CN104840431A - 一种含有伏立康唑的药物组合物 - Google Patents
一种含有伏立康唑的药物组合物 Download PDFInfo
- Publication number
- CN104840431A CN104840431A CN201410049442.5A CN201410049442A CN104840431A CN 104840431 A CN104840431 A CN 104840431A CN 201410049442 A CN201410049442 A CN 201410049442A CN 104840431 A CN104840431 A CN 104840431A
- Authority
- CN
- China
- Prior art keywords
- voriconazole
- pharmaceutical composition
- solution
- glycine
- weight portion
- 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
- BCEHBSKCWLPMDN-MGPLVRAMSA-N voriconazole Chemical compound C1([C@H](C)[C@](O)(CN2N=CN=C2)C=2C(=CC(F)=CC=2)F)=NC=NC=C1F BCEHBSKCWLPMDN-MGPLVRAMSA-N 0.000 title claims abstract description 67
- 229960004740 voriconazole Drugs 0.000 title claims abstract description 65
- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 18
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims abstract description 23
- 239000000843 powder Substances 0.000 claims abstract description 21
- 239000000203 mixture Substances 0.000 claims abstract description 11
- 239000004471 Glycine Substances 0.000 claims abstract description 10
- 239000003937 drug carrier Substances 0.000 claims abstract description 5
- 238000003756 stirring Methods 0.000 claims description 33
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 26
- 238000000034 method Methods 0.000 claims description 17
- 229920002307 Dextran Polymers 0.000 claims description 15
- 238000004108 freeze drying Methods 0.000 claims description 13
- HXFCUMCLVYNZDM-UHFFFAOYSA-N 2-aminoacetic acid;sodium Chemical compound [Na].NCC(O)=O HXFCUMCLVYNZDM-UHFFFAOYSA-N 0.000 claims 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 claims description 8
- 229930195725 Mannitol Natural products 0.000 claims description 8
- 239000000594 mannitol Substances 0.000 claims description 8
- 235000010355 mannitol Nutrition 0.000 claims description 8
- 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 claims description 4
- 239000008101 lactose Substances 0.000 claims description 4
- 239000003125 aqueous solvent Substances 0.000 claims description 3
- 230000001954 sterilising effect Effects 0.000 claims description 3
- 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 claims 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 claims description 2
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims description 2
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims description 2
- 239000003795 chemical substances by application Substances 0.000 claims description 2
- 239000008103 glucose Substances 0.000 claims description 2
- FZWBNHMXJMCXLU-BLAUPYHCSA-N isomaltotriose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1OC[C@@H]1[C@@H](O)[C@H](O)[C@@H](O)[C@@H](OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C=O)O1 FZWBNHMXJMCXLU-BLAUPYHCSA-N 0.000 claims description 2
- 239000000600 sorbitol Substances 0.000 claims description 2
- 238000002347 injection Methods 0.000 abstract description 15
- 239000007924 injection Substances 0.000 abstract description 15
- 238000002360 preparation method Methods 0.000 abstract description 8
- 238000004519 manufacturing process Methods 0.000 abstract description 3
- 230000009286 beneficial effect Effects 0.000 abstract description 2
- 239000003814 drug Substances 0.000 abstract 1
- 235000013905 glycine and its sodium salt Nutrition 0.000 abstract 1
- 239000004247 glycine and its sodium salt Substances 0.000 abstract 1
- 238000009776 industrial production Methods 0.000 abstract 1
- 229940029258 sodium glycinate Drugs 0.000 abstract 1
- WUWHFEHKUQVYLF-UHFFFAOYSA-M sodium;2-aminoacetate Chemical compound [Na+].NCC([O-])=O WUWHFEHKUQVYLF-UHFFFAOYSA-M 0.000 abstract 1
- 238000003860 storage Methods 0.000 abstract 1
- 239000000243 solution Substances 0.000 description 37
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 23
- 229940090044 injection Drugs 0.000 description 14
- 239000000047 product Substances 0.000 description 12
- 238000012360 testing method Methods 0.000 description 11
- 239000008215 water for injection Substances 0.000 description 11
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 description 10
- 238000010521 absorption reaction Methods 0.000 description 10
- 229910052799 carbon Inorganic materials 0.000 description 10
- 238000004140 cleaning Methods 0.000 description 10
- 238000005261 decarburization Methods 0.000 description 10
- 238000001914 filtration Methods 0.000 description 10
