composition can further comprise pullulan (CAS number 9057-02-7), wherein the pullulan has a highly ordered molecular structure, and can be cooperated with gelatin to form a wall film with excellent compactness and certain strength, so that microcrystalline cellulose can only be attached to the surface of the wall film and cannot be combined with a wall material, and the problem of reduced stability of the pharmaceutical product is solved.
Therefore, compared with the prior art, the invention has the following advantages:
(1) the microencapsulated animal medicine has the characteristics of round particles, good capsule material coating effect and good free-running property, and can isolate effective medicinal components from the outside, thereby achieving the purposes of masking taste, preventing moisture, improving the stability of the medicine and improving the utilization rate of the medicine, and having good market prospect.
(2) The microencapsulated animal medicine improves the wall sticking problem in the spray drying process, improves the production efficiency, reduces the product loss, reduces the production cost, has stable process and controllable conditions, and is suitable for industrial flow line production of microencapsulated medicines.
Detailed Description
The present invention will be described in further detail with reference to specific examples.
Example 1 microencapsulated animal medicine of the invention and Process for its preparation
The formula is as follows: 25kg of tilmicosin, 30kg of gelatin, 40kg of cane sugar, 805kg of tween-starch, 30kg of corn starch and 3kg of microcrystalline cellulose;
the preparation method comprises the following steps:
s1, preparation of wall materials: dissolving gelatin and sucrose in a formula amount in 200kg of water to obtain a water phase A;
s2, preparation of capsule wall materials: dissolving tilmicosin in 300kg of water, and adding tween-80 to obtain an oil phase B;
s3, preparation of a dispersion system: adding the oil phase B into the water phase A under the conditions that the shearing power is 50kW and the stirring speed is 10000r/min, and then removing part of water under the conditions that the stirring time is 15min and the temperature is 50 ℃ to form microemulsion;
s4, spray granulation and drying: adding a mixed filler of corn starch and microcrystalline cellulose in a formula amount into a spray granulation tower, pumping the microemulsion into the spray granulation tower for spray granulation and drying to obtain microencapsulated animal medicine particles and powder, wherein the total yield is 92.7%, collecting the microencapsulated animal medicine particles, and sieving the microencapsulated animal medicine particles by a sieve of 30-120 meshes to obtain the microencapsulated animal medicine. In addition, the inner wall of the tower is observed after the spray drying is finished, the phenomenon of wall adhesion is slight, and the materials are easy to scrape off.
Product detection: the tilmicosin particles prepared by the method have good fluidity and no agglomeration, the granularity is 30-120 meshes, the detected water content is less than or equal to 5%, the tilmicosin accounts for 22.6% of the total weight of the particles, and the corn starch accounts for 16% of the total weight of the particles.
Example 2 microencapsulated animal medicine of the invention and Process for its preparation
The formula is as follows: 30kg of tiamulin fumarate, 30kg of gelatin, 35kg of glucose, 805kg of tween-805 kg, 40kg of corn starch and 8kg of microcrystalline cellulose;
the preparation method comprises the following steps:
s1, preparation of wall materials: dissolving gelatin and glucose in a formula amount in 200kg of water to obtain a water phase A;
s2, preparation of capsule wall materials: dissolving tiamulin fumarate in 400kg of 85% ethanol by volume, and adding tween-80 to obtain oil phase B;
s3, preparation of a dispersion system: adding the oil phase B into the water phase A under the conditions that the shearing power is 50kW and the stirring speed is 5000r/min, and then removing ethanol under the conditions that the stirring time is 15min and the temperature is 50 ℃ to form microemulsion;
s4, spray granulation and drying: adding a mixed filler of corn starch and microcrystalline cellulose in a formula amount into a spray granulation tower, pumping the microemulsion into the spray granulation tower for spray granulation and drying to obtain microencapsulated animal medicine particles and powder, wherein the total yield is 89.4%, collecting the microencapsulated animal medicine particles, and sieving the microencapsulated animal medicine particles by a sieve of 30-120 meshes to obtain the microencapsulated animal medicine. In addition, the inner wall of the tower is observed after the spray drying is finished, the phenomenon of wall adhesion is slight, and the materials are easy to scrape off.
Product detection: the tiamulin fumarate particles prepared by the method have good fluidity and are not agglomerated, the granularity is 30-120 meshes, the detected water content is less than or equal to 5%, the tiamulin fumarate accounts for 27.0% of the total weight of the particles, and the corn starch accounts for 20% of the total weight of the particles.
