CN113476406A - Veterinary compound amoxicillin powder and preparation process thereof - Google Patents
Veterinary compound amoxicillin powder and preparation process thereof Download PDFInfo
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- CN113476406A CN113476406A CN202110610992.XA CN202110610992A CN113476406A CN 113476406 A CN113476406 A CN 113476406A CN 202110610992 A CN202110610992 A CN 202110610992A CN 113476406 A CN113476406 A CN 113476406A
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- amoxicillin
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- LSQZJLSUYDQPKJ-NJBDSQKTSA-N amoxicillin Chemical compound C1([C@@H](N)C(=O)N[C@H]2[C@H]3SC([C@@H](N3C2=O)C(O)=O)(C)C)=CC=C(O)C=C1 LSQZJLSUYDQPKJ-NJBDSQKTSA-N 0.000 title claims abstract description 77
- 229960003022 amoxicillin Drugs 0.000 title claims abstract description 77
- LSQZJLSUYDQPKJ-UHFFFAOYSA-N p-Hydroxyampicillin Natural products O=C1N2C(C(O)=O)C(C)(C)SC2C1NC(=O)C(N)C1=CC=C(O)C=C1 LSQZJLSUYDQPKJ-UHFFFAOYSA-N 0.000 title claims abstract description 77
- 150000001875 compounds Chemical class 0.000 title claims abstract description 34
- 239000000843 powder Substances 0.000 title claims abstract description 32
- 238000002360 preparation method Methods 0.000 title claims abstract description 22
- ABVRVIZBZKUTMK-JSYANWSFSA-M potassium clavulanate Chemical compound [K+].[O-]C(=O)[C@H]1C(=C/CO)/O[C@@H]2CC(=O)N21 ABVRVIZBZKUTMK-JSYANWSFSA-M 0.000 claims abstract description 23
- 229940038649 clavulanate potassium Drugs 0.000 claims abstract description 19
- 238000001816 cooling Methods 0.000 claims abstract description 14
- 238000004519 manufacturing process Methods 0.000 claims abstract description 12
- 239000003085 diluting agent Substances 0.000 claims abstract description 8
- 239000003381 stabilizer Substances 0.000 claims abstract description 8
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 8
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims abstract description 7
- 229910052782 aluminium Inorganic materials 0.000 claims abstract description 7
- 239000011888 foil Substances 0.000 claims abstract description 7
- 238000004806 packaging method and process Methods 0.000 claims abstract description 7
- 238000007873 sieving Methods 0.000 claims abstract description 7
- PMZURENOXWZQFD-UHFFFAOYSA-L Sodium Sulfate Chemical compound [Na+].[Na+].[O-]S([O-])(=O)=O PMZURENOXWZQFD-UHFFFAOYSA-L 0.000 claims description 12
- 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 12
- 229930006000 Sucrose Natural products 0.000 claims description 12
- GCLGEJMYGQKIIW-UHFFFAOYSA-H sodium hexametaphosphate Chemical compound [Na]OP1(=O)OP(=O)(O[Na])OP(=O)(O[Na])OP(=O)(O[Na])OP(=O)(O[Na])OP(=O)(O[Na])O1 GCLGEJMYGQKIIW-UHFFFAOYSA-H 0.000 claims description 12
- 235000019982 sodium hexametaphosphate Nutrition 0.000 claims description 12
- 235000019832 sodium triphosphate Nutrition 0.000 claims description 12
- 239000005720 sucrose Substances 0.000 claims description 12
- 239000001577 tetrasodium phosphonato phosphate Substances 0.000 claims description 12
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 4
- 229920000858 Cyclodextrin Polymers 0.000 claims description 2
- 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 claims description 2
- 239000001116 FEMA 4028 Substances 0.000 claims description 2
- 229930195725 Mannitol Natural products 0.000 claims description 2
- 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 claims description 2
- 235000011175 beta-cyclodextrine Nutrition 0.000 claims description 2
- 229960004853 betadex Drugs 0.000 claims description 2
- 239000000594 mannitol Substances 0.000 claims description 2
- 235000010355 mannitol Nutrition 0.000 claims description 2
- HELHAJAZNSDZJO-OLXYHTOASA-L sodium L-tartrate Chemical compound [Na+].[Na+].[O-]C(=O)[C@H](O)[C@@H](O)C([O-])=O HELHAJAZNSDZJO-OLXYHTOASA-L 0.000 claims description 2
- 239000011780 sodium chloride Substances 0.000 claims description 2
- 239000001509 sodium citrate Substances 0.000 claims description 2
