JPH11500737A - プロポフォールとエデテートとを含有する水中油滴エマルジョン - Google Patents
プロポフォールとエデテートとを含有する水中油滴エマルジョンInfo
- Publication number
- JPH11500737A JPH11500737A JP8528148A JP52814896A JPH11500737A JP H11500737 A JPH11500737 A JP H11500737A JP 8528148 A JP8528148 A JP 8528148A JP 52814896 A JP52814896 A JP 52814896A JP H11500737 A JPH11500737 A JP H11500737A
- Authority
- JP
- Japan
- Prior art keywords
- water
- sterile
- oil
- propofol
- edetate
- 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
- OLBCVFGFOZPWHH-UHFFFAOYSA-N propofol Chemical compound CC(C)C1=CC=CC(C(C)C)=C1O OLBCVFGFOZPWHH-UHFFFAOYSA-N 0.000 title claims abstract description 102
- 229960004134 propofol Drugs 0.000 title claims abstract description 87
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 title claims description 59
- 229940009662 edetate Drugs 0.000 title claims description 40
- 239000007764 o/w emulsion Substances 0.000 title claims description 40
- 239000008194 pharmaceutical composition Substances 0.000 claims abstract description 46
- 238000000034 method Methods 0.000 claims abstract description 40
- 206010002091 Anaesthesia Diseases 0.000 claims abstract description 11
- 230000037005 anaesthesia Effects 0.000 claims abstract description 11
- 239000000203 mixture Substances 0.000 claims description 143
- 239000003814 drug Substances 0.000 claims description 88
- 229940079593 drug Drugs 0.000 claims description 76
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 61
- 239000002904 solvent Substances 0.000 claims description 44
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 41
- 239000004094 surface-active agent Substances 0.000 claims description 40
- 238000009472 formulation Methods 0.000 claims description 38
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 36
- 238000007911 parenteral administration Methods 0.000 claims description 30
- 239000000839 emulsion Substances 0.000 claims description 24
- 244000005700 microbiome Species 0.000 claims description 22
- 238000011109 contamination Methods 0.000 claims description 21
- 239000003549 soybean oil Substances 0.000 claims description 15
- 235000012424 soybean oil Nutrition 0.000 claims description 15
- -1 fatty acid ester Chemical class 0.000 claims description 12
- 230000000813 microbial effect Effects 0.000 claims description 12
- 241001465754 Metazoa Species 0.000 claims description 10
- 235000015112 vegetable and seed oil Nutrition 0.000 claims description 10
- 239000008158 vegetable oil Substances 0.000 claims description 10
- 229940035674 anesthetics Drugs 0.000 claims description 9
- 239000008280 blood Substances 0.000 claims description 9
- 210000004369 blood Anatomy 0.000 claims description 9
- 239000003193 general anesthetic agent Substances 0.000 claims description 9
- 230000001332 colony forming effect Effects 0.000 claims description 8
- 230000000670 limiting effect Effects 0.000 claims description 8
- 239000004615 ingredient Substances 0.000 claims description 7
- 229940124597 therapeutic agent Drugs 0.000 claims description 7
- 235000010469 Glycine max Nutrition 0.000 claims description 6
- 239000011782 vitamin Substances 0.000 claims description 6
- 229940088594 vitamin Drugs 0.000 claims description 6
- 229930003231 vitamin Natural products 0.000 claims description 6
- 235000013343 vitamin Nutrition 0.000 claims description 6
- 230000000844 anti-bacterial effect Effects 0.000 claims description 5
- 229940088710 antibiotic agent Drugs 0.000 claims description 5
- 239000002111 antiemetic agent Substances 0.000 claims description 5
- 229940121375 antifungal agent Drugs 0.000 claims description 5
- 239000002246 antineoplastic agent Substances 0.000 claims description 5
- 229940041181 antineoplastic drug Drugs 0.000 claims description 5
- 210000003169 central nervous system Anatomy 0.000 claims description 5