Example 3 microencapsulated animal medicine of the invention and Process for its preparation
The formula is as follows: 25kg of enrofloxacin sodium, 30kg of gelatin, 40kg of cane sugar, 805kg of tween-805, 35kg of rice bran and 5kg of microcrystalline cellulose;
the preparation method comprises the following steps:
s1, preparation of wall materials: dissolving gelatin and sucrose in a formula amount in 200kg of water to obtain a water phase A;
s2, preparation of capsule wall materials: dissolving enrofloxacin sodium in 300kg of water, and adding tween-80 to obtain an oil phase B;
s3, preparation of a dispersion system: adding the oil phase B into the water phase A under the conditions that the shearing power is 80kW and the stirring speed is 5000r/min, and then removing part of water under the conditions that the stirring time is 20min and the temperature is 50 ℃ to form microemulsion;
s4, spray granulation and drying: adding a mixed filler of rice bran and microcrystalline cellulose in a formula amount into a spray granulation tower, pumping the microemulsion into the spray granulation tower for spray granulation and drying to obtain microencapsulated animal medicine particles and powder, wherein the total yield is 93.0%, collecting the microencapsulated animal medicine particles, and sieving the microencapsulated animal medicine particles by a sieve of 30-120 meshes to obtain the microencapsulated animal medicine. In addition, the inner wall of the tower is observed after the spray drying is finished, the phenomenon of wall adhesion is slight, and the materials are easy to scrape off.
Product detection: the enrofloxacin sodium particles prepared by the method have good fluidity and no agglomeration, the particle size is 30-120 meshes, the detected moisture is less than or equal to 5%, the enrofloxacin sodium accounts for 22.5% of the total weight of the particles, and the rice bran accounts for 18% of the total weight of the particles.
Example 4 microencapsulated animal medicine of the invention and Process for its preparation
The formula is as follows: 10kg of florfenicol, 40kg of gelatin, 45kg of glucose, 805kg of tween-corn starch, 35kg of corn starch and 6kg of microcrystalline cellulose;
the preparation method comprises the following steps:
s1, preparation of wall materials: dissolving gelatin and glucose in a formula amount in 200kg of water to obtain a water phase A;
s2, preparation of capsule wall materials: dissolving florfenicol in 250kg of water, and then adding tween-80 to obtain an oil phase B;
s3, preparation of a dispersion system: adding the oil phase B into the water phase A under the conditions that the shearing power is 60kW and the stirring speed is 8000r/min, and then removing part of water under the conditions that the stirring time is 20min and the temperature is 50 ℃ to form microemulsion;
s4, spray granulation and drying: adding a mixed filler of corn starch and microcrystalline cellulose in a formula amount into a spray granulation tower, pumping the microemulsion into the spray granulation tower for spray granulation and drying to obtain microencapsulated animal medicine particles and powder, wherein the total yield is 90.0%, collecting the microencapsulated animal medicine particles, and sieving the microencapsulated animal medicine particles by a sieve of 30-120 meshes to obtain the microencapsulated animal medicine. In addition, the inner wall of the tower is observed after the spray drying is finished, the phenomenon of wall adhesion is slight, and the materials are easy to scrape off.
Product detection: the florfenicol particles prepared by the method have good fluidity and no agglomeration, the granularity is 30-120 meshes, the detected water content is less than or equal to 5%, the florfenicol accounts for 9.1% of the total weight of the particles, and the corn starch accounts for 17% of the total weight of the particles.
Example 5 microencapsulated animal medicine of the invention and Process for its preparation
The formula is as follows: 25kg of tilmicosin, 30kg of gelatin, 38kg of cane sugar, 2kg of pullulan, 805kg of tween-corn starch, 30kg of corn starch and 3kg of microcrystalline cellulose;
the preparation method comprises the following steps:
s1, preparation of wall materials: dissolving gelatin, sucrose and pullulan with a formula ratio in 200kg of water to obtain a water phase A;
s2, preparation of capsule wall materials: dissolving tilmicosin in 300kg of water, and adding tween-80 to obtain an oil phase B;
s3, preparation of a dispersion system: adding the oil phase B into the water phase A under the conditions that the shearing power is 50kW and the stirring speed is 10000r/min, and then removing part of water under the conditions that the stirring time is 15min and the temperature is 50 ℃ to form microemulsion;
s4, spray granulation and drying: adding a mixed filler of corn starch and microcrystalline cellulose in a formula amount into a spray granulation tower, pumping the microemulsion into the spray granulation tower for spray granulation and drying to obtain microencapsulated animal medicine particles and powder, wherein the total yield is 91.3%, collecting the microencapsulated animal medicine particles, and sieving the microencapsulated animal medicine particles by a sieve of 30-120 meshes to obtain the microencapsulated animal medicine. In addition, the inner wall of the tower is observed after the spray drying is finished, the phenomenon of wall adhesion is slight, and the materials are easy to scrape off.
