CN111671982A - Medicinal coating composition and preparation method thereof - Google Patents
Medicinal coating composition and preparation method thereof Download PDFInfo
- Publication number
- CN111671982A CN111671982A CN202010381154.5A CN202010381154A CN111671982A CN 111671982 A CN111671982 A CN 111671982A CN 202010381154 A CN202010381154 A CN 202010381154A CN 111671982 A CN111671982 A CN 111671982A
- Authority
- CN
- China
- Prior art keywords
- component
- solution
- coating composition
- solvent
- saccule
- 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.)
- Pending
Links
- 239000008199 coating composition Substances 0.000 title claims abstract description 16
- 238000002360 preparation method Methods 0.000 title description 8
- 239000003814 drug Substances 0.000 claims abstract description 58
- 239000000243 solution Substances 0.000 claims abstract description 36
- 229940079593 drug Drugs 0.000 claims abstract description 34
- 239000002904 solvent Substances 0.000 claims abstract description 34
- 238000000034 method Methods 0.000 claims abstract description 24
- 239000000203 mixture Substances 0.000 claims abstract description 20
- 238000002156 mixing Methods 0.000 claims abstract description 19
- 230000002792 vascular Effects 0.000 claims abstract description 13
- 238000000576 coating method Methods 0.000 claims abstract description 12
- 206010020718 hyperplasia Diseases 0.000 claims abstract description 12
- 239000011259 mixed solution Substances 0.000 claims abstract description 12
- 239000011248 coating agent Substances 0.000 claims abstract description 11
- 239000003124 biologic agent Substances 0.000 claims abstract description 9
- 239000000546 pharmaceutical excipient Substances 0.000 claims abstract description 8
- 239000004094 surface-active agent Substances 0.000 claims abstract description 8
- 239000000126 substance Substances 0.000 claims abstract description 7
- 238000007789 sealing Methods 0.000 claims abstract description 4
- 238000003756 stirring Methods 0.000 claims abstract description 4
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 39
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 claims description 27
- YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 claims description 27
- XEKOWRVHYACXOJ-UHFFFAOYSA-N Ethyl acetate Chemical compound CCOC(C)=O XEKOWRVHYACXOJ-UHFFFAOYSA-N 0.000 claims description 27
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 claims description 27
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims description 18
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 claims description 18
- WYURNTSHIVDZCO-UHFFFAOYSA-N Tetrahydrofuran Chemical compound C1CCOC1 WYURNTSHIVDZCO-UHFFFAOYSA-N 0.000 claims description 18
- 210000005077 saccule Anatomy 0.000 claims description 16
- 229930012538 Paclitaxel Natural products 0.000 claims description 14
- 229960001592 paclitaxel Drugs 0.000 claims description 14
- 239000008200 pharmaceutical coating composition Substances 0.000 claims description 14
- RCINICONZNJXQF-MZXODVADSA-N taxol Chemical compound O([C@@H]1[C@@]2(C[C@@H](C(C)=C(C2(C)C)[C@H](C([C@]2(C)[C@@H](O)C[C@H]3OC[C@]3([C@H]21)OC(C)=O)=O)OC(=O)C)OC(=O)[C@H](O)[C@@H](NC(=O)C=1C=CC=CC=1)C=1C=CC=CC=1)O)C(=O)C1=CC=CC=C1 RCINICONZNJXQF-MZXODVADSA-N 0.000 claims description 14
- HEDRZPFGACZZDS-UHFFFAOYSA-N Chloroform Chemical compound ClC(Cl)Cl HEDRZPFGACZZDS-UHFFFAOYSA-N 0.000 claims description 11
- 235000019441 ethanol Nutrition 0.000 claims description 10
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 10
- 229960000583 acetic acid Drugs 0.000 claims description 9
- 229960001701 chloroform Drugs 0.000 claims description 9
- 239000012362 glacial acetic acid Substances 0.000 claims description 9
- YLQBMQCUIZJEEH-UHFFFAOYSA-N tetrahydrofuran Natural products C=1C=COC=1 YLQBMQCUIZJEEH-UHFFFAOYSA-N 0.000 claims description 9
- 150000003904 phospholipids Chemical class 0.000 claims description 8
- 230000002093 peripheral effect Effects 0.000 claims description 7
- JVTAAEKCZFNVCJ-REOHCLBHSA-N L-lactic acid Chemical compound C[C@H](O)C(O)=O JVTAAEKCZFNVCJ-REOHCLBHSA-N 0.000 claims description 6
- 210000004351 coronary vessel Anatomy 0.000 claims description 6
