CN113908134B - Preparation method of cefadroxil dispersion coated tablet - Google Patents
Preparation method of cefadroxil dispersion coated tablet Download PDFInfo
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- CN113908134B CN113908134B CN202111470141.6A CN202111470141A CN113908134B CN 113908134 B CN113908134 B CN 113908134B CN 202111470141 A CN202111470141 A CN 202111470141A CN 113908134 B CN113908134 B CN 113908134B
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- cefadroxil
- parts
- coating
- coated tablet
- gastric
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- NBFNMSULHIODTC-CYJZLJNKSA-N cefadroxil monohydrate Chemical compound O.C1([C@@H](N)C(=O)N[C@H]2[C@@H]3N(C2=O)C(=C(CS3)C)C(O)=O)=CC=C(O)C=C1 NBFNMSULHIODTC-CYJZLJNKSA-N 0.000 title claims abstract description 82
- 229960004841 cefadroxil Drugs 0.000 title claims abstract description 81
- 238000002360 preparation method Methods 0.000 title claims abstract description 17
- 239000006185 dispersion Substances 0.000 title claims description 9
- 238000000576 coating method Methods 0.000 claims abstract description 62
- 239000011248 coating agent Substances 0.000 claims abstract description 57
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 32
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 28
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 26
- 239000000843 powder Substances 0.000 claims abstract description 20
- 235000019359 magnesium stearate Nutrition 0.000 claims abstract description 16
- 239000007888 film coating Substances 0.000 claims abstract description 14
- 238000009501 film coating Methods 0.000 claims abstract description 14
- 229920002472 Starch Polymers 0.000 claims abstract description 13
- 239000007788 liquid Substances 0.000 claims abstract description 13
- 239000008213 purified water Substances 0.000 claims abstract description 13
- 239000008107 starch Substances 0.000 claims abstract description 13
- 235000019698 starch Nutrition 0.000 claims abstract description 13
- 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 claims abstract description 12
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims abstract description 12
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 claims abstract description 12
- 229940031703 low substituted hydroxypropyl cellulose Drugs 0.000 claims abstract description 12
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims abstract description 12
- 239000008108 microcrystalline cellulose Substances 0.000 claims abstract description 12
- 229940016286 microcrystalline cellulose Drugs 0.000 claims abstract description 12
- 239000011734 sodium Substances 0.000 claims abstract description 12
- 229910052708 sodium Inorganic materials 0.000 claims abstract description 12
- 239000002994 raw material Substances 0.000 claims abstract description 8
- 238000005303 weighing Methods 0.000 claims abstract description 7
- 238000002156 mixing Methods 0.000 claims description 28
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 claims description 12
- 238000001035 drying Methods 0.000 claims description 11
- 238000007580 dry-mixing Methods 0.000 claims description 10
- 239000008187 granular material Substances 0.000 claims description 10
- 238000005507 spraying Methods 0.000 claims description 10
- 238000007873 sieving Methods 0.000 claims description 7
- 239000004925 Acrylic resin Substances 0.000 claims description 6
- 229920000178 Acrylic resin Polymers 0.000 claims description 6
- 239000002202 Polyethylene glycol Substances 0.000 claims 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 claims description 6
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 6
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 6
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 6
- 229920001223 polyethylene glycol Polymers 0.000 claims description 6
- 239000004408 titanium dioxide Substances 0.000 claims description 6
- 230000002496 gastric effect Effects 0.000 claims description 5
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims description 5
- 239000007921 spray Substances 0.000 claims description 5
- 230000004584 weight gain Effects 0.000 claims description 5
- 235000019786 weight gain Nutrition 0.000 claims description 5
- 239000002002 slurry Substances 0.000 claims description 4
- 238000000034 method Methods 0.000 abstract description 7
- 239000003814 drug Substances 0.000 abstract description 5
- 238000010521 absorption reaction Methods 0.000 abstract description 4
- 239000000463 material Substances 0.000 abstract description 3
- 210000000214 mouth Anatomy 0.000 abstract description 3
- 230000009471 action Effects 0.000 abstract description 2
- 230000003115 biocidal effect Effects 0.000 abstract description 2
- 229940079593 drug Drugs 0.000 abstract description 2
- 239000000825 pharmaceutical preparation Substances 0.000 abstract description 2
- 239000008280 blood Substances 0.000 abstract 1