Product detection: the tilmicosin particles prepared by the method have good fluidity and no agglomeration, the particle size is 30-120 meshes, the detected water content is less than or equal to 5%, the tilmicosin accounts for 22.8% of the total weight of the particles, and the corn starch accounts for 17% of the total weight of the particles.
Example 6 microencapsulated animal medicine of the invention and Process for its preparation
The formula is as follows: 30kg of tiamulin fumarate, 30kg of gelatin, 30kg of glucose, 5kg of pullulan, 805kg of tween-805, 40kg of corn starch and 8kg of microcrystalline cellulose;
the preparation method comprises the following steps:
s1, preparation of wall materials: dissolving gelatin, glucose and pullulan with the formula ratio in 200kg of water to obtain a water phase A;
s2, preparation of capsule wall materials: dissolving tiamulin fumarate in 400kg of 85% ethanol by volume, and adding tween-80 to obtain oil phase B;
s3, preparation of a dispersion system: adding the oil phase B into the water phase A under the conditions that the shearing power is 50kW and the stirring speed is 5000r/min, and then removing ethanol under the conditions that the stirring time is 15min and the temperature is 50 ℃ to form microemulsion;
s4, spray granulation and drying: adding a mixed filler of corn starch and microcrystalline cellulose in a formula amount into a spray granulation tower, pumping the microemulsion into the spray granulation tower for spray granulation and drying to obtain microencapsulated animal medicine particles and powder, wherein the total yield is 90.0%, collecting the microencapsulated animal medicine particles, and sieving the microencapsulated animal medicine particles by a sieve of 30-120 meshes to obtain the microencapsulated animal medicine. In addition, the inner wall of the tower is observed after the spray drying is finished, the phenomenon of wall adhesion is slight, and the materials are easy to scrape off.
Product detection: the tiamulin fumarate particles prepared by the method have good fluidity and are not agglomerated, the granularity is 30-120 meshes, the detected water content is less than or equal to 5%, the tiamulin fumarate accounts for 27.3% of the total weight of the particles, and the corn starch accounts for 22% of the total weight of the particles.
Example 7 microencapsulated animal medicine of the invention and Process for its preparation
The formula is as follows: 25kg of enrofloxacin sodium, 30kg of gelatin, 33kg of cane sugar, 7kg of pullulan, 805kg of tween-805, 35kg of rice bran and 5kg of microcrystalline cellulose;
the preparation method comprises the following steps:
s1, preparation of wall materials: dissolving gelatin, sucrose and pullulan with a formula ratio in 200kg of water to obtain a water phase A;
s2, preparation of capsule wall materials: dissolving enrofloxacin sodium in 300kg of water, and adding tween-80 to obtain an oil phase B;
s3, preparation of a dispersion system: adding the oil phase B into the water phase A under the conditions that the shearing power is 80kW and the stirring speed is 5000r/min, and then removing part of water under the conditions that the stirring time is 20min and the temperature is 50 ℃ to form microemulsion;
s4, spray granulation and drying: adding a mixed filler of rice bran and microcrystalline cellulose in a formula amount into a spray granulation tower, pumping the microemulsion into the spray granulation tower for spray granulation and drying to obtain microencapsulated animal medicine particles and powder, wherein the total yield is 93.8%, collecting the microencapsulated animal medicine particles, and sieving the microencapsulated animal medicine particles by a sieve of 30-120 meshes to obtain the microencapsulated animal medicine. In addition, the inner wall of the tower is observed after the spray drying is finished, the phenomenon of wall adhesion is slight, and the materials are easy to scrape off.
Product detection: the enrofloxacin sodium particles prepared by the method have good fluidity and no agglomeration, the particle size is 30-120 meshes, the detected moisture is less than or equal to 5%, the enrofloxacin sodium accounts for 22.6% of the total weight of the particles, and the rice bran accounts for 20% of the total weight of the particles.