- 239000003995 emulsifying agent Substances 0.000 claims description 6
- 238000007917 intracranial administration Methods 0.000 claims description 6
- 238000009210 therapy by ultrasound Methods 0.000 claims description 6
- 235000019359 magnesium stearate Nutrition 0.000 claims description 5
- 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 4
- 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 4
- 229930195725 Mannitol Natural products 0.000 claims description 4
- 229920001213 Polysorbate 20 Polymers 0.000 claims description 4
- 235000014113 dietary fatty acids Nutrition 0.000 claims description 4
- 239000000194 fatty acid Substances 0.000 claims description 4
- 229930195729 fatty acid Natural products 0.000 claims description 4
- 150000004665 fatty acids Chemical class 0.000 claims description 4
- 239000008103 glucose Substances 0.000 claims description 4
- 239000000594 mannitol Substances 0.000 claims description 4
- 235000010355 mannitol Nutrition 0.000 claims description 4
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims description 4
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims description 4
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims description 4
- 229920000053 polysorbate 80 Polymers 0.000 claims description 4
- 102000004169 proteins and genes Human genes 0.000 claims description 4
- 108090000623 proteins and genes Proteins 0.000 claims description 4
- ZAHRKKWIAAJSAO-UHFFFAOYSA-N rapamycin Natural products COCC(O)C(=C/C(C)C(=O)CC(OC(=O)C1CCCCN1C(=O)C(=O)C2(O)OC(CC(OC)C(=CC=CC=CC(C)CC(C)C(=O)C)C)CCC2C)C(C)CC3CCC(O)C(C3)OC)C ZAHRKKWIAAJSAO-UHFFFAOYSA-N 0.000 claims description 4
- QFJCIRLUMZQUOT-HPLJOQBZSA-N sirolimus Chemical compound C1C[C@@H](O)[C@H](OC)C[C@@H]1C[C@@H](C)[C@H]1OC(=O)[C@@H]2CCCCN2C(=O)C(=O)[C@](O)(O2)[C@H](C)CC[C@H]2C[C@H](OC)/C(C)=C/C=C/C=C/[C@@H](C)C[C@@H](C)C(=O)[C@H](OC)[C@H](O)/C(C)=C/[C@@H](C)C(=O)C1 QFJCIRLUMZQUOT-HPLJOQBZSA-N 0.000 claims description 4
- 229960002930 sirolimus Drugs 0.000 claims description 4
- 238000005507 spraying Methods 0.000 claims description 4
- XFRVVPUIAFSTFO-UHFFFAOYSA-N 1-Tridecanol Chemical compound CCCCCCCCCCCCCO XFRVVPUIAFSTFO-UHFFFAOYSA-N 0.000 claims description 3
- VOXZDWNPVJITMN-ZBRFXRBCSA-N 17β-estradiol Chemical compound OC1=CC=C2[C@H]3CC[C@](C)([C@H](CC4)O)[C@@H]4[C@@H]3CCC2=C1 VOXZDWNPVJITMN-ZBRFXRBCSA-N 0.000 claims description 3
- HKVAMNSJSFKALM-GKUWKFKPSA-N Everolimus Chemical compound C1C[C@@H](OCCO)[C@H](OC)C[C@@H]1C[C@@H](C)[C@H]1OC(=O)[C@@H]2CCCCN2C(=O)C(=O)[C@](O)(O2)[C@H](C)CC[C@H]2C[C@H](OC)/C(C)=C/C=C/C=C/[C@@H](C)C[C@@H](C)C(=O)[C@H](OC)[C@H](O)/C(C)=C/[C@@H](C)C(=O)C1 HKVAMNSJSFKALM-GKUWKFKPSA-N 0.000 claims description 3
- JZNWSCPGTDBMEW-UHFFFAOYSA-N Glycerophosphorylethanolamin Natural products NCCOP(O)(=O)OCC(O)CO JZNWSCPGTDBMEW-UHFFFAOYSA-N 0.000 claims description 3
- SQUHHTBVTRBESD-UHFFFAOYSA-N Hexa-Ac-myo-Inositol Natural products CC(=O)OC1C(OC(C)=O)C(OC(C)=O)C(OC(C)=O)C(OC(C)=O)C1OC(C)=O SQUHHTBVTRBESD-UHFFFAOYSA-N 0.000 claims description 3
- 102000004895 Lipoproteins Human genes 0.000 claims description 3
- 108090001030 Lipoproteins Proteins 0.000 claims description 3
- ZDZOTLJHXYCWBA-VCVYQWHSSA-N N-debenzoyl-N-(tert-butoxycarbonyl)-10-deacetyltaxol Chemical compound O([C@H]1[C@H]2[C@@](C([C@H](O)C3=C(C)[C@@H](OC(=O)[C@H](O)[C@@H](NC(=O)OC(C)(C)C)C=4C=CC=CC=4)C[C@]1(O)C3(C)C)=O)(C)[C@@H](O)C[C@H]1OC[C@]12OC(=O)C)C(=O)C1=CC=CC=C1 ZDZOTLJHXYCWBA-VCVYQWHSSA-N 0.000 claims description 3
- 229920001214 Polysorbate 60 Polymers 0.000 claims description 3
- ATBOMIWRCZXYSZ-XZBBILGWSA-N [1-[2,3-dihydroxypropoxy(hydroxy)phosphoryl]oxy-3-hexadecanoyloxypropan-2-yl] (9e,12e)-octadeca-9,12-dienoate Chemical compound CCCCCCCCCCCCCCCC(=O)OCC(COP(O)(=O)OCC(O)CO)OC(=O)CCCCCCC\C=C\C\C=C\CCCCC ATBOMIWRCZXYSZ-XZBBILGWSA-N 0.000 claims description 3
- AWUCVROLDVIAJX-UHFFFAOYSA-N alpha-glycerophosphate Natural products OCC(O)COP(O)(O)=O AWUCVROLDVIAJX-UHFFFAOYSA-N 0.000 claims description 3
- 239000012874 anionic emulsifier Substances 0.000 claims description 3
- 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 3
- 239000001506 calcium phosphate Substances 0.000 claims description 3
