CN101862305A - Ambroxol hydrochloride sustained-release pellet and preparation method - Google Patents
Ambroxol hydrochloride sustained-release pellet and preparation method Download PDFInfo
- Publication number
- CN101862305A CN101862305A CN200910082237A CN200910082237A CN101862305A CN 101862305 A CN101862305 A CN 101862305A CN 200910082237 A CN200910082237 A CN 200910082237A CN 200910082237 A CN200910082237 A CN 200910082237A CN 101862305 A CN101862305 A CN 101862305A
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- CN
- China
- Prior art keywords
- release
- slow
- release micro
- pill
- preparation
- 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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- 238000002360 preparation method Methods 0.000 title claims abstract description 20
- 238000013268 sustained release Methods 0.000 title claims abstract description 13
- 239000012730 sustained-release form Substances 0.000 title claims abstract description 13
- QNVKOSLOVOTXKF-UHFFFAOYSA-N 4-[(2-amino-3,5-dibromophenyl)methylamino]cyclohexan-1-ol;hydron;chloride Chemical compound Cl.NC1=C(Br)C=C(Br)C=C1CNC1CCC(O)CC1 QNVKOSLOVOTXKF-UHFFFAOYSA-N 0.000 title claims description 17
- 229960000985 ambroxol hydrochloride Drugs 0.000 title claims description 17
- 239000008188 pellet Substances 0.000 title abstract description 6
- 238000000576 coating method Methods 0.000 claims abstract description 23
- 239000011248 coating agent Substances 0.000 claims abstract description 16
- 239000006187 pill Substances 0.000 claims description 25
- 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 14
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 10
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 10
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 10
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 10
- 238000003756 stirring Methods 0.000 claims description 10
- 229960003943 hypromellose Drugs 0.000 claims description 8
- 239000002202 Polyethylene glycol Substances 0.000 claims description 7
- 239000011247 coating layer Substances 0.000 claims description 7
- 239000010410 layer Substances 0.000 claims description 7
- 229920001223 polyethylene glycol Polymers 0.000 claims description 7
- 239000003795 chemical substances by application Substances 0.000 claims description 6
- 239000000945 filler Substances 0.000 claims description 6
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 5
- 239000011230 binding agent Substances 0.000 claims description 5
- 239000002775 capsule Substances 0.000 claims description 5
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 5
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 5
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 5
- 238000002156 mixing Methods 0.000 claims description 5
- 239000007779 soft material Substances 0.000 claims description 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 5
- 229920002472 Starch Polymers 0.000 claims description 4
- GUBGYTABKSRVRQ-QKKXKWKRSA-N lactose group Chemical group OC1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@@H](O)[C@H](O2)CO)[C@H](O1)CO GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 4
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 4
- 239000004014 plasticizer Substances 0.000 claims description 4
- 239000008107 starch Substances 0.000 claims description 4
- 235000019698 starch Nutrition 0.000 claims 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 claims description 3
- 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 description 3
- 229930195725 Mannitol Natural products 0.000 claims description 3
- 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 3
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 3
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 claims description 3
- 238000004132 cross linking Methods 0.000 claims description 3
- 239000008101 lactose Substances 0.000 claims description 3
- 239000000594 mannitol Substances 0.000 claims description 3
- 235000010355 mannitol Nutrition 0.000 claims description 3