Example 8 microencapsulated animal medicine of the invention and Process for its preparation
The formula is as follows: 10kg of florfenicol, 40kg of gelatin, 41kg of glucose, 4kg of pullulan, 805kg of tween-805, 35kg of corn starch and 6kg of microcrystalline cellulose;
the preparation method comprises the following steps:
s1, preparation of wall materials: dissolving gelatin, glucose and pullulan with the formula ratio in 200kg of water to obtain a water phase A;
s2, preparation of capsule wall materials: dissolving florfenicol in 250kg of water, and then adding tween-80 to obtain an oil phase B;
s3, preparation of a dispersion system: adding the oil phase B into the water phase A under the conditions that the shearing power is 60kW and the stirring speed is 8000r/min, and then removing part of water under the conditions that the stirring time is 20min and the temperature is 50 ℃ to form microemulsion;
s4, spray granulation and drying: adding a mixed filler of corn starch and microcrystalline cellulose in a formula amount into a spray granulation dryer, pumping the microemulsion into a spray granulation tower for spray granulation and drying to obtain microencapsulated animal medicine particles and powder, wherein the total yield is 90.5%, collecting the microencapsulated animal medicine particles, and sieving the microencapsulated animal medicine particles by a sieve of 30-120 meshes to obtain the microencapsulated animal medicine. In addition, the inner wall of the tower is observed after the spray drying is finished, the phenomenon of wall adhesion is slight, and the materials are easy to scrape off.
Product detection: the florfenicol particles prepared by the method have good fluidity and are not agglomerated, the granularity is 30-120 meshes, the detected water content is less than or equal to 5 percent, the florfenicol accounts for 9.3 percent of the total weight of the particles, and the corn starch accounts for 18 percent of the total weight of the particles.
In steps S4 described in embodiments 1 to 8 of the present invention, a conventional spray granulation dryer is used to achieve simultaneous granulation and drying, wherein the conditions of spray granulation and drying are as follows: the upper air inlet temperature is 120 ℃, and the air inlet quantity is 1500m3The lower air inlet temperature is 100 ℃, and the air inlet volume is 1200m3The rotating speed of the spray head is 3000r/min, and the liquid inlet amount is 30L/h. In examples 1 to 8, the total yield is [ total weight of particles and powder/total addition amount of each material ]]X 100%, wherein the total weight of particles and powder does not include the weight of the subsequently scraped material.
Test example 1
And (3) observing the improvement effect of different auxiliary materials on the wall sticking problem in the spray drying process, setting the following comparative example, and observing the condition of the inner wall of the tower after the spray drying is finished.
Comparative example 1: the present comparative example differs from example 1 only in that no microcrystalline cellulose is added. The total yield is 53.7%, and the inner wall of the tower is observed after the spray drying is finished, so that the wall is seriously adhered, and the caking is difficult to scrape.
Comparative example 2: the present comparative example differs from example 2 only in that no microcrystalline cellulose is added. The total yield is 49.0%, and the inner wall of the tower is observed after the spray drying is finished, so that the wall is seriously adhered, and the caking is difficult to scrape.
Comparative example 3: the present comparative example differs from example 5 only in that no microcrystalline cellulose is added. The total yield is 44.6%, and the inner wall of the tower is observed after the spray drying is finished, so that the wall is seriously adhered, and the caking is difficult to scrape.
Comparative example 4: the present comparative example differs from example 7 only in that no microcrystalline cellulose is added. The total yield is 38.3%, and the inner wall of the tower is observed after the spray drying is finished, so that the wall is seriously adhered, and the caking is difficult to scrape.
Comparative example 5: the comparative example differs from example 2 only in that talc is used instead of microcrystalline cellulose, in the same amount. The total yield was 58.7%, and the inner wall of the column was observed after the spray drying was completed, and the wall was seriously adhered, and a part of the cake was scraped off.
Comparative example 6: the comparative example differs from example 2 only in that instead of microcrystalline cellulose, silicon dioxide is used in a constant amount. The total yield was 65.2%, and the inner wall of the column was observed after the spray drying was completed, and the wall was seriously adhered, and part of the cake was scraped off.
From the above comparison, it can be seen that: under the condition of not adding microcrystalline cellulose, the materials are easy to stick to the wall in the spray drying process, and the wall sticking condition is serious, so that the materials are caked and difficult to scrape, and the total yield is obviously reduced; and talc powder or silicon dioxide is added into the filler, so that the wall sticking condition is not well improved, and the material composition of the invention indicates that the microcrystalline cellulose can better improve the material fluidity and effectively improve the wall sticking phenomenon.