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 claims description 3
- 235000013539 calcium stearate Nutrition 0.000 claims description 3
- 239000008116 calcium stearate Substances 0.000 claims description 3
- CFKVDGBWWNMDKZ-UHFFFAOYSA-L calcium;pyridine-3-carboxylate Chemical compound [Ca+2].[O-]C(=O)C1=CC=CN=C1.[O-]C(=O)C1=CC=CN=C1 CFKVDGBWWNMDKZ-UHFFFAOYSA-L 0.000 claims description 3
- 150000001720 carbohydrates Chemical class 0.000 claims description 3
- 125000002091 cationic group Chemical group 0.000 claims description 3
- 229960003668 docetaxel Drugs 0.000 claims description 3
- LQZZUXJYWNFBMV-UHFFFAOYSA-N dodecan-1-ol Chemical compound CCCCCCCCCCCCO LQZZUXJYWNFBMV-UHFFFAOYSA-N 0.000 claims description 3
- 229960005309 estradiol Drugs 0.000 claims description 3
- 229930182833 estradiol Natural products 0.000 claims description 3
- 238000001704 evaporation Methods 0.000 claims description 3
- 229960005167 everolimus Drugs 0.000 claims description 3
- 235000021588 free fatty acids Nutrition 0.000 claims description 3
- 239000007943 implant Substances 0.000 claims description 3
- 238000002513 implantation Methods 0.000 claims description 3
- CDAISMWEOUEBRE-GPIVLXJGSA-N inositol Chemical compound O[C@H]1[C@H](O)[C@@H](O)[C@H](O)[C@H](O)[C@@H]1O CDAISMWEOUEBRE-GPIVLXJGSA-N 0.000 claims description 3
- 229960000367 inositol Drugs 0.000 claims description 3
- 150000002632 lipids Chemical class 0.000 claims description 3
- 150000005830 nonesterified fatty acids Chemical class 0.000 claims description 3
- 239000012875 nonionic emulsifier Substances 0.000 claims description 3
- WTJKGGKOPKCXLL-RRHRGVEJSA-N phosphatidylcholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCCCCCCC=CCCCCCCCC WTJKGGKOPKCXLL-RRHRGVEJSA-N 0.000 claims description 3
- 150000008104 phosphatidylethanolamines Chemical class 0.000 claims description 3
- CDAISMWEOUEBRE-UHFFFAOYSA-N scyllo-inosotol Natural products OC1C(O)C(O)C(O)C(O)C1O CDAISMWEOUEBRE-UHFFFAOYSA-N 0.000 claims description 3
- 150000003431 steroids Chemical class 0.000 claims description 3
- 229960004793 sucrose Drugs 0.000 claims description 3
- 239000006228 supernatant Substances 0.000 claims description 3
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 claims description 3
- 229940078499 tricalcium phosphate Drugs 0.000 claims description 3
- 229910000391 tricalcium phosphate Inorganic materials 0.000 claims description 3
- 235000019731 tricalcium phosphate Nutrition 0.000 claims description 3
- 239000011782 vitamin Substances 0.000 claims description 3
- 229940088594 vitamin Drugs 0.000 claims description 3
- 235000013343 vitamin Nutrition 0.000 claims description 3
- 229930003231 vitamin Natural products 0.000 claims description 3
- 150000003722 vitamin derivatives Chemical class 0.000 claims description 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 3
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound 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 claims description 2
- 238000007598 dipping method Methods 0.000 claims 1
- 210000004204 blood vessel Anatomy 0.000 abstract description 21
- 239000008280 blood Substances 0.000 abstract description 4
- 210000004369 blood Anatomy 0.000 abstract description 4
- 230000004663 cell proliferation Effects 0.000 description 3
- DGAIEPBNLOQYER-UHFFFAOYSA-N iopromide Chemical compound COCC(=O)NC1=C(I)C(C(=O)NCC(O)CO)=C(I)C(C(=O)N(C)CC(O)CO)=C1I DGAIEPBNLOQYER-UHFFFAOYSA-N 0.000 description 3
- 229960002603 iopromide Drugs 0.000 description 3
- 210000001519 tissue Anatomy 0.000 description 3
- XSQUKJJJFZCRTK-UHFFFAOYSA-N Urea Chemical compound NC(N)=O XSQUKJJJFZCRTK-UHFFFAOYSA-N 0.000 description 2
- 238000003618 dip coating Methods 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 230000008929 regeneration Effects 0.000 description 2
- 238000011069 regeneration method Methods 0.000 description 2
- 208000037803 restenosis Diseases 0.000 description 2
- 229940087291 tridecyl alcohol Drugs 0.000 description 2
- HOQWCELNTHTYAP-UHFFFAOYSA-N 4-[[4-(5-methyl-3-phenyl-1,2-oxazol-4-yl)pyrimidin-2-yl]amino]cyclohexan-1-ol Chemical compound CC=1ON=C(C=2C=CC=CC=2)C=1C(N=1)=CC=NC=1NC1CCC(O)CC1 HOQWCELNTHTYAP-UHFFFAOYSA-N 0.000 description 1
