CN114948884B - Doxycycline hydrochloride flavor tablet for pets and preparation method thereof - Google Patents
Doxycycline hydrochloride flavor tablet for pets and preparation method thereof Download PDFInfo
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- CN114948884B CN114948884B CN202210467132.XA CN202210467132A CN114948884B CN 114948884 B CN114948884 B CN 114948884B CN 202210467132 A CN202210467132 A CN 202210467132A CN 114948884 B CN114948884 B CN 114948884B
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- doxycycline hydrochloride
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- PTNZGHXUZDHMIQ-UHFFFAOYSA-N 4-(dimethylamino)-1,5,10,11,12a-pentahydroxy-6-methyl-3,12-dioxo-4a,5,5a,6-tetrahydro-4h-tetracene-2-carboxamide;hydrochloride Chemical compound Cl.C1=CC=C2C(C)C(C(O)C3C(C(O)=C(C(N)=O)C(=O)C3N(C)C)(O)C3=O)C3=C(O)C2=C1O PTNZGHXUZDHMIQ-UHFFFAOYSA-N 0.000 title claims abstract description 87
- 229960004082 doxycycline hydrochloride Drugs 0.000 title claims abstract description 87
- 239000000796 flavoring agent Substances 0.000 title claims abstract description 63
- 235000019634 flavors Nutrition 0.000 title claims abstract description 54
- 238000002360 preparation method Methods 0.000 title claims abstract description 18
- 239000000314 lubricant Substances 0.000 claims abstract description 28
- 239000000945 filler Substances 0.000 claims abstract description 27
- 238000000034 method Methods 0.000 claims abstract description 21
- 230000008569 process Effects 0.000 claims abstract description 19
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical group [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 40
- 235000019359 magnesium stearate Nutrition 0.000 claims description 20
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 19
- 235000015278 beef Nutrition 0.000 claims description 19
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 18
- 229920002472 Starch Polymers 0.000 claims description 18
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 18
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 18
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 18
- 239000008107 starch Substances 0.000 claims description 18
- 235000019698 starch Nutrition 0.000 claims description 18
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 17
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 17
- 229940075614 colloidal silicon dioxide Drugs 0.000 claims description 17
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims description 17
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims description 17
- 239000000203 mixture Substances 0.000 claims description 10
- 238000007907 direct compression Methods 0.000 claims description 9
- 235000013355 food flavoring agent Nutrition 0.000 claims description 9
- 239000000463 material Substances 0.000 claims description 8
- 239000002245 particle Substances 0.000 claims description 5
- 239000002994 raw material Substances 0.000 claims description 3
- 238000007908 dry granulation Methods 0.000 abstract description 12
- 238000005550 wet granulation Methods 0.000 abstract description 12
- 238000004519 manufacturing process Methods 0.000 abstract description 11
- 239000003795 chemical substances by application Substances 0.000 abstract description 9
- 235000019629 palatability Nutrition 0.000 abstract description 9
- 230000007062 hydrolysis Effects 0.000 abstract description 3
- 238000006460 hydrolysis reaction Methods 0.000 abstract description 3
- 230000000052 comparative effect Effects 0.000 description 14
- 238000002156 mixing Methods 0.000 description 9
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 6
- 229930195725 Mannitol Natural products 0.000 description 6
- 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 6
- 239000000594 mannitol Substances 0.000 description 6
- 235000010355 mannitol Nutrition 0.000 description 6
- 239000011734 sodium Substances 0.000 description 5
- 229910052708 sodium Inorganic materials 0.000 description 5
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 4
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 description 4
- 239000007884 disintegrant Substances 0.000 description 4
- 239000008187 granular material Substances 0.000 description 4
- 239000012535 impurity Substances 0.000 description 4
- 239000008101 lactose Substances 0.000 description 4
- 239000000454 talc Substances 0.000 description 4
- 235000012222 talc Nutrition 0.000 description 4
