LV10838B - Therapeutical composition - Google Patents

Description

LV 10838 JIEKAPCTBEHHAfl Κ0ΜΠ03ΗΙΡ1 Η3θ6ρβΤΘΗΗβ OTHOCHTCfl K ΜΘ,Π,ΗΙ1ΗΗΘ, ΚΟΗΚρβΤΗΟ Κ JieKapCTBeHHbIM CpeflCTBaM flJIH Jie~ nemin repnecBHpycHbix ΗΗφβκρκΗ rjiaaa. ΜβΒΘΟΤΗΟ ΙφΗΜΘΗΘΗΗΘ flJIH ΛΘΜΘΗΗΗ BHpyCHbIX ΠΟρείΧβΗΗΗ TJia3a (ΓβρΠΘΤΗΜΘΟΚΗΧ Kepa-thtob h KepaToyBeHTOB) au,HKJioryaH03HHa (apnKJiOBnp) /1-7/. H3BecTHa rjia3Han Ma3b "3oBHpaKc", πρμμθηηθμβη fljin jieneHHH KepaTHTOB, Bbi3biBa-eMbix BnpycoM npocToro repneca /8-11/. IlpenapaT coflepsHT 3% aiļHKJioryaH03HHa, paBHO-MepHO pacnpeflejieHHoro b CTepmībHOH 6ejiofl napa$HHOBOH οοηοβθ, h npeflCTaBJiaeT co6oh 6ejiyw hjih 6ejiyw c sejiTOBaTbiM οττθηκομ Maccy. BbinycKaeTCfl b Ty6ax no 4,5 r (coflep-jtaHHe aiļHKJioryaH03HHa 135 μγ).

Ma3b HaHOCHT Ha ΜΗΛΗ»» BHyTpeHHH)K) nOBepXHOCTb KOHHOHKTHBajlbHOrO MeuiKa 5 pa3 B fleHb, npH6jlH3HTejlbHO C 4-Χ naCOBblM HHTepBaJIOM. H3 rJia3H0H Ma3H aiļHKJI0ryaH03KH Bca-CbiBaeTCH nepe3 θπητθληη poroBHiļbi η ποβθρχηοοτημθ τκβηη rjia3a. B pe3yjibTaTe b κη^κοη $a3e TKaHen rjia3 flocTHraeTcn TOKcmmaH ajih BHpycoB KOHiļeHTpaiļHH. Ηθ,ιι,οοτβτκθΜΗ η3βθοτηοη jieKapcTBemoH φορΜΜ ηβλλθτοη HeflocTaTonHo βμοοκοθ bmcbo-βοΧ,Π,ΘΗΗΘ aiļHKJI0ryaH03HHa H3 Μ33ΘΒ0Η OCHOBbl, HeB03M0HH0CTb TOHHOH fl03Hp0BKH Iipenapa-Ta, a TaK»e Hey,n,o6cTBo πρημθηθηηη. Iļejlb Η3θ6ρβΤΘΗΗΗ - ΠΟΒΜΙΙΙβΗΗβ 6HOflOCTynHOCTH, TOUHOCTb fl03Hp0BaHHH H y,ū106CTB0 ΠρΗ ηρΗΜΘΗΘΗΜΗ.

IlocTaBJieHHaH pejib flocTHraeTcn jieKapcTBemofi κομπο3ηι1ηθη fljra JieneHnn repnera-μθοκηχ KepaTHTOB η κθρ3τοκοηήοηκτηβητοβ , KOTopaH npeflCTaBJineT co6oh cycneH3HH), BKjnonaH)inyH) au,HKJioryaH03HH, ay6a3HflaH, ηηπβγηη , nponHJinapaoKCH6eH3oaT, 6opHyro khc-jioTy h flHCTHjuiHpoBaHHyio BO,ņy πρκ cjieflyiomeM cοοτηοιπθηηη κομποηθητοβ, % (Macc.): apHKJioryaH03HH 1,0 - 5,0 0,3 - 1,0 1,6 - 2,0 0,07 - 0,14 0,03 - 0,06 ocTajībHoe ay6a3HflaH 6opHaa KHCJioTa ΗΗΠΒΓΗΗ