- 239000012982 microporous membrane Substances 0.000 description 10
- 239000013558 reference substance Substances 0.000 description 10
- 239000002671 adjuvant Substances 0.000 description 8
- 229920000858 Cyclodextrin Polymers 0.000 description 7
- 238000004811 liquid chromatography Methods 0.000 description 6
- HFHDHCJBZVLPGP-UHFFFAOYSA-N schardinger α-dextrin Chemical compound O1C(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(O)C2O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC2C(O)C(O)C1OC2CO HFHDHCJBZVLPGP-UHFFFAOYSA-N 0.000 description 6
- WEVYAHXRMPXWCK-UHFFFAOYSA-N acetonitrile Substances CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 description 4
- 239000000470 constituent Substances 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- 239000012535 impurity Substances 0.000 description 4
- 229920000136 polysorbate Polymers 0.000 description 4
- 239000002904 solvent Substances 0.000 description 4
- BCEHBSKCWLPMDN-HWPZZCPQSA-N (2s,3r)-2-(2,4-difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1,2,4-triazol-1-yl)butan-2-ol Chemical compound C1([C@@H](C)[C@@](O)(CN2N=CN=C2)C=2C(=CC(F)=CC=2)F)=NC=NC=C1F BCEHBSKCWLPMDN-HWPZZCPQSA-N 0.000 description 3
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 3
- NINIDFKCEFEMDL-UHFFFAOYSA-N Sulfur Chemical compound [S] NINIDFKCEFEMDL-UHFFFAOYSA-N 0.000 description 3
- 239000005864 Sulphur Substances 0.000 description 3
- PBCJIPOGFJYBJE-UHFFFAOYSA-N acetonitrile;hydrate Chemical compound O.CC#N PBCJIPOGFJYBJE-UHFFFAOYSA-N 0.000 description 3
- 239000000654 additive Substances 0.000 description 3
- 230000000052 comparative effect Effects 0.000 description 3
- 239000003960 organic solvent Substances 0.000 description 3
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 2
- KWOLFJPFCHCOCG-UHFFFAOYSA-N Acetophenone Chemical compound CC(=O)C1=CC=CC=C1 KWOLFJPFCHCOCG-UHFFFAOYSA-N 0.000 description 2
- 230000000996 additive effect Effects 0.000 description 2
- 238000003556 assay Methods 0.000 description 2
- 239000006184 cosolvent Substances 0.000 description 2
- 238000010812 external standard method Methods 0.000 description 2
- 239000000945 filler Substances 0.000 description 2
- 238000004128 high performance liquid chromatography Methods 0.000 description 2
- 208000015181 infectious disease Diseases 0.000 description 2
- 230000014759 maintenance of location Effects 0.000 description 2
- 229920001983 poloxamer Polymers 0.000 description 2
- 231100000331 toxic Toxicity 0.000 description 2
- 230000002588 toxic effect Effects 0.000 description 2
- 229940082636 voriconazole injection Drugs 0.000 description 2
- XUKUURHRXDUEBC-SXOMAYOGSA-N (3s,5r)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-propan-2-ylpyrrol-1-yl]-3,5-dihydroxyheptanoic acid Chemical compound C=1C=CC=CC=1C1=C(C=2C=CC(F)=CC=2)N(CC[C@@H](O)C[C@H](O)CC(O)=O)C(C(C)C)=C1C(=O)NC1=CC=CC=C1 XUKUURHRXDUEBC-SXOMAYOGSA-N 0.000 description 1
- UHPMCKVQTMMPCG-UHFFFAOYSA-N 5,8-dihydroxy-2-methoxy-6-methyl-7-(2-oxopropyl)naphthalene-1,4-dione Chemical compound CC1=C(CC(C)=O)C(O)=C2C(=O)C(OC)=CC(=O)C2=C1O UHPMCKVQTMMPCG-UHFFFAOYSA-N 0.000 description 1
- USFZMSVCRYTOJT-UHFFFAOYSA-N Ammonium acetate Chemical compound N.CC(O)=O USFZMSVCRYTOJT-UHFFFAOYSA-N 0.000 description 1
- 239000005695 Ammonium acetate Substances 0.000 description 1
- 201000002909 Aspergillosis Diseases 0.000 description 1
- 208000036641 Aspergillus infections Diseases 0.000 description 1
- RZLDDWOTMYJCGX-UHFFFAOYSA-N CCC1=C(CF)C=NC2N1C2 Chemical compound CCC1=C(CF)C=NC2N1C2 RZLDDWOTMYJCGX-UHFFFAOYSA-N 0.000 description 1
- 241000223218 Fusarium Species 0.000 description 1
- 241000235645 Pichia kudriavzevii Species 0.000 description 1
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 description 1
- 241000132889 Scedosporium Species 0.000 description 1
- 229960000583 acetic acid Drugs 0.000 description 1
- 229940043376 ammonium acetate Drugs 0.000 description 1
- 235000019257 ammonium acetate Nutrition 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 229940121375 antifungal agent Drugs 0.000 description 1
- 239000003429 antifungal agent Substances 0.000 description 1
- 239000003963 antioxidant agent Substances 0.000 description 1
- 230000003078 antioxidant effect Effects 0.000 description 1
- 239000011324 bead Substances 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 239000000872 buffer Substances 0.000 description 1