- 229920001800 Shellac Polymers 0.000 description 1
- 125000004063 butyryl group Chemical group O=C([*])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 description 1
- 239000004202 carbamide Substances 0.000 description 1
- 239000000470 constituent Substances 0.000 description 1
- 229940057975 ethyl citrate Drugs 0.000 description 1
- 235000001727 glucose Nutrition 0.000 description 1
- 125000002791 glucosyl group Chemical group C1([C@H](O)[C@@H](O)[C@H](O)[C@H](O1)CO)* 0.000 description 1
- 210000002837 heart atrium Anatomy 0.000 description 1
- 210000003701 histiocyte Anatomy 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- HEDOODBJFVUQMS-UHFFFAOYSA-N n-[2-(5-methoxy-1h-indol-3-yl)ethyl]-n-methylpropan-2-amine Chemical group COC1=CC=C2NC=C(CCN(C)C(C)C)C2=C1 HEDOODBJFVUQMS-UHFFFAOYSA-N 0.000 description 1
- 231100000915 pathological change Toxicity 0.000 description 1
- 230000036285 pathological change Effects 0.000 description 1
- KASDHRXLYQOAKZ-ZPSXYTITSA-N pimecrolimus Chemical compound C/C([C@H]1OC(=O)[C@@H]2CCCCN2C(=O)C(=O)[C@]2(O)O[C@@H]([C@H](C[C@H]2C)OC)[C@@H](OC)C[C@@H](C)C/C(C)=C/[C@H](C(C[C@H](O)[C@H]1C)=O)CC)=C\[C@@H]1CC[C@@H](Cl)[C@H](OC)C1 KASDHRXLYQOAKZ-ZPSXYTITSA-N 0.000 description 1
- 229960005330 pimecrolimus Drugs 0.000 description 1
- 239000004208 shellac Substances 0.000 description 1
- 229940113147 shellac Drugs 0.000 description 1
- ZLGIYFNHBLSMPS-ATJNOEHPSA-N shellac Chemical compound OCCCCCC(O)C(O)CCCCCCCC(O)=O.C1C23[C@H](C(O)=O)CCC2[C@](C)(CO)[C@@H]1C(C(O)=O)=C[C@@H]3O ZLGIYFNHBLSMPS-ATJNOEHPSA-N 0.000 description 1
- 235000013874 shellac Nutrition 0.000 description 1
- 210000000329 smooth muscle myocyte Anatomy 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- 210000004509 vascular smooth muscle cell Anatomy 0.000 description 1
- CGTADGCBEXYWNE-JUKNQOCSSA-N zotarolimus Chemical compound N1([C@H]2CC[C@@H](C[C@@H](C)[C@H]3OC(=O)[C@@H]4CCCCN4C(=O)C(=O)[C@@]4(O)[C@H](C)CC[C@H](O4)C[C@@H](/C(C)=C/C=C/C=C/[C@@H](C)C[C@@H](C)C(=O)[C@H](OC)[C@H](O)/C(C)=C/[C@@H](C)C(=O)C3)OC)C[C@H]2OC)C=NN=N1 CGTADGCBEXYWNE-JUKNQOCSSA-N 0.000 description 1
- 229950009819 zotarolimus Drugs 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/08—Materials for coatings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/08—Materials for coatings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
- A61L29/16—Biologically active materials, e.g. therapeutic substances
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/16—Biologically active materials, e.g. therapeutic substances
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/416—Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
- A61L2300/606—Coatings
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- Biomedical Technology (AREA)
- Medicinal Chemistry (AREA)
- Molecular Biology (AREA)
- Heart & Thoracic Surgery (AREA)
- Surgery (AREA)
- Vascular Medicine (AREA)
- Materials For Medical Uses (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses a drug coating composition, which comprises a component A: a biologic agent; and (B) component: medicines for treating vascular inner wall hyperplasia; and (3) component C: a surfactant; and (3) component D: an excipient; and (3) component E: a mixed solution of the component A and the component C; and (3) component F: a mixed solution of the component B and the component C; a component G: a mixed solution of the component E and the component F; a component H: different solvents for all the above components are prepared by the following steps: sequentially preparing the solution of the component E, the solution of the component F and the solution of the component G, then adding a solvent into the component G, fully mixing the components at the concentration of 0.1-10 mg/ml, then adding 1-10 mg of the fourth component substance, uniformly stirring, and sealing to obtain the medicinal coating composition for coating the surface of the implanted or interventional medical device. The invention can prevent the loss of the medicine in the process that the device enters the blood vessel, and can also be dissolved in the blood rapidly, so that the medicine composition is directly attached to the focus of the blood vessel.