- 150000003431 steroids Chemical class 0.000 claims description 5
- 229940126585 therapeutic drug Drugs 0.000 claims description 5
- 150000003722 vitamin derivatives Chemical class 0.000 claims description 5
- 230000003474 anti-emetic effect Effects 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
- 238000004519 manufacturing process Methods 0.000 claims description 4
- 239000000725 suspension Substances 0.000 claims description 4
- 230000001225 therapeutic effect Effects 0.000 claims description 4
- 241000222122 Candida albicans Species 0.000 claims description 2
- 239000012190 activator Substances 0.000 claims description 2
- 229940095731 candida albicans Drugs 0.000 claims description 2
- 235000013305 food Nutrition 0.000 claims description 2
- 230000002538 fungal effect Effects 0.000 claims description 2
- 238000010186 staining Methods 0.000 claims description 2
- 239000008223 sterile water Substances 0.000 claims description 2
- 241000588722 Escherichia Species 0.000 claims 1
- 241000589516 Pseudomonas Species 0.000 claims 1
- 206010039897 Sedation Diseases 0.000 abstract description 12
- 230000003444 anaesthetic effect Effects 0.000 abstract description 12
- 230000036280 sedation Effects 0.000 abstract description 12
- 238000002695 general anesthesia Methods 0.000 abstract description 8
- 230000001939 inductive effect Effects 0.000 abstract description 3
- 239000003755 preservative agent Substances 0.000 description 15
- 229940072271 diprivan Drugs 0.000 description 12
- 238000012360 testing method Methods 0.000 description 12
- 239000003795 chemical substances by application Substances 0.000 description 9
- 239000000468 intravenous fat emulsion Substances 0.000 description 7
- 239000008389 polyethoxylated castor oil Substances 0.000 description 7
- 239000000126 substance Substances 0.000 description 7
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 6
- 239000003921 oil Substances 0.000 description 6
- 235000019198 oils Nutrition 0.000 description 6
- 239000000654 additive Substances 0.000 description 5
- 239000008346 aqueous phase Substances 0.000 description 5
- 230000002335 preservative effect Effects 0.000 description 5
- OVBJJZOQPCKUOR-UHFFFAOYSA-L EDTA disodium salt dihydrate Chemical compound O.O.[Na+].[Na+].[O-]C(=O)C[NH+](CC([O-])=O)CC[NH+](CC([O-])=O)CC([O-])=O OVBJJZOQPCKUOR-UHFFFAOYSA-L 0.000 description 4
- 229920002685 Polyoxyl 35CastorOil Polymers 0.000 description 4
- 230000000845 anti-microbial effect Effects 0.000 description 4
- 239000007864 aqueous solution Substances 0.000 description 4
- 239000003085 diluting agent Substances 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- 238000001990 intravenous administration Methods 0.000 description 4
- QUANRIQJNFHVEU-UHFFFAOYSA-N oxirane;propane-1,2,3-triol Chemical compound C1CO1.OCC(O)CO QUANRIQJNFHVEU-UHFFFAOYSA-N 0.000 description 4
- 238000011160 research Methods 0.000 description 4
- GEHJYWRUCIMESM-UHFFFAOYSA-L sodium sulfite Chemical compound [Na+].[Na+].[O-]S([O-])=O GEHJYWRUCIMESM-UHFFFAOYSA-L 0.000 description 4
- 208000028399 Critical Illness Diseases 0.000 description 3
- 241000282412 Homo Species 0.000 description 3
- 241000191967 Staphylococcus aureus Species 0.000 description 3
- 239000004599 antimicrobial Substances 0.000 description 3
- 230000008901 benefit Effects 0.000 description 3
- 239000004359 castor oil Substances 0.000 description 3
- 235000019438 castor oil Nutrition 0.000 description 3
- 230000008859 change Effects 0.000 description 3
- 238000006243 chemical reaction Methods 0.000 description 3
- 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 3
- 238000001802 infusion Methods 0.000 description 3
- 238000012423 maintenance Methods 0.000 description 3
- 230000002906 microbiologic effect Effects 0.000 description 3
