CN110215437B - 一种盐酸二甲双胍片及其制备方法 - Google Patents
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- CN110215437B CN110215437B CN201910650854.7A CN201910650854A CN110215437B CN 110215437 B CN110215437 B CN 110215437B CN 201910650854 A CN201910650854 A CN 201910650854A CN 110215437 B CN110215437 B CN 110215437B
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- metformin hydrochloride
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- XZWYZXLIPXDOLR-UHFFFAOYSA-N metformin hydrochloride Natural products CN(C)C(=N)NC(N)=N XZWYZXLIPXDOLR-UHFFFAOYSA-N 0.000 title claims abstract description 118
- 229960004329 metformin hydrochloride Drugs 0.000 title claims abstract description 116
- OETHQSJEHLVLGH-UHFFFAOYSA-N metformin hydrochloride Chemical compound Cl.CN(C)C(=N)N=C(N)N OETHQSJEHLVLGH-UHFFFAOYSA-N 0.000 title claims abstract description 116
- 238000002360 preparation method Methods 0.000 title claims abstract description 53
- 239000000463 material Substances 0.000 claims abstract description 56
- 239000000314 lubricant Substances 0.000 claims abstract description 53
- 239000000853 adhesive Substances 0.000 claims abstract description 50
- 230000001070 adhesive effect Effects 0.000 claims abstract description 50
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 26
- 235000019359 magnesium stearate Nutrition 0.000 claims abstract description 13
- 235000021355 Stearic acid Nutrition 0.000 claims abstract description 10
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims abstract description 10
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims abstract description 10
- RYYKJJJTJZKILX-UHFFFAOYSA-M sodium octadecanoate Chemical compound [Na+].CCCCCCCCCCCCCCCCCC([O-])=O RYYKJJJTJZKILX-UHFFFAOYSA-M 0.000 claims abstract description 10
- 239000008117 stearic acid Substances 0.000 claims abstract description 10
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 30
- 239000002245 particle Substances 0.000 claims description 19
- 239000008367 deionised water Substances 0.000 claims description 16
- 229910021641 deionized water Inorganic materials 0.000 claims description 16
- 239000000725 suspension Substances 0.000 claims description 16
- 229940114930 potassium stearate Drugs 0.000 claims description 10
- ANBFRLKBEIFNQU-UHFFFAOYSA-M potassium;octadecanoate Chemical compound [K+].CCCCCCCCCCCCCCCCCC([O-])=O ANBFRLKBEIFNQU-UHFFFAOYSA-M 0.000 claims description 10
- 229920003081 Povidone K 30 Polymers 0.000 claims description 9
- 238000001035 drying Methods 0.000 claims description 9
- 238000002156 mixing Methods 0.000 claims description 8
- OKODKVMXHLUQSW-JITBQSAISA-M sodium;(e)-4-hydroxy-4-oxobut-2-enoate;octadecanoic acid Chemical compound [Na+].OC(=O)\C=C\C([O-])=O.CCCCCCCCCCCCCCCCCC(O)=O OKODKVMXHLUQSW-JITBQSAISA-M 0.000 claims description 8
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 7
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 7
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 7
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 5
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 5
- 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 5
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims description 5
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims description 5
- 239000011248 coating agent Substances 0.000 claims description 4
- 239000011230 binding agent Substances 0.000 claims description 3
- 238000000576 coating method Methods 0.000 claims description 3
- 239000008187 granular material Substances 0.000 claims description 2
- 229960003943 hypromellose Drugs 0.000 claims description 2
- 229940057948 magnesium stearate Drugs 0.000 claims description 2
- 229940080350 sodium stearate Drugs 0.000 claims description 2
- 229960004274 stearic acid Drugs 0.000 claims description 2
- 238000004090 dissolution Methods 0.000 abstract description 39