Test example two
Comparative example 7: the pullulan in example 7 was replaced with chitosan at a constant amount to prepare a microencapsulated animal medicine.
Comparative example 8: the pullulan in example 7 was replaced with trehalose at a constant amount to prepare a microencapsulated animal medicine.
The microencapsulated animal drugs prepared in examples 1 to 8 and comparative examples 7 to 8 were subjected to a high temperature and high humidity accelerated stability test at a temperature of 40 ℃. + -. 2 ℃ and a humidity of 75%. + -. 5% for 6 months, and the test results are shown in table 1 below.
TABLE 1 stability test results for each microencapsulated animal drug product
As can be seen from table 1 above: the microencapsulated animal medicine of the embodiments 5 to 8 of the invention passes the high temperature and high humidity accelerated test, the relative marked quantity after 6 months has no obvious change, the stability is high, and the validity period can be estimated to be 2 years. Compared with the examples 5 to 8, the pullulan is not added in the examples 1 to 4, so that the relative marked amount is rapidly reduced under a high-temperature high-humidity accelerated test, and the stability is obviously reduced; in contrast, in comparative examples 7 and 8, chitosan and trehalose were used instead of pullulan, respectively, and as a result, these two polysaccharides had no significant effect on improving the stability of microencapsulated animal drugs.
The foregoing is a more detailed description of the invention in connection with specific preferred embodiments and it is not intended that the invention be limited to these specific details. For those skilled in the art to which the invention pertains, several simple deductions or substitutions can be made without departing from the spirit of the invention, and all shall be considered as belonging to the protection scope of the invention.
Claims (2)
1. A microencapsulated animal medicine characterized by: comprises raw material medicines, wall materials, external fillers and an emulsifier;
the raw material medicine is one of tilmicosin or a salt thereof, tiamulin or a salt thereof, enrofloxacin or a salt thereof and florfenicol;
the wall material comprises the following preparation raw materials in parts by weight: 30-40 parts of gelatin, 30-50 parts of saccharides and 2-7 parts of pullulan; the saccharide is glucose or sucrose;
the external filler comprises the following preparation raw materials in parts by weight: 30-40 parts of corn starch or rice bran and 3-8 parts of microcrystalline cellulose;
the emulsifier is tween-80;
the preparation method of the microencapsulated animal medicine comprises the following steps:
s1, preparation of wall materials: dissolving gelatin, saccharides and pullulan in formula amount in water to obtain a water phase A;
s2, preparation of capsule wall materials: dissolving the raw material medicines in a solvent, and adding an emulsifier to obtain an oil phase B; the solvent is ethanol or water;
s3, preparation of a dispersion system: adding the oil phase B into the water phase A under the conditions that the shearing power is 50-80 kW and the stirring speed is 5000-10000 r/min, and then removing the solvent under the conditions that the stirring time is 15-20 min and the temperature is 50 ℃ to form a microemulsion;
s4, spray granulation and drying: adding an external filler with a formula amount into a spray granulation tower, pumping the microemulsion into the spray granulation tower for spray granulation and drying to obtain microencapsulated animal medicine particles and powder, collecting the microencapsulated animal medicine particles, and sieving the microencapsulated animal medicine particles by a sieve with 30-120 meshes to obtain the microencapsulated animal medicine.
2. A process for the preparation of a microencapsulated animal medicine as claimed in claim 1, which comprises the following steps:
s1, preparation of wall materials: dissolving gelatin, saccharides and pullulan in formula amount in water to obtain a water phase A;
s2, preparation of capsule wall materials: dissolving the raw material medicines in a solvent, and adding an emulsifier to obtain an oil phase B; the solvent is ethanol or water;
s3, preparation of a dispersion system: adding the oil phase B into the water phase A under the conditions that the shearing power is 50-80 kW and the stirring speed is 5000-10000 r/min, and then removing the solvent under the conditions that the stirring time is 15-20 min and the temperature is 50 ℃ to form a microemulsion;
s4, spray granulation and drying: adding an external filler with a formula amount into a spray granulation tower, pumping the microemulsion into the spray granulation tower for spray granulation and drying to obtain microencapsulated animal medicine particles and powder, collecting the microencapsulated animal medicine particles, and sieving the microencapsulated animal medicine particles by a sieve with 30-120 meshes to obtain the microencapsulated animal medicine.
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