nponHJinapaoKCH6eH3oaT BOfla flHCTHJUIHpOBaHHaH J\nsi CTa6HJiH3aiļHH cycneH3HH Hcnojib30BaH ay6a3HflaH - nojiHcaxapnfl μηκρο6ηογο npOHCXO*fleHHH, KOTOpbIH Π03Β0ΛΗΘΤ nOJiynaTb flJIHTeJIbHO CTaČHJIbHbie CycneH3HH /12-14/. OnTHMajībHaa ceflHMeHTaiļHOHHan ycToiwHBOCTb apHKJioryaH03HHa b cycneH3HHx flocTHraeTcn npH coflep*aHHH ay6a3HflaHa ot 0,3 flo 1%. ,ļjIH npeflOTBpameHHH pa3MH0*eHHH MHKp00praHH3M0B B COCTaB K0Mn03HU.HH BBefleHbl KOHcepBHpywmHe areHTbi ηηπβγηη h nponHJinapaoKCH6eH3oaT. B cocTaB cycneH3HH aiļHoo-ryaH03HHa αλη η30τοηηροββηηη npenapaTa BBefleHa TaKace 6opHaa KHCJioTa b κολημθοτβθ 1,6-2,0%. BopHaa KHCJioTa πομημο cbohx H30TOHHpyiomnx h 6aKTepH0CTaTHnecKHx cbohctb B 3HaUHTeJIbH0H ΟΤΘΠΘΗΗ Cn0C06CTByeT CTa0HJlH3aiJHH CyCneH3HH 3a ΟΠΘΤ nOBblllieHHH flHHa-MHuecKOH bh3kocth pacTBopoB ay6a3HAaHa.

Bce yKa3aHHbie κομποηθητμ cycneH3HH pa3peuieHbi κ πρημθηθηηιο b rjia3Hbix JieKapcT-βθηηηχ npenapaTax. ΗηΧΘ npHBOflHTCH ΠρΗΜβρΜ ΠρΗΓΟΤΟΒΛΘΗΗΗ npeflJIOJKeHHOH JieKapCTBeHHOii Κ0ΜΠ03Ηφ1Η. ΠΡΗΜΕΡ I. riopoiiiK0ByK) cMecb, cocTOHmyio H3 0,3 r ay6a3HAaHa, 2,0 r βορΗοίί khcjiotm, 0,07 r HHnaruHa h 0,03 r nponHJinapaoKCH6eH3oaTa, 3acbinawT πρκ HenpepbiBHOM nepeMeuiHBaHHH b 96,6 mji BOflbi, npeflBapHTejibHO noflorpeTon po TeMnepaTypbi 60°C, h ocTaBJimoT αλη Ha6y-xaHHH b TeneHHe 30 MHHyT. Ha6yxuiyw CMecb nporpeeaioT πρκ TeMnepaType 70-80°C flo noji- ΗΟΓΟ paCTBOpeHHH ΗΗΓρβΑΗΘΗΤΟΒ H $HJIbTpyK)T ΠΟΑ BBKyyMOM Πθρβ3 CTeKJlHHHblH <|)HJIbTp. PacTBop cTepHJiH3yioT napoM ποα α&βλθηηθμ πρκ TeMnepaType +I20-I2I°C b τθπθηηθ 8 mh-HyT. rip0CTepHJIH30BaHHblH CyXHM HarpeTblM Β03ΑΥΧ0Μ aU,HKJIOryaH03HH B KOJIHUeCTBe 1,0 Γ acenTHUeCKH CMeillHBaiOT C OXJia*AeHHblM paCTBOpOM H H3MeJIbHa»T Ha pOTOpHOM H3MeJIbnHTe— jie TKaHen PT-2 npn nacTOTe BpauļeHHH poTopa 5000 mhh-^·.