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims description 2
- 235000011083 sodium citrates Nutrition 0.000 claims description 2
- 239000001433 sodium tartrate Substances 0.000 claims description 2
- 229960002167 sodium tartrate Drugs 0.000 claims description 2
- 235000011004 sodium tartrates Nutrition 0.000 claims description 2
- 239000003814 drug Substances 0.000 abstract description 7
- 238000000034 method Methods 0.000 abstract description 6
- HZZVJAQRINQKSD-UHFFFAOYSA-N Clavulanic acid Natural products OC(=O)C1C(=CCO)OC2CC(=O)N21 HZZVJAQRINQKSD-UHFFFAOYSA-N 0.000 abstract description 3
- HZZVJAQRINQKSD-PBFISZAISA-N clavulanic acid Chemical compound OC(=O)[C@H]1C(=C/CO)/O[C@@H]2CC(=O)N21 HZZVJAQRINQKSD-PBFISZAISA-N 0.000 abstract description 3
- 238000009776 industrial production Methods 0.000 abstract description 3
- 238000003860 storage Methods 0.000 abstract description 3
- 229940090805 clavulanate Drugs 0.000 abstract 1
- 230000000844 anti-bacterial effect Effects 0.000 description 11
- 241000894006 Bacteria Species 0.000 description 3
- 102000004190 Enzymes Human genes 0.000 description 3
- 108090000790 Enzymes Proteins 0.000 description 3
- 229930182555 Penicillin Natural products 0.000 description 3
- JGSARLDLIJGVTE-MBNYWOFBSA-N Penicillin G Chemical compound N([C@H]1[C@H]2SC([C@@H](N2C1=O)C(O)=O)(C)C)C(=O)CC1=CC=CC=C1 JGSARLDLIJGVTE-MBNYWOFBSA-N 0.000 description 3
- 238000010521 absorption reaction Methods 0.000 description 3
- 229940079593 drug Drugs 0.000 description 3
- 238000002474 experimental method Methods 0.000 description 3
- 229940049954 penicillin Drugs 0.000 description 3
- 108090000204 Dipeptidase 1 Proteins 0.000 description 2
- 230000001133 acceleration Effects 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 2
- 239000003782 beta lactam antibiotic agent Substances 0.000 description 2
- 239000003781 beta lactamase inhibitor Substances 0.000 description 2
- 102000006635 beta-lactamase Human genes 0.000 description 2
- 229940126813 beta-lactamase inhibitor Drugs 0.000 description 2
- 125000003460 beta-lactamyl group Chemical group 0.000 description 2
- 230000015556 catabolic process Effects 0.000 description 2
- 229960003324 clavulanic acid Drugs 0.000 description 2
- 238000006731 degradation reaction Methods 0.000 description 2
- 208000015181 infectious disease Diseases 0.000 description 2
- 239000003112 inhibitor Substances 0.000 description 2
- 239000002994 raw material Substances 0.000 description 2
- 238000001228 spectrum Methods 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 239000000273 veterinary drug Substances 0.000 description 2
- 239000002132 β-lactam antibiotic Substances 0.000 description 2
- 229940124586 β-lactam antibiotics Drugs 0.000 description 2
- 229940126085 β‑Lactamase Inhibitor Drugs 0.000 description 2
- 208000035143 Bacterial infection Diseases 0.000 description 1
- 206010024971 Lower respiratory tract infections Diseases 0.000 description 1
- 206010033078 Otitis media Diseases 0.000 description 1
- 208000008469 Peptic Ulcer Diseases 0.000 description 1
- 206010034719 Personality change Diseases 0.000 description 1
- 206010057190 Respiratory tract infections Diseases 0.000 description 1
- MTCFGRXMJLQNBG-UHFFFAOYSA-N Serine Natural products OCC(N)C(O)=O MTCFGRXMJLQNBG-UHFFFAOYSA-N 0.000 description 1
- 206010046306 Upper respiratory tract infection Diseases 0.000 description 1
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 1
- 208000022362 bacterial infectious disease Diseases 0.000 description 1
- 230000003115 biocidal effect Effects 0.000 description 1
- 206010006451 bronchitis Diseases 0.000 description 1
- 125000002915 carbonyl group Chemical group [*:2]C([*:1])=O 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 229960002626 clarithromycin Drugs 0.000 description 1
- AGOYDEPGAOXOCK-KCBOHYOISA-N clarithromycin Chemical compound O([C@@H]1[C@@H](C)C(=O)O[C@@H]([C@@]([C@H](O)[C@@H](C)C(=O)[C@H](C)C[C@](C)([C@H](O[C@H]2[C@@H]([C@H](C[C@@H](C)O2)N(C)C)O)[C@H]1C)OC)(C)O)CC)[C@H]1C[C@@](C)(OC)[C@@H](O)[C@H](C)O1 AGOYDEPGAOXOCK-KCBOHYOISA-N 0.000 description 1