- 229910052623 talc Inorganic materials 0.000 description 4
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 description 3
- 241000282472 Canis lupus familiaris Species 0.000 description 3
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 3
- 229960000913 crospovidone Drugs 0.000 description 3
- 238000011068 loading method Methods 0.000 description 3
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 description 3
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 description 3
- 239000000843 powder Substances 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- 239000005715 Fructose Substances 0.000 description 2
- 229930091371 Fructose Natural products 0.000 description 2
- RFSUNEUAIZKAJO-ARQDHWQXSA-N Fructose Chemical compound OC[C@H]1O[C@](O)(CO)[C@@H](O)[C@@H]1O RFSUNEUAIZKAJO-ARQDHWQXSA-N 0.000 description 2
- 241000287828 Gallus gallus Species 0.000 description 2
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 2
- 241001465754 Metazoa Species 0.000 description 2
- 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 description 2
- 229930006000 Sucrose Natural products 0.000 description 2
- 239000004098 Tetracycline Substances 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- MVPICKVDHDWCJQ-UHFFFAOYSA-N ethyl 3-pyrrolidin-1-ylpropanoate Chemical compound CCOC(=O)CCN1CCCC1 MVPICKVDHDWCJQ-UHFFFAOYSA-N 0.000 description 2
- -1 glidant Substances 0.000 description 2
- 125000004029 hydroxymethyl group Chemical group [H]OC([H])([H])* 0.000 description 2
- 229940040511 liver extract Drugs 0.000 description 2
- 229960001855 mannitol Drugs 0.000 description 2
- 229910002055 micronized silica Inorganic materials 0.000 description 2
- 239000008188 pellet Substances 0.000 description 2
- 238000011160 research Methods 0.000 description 2
- 239000000741 silica gel Substances 0.000 description 2
- 239000002002 slurry Substances 0.000 description 2
- 229940045902 sodium stearyl fumarate Drugs 0.000 description 2
- 239000005720 sucrose Substances 0.000 description 2
- 229960002180 tetracycline Drugs 0.000 description 2
- 229930101283 tetracycline Natural products 0.000 description 2
- 235000019364 tetracycline Nutrition 0.000 description 2
- 150000003522 tetracyclines Chemical class 0.000 description 2
- 239000004408 titanium dioxide Substances 0.000 description 2
- 239000000273 veterinary drug Substances 0.000 description 2
- SGKRLCUYIXIAHR-AKNGSSGZSA-N (4s,4ar,5s,5ar,6r,12ar)-4-(dimethylamino)-1,5,10,11,12a-pentahydroxy-6-methyl-3,12-dioxo-4a,5,5a,6-tetrahydro-4h-tetracene-2-carboxamide Chemical compound C1=CC=C2[C@H](C)[C@@H]([C@H](O)[C@@H]3[C@](C(O)=C(C(N)=O)C(=O)[C@H]3N(C)C)(O)C3=O)C3=C(O)C2=C1O SGKRLCUYIXIAHR-AKNGSSGZSA-N 0.000 description 1
- 206010067484 Adverse reaction Diseases 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- 241000606161 Chlamydia Species 0.000 description 1
- 206010011224 Cough Diseases 0.000 description 1
- 241000192125 Firmicutes Species 0.000 description 1
- 241000204031 Mycoplasma Species 0.000 description 1
- 241000606701 Rickettsia Species 0.000 description 1
- 241000589970 Spirochaetales Species 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 230000006838 adverse reaction Effects 0.000 description 1
- 239000003242 anti bacterial agent Substances 0.000 description 1
- 229940088710 antibiotic agent Drugs 0.000 description 1
- 230000003115 biocidal effect Effects 0.000 description 1
- 206010006451 bronchitis Diseases 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 238000007906 compression Methods 0.000 description 1
- 230000006835 compression Effects 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 229960003722 doxycycline Drugs 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 230000036449 good health Effects 0.000 description 1
- 238000005469 granulation Methods 0.000 description 1
- 230000003179 granulation Effects 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 229960001375 lactose Drugs 0.000 description 1
- 230000000670 limiting effect Effects 0.000 description 1
- 238000005453 pelletization Methods 0.000 description 1
- 230000035699 permeability Effects 0.000 description 1
- 238000004080 punching Methods 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 230000002829 reductive effect Effects 0.000 description 1
- 238000007873 sieving Methods 0.000 description 1
- 229940083542 sodium Drugs 0.000 description 1
- 239000007779 soft material Substances 0.000 description 1
