CN103893131A - 一种含有非布司他的固体药物组合物 - Google Patents
一种含有非布司他的固体药物组合物 Download PDFInfo
- Publication number
- CN103893131A CN103893131A CN201410155591.XA CN201410155591A CN103893131A CN 103893131 A CN103893131 A CN 103893131A CN 201410155591 A CN201410155591 A CN 201410155591A CN 103893131 A CN103893131 A CN 103893131A
- Authority
- CN
- China
- Prior art keywords
- febustat
- sodium bicarbonate
- solid composite
- composite medicament
- 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.)
- Granted
Links
- 239000000203 mixture Substances 0.000 title claims abstract description 31
- BQSJTQLCZDPROO-UHFFFAOYSA-N febuxostat Chemical compound C1=C(C#N)C(OCC(C)C)=CC=C1C1=NC(C)=C(C(O)=O)S1 BQSJTQLCZDPROO-UHFFFAOYSA-N 0.000 title abstract description 16
- 229960005101 febuxostat Drugs 0.000 title abstract description 15
- 229940126589 solid medicine Drugs 0.000 title abstract 6
- 239000003814 drug Substances 0.000 claims abstract description 55
- 239000007787 solid Substances 0.000 claims abstract description 38
- 238000002360 preparation method Methods 0.000 claims abstract description 28
- 239000003651 drinking water Substances 0.000 claims abstract description 10
- 235000020188 drinking water Nutrition 0.000 claims abstract description 10
- 238000003756 stirring Methods 0.000 claims abstract description 7
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims description 44
- 239000008187 granular material Substances 0.000 claims description 38
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 35
- 239000002131 composite material Substances 0.000 claims description 32
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 28
- 229910000030 sodium bicarbonate Inorganic materials 0.000 claims description 22
- 235000017557 sodium bicarbonate Nutrition 0.000 claims description 22
- 239000000945 filler Substances 0.000 claims description 17
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims description 12
- 229920003081 Povidone K 30 Polymers 0.000 claims description 12
- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 claims description 12
- 239000011975 tartaric acid Substances 0.000 claims description 12
- 235000002906 tartaric acid Nutrition 0.000 claims description 12
- 229960004543 anhydrous citric acid Drugs 0.000 claims description 10
- 239000000853 adhesive Substances 0.000 claims description 8
- 230000001070 adhesive effect Effects 0.000 claims description 8
- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 claims description 7
- 201000005569 Gout Diseases 0.000 claims description 7
- 239000002671 adjuvant Substances 0.000 claims description 7
- 239000000126 substance Substances 0.000 claims description 7
- 238000004364 calculation method Methods 0.000 claims description 5
- 229960004106 citric acid Drugs 0.000 claims description 5
- 239000012528 membrane Substances 0.000 claims description 5
- 229920003023 plastic Polymers 0.000 claims description 5
- 239000004033 plastic Substances 0.000 claims description 5
- 239000007779 soft material Substances 0.000 claims description 5
- 230000003472 neutralizing effect Effects 0.000 claims description 4
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 4
- 238000004090 dissolution Methods 0.000 abstract description 12
- 239000000463 material Substances 0.000 abstract description 3
- 239000002994 raw material Substances 0.000 abstract description 3
- 239000007788 liquid Substances 0.000 abstract description 2
- 238000011160 research Methods 0.000 abstract description 2
- 230000001133 acceleration Effects 0.000 abstract 1
- 238000001727 in vivo Methods 0.000 abstract 1
- 229940079593 drug Drugs 0.000 description 20
- 239000000243 solution Substances 0.000 description 20
- 239000003826 tablet Substances 0.000 description 12
- 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 11
- 229930195725 Mannitol Natural products 0.000 description 11
- 239000000594 mannitol Substances 0.000 description 11
- 235000010355 mannitol Nutrition 0.000 description 11
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical class [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 description 9
- 229940069428 antacid Drugs 0.000 description 9
- 239000003159 antacid agent Substances 0.000 description 9
- 230000001458 anti-acid effect Effects 0.000 description 9
- 230000000694 effects Effects 0.000 description 9
- LEHOTFFKMJEONL-UHFFFAOYSA-N Uric Acid Chemical compound N1C(=O)NC(=O)C2=C1NC(=O)N2 LEHOTFFKMJEONL-UHFFFAOYSA-N 0.000 description 8
- 108010093894 Xanthine oxidase Proteins 0.000 description 7