- 230000002860 competitive effect Effects 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 239000007919 dispersible tablet Substances 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000005469 granulation Methods 0.000 description 1
- 230000003179 granulation Effects 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 230000002427 irreversible effect Effects 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 229910052760 oxygen Inorganic materials 0.000 description 1
- 239000001301 oxygen Substances 0.000 description 1
- 208000011906 peptic ulcer disease Diseases 0.000 description 1
- 239000006187 pill Substances 0.000 description 1
- 229940126409 proton pump inhibitor Drugs 0.000 description 1
- 239000000612 proton pump inhibitor Substances 0.000 description 1
- 238000007086 side reaction Methods 0.000 description 1
- 210000004872 soft tissue Anatomy 0.000 description 1
- 239000007921 spray Substances 0.000 description 1
- 150000003952 β-lactams Chemical class 0.000 description 1
Classifications
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/143—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with inorganic compounds
-
- 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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/42—Oxazoles
- A61K31/424—Oxazoles condensed with heterocyclic ring systems, e.g. clavulanic acid
-
- 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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/425—Thiazoles
- A61K31/429—Thiazoles condensed with heterocyclic ring systems
- A61K31/43—Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula, e.g. penicillins, penems
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Communicable Diseases (AREA)
- Oncology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Inorganic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention belongs to the technical field of veterinary medicine, and particularly relates to a veterinary compound amoxicillin powder and a preparation process thereof, wherein the veterinary compound amoxicillin powder comprises, by percentage, 1:1 amoxicillin and clavulanate 5-10%, amoxicillin 10-25%, a stabilizer 20-60%, a water softener 0.1-0.5%, and a diluent 20-65%; controlling the production environment temperature to be less than or equal to 20 ℃, and controlling the relative humidity to be less than or equal to 30 percent: sieving the diluent with a 80-mesh sieve, uniformly mixing in a mixer, and cooling to room temperature; premixing amoxicillin, a stabilizer and a water softener, adding into a mixer, mixing uniformly, and cooling to room temperature; adding 1:1 amoxicillin and clavulanate potassium into a mixer to mix for 20-30 minutes, and packaging with aluminum foil bags to obtain the compound amoxicillin powder, which is not easy to absorb moisture and agglomerate, stable in character, not easy to change color, stable in property in the production and storage process, simple in preparation process, strong in operability and suitable for industrial production.
Description
Technical Field
The invention belongs to the technical field of veterinary medicines, and particularly relates to a veterinary compound amoxicillin powder and a preparation process thereof.
Background
Amoxicillin, also known as amoxicillin, belongs to beta-lactam antibiotics, is a semi-synthetic penicillin medicament, has the antibacterial property similar to that of natural penicillin, is good in oral administration absorption, good in antibacterial activity and less in side reaction, and is commonly used for various bacterial infection diseases in clinic. The traditional Chinese medicine composition is mainly used for treating otitis media, upper respiratory tract infection, urogenital tract infection, skin soft tissue and other infections, can also be used for treating lower respiratory tract infection such as acute bronchitis and the like, and can also be combined with clarithromycin and a proton pump inhibitor for oral administration to reduce the recurrence rate of peptic ulcer.
