CN115624533A - Nifedipine controlled release tablet, preparation method and application thereof - Google Patents
Nifedipine controlled release tablet, preparation method and application thereof Download PDFInfo
- Publication number
- CN115624533A CN115624533A CN202211652847.9A CN202211652847A CN115624533A CN 115624533 A CN115624533 A CN 115624533A CN 202211652847 A CN202211652847 A CN 202211652847A CN 115624533 A CN115624533 A CN 115624533A
- Authority
- CN
- China
- Prior art keywords
- nifedipine
- controlled release
- release tablet
- inclusion
- mixing
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- HYIMSNHJOBLJNT-UHFFFAOYSA-N nifedipine Chemical compound COC(=O)C1=C(C)NC(C)=C(C(=O)OC)C1C1=CC=CC=C1[N+]([O-])=O HYIMSNHJOBLJNT-UHFFFAOYSA-N 0.000 title claims abstract description 81
- 229960001597 nifedipine Drugs 0.000 title claims abstract description 81
- 238000013270 controlled release Methods 0.000 title claims abstract description 47
- 238000002360 preparation method Methods 0.000 title claims abstract description 23
- 238000002156 mixing Methods 0.000 claims abstract description 37
- 239000002245 particle Substances 0.000 claims abstract description 29
- 229920000858 Cyclodextrin Polymers 0.000 claims abstract description 25
- 239000001116 FEMA 4028 Substances 0.000 claims abstract description 25
- 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 abstract description 25
- 235000011175 beta-cyclodextrine Nutrition 0.000 claims abstract description 25
- 229960004853 betadex Drugs 0.000 claims abstract description 25
- 239000000463 material Substances 0.000 claims abstract description 23
- 241001506047 Tremella Species 0.000 claims abstract description 16
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- 229920001282 polysaccharide Polymers 0.000 claims abstract description 16
- 239000005017 polysaccharide Substances 0.000 claims abstract description 16
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims abstract description 15
- 239000001768 carboxy methyl cellulose Substances 0.000 claims abstract description 15
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- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims abstract description 15
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- 206010002383 Angina Pectoris Diseases 0.000 claims description 3
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- 239000007864 aqueous solution Substances 0.000 claims description 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 2
- IDGUHHHQCWSQLU-UHFFFAOYSA-N ethanol;hydrate Chemical compound O.CCO IDGUHHHQCWSQLU-UHFFFAOYSA-N 0.000 abstract description 7
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- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 4
- 239000012528 membrane Substances 0.000 description 4
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- 239000008280 blood Substances 0.000 description 3
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- 238000013268 sustained release Methods 0.000 description 3
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 description 2
- 229920002472 Starch Polymers 0.000 description 2
- 239000005557 antagonist Substances 0.000 description 2
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- OSGAYBCDTDRGGQ-UHFFFAOYSA-L calcium sulfate Chemical compound [Ca+2].[O-]S([O-])(=O)=O OSGAYBCDTDRGGQ-UHFFFAOYSA-L 0.000 description 2
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- YNGDWRXWKFWCJY-UHFFFAOYSA-N 1,4-Dihydropyridine Chemical compound C1C=CNC=C1 YNGDWRXWKFWCJY-UHFFFAOYSA-N 0.000 description 1
- 206010067484 Adverse reaction Diseases 0.000 description 1
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
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- 102000003922 Calcium Channels Human genes 0.000 description 1
- 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 1
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- 229930195725 Mannitol Natural products 0.000 description 1
- 201000001068 Prinzmetal angina Diseases 0.000 description 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 1
- 235000021355 Stearic acid Nutrition 0.000 description 1
- 208000007536 Thrombosis Diseases 0.000 description 1
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- 235000010216 calcium carbonate Nutrition 0.000 description 1
- FUFJGUQYACFECW-UHFFFAOYSA-L calcium hydrogenphosphate Chemical compound [Ca+2].OP([O-])([O-])=O FUFJGUQYACFECW-UHFFFAOYSA-L 0.000 description 1
- 230000001964 calcium overload Effects 0.000 description 1
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 description 1
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- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 1