- 230000002950 deficient Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 230000003203 everyday effect Effects 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 239000012467 final product Substances 0.000 description 1
- RFHAOTPXVQNOHP-UHFFFAOYSA-N fluconazole Chemical compound C1=NC=NN1CC(C=1C(=CC(F)=CC=1)F)(O)CN1C=NC=N1 RFHAOTPXVQNOHP-UHFFFAOYSA-N 0.000 description 1
- 229960004884 fluconazole Drugs 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 239000012362 glacial acetic acid Substances 0.000 description 1
- 238000005286 illumination Methods 0.000 description 1
- 238000012417 linear regression Methods 0.000 description 1
- 239000002398 materia medica Substances 0.000 description 1
- 230000000813 microbial effect Effects 0.000 description 1
- 239000011259 mixed solution Substances 0.000 description 1
- 229910000403 monosodium phosphate Inorganic materials 0.000 description 1
- 235000019799 monosodium phosphate Nutrition 0.000 description 1
- YTJSFYQNRXLOIC-UHFFFAOYSA-N octadecylsilane Chemical compound CCCCCCCCCCCCCCCCCC[SiH3] YTJSFYQNRXLOIC-UHFFFAOYSA-N 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 229960000502 poloxamer Drugs 0.000 description 1
- 230000000750 progressive effect Effects 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- 239000000741 silica gel Substances 0.000 description 1
- 229910002027 silica gel Inorganic materials 0.000 description 1
- 239000000377 silicon dioxide Substances 0.000 description 1
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 238000003786 synthesis reaction Methods 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- ODLHGICHYURWBS-LKONHMLTSA-N trappsol cyclo Chemical compound CC(O)COC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)COCC(O)C)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1COCC(C)O ODLHGICHYURWBS-LKONHMLTSA-N 0.000 description 1
- 150000003852 triazoles Chemical class 0.000 description 1
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- Medicinal Preparation (AREA)
Abstract
Description
Claims (7)
Priority Applications (1)
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CN201410049442.5A CN104840431B (zh) | 2014-02-13 | 2014-02-13 | 一种含有伏立康唑的药物组合物 |
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CN201410049442.5A CN104840431B (zh) | 2014-02-13 | 2014-02-13 | 一种含有伏立康唑的药物组合物 |
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CN104840431A true CN104840431A (zh) | 2015-08-19 |
CN104840431B CN104840431B (zh) | 2017-09-08 |
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Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1999018959A1 (en) * | 1997-10-14 | 1999-04-22 | Eisai Co., Ltd. | Pharmaceutical formulation comprising glycine as a stabilizer |
CN1788725A (zh) * | 2004-12-15 | 2006-06-21 | 北京博尔达生物技术开发有限公司 | 注射用伏立康唑冻干粉针剂及其制备方法 |
CN1813751A (zh) * | 2005-11-24 | 2006-08-09 | 南京都药医药科技有限公司 | 一种伏立康唑注射剂及其制备方法 |
EP2409699A1 (en) * | 2010-07-23 | 2012-01-25 | Combino Pharm, S.L. | Stable compositions of voriconazole |
CN102772409A (zh) * | 2012-08-20 | 2012-11-14 | 长春海悦药业有限公司 | 一种药物组合物 |
-
2014
- 2014-02-13 CN CN201410049442.5A patent/CN104840431B/zh active Active
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1999018959A1 (en) * | 1997-10-14 | 1999-04-22 | Eisai Co., Ltd. | Pharmaceutical formulation comprising glycine as a stabilizer |
CN1788725A (zh) * | 2004-12-15 | 2006-06-21 | 北京博尔达生物技术开发有限公司 | 注射用伏立康唑冻干粉针剂及其制备方法 |
CN1813751A (zh) * | 2005-11-24 | 2006-08-09 | 南京都药医药科技有限公司 | 一种伏立康唑注射剂及其制备方法 |
EP2409699A1 (en) * | 2010-07-23 | 2012-01-25 | Combino Pharm, S.L. | Stable compositions of voriconazole |
CN102772409A (zh) * | 2012-08-20 | 2012-11-14 | 长春海悦药业有限公司 | 一种药物组合物 |
Non-Patent Citations (2)
Title |
---|
张传军,鲁慧敏: "伏立康唑滴眼液的制备及质量控制", 《中国现代应用药学杂志》 * |
程民: "羟丙基β-环糊精对伏立康唑增溶作用的研究", 《安徽医药》 * |
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Address after: 130012, 672, pioneering street, hi tech Zone, Jilin, Changchun Applicant after: CHANGCHUN HAIYUE PHARMACEUTICAL Co.,Ltd. Address before: 130012, 672, pioneering street, hi tech Zone, Jilin, Changchun Applicant before: Changchun Haiyue Pharmaceutical Co.,Ltd. |
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Denomination of invention: A drug combination containing voriconazole Effective date of registration: 20231226 Granted publication date: 20170908 Pledgee: China Construction Bank Co.,Ltd. Changchun Science and Technology Sub branch Pledgor: CHANGCHUN HAIYUE PHARMACEUTICAL Co.,Ltd. Registration number: Y2023220000149 |