CN116549401B - 一种头孢呋辛酯微球掩味制剂及其制备方法 - Google Patents
一种头孢呋辛酯微球掩味制剂及其制备方法 Download PDFInfo
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- CN116549401B CN116549401B CN202310644442.9A CN202310644442A CN116549401B CN 116549401 B CN116549401 B CN 116549401B CN 202310644442 A CN202310644442 A CN 202310644442A CN 116549401 B CN116549401 B CN 116549401B
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- Prior art keywords
- cefuroxime axetil
- microspheres
- microsphere
- tartaric acid
- acesulfame potassium
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- KEJCWVGMRLCZQQ-YJBYXUATSA-N Cefuroxime axetil Chemical compound N([C@@H]1C(N2C(=C(COC(N)=O)CS[C@@H]21)C(=O)OC(C)OC(C)=O)=O)C(=O)\C(=N/OC)C1=CC=CO1 KEJCWVGMRLCZQQ-YJBYXUATSA-N 0.000 title claims abstract description 167
- 229960002620 cefuroxime axetil Drugs 0.000 title claims abstract description 167
- 239000004005 microsphere Substances 0.000 title claims abstract description 144
- 238000002360 preparation method Methods 0.000 title claims abstract description 44
- 235000019640 taste Nutrition 0.000 title abstract description 37
- 230000000873 masking effect Effects 0.000 title abstract description 21
- 208000019505 Deglutition disease Diseases 0.000 claims abstract description 6
- 239000000725 suspension Substances 0.000 claims description 67
- 238000002156 mixing Methods 0.000 claims description 39
- WBZFUFAFFUEMEI-UHFFFAOYSA-M Acesulfame k Chemical compound [K+].CC1=CC(=O)[N-]S(=O)(=O)O1 WBZFUFAFFUEMEI-UHFFFAOYSA-M 0.000 claims description 36
- 235000010358 acesulfame potassium Nutrition 0.000 claims description 36
- 229960004998 acesulfame potassium Drugs 0.000 claims description 36
- 239000000619 acesulfame-K Substances 0.000 claims description 36
- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 claims description 35
- 239000011975 tartaric acid Substances 0.000 claims description 35
- 235000002906 tartaric acid Nutrition 0.000 claims description 35
- 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 33
- 229930006000 Sucrose Natural products 0.000 claims description 33
- 239000005720 sucrose Substances 0.000 claims description 33
- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 claims description 26
- 108010011485 Aspartame Proteins 0.000 claims description 23
- 235000006040 Prunus persica var persica Nutrition 0.000 claims description 23
- 239000000605 aspartame Substances 0.000 claims description 23
- 235000010357 aspartame Nutrition 0.000 claims description 23
- IAOZJIPTCAWIRG-QWRGUYRKSA-N aspartame Chemical compound OC(=O)C[C@H](N)C(=O)N[C@H](C(=O)OC)CC1=CC=CC=C1 IAOZJIPTCAWIRG-QWRGUYRKSA-N 0.000 claims description 23
- 229960003438 aspartame Drugs 0.000 claims description 23
- 244000246386 Mentha pulegium Species 0.000 claims description 21
- 235000016257 Mentha pulegium Nutrition 0.000 claims description 21
- 235000004357 Mentha x piperita Nutrition 0.000 claims description 21
- 235000001050 hortel pimenta Nutrition 0.000 claims description 21
- 229920001285 xanthan gum Polymers 0.000 claims description 21
- 235000010493 xanthan gum Nutrition 0.000 claims description 21
- 239000000230 xanthan gum Substances 0.000 claims description 21
- 229940082509 xanthan gum Drugs 0.000 claims description 21
- 239000001856 Ethyl cellulose Substances 0.000 claims description 20
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 claims description 20
- 235000019325 ethyl cellulose Nutrition 0.000 claims description 20
- 229920001249 ethyl cellulose Polymers 0.000 claims description 20
- 238000000034 method Methods 0.000 claims description 17
- 244000144730 Amygdalus persica Species 0.000 claims description 16
- 239000008187 granular material Substances 0.000 claims description 14
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 13
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 13
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 13
- 238000007873 sieving Methods 0.000 claims description 13
- 238000005303 weighing Methods 0.000 claims description 13
- 229960001367 tartaric acid Drugs 0.000 claims description 12
- 239000000839 emulsion Substances 0.000 claims description 11
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims description 9
- 229920003132 hydroxypropyl methylcellulose phthalate Polymers 0.000 claims description 9
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- 239000000843 powder Substances 0.000 claims description 8
- 239000002245 particle Substances 0.000 claims description 7
- XNGIFLGASWRNHJ-UHFFFAOYSA-L phthalate(2-) Chemical compound [O-]C(=O)C1=CC=CC=C1C([O-])=O XNGIFLGASWRNHJ-UHFFFAOYSA-L 0.000 claims description 6
- 239000003995 emulsifying agent Substances 0.000 claims description 5
- 239000003960 organic solvent Substances 0.000 claims description 5
- 239000002904 solvent Substances 0.000 claims description 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 5
- 238000001035 drying Methods 0.000 claims description 4