- 229910052757 nitrogen Inorganic materials 0.000 description 3
- 239000012071 phase Substances 0.000 description 3
- HRZFUMHJMZEROT-UHFFFAOYSA-L sodium disulfite Chemical compound [Na+].[Na+].[O-]S(=O)S([O-])(=O)=O HRZFUMHJMZEROT-UHFFFAOYSA-L 0.000 description 3
- 229940001584 sodium metabisulfite Drugs 0.000 description 3
- 235000010262 sodium metabisulphite Nutrition 0.000 description 3
- CFKMVGJGLGKFKI-UHFFFAOYSA-N 4-chloro-m-cresol Chemical compound CC1=CC(O)=CC=C1Cl CFKMVGJGLGKFKI-UHFFFAOYSA-N 0.000 description 2
- 206010002198 Anaphylactic reaction Diseases 0.000 description 2
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 description 2
- 241000588724 Escherichia coli Species 0.000 description 2
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N Phenol Chemical compound OC1=CC=CC=C1 ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 description 2
- 241000589517 Pseudomonas aeruginosa Species 0.000 description 2
- 208000003455 anaphylaxis Diseases 0.000 description 2
- 239000003963 antioxidant agent Substances 0.000 description 2
- 235000006708 antioxidants Nutrition 0.000 description 2
- UEAVLBXLOZNDHT-UHFFFAOYSA-K calcium;sodium;2-[2-[bis(carboxylatomethyl)amino]ethyl-(carboxymethyl)amino]acetate Chemical compound [Na+].[Ca+2].OC(=O)CN(CC([O-])=O)CCN(CC([O-])=O)CC([O-])=O UEAVLBXLOZNDHT-UHFFFAOYSA-K 0.000 description 2
- OSASVXMJTNOKOY-UHFFFAOYSA-N chlorobutanol Chemical compound CC(C)(O)C(Cl)(Cl)Cl OSASVXMJTNOKOY-UHFFFAOYSA-N 0.000 description 2
- 230000000052 comparative effect Effects 0.000 description 2
- 238000011161 development Methods 0.000 description 2
- 150000002148 esters Chemical group 0.000 description 2
- 235000019197 fats Nutrition 0.000 description 2
- 230000006698 induction Effects 0.000 description 2
- 238000002347 injection Methods 0.000 description 2
- 239000007924 injection Substances 0.000 description 2
- 229940028435 intralipid Drugs 0.000 description 2
- 239000013618 particulate matter Substances 0.000 description 2
- 238000002360 preparation method Methods 0.000 description 2
- 150000003839 salts Chemical class 0.000 description 2
- 239000003352 sequestering agent Substances 0.000 description 2
- 229940037001 sodium edetate Drugs 0.000 description 2
- 235000010265 sodium sulphite Nutrition 0.000 description 2
- 239000007787 solid Substances 0.000 description 2
- 239000003381 stabilizer Substances 0.000 description 2
- 230000004083 survival effect Effects 0.000 description 2
- 239000008181 tonicity modifier Substances 0.000 description 2
- 239000008215 water for injection Substances 0.000 description 2
- JCIIKRHCWVHVFF-UHFFFAOYSA-N 1,2,4-thiadiazol-5-amine;hydrochloride Chemical compound Cl.NC1=NC=NS1 JCIIKRHCWVHVFF-UHFFFAOYSA-N 0.000 description 1
- DUHUCHOQIDJXAT-OLVMNOGESA-N 3-hydroxy-(3-α,5-α)-Pregnane-11,20-dione Chemical compound C([C@@H]1CC2)[C@H](O)CC[C@]1(C)[C@@H]1[C@@H]2[C@@H]2CC[C@H](C(=O)C)[C@@]2(C)CC1=O DUHUCHOQIDJXAT-OLVMNOGESA-N 0.000 description 1
- HIQIXEFWDLTDED-UHFFFAOYSA-N 4-hydroxy-1-piperidin-4-ylpyrrolidin-2-one Chemical compound O=C1CC(O)CN1C1CCNCC1 HIQIXEFWDLTDED-UHFFFAOYSA-N 0.000 description 1
- FJKROLUGYXJWQN-UHFFFAOYSA-N 4-hydroxybenzoic acid Chemical class OC(=O)C1=CC=C(O)C=C1 FJKROLUGYXJWQN-UHFFFAOYSA-N 0.000 description 1
- 241000251468 Actinopterygii Species 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
- NLZUEZXRPGMBCV-UHFFFAOYSA-N Butylhydroxytoluene Chemical class CC1=CC(C(C)(C)C)=C(O)C(C(C)(C)C)=C1 NLZUEZXRPGMBCV-UHFFFAOYSA-N 0.000 description 1
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
- 241000222120 Candida <Saccharomycetales> Species 0.000 description 1
- 206010011409 Cross infection Diseases 0.000 description 1
- QXNVGIXVLWOKEQ-UHFFFAOYSA-N Disodium Chemical class [Na][Na] QXNVGIXVLWOKEQ-UHFFFAOYSA-N 0.000 description 1