Description
Technical Field
The embodiment of the invention relates to the technical field of drug coatings, in particular to a drug coating composition for an implanted or interventional medical device and a preparation method thereof.
Background
The medicine coating stent and the saccule are both essentially catheter non-delivery devices, cell proliferation is inhibited by carrying the medicine coating, and the effect of inhibiting smooth muscle cell proliferation is achieved by different methods and time for carrying the medicine, so that the restenosis of the blood vessel is prevented.
The coating composition of the peripheral main medicine balloon company mainly at home and abroad is as follows: the components of the Cotavance drug from Bayer-Medrd corporation are: paclitaxel + iopromide; the composition of the in.pact drug from Invatec-Medtronic corporation is: paclitaxel + urea; the composition of the sequent (tm) plexase drug from braun corporation is: paclitaxel + iopromide; the constituents of the Passeo-18 Lux drug from Biotronik corporation are: paclitaxel + butyryl tri-n-ethyl citrate; the components of the Elutax medicine of Aachen-Resonance company are as follows: pure paclitaxel; the ABT drugs from abbott vascular company have the following components: zotarolimus; the composition of the advanced 18PTX drug from COOKMedical corporation is: pure paclitaxel; the components of Moxy drugs from the company Lutonix are: paclitaxel + shellac; the Clearway medicine of the Atrium company comprises the following components: paclitaxel + fatty acid; the ingredients of the whole county company canoe drug are: paclitaxel + iopromide + ethanol; the AcoArt drugs from Proreda comprise the following components: paclitaxel + magnesium stearate.
The existing medicine coating composition is uniformly mixed by an ultrasonic spraying machine and then sprayed on the outer surface of a stent or a balloon; the existing drug balloon can lose a large amount of drugs in the process of entering blood vessels, and even more, the drug coating can fall off in a large scale in the process of entering the blood vessels. In addition, the balloon medicine coating acts on the pathological changes, and the medicine cannot be quickly absorbed by blood vessel histiocyte, so that the cell proliferation cannot be well inhibited, and a good treatment effect cannot be achieved.
Disclosure of Invention
Therefore, the embodiment of the invention provides a drug coating composition and a preparation method thereof, which aim to solve the problems in the prior art.
In order to achieve the above object, an embodiment of the present invention provides the following:
in a first aspect of embodiments of the present invention, there is provided a pharmaceutical coating composition comprising the following components:
and (2) component A: a biologic agent;
and (B) component: medicines for treating vascular inner wall hyperplasia;
and (3) component C: a surfactant;
and (3) component D: an excipient;
and (3) component E: a mixed solution of the component A and the component C;
and (3) component F: a mixed solution of the component B and the component C;
a component G: a mixed solution of the component E and the component F;
a component H: different solvents for all of the above components;
in a preferred embodiment of the present invention, the biological agent is at least one of phospholipid 80h, phospholipid 90h, lipid S75, lipoid E80, lipoid EPC, lipoid E75, phosphatidylcholine, phosphatidylglycerol and phosphatidylethanolamine.
In a preferred embodiment of the present invention, the drug for treating vascular inner wall hyperplasia is one of paclitaxel, docetaxel, rapamycin, everolimus, picrolimus or bayer rolimus. (same as above 2)
As a preferable embodiment of the present invention, the surfactant is at least one of lauryl alcohol ethoxylate, tridecyl alcohol ethoxylate, cationic emulsifier, anionic emulsifier, zwitterionic emulsifier, nonionic emulsifier, tween 20, tween 60 or tween 80.
In a preferred embodiment of the present invention, the excipient is at least one of steroid, vitamin, estradiol, esterified fatty acid, non-esterified fatty acid, inositol, L-lactic acid, lipoprotein, carbohydrate, tricalcium phosphate, precipitated calcium nicotinate, glucose, d-sucrose, mannitol, magnesium stearate, and calcium stearate.