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- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 14
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- 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
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- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 description 2
- 210000001035 gastrointestinal tract Anatomy 0.000 description 2
- 229940045109 genistein Drugs 0.000 description 2
- TZBJGXHYKVUXJN-UHFFFAOYSA-N genistein Natural products C1=CC(O)=CC=C1C1=COC2=CC(O)=CC(O)=C2C1=O TZBJGXHYKVUXJN-UHFFFAOYSA-N 0.000 description 2
- 235000006539 genistein Nutrition 0.000 description 2
- ZCOLJUOHXJRHDI-CMWLGVBASA-N genistein 7-O-beta-D-glucoside Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1OC1=CC(O)=C2C(=O)C(C=3C=CC(O)=CC=3)=COC2=C1 ZCOLJUOHXJRHDI-CMWLGVBASA-N 0.000 description 2
- 230000003451 hyperinsulinaemic effect Effects 0.000 description 2
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- NOESYZHRGYRDHS-UHFFFAOYSA-N insulin Chemical compound N1C(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(NC(=O)CN)C(C)CC)CSSCC(C(NC(CO)C(=O)NC(CC(C)C)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCC(O)=O)C(=O)NC(CC(N)=O)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CSSCC(NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2C=CC(O)=CC=2)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2NC=NC=2)NC(=O)C(CO)NC(=O)CNC2=O)C(=O)NCC(=O)NC(CCC(O)=O)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC(O)=CC=3)C(=O)NC(C(C)O)C(=O)N3C(CCC3)C(=O)NC(CCCCN)C(=O)NC(C)C(O)=O)C(=O)NC(CC(N)=O)C(O)=O)=O)NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)CC=1C=CC=CC=1)C(C)C)CC1=CN=CN1 NOESYZHRGYRDHS-UHFFFAOYSA-N 0.000 description 2
- 239000012528 membrane Substances 0.000 description 2
- 229960003105 metformin Drugs 0.000 description 2
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- 230000000638 stimulation Effects 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 208000024891 symptom Diseases 0.000 description 2
- 229940123208 Biguanide Drugs 0.000 description 1
- XNCOSPRUTUOJCJ-UHFFFAOYSA-N Biguanide Chemical compound NC(N)=NC(N)=N XNCOSPRUTUOJCJ-UHFFFAOYSA-N 0.000 description 1
- 102000004877 Insulin Human genes 0.000 description 1
- 108090001061 Insulin Proteins 0.000 description 1
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- 239000002552 dosage form Substances 0.000 description 1
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- 238000010828 elution Methods 0.000 description 1
- MVPICKVDHDWCJQ-UHFFFAOYSA-N ethyl 3-pyrrolidin-1-ylpropanoate Chemical compound CCOC(=O)CCN1CCCC1 MVPICKVDHDWCJQ-UHFFFAOYSA-N 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 210000004051 gastric juice Anatomy 0.000 description 1
- 239000003316 glycosidase inhibitor Substances 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 229940125396 insulin Drugs 0.000 description 1
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- 229940068918 polyethylene glycol 400 Drugs 0.000 description 1
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- 210000000813 small intestine Anatomy 0.000 description 1
- 229940045902 sodium stearyl fumarate Drugs 0.000 description 1
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- 235000012222 talc Nutrition 0.000 description 1
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- 150000001467 thiazolidinediones Chemical class 0.000 description 1
- 239000004408 titanium dioxide Substances 0.000 description 1
Images
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
- A61K31/13—Amines
- A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
-
- 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
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
- A61K9/28—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
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Diabetes (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Hematology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Obesity (AREA)