- 229940032147 starch Drugs 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 208000024891 symptom Diseases 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
- A61K31/65—Tetracyclines
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/14—Antitussive agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Landscapes
- Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Pulmonology (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses a doxycycline hydrochloride flavor tablet for pets and a preparation method thereof, wherein the flavor tablet comprises the following components: 1 to 50 parts of doxycycline hydrochloride, 100 to 200 parts of filler, 2 to 10 parts of disintegrating agent, 2 to 10 parts of glidant, 1 to 10 parts of lubricant and 5 to 15 parts of phagostimulant. The doxycycline hydrochloride flavor tablet of some examples of the invention has better compressibility in actual production, and the tablet has smooth surface and stable property; the method can effectively reduce the cost of the conventional wet granulation and dry granulation processes of the product, simplify the production process, avoid the hydrolysis of doxycycline hydrochloride and the damage of palatability caused by the wet granulation, and has the advantages of simple operation, good palatability and stable product property.
Description
Technical Field
The invention belongs to the field of veterinary medicine preparations, and particularly relates to doxycycline hydrochloride flavor tablets for pets and a preparation method thereof.
Background
Doxycycline hydrochloride, which is also called doxycycline or deoxyoxytetracycline, belongs to a second-generation semisynthetic tetracycline derivative, has an inhibiting effect on gram-negative bacteria, gram-positive bacteria, spirochete, rickettsia, mycoplasma, chlamydia and the like, is a broad-spectrum antibiotic, has the characteristics of high oral bioavailability, high fat solubility, strong tissue permeability, wide distribution and the like, is one of antibiotics with more clinical application of veterinary drugs and better treatment effect, and is mainly used for treating symptoms such as cold, cough, bronchitis and the like of pets. With the development of new auxiliary materials and the development of new preparation technology, the doxycycline hydrochloride new preparation is worthy of further development and utilization, and has wider development prospect.
The dosage forms for pet treatment in the market at present mainly comprise tablets, and the process mainly comprises wet granulation and dry granulation. The traditional wet granulation process is complex, and the soft material is prepared and then is dried for a long time, and the process can lead to the degradation of doxycycline hydrochloride when meeting heat like other tetracycline medicaments, so that related substances are increased, and the quality of the product is affected; in addition, as the pet is used, a certain proportion of phagostimulant is added in the prescription, and the taste of the phagostimulant can be diluted in the drying process according to the traditional wet granulation process, the palatability can be poor, and the feeding initiative of the pet is reduced. The dry granulation process is to carry out the dry granulation and then tabletting, and the process is more complex than the direct compression process, so that the investment cost is high, the manpower and material resources are consumed, and the production cost is increased.
Doxycycline hydrochloride has certain viscosity and poor fluidity, and in a direct compression process, the difficulty is high, and the phenomena of sticking, punching and splitting easily occur, especially in large-sized tablets. Thus, the processes commonly used in the market are mainly wet granulation and dry granulation.
Disclosure of Invention
The invention aims to solve the technical problem of providing the doxycycline hydrochloride tablet for pets by a direct compression process and the preparation method thereof, which can effectively reduce the cost of the conventional wet granulation and dry granulation processes of the product at present, avoid the hydrolysis and the damage of palatability of doxycycline hydrochloride caused by the wet granulation, and simplify the production process by the investment of equipment and production cost in the dry granulation production process.