IlojiyueHHaH κομπο3ηι1ηη ημθθτ cjieAywmHH cocTaB, % (Macc.): au,HKJioryaH03HH - 1,0 ay6a3HAaH - 0,3 6opHan KHCJioTa - 2,0 HHnarHH - 0,07 nponHjmapaoKCn6eH3oaT - 0,03 BOAa AncTHJiJiHpoBaHHaH - 96,6 ΠΡΗΜΕΡ 2. nopomKOByio cMecb, cocTOHinyro H3 0,5 r ay6a3HAaHa, 1,9 r 6opHOfi khcjioth, 0,I05r HHnarHHa» h 0,045 r nponHJinapaoKCH6eH3oaTa, 3acbinai0T b 94,45 mji boah, npeABapnTejibHO noAorpeTOH ao TeMnepaTypbi 60°C, h ocTaBJinioT a^h Ha6yxaHHH b τθπθηηθ 30 MHHyT. Ha-6yxuiyio cMecb nporpeBaioT npn TeMnepaType 70-80°C ao ποαηογο pacTBopeHHH ηηγρθαηθητοβ h $HjibTpywT ποα BaKyyMOM uepe3 οτθοηηημη <£njibTp. PacTBop CTepHJiH3yioT napoM ποα AaBJieHHeM npn TeMnepaType I20-I2I°C β τθπθηηθ 8 MHHyT. np0CTepHJIH30BaHHbIH CyXHM HarpeTblM B03AyXOM aU,HKJI0ryaH03HH B KOJIHUeCTBe 3,0 r -3' LV 10838 acenTHuecKH cMeuiHBaiOT c oxjia*flēHHbiM pacTBopoM h H3MeJibnaioT Ha ροτορΗΟΜ ηθμθλβμη-Tejie TKaHeH PT-2 npH nacTOTe BpameHHH poTopa 5000 mhh-^. flojiyueHHaH κομπο3ηαηη ημθθτ cjiefljrcomHft cocTaB, % (Macc.): apHKJioryaH03HH - 3,0 ayča3HflaH - 0,5 6opHan KHCJioTa - 2,0 HHnarHH - 0,105 npomumapaoKcn6eH3oaT - 0,045 BOfla flHCTHJiJiHpoBaHHaH - 94,45 ΠΡΗΗΕΡ 3. IIopomKOByH) CMecb, cocTOHiiņno H3 1,0 r ay6a3HflaHa, 1,6 r 6opHOH khcjiotm, 0,14 r HtinarHHa h 0,06 r nponnjmapaoKCn6eH3oaTa 3acbmaiOT b 92,2 mji boam, npeflBapHTejibHo noflorpeTofl flo TeMnepaTypu 60°C, h ocTaBJunoT ajm Ha6yxaHHH b τθμθηηθ 30 MHHyT. Ha-6yxuiyK) CMecb nporpesaroT npn TeMnepaType 70-80°C flo ποληογο pacTBopeHRH HHrpeflHeH-TOB H $HJIbTpyi0T ΠΟΑ BaKyyMOM uepe3 CTeKJIHHHblH (J)HJIbTp. PaCTBOp CTepHJIH3yH)T napOM nofl flaBJieHHeM npn TeMnepaType I20-I2I°C b Tenemie 8 MHHyT. IIpocTepHjiH30BaHHbrii cyxHM HarpeTbiM B03flyxoM aiļHKJioryaH03HH b κολημθοτβθ 5,0 r aceriTmiecKH cMeniHBaiOT c oxjia*flēHHMM pacTBopoM h HSMeJibnaioT Ha ροτορΗΟΜ H3Me jiβ*·ιητθ— jie TKaHeH PT-2 npn nacTOTe BpameHHH poTopa 5000 mhh-^. nojiyyeHHaH κομποθηαηη ημθθτ cjieflyiomHH cocTaB, % (Macc.): aiļHKHoryaH03HH - 5,0 ay6a3HflaH - 1,0 6opHan KHCJioTa - 1,6 HHnarHH - 0,14 nponHjmapaoKCH6eH3oaT - 0,06 BOfla flHCTHJUiHpoBaHHaH - 92,2

MeTOflOM paBHOBecHoro flnajiH3a nepe3 Lļejuio$aHOByw MeM6paHy opeHeHa 3φφβκτΗΒΗ00Ή> npenapaTa b cpaBHeHHH c 3% rjia3H0H Ma3bro "3oBHpaKCM (BejinaM $ayHfleHiiiH JlT/ļ, BejiHKO-6pHTaHHn) (pHc.1,2). ycTaHOBJieHO, mto H3 3% npenapaTa Ha ay6a3HflaHe BbicBočoacflaeTCH 3a 6 nacoB 100%-Hoe KOjinnecTBo aiļHKJioryaH03HHa, b to BpeMH KaK H3 τβκοίί *e HaBecKH Ma3H flHaHH3 npoxoflHT JiMib Ha 69,2% 3a MaKCHMajībHoe BpeMH (9 iļacoB). Πρπ flnaHH3e cycneH3HH Haņajio ycTaHOBJieHHH paBHOBecHOH KOHiļeHTpaifliH OTMenaeTCH κ 2 nacaM (63,6% aiļHKJioryaH03HHa) h npoflOjmaeTCH flo 6 nacoB. PaBHOBecHan KOHpeHTpa-Phh aiļHKjioryaH03HHa b flnaJiH3aTe H3 Ma3H HanHHaeT ycTaHaBjiHBaTbCH jinuib κ 7 nacaM (60,85%).