- QZKRHPLGUJDVAR-UHFFFAOYSA-K EDTA trisodium salt Chemical compound [Na+].[Na+].[Na+].OC(=O)CN(CC([O-])=O)CCN(CC([O-])=O)CC([O-])=O QZKRHPLGUJDVAR-UHFFFAOYSA-K 0.000 description 1
- LVGKNOAMLMIIKO-UHFFFAOYSA-N Elaidinsaeure-aethylester Natural products CCCCCCCCC=CCCCCCCCC(=O)OCC LVGKNOAMLMIIKO-UHFFFAOYSA-N 0.000 description 1
- 241000191070 Escherichia coli ATCC 8739 Species 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
- 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 1
- 241000699670 Mus sp. Species 0.000 description 1
- 235000019483 Peanut oil Nutrition 0.000 description 1
- 229920003171 Poly (ethylene oxide) Polymers 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
- 229920002675 Polyoxyl Polymers 0.000 description 1
- WINXNKPZLFISPD-UHFFFAOYSA-M Saccharin sodium Chemical compound [Na+].C1=CC=C2C(=O)[N-]S(=O)(=O)C2=C1 WINXNKPZLFISPD-UHFFFAOYSA-M 0.000 description 1
- 235000019485 Safflower oil Nutrition 0.000 description 1
- 235000019486 Sunflower oil Nutrition 0.000 description 1
- 206010047700 Vomiting Diseases 0.000 description 1
- RXDLGFMMQFNVLI-UHFFFAOYSA-N [Na].[Na].[Ca] Chemical compound [Na].[Na].[Ca] RXDLGFMMQFNVLI-UHFFFAOYSA-N 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 239000013543 active substance Substances 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 229960003305 alfaxalone Drugs 0.000 description 1
- 239000003513 alkali Substances 0.000 description 1
- 230000036592 analgesia Effects 0.000 description 1
- 229940125683 antiemetic agent Drugs 0.000 description 1
- 239000002518 antifoaming agent Substances 0.000 description 1
- 239000003125 aqueous solvent Substances 0.000 description 1
- 235000010323 ascorbic acid Nutrition 0.000 description 1
- 229960005070 ascorbic acid Drugs 0.000 description 1
- 239000011668 ascorbic acid Substances 0.000 description 1
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 1
- 208000010668 atopic eczema Diseases 0.000 description 1
- 229940125717 barbiturate Drugs 0.000 description 1
- HNYOPLTXPVRDBG-UHFFFAOYSA-N barbituric acid Chemical compound O=C1CC(=O)NC(=O)N1 HNYOPLTXPVRDBG-UHFFFAOYSA-N 0.000 description 1
- 230000004888 barrier function Effects 0.000 description 1
- 229920001400 block copolymer Polymers 0.000 description 1
- 230000008499 blood brain barrier function Effects 0.000 description 1
- 210000001218 blood-brain barrier Anatomy 0.000 description 1
- 210000004556 brain Anatomy 0.000 description 1
- 235000010633 broth Nutrition 0.000 description 1
- 239000000872 buffer Substances 0.000 description 1
- 239000011575 calcium Substances 0.000 description 1
- 229910052791 calcium Inorganic materials 0.000 description 1
- 229960004926 chlorobutanol Drugs 0.000 description 1
- 229960002242 chlorocresol Drugs 0.000 description 1
- 238000004587 chromatography analysis Methods 0.000 description 1
- 239000003240 coconut oil Substances 0.000 description 1
- 235000019864 coconut oil Nutrition 0.000 description 1
- 235000012716 cod liver oil Nutrition 0.000 description 1
- 239000003026 cod liver oil Substances 0.000 description 1
- 235000005687 corn oil Nutrition 0.000 description 1
- 239000002285 corn oil Substances 0.000 description 1
- 238000012937 correction Methods 0.000 description 1
- 235000012343 cottonseed oil Nutrition 0.000 description 1
- 239000002385 cottonseed oil Substances 0.000 description 1
- 238000002405 diagnostic procedure Methods 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- AAOVKJBEBIDNHE-UHFFFAOYSA-N diazepam Chemical compound N=1CC(=O)N(C)C2=CC=C(Cl)C=C2C=1C1=CC=CC=C1 AAOVKJBEBIDNHE-UHFFFAOYSA-N 0.000 description 1
- 229960003529 diazepam Drugs 0.000 description 1
- 238000010790 dilution Methods 0.000 description 1
- 239000012895 dilution Substances 0.000 description 1
- 229940008099 dimethicone Drugs 0.000 description 1
- 239000004205 dimethyl polysiloxane Substances 0.000 description 1