- 210000004369 blood Anatomy 0.000 abstract 1
- 239000003826 tablet Substances 0.000 description 57
- 238000004090 dissolution Methods 0.000 description 22
- 239000000243 solution Substances 0.000 description 19
- 239000012535 impurity Substances 0.000 description 10
- 238000003756 stirring Methods 0.000 description 8
- 230000001133 acceleration Effects 0.000 description 6
- 239000013558 reference substance Substances 0.000 description 6
- 238000012360 testing method Methods 0.000 description 6
- 239000012488 sample solution Substances 0.000 description 5
- 230000000052 comparative effect Effects 0.000 description 4
- 239000007919 dispersible tablet Substances 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- 238000012986 modification Methods 0.000 description 4
- 230000004048 modification Effects 0.000 description 4
- 239000003960 organic solvent Substances 0.000 description 4
- 239000002245 particle Substances 0.000 description 4
- NVIAYEIXYQCDAN-CLZZGJSISA-N 7beta-aminodeacetoxycephalosporanic acid Chemical compound S1CC(C)=C(C(O)=O)N2C(=O)[C@@H](N)[C@@H]12 NVIAYEIXYQCDAN-CLZZGJSISA-N 0.000 description 3
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical group OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 3
- 230000009102 absorption Effects 0.000 description 3
- 238000009835 boiling Methods 0.000 description 3
- 238000007865 diluting Methods 0.000 description 3
- 238000010828 elution Methods 0.000 description 3
- 238000011835 investigation Methods 0.000 description 3
- LJCWONGJFPCTTL-UHFFFAOYSA-N 4-hydroxyphenylglycine Chemical compound OC(=O)C(N)C1=CC=C(O)C=C1 LJCWONGJFPCTTL-UHFFFAOYSA-N 0.000 description 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 2
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- 230000004075 alteration Effects 0.000 description 2
- 230000000844 anti-bacterial effect Effects 0.000 description 2
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 2
- 238000010790 dilution Methods 0.000 description 2
- 239000012895 dilution Substances 0.000 description 2
- 239000000945 filler Substances 0.000 description 2
- 239000000706 filtrate Substances 0.000 description 2
- 238000001914 filtration Methods 0.000 description 2
- 230000014759 maintenance of location Effects 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 230000000873 masking effect Effects 0.000 description 2
- 229910000402 monopotassium phosphate Inorganic materials 0.000 description 2
- 235000019796 monopotassium phosphate Nutrition 0.000 description 2
- 239000006191 orally-disintegrating tablet Substances 0.000 description 2
- 239000001301 oxygen Substances 0.000 description 2
- 229910052760 oxygen Inorganic materials 0.000 description 2
- 239000008194 pharmaceutical composition Substances 0.000 description 2
- 239000000546 pharmaceutical excipient Substances 0.000 description 2
- PJNZPQUBCPKICU-UHFFFAOYSA-N phosphoric acid;potassium Chemical compound [K].OP(O)(O)=O PJNZPQUBCPKICU-UHFFFAOYSA-N 0.000 description 2
- 238000000926 separation method Methods 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- JSKBOTPKGOLKID-UHFFFAOYSA-N 2-anilino-2-hydroxyacetic acid Chemical compound OC(=O)C(O)NC1=CC=CC=C1 JSKBOTPKGOLKID-UHFFFAOYSA-N 0.000 description 1
- 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 1
- KWYUFKZDYYNOTN-UHFFFAOYSA-M Potassium hydroxide Chemical compound [OH-].[K+] KWYUFKZDYYNOTN-UHFFFAOYSA-M 0.000 description 1
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 description 1
- 229930006000 Sucrose Natural products 0.000 description 1
- 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 1
- 238000002835 absorbance Methods 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 229910000147 aluminium phosphate Inorganic materials 0.000 description 1
- 239000003242 anti bacterial agent Substances 0.000 description 1
- 229940088710 antibiotic agent Drugs 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000033228 biological regulation Effects 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- YGBFLZPYDUKSPT-MRVPVSSYSA-N cephalosporanic acid Chemical compound S1CC(COC(=O)C)=C(C(O)=O)N2C(=O)C[C@H]21 YGBFLZPYDUKSPT-MRVPVSSYSA-N 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 230000006866 deterioration Effects 0.000 description 1
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 description 1
- 239000012738 dissolution medium Substances 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 238000010812 external standard method Methods 0.000 description 1
- 238000000227 grinding Methods 0.000 description 1
- 238000004128 high performance liquid chromatography Methods 0.000 description 1
- 229960003943 hypromellose Drugs 0.000 description 1
- 230000000968 intestinal effect Effects 0.000 description 1
- 239000008101 lactose Substances 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 231100000053 low toxicity Toxicity 0.000 description 1
- 239000000314 lubricant Substances 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 239000002609 medium Substances 0.000 description 1
