CN104586804B - 一种稳定性好的来曲唑片的制备方法 - Google Patents
一种稳定性好的来曲唑片的制备方法 Download PDFInfo
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- CN104586804B CN104586804B CN201510077799.9A CN201510077799A CN104586804B CN 104586804 B CN104586804 B CN 104586804B CN 201510077799 A CN201510077799 A CN 201510077799A CN 104586804 B CN104586804 B CN 104586804B
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- parts
- letrozole
- piece
- preparation
- ethanol
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- 229960003881 letrozole Drugs 0.000 title claims abstract description 30
- HPJKCIUCZWXJDR-UHFFFAOYSA-N letrozole Chemical compound C1=CC(C#N)=CC=C1C(N1N=CN=C1)C1=CC=C(C#N)C=C1 HPJKCIUCZWXJDR-UHFFFAOYSA-N 0.000 title claims abstract description 30
- 238000002360 preparation method Methods 0.000 title claims abstract description 20
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 33
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims abstract description 12
- ZLNQQNXFFQJAID-UHFFFAOYSA-L magnesium carbonate Chemical compound [Mg+2].[O-]C([O-])=O ZLNQQNXFFQJAID-UHFFFAOYSA-L 0.000 claims abstract description 10
- 239000001095 magnesium carbonate Substances 0.000 claims abstract description 10
- 229910000021 magnesium carbonate Inorganic materials 0.000 claims abstract description 10
- 239000000203 mixture Substances 0.000 claims abstract description 10
- 239000000843 powder Substances 0.000 claims abstract description 10
- 239000000741 silica gel Substances 0.000 claims abstract description 10
- 229910002027 silica gel Inorganic materials 0.000 claims abstract description 10
- 239000000945 filler Substances 0.000 claims abstract description 9
- 239000012467 final product Substances 0.000 claims abstract description 9
- 239000000314 lubricant Substances 0.000 claims abstract description 9
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 claims abstract description 8
- OGIDPMRJRNCKJF-UHFFFAOYSA-N titanium oxide Inorganic materials [Ti]=O OGIDPMRJRNCKJF-UHFFFAOYSA-N 0.000 claims abstract description 8
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 16
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 8
- 235000019359 magnesium stearate Nutrition 0.000 claims description 8
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 8
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 8
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 8
- 239000003795 chemical substances by application Substances 0.000 claims description 7
- 229920002472 Starch Polymers 0.000 claims description 6
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 claims description 6
- 239000008107 starch Substances 0.000 claims description 6
- 235000019698 starch Nutrition 0.000 claims description 6
- 239000011734 sodium Substances 0.000 claims description 4
- 229910052708 sodium Inorganic materials 0.000 claims description 4
- 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
- 150000003851 azoles Chemical class 0.000 claims description 2
- 238000004090 dissolution Methods 0.000 abstract description 7
- 238000000034 method Methods 0.000 abstract description 7
- 239000007884 disintegrant Substances 0.000 abstract description 3
- 239000003814 drug Substances 0.000 abstract description 3
- 238000007873 sieving Methods 0.000 abstract description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 8
- 239000000047 product Substances 0.000 description 5
- 229940080313 sodium starch Drugs 0.000 description 5
- 229940032147 starch Drugs 0.000 description 5
- 238000003556 assay Methods 0.000 description 4
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 description 3
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 3
- 239000000463 material Substances 0.000 description 3
- 238000012360 testing method Methods 0.000 description 3
- 238000005550 wet granulation Methods 0.000 description 3
- 206010006187 Breast cancer Diseases 0.000 description 2