As a preferred embodiment of the present invention, the solvent in which the component a is dissolved is at least one selected from the group consisting of absolute ethanol, methanol, ethanol, tetrahydrofuran, acetone, glacial acetic acid, dichloromethane, chloroform, ethyl acetate, and isopropanol;
the solvent for dissolving the component B is at least one selected from absolute ethyl alcohol, methanol, ethanol, tetrahydrofuran, acetone, glacial acetic acid, dichloromethane, trichloromethane, ethyl acetate and isopropanol;
the solvent for dissolving the component C is at least one selected from water, absolute ethyl alcohol, methanol, ethanol, tetrahydrofuran, acetone, glacial acetic acid, dichloromethane, trichloromethane, ethyl acetate and isopropanol.
As a preferred aspect of the present invention, the drug coating composition for implantation or interventional medical device comprises: coronary vessel stent, coronary vessel saccule, peripheral vessel stent, peripheral vessel saccule, intracranial vessel stent, intracranial vessel saccule, urethral stent, urethral saccule, esophageal stent and esophageal saccule.
In a second aspect of embodiments of the present invention, there is provided a method of preparing a pharmaceutical coating composition, comprising the steps of:
sequentially preparing the solution of the component E, the solution of the component F and the solution of the component G, then adding a solvent into the component G, fully mixing the components at the concentration of 0.1-10 mg/ml, then adding 1-10 mg of the fourth component substance, uniformly stirring, and sealing to obtain the medicinal coating composition for coating the surface of the implanted or interventional medical device.
As a preferable scheme of the invention, the configuration method of the component E comprises the following steps:
fully mixing the component A with a solvent to prepare the mixture with the concentration of 1 mg/ml-100 g/ml; fully mixing the component C with a solvent to prepare the mixture with the concentration of 0.01 mg/ml-0.1 mg/ml; and adding the component A solution into the component C solution, and performing low-temperature ultrasonic treatment for 10 to 120 minutes to form a component D solution, wherein the ultrasonic frequency is 1 to 50 Hz.
As a preferable aspect of the present invention, the method for preparing the component F comprises:
fully mixing the component B with a solvent to prepare the mixture with the concentration of 0.1 mg/ml-10 mg/ml; fully mixing the component C with a solvent to prepare the mixture with the concentration of 0.01 mg/ml-0.1 mg/ml; and adding the component B solution into the component C solution, and performing low-temperature ultrasonic treatment for 10 to 120 minutes to form a component D solution, wherein the ultrasonic frequency is 1 to 50 Hz.
As a preferable aspect of the present invention, the method for preparing the component G comprises:
and adding 2-20 ml of the component E solution into 100ml of the component F solution, performing ultrasonic full mixing, transferring into a separating funnel, adding the solvent, shaking, standing for a period of time, taking the supernatant, and evaporating to dryness to obtain a component G substance.
As a preferred embodiment of the present invention, the pharmaceutical coating composition has a coating density of 0.1ug/mm on the surface of the implant or interventional medical device by spray coating or dip coating2～10ug/mm2The net drug content is 0.2ug/mm2～6ug/mm2。
The embodiment of the invention has the following advantages:
the invention sticks or wraps the medicine for treating the blood vessel inner wall hyperplasia together by the biological preparation, can carry the medicine to rapidly enter the blood vessel tissue of a human body, and simultaneously, when the apparatus enters the blood vessel focus, the apparatus can prevent the medicine from losing in the process of entering the blood vessel and can be rapidly dissolved in the blood, so that the medicine composition is directly attached to the blood vessel focus.
Detailed Description
The present invention is described in terms of particular embodiments, other advantages and features of the invention will become apparent to those skilled in the art from the following disclosure, and it is to be understood that the described embodiments are merely exemplary of the invention and that it is not intended to limit the invention to the particular embodiments disclosed. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
Example 1:
the present invention provides in a first aspect of embodiments of the present invention, a pharmaceutical coating composition comprising the following components:
and (2) component A: a biologic agent;
and (B) component: medicines for treating vascular inner wall hyperplasia;
and (3) component C: a surfactant;
and (3) component D: an excipient;
and (3) component E: a mixed solution of the component A and the component C;
and (3) component F: a mixed solution of the component B and the component C;
a component G: a mixed solution of the component E and the component F;
a component H: different solvents for all of the above components;
wherein the biological agent is at least one of phospholipid 80h, phospholipid 90h, lipid S75, lipoid protein E80, lipoid protein EPC, lipoid protein E75, phosphatidylcholine, phosphatidylglycerol and phosphatidylethanolamine.
The biological agent is preferably phospholipid 80h, phospholipid 90h and lipoid protein E75, and can stick or wrap the medicines for treating vascular wall hyperplasia; and can carry medicine to enter human vascular tissue quickly.
The medicine for treating vascular inner wall hyperplasia is one of paclitaxel, docetaxel, rapamycin, everolimus, Rutacrolimus or Bayer Rilimus.