- 235000013870 dimethyl polysiloxane Nutrition 0.000 description 1
- AMTWCFIAVKBGOD-UHFFFAOYSA-N dioxosilane;methoxy-dimethyl-trimethylsilyloxysilane Chemical compound O=[Si]=O.CO[Si](C)(C)O[Si](C)(C)C AMTWCFIAVKBGOD-UHFFFAOYSA-N 0.000 description 1
- 238000002845 discoloration Methods 0.000 description 1
- 229960001484 edetic acid Drugs 0.000 description 1
- 238000004945 emulsification Methods 0.000 description 1
- 230000001804 emulsifying effect Effects 0.000 description 1
- 150000002170 ethers Chemical class 0.000 description 1
- LVGKNOAMLMIIKO-QXMHVHEDSA-N ethyl oleate Chemical compound CCCCCCCC\C=C/CCCCCCCC(=O)OCC LVGKNOAMLMIIKO-QXMHVHEDSA-N 0.000 description 1
- 229940093471 ethyl oleate Drugs 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 238000005194 fractionation Methods 0.000 description 1
- 239000012458 free base Substances 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 230000000147 hypnotic effect Effects 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 238000010348 incorporation Methods 0.000 description 1
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- 238000011835 investigation Methods 0.000 description 1
- 150000002500 ions Chemical class 0.000 description 1
- XUGNVMKQXJXZCD-UHFFFAOYSA-N isopropyl palmitate Chemical compound CCCCCCCCCCCCCCCC(=O)OC(C)C XUGNVMKQXJXZCD-UHFFFAOYSA-N 0.000 description 1
- 239000008101 lactose Substances 0.000 description 1
- 150000002632 lipids Chemical class 0.000 description 1
- 150000002634 lipophilic molecules Chemical class 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 150000004668 long chain fatty acids Chemical class 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 150000004667 medium chain fatty acids Chemical class 0.000 description 1
- 125000002496 methyl group Chemical group [H]C([H])([H])* 0.000 description 1
- 230000007935 neutral effect Effects 0.000 description 1
- 239000002736 nonionic surfactant Substances 0.000 description 1
- 235000016709 nutrition Nutrition 0.000 description 1
- 230000035764 nutrition Effects 0.000 description 1
- 239000004006 olive oil Substances 0.000 description 1
- 235000008390 olive oil Nutrition 0.000 description 1
- 239000001301 oxygen Substances 0.000 description 1
- 229910052760 oxygen Inorganic materials 0.000 description 1
- 235000016236 parenteral nutrition Nutrition 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 239000000312 peanut oil Substances 0.000 description 1
- 229960003742 phenol Drugs 0.000 description 1
- WVDDGKGOMKODPV-ZQBYOMGUSA-N phenyl(114C)methanol Chemical compound O[14CH2]C1=CC=CC=C1 WVDDGKGOMKODPV-ZQBYOMGUSA-N 0.000 description 1
- 229940096826 phenylmercuric acetate Drugs 0.000 description 1
- PDTFCHSETJBPTR-UHFFFAOYSA-N phenylmercuric nitrate Chemical compound [O-][N+](=O)O[Hg]C1=CC=CC=C1 PDTFCHSETJBPTR-UHFFFAOYSA-N 0.000 description 1
- 229920000435 poly(dimethylsiloxane) Polymers 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
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- 230000008569 process Effects 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 229960004948 propanidid Drugs 0.000 description 1
- KEJXLQUPYHWCNM-UHFFFAOYSA-N propanidid Chemical compound CCCOC(=O)CC1=CC=C(OCC(=O)N(CC)CC)C(OC)=C1 KEJXLQUPYHWCNM-UHFFFAOYSA-N 0.000 description 1
- 125000001436 propyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])[H] 0.000 description 1
- 235000010232 propyl p-hydroxybenzoate Nutrition 0.000 description 1
- 239000004405 propyl p-hydroxybenzoate Substances 0.000 description 1
- QELSKZZBTMNZEB-UHFFFAOYSA-N propylparaben Chemical compound CCCOC(=O)C1=CC=C(O)C=C1 QELSKZZBTMNZEB-UHFFFAOYSA-N 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 230000002829 reductive effect Effects 0.000 description 1
- 238000012827 research and development Methods 0.000 description 1