The technical scheme adopted by the invention is as follows:
in a first aspect of the invention, there is provided:
the doxycycline hydrochloride flavor tablet for pets comprises the following components in parts by mass: 1 to 50 parts of doxycycline hydrochloride, 100 to 200 parts of filler, 2 to 10 parts of disintegrating agent, 2 to 10 parts of glidant, 1 to 10 parts of lubricant and 5 to 15 parts of phagostimulant.
In some examples of doxycycline hydrochloride flavor tablets for pets, the mass composition comprises: 5 to 30 parts of doxycycline hydrochloride, 100 to 150 parts of filler, 2 to 5 parts of disintegrating agent, 2 to 6 parts of glidant, 1 to 8 parts of lubricant and 5 to 10 parts of phagostimulant.
In some examples of doxycycline hydrochloride flavored tablets for pets, the filler is selected from at least one of microcrystalline cellulose, starch, lactose, mannitol, sucrose, fructose.
In some examples of doxycycline hydrochloride flavored tablets for pets, the disintegrant is at least one selected from the group consisting of sodium carboxymethyl starch, crospovidone, and sodium carboxymethyl cellulose.
In some examples of doxycycline hydrochloride flavored tablets for pets, the glidant is at least one selected from the group consisting of colloidal silicon dioxide, micronized silica gel, and titanium dioxide.
In some examples of doxycycline hydrochloride flavored tablets for pets, the lubricant is selected from at least one of magnesium stearate, talc, sodium stearyl fumarate.
In some examples of doxycycline hydrochloride flavored tablets for pets, the filler is selected from at least one of microcrystalline cellulose, starch.
In some examples of doxycycline hydrochloride flavored tablets for pets, the disintegrant is sodium carboxymethyl cellulose.
In some examples of doxycycline hydrochloride flavored tablets for pets, the glidant is colloidal silicon dioxide.
In some examples of doxycycline hydrochloride flavored tablets for pets, the lubricant is selected from at least one of magnesium stearate, talc.
In some examples of doxycycline hydrochloride flavored tablets for pets, the lubricant is magnesium stearate.
In some examples of doxycycline hydrochloride flavored tablets for pets, the phagostimulant is selected from one of chicken liver extract, beef flavor.
In some examples of doxycycline hydrochloride flavor tablets for pets, the mass composition comprises: 5 to 30 parts of doxycycline hydrochloride, 100 to 150 parts of filler, 2 to 5 parts of sodium carboxymethylcellulose, 2 to 6 parts of colloidal silicon dioxide, 1 to 8 parts of lubricant and 5 to 10 parts of beef flavor.
In some examples of doxycycline hydrochloride flavor tablets for pets, the mass composition comprises: 5-30 parts of doxycycline hydrochloride, 100-150 parts of filler, 2-5 parts of sodium carboxymethylcellulose, 2-6 parts of colloidal silicon dioxide, 1-8 parts of lubricant and 5-10 parts of beef flavor flavoring agent, wherein the filler is microcrystalline cellulose or starch.
In some examples of doxycycline hydrochloride flavor tablets for pets, the mass composition comprises: 5-30 parts of doxycycline hydrochloride, 100-150 parts of filler, 2-5 parts of sodium carboxymethyl cellulose, 2-6 parts of colloidal silicon dioxide, 1-8 parts of lubricant and 5-10 parts of beef flavor flavoring agent, wherein the filler is microcrystalline cellulose or starch, and the lubricant is magnesium stearate and talcum powder.
In a second aspect of the invention, there is provided:
the preparation method of the doxycycline hydrochloride flavor tablet for pets comprises the following steps:
s1) evenly mixing doxycycline hydrochloride, a filling agent, a disintegrating agent, a glidant and a phagostimulant;
s2) uniformly mixing the mixed particles with a lubricant, and tabletting to obtain the doxycycline hydrochloride flavor tablet for pets.
