CN110037995B - 一种稳定的盐酸帕罗西汀片剂及其制备方法 - Google Patents
一种稳定的盐酸帕罗西汀片剂及其制备方法 Download PDFInfo
- Publication number
- CN110037995B CN110037995B CN201910310282.8A CN201910310282A CN110037995B CN 110037995 B CN110037995 B CN 110037995B CN 201910310282 A CN201910310282 A CN 201910310282A CN 110037995 B CN110037995 B CN 110037995B
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- CN
- China
- Prior art keywords
- paroxetine hydrochloride
- parts
- tablet
- hydrochloride tablet
- stable
- 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.)
- Expired - Fee Related
Links
- AHOUBRCZNHFOSL-UHFFFAOYSA-N 3-(1,3-benzodioxol-5-yloxymethyl)-4-(4-fluorophenyl)piperidine Chemical compound C1=CC(F)=CC=C1C1C(COC=2C=C3OCOC3=CC=2)CNCC1 AHOUBRCZNHFOSL-UHFFFAOYSA-N 0.000 title claims abstract description 184
- 229960005183 paroxetine hydrochloride Drugs 0.000 title claims abstract description 92
- 238000002360 preparation method Methods 0.000 title claims abstract description 31
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical group [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 46
- 229930006000 Sucrose Natural products 0.000 claims abstract description 33
- 235000019359 magnesium stearate Nutrition 0.000 claims abstract description 23
- 229920002472 Starch Polymers 0.000 claims abstract description 22
- 239000011734 sodium Substances 0.000 claims abstract description 22
- 229910052708 sodium Inorganic materials 0.000 claims abstract description 22
- 239000008107 starch Substances 0.000 claims abstract description 22
- 235000019698 starch Nutrition 0.000 claims abstract description 22
- 238000005550 wet granulation Methods 0.000 claims abstract description 21
- 229920003081 Povidone K 30 Polymers 0.000 claims abstract description 14
- 239000000945 filler Substances 0.000 claims abstract description 14
- 239000000314 lubricant Substances 0.000 claims abstract description 9
- 239000003381 stabilizer Substances 0.000 claims abstract description 9
- 239000000853 adhesive Substances 0.000 claims abstract description 8
- 230000001070 adhesive effect Effects 0.000 claims abstract description 8
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 7
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical group [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 claims abstract description 6
- 239000011575 calcium Substances 0.000 claims abstract description 6
- 229910052791 calcium Inorganic materials 0.000 claims abstract description 6
- 150000004683 dihydrates Chemical class 0.000 claims abstract description 6
- 239000003826 tablet Substances 0.000 claims description 78
- 239000005720 sucrose Substances 0.000 claims description 28
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 16
- 239000000080 wetting agent Substances 0.000 claims description 14
- 239000000463 material Substances 0.000 claims description 8
- 239000008213 purified water Substances 0.000 claims description 8
- 238000000034 method Methods 0.000 claims description 7
- 239000011248 coating agent Substances 0.000 claims description 6
- 238000000576 coating method Methods 0.000 claims description 6
- 239000008187 granular material Substances 0.000 claims description 5
- 239000000843 powder Substances 0.000 claims description 5
- 239000007884 disintegrant Substances 0.000 claims description 4
- 238000002156 mixing Methods 0.000 claims description 3
- 239000002245 particle Substances 0.000 claims description 3
- 230000008569 process Effects 0.000 claims description 3
- 239000007864 aqueous solution Substances 0.000 claims description 2
- 238000001035 drying Methods 0.000 claims description 2
- 239000007941 film coated tablet Substances 0.000 claims description 2
- 125000000185 sucrose group Chemical group 0.000 claims description 2
- 238000005303 weighing Methods 0.000 claims description 2
- 229960004793 sucrose Drugs 0.000 abstract description 32
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical group 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 abstract description 31
- XAAHAAMILDNBPS-UHFFFAOYSA-L calcium hydrogenphosphate dihydrate Chemical compound O.O.[Ca+2].OP([O-])([O-])=O XAAHAAMILDNBPS-UHFFFAOYSA-L 0.000 abstract description 24
- 239000003814 drug Substances 0.000 abstract description 5