MccjieflOBaHHe βμοβοαοκαθηηη aijHKJioryaH03HHa H3 npenapaTa noKa3biBaeT, ητο flHajiHS cycneH3HH npoxoflHT no ypaBHeHHW c KOHCTaHTOH 0,5 Ma3H - 0,14. TaKHM o6pa30M, bmcbo- 6ο*αθηηη au,HKJioryaH03HHa m Ma3H hocht 6ολθθ npojioHrHpoBaHHbiīi xapaKTep, b cpeflHeM 3a Ka)Kflbiii Mac b flHa;iH3aT nepexoflHT okojio 8% au,HKJioryaH03HHa. MaKCHMyM BbicBOflo*fle-hhh au,HKJioryaHo3HHa H3 cycneH3nn HafijiroflaeTCH κ 3-5 nacaM. ripu CpaBHeHHH KpHBblX BbICB000)KfleHHH atl,HKJ10ryaH03HHa H3 3% CycneH3HH H 3% Ma3H "3oBHpaKc" ycTaHOBJieHo, mto 3a BpeMH ycTaHOBjieHHH nojmoro paBHOBecHH b flHajiH3aTe o6HapyjKHBaeTCH b 1,44 pa3a 6ojibuie apHKJioryaH03HHa m cycneH3HH, μθμ H3 Ma3H. ļipu 3tom 3a nepBbiH Mac H3 cycneH3HH b flHajiH3aT BbicBo6o)KflaeTCH b 3,05 pa3a 6ojibaie au,HK-jioryaH03HHa, μθμ H3 Ma3H, 3a Βτοροίί - b 3,37 pa3a. llojiyMeHHbie flaHHbie πο3βο;ιηιοτ npeflnojioraTb 6ojibiuyio h 6ojiee 6bicTpyw BcacbiBaeMOCTb apHKjioryaH03HHa H3 3% cycneH3HH b cpaBHeHHH c Ma3bio. ΠρΟΒΘΑΘΗΟ CpaBHMTeJIbHOe H3yM6HHe θφφβΚΤΗΒΗΟΟΤΗ 1% m3% CyeneH3HH aiļHKJ10ryaH03H-Ha b λθμθηηη 3KcnepnMeHTajibHoro repneTHMecKoro KepaTHTa kpojihkob. 3KCnepHMeHTaJIbHblH KepaTHT B0Cnp0H3B0flHJIH ΠΟ οδ^ΘΠρΗΗΗΤΟΗ MeTOflHKe nyTeM HH- CTHJutfliļHH 0,2 mji BHpyccoflep*amero MaTepnajia Ha CKapH$HiļHpoBaHHyio poroBnny noc;ie npe,n,BapnTejibHOH Mecraon aHecTe3HH eē 1% pacTBopoM flHKanHa. B onbīTe Hcnojib30Bajin f\ n uiTaMM BHpyca npocToro repneca I ceporana "I-C". Τπτρ B«pyca Ι0°’υ 11Π11 50/mji. Λθμθηηθ HaMHHajiH Ha 3 cyxKH, Korfla paaBHBajiacb τηπημηηη KapraHa τομθμηογο rep-neTHMecKoro KepaTHTa. MccjieflOBaHHH npoBefleHbi Ha 12 κροΛΗκβχ noposu raHHuiHJuia, Macca KaKjļoro 2-2,5 κγ, κοτορΜθ 6ηλη pa3flejieHbi Ha 3 rpynnbi no 4 KpojiHKa (8 rjia3) b Ka«-flofi. B I rpynne b κοηβιοηκτηβολβηυιο nojiocTb o6ohx rjia3 KpojiHKa bboahjih no 2 KaruiM 5 pa3 b fleHb 3% cycneH3HH apHKJioryaH03HHa. Bo 2 rpynne - no 2 KanjiH 5 pa3 b ,π,θηβ 1% cycneH3HH apHKJioryaH03HHa. B 3 rpynne (κοητροηβηοη) - no 2 KamiH Φη3ηολογημθοκογο pacTBopa b Te *e βρθμθηημθ npoMe*yTKH, mto h β I h 2 rpynnax.