- 239000001253 polyvinylpolypyrrolidone Substances 0.000 claims description 3
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims description 3
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims description 3
- 239000011734 sodium Substances 0.000 claims description 3
- 229910052708 sodium Inorganic materials 0.000 claims description 3
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims description 3
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims description 3
- 239000000853 adhesive Substances 0.000 claims description 2
- 230000001070 adhesive effect Effects 0.000 claims description 2
- 238000013265 extended release Methods 0.000 claims description 2
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical class 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 2
- 239000002994 raw material Substances 0.000 claims description 2
- 230000001154 acute effect Effects 0.000 abstract description 4
- 206010062717 Increased upper airway secretion Diseases 0.000 abstract description 3
- 239000003814 drug Substances 0.000 abstract description 3
- 208000026435 phlegm Diseases 0.000 abstract description 3
- 229960005174 ambroxol Drugs 0.000 abstract description 2
- JBDGDEWWOUBZPM-XYPYZODXSA-N ambroxol Chemical compound NC1=C(Br)C=C(Br)C=C1CN[C@@H]1CC[C@@H](O)CC1 JBDGDEWWOUBZPM-XYPYZODXSA-N 0.000 abstract description 2
- 230000000694 effects Effects 0.000 abstract description 2
- 230000007774 longterm Effects 0.000 abstract description 2
- 239000000203 mixture Substances 0.000 abstract description 2
- 208000030090 Acute Disease Diseases 0.000 abstract 1
- 208000014085 Chronic respiratory disease Diseases 0.000 abstract 1
- 230000003578 releasing effect Effects 0.000 description 6
- 206010036790 Productive cough Diseases 0.000 description 3
- 208000018569 Respiratory Tract disease Diseases 0.000 description 3
- 230000001684 chronic effect Effects 0.000 description 3
- 239000003405 delayed action preparation Substances 0.000 description 3
- 230000002496 gastric effect Effects 0.000 description 3
- 230000028327 secretion Effects 0.000 description 3
- 238000011282 treatment Methods 0.000 description 3
- 239000007864 aqueous solution Substances 0.000 description 2
- 208000006673 asthma Diseases 0.000 description 2
- 206010006451 bronchitis Diseases 0.000 description 2
- DOIRQSBPFJWKBE-UHFFFAOYSA-N dibutyl phthalate Chemical compound CCCCOC(=O)C1=CC=CC=C1C(=O)OCCCC DOIRQSBPFJWKBE-UHFFFAOYSA-N 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 230000003203 everyday effect Effects 0.000 description 2
- 238000000338 in vitro Methods 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 206010001052 Acute respiratory distress syndrome Diseases 0.000 description 1
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 description 1
- 206010006458 Bronchitis chronic Diseases 0.000 description 1
- MQIUGAXCHLFZKX-UHFFFAOYSA-N Di-n-octyl phthalate Natural products CCCCCCCCOC(=O)C1=CC=CC=C1C(=O)OCCCCCCCC MQIUGAXCHLFZKX-UHFFFAOYSA-N 0.000 description 1
- 208000013616 Respiratory Distress Syndrome Diseases 0.000 description 1
- DOOTYTYQINUNNV-UHFFFAOYSA-N Triethyl citrate Chemical compound CCOC(=O)CC(O)(C(=O)OCC)CC(=O)OCC DOOTYTYQINUNNV-UHFFFAOYSA-N 0.000 description 1
- 239000011149 active material Substances 0.000 description 1
- 239000013543 active substance Substances 0.000 description 1
- 230000009798 acute exacerbation Effects 0.000 description 1
- BJQHLKABXJIVAM-UHFFFAOYSA-N bis(2-ethylhexyl) phthalate Chemical compound CCCCC(CC)COC(=O)C1=CC=CC=C1C(=O)OCC(CC)CCCC BJQHLKABXJIVAM-UHFFFAOYSA-N 0.000 description 1
- 210000000621 bronchi Anatomy 0.000 description 1
- 201000009267 bronchiectasis Diseases 0.000 description 1
- 208000007451 chronic bronchitis Diseases 0.000 description 1
- 230000001886 ciliary effect Effects 0.000 description 1
- 230000004064 dysfunction Effects 0.000 description 1
- 239000003172 expectorant agent Substances 0.000 description 1
- 230000003419 expectorant effect Effects 0.000 description 1