- 229940079593 drug Drugs 0.000 abstract description 3
- 235000019700 dicalcium phosphate Nutrition 0.000 description 30
- 230000000052 comparative effect Effects 0.000 description 21
- 229940032147 starch Drugs 0.000 description 20
- FUFJGUQYACFECW-UHFFFAOYSA-L calcium hydrogenphosphate Chemical compound [Ca+2].OP([O-])([O-])=O FUFJGUQYACFECW-UHFFFAOYSA-L 0.000 description 15
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 12
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 12
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 12
- 229940069328 povidone Drugs 0.000 description 12
- 238000012360 testing method Methods 0.000 description 11
- 238000002441 X-ray diffraction Methods 0.000 description 8
- 239000004615 ingredient Substances 0.000 description 8
- 239000000203 mixture Substances 0.000 description 6
- 239000000243 solution Substances 0.000 description 6
- 230000008859 change Effects 0.000 description 5
- 239000013078 crystal Substances 0.000 description 4
- RBLGLDWTCZMLRW-UHFFFAOYSA-K dicalcium phosphate dihydrate Substances O.O.[Ca+2].[Ca+2].[O-]P([O-])([O-])=O RBLGLDWTCZMLRW-UHFFFAOYSA-K 0.000 description 4
- 238000009472 formulation Methods 0.000 description 4
- 229920000168 Microcrystalline cellulose Polymers 0.000 description 3
- 150000001875 compounds Chemical class 0.000 description 3
- 229940095079 dicalcium phosphate anhydrous Drugs 0.000 description 3
- 235000019813 microcrystalline cellulose Nutrition 0.000 description 3
- 229940016286 microcrystalline cellulose Drugs 0.000 description 3
- 239000008108 microcrystalline cellulose Substances 0.000 description 3
- AHOUBRCZNHFOSL-YOEHRIQHSA-N (+)-Casbol Chemical compound C1=CC(F)=CC=C1[C@H]1[C@H](COC=2C=C3OCOC3=CC=2)CNCC1 AHOUBRCZNHFOSL-YOEHRIQHSA-N 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 229960002296 paroxetine Drugs 0.000 description 2
- 238000003860 storage Methods 0.000 description 2
- 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 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical group Cl VEXZGXHMUGYJMC-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
- 230000001430 anti-depressive effect Effects 0.000 description 1
- 239000000935 antidepressant agent Substances 0.000 description 1
- 229940005513 antidepressants Drugs 0.000 description 1
- 150000008378 aryl ethers Chemical class 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 239000011230 binding agent Substances 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 230000006866 deterioration Effects 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 238000007908 dry granulation Methods 0.000 description 1
- 239000000428 dust Substances 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 238000011049 filling Methods 0.000 description 1
- 239000000796 flavoring agent Substances 0.000 description 1
- 235000013355 food flavoring agent Nutrition 0.000 description 1
- 230000005251 gamma ray Effects 0.000 description 1
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 description 1
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 1
- 235000010979 hydroxypropyl methyl cellulose Nutrition 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
- 238000009776 industrial production Methods 0.000 description 1
- 239000008101 lactose Substances 0.000 description 1
- 229940057948 magnesium stearate Drugs 0.000 description 1
- 235000012054 meals Nutrition 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 239000007935 oral tablet Substances 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 230000000717 retained effect Effects 0.000 description 1
- 150000003335 secondary amines Chemical group 0.000 description 1
- 235000015424 sodium Nutrition 0.000 description 1
- 229940079832 sodium starch glycolate Drugs 0.000 description 1
- 239000008109 sodium starch glycolate Substances 0.000 description 1
- 229920003109 sodium starch glycolate Polymers 0.000 description 1
- 239000000600 sorbitol Substances 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 239000003643 water by type 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
- A61K31/33—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
- A61K31/445—Non condensed piperidines, e.g. piperocaine
- A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