Ha MOflejiH SKcnepHMeHTajībHoro ocTporo repneTHMecKoro KepaTHTa y*e Mepe3 2 ahh nocjie Hanajia λθμθηηη- TnatecTb κληηημθοκογο τθμθηηη KepaTHTa yMeHbiiiHJiacb β I h 2 rpyn-nax χηβοτημχ, KOTopbiM npoBOflHJiocb jieMeHHe aiļHKJioryaH03HHOM h ycHJWJiacb b 3 (κοΗτρο-jibHOH) rpynne, β κοτοροϋ jkhbothmm 3aKanbiBajiH njiapeēo (Ta6ji.I).

Ha 4-e cyTKH ot MOMeHTa Hanajia jieneHRH β I rpynne ηβλθηηη KepaTHTa nojiHOCTbio perpeccnpoBajiH. B 6ojibmHHCTBe rjia3, jieMeHHbix 3% cycneH3Heii aiļHKJioryaH03HHa, nepn-KopHeajībHan ηηβθκαηη Hcne3Jia, poroBHpa <ļuiyopecu,eHHOM He oKpauiHBajiacb. Bo 2 rpynne THJKecTb KJiHHHMecKoro τθμθηηη KepaTHTa TaKJice cTajia cjia6ee. OflHaKO npn (5homhkpocko-πημθοκομ HCCJieflOBaHHH b nojioBHHe r\na3 OTMeMajiacb HesHaMHTeJibHan nepHKopHeajībHafl HHt-βκυ,ΗΗ h poroBHiļa oKpauiHBajiacb $JiyopecpeHHOM b BHfle θαηηημημχ τομθμημχ apo3HH. B koh-TpoJibHOH rpynne y κηβοτημχ ηβλθηηη KepaTHTa npoflOJMajiH 33μθτηο nporpeccnpoBaTb. B τρβχ rjia3ax OTMeMajiacb BbipajKeHHan cMeuiaHHaH ηηβθκη,ηη, poroBHpa OKpauiHBajiaCb $Jiyopec-υ,βΗΗΟΜ b BHfle oMaroB pa3MepoM ot 1/4 flo 1/2 eē ποΒβρχΗοοτΗ; b ocTajibHbix ma3ax -pe3K0 BbipaweHHaH nepHKopHeajībHaH HHTbeKflHH, poroenna OKpauiHBajiacb $Jiyopecu,eHHOM b BHfle ΜΗΟ)ΚΘΟΤΒΘΗΗΗΧ ΤΟΜΘΜΗΗΧ 3p03HH. LV 10838

Ha 10 AeHb ot MOMeHTa 3apaKeHHH (7 α,θηβ jieueHHH) 4 KpojiHKa πογη6λμ ot repne-TtmecKoro 3Hu;e<i)ajiHTa. BocnajiHTejibHbie ηβλθηηη b rjia3ax kpojihkob I h 2 rpynn 6wjih He3HaunTejibHbi, a b 3 rpynne ocTaeajiHCb BbipaaceHHbiMH.

TaKHM 00pa30M, npOBeflēHHbie HCCJieAOBaHHH nOKa3ajIH BblCOKyiO 3$$eKTHBHOCTb MeCTHO-ro πρΗΜθΗθΗΗΒ 1% h 3% cycneH3Hn aiļHKJioryaH03HHa b JienemiH 3KcnepHMeHTajibHoro repne-TH^ecKoro KepaTHTa, 6ojiee BbrpaweHHyro npn hhcthjuihphh 3% KOHpeHTpaiļHH npenapaTa. flpoBefleHo cpaBHHTejibHoe H3yneHHe 3φφβκτΗΒΗθοτπ 3% cycneH3nn au,HKJioryaH03HHa h 37o Ma3H apHKJiOBHpa ($npMa BeJiKaM fayHfleiiuiH JITJļ) b JieneHHH 3KcnepHMeHTajibHoro repne-τημθοκογο KepaTHTa KpojutKOB. 3KCnepHMeHTaJIbHbIH KepaTHT BOCIipOH3BOAHJIH ΠΟ o6menpHHHTOH MeTOflHKe nyTēM HHCTHJl·- jiHiļHH 0,2 mji BHpyccoflepxamero MaTepHaJia Ha cKapn$HUHpoBaHHyw poroBHijy nocjie npeflea- pHTejIbHOH ΜΘΟΤΗΟΗ 3ΗβΟΤβ3ΗΗ eē 1% paCTBOpOM flHKaHHa. B ΟΠΜΤΘ HCn0JIb30B£lJIH UIT3MM BH- fi s pyca npocToro repneca I cepoTHna "I-c". Τκτρ BHpyca 10 ’