- 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 2
- 229940046836 anti-estrogen Drugs 0.000 description 2
- 230000001833 anti-estrogenic effect Effects 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 229940011871 estrogen Drugs 0.000 description 2
- 239000000262 estrogen Substances 0.000 description 2
- 239000000328 estrogen antagonist Substances 0.000 description 2
- 239000000706 filtrate Substances 0.000 description 2
- 239000008101 lactose Substances 0.000 description 2
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 description 2
- 229920000053 polysorbate 80 Polymers 0.000 description 2
- 238000000870 ultraviolet spectroscopy Methods 0.000 description 2
- KUFNEMCYFOJAGR-UHFFFAOYSA-N 4-benzyl-2h-triazole Chemical class C=1C=CC=CC=1CC1=CNN=N1 KUFNEMCYFOJAGR-UHFFFAOYSA-N 0.000 description 1
- 208000026310 Breast neoplasm Diseases 0.000 description 1
- 208000005623 Carcinogenesis Diseases 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
- 206010013786 Dry skin Diseases 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 229930195725 Mannitol Natural products 0.000 description 1
- 229920000881 Modified starch Polymers 0.000 description 1
- 229960003437 aminoglutethimide Drugs 0.000 description 1
- ROBVIMPUHSLWNV-UHFFFAOYSA-N aminoglutethimide Chemical compound C=1C=C(N)C=CC=1C1(CC)CCC(=O)NC1=O ROBVIMPUHSLWNV-UHFFFAOYSA-N 0.000 description 1
- 230000000259 anti-tumor effect Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000033228 biological regulation Effects 0.000 description 1
- 230000036952 cancer formation Effects 0.000 description 1
- 231100000504 carcinogenesis Toxicity 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 238000004925 denaturation Methods 0.000 description 1
- 230000036425 denaturation Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 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 description 1
- 239000012738 dissolution medium Substances 0.000 description 1
- 238000011978 dissolution method Methods 0.000 description 1
- MOTZDAYCYVMXPC-UHFFFAOYSA-N dodecyl hydrogen sulfate Chemical compound CCCCCCCCCCCCOS(O)(=O)=O MOTZDAYCYVMXPC-UHFFFAOYSA-N 0.000 description 1
- 229940043264 dodecyl sulfate Drugs 0.000 description 1
- 238000001647 drug administration Methods 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 231100000734 genotoxic potential Toxicity 0.000 description 1
- 239000003862 glucocorticoid Substances 0.000 description 1
- 239000005556 hormone Substances 0.000 description 1
- 229940088597 hormone Drugs 0.000 description 1
- 239000012943 hotmelt Substances 0.000 description 1
- 239000001863 hydroxypropyl cellulose Substances 0.000 description 1
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 229960001375 lactose Drugs 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 239000000594 mannitol Substances 0.000 description 1
- 235000010355 mannitol Nutrition 0.000 description 1
- 229960001855 mannitol Drugs 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 239000002547 new drug Substances 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 description 1
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 description 1
- 230000028327 secretion Effects 0.000 description 1
- 239000000377 silicon dioxide Substances 0.000 description 1
- PANBYUAFMMOFOV-UHFFFAOYSA-N sodium;sulfuric acid Chemical compound [Na].OS(O)(=O)=O PANBYUAFMMOFOV-UHFFFAOYSA-N 0.000 description 1
- 239000007962 solid dispersion Substances 0.000 description 1
- 230000006641 stabilisation Effects 0.000 description 1
- 238000011105 stabilization Methods 0.000 description 1
- 230000000638 stimulation Effects 0.000 description 1
- 231100001274 therapeutic index Toxicity 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 210000001685 thyroid gland Anatomy 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- 230000004614 tumor growth Effects 0.000 description 1
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- Medicinal Preparation (AREA)