- 239000000835 fiber Substances 0.000 description 1
- 208000030603 inherited susceptibility to asthma Diseases 0.000 description 1
- 210000004072 lung Anatomy 0.000 description 1
- 239000003580 lung surfactant Substances 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 230000000420 mucociliary effect Effects 0.000 description 1
- 230000003204 osmotic effect Effects 0.000 description 1
- 238000012856 packing Methods 0.000 description 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 1
- 230000002980 postoperative effect Effects 0.000 description 1
- 230000002028 premature Effects 0.000 description 1
- 238000011321 prophylaxis Methods 0.000 description 1
- 230000002685 pulmonary effect Effects 0.000 description 1
- 210000002345 respiratory system Anatomy 0.000 description 1
- 239000002002 slurry Substances 0.000 description 1
- 208000024794 sputum Diseases 0.000 description 1
- 210000003802 sputum Anatomy 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 239000001069 triethyl citrate Substances 0.000 description 1
- VMYFZRTXGLUXMZ-UHFFFAOYSA-N triethyl citrate Natural products CCOC(=O)C(O)(C(=O)OCC)C(=O)OCC VMYFZRTXGLUXMZ-UHFFFAOYSA-N 0.000 description 1
- 235000013769 triethyl citrate Nutrition 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Description
Claims (9)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN200910082237.8A CN101862305B (en) | 2009-04-20 | 2009-04-20 | Ambroxol hydrochloride sustained-release pellet and preparation method |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN200910082237.8A CN101862305B (en) | 2009-04-20 | 2009-04-20 | Ambroxol hydrochloride sustained-release pellet and preparation method |
Publications (2)
Publication Number | Publication Date |
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CN101862305A true CN101862305A (en) | 2010-10-20 |
CN101862305B CN101862305B (en) | 2014-05-07 |
Family
ID=42954369
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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CN200910082237.8A Active CN101862305B (en) | 2009-04-20 | 2009-04-20 | Ambroxol hydrochloride sustained-release pellet and preparation method |
Country Status (1)
Country | Link |
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CN (1) | CN101862305B (en) |
Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102266293A (en) * | 2011-07-21 | 2011-12-07 | 佛山市隆信医药科技有限公司 | Ambroxol hydrochloride sustained-release dry suspension and preparation method thereof |
CN102772391A (en) * | 2012-08-16 | 2012-11-14 | 河南新帅克制药股份有限公司 | Ambroxol hydrochloride sustained release capsule and preparation method thereof |
CN103054832A (en) * | 2012-12-26 | 2013-04-24 | 河南中帅医药科技发展有限公司 | Minocycline hydrochloride sustained-release capsule and preparation method thereof |
CN103211789A (en) * | 2012-01-18 | 2013-07-24 | 北京天衡药物研究院 | Ambroxol hydrochloride film-controlled slow-release pellet capsule |
CN105456202A (en) * | 2015-12-08 | 2016-04-06 | 青岛正大海尔制药有限公司 | Ambroxol and salbutamol pellet |
CN107569473A (en) * | 2017-09-28 | 2018-01-12 | 南京易亨制药有限公司 | A kind of Sustained Release Ambroxol Hydrochloride Capsules and preparation method thereof |
Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR930011993B1 (en) * | 1991-12-23 | 1993-12-23 | 주식회사 럭키 | Process for preparing prolonged release of ambroxol preparation |
US6251429B1 (en) * | 1991-12-11 | 2001-06-26 | Therapicon Slr | Programmed release ambroxol—HCl dosage forms |
CN1415287A (en) * | 2002-11-28 | 2003-05-07 | 沈阳药科大学 | Hydrochloric ambroxol osmotic pump type controlled release formulation and its preparation method |
CN1600296A (en) * | 2003-09-22 | 2005-03-30 | 北京德众万全药物技术开发有限公司 | Method for preparing tiny pellets of difficult soluble drugs and formulation containing the pellets |
JP2008013480A (en) * | 2006-07-05 | 2008-01-24 | Sawai Pharmaceutical Co Ltd | Drug-containing micro-particle and method for producing the same |
CN101288659A (en) * | 2007-04-18 | 2008-10-22 | 王雷波 | Floating type pellets in stomach and preparation method thereof |
-
2009