Clavulanic acid, also known as clavulanic acid, is an oxygen-containing parent nucleus antibiotic, has weak antibacterial action, has no clinical value when being used alone, and is often used together with other beta-lactam antibiotics to enhance the antibacterial action. The structure of the inhibitor is very similar to that of mother nucleus of penicillin and cefamycin, and the inhibitor is a natural irreversible competitive beta-lactamase inhibitor produced by bacteria, contains a beta-lactam ring, and can be used together with amoxicillin to enhance the antibacterial activity, increase the antibacterial spectrum and reduce the minimum antibacterial concentration by the reaction of carbonyl on the beta-lactam ring and serine hydroxyl in an enzyme molecule to acidylate the enzyme so as to lose the activity.
The amoxicillin and clavulanate potassium is a compound preparation of amoxicillin and beta-lactamase inhibitor and clavulanate potassium. The compound preparation has wide antibacterial spectrum, strong bactericidal capability and more than 90 percent of oral absorption rate, can obviously enhance the antibacterial activity of amoxicillin on beta-lactam enzyme producing strains, has good antibacterial activity on most of beta-lactamase producing bacteria, and does not influence respective absorption after the amoxicillin and the beta-lactamase producing bacteria are simultaneously administrated, but the compound amoxicillin soluble powder produced by most domestic manufacturers at present has poor stability, is easy to absorb moisture, is easy to discolor and agglomerate after being stored for a period of time, has reduced content and influences bioavailability. CN110051637A discloses that the method of dripping pills and spray granulation is used for preparing the amoxicillin and clavulanate potassium preparation, although the exposure time of the medicine in the air is reduced, the operation process is more complicated, and the production is not facilitated.
The preparation of the amoxicillin and clavulanate potassium dispersible tablets in CN109248150A is convenient to package and store, but has limitations in feeding, aiming at the problems, the invention prepares the compound amoxicillin powder, which meets the production process, has stable property, is not easy to degrade, has strong process operability, is convenient to feed and store, and is beneficial to popularization.
Disclosure of Invention
The invention aims to solve the problems in the prior art and provides the veterinary compound amoxicillin powder and the preparation process thereof.
The invention adopts the specific technical scheme that: the key point of the veterinary compound amoxicillin powder is that the veterinary compound amoxicillin powder comprises the following components in percentage: 1:1 of 5 to 10 percent of amoxicillin and clavulanate potassium, 10 to 25 percent of amoxicillin, 20 to 60 percent of stabilizer, 0.5 to 5 percent of water softener and 20 to 65 percent of diluent.
The contents of all components are as follows according to percentage: 1:1 of amoxicillin and clavulanate potassium 5%, amoxicillin 15%, anhydrous sodium sulfate 20%, sodium hexametaphosphate 20%, sodium tripolyphosphate 0.5%, and sucrose 39.5%.
The stabilizer is one or at least two of anhydrous sodium sulfate and sodium hexametaphosphate.
The water softener is one or at least two of sodium tripolyphosphate, sodium citrate and sodium tartrate.
The diluent is one or at least two of mannitol, sucrose, beta cyclodextrin and sodium chloride.
A preparation process of veterinary compound amoxicillin powder is characterized by comprising the following steps:
controlling the production environment temperature to be less than or equal to 20 ℃, and controlling the relative humidity to be less than or equal to 30 percent:
sieving the diluent with a 80-mesh sieve, uniformly mixing in a mixer, and cooling to room temperature;
premixing amoxicillin, a stabilizer and a water softener, adding into a mixer, mixing uniformly, and cooling to room temperature;
adding 1:1 amoxicillin and clavulanate potassium into a mixer, mixing for 20-30 minutes, and packaging with aluminum foil bags to obtain the compound amoxicillin powder.
The invention has the beneficial effects that:
(1) the compound amoxicillin powder prepared by the invention is not easy to absorb moisture and agglomerate, has stable properties and is not easy to change color, and has stable properties in the production and storage processes.
(2) The preparation method is simple in preparation process, strong in operability and suitable for industrial production.
Detailed Description
The invention will be further illustrated with reference to specific examples:
first, an embodiment
Example 1
A veterinary compound amoxicillin powder and a preparation method thereof are disclosed, which comprises the following components in parts by weight:
the preparation method comprises the following steps:
1:1 of 5 percent of amoxicillin and clavulanate potassium, 10 percent of amoxicillin, 15 percent of anhydrous sodium sulfate, 30 percent of sodium hexametaphosphate, 5 percent of sodium tripolyphosphate and 35 percent of sucrose.