- 239000011259 mixed solution Substances 0.000 description 1
- YTJSFYQNRXLOIC-UHFFFAOYSA-N octadecylsilane Chemical compound CCCCCCCCCCCCCCCCCC[SiH3] YTJSFYQNRXLOIC-UHFFFAOYSA-N 0.000 description 1
- 229940124588 oral cephalosporin Drugs 0.000 description 1
- 230000003647 oxidation Effects 0.000 description 1
- 238000007254 oxidation reaction Methods 0.000 description 1
- 239000008055 phosphate buffer solution Substances 0.000 description 1
- 239000012088 reference solution Substances 0.000 description 1
- 230000004044 response Effects 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 239000000377 silicon dioxide Substances 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 238000002604 ultrasonography Methods 0.000 description 1
- 238000000870 ultraviolet spectroscopy Methods 0.000 description 1
- 239000000080 wetting agent Substances 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
- A61K31/542—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame ortho- or peri-condensed with heterocyclic ring systems
- A61K31/545—Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins, cefaclor, or cephalexine
-
- 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
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. 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
- A61K9/20—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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2813—Inorganic compounds
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
Abstract
The application belongs to the technical field of pharmaceutical preparations, and provides a cefadroxil dispersible coated tablet and a preparation method thereof, wherein the cefadroxil dispersible coated tablet is prepared from the following components in parts by weight: 250 parts of cefadroxil, 185 parts of microcrystalline cellulose, 25 parts of low-substituted hydroxypropyl cellulose, 37.5 parts of carboxymethyl starch sodium, 1.25 parts of magnesium stearate and 174.8 parts of ethanol; the coated tablet is gastric-soluble, and the gastric-soluble film coating is prepared from gastric-soluble coating powder and purified water; the method comprises the following steps: s1, weighing all raw material components in proportion; s2, preparing cefadroxil tablets; s3, preparing coating liquid; s4, coating. The cefadroxil coated tablet prepared by the application adopts a water-soluble coating material, can be rapidly dissolved out, has the advantage of rapid onset of action, meets the requirement of rapid absorption of antibiotic medicines and peak blood concentration in a short time, and simultaneously avoids bad compliance of patients caused by disintegration in the oral cavity due to the coating treatment.
Description
Technical Field
The application belongs to the technical field of pharmaceutical preparations, and provides a cefadroxil dispersible coated tablet and a preparation method thereof.
Background
Cefadroxil, chemical name (6R, 7R) -3-methyl-7- [ (R) -2-amino-2- (4-hydroxy phenyl) acetamido ] -8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid monohydrate, is a well known antibiotic with antibacterial activity, is a second generation oral cephalosporin developed by Bolisido-Meier company in United states, and has the characteristics of broad antibacterial spectrum, weak antigenicity, good curative effect, low toxicity and safe use.
The dosage forms of cefadroxil on the market at home and abroad at present mainly comprise tablets, capsules, granules, suspension and the like. The Chinese patent application with the application number of 200410007545.1 discloses a cefadroxil orally disintegrating tablet and a preparation method thereof, wherein the cefadroxil orally disintegrating tablet comprises an effective amount of cefadroxil and a medicinal excipient which can rapidly and conveniently release medicines in the oral cavity, and the medicinal excipient is a water-soluble filling agent, a disintegrating agent, a lubricating agent, a wetting agent or an adhesive, and the tablet is rapid in disintegration and rapid in onset of action; the intestinal residue is small, the absorption is sufficient, and the side effect is low; convenient administration and good taste.
The Chinese patent application with the application number of 200610200517.0 discloses a cefadroxil preparation and a preparation method thereof, which mainly aims at the problems of quick dissolution, quick effect and bioavailability of antibiotics, and provides a cefadroxil dispersible tablet, wherein the pharmaceutical composition of the cefadroxil dispersible tablet is 80-180 parts of cefadroxil, and auxiliary materials are as follows: 20-100 parts of microcrystalline cellulose, 10-60 parts of lactose, 10-120 parts of low-substituted hydroxypropyl cellulose, 2-5 parts of sodium dodecyl sulfate, 5-15 parts of sodium chloride and 1-10 parts of magnesium stearate.