In some preparation method examples, including doxycycline hydrochloride, filler, disintegrating agent, glidant, lubricant and phagostimulant are sieved by a 30-mesh sieve for granulating, diluted and uniformly mixed in a rotary mixer at a rotating speed of 20 revolutions per minute according to a raw and auxiliary materials equal ratio gradient principle, and the prepared granules and the lubricant are mixed for 3 minutes at the same rotating speed and then are tabletted by a direct compression process.
The beneficial effects of the invention are as follows:
the doxycycline hydrochloride flavor tablet of some examples of the invention has better compressibility in actual production, and the tablet has smooth surface and stable property.
The doxycycline hydrochloride flavor tablet of some examples of the invention can effectively reduce the cost of the conventional wet granulation and dry granulation processes of the product at present, simplify the production process, avoid the hydrolysis of doxycycline hydrochloride and the damage of palatability caused by wet granulation, and has the advantages of simple operation, good palatability and stable product property.
Drawings
Fig. 1 is a photograph of the tablet of example 1.
Fig. 2 is a photograph of the tablet of example 3.
Detailed Description
In a first aspect of the invention, there is provided:
the doxycycline hydrochloride flavor tablet for pets comprises the following components in parts by mass: 1 to 50 parts of doxycycline hydrochloride, 100 to 200 parts of filler, 2 to 10 parts of disintegrating agent, 2 to 10 parts of glidant, 1 to 10 parts of lubricant and 5 to 15 parts of phagostimulant.
In some examples of doxycycline hydrochloride flavor tablets for pets, the mass composition comprises: 1 to 50 parts of doxycycline hydrochloride, 100 to 150 parts of filler, 2 to 5 parts of disintegrating agent, 2 to 6 parts of glidant, 1 to 8 parts of lubricant and 5 to 10 parts of phagostimulant.
In some examples of doxycycline hydrochloride flavored tablets for pets, the filler is selected from at least one of microcrystalline cellulose, starch, lactose, mannitol, sucrose, fructose.
In some examples of doxycycline hydrochloride flavored tablets for pets, the disintegrant is at least one selected from the group consisting of sodium carboxymethyl starch, crospovidone, and sodium carboxymethyl cellulose.
In some examples of doxycycline hydrochloride flavored tablets for pets, the glidant is at least one selected from the group consisting of colloidal silicon dioxide, micronized silica gel, and titanium dioxide.
In some examples of doxycycline hydrochloride flavored tablets for pets, the lubricant is selected from at least one of magnesium stearate, talc, sodium stearyl fumarate.
In some examples of doxycycline hydrochloride flavored tablets for pets, the filler is selected from at least one of microcrystalline cellulose, starch.
In some examples of doxycycline hydrochloride flavored tablets for pets, the disintegrant is sodium carboxymethyl cellulose.
In some examples of doxycycline hydrochloride flavored tablets for pets, the glidant is colloidal silicon dioxide.
In some examples of doxycycline hydrochloride flavored tablets for pets, the lubricant is selected from at least one of magnesium stearate, talc.
In some examples of doxycycline hydrochloride flavored tablets for pets, the lubricant is magnesium stearate.
The action of the phagostimulant enables the pets to eat more actively, has no influence on the tabletting and stability of the flavor tablets, and can be adjusted correspondingly according to the preference of the pets. In some examples of doxycycline hydrochloride flavored tablets for pets, the phagostimulant is selected from one of chicken liver extract, beef flavor.
In some examples of doxycycline hydrochloride flavor tablets for pets, the mass composition comprises: 5 to 30 parts of doxycycline hydrochloride, 100 to 150 parts of filler, 2 to 5 parts of sodium carboxymethylcellulose, 2 to 6 parts of colloidal silicon dioxide, 1 to 8 parts of lubricant and 5 to 10 parts of beef flavor. Researches show that the doxycycline hydrochloride flavor tablet with the composition is easier to tablet, and has better direct tablet effect and smoother surface.