The production environment temperature is controlled to be less than or equal to 20 ℃, the relative humidity is controlled to be less than or equal to 30%, and the operation is carried out according to the following steps:
sieving sucrose with a 80-mesh sieve, uniformly mixing in a mixer, and cooling to room temperature;
premixing amoxicillin, anhydrous sodium sulfate, sodium hexametaphosphate and sodium tripolyphosphate, adding into a mixer, mixing uniformly, and cooling to room temperature;
adding 1:1 amoxicillin and clavulanate potassium into a mixer to mix for 20 minutes, and packaging with aluminum foil bags to obtain the compound amoxicillin powder.
Example 2
A veterinary compound amoxicillin powder and a preparation method thereof are disclosed, which comprises the following components in parts by weight:
1:1 of amoxicillin and clavulanate potassium 5%, amoxicillin 15%, anhydrous sodium sulfate 20%, sodium hexametaphosphate 20%, sodium tripolyphosphate 0.5%, and sucrose 39.5%.
The preparation method comprises the following steps:
the production environment temperature is controlled to be less than or equal to 20 ℃, the relative humidity is controlled to be less than or equal to 30%, and the operation is carried out according to the following steps:
sieving sucrose with a 80-mesh sieve, uniformly mixing in a mixer, and cooling to room temperature;
premixing amoxicillin, anhydrous sodium sulfate, sodium hexametaphosphate and sodium tripolyphosphate, adding into a mixer, mixing uniformly, and cooling to room temperature;
1:1 adding the amoxicillin and clavulanate potassium into a mixer to mix for 30 minutes, and packaging with aluminum foil bags to obtain the compound amoxicillin powder.
Example 3
A veterinary compound amoxicillin powder and a preparation method thereof are disclosed, which comprises the following components in parts by weight:
1:1 of amoxicillin and clavulanate potassium 5%, amoxicillin 20%, anhydrous sodium sulfate 10%, sodium hexametaphosphate 30%, sodium tripolyphosphate 1% and sucrose 34%.
The preparation method comprises the following steps:
the production environment temperature is controlled to be less than or equal to 20 ℃, the relative humidity is controlled to be less than or equal to 30%, and the operation is carried out according to the following steps:
sieving sucrose with a 80-mesh sieve, uniformly mixing in a mixer, and cooling to room temperature;
premixing amoxicillin, anhydrous sodium sulfate, sodium hexametaphosphate and sodium tripolyphosphate, adding into a mixer, mixing uniformly, and cooling to room temperature;
1:1 adding the amoxicillin and clavulanate potassium into a mixer to mix for 25 minutes, and packaging with aluminum foil bags to obtain the compound amoxicillin powder.
Example 4
A veterinary compound amoxicillin powder and a preparation method thereof are disclosed, which comprises the following components in parts by weight:
1:1 of amoxicillin and clavulanate potassium 10%, amoxicillin 25%, anhydrous sodium sulfate 30%, sodium hexametaphosphate 10%, sodium tripolyphosphate 0.5%, and sucrose 24.5%.
The preparation method comprises the following steps:
the production environment temperature is controlled to be less than or equal to 20 ℃, the relative humidity is controlled to be less than or equal to 30%, and the operation is carried out according to the following steps:
sieving sucrose with a 80-mesh sieve, uniformly mixing in a mixer, and cooling to room temperature;
premixing amoxicillin, anhydrous sodium sulfate, sodium hexametaphosphate and sodium tripolyphosphate, adding into a mixer, mixing uniformly, and cooling to room temperature;
1:1 adding the amoxicillin and clavulanate potassium into a mixer to mix for 23 minutes, and packaging with aluminum foil bags to obtain the compound amoxicillin powder.