The Chinese patent application with the application number of 2015104198. X discloses a cefadroxil coated tablet and a preparation method thereof, wherein the cefadroxil tablet is coated mainly to solve the problem of taste masking, and the pharmaceutical composition is as follows: 70-90 parts of cefadroxil, 10-20 parts of sucrose, 5-15 parts of starch, 0.5-5 parts of magnesium stearate, 0.3-3 parts of carboxymethyl starch sodium and 55-75 parts of gastric-soluble coating powder in percentage by mass, wherein the gastric-soluble film coating is prepared from the gastric-soluble coating powder and 30-60% ethanol.
The preparation can be used for solving the problems of quick dissolution, quick response and partial taste masking. However, all the problems are not solved at the same time, and some of the problems also introduce organic solvents, so that new organic residues are caused, and the application of the organic solvents is limited to a certain extent.
Disclosure of Invention
Aiming at the problems of slight odor, easy moisture absorption, oxidation and deterioration and unwilling of patients to take orally in the prior art, the application aims to provide the cefadroxil coated tablet which has good taste, convenient taking, rapid dissolution, less introduced impurities, high bioavailability and simple and easy preparation method; meanwhile, the latest water-soluble film coating components are adopted, no organic solvent is introduced, the risk of organic residues is avoided, and the environment is protected.
The application aims at providing a cefadroxil dispersible coated tablet which is prepared from the following components in parts by weight:
250 parts of cefadroxil, 185 parts of microcrystalline cellulose, 25 parts of low-substituted hydroxypropyl cellulose, 37.5 parts of carboxymethyl starch sodium, 1.25 parts of magnesium stearate and 174.8 parts of ethanol;
the coated tablet is gastric-soluble, and the gastric-soluble film coating is prepared from gastric-soluble coating powder and purified water.
Preferably, the gastric-soluble coating powder comprises gastric-soluble acrylic resin, hypromellose, polyethylene glycol, talcum powder and titanium dioxide.
Preferably, the mass ratio of the gastric-soluble acrylic resin to the hydroxypropyl methylcellulose to the polyethylene glycol to the talcum powder to the titanium dioxide is 1:0.5:0.5:0.5:0.5.
preferably, the dosage of the gastric-soluble coating powder is 2.5-3.5% of the mass of the coated tablet.
Preferably, the mass ratio of the gastric-soluble coating powder to the purified water is 1:4-6.
The second purpose of the application is to provide a preparation method of the cefadroxil dispersible coated tablet, which comprises the following steps:
s1, weighing all raw material components in proportion;
s2, preparing cefadroxil tablets: dry-mixing cefadroxil, microcrystalline cellulose, low-substituted hydroxypropyl cellulose and carboxymethyl starch sodium, adding ethanol, sequentially wet-mixing at low speed and high speed, sieving with 16 mesh sieve to obtain wet granule, drying, sieving with 16 mesh sieve, adding magnesium stearate, mixing, and tabletting;
s3, preparing coating liquid: adding gastric soluble coating powder into purified water for dispersion;
s4, coating: and (3) placing the cefadroxil tablets in the S2 into a coating pot, and spraying the coating liquid in the S3 to the cefadroxil tablets for coating.
Preferably, in S2, the dry mixing time is 1-3 min, the low-speed wet mixing time is 2-4 min and the high-speed wet mixing time is 1-2 min.
Preferably, in S2, the drying temperature is 60 ℃, the drying time is 90min, and the moisture content of the dried particles is 4.0-6.5%.
Preferably, in S2, the total mixing time is 18-25 min.
Preferably, in S4, the rotating speed of the coating pan is 15r/min, the air inlet temperature is 80-90 ℃, when the air exhaust temperature is more than or equal to 50 ℃, the spraying is started, and in the coating process, the temperature is controlled to be 45-50 ℃, the rotating speed is 3.5-17 rpm, and the spray gun pressure is 0.35-0.50 Mpa; the weight gain of the film coating is 2.5-3.5% of that of the cefadroxil tablet.
Compared with the prior art, the beneficial effects are that:
1. the dispersible coated tablet prepared by the application not only maintains the advantages of quick dissolution and quick effect of the dispersible tablet, but also increases the water-soluble film coating, and as the odor is covered by the coating treatment, the poor compliance of patients caused by disintegration in the oral cavity is avoided, and the dispersible coated tablet is easy to be taken orally; the coating treatment also isolates water and oxygen in the air, so that the quality stability of the medicine in the retention period is improved; the water-soluble coating material is adopted, so that the safety and reliability are realized, no organic residue exists, no organic solvent is used in the production process, the explosion-proof requirement is avoided, and the medicine application of patients is safer.