- A61K31/4525—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a five-membered ring with oxygen as a ring hetero atom
-
- 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
- A61K9/2009—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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- 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
- A61K9/2059—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
- A61K9/2833—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
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/24—Antidepressants
Landscapes
- 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)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Psychiatry (AREA)
- General Chemical & Material Sciences (AREA)
- Inorganic Chemistry (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Pain & Pain Management (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Medicinal Preparation (AREA)
- Plural Heterocyclic Compounds (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
组别 | 0天 | 加速1月 | 加速2月 | 加速3月 | 加速6月 |
实验组/N | 110 | 123 | 116 | 104 | 98 |
对照组/N | 97 | 86 | 66 | 53 | 43 |
Claims (5)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201910310282.8A CN110037995B (zh) | 2019-04-17 | 2019-04-17 | 一种稳定的盐酸帕罗西汀片剂及其制备方法 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
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CN201910310282.8A CN110037995B (zh) | 2019-04-17 | 2019-04-17 | 一种稳定的盐酸帕罗西汀片剂及其制备方法 |
Publications (2)
Publication Number | Publication Date |
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CN110037995A CN110037995A (zh) | 2019-07-23 |
CN110037995B true CN110037995B (zh) | 2021-07-06 |
Family
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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CN201910310282.8A Expired - Fee Related CN110037995B (zh) | 2019-04-17 | 2019-04-17 | 一种稳定的盐酸帕罗西汀片剂及其制备方法 |
Country Status (1)
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CN (1) | CN110037995B (zh) |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
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CN111803460A (zh) * | 2020-07-20 | 2020-10-23 | 华益药业科技(安徽)有限公司 | 一种帕罗西汀片生产工艺 |
CN112641750A (zh) * | 2021-01-12 | 2021-04-13 | 江苏睿实生物科技有限公司 | 一种盐酸帕罗西汀片剂及其制备方法 |
Family Cites Families (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6168805B1 (en) * | 1998-05-07 | 2001-01-02 | Endo Pharmaceuticals, Inc. | Aqueous process for manufacturing paroxetine solid dispersions |
CA2471715A1 (en) * | 2001-12-28 | 2003-07-17 | Teva Pharmaceutical Industries Ltd. | A stable pharmaceutical formulation of paroxetine hydrochloride anhydrous and a process for preparation thereof |
KR20090082213A (ko) * | 2006-10-13 | 2009-07-29 | 얀센 파마슈티카 엔.브이. | 페닐알킬아미노 카바메이트 조성물 |
CN104523645A (zh) * | 2014-11-20 | 2015-04-22 | 美吉斯制药(厦门)有限公司 | 甲磺酸帕罗西汀片芯及其包衣片的制备方法 |
-
2019
- 2019-04-17 CN CN201910310282.8A patent/CN110037995B/zh not_active Expired - Fee Related
Also Published As
Publication number | Publication date |
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CN110037995A (zh) | 2019-07-23 |
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Effective date of registration: 20220705 Address after: 276800 4th floor, office building, No. 99, Shenzhen Middle Road, Kuishan street, Rizhao Economic Development Zone, Shandong Province Patentee after: Shandong Qirong Technology Co.,Ltd. Address before: 052500 Industrial Park, Shenze County, Shijiazhuang City, Hebei Province (No. 16, West Ring Road) Patentee before: SHIJIAZHUANG LONZEAL PHARMACEUTICAL CO.,LTD. |
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Effective date of registration: 20220823 Address after: 276800 4th floor, office building, No. 99, Shenzhen Middle Road, Kuishan street, Rizhao Economic Development Zone, Shandong Province Patentee after: Shandong Qirong Technology Co.,Ltd. Patentee after: Shandong Xinglian Pharmaceutical Co.,Ltd. Address before: 276800 4th floor, office building, No. 99, Shenzhen Middle Road, Kuishan street, Rizhao Economic Development Zone, Shandong Province Patentee before: Shandong Qirong Technology Co.,Ltd. |
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CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20210706 |