JleneHHe HanHHajiH Ha 3 cyTKH, Kor^a pa3BHBajiacb THmroHaH KapTHHa TonenHoro rep-neTHnecKoro KepaTHTa. HccjieflOBaHHH npoBefleHbi Ha 12 KpojiHKax nopoflbi fllHHniHjiJia, Macca Ka*floro 2,5-3,0 κγ, κοτορΗβ 6buiH pa3flejieHbi Ha 3 rpyniibi no 4 KpojiHKa (8 rjia3) b Ka*-,ιι,οη. B I rpynne b KOHbiOHKTHBajibHyH) nojiocTb o6ohx rjia3 kpojihkob bboahjih no 2 KaruiH 3 pa3a b AeHb 3% cycneH3HH aiļHKJioryaH03HHa. Bo 2 rpynne aaKJiaAbiBajin 3% Ma3b apHKJio-BHpa 3 pa3a b fleHb. 3 rpynna 6buia κοητροαβηοη (njiape6o). MHTeHCHBHOCTb ΓβρΠΘΤΗΗΘΟΚΗΧ nopaJKeHHH porOBHIļbl ΟΠρβΑβΛΗΛΗ C nOMOllļblO βπΟΜΗΚρΟΟ-ΚΟΠΗΗ H OpeHHBaJIH ΠΟ Tpex6ajIbHOH UlKaJie, yUHTblBan KOJIHUeCTBO 3p03HH H pa3Mepbl H3bH3-BJieHHH porOBHIļbl. B cpaBHHBaeMbix rpyrmax «ηβοτημχ y*e nepe3 2 fļm nocjie Hanajia jieueHHH TH*ecTb KJiHHHnecKoro TeneHHH SKcnepHMeHTaJībHoro, ocTporo repneTHnecKoro KepaTHTa β I h 2 rpynnax *ηβοήβ>ιχ yMeHbiiiHJiacb h cocTaBHJia οοοτΒβτοτΒβΗΗο b 6ajuiax 0,6^0,2; 0,7-0,3, b 3 (KOHTpojibHoii) rpynne ycHJiHJiacb h cocTaBHJia b 6ajmax 1,6^0,3 (Tafijinpa 2).

Ha 4-e cyTKH οτ μομθητβ HanaJia jieneHHH b 4 rna3ax I rpynnw nepHKopHeajībHan HHBeKiļHH ncneejia, poroBHpa $jiyopecpeHHOM He OKpauiHBajiacb, b ocTajibHbix rjia3ax, TaK-*e KaK h b fiojibiiiHHCTBe rjia3 2 rpynnw oTMenajiacb He3HanHTejibHaH nepHKopHeaJībHafl hhtt-θκαηη, poroBHpa OKpaniHBajiacb $jiyopecpeHHOM β βηαθ θαηηημηηχ τοηβηΗωχ 3ρο3Ηίί. Β 3 (KOHTpojibHOH) rpynne y *hbothwx ηβλθηηη KepaTHTa npoAOJiacajiH nporpeccnpo-BaTb. B 6ojibiiiHHCTBe rjia3 OTMenaAacb Bbipa*eHHan CMeuiaHHaH ηηβθκιι,ηη, poroenpa OKpaiun-eajiacb $JiyopecpeHHOM β βηαθ onaroB pa3MepaMH οτ 1/4 ao 1/2 ποΒβρχΗοοτπ. ĪHMcecTb repneTHnecKoro KepaTHTa β I, 2 h 3 rpynnax cocTaBjnuia οοοτβθτοτβθηηο 0,3-0,3; 0,5-0,2; 1,9-0,3. Ha 10 Ae«b ot MOMeHTa 3apa*eHHH (7 αθηβ JieneHHfl) b 6ojibuiHHCTe r\na3 I h 2 rpynnu ηβλθηηη KepaTHTa nojiHOCTbio perpeccHpoBajin, a b 3 rpynne ocTaBaJincb Bbipa-seHHbiMH h cocTaBJiiuiH οοοτΒβτοτΒβΗΗο b 6ajniax 0,ī-0,2; 0,2—0,2; 1,7-0,5.