2. The cefadroxil coated tablet or dispersible tablet in the prior art has strong hygroscopicity, active ingredients are degraded due to the absorption of water vapor during long-term storage, impurities are introduced, the dissolution rate is reduced, and the like; the cefadroxil coated tablet prepared by the application has ideal dissolution rate, the dissolution rate after an acceleration test is not changed greatly, and the dissolution rate of the commercially available cefadroxil coated tablet after the acceleration test is obviously reduced.
3. The preparation method of the cefadroxil coated tablet is simple, has high industrial feasibility, and the raw materials in the preparation prescription are easy to obtain, the price is low, and the production cost of the cefadroxil coated tablet can be obviously reduced.
Detailed Description
The technical solutions in the embodiments of the present application will be clearly and completely described in the following in conjunction with the embodiments of the present application, and it is obvious that the described embodiments are only some embodiments of the present application, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application.
It should be noted that the technical terms used in the present application are only for describing specific examples, and are not intended to limit the scope of the present application, and various raw materials, reagents, instruments and equipment used in the following examples of the present application are commercially available or prepared by the existing methods, wherein the volume fraction of ethanol is 70%, unless otherwise specifically indicated.
Example 1
The cefadroxil dispersible coated tablet is prepared from the following components in parts by weight:
250 parts of cefadroxil, 185 parts of microcrystalline cellulose, 25 parts of low-substituted hydroxypropyl cellulose, 37.5 parts of carboxymethyl starch sodium, 1.25 parts of magnesium stearate and 174.8 parts of 70% ethanol;
the coated tablet is gastric-soluble, and the gastric-soluble film coating is prepared from gastric-soluble acrylic resin, hydroxypropyl methylcellulose, polyethylene glycol, talcum powder and titanium dioxide in a mass ratio of 1:0.5:0.5:0.5:0.5 part of formed gastric-soluble coating powder 14.5 parts and 72.5 parts of purified water.
The preparation method of the cefadroxil dispersible coated tablet comprises the following steps:
s1, weighing all raw material components in proportion;
s2, preparing cefadroxil tablets: adding cefadroxil, microcrystalline cellulose, low-substituted hydroxypropyl cellulose and carboxymethyl starch sodium into a wet mixing granulator, dry-mixing for 2min at a low speed, adding 70% ethanol by volume fraction, sequentially carrying out low-speed wet mixing for 3min, and sieving with a 16-mesh sieve after high-speed wet mixing for 2min to obtain wet particles, wherein the low-speed dry mixing is carried out at a main machine stirring speed of 150 rpm, the cutter speed of 1500 rpm, the high-speed wet mixing is carried out at a main machine stirring speed of 270 rpm, and the cutter speed of 3000 rpm; then drying by a boiling dryer, setting the air inlet temperature to 60 ℃ for 90min, and controlling the water content to be 4.0-6.5%; after the granules are sized by a 16-mesh sieve, adding magnesium stearate, mixing for 25min, drying, after the granules are sized by the 16-mesh sieve, adding magnesium stearate, mixing for 20min, and tabletting;
s3, preparing coating liquid: adding gastric soluble coating powder into purified water for dispersion;
s4, coating: putting the cefadroxil tablets in S2 into a coating pot, setting the rotating speed of the coating pot to be 15r/min, setting the air inlet temperature to be 80-90 ℃, starting spraying slurry when the air exhaust temperature is more than or equal to 50 ℃, spraying the coating liquid in S3 to the cefadroxil tablets for coating, and controlling the temperature of a tablet bed to be 45-50 ℃ and the rotating speed to be 3.5-17 rpm and the spray gun pressure to be 0.35-0.50 Mpa for coating in the coating process, wherein the weight gain range of the film coating is 2.5-3.5%.
Example 2
The cefadroxil dispersible coated tablet is prepared from the following components in parts by weight:
250 parts of cefadroxil, 185 parts of microcrystalline cellulose, 25 parts of low-substituted hydroxypropyl cellulose, 37.5 parts of carboxymethyl starch sodium, 1.25 parts of magnesium stearate and 174.8 parts of 70% ethanol;
the coated tablet is gastric-soluble, and the gastric-soluble film coating is prepared from gastric-soluble acrylic resin, hydroxypropyl methylcellulose, polyethylene glycol, talcum powder and titanium dioxide in a mass ratio of 1:0.5:0.5:0.5:0.5 part of formed gastric-soluble coating powder 14.5 parts and 58 parts of purified water.