- 238000009835 boiling Methods 0.000 claims description 3
- 239000000825 pharmaceutical preparation Substances 0.000 claims description 2
- 238000003756 stirring Methods 0.000 claims 4
- 235000006679 Mentha X verticillata Nutrition 0.000 claims 2
- 235000002899 Mentha suaveolens Nutrition 0.000 claims 2
- 235000001636 Mentha x rotundifolia Nutrition 0.000 claims 2
- 238000004519 manufacturing process Methods 0.000 claims 1
- 238000004090 dissolution Methods 0.000 abstract description 20
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- 229960001668 cefuroxime Drugs 0.000 description 7
- JFPVXVDWJQMJEE-IZRZKJBUSA-N cefuroxime Chemical compound N([C@@H]1C(N2C(=C(COC(N)=O)CS[C@@H]21)C(O)=O)=O)C(=O)\C(=N/OC)C1=CC=CO1 JFPVXVDWJQMJEE-IZRZKJBUSA-N 0.000 description 7
- 238000010298 pulverizing process Methods 0.000 description 7
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- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 6
- 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 description 5
- 239000002994 raw material Substances 0.000 description 5
- 229920000623 Cellulose acetate phthalate Polymers 0.000 description 4
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 description 4
- 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 4
- 229930195725 Mannitol Natural products 0.000 description 4
- 229940081734 cellulose acetate phthalate Drugs 0.000 description 4
- 239000000594 mannitol Substances 0.000 description 4
- 235000010355 mannitol Nutrition 0.000 description 4
- 239000002609 medium Substances 0.000 description 4
- 239000000243 solution Substances 0.000 description 4
- 239000000600 sorbitol Substances 0.000 description 4
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- 239000000375 suspending agent Substances 0.000 description 3
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
- 229920000168 Microcrystalline cellulose Polymers 0.000 description 2
- 238000009825 accumulation Methods 0.000 description 2
- 230000000844 anti-bacterial effect Effects 0.000 description 2
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- 125000003118 aryl group Chemical group 0.000 description 2
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- FTLYMKDSHNWQKD-UHFFFAOYSA-N (2,4,5-trichlorophenyl)boronic acid Chemical compound OB(O)C1=CC(Cl)=C(Cl)C=C1Cl FTLYMKDSHNWQKD-UHFFFAOYSA-N 0.000 description 1
- 241000416162 Astragalus gummifer Species 0.000 description 1
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- 235000016623 Fragaria vesca Nutrition 0.000 description 1
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- 206010018612 Gonorrhoea Diseases 0.000 description 1
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- 239000008351 acetate buffer Substances 0.000 description 1
- 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 description 1
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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
- A61K31/546—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 containing further heterocyclic rings, e.g. cephalothin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- 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
- A61K9/10—Dispersions; Emulsions
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- 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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- 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
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Inorganic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Oncology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Communicable Diseases (AREA)
- Dispersion Chemistry (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
Description
头孢呋辛酯 | 30-50% |
羟丙甲纤维素邻苯二甲酸酯 | 30-60% |
乙基纤维素 | 20-30% |
头孢呋辛酯微球 | 20.0-30.0% |
黄原胶 | 5.0-10.0% |
蔗糖 | 50.0-90.0% |
阿司帕坦 | 1.0-3.0% |
安赛蜜 | 1.0-3.0% |
酒石酸 | 3.0-6.0% |
薄荷香精 | 0.1-0.5% |
桃子香精 | 0.5-5.0% |
头孢呋辛酯微球 | 25% |
黄原胶 | 7% |
蔗糖 | 57.63% |
阿司帕坦 | 1.5% |
安赛蜜 | 1.5% |
酒石酸 | 4.5% |
十二烷基硫酸钠 | 0.07% |
薄荷香精 | 0.3% |
桃子香精 | 2.5% |
头孢呋辛酯 | 40% |
羟丙甲纤维素邻苯二甲酸酯 | 40% |
乙基纤维素 | 20% |
头孢呋辛酯 | 40% |
羟丙甲纤维素邻苯二甲酸酯 | 30% |
乙基纤维素 | 30% |
头孢呋辛酯微球 | 25% |
羟丙甲纤维素 | 7% |
蔗糖 | 57.7% |
阿司帕坦 | 1.5% |
安赛蜜 | 1.5% |
酒石酸 | 4.5% |
薄荷香精 | 0.3% |
桃子香精 | 2.5% |
头孢呋辛酯 | 40% |
羟丙甲纤维素邻苯二甲酸酯 | 50% |
乙基纤维素 | 10% |
头孢呋辛酯微球 | 25% |
黄原胶 | 7% |
甘露醇 | 57.7% |
阿司帕坦 | 1.5% |
安赛蜜 | 1.5% |
酒石酸 | 4.5% |
薄荷香精 | 0.3% |
桃子香精 | 2.5% |
头孢呋辛酯 | 50% |
羟丙甲纤维素邻苯二甲酸酯 | 33% |
乙基纤维素 | 17% |
头孢呋辛酯 | 40% |
醋酸纤维素邻苯二甲酸酯 | 40% |
乙基纤维素 | 20% |
头孢呋辛酯微球 | 25% |
黄原胶 | 5% |
羟丙甲纤维素 | 5% |
蔗糖 | 54.7% |
阿司帕坦 | 1.5% |
安赛蜜 | 1.5% |
酒石酸 | 4.5% |
薄荷香精 | 0.3% |
桃子香精 | 2.5% |
头孢呋辛酯 | 40% |
羟丙甲纤维素邻苯二甲酸酯 | 40% |
乙基纤维素 | 20% |
头孢呋辛酯微球 | 25% |
黄原胶 | 7% |
山梨醇 | 57.7% |
阿司帕坦 | 1.5% |
安赛蜜 | 1.5% |
酒石酸 | 4.5% |
薄荷香精 | 0.3% |
桃子香精 | 2.5% |
头孢呋辛酯微球 | 25% |
黄原胶 | 7% |
蔗糖 | 57.63% |
阿司帕坦 | 1.5% |
安赛蜜 | 1.5% |
酒石酸 | 4.5% |
十二烷基硫酸钠 | 0.07% |
薄荷香精 | 0.3% |
桃子香精 | 2.5% |
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