The medicine for treating the vascular inner wall hyperplasia is preferably paclitaxel and rapamycin, can inhibit the regeneration of vascular smooth muscle cells and reduce vascular restenosis; and can be better adhered or wrapped by biological agents.
The surfactant is at least one of lauryl alcohol ethoxylate, tridecanol ethoxylate, cationic emulsifier, anionic emulsifier, zwitterionic emulsifier, nonionic emulsifier, Tween 20, Tween 60 or Tween 80.
The surfactant is preferably Tween 20 or Tween 80; the biological preparation and the medicines for treating the vascular inner wall hyperplasia can be promoted to be dissolved in the solvent for dissolving the component A; less solvent is used for completely dissolving the biological preparation and the medicine for treating the regeneration of the inner wall of the blood vessel.
The excipient is at least one of steroid, vitamin, estradiol, esterified fatty acid, non-esterified fatty acid, inositol, L-lactic acid, lipoprotein, carbohydrate, tricalcium phosphate, precipitated calcium nicotinate, glucose, D-sucrose, mannitol, magnesium stearate, and calcium stearate.
The excipient is preferably glucose, mannitol, or magnesium stearate; can reduce the drug loss during the process of the device entering the blood vessel; the device can be used for preventing the drug loss in the process of entering the blood vessel when entering the blood vessel focus, and can be quickly dissolved in the blood, so that the drug composition can be directly attached to the blood vessel focus.
The solvent for dissolving the component A is at least one selected from absolute ethyl alcohol, methanol, ethanol, tetrahydrofuran, acetone, glacial acetic acid, dichloromethane, trichloromethane, ethyl acetate and isopropanol;
the solvent for dissolving the component B is at least one selected from absolute ethyl alcohol, methanol, ethanol, tetrahydrofuran, acetone, glacial acetic acid, dichloromethane, trichloromethane, ethyl acetate and isopropanol;
the solvent for dissolving the component C is at least one selected from water, absolute ethyl alcohol, methanol, ethanol, tetrahydrofuran, acetone, glacial acetic acid, dichloromethane, trichloromethane, ethyl acetate and isopropanol.
As a preferred aspect of the present invention, the drug coating composition for implantation or interventional medical device comprises: coronary vessel stent, coronary vessel saccule, peripheral vessel stent, peripheral vessel saccule, intracranial vessel stent, intracranial vessel saccule, urethral stent, urethral saccule, esophageal stent and esophageal saccule.
Example 2:
based on the components of the composition of example 1, a method for preparing a pharmaceutical coating composition is provided, comprising the steps of:
sequentially preparing the solution of the component E, the solution of the component F and the solution of the component G, then adding a solvent into the component G, fully mixing the components at the concentration of 0.1-10 mg/ml, then adding 1-10 mg of the fourth component substance, uniformly stirring, and sealing to obtain the medicinal coating composition for coating the surface of the implanted or interventional medical device.
8. The method for preparing the pharmaceutical coating composition according to claim 6, wherein the method for preparing the component E comprises the following steps:
fully mixing the component A with a solvent to prepare the mixture with the concentration of 1 mg/ml-100 g/ml; fully mixing the component C with a solvent to prepare the mixture with the concentration of 0.01 mg/ml-0.1 mg/ml; and adding the component A solution into the component C solution, and performing low-temperature ultrasonic treatment for 10 to 120 minutes to form a component D solution, wherein the ultrasonic frequency is 1 to 50 Hz.
As a preferable aspect of the present invention, the method for preparing the component F comprises:
fully mixing the component B with a solvent to prepare the mixture with the concentration of 0.1 mg/ml-10 mg/ml; fully mixing the component C with a solvent to prepare the mixture with the concentration of 0.01 mg/ml-0.1 mg/ml; and adding the component B solution into the component C solution, and performing low-temperature ultrasonic treatment for 10 to 120 minutes to form a component D solution, wherein the ultrasonic frequency is 1 to 50 Hz.
As a preferable aspect of the present invention, the method for preparing the component G comprises:
and adding 2-20 ml of the component E solution into 100ml of the component F solution, performing ultrasonic full mixing, transferring into a separating funnel, adding the solvent, shaking, standing for a period of time, taking the supernatant, and evaporating to dryness to obtain a component G substance.
As a preferred embodiment of the present invention, the pharmaceutical coating composition has a coating density of 0.1ug/mm on the surface of the implant or interventional medical device by spray coating or dip coating2～10ug/mm2The net drug content is 0.2ug/mm2～6ug/mm2。
The invention sticks or wraps the medicine for treating the blood vessel inner wall hyperplasia together by the biological preparation, can carry the medicine to rapidly enter the blood vessel tissue of a human body, and simultaneously, when the apparatus enters the blood vessel focus, the apparatus can prevent the medicine from losing in the process of entering the blood vessel and can be rapidly dissolved in the blood, so that the medicine composition is directly attached to the blood vessel focus.