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CN201510077799.9A CN104586804B (zh) | 2015-02-13 | 2015-02-13 | 一种稳定性好的来曲唑片的制备方法 |
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Families Citing this family (5)
Publication number | Priority date | Publication date | Assignee | Title |
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CN106983727B (zh) * | 2017-05-27 | 2020-04-14 | 江苏苏南药业实业有限公司 | 一种来曲唑片及制备方法 |
CN109498584A (zh) * | 2017-09-15 | 2019-03-22 | 万特制药(海南)有限公司 | 一种含有来曲唑的分散片及其新型制备方法 |
CN107737112B (zh) * | 2017-11-07 | 2020-05-19 | 海南锦瑞制药有限公司 | 一种来曲唑片及其制备方法 |
CN111012752B (zh) * | 2019-12-31 | 2020-09-01 | 瀚晖制药有限公司 | 一种来曲唑片及其制备方法 |
CN115444830A (zh) * | 2022-08-25 | 2022-12-09 | 海南锦瑞制药有限公司 | 一种来曲唑片的制备方法 |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1660093A (zh) * | 2005-01-20 | 2005-08-31 | 北京科信必成医药科技发展有限公司 | 奥美拉唑及其衍生物的口腔崩解片及其制备工艺 |
CN101057939A (zh) * | 2006-04-21 | 2007-10-24 | 北京因科瑞斯生物制品研究所 | 一种具有清热凉血、化瘀止血的中药制剂及其制备方法 |
CN102485217A (zh) * | 2010-12-03 | 2012-06-06 | 深圳海王药业有限公司 | 高溶出度来曲唑片及其制备方法 |
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- 2015-02-13 CN CN201510077799.9A patent/CN104586804B/zh active Active
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1660093A (zh) * | 2005-01-20 | 2005-08-31 | 北京科信必成医药科技发展有限公司 | 奥美拉唑及其衍生物的口腔崩解片及其制备工艺 |
CN101057939A (zh) * | 2006-04-21 | 2007-10-24 | 北京因科瑞斯生物制品研究所 | 一种具有清热凉血、化瘀止血的中药制剂及其制备方法 |
CN102485217A (zh) * | 2010-12-03 | 2012-06-06 | 深圳海王药业有限公司 | 高溶出度来曲唑片及其制备方法 |
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CB03 | Change of inventor or designer information | ||
CB03 | Change of inventor or designer information |
Inventor after: Sha Sha Inventor after: Liu Ye Inventor after: Li Yong Inventor before: Meng Honglin |
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TA01 | Transfer of patent application right | ||
TA01 | Transfer of patent application right |
Effective date of registration: 20170601 Address after: 266300 Jiaozhou Central Hospital, 29 Xuzhou Road, Shandong, Qingdao, Jiaozhou, China Applicant after: Sha Sha Address before: 264404 Zeku Town, Wendeng District, Shandong, Zeku, Weihai Applicant before: Meng Honglin |
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Effective date of registration: 20191112 Address after: Room 301-15, building 1, No.111, Guigu Er Road, Luoxing street, Jiashan County, Jiaxing City, Zhejiang Province Patentee after: Jiashan chuangyue Intellectual Property Service Co.,Ltd. Address before: Qingdao Jiaozhou Central Hospital, 29 Xuzhou Road, Jiaozhou City Patentee before: Sha Sha |
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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: Preparation of letrozole tablets with good stability Effective date of registration: 20210518 Granted publication date: 20170623 Pledgee: Zhejiang Jiashan rural commercial bank Limited by Share Ltd. science and technology sub branch Pledgor: Jiashan chuangyue Intellectual Property Service Co.,Ltd. Registration number: Y2021330000411 |
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Date of cancellation: 20231129 Granted publication date: 20170623 Pledgee: Zhejiang Jiashan rural commercial bank Limited by Share Ltd. science and technology sub branch Pledgor: Jiashan chuangyue Intellectual Property Service Co.,Ltd. Registration number: Y2021330000411 |
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Effective date of registration: 20240223 Address after: Room 401-89, Building 1, No. 111 Guigu Second Road, Luoxing Street, Jiashan County, Jiaxing City, Zhejiang Province, 314100 (Residence application) Patentee after: Jiashan Luoxing Venture Capital Co.,Ltd. Country or region after: China Address before: Room 301-15, building 1, No. 111, Guigu 2nd Road, Luoxing street, Jiashan County, Jiaxing City, Zhejiang Province Patentee before: Jiashan chuangyue Intellectual Property Service Co.,Ltd. Country or region before: China |