- Endocrinology (AREA)
- Emergency Medicine (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Description
时间(min) | 0 | 15 | 30 | 45 | 60 | 90 |
实施例15(%) | 0.00 | 45.51 | 61.61 | 74.92 | 83.90 | 100.41 |
实施例16(%) | 0.00 | 46.81 | 64.17 | 74.26 | 81.01 | 98.45 |
实施例17(%) | 0.00 | 50.35 | 68.99 | 77.67 | 85.24 | 100.57 |
原研制剂(%) | 0.00 | 51.25 | 65.45 | 78.35 | 82.65 | 100.32 |
时间(min) | 0 | 15 | 30 | 45 | 60 | 90 |
实施例15(%) | 0.00 | 42.22 | 58.12 | 69.46 | 77.34 | 99.31 |
实施例16(%) | 0.00 | 46.65 | 59.24 | 71.71 | 83.45 | 99.67 |
实施例17(%) | 0.00 | 41.54 | 57.33 | 72.94 | 83.27 | 95.85 |
原研制剂(%) | 0.00 | 46.86 | 63.17 | 73.53 | 82.62 | 100.01 |
时间(min) | 0 | 15 | 30 | 45 | 60 | 90 |
实施例15(%) | 0.00 | 54.31 | 74.41 | 90.14 | 97.81 | 100.31 |
实施例16(%) | 0.00 | 53.13 | 70.66 | 84.62 | 92.01 | 99.17 |
实施例17(%) | 0.00 | 57.81 | 79.64 | 88.14 | 95.48 | 99.76 |
原研制剂(%) | 0.00 | 63.57 | 76.56 | 92.46 | 98.47 | 100.24 |
时间(min) | 0 | 15 | 30 | 45 | 60 | 90 |
实施例15(%) | 0.00 | 46.06 | 76.44 | 95.19 | 100.14 | 101.85 |
实施例16(%) | 0.00 | 44.70 | 71.15 | 89.53 | 100.00 | 100.99 |
实施例17(%) | 0.00 | 42.36 | 69.28 | 92.43 | 100.56 | 101.54 |
原研制剂(%) | 0.00 | 47.51 | 75.62 | 92.31 | 100.45 | 102.31 |
时间(min) | 0 | 15 | 30 | 45 | 60 | 90 |
实施例4(%) | 0.00 | 46.32 | 61.32 | 84.09 | 96.53 | 99.77 |
实施例5(%) | 0.00 | 47.51 | 64.16 | 83.16 | 96.16 | 100.15 |
实施例6(%) | 0.00 | 44.81 | 60.59 | 81.11 | 93.58 | 101.29 |
实施例7(%) | 0.00 | 43.59 | 62.63 | 79.82 | 96.27 | 101.5 |
实施例8(%) | 0.00 | 42.67 | 57.78 | 77.91 | 94.45 | 97.51 |
实施例9(%) | 0.00 | 41.82 | 56.85 | 76.64 | 95.65 | 99.87 |
实施例10(%) | 0.00 | 38.91 | 53.91 | 73.94 | 89.16 | 95.51 |
实施例11(%) | 0.00 | 38.94 | 54.94 | 72.83 | 89.51 | 94.63 |
原研制剂(%) | 0.00 | 51.25 | 65.45 | 78.35 | 82.65 | 100.32 |
时间(min) | 0 | 15 | 30 | 45 | 60 | 90 |
商业批1(%) | 0.00 | 47.7 | 65.2 | 75.5 | 81.9 | 97.4 |
商业批2(%) | 0.00 | 48.5 | 65.2 | 74.6 | 83.7 | 99.7 |
商业批3(%) | 0.00 | 44.1 | 59.7 | 70.8 | 79.2 | 95.8 |
原研制剂批号1(%) | 0.00 | 42.8 | 56.7 | 70.7 | 82.1 | 101.7 |
原研制剂批号2(%) | 0.00 | 47.7 | 65.2 | 75.5 | 81.9 | 97.4 |
时间(min) | 0 | 15 | 30 | 45 | 60 | 90 |
商业批1(%) | 0.00 | 46.6 | 59.2 | 71.7 | 83.4 | 96.0 |
商业批2(%) | 0.00 | 46.0 | 63.1 | 73.7 | 82.6 | 97.2 |
商业批3(%) | 0.00 | 44.0 | 64.3 | 72.3 | 83.5 | 96.7 |
原研制剂批号1(%) | 0.00 | 52.3 | 70.1 | 87.4 | 99.0 | 102.3 |
原研制剂批号2(%) | 0.00 | 46.9 | 63.2 | 73.5 | 82.6 | 100.0 |
时间(min) | 0 | 15 | 30 | 45 | 60 | 90 |
实施例15(%) | 0.00 | 57.3 | 75.9 | 89.7 | 95.6 | 96.7 |
实施例16(%) | 0.00 | 53.1 | 70.6 | 84.6 | 92.0 | 94.8 |
实施例17(%) | 0.00 | 51.2 | 71.2 | 84.7 | 96.4 | 99.6 |
原研制剂批号1(%) | 0.00 | 57.4 | 81.3 | 96.8 | 100.8 | 102.9 |
原研制剂批号2(%) | 0.00 | 47.5 | 75.6 | 92.3 | 100.4 | 102.3 |
Claims (8)
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US20030104049A1 (en) * | 2001-12-05 | 2003-06-05 | Sherman Bernard Charles | Metformin Hydrochloride tablets |
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CN109432030A (zh) * | 2018-12-03 | 2019-03-08 | 瀚晖制药有限公司 | 一种沙格列汀二甲双胍双层片及其制备方法 |
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2019
- 2019-07-18 CN CN201910650854.7A patent/CN110215437B/zh active Active
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US6117451A (en) * | 1998-08-25 | 2000-09-12 | Pharmalogix, Inc. | Direct compression metformin hydrochloride tablets |
US20030104049A1 (en) * | 2001-12-05 | 2003-06-05 | Sherman Bernard Charles | Metformin Hydrochloride tablets |
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CN109432030A (zh) * | 2018-12-03 | 2019-03-08 | 瀚晖制药有限公司 | 一种沙格列汀二甲双胍双层片及其制备方法 |
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Aoi Ariyasu,等.Delay effect of magnesium stearate on tablet dissolution in acidic medium.《International Journal of Pharmaceutics》.2016,第511卷(第2期),第2.1.2项. * |
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