The preparation method of the cefadroxil dispersible coated tablet comprises the following steps:
s1, weighing all raw material components in proportion;
s2, preparing cefadroxil tablets: adding cefadroxil, microcrystalline cellulose, low-substituted hydroxypropyl cellulose and carboxymethyl starch sodium into a wet mixing granulator, dry-mixing for 2min at low speed, adding 70% ethanol, sequentially carrying out low-speed wet mixing for 4min, and carrying out high-speed wet mixing for 1min, and then sieving with a 16-mesh sieve to obtain wet particles, wherein the low-speed dry mixing is the stirring speed of a main machine of 150 rpm, the stirring speed of a cutter of 1500 rpm, and the high-speed wet mixing is the stirring speed of the main machine of 270 rpm, and the stirring speed of the cutter of 3000 rpm; then drying by a boiling dryer, setting the air inlet temperature to 60 ℃ for 90min, and controlling the water content to be 4.0-6.5%; after the granules are sized by a 16-mesh sieve, adding magnesium stearate, mixing for 18min, drying, after the granules are sized by the 16-mesh sieve, adding magnesium stearate, mixing for 20min, and tabletting;
s3, preparing coating liquid: adding gastric soluble coating powder into purified water for dispersion;
s4, coating: putting the cefadroxil tablets in S2 into a coating pot, setting the rotating speed of the coating pot to be 15r/min, setting the air inlet temperature to be 80-90 ℃, starting spraying slurry when the air exhaust temperature is more than or equal to 50 ℃, spraying the coating liquid in S3 to the cefadroxil tablets for coating, and controlling the temperature of a tablet bed to be 45-50 ℃ and the rotating speed to be 3.5-17 rpm and the spray gun pressure to be 0.35-0.50 Mpa in the coating process, wherein the weight gain range of the film coating is 2.5-3.5%.
Example 3
The cefadroxil dispersible coated tablet is prepared from the following components in parts by weight:
250 parts of cefadroxil, 185 parts of microcrystalline cellulose, 25 parts of low-substituted hydroxypropyl cellulose, 37.5 parts of carboxymethyl starch sodium, 1.25 parts of magnesium stearate and 174.8 parts of 70% ethanol;
the coated tablet is gastric-soluble, and the gastric-soluble film coating is prepared from gastric-soluble acrylic resin, hydroxypropyl methylcellulose, polyethylene glycol, talcum powder and titanium dioxide in a mass ratio of 1:0.5:0.5:0.5:0.5 part of formed gastric-soluble coating powder 14.5 parts and 87 parts of purified water.
The preparation method of the cefadroxil dispersible coated tablet comprises the following steps:
s1, weighing all raw material components in proportion;
s2, preparing cefadroxil tablets: adding cefadroxil, microcrystalline cellulose, low-substituted hydroxypropyl cellulose and carboxymethyl starch sodium into a wet mixing granulator, dry-mixing for 1min at a low speed, adding 70% ethanol by volume fraction, sequentially carrying out low-speed wet mixing for 2min, and sieving with a 16-mesh sieve after high-speed wet mixing for 2min to obtain wet particles, wherein the low-speed dry mixing is carried out at a main machine stirring speed of 150 rpm, the cutter speed of 1500 rpm, the high-speed wet mixing is carried out at a main machine stirring speed of 270 rpm, and the cutter speed of 3000 rpm; then drying by a boiling dryer, setting the air inlet temperature to 60 ℃ for 90min, and controlling the water content to be 4.0-6.5%; after the granules are sized by a 16-mesh sieve, adding magnesium stearate, mixing for 20min, drying, after the granules are sized by the 16-mesh sieve, adding magnesium stearate, mixing for 20min, and tabletting;
s3, preparing coating liquid: adding gastric soluble coating powder into purified water for dispersion;
s4, coating: putting the cefadroxil tablets in S2 into a coating pot, setting the rotating speed of the coating pot to be 15r/min, setting the air inlet temperature to be 80-90 ℃, starting spraying slurry when the air exhaust temperature is more than or equal to 50 ℃, spraying the coating liquid in S3 to the cefadroxil tablets for coating, and controlling the temperature of a tablet bed to be 45-50 ℃ and the rotating speed to be 3.5-17 rpm and the spray gun pressure to be 0.35-0.50 Mpa in the coating process, wherein the weight gain range of the film coating is 2.5-3.5%.
Comparative example 1
The cefadroxil coated tablet is commercially available, and is produced by European Italian pharmaceutical Co-Ltd, approved paper: chinese medicine standard character H20212521.