Although the invention has been described in detail above with reference to a general description and specific examples, it will be apparent to one skilled in the art that modifications or improvements may be made thereto based on the invention. Accordingly, such modifications and improvements are intended to be within the scope of the invention as claimed.
Claims (12)
1. A pharmaceutical coating composition comprising the following components:
and (2) component A: a biologic agent;
and (B) component: medicines for treating vascular inner wall hyperplasia;
and (3) component C: a surfactant;
and (3) component D: an excipient;
and (3) component E: a mixed solution of the component A and the component C;
and (3) component F: a mixed solution of the component B and the component C;
a component G: a mixed solution of the component E and the component F;
a component H: different solvents for all the above components.
2. The pharmaceutical coating composition of claim 1,
the biological agent is at least one of phospholipid 80h, phospholipid 90h, lipid S75, lipoid protein E80, lipoid protein EPC, lipoid protein E75, phosphatidylcholine, phosphatidylglycerol and phosphatidylethanolamine.
3. The pharmaceutical coating composition of claim 1,
the medicine for treating vascular inner wall hyperplasia is one of paclitaxel, docetaxel, rapamycin, everolimus, Rutacrolimus or Bayer Rilimus.
4. The pharmaceutical coating composition of claim 1,
the surfactant is at least one of lauryl alcohol ethoxylate, tridecanol ethoxylate, cationic emulsifier, anionic emulsifier, zwitterionic emulsifier, nonionic emulsifier, Tween 20, Tween 60 or Tween 80.
5. The pharmaceutical coating composition of claim 1,
the excipient is at least one of steroid, vitamin, estradiol, esterified fatty acid, non-esterified fatty acid, inositol, L-lactic acid, lipoprotein, carbohydrate, tricalcium phosphate, precipitated calcium nicotinate, glucose, D-sucrose, mannitol, magnesium stearate and calcium stearate.
6. The pharmaceutical coating composition of claim 1, wherein the solvent in which component a is dissolved is at least one selected from the group consisting of absolute ethanol, methanol, ethanol, tetrahydrofuran, acetone, glacial acetic acid, dichloromethane, chloroform, ethyl acetate, and isopropanol;
the solvent for dissolving the component B is at least one selected from absolute ethyl alcohol, methanol, ethanol, tetrahydrofuran, acetone, glacial acetic acid, dichloromethane, trichloromethane, ethyl acetate and isopropanol;
the solvent for dissolving the component C is at least one selected from water, absolute ethyl alcohol, methanol, ethanol, tetrahydrofuran, acetone, glacial acetic acid, dichloromethane, trichloromethane, ethyl acetate and isopropanol.
7. The drug coating composition of claim 1, wherein the drug coating composition is for implantation or interventional medical devices comprising: coronary vessel stent, coronary vessel saccule, peripheral vessel stent, peripheral vessel saccule, intracranial vessel stent, intracranial vessel saccule, urethral stent, urethral saccule, esophageal stent and esophageal saccule.
8. A method for preparing a pharmaceutical coating composition, comprising the steps of:
sequentially preparing the solution of the component E, the solution of the component F and the solution of the component G, then adding a solvent into the component G, fully mixing the components at the concentration of 0.1-10 mg/ml, then adding 1-10 mg of the fourth component substance, uniformly stirring, and sealing to obtain the medicinal coating composition for coating the surface of the implanted or interventional medical device.
9. The method of claim 8, wherein the step of formulating component E comprises:
fully mixing the component A with a solvent to prepare the mixture with the concentration of 1 mg/ml-100 g/ml; fully mixing the component C with a solvent to prepare the mixture with the concentration of 0.01 mg/ml-0.1 mg/ml; and adding the component A solution into the component C solution, and performing low-temperature ultrasonic treatment for 10 to 120 minutes to form a component D solution, wherein the ultrasonic frequency is 1 to 50 Hz.
10. The method of claim 8, wherein the component F is formulated by a method comprising:
fully mixing the component B with a solvent to prepare the mixture with the concentration of 0.1 mg/ml-10 mg/ml; fully mixing the component C with a solvent to prepare the mixture with the concentration of 0.01 mg/ml-0.1 mg/ml; and adding the component B solution into the component C solution, and performing low-temperature ultrasonic treatment for 10 to 120 minutes to form a component D solution, wherein the ultrasonic frequency is 1 to 50 Hz.
11. The method of claim 8, wherein the component G is formulated by a method comprising:
and adding 2-20 ml of the component E solution into 100ml of the component F solution, performing ultrasonic full mixing, transferring into a separating funnel, adding the solvent, shaking, standing for a period of time, taking the supernatant, and evaporating to dryness to obtain a component G substance.
12. The method of claim 8, wherein the drug coating composition is applied by spraying or dipping to the surface of the implant or interventional medical device at a coating density of 0.1ug/mm2～10ug/mm2The net drug content is 0.2ug/mm2～6ug/mm2。
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