Second, experimental results
Placing a sample in a constant temperature and humidity box with the temperature of 40 ℃ and the humidity of 75% for 6-month stability investigation, simultaneously placing a 1:1 amoxicillin and potassium clavulanate raw material and a certain commercially available product in an accelerating box for accelerating observation for 6 months, detecting the degradation rate change and the moisture and character change of the amoxicillin and the potassium clavulanate in 0, 1, 3 and 6 months according to a method of 2017 edition of chemical drug book of veterinary drug quality standards, wherein the experimental results are shown in the table:
TABLE 1 sample degradation rate
Experiments prove that after accelerated experiments, the content of amoxicillin and potassium clavulanate in the compound amoxicillin powder under the condition of the invention is not changed greatly, the compound amoxicillin powder meets the specification of 2017 edition of chemical drug book of veterinary drug quality standard, the content of amoxicillin and potassium clavulanate in example 2 is reduced less, and is reduced by 1.49% and 3.46% respectively, and the compound amoxicillin powder meets the requirements of production and storage.
TABLE 2 moisture content (%)
TABLE 3 product Property Change
The experimental moisture and character data show that the stability of the product can be improved by adding a certain amount of auxiliary materials, the six-month acceleration of the product can be shown to still meet the pharmacopeia standard by long-term acceleration experiments, the stability of the product is obviously superior to that of the raw materials and commercial products, and the industrial production can be realized.
Claims (6)
1. The veterinary compound amoxicillin powder is characterized by comprising the following components in percentage: 1:1 of 5 to 10 percent of amoxicillin and clavulanate potassium, 10 to 25 percent of amoxicillin, 20 to 60 percent of stabilizer, 0.5 to 5 percent of water softener and 20 to 65 percent of diluent.
2. The veterinary compound amoxicillin powder according to claim 1, characterized in that the stabilizer is one or at least two of anhydrous sodium sulfate and sodium hexametaphosphate.
3. The veterinary compound amoxicillin powder according to claim 1, characterized in that the water softener is one or at least two of sodium tripolyphosphate, sodium citrate and sodium tartrate.
4. The veterinary compound amoxicillin powder according to claim 1, characterized in that the diluent is one or at least two of mannitol, sucrose, beta cyclodextrin and sodium chloride.
5. The veterinary compound amoxicillin powder according to claim 1, characterized in that the contents of the components are as follows according to percentage: 1:1 of amoxicillin and clavulanate potassium 5%, amoxicillin 15%, anhydrous sodium sulfate 20%, sodium hexametaphosphate 20%, sodium tripolyphosphate 0.5%, and sucrose 39.5%.
6. The preparation process of the compound amoxicillin powder for veterinary use as claimed in claim 1, which comprises the following steps:
controlling the production environment temperature to be less than or equal to 20 ℃, and controlling the relative humidity to be less than or equal to 30 percent:
sieving the diluent with a 80-mesh sieve, uniformly mixing in a mixer, and cooling to room temperature;
premixing amoxicillin, a stabilizer and a water softener, adding into a mixer, mixing uniformly, and cooling to room temperature;
adding 1:1 amoxicillin and clavulanate potassium into a mixer, mixing for 20-30 minutes, and packaging with aluminum foil bags to obtain the compound amoxicillin powder.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114869884A (en) * | 2021-07-30 | 2022-08-09 | 江苏恒丰强生物技术有限公司 | Compound amoxicillin powder for porcine respiratory diseases and preparation method thereof |
| CN117379378A (en) * | 2023-12-07 | 2024-01-12 | 山东金瑞生物科技有限公司 | Compound amoxicillin soluble powder for livestock and preparation process thereof |
| IT202200023823A1 (en) * | 2022-11-18 | 2024-05-18 | Dox Al Italia Spa | HYPOTHERMIC STABILIZATION PROCESS OF RAW MATERIALS SUBJECTED TO TRANSPORT STRESS |
-
2021
- 2021-06-01 CN CN202110610992.XA patent/CN113476406A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114869884A (en) * | 2021-07-30 | 2022-08-09 | 江苏恒丰强生物技术有限公司 | Compound amoxicillin powder for porcine respiratory diseases and preparation method thereof |
| IT202200023823A1 (en) * | 2022-11-18 | 2024-05-18 | Dox Al Italia Spa | HYPOTHERMIC STABILIZATION PROCESS OF RAW MATERIALS SUBJECTED TO TRANSPORT STRESS |
| CN117379378A (en) * | 2023-12-07 | 2024-01-12 | 山东金瑞生物科技有限公司 | Compound amoxicillin soluble powder for livestock and preparation process thereof |
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