The cefadroxil coated tablets prepared in the examples were subjected to the relevant substance measurement conditions as in comparative example 1, and were specifically put into the following:
taking cefadroxil coated tablets prepared in the embodiment 1 and the comparative example 1 of the application, grinding into fine powder, adding a mobile phase A for dissolution and dilution to prepare a solution containing 1mg of cefadroxil in each 1mL, filtering, and taking a subsequent filtrate as a sample solution; 1mL of the solution is precisely measured, placed in a 100mL measuring flask, diluted to a scale by using the mobile phase A, and shaken uniformly to serve as a control solution. Weighing about 10mg of alpha-p-hydroxyphenylglycine reference, placing into a 10mL measuring flask, dissolving and diluting to a scale by using a proper amount of ultrasonic waves of a mobile phase A, and shaking uniformly to obtain a reference solution (1); about 10mg of 7-amino-desacetoxy-cephalosporanic acid reference substance is weighed, placed in a 10mL measuring flask, dissolved by pH7.0 phosphate buffer solution (28.4 g of anhydrous disodium hydrogen phosphate is weighed, 800mL of water is added for dissolution, the pH is adjusted to 7.0 by 30% of phosphoric acid solution, the solution is diluted to 1000mL of water and mixed uniformly), dissolved and diluted to a scale by a proper amount of ultrasound, and shaken uniformly to be used as reference substance solution (2). Precisely measuring 1mL of each of the reference substance solutions (1) and (2), placing into a 100mL measuring flask, diluting to a scale with the mobile phase A, and shaking uniformly to obtain the impurity reference substance solution. Determining by high performance liquid chromatography (general rule 0512), and using octadecylsilane chemically bonded silica as filler; mobile phase a was 0.02mol/L potassium dihydrogen phosphate solution (2.72 g potassium dihydrogen phosphate in about 800mL water, pH adjusted to 5.0 with 1mol/L potassium hydroxide solution, diluted to 1000mL with water, mixed); mobile phase B is methanol; the flow rate is 1.0mL per minute; the detection wavelength is 220nm; linear gradient elution was performed as follows: 20 mu L of the mixed solution of the impurity reference substance solution and the sample solution (9:1) is injected into a liquid chromatograph, and a chromatogram is recorded. The retention time of the cefadroxil peak is about 10 minutes and the degree of separation of the alpha-hydroxyphenylglycine peak and the 7-aminodesacetoxy cephalosporanic acid peak should be greater than 5.0. The degree of separation of the 7-aminodesacetoxy cephalosporanic acid peak from the cefadroxil peak should be more than 5.0. Precisely measuring 20 μl of each of the sample solution, the control solution and the impurity control solution, respectively, and injecting into a liquid chromatograph for recording the chromatogram. The chromatogram of the sample solution has impurity peaks, and the peak areas of the alpha-p-hydroxyphenylglycine and the 7-amino deacetylated oxygen cephalosporanic acid are calculated according to an external standard method, and are not more than 1.0 percent; the other individual impurity peak areas should not be greater than the main peak area of the control solution (1.0%), and the sum of the other individual impurity peak areas should not be greater than 3 times the main peak area of the control solution (3.0%). (any peak in the sample solution that is 0.05 times smaller than the main peak area of the control solution is negligible)
The time and proportion of gradient elution are as follows:
| time (min) | Mobile phase a (%) | Mobile phase B (%) |
| 0 | 98 | 2 |
| 1 | 98 | 2 |
| 25 | 70 | 30 |
| 28 | 98 | 2 |
| 40 | 98 | 2 |
Table 1 stability investigation of cefadroxil coated tablets
As can be seen from Table 1, the appearance shape and impurities of the tablets of the present application were not substantially changed in the accelerated test of the tablets, whereas the impurity content of the tablets currently on the market was significantly increased in the accelerated test. This shows that the stability of the cefadroxil dispersion coated tablets prepared by the application is significantly higher than that of the commercially available tablets.
Taking cefadroxil dispersible coated tablets prepared in example 1, sampling three times, measuring the dissolution rate according to a dissolution rate measuring method (a second method of dissolution rate and release rate measuring method of four appendices of China pharmacopoeia 2020 edition), taking 900mL of water as a dissolution medium, rotating at 50 revolutions per minute, taking solutions respectively according to the method, filtering when the water is used for 1, 2, 3, 4, 5, 10 and 30 minutes, precisely measuring the subsequent filtrate, adding water for quantitative dilution to prepare a solution with about 25 mug in each 1mL, taking a proper amount of cefadroxil reference substance, adding water for dissolution, and quantitatively diluting to prepare a solution with 25 mug in each 1 mL. The elution amount of each sheet was calculated by measuring absorbance at a wavelength of 263nm by ultraviolet-visible spectrophotometry. The limit should be 80% (30 min) of the indicated amount and should be in compliance with the regulations, as shown in Table 2.