- 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 1
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- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 1
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 description 1
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Images
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-
- 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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4422—1,4-Dihydropyridines, e.g. nifedipine, nicardipine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
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- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/69—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
- A61K47/6949—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
- A61K47/6951—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes using cyclodextrin
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- 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
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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- A61P3/06—Antihyperlipidemics
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- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
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- A61P9/00—Drugs for disorders of the cardiovascular system
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- 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
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Abstract
Description
Sampling point | Example 1 | Example 2 | Example 3 | Example 4 |
2h | 10.6 | 12.2 | 9.4 | 11.5 |
4h | 21.7 | 23.1 | 17.5 | 20.2 |
8h | 40.4 | 43.9 | 38.1 | 39.7 |
12h | 61.1 | 57.7 | 58.5 | 60.8 |
16h | 80.3 | 84.2 | 77.3 | 89.1 |
24h | 100.8 | 99.4 | 100.7 | 100.6 |
Sampling point | Comparative example 1 | Comparative example 2 | Comparative example 3 | Comparative example 4 |
2h | 14 | 11.2 | 7.5 | 18.7 |
4h | 24.6 | 21.3 | 15.9 | 39.4 |
8h | 46.3 | 42.7 | 45.7 | 62.1 |
12h | 70.7 | 63.9 | 86.3 | 97.9 |
16h | 92.1 | 79.3 | 101.0 | 100.2 |
24h | 99.5 | 98.8 | 101.3 | 100.8 |
Detecting items | 0 month | 1 month | 3 month |
Example 1 | 100.8 | 99.5 | 100.7 |
Example 2 | 100.3 | 99.7 | 100.8 |
Example 3 | 100.4 | 99.8 | 99.5 |
Example 4 | 100.8 | 99.9 | 100.9 |
Comparative example 1 | 99.5 | 96.4 | 88.2 |
Comparative example 2 | 100.2 | 97.2 | 95.4 |
Comparative example 3 | 100.6 | 99.8 | 99.1 |
Comparative example 4 | 100.3 | 93.0 | 87.8 |
Detecting items | 0 month | 1 month | 3 month |
Example 1 | 0.06 | 0.05 | 0.06 |
Example 2 | 0.06 | 0.04 | 0.05 |
Example 3 | 0.06 | 0.06 | 0.07 |
Example 4 | 0.06 | 0.05 | 0.06 |
Comparative example 1 | 0.06 | 0.08 | 0.14 |
Comparative example 2 | 0.05 | 0.07 | 0.11 |
Comparative example 3 | 0.06 | 0.05 | 0.05 |
Comparative example 4 | 0.05 | 0.08 | 0.17 |
Detecting items | 0 month | 1 month | 3 month |
Example 1 | 100.8 | 100.2 | 100.7 |
Example 2 | 99.4 | 100.3 | 99.6 |
Example 3 | 100.7 | 100.8 | 101.5 |
Example 4 | 100.6 | 100.4 | 99.7 |
Comparative example 1 | 99.5 | 91.6 | 86.8 |
Comparative example 2 | 98.8 | 95.4 | 92.7 |
Comparative example 3 | 101.3 | 99.3 | 96.1 |
Comparative example 4 | 100.8 | 92.5 | 80.9 |
Claims (10)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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CN202211652847.9A CN115624533B (en) | 2022-12-22 | 2022-12-22 | Nifedipine controlled release tablet, preparation method and application thereof |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN202211652847.9A CN115624533B (en) | 2022-12-22 | 2022-12-22 | Nifedipine controlled release tablet, preparation method and application thereof |
Publications (2)
Publication Number | Publication Date |
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CN115624533A true CN115624533A (en) | 2023-01-20 |
CN115624533B CN115624533B (en) | 2023-04-07 |
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CN202211652847.9A Active CN115624533B (en) | 2022-12-22 | 2022-12-22 | Nifedipine controlled release tablet, preparation method and application thereof |
Country Status (1)
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Citations (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5773025A (en) * | 1993-09-09 | 1998-06-30 | Edward Mendell Co., Inc. | Sustained release heterodisperse hydrogel systems--amorphous drugs |
EP0852141A1 (en) * | 1996-08-16 | 1998-07-08 | J.B. Chemicals & Pharmaceuticals Ltd. | Nifedipine containing pharmaceutical extended release composition and a process for the preparation thereof |
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