In some examples of doxycycline hydrochloride flavor tablets for pets, the mass composition comprises: 5-30 parts of doxycycline hydrochloride, 100-150 parts of filler, 2-5 parts of sodium carboxymethylcellulose, 2-6 parts of colloidal silicon dioxide, 1-8 parts of lubricant and 5-10 parts of beef flavor flavoring agent, wherein the filler is microcrystalline cellulose or starch. Research shows that the filler is easier to be mixed with doxycycline hydrochloride uniformly, and is beneficial to maintaining the stability of doxycycline hydrochloride.
In some examples of doxycycline hydrochloride flavor tablets for pets, the mass composition comprises: 5-30 parts of doxycycline hydrochloride, 100-150 parts of filler, 2-5 parts of sodium carboxymethyl cellulose, 2-6 parts of colloidal silicon dioxide, 1-8 parts of lubricant and 5-10 parts of beef flavor flavoring agent, wherein the filler is microcrystalline cellulose or starch, and the lubricant is magnesium stearate and talcum powder.
In a second aspect of the invention, there is provided:
the preparation method of the doxycycline hydrochloride flavor tablet for pets comprises the following steps:
s1) evenly mixing doxycycline hydrochloride, a filling agent, a disintegrating agent, a glidant and a phagostimulant;
s2) uniformly mixing the mixed particles with a lubricant, and tabletting to obtain the doxycycline hydrochloride flavor tablet for pets.
In some preparation method examples, including doxycycline hydrochloride, filler, disintegrating agent, glidant, lubricant and phagostimulant are sieved by a 30-mesh sieve for granulating, diluted and uniformly mixed in a rotary mixer at a rotating speed of 20 revolutions per minute according to a raw and auxiliary materials equal ratio gradient principle, and the prepared granules and the lubricant are mixed for 3 minutes at the same rotating speed and then are tabletted by a direct compression process. The data show that the raw materials can be well mixed, and the doxycycline hydrochloride flavor tablet for pets with high quality can be obtained.
The invention aims to simplify the production process of doxycycline hydrochloride flavor tablets, reduce the production cost through a direct compression process and shorten the production time. Specific examples are as follows:
example 1
The doxycycline hydrochloride flavor tablet for pets comprises the following components in parts by mass:
10 parts of doxycycline hydrochloride, 100 parts of microcrystalline cellulose, 2 parts of sodium carboxymethyl cellulose, 2 parts of colloidal silicon dioxide, 1.5 parts of magnesium stearate and 10 parts of phagostimulant, wherein the phagostimulant is beef flavor.
The preparation method comprises the following steps: sieving doxycycline hydrochloride, microcrystalline cellulose, sodium carboxymethyl cellulose and beef flavor respectively, granulating, uniformly mixing in a rotary mixer at a rotating speed of 20 rpm in an equal ratio gradient, mixing the obtained granules with magnesium stearate at a rotating speed of 20 rpm for 3 minutes, and tabletting.
Example 2
The doxycycline hydrochloride flavor tablet for pets comprises the following components in parts by mass:
30 parts of doxycycline hydrochloride, 100 parts of microcrystalline cellulose, 30 parts of lactose, 10 parts of mannitol, 3 parts of sodium carboxymethyl cellulose, 6 parts of colloidal silicon dioxide, 5 parts of talcum powder, 3 parts of magnesium stearate and 10 parts of phagostimulant, wherein the phagostimulant is beef flavor.
The preparation method comprises the following steps: doxycycline hydrochloride, microcrystalline cellulose, lactose, mannitol, sodium carboxymethylcellulose, talcum powder, colloidal silicon dioxide and beef flavor flavoring agent are respectively sieved by a 30-mesh sieve for granulation, uniformly mixed in a rotary mixer at a rotating speed of 20 rpm in an equal ratio gradient, then the prepared particles and magnesium stearate are mixed for 3 minutes at the rotating speed of 20 rpm, and finally tabletting is carried out.