Table 2 dissolution investigation of cefadroxil coated tablets prepared in example 1
The cefadroxil dispersion coated tablets prepared in example 1 of the present application were subjected to three samples and then subjected to dissolution after 6 months acceleration (acceleration conditions 40 ℃,75% rh), and the average dissolution rate in water as follows:
table 3 dissolution investigation after 6 months acceleration of cefadroxil coated tablets prepared in example 1
Table 4 comparative example 1 shows dissolution after 6 months acceleration (water medium)
The experimental data in tables 3 and 4 show that the cefadroxil coated tablet of the application has ideal dissolution, meets the quality standard requirement in 2min, has no obvious change in dissolution rate after the accelerated test, and has low dissolution rate after the accelerated test.
It should be noted that, when numerical ranges are referred to in the present application, it should be understood that two endpoints of each numerical range and any numerical value between the two endpoints are optional, and because the adopted step method is the same as the embodiment, in order to prevent redundancy, the present application describes a preferred embodiment. While preferred embodiments of the present application have been described, additional variations and modifications in those embodiments may occur to those skilled in the art once they learn of the basic inventive concepts. It is therefore intended that the following claims be interpreted as including the preferred embodiments and all such alterations and modifications as fall within the scope of the application.
It will be apparent to those skilled in the art that various modifications and variations can be made to the present application without departing from the spirit or scope of the application. Thus, it is intended that the present application also include such modifications and alterations insofar as they come within the scope of the appended claims or the equivalents thereof.
Claims (5)
1. The cefadroxil dispersible coated tablet is characterized by being prepared from the following components in parts by weight:
250 parts of cefadroxil, 185 parts of microcrystalline cellulose, 25 parts of low-substituted hydroxypropyl cellulose, 37.5 parts of carboxymethyl starch sodium, 1.25 parts of magnesium stearate and 174.8 parts of ethanol;
the coated tablet is gastric-soluble, and the gastric-soluble film coating is prepared from gastric-soluble coating powder and purified water;
the mass ratio of the gastric-soluble coating powder to the purified water is 1:4-6;
the gastric-soluble coating powder comprises the following components of gastric-soluble acrylic resin, hydroxypropyl methylcellulose, polyethylene glycol, talcum powder and titanium dioxide in a mass ratio of 1:0.5:0.5:0.5:0.5;
the dosage of the gastric-soluble coating powder is 2.5-3.5% of the mass of the coated tablet;
the preparation method of the cefadroxil dispersible coated tablet comprises the following steps:
s1, weighing all raw material components in proportion;
s2, preparing cefadroxil tablets: dry-mixing cefadroxil, microcrystalline cellulose, low-substituted hydroxypropyl cellulose and carboxymethyl starch sodium, adding ethanol, sequentially wet-mixing at low speed and high speed, sieving with 16 mesh sieve to obtain wet granule, drying, sieving with 16 mesh sieve, adding magnesium stearate, mixing, and tabletting;
s3, preparing coating liquid: adding gastric soluble coating powder into purified water for dispersion;
s4, coating: and (3) placing the cefadroxil tablets in the S2 into a coating pot, and spraying the coating liquid in the S3 to the cefadroxil tablets for coating.
2. The cefadroxil dispersible coated tablet of claim 1, wherein in S2, the dry mixing time is 1-3 min, the low speed wet mixing time is 2-4 min and the high speed wet mixing time is 1-2 min.
3. The cefadroxil dispersible coated tablet of claim 1, wherein in S2, the drying temperature is 60 ℃, the time is 90min, and the moisture content of the dried granules is 4.0-6.5%.
4. The cefadroxil dispersible coated tablet of claim 1, wherein in S2 the total mixing time is 18-25 min.
5. The cefadroxil dispersible coated tablet according to claim 1, wherein in S4, the rotating speed of the coating pan is 15r/min, the air inlet temperature is 80-90 ℃, when the air exhaust temperature is more than or equal to 50 ℃, slurry spraying is started, and the temperature is controlled to be 45-50 ℃ during the coating process, the rotating speed is 3.5-17 rpm, and the spray gun pressure is 0.35-0.50 Mpa; the weight gain of the film coating is 2.5-3.5% of that of the cefadroxil tablet.
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