- 2009-04-20 CN CN200910082237.8A patent/CN101862305B/en active Active
Patent Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6251429B1 (en) * | 1991-12-11 | 2001-06-26 | Therapicon Slr | Programmed release ambroxol—HCl dosage forms |
KR930011993B1 (en) * | 1991-12-23 | 1993-12-23 | 주식회사 럭키 | Process for preparing prolonged release of ambroxol preparation |
CN1415287A (en) * | 2002-11-28 | 2003-05-07 | 沈阳药科大学 | Hydrochloric ambroxol osmotic pump type controlled release formulation and its preparation method |
CN1600296A (en) * | 2003-09-22 | 2005-03-30 | 北京德众万全药物技术开发有限公司 | Method for preparing tiny pellets of difficult soluble drugs and formulation containing the pellets |
JP2008013480A (en) * | 2006-07-05 | 2008-01-24 | Sawai Pharmaceutical Co Ltd | Drug-containing micro-particle and method for producing the same |
CN101288659A (en) * | 2007-04-18 | 2008-10-22 | 王雷波 | Floating type pellets in stomach and preparation method thereof |
Non-Patent Citations (2)
Title |
---|
上海医药工业研究院药物制剂研究中心,等: "《药用辅料应用技术》", 31 July 2002, 中国医药科技出版社 * |
佟杰: "复方罗红霉素缓释微丸胶囊的研制", 《中国优秀硕士学位论文全文数据库》 * |
Cited By (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102266293A (en) * | 2011-07-21 | 2011-12-07 | 佛山市隆信医药科技有限公司 | Ambroxol hydrochloride sustained-release dry suspension and preparation method thereof |
CN102266293B (en) * | 2011-07-21 | 2013-05-01 | 佛山市隆信医药科技有限公司 | Ambroxol hydrochloride sustained-release dry suspension and preparation method thereof |
CN103211789A (en) * | 2012-01-18 | 2013-07-24 | 北京天衡药物研究院 | Ambroxol hydrochloride film-controlled slow-release pellet capsule |
CN103211789B (en) * | 2012-01-18 | 2017-07-11 | 北京天衡药物研究院有限公司 | Ambroxol hydrochloride film-controlled slow-release micro pill capsule |
CN102772391A (en) * | 2012-08-16 | 2012-11-14 | 河南新帅克制药股份有限公司 | Ambroxol hydrochloride sustained release capsule and preparation method thereof |
CN103054832A (en) * | 2012-12-26 | 2013-04-24 | 河南中帅医药科技发展有限公司 | Minocycline hydrochloride sustained-release capsule and preparation method thereof |
CN105456202A (en) * | 2015-12-08 | 2016-04-06 | 青岛正大海尔制药有限公司 | Ambroxol and salbutamol pellet |
CN107569473A (en) * | 2017-09-28 | 2018-01-12 | 南京易亨制药有限公司 | A kind of Sustained Release Ambroxol Hydrochloride Capsules and preparation method thereof |
Also Published As
Publication number | Publication date |
---|---|
CN101862305B (en) | 2014-05-07 |
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Legal Events
Date | Code | Title | Description |
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C06 | Publication | ||
PB01 | Publication | ||
C10 | Entry into substantive examination | ||
SE01 | Entry into force of request for substantive examination | ||
DD01 | Delivery of document by public notice |
Addressee: Beijing D-Venturepharm Technology Development Co.,Ltd. Document name: Notification of an Office Action |
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C14 | Grant of patent or utility model | ||
GR01 | Patent grant | ||
TR01 | Transfer of patent right | ||
TR01 | Transfer of patent right |
Effective date of registration: 20210113 Address after: 570314 no.279 Nanhai Avenue, Xiuying District, Haikou City, Hainan Province Patentee after: AVENTIS PHARMA (HAINAN) Co.,Ltd. Address before: 100097, Wanquan mansion, 3 Jin Zhuang, Haidian District, Beijing, Sijiqing Patentee before: BEIJING D-VENTUREPHARM TECHNOLOGY DEVELOPMENT Co.,Ltd. |
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DD01 | Delivery of document by public notice | ||
DD01 | Delivery of document by public notice |
Addressee: Song Xuemei Document name: Notice of conformity |
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PE01 | Entry into force of the registration of the contract for pledge of patent right | ||
PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of invention: A sustained-release microsphere of ambroxol hydrochloride and its preparation method Granted publication date: 20140507 Pledgee: Sanya Rural Commercial Bank Co.,Ltd. Pledgor: AVENTIS PHARMA (HAINAN) Co.,Ltd. Registration number: Y2024980014810 |