- 238000000034 method Methods 0.000 description 7
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 7
- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 description 6
- TVWHNULVHGKJHS-UHFFFAOYSA-N Uric acid Natural products N1C(=O)NC(=O)C2NC(=O)NC21 TVWHNULVHGKJHS-UHFFFAOYSA-N 0.000 description 6
- 238000005516 engineering process Methods 0.000 description 6
- 229940116269 uric acid Drugs 0.000 description 6
- 102100033220 Xanthine oxidase Human genes 0.000 description 5
- KDCGOANMDULRCW-UHFFFAOYSA-N 7H-purine Chemical compound N1=CNC2=NC=NC2=C1 KDCGOANMDULRCW-UHFFFAOYSA-N 0.000 description 4
- 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 4
- 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 4
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 description 4
- 239000003795 chemical substances by application Substances 0.000 description 4
- 239000008101 lactose Substances 0.000 description 4
- 239000007864 aqueous solution Substances 0.000 description 3
- 230000015572 biosynthetic process Effects 0.000 description 3
- 239000007919 dispersible tablet Substances 0.000 description 3
- 238000009472 formulation Methods 0.000 description 3
- 239000008194 pharmaceutical composition Substances 0.000 description 3
- -1 poly-hydrocarbon oxygen esters Chemical class 0.000 description 3
- LRFVTYWOQMYALW-UHFFFAOYSA-N 9H-xanthine Chemical compound O=C1NC(=O)NC2=C1NC=N2 LRFVTYWOQMYALW-UHFFFAOYSA-N 0.000 description 2
- 108090000790 Enzymes Proteins 0.000 description 2
- 102000004190 Enzymes Human genes 0.000 description 2
- 239000004698 Polyethylene Substances 0.000 description 2
- 102000005773 Xanthine dehydrogenase Human genes 0.000 description 2
- 108010091383 Xanthine dehydrogenase Proteins 0.000 description 2
- 229960003459 allopurinol Drugs 0.000 description 2
- OFCNXPDARWKPPY-UHFFFAOYSA-N allopurinol Chemical compound OC1=NC=NC2=C1C=NN2 OFCNXPDARWKPPY-UHFFFAOYSA-N 0.000 description 2
- 239000011230 binding agent Substances 0.000 description 2
- 239000004359 castor oil Substances 0.000 description 2
- 235000019438 castor oil Nutrition 0.000 description 2
- 230000001684 chronic effect Effects 0.000 description 2
- 239000006185 dispersion Substances 0.000 description 2
- ZEMPKEQAKRGZGQ-XOQCFJPHSA-N glycerol triricinoleate Natural products CCCCCC[C@@H](O)CC=CCCCCCCCC(=O)OC[C@@H](COC(=O)CCCCCCCC=CC[C@@H](O)CCCCCC)OC(=O)CCCCCCCC=CC[C@H](O)CCCCCC ZEMPKEQAKRGZGQ-XOQCFJPHSA-N 0.000 description 2
- FDGQSTZJBFJUBT-UHFFFAOYSA-N hypoxanthine Chemical compound O=C1NC=NC2=C1NC=N2 FDGQSTZJBFJUBT-UHFFFAOYSA-N 0.000 description 2
- 239000000314 lubricant Substances 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 230000008018 melting Effects 0.000 description 2
- 238000002844 melting Methods 0.000 description 2
- 229920000573 polyethylene Polymers 0.000 description 2
- 230000004144 purine metabolism Effects 0.000 description 2
- HNJBEVLQSNELDL-UHFFFAOYSA-N pyrrolidin-2-one Chemical compound O=C1CCCN1 HNJBEVLQSNELDL-UHFFFAOYSA-N 0.000 description 2
- 238000005070 sampling Methods 0.000 description 2
- 229910000029 sodium carbonate Inorganic materials 0.000 description 2
- 239000004094 surface-active agent Substances 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- RFVNOJDQRGSOEL-UHFFFAOYSA-N 2-hydroxyethyl octadecanoate Chemical class CCCCCCCCCCCCCCCCCC(=O)OCCO RFVNOJDQRGSOEL-UHFFFAOYSA-N 0.000 description 1
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 description 1
- 239000004215 Carbon black (E152) Substances 0.000 description 1
- 208000024172 Cardiovascular disease Diseases 0.000 description 1
- 201000001431 Hyperuricemia Diseases 0.000 description 1
- UGQMRVRMYYASKQ-UHFFFAOYSA-N Hypoxanthine nucleoside Natural products OC1C(O)C(CO)OC1N1C(NC=NC2=O)=C2N=C1 UGQMRVRMYYASKQ-UHFFFAOYSA-N 0.000 description 1
- 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 description 1
- 229920000881 Modified starch Polymers 0.000 description 1
- 229920002472 Starch Polymers 0.000 description 1
- 238000009825 accumulation Methods 0.000 description 1
- 229960002708 antigout preparations Drugs 0.000 description 1
- 239000000872 buffer Substances 0.000 description 1
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 239000013078 crystal Substances 0.000 description 1
- 230000008021 deposition Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 206010012601 diabetes mellitus Diseases 0.000 description 1
- 230000037213 diet Effects 0.000 description 1
- 235000005911 diet Nutrition 0.000 description 1
- 238000001647 drug administration Methods 0.000 description 1