- 230000004044 response Effects 0.000 description 1
- 235000005713 safflower oil Nutrition 0.000 description 1
- 239000003813 safflower oil Substances 0.000 description 1
- YGSDEFSMJLZEOE-UHFFFAOYSA-M salicylate Chemical compound OC1=CC=CC=C1C([O-])=O YGSDEFSMJLZEOE-UHFFFAOYSA-M 0.000 description 1
- 230000001624 sedative effect Effects 0.000 description 1
- 229940083037 simethicone Drugs 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 159000000000 sodium salts Chemical class 0.000 description 1
- PESXGULMKCKJCC-UHFFFAOYSA-M sodium;4-methoxycarbonylphenolate Chemical compound [Na+].COC(=O)C1=CC=C([O-])C=C1 PESXGULMKCKJCC-UHFFFAOYSA-M 0.000 description 1
- IXMINYBUNCWGER-UHFFFAOYSA-M sodium;4-propoxycarbonylphenolate Chemical compound [Na+].CCCOC(=O)C1=CC=C([O-])C=C1 IXMINYBUNCWGER-UHFFFAOYSA-M 0.000 description 1
- 239000008247 solid mixture Substances 0.000 description 1
- 230000003381 solubilizing effect Effects 0.000 description 1
- 230000000087 stabilizing effect Effects 0.000 description 1
- 230000003068 static effect Effects 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 239000002600 sunflower oil Substances 0.000 description 1
- 230000009469 supplementation Effects 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- UEUXEKPTXMALOB-UHFFFAOYSA-J tetrasodium;2-[2-[bis(carboxylatomethyl)amino]ethyl-(carboxylatomethyl)amino]acetate Chemical compound [Na+].[Na+].[Na+].[Na+].[O-]C(=O)CN(CC([O-])=O)CCN(CC([O-])=O)CC([O-])=O UEUXEKPTXMALOB-UHFFFAOYSA-J 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
- 235000013619 trace mineral Nutrition 0.000 description 1
- 239000011573 trace mineral Substances 0.000 description 1
- UFTFJSFQGQCHQW-UHFFFAOYSA-N triformin Chemical compound O=COCC(OC=O)COC=O UFTFJSFQGQCHQW-UHFFFAOYSA-N 0.000 description 1
- 229960005066 trisodium edetate Drugs 0.000 description 1
- 210000003462 vein Anatomy 0.000 description 1
- 230000035899 viability Effects 0.000 description 1
- 239000002699 waste material Substances 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
- A61K31/05—Phenols
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
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- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
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- A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
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Abstract
Description
Claims (1)
- 【特許請求の範囲】 1.水不混和性溶媒中に溶解したプロポフォールを水によって乳化し、界面 活性剤を用いて安定化した水中油滴エマルジョンを含み、偶発的な外部からの汚 染後に少なくとも24時間微生物の有意な増殖を防止するために充分な量のエデ テートをさらに含む非経口投与用の無菌薬剤組成物。 2.エデテート量が、103コロニー形成単位までによる汚染後の少なくと も24時間、(20〜25℃の範囲内の温度において)臨床関連微生物の増殖を 10倍以下の増加に抑制するために充分である、請求項1記載の無菌薬剤組成物 。 3.臨床関連微生物がStaphylococcus aureus、Es cherchia coli 、Candida albicans、及びPse udomonas aeruinosa の菌株から選択される、請求項2記載の 無菌薬剤組成物。 4.水不混和性溶媒中に溶解したプロポフォールを水によって乳化し、界面 活性剤によって安定化した水中油滴エマルジョンを含む請求項1記載の無菌薬剤 組成物であって、Staphlococcus aureus ATCC653 8、Escherchia coliATCC8739、Pseudomona s aeruginosa ATCC9027及びCandida albic ans ATCC10231の各々の洗浄した懸濁液を前記組成物の別々のアリ コートに約50コロニー形成単位/mlで、20〜25℃の範囲内の温度におい て加え、前記アリコートを20〜25℃においてインキュベートし、24時間後 の生残数に関して検査する試験によって測定して、前記微生物の各々の増殖を1 0倍以下の増加に抑制するために充分な量のエデテートをさらに含む無菌薬剤組 成物。 5.エデテートがエデト酸二ナトリウムである、請求項1〜4のいずれかに 記載の無菌薬剤組成物。 6.30重量%までの水不混和性溶媒を含む、請求項1〜5のいずれかに記 載の無菌薬剤組成物。 7.10重量%から20重量%までの水不混和性溶媒を含む、請求項6記載 の無菌薬剤組成物。 8.水不混和性溶媒が植物油又は脂肪酸エステルである、請求項1〜7のい ずれかに記載の無菌薬剤組成物。 9.植物油が大豆油である、請求項8記載の無菌薬剤組成物。 10.界面活性剤が天然生成ホスファチドである、請求項1〜9のいずれか に記載の無菌薬剤組成物。 11.ホスファチドが卵ホスファチド又は大豆ホスファチドである、請求項 10記載の無菌薬剤組成物。 12.pHが6.0〜8.5である、請求項1〜11のいずれかに記載の無 菌薬剤組成物。 13.水酸化ナトリウムが存在する、請求項12記載の無菌薬剤組成物。 14.血液と等張性である、請求項1〜13のいずれかに記載の無菌薬剤組 成物。 15.グリセロールを配合することによって血液と等張性にされる、請求項 14記載の無菌薬剤組成物。 16.1重量%から2重量%までのプロポフォールを含む、請求項1〜15 のいずれかに記載の無菌薬剤組成物。 17.約1重量%のプロポフォールを含有する、請求項16記載の無菌薬剤 組成物。 18.約2重量%のプロポフォールを含有する、請求項16記載の無菌薬剤 組成物。 19.