Example 3
The doxycycline hydrochloride flavor tablet for pets comprises the following components in parts by mass:
50 parts of doxycycline hydrochloride, 35 parts of microcrystalline cellulose, 30 parts of starch, 70 parts of mannitol, 5 parts of sodium carboxymethyl cellulose, 3 parts of talcum powder, 4 parts of colloidal silicon dioxide, 3 parts of magnesium stearate and 10 parts of phagostimulant, wherein the phagostimulant is beef flavor.
The preparation method comprises the following steps: doxycycline hydrochloride, microcrystalline cellulose, starch, mannitol, crospovidone, talcum powder, colloidal silicon dioxide and beef flavor flavoring agent are respectively sieved by a 30-mesh sieve for finishing, uniformly mixed in a rotary mixer at a rotating speed of 20 rpm in an equal ratio gradient, then the prepared particles and magnesium stearate are mixed for 3 minutes at the rotating speed of 20 rpm, and finally tabletting is carried out.
Comparative example 1:
the doxycycline hydrochloride flavor tablet for pets comprises the following components in parts by mass:
the preparation method comprises the following steps of adding 50 parts of doxycycline hydrochloride, 150 parts of microcrystalline cellulose, 10 parts of hydroxymethyl starch sodium, 50 parts of 10% starch slurry, 1 part of magnesium stearate and 10 parts of beef flavor flavoring agent into a mixer, and uniformly mixing. 10% starch slurry was added to the mixer and mixed for 5 minutes. Wet granulating and finishing. The prepared granules were mixed with magnesium stearate for 3 minutes and tabletted.
Comparative example 2:
50 parts of doxycycline hydrochloride, 150 parts of microcrystalline cellulose, 10 parts of hydroxymethyl starch sodium, 1 part of magnesium stearate and 10 parts of beef flavor. And uniformly mixing doxycycline hydrochloride, microcrystalline cellulose, sodium carboxymethyl starch and beef flavor, granulating by a dry method to obtain pellets, mixing the prepared pellets with magnesium stearate for 3 minutes, and tabletting.
Comparative examples and examples specific implementation of the compression cases the comparative cases are shown in table 1.
TABLE 1
The results of the substances related to the examples and comparative examples are shown in Table 2.
TABLE 2
| Numbering device | Impurity X (maximum single impurity) | Standard (not more than 1.0%) |
| Raw materials | 0.818% | Qualified product |
| Example 1 | 0.825% | Qualified product |
| Example 2 | 0.851% | Qualified product |
| Example 3 | 0.832% | Qualified product |
| Comparative example 1 | 1.623% | Failure to pass |
| Comparative example 2 | 0.877% | Qualified product |
The test data in Table 2 show that the maximum single impurity increase by wet granulation does not meet the requirements of the classical veterinary drugs; and the dry granulation is adopted, so that the labor, material resources and equipment cost are increased. The granulating process has the advantages of no obvious change of the maximum single impurity, stable product, simple process, time saving and cost reduction.
Examples the tabletting conditions are shown in table 3.
TABLE 3 Table 3
| Numbering device | Tabletting conditions | Remarks |
| Example 1 | The powder has good fluidity, good compressibility, stable hardness and loading | Tablet surface smoothness (figure 1) |
| Example 2 | The powder has good fluidity, good compressibility, stable hardness and loading | The tablet has smooth surface |
| Example 3 | The powder has good fluidity, good compressibility, stable hardness and loading | Tablet surface smoothness (figure 2) |
The formula of the embodiment of the invention has good compressibility, and the obtained tablet has smooth and clean surface and good application prospect.
Animal test:
the test animals are selected to have good health status and weight close to that of the adult dogs and are divided into three groups, the weight and sexes of each group are kept balanced as much as possible, each dog is fed with 1 piece, feeding conditions are observed, feeding samples of each test group are exchanged in turn after every other day, each group feeds three test samples, and the final feeding conditions are counted.
The results of the substances related to the examples and the comparative examples are shown in Table 4.