- 230000002255 enzymatic effect Effects 0.000 description 1
- 230000029142 excretion Effects 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 210000004211 gastric acid Anatomy 0.000 description 1
- 238000005286 illumination Methods 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 239000003112 inhibitor Substances 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 238000009434 installation Methods 0.000 description 1
- 210000003734 kidney Anatomy 0.000 description 1
- 206010025482 malaise Diseases 0.000 description 1
- 230000004060 metabolic process Effects 0.000 description 1
- 238000012856 packing Methods 0.000 description 1
- 229940051841 polyoxyethylene ether Drugs 0.000 description 1
- 229920000056 polyoxyethylene ether Polymers 0.000 description 1
- 230000003389 potentiating effect Effects 0.000 description 1
- 238000001556 precipitation Methods 0.000 description 1
- 239000008213 purified water Substances 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 238000001304 sample melting Methods 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 239000012453 solvate Substances 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 238000013519 translation Methods 0.000 description 1
- 230000014616 translation Effects 0.000 description 1
- 229940063477 uloric Drugs 0.000 description 1
- 210000001835 viscera Anatomy 0.000 description 1
- 239000000080 wetting agent Substances 0.000 description 1
- 229940075420 xanthine Drugs 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
Abstract
Description
原辅料 | 含量/重量百分比 |
非布司他 | 20mg-120mg |
无水柠檬酸 | 19%-30% |
用于中和柠檬酸的碳酸氢钠 | 25%-40% |
用于提高溶液pH值的碳酸氢钠 | 1.7g-2.0g |
填充剂 | 适量 |
无水粘合剂 | 适量 |
总重 | 5.0g-10.0g |
原辅料 | 含量/重量百分比 |
非布司他 | 20mg-120mg |
酒石酸 | 22%-35% |
用于中和酒石酸的碳酸氢钠 | 25%-40% |
用于提高溶液pH值的碳酸氢钠 | 1.7g-2.0g |
填充剂 | 适量 |
无水粘合剂 | 适量 |
总重 | 5.0g-10.0g |
原辅料 | 规格1 | 规格2 | 规格3 | 规格4 |
非布司他 | 20.0g | 40.0g | 80.0g | 120.0g |
无水柠檬酸 | 950g | 1100g | 2600g | 3000g |
用于中和制酸剂的碳酸氢钠 | 1250g | 1500g | 3500g | 4000g |
用于提高溶液pH值的碳酸氢钠 | 2000g | 1700g | 2000g | 1700g |
甘露醇 | 780g | 660g | 1820g | 1220g |
5%PVP K30无水乙醇溶液 | 适量 | 适量 | 适量 | 适量 |
干物料总重约 | 5000g | 5000g | 10000g | 10000g |
共制成 | 1000袋 | 1000袋 | 1000袋 | 1000袋 |
原辅料 | 规格1 | 规格2 | 规格3 | 规格4 |
非布司他 | 20.0g | 40.0g | 80.0g | 120.0g |
酒石酸 | 1100g | 1350g | 3100g | 3500g |
用于中和酒石酸的碳酸氢钠 | 1250g | 1500g | 3500g | 4000g |
用于提高溶液pH值的碳酸氢钠 | 2000g | 1700g | 2000g | 1700g |
甘露醇 | 630g | 410g | 1320g | 680g |
5%PVP K30无水乙醇溶液 | 适量 | 适量 | 适量 | 适量 |
干物料总重约 | 5000g | 5000g | 10000g | 10000g |
共制成 | 1000袋 | 1000袋 | 1000袋 | 1000袋 |
Claims (10)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201410155591.XA CN103893131B (zh) | 2014-04-17 | 2014-04-17 | 一种含有非布司他的固体药物组合物 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201410155591.XA CN103893131B (zh) | 2014-04-17 | 2014-04-17 | 一种含有非布司他的固体药物组合物 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN103893131A true CN103893131A (zh) | 2014-07-02 |
CN103893131B CN103893131B (zh) | 2016-01-13 |
Family
ID=50984927
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN201410155591.XA Expired - Fee Related CN103893131B (zh) | 2014-04-17 | 2014-04-17 | 一种含有非布司他的固体药物组合物 |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN103893131B (zh) |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2017081609A1 (en) * | 2015-11-09 | 2017-05-18 | Morningside Ventures Limited | Methods and compositions for promoting adult neurogenesis |
CN111481620A (zh) * | 2020-04-22 | 2020-08-04 | 广东一力罗定制药有限公司 | 一种非布司他口服液及其制备工艺 |
Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102895209A (zh) * | 2011-12-15 | 2013-01-30 | 宁夏康亚药业有限公司 | 非布司他片剂 |
-
2014
- 2014-04-17 CN CN201410155591.XA patent/CN103893131B/zh not_active Expired - Fee Related
Patent Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102895209A (zh) * | 2011-12-15 | 2013-01-30 | 宁夏康亚药业有限公司 | 非布司他片剂 |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2017081609A1 (en) * | 2015-11-09 | 2017-05-18 | Morningside Ventures Limited | Methods and compositions for promoting adult neurogenesis |
CN109152768A (zh) * | 2015-11-09 | 2019-01-04 | 晨兴生命科技有限公司 | 用于促进成体神经发生的方法和组合物 |
US11607403B2 (en) | 2015-11-09 | 2023-03-21 | Morningside Ventures Limited | Methods and compositions for promoting adult neurogenesis |
CN111481620A (zh) * | 2020-04-22 | 2020-08-04 | 广东一力罗定制药有限公司 | 一种非布司他口服液及其制备工艺 |
Also Published As
Publication number | Publication date |
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CN103893131B (zh) | 2016-01-13 |
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