水不混和性溶媒中に溶解したプロポフォールを水によって乳化し、界 面活性剤によって安定化した水中油滴エマルジョンを含み、3x10-5〜9x1 0-4の範囲内のモル濃度であるエデテート量をさらに含む、非経口投与用の無菌 薬剤組成物。 20.エデテート量が3x10-5〜7.5x10-4の範囲内のモル濃度であ る、請求項19記載の無菌薬剤組成物。 21.エデテート量が1.5x10-4〜3.0x10-4の範囲内のモル濃度 である、請求項20記載の無菌薬剤組成物。 22.エデテート量が約1.5x10-4のモル濃度である、請求項21記載 の無菌薬剤組成物。 23.エデテートの供給源がエデト酸二ナトリウムである、請求項19〜2 2のいずれかに記載の無菌薬剤組成物。 24.30重量%までの水不混和性溶媒を含む、請求項19〜23のいずれ かに記載の無菌薬剤組成物。 25.10重量%から20重量%までの水不混和性溶媒を含む、請求項24 記載の無菌薬剤組成物。 26.水不混和性溶媒が植物油又は脂肪酸エステルである、請求項19〜2 5のいずれかに記載の無菌薬剤組成物。 27.植物油が大豆油である、請求項26記載の無菌薬剤組成物。 28.界面活性剤が天然生成ホスファチドである、請求項19〜27のいず れかに記載の無菌薬剤組成物。 29.ホスファチドが卵ホスファチド又は大豆ホスファチドである、請求項 28記載の無菌薬剤組成物。 30.pHが6.0〜8.5である、請求項19〜29のいずれかに記載の 無菌薬剤組成物。 31.水酸化ナトリウムが存在する、請求項30記載の無菌薬剤組成物。 32.血液と等張性である、請求項19〜31のいずれかに記載の無菌薬剤 組成物。 33.グリセロールを配合することによって血液と等張性にされる、請求項 32記載の無菌薬剤組成物。 34.1重量%から2重量%までのプロポフォールを含む、請求項19〜3 3のいずれかに記載の無菌薬剤組成物。 35.約1重量%のプロポフォールを含有する、請求項34記載の無菌薬剤 組成物。 36.約2重量%のプロポフォールを含有する、請求項34記載の無菌薬剤 組成物。 37.下記成分: (a)1重量%のプロポフォール (b)10重量%の大豆油 (c)1.2重量%の卵ホスファチド (d)2.25重量%のグリセロール (e)0.005重量%のエデト酸二ナトリウム (f)水酸化ナトリウム (g)水 を含む、水中油滴エマルジョンの形状の非経口投与用無菌薬剤組成物。 38.下記成分: (a)2重量%のプロポフォール (b)10重量%の大豆油 (c)1.2重量%の卵ホスファチド (d)2.25重量%のグリセロール (e)0.005重量%のエデト酸二ナトリウム (f)水酸化ナトリウム (g)水 を含む、水中油滴エマルジョンの形状の非経口投与用無菌薬剤組成物。 39.水不混和性溶媒中に溶解したプロポフォールを水によって乳化し、界 面活性剤を用いて安定化した水中油滴エマルジョンへのエデテートの使用を含む 、非経口投与用無菌薬剤組成物中の微生物増殖の可能性を制限する方法であって 、エデテート量が偶発的な外部からの汚染後の少なくとも24時間、微生物の有 意な増殖を防止するために充分である方法。 40.水不混和性溶媒中に溶解したプロポフォールを水によって乳化し、界 面活性剤を用いて安定化した水中油滴エマルジョンへのエデテートの使用を含む 、非経口投与用無菌薬剤組成物中の微生物増殖の可能性を制限する方法であって 、 エデテート量が3x10-5〜9x10-4の範囲内のモル濃度である方法。 41.温血動物に麻酔を生じる方法であって、請求項1〜18のいずれかに 記載の無菌薬剤組成物の有効量を投与することを含む方法。 42.温血動物に麻酔を生じる方法であって、請求項19〜36のいずれか に記載の無菌薬剤組成物の有効量を投与することを含む方法。 43.温血動物に麻酔を生じる方法であって、請求項37又は38に記載の 無菌薬剤組成物の有効量を投与することを含む方法。 44.プロポフォールを水によって乳化し、界面活性剤を用いて安定化した 水中油滴エマルジョンを含み、偶発的な外部からの汚染後の少なくとも24時間 、微生物の有意な増殖を防止するために充分なエデテート量をさらに含む、非経 口投与用無菌薬剤組成物。 45.プロポフォールを水によって乳化し、界面活性剤を用いて安定化した 水中油滴エマルジョンを含み、3x10-5〜9x10-4の範囲内のモル濃度であ るエデテート量をさらに含む、非経口投与用無菌薬剤組成物。 46.プロポフォールを水によって乳化し、界面活性剤を用いて安定化した 水中油滴エマルジョンへのエデテートの使用を含む、非経口投与用無菌薬剤組成 物中の微生物増殖の可能性を制限する方法であって、エデテート量が偶発的な外 部からの汚染後の少なくとも24時間、微生物の有意な増殖を防止するために充 分である方法。 47.プロポフォールを水によって乳化し、界面活性剤を用いて安定化した 水中油滴エマルジョンへのエデテートの使用を含む、非経口投与用無菌薬剤組成 物中の微生物増殖の可能性を制限する方法であって、エデテート量が3x10-5 〜9x10-4の範囲内のモル濃度である方法。 48.プロポフォールの水中油滴エマルジョンの投与時間及び/又は投与セ ット交換の間の時間を改善する方法であって、前記エマルジョン中に偶発的な外 部からの汚染後の少なくとも24時間、微生物の有意な増殖を防止するために充 分なエデテート量を含めることによる方法。 49.プロポフォールの水中油滴エマルジョンの投与時間及び/又は投与セ ット交換の間の時間を改善する方法であって、前記エマルジョン中に3x10-5 〜9x10-4の範囲内のモル濃度のエデテートを含めることによる方法。 50.水によって乳化し、界面活性剤を用いて安定化した水中油滴エマルジ ョンを含み、偶発的な外部からの汚染後の少なくとも24時間、微生物の有意な 増殖を防止するために充分なエデテート量をさらに含む、非経口投与用の無菌水 性組成物。 51.水によって乳化し、界面活性剤を用いて安定化した水中油滴エマルジ ョンを含み、3x10-5〜9x10-4の範囲内のモル濃度のエデテート量をさら に含む、非経口投与用の無菌水性組成物。 52.単独の又は水不混和性溶媒中に溶解した治療剤又は薬剤を水によって 乳化し、界面活性剤を用いて安定化した、治療剤又は薬剤を含有する水中油滴エ マルジョンを含み、偶発的な外部からの汚染後の少なくとも24時間、微生物の 有意な増殖を防止するために充分なエデテート量をさらに含む無菌薬剤組成物。 53.単独の又は水不混和性溶媒中に溶解した治療剤又は薬剤を水によって 乳化し、界面活性剤を用いて安定化した、治療剤又は薬剤を含有する水中油滴エ マルジョンを含み、3x10-5〜9x10-4の範囲内のモル濃度であるエデテー ト量をさらに含む、非経口投与用の無菌水性組成物。 54.抗真菌剤、麻酔薬、抗菌剤、抗癌薬、制吐剤、中枢神経系に作用する 薬剤、ステロイド、バルビツール剤又はビタミン製剤を含む、請求項52記載の 組成物。 55.抗真菌剤、麻酔薬、抗菌剤、抗癌薬、制吐剤、中枢神経系に作用する 薬剤、ステロイド、バルビツール剤又はビタミン製剤を含む、請求項53記載の 組成物。
Applications Claiming Priority (19)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB9405593A GB9405593D0 (en) | 1994-03-22 | 1994-03-22 | Pharmaceutical compositions |
NZ282005A NZ282005A (en) | 1994-03-22 | 1995-03-17 | Oil in water emulsions containing propofol (2,6 diisopropylphenol) and edetate |
CH00393/03A CH693762A5 (de) | 1994-03-22 | 1995-03-17 | Wässrige Zusammensetzungen enthaltend eine Öl-in-Wasser-Emulsion |
CH01282/04A CH694423A5 (de) | 1994-03-22 | 1995-03-17 | Verwendung von Edetat zur Stabilisierung von pharmzeutischen Zusammensetzungen. |
BE9500241A BE1009198A5 (fr) | 1994-03-22 | 1995-03-17 | Compositions pharmaceutiques nouvelles contenant du propofol. |
PCT/GB1995/000579 WO1996029064A1 (en) | 1994-03-22 | 1995-03-17 | Oil in water emulsions containing propofol and edetate |