TABLE 4 Table 4
| Test sample | Whether or not to actively feed | Number of remaining sheets | Adverse reactions |
| Example 1 | Is that | 0 | Without any means for |
| Example 2 | Is that | 1 | Without any means for |
| Example 3 | Is that | 0 | Without any means for |
| Comparative example 1 | Is that | 3 | Without any means for |
| Comparative example 2 | Is that | 1 | Without any means for |
| Example 1 | Is that | 0 | Without any means for |
| Example 2 | Is that | 0 | Without any means for |
| Example 3 | Is that | 0 | Without any means for |
| Comparative example 1 | Is that | 2 | Without any means for |
| Comparative example 2 | Is that | 0 | Without any means for |
| Example 1 | Is that | 1 | Without any means for |
| Example 2 | Is that | 0 | Without any means for |
| Example 3 | Is that | 1 | Without any means for |
| Comparative example 1 | Is that | 4 | Without any means for |
| Comparative example 2 | Is that | 1 | Without any means for |
The test data in table 4 shows that feeding of dogs to different process pelletization flavor tablets indicates that during wet granulation, a portion of the flavor of the phagostimulant may be lost, affecting the palatability of the tablets. And dry granulation and direct compression tablets can better preserve the palatability of the tablets. But combines comprehensive consideration, compared with dry granulation, the direct compression process can greatly reduce cost, save manpower and material resources, has the advantages of dry granulation, has better stability and palatability, and is an ideal doxycycline hydrochloride flavor tablet preparation process.
The above description of the present invention is further illustrated in detail and should not be taken as limiting the practice of the present invention. It is within the scope of the present invention for those skilled in the art to make simple deductions or substitutions without departing from the concept of the present invention.
Claims (1)
1. A doxycycline hydrochloride flavor tablet for pets, which is characterized in that: the mass composition of the material comprises: 5 to 30 parts of doxycycline hydrochloride, 100 to 150 parts of filler, 2 to 5 parts of sodium carboxymethylcellulose, 2 to 6 parts of colloidal silicon dioxide, 1 to 8 parts of lubricant and 5 to 10 parts of beef flavor flavoring agent;
wherein the filler is microcrystalline cellulose or starch, the lubricant is magnesium stearate, and the preparation method of the doxycycline hydrochloride flavor tablet for pets comprises the following steps: doxycycline hydrochloride, a filling agent, sodium carboxymethyl cellulose, colloidal silicon dioxide, magnesium stearate and beef flavor flavoring agent are respectively sieved by a 30-mesh sieve for finishing, diluted and uniformly mixed in a rotary mixer according to the principle of gradient of raw materials and auxiliary materials in equal ratio at a rotating speed of 20 revolutions per minute, and the prepared particles and a lubricant are mixed for 3 minutes at the same rotating speed and are pressed into tablets through a direct compression process.
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN106924198A (en) * | 2015-12-31 | 2017-07-07 | 恒盛高科（天津）生物技术有限公司 | Doxycycline hydrochloride oral disintegrating tablet for domestic fowls and preparation method thereof |
| CN110368367A (en) * | 2019-08-27 | 2019-10-25 | 佛山市南海东方澳龙制药有限公司 | Bio-Tab and its preparation method and application, antibacterials |
| CN110859813A (en) * | 2019-11-27 | 2020-03-06 | 河北远征药业有限公司 | Polyciclovir hydrochloride tablet for pets and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106924198A (en) * | 2015-12-31 | 2017-07-07 | 恒盛高科（天津）生物技术有限公司 | Doxycycline hydrochloride oral disintegrating tablet for domestic fowls and preparation method thereof |
| CN110368367A (en) * | 2019-08-27 | 2019-10-25 | 佛山市南海东方澳龙制药有限公司 | Bio-Tab and its preparation method and application, antibacterials |
| CN110859813A (en) * | 2019-11-27 | 2020-03-06 | 河北远征药业有限公司 | Polyciclovir hydrochloride tablet for pets and preparation method thereof |
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