EP95911412A EP0814787B1 (en) | 1994-03-22 | 1995-03-17 | Oil in water emulsions containing propofol and disodium edetate |
CH02011/97A CH693764A5 (de) | 1994-03-22 | 1995-03-17 | Pharmazeutische Zusammensetzung enthaltend Propofol und Edetat. |
FR9503128A FR2731617B1 (fr) | 1994-03-22 | 1995-03-17 | Compositions pharmaceutiques nouvelles contenant du propofol |
PL95322278A PL186354B1 (pl) | 1994-03-22 | 1995-03-17 | Jałowe kompozycje farmaceutyczne oraz sposoby ograniczania potencjału wzrostowego drobnoustrojów i poprawiania czasu stosowania emulsji |
ZA952239A ZA952239B (en) | 1994-03-22 | 1995-03-17 | Pharmaceutical compositions |
BR9510452A BR9510452A (pt) | 1994-03-22 | 1995-03-17 | Composição farmacêutica e aquosa estéril para a administração parenteral processos para limitar o potencial de crescimento microbiano em composição farmacêutica estéril para a administração parenteral para produzir anestesia em um animal de sangue quente e para aperfeiçoar o tempo de administração e/ou o tempo entre as trocas de conjuntos |
CA002212794A CA2212794C (en) | 1994-03-22 | 1995-03-17 | Oil in water emulsions containing propofol and edetate |
HU9702180A HU227951B1 (en) | 1994-03-22 | 1995-03-17 | Oil in water emulsions containing propofol and disodium edetate |
NZ500588A NZ500588A (en) | 1994-03-22 | 1995-03-17 | Oil in water emulsions containing propofol and edetate for producing anaesthesia |
DE19509828A DE19509828A1 (de) | 1994-03-22 | 1995-03-17 | Pharmazeutische Zusammensetzungen |
NO19974278A NO320007B1 (no) | 1994-03-22 | 1997-09-16 | Steril farmasoytisk blanding inneholdende propofol og edetat for parenteral administrering, fremgangsmate for a begrense potensialet for mikrobevekst i blandingen, samt anvendelse derav. |
JP00624199A JP4012328B2 (ja) | 1994-03-22 | 1999-01-13 | エデテートを含有する水中油滴エマルジョン |
FI20085586A FI120641B (fi) | 1994-03-22 | 2008-06-13 | Ruuansulatuskanavan ulkopuolisesti annettavat rasvaemulsiot, jotka sisältävät edetaattia säilöntäaineena |
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US (1) | US5714520A (ja) |
EP (2) | EP1238677B1 (ja) |
JP (2) | JP3067806B2 (ja) |
AT (2) | ATE312625T1 (ja) |
AU (1) | AU710143B2 (ja) |
BE (1) | BE1009198A5 (ja) |
BR (1) | BR9510452A (ja) |
CA (1) | CA2212794C (ja) |
CH (4) | CH694396A5 (ja) |
CZ (1) | CZ297549B6 (ja) |
DE (2) | DE19509828A1 (ja) |
DK (3) | DK0814787T3 (ja) |
ES (2) | ES2253469T3 (ja) |
FI (2) | FI120640B (ja) |
FR (1) | FR2731617B1 (ja) |
GB (2) | GB9405593D0 (ja) |
HK (1) | HK1008927A1 (ja) |
HU (1) | HU227951B1 (ja) |
IL (1) | IL113021A (ja) |
IT (1) | IT1281193B1 (ja) |
LU (1) | LU90136B1 (ja) |
MX (1) | MX9707005A (ja) |
NO (2) | NO320007B1 (ja) |
NZ (2) | NZ282005A (ja) |
PL (1) | PL186354B1 (ja) |
PT (1) | PT814787E (ja) |
RU (1) | RU2147432C1 (ja) |
SE (2) | SE523909C2 (ja) |
SI (1) | SI0814787T1 (ja) |
SK (1) | SK286375B6 (ja) |
TW (1) | TW458781B (ja) |
WO (1) | WO1996029064A1 (ja) |
ZA (1) | ZA952239B (ja) |
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JP2002541086A (ja) * | 1999-04-05 | 2002-12-03 | バクスター・インターナショナル・インコーポレイテッド | 強化された微生物的特徴を有するプロポフォール処方物 |
JP2005526108A (ja) * | 2002-04-08 | 2005-09-02 | ギルフォード ファーマシューティカルズ インコーポレイテッド | プロポフォールの水溶性プロドラッグを含む薬学的組成物およびその投与方法 |
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1994
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
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JP2002541086A (ja) * | 1999-04-05 | 2002-12-03 | バクスター・インターナショナル・インコーポレイテッド | 強化された微生物的特徴を有するプロポフォール処方物 |
JP2005526108A (ja) * | 2002-04-08 | 2005-09-02 | ギルフォード ファーマシューティカルズ インコーポレイテッド | プロポフォールの水溶性プロドラッグを含む薬学的組成物およびその投与方法 |
JP2010195803A (ja) * | 2002-04-08 | 2010-09-09 | Eisai Inc | プロポフォールの水溶性プロドラッグを含む薬学的組成物およびその投与方法 |
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