TaKHM o6pa30M, npoBeflēHHbie HccjieflOBaHHH riOKa3ajin BbicoKyK) 3$$eKTHBH0CTb 3% Masu auHKJiOBHpa h 3% cycneH3HH apHKJioryaH03HHa, 6ολθθ Bbipa*eHHyK) y nocjieflHefi, b Tepa-πηη 3KcnepHMeHTajibHoro repneTHuecKoro KepaTHTa. ΚροΜΘ τογο, npefljio*eHHaH cycneH3HH apHKjioryaH03HHa ηθ HapymaeT οπτημθοκηχ CBOHCTB pOrOBHbļbl TJia3a B OTJIHMHe OT 3% Μ33Η "3oBHpaKc" KOTOpaH CMeiUHBaeTCH CO CJlē3-hoh «HflKOCTbH) η πποχο pacnpeflejiHeTCH Ha cjih3hctoh rjia3a.

I — .-f LV 10838

Tadjinpa I

TaKecTb KJiHHHnecKoro τθμθηηη SKcnepHMeHTajībHoro repneTHnecKoro KepaTHTa y κροΛΜκοΒ, jieyeHHbix ī%n 3% cycneH3nefi apHKJioryaH03HHa Ha ay6a3HflaHe h ruiau,e6o (b 6ajuiax)

fP Kpo- JIH- KOB ΓΡΥΠΠΑ

CpoK Ha6juofleHHH τηκθοτη 3KcnepHMeHTajibHoro repneTnuecKoro KepaTHTa (b ahhx): b HHCJiHTejie - ot MOMeHTa 3apa*eHHH, b 3HaMeHaTejie - ot Hanajia jieneHHH 3/0 5/2 7/4 10/7’ npaBbin rjia3 JieBblH rjia3 npaBblH JieBblH rjia3 rjia3 npaBblH JieBblH rjias rjia3 npaBblH JieBblH rjia3 rjia3 Jlenerae 3% I 1,0 0,5 0,5 0 0 0 0 0 cycneH3He0 2 1,5 1,0 1,0 0,5 0,5 0 πογη6 aiļHKJioryaHo- 3 1,0 0,5 0,5 0,5 0 0 0 0 3HHa 4 1,0 1,0 0,5 0,5 0,5 0 0,5 0 0,9+0,3 0,5+0,15 0,1+0,2 JleueHHe 1% 5 » 0,5 0,5 0,5 0 0 0 0 0 cycneH3HeH 6 1,0 1,0 1,0 0,5 0,5 0,5 πογη6 apHKJioryaHo- 7 1,0 1,0 1,0 1,0 0,5 0,5 0,5 0,5 3HHa 8 0,5 1,0 0,5 0,5 0,5 0 0 0 0,8+0,3 0,6+0,2 0,3+0,1 IlojiyyaBuiHe 9 0,5 0,5 1,0 1,0 1,0 1,5 πογη6 ruiape6o 10 1,0 1,0 1,0 1,5 1,5 2,0 2,0 2,0 II 1,5 1,0 1,5 1,5 1,5 2,0 πογη6 12 1,0 1,0 1,0 1,5 1,5 2,0 2,0 2,0 0,9+0,3 1,2+0,3 1,6+0,3

Ta6jiHiļa 2

TfmecTb KJiHHHnecKoro τθ«θηηη 3KcnepHMeHTaJibHoro repneTmiecKoro KepaTMTa y KpojiHKOB, JieueHHbix 3% cycneH3Heii au,nKJioryaH03MHa η 3% Ma3bfo aijHKJioBHpa (b 6ajuiax)

IlpOBOflHMOe jieueHHe N? KpO- JIH- KOB ϋροκ Ha6juofleHHH τηκθοτη 3KcnepnMeHTajibHoro repneTH^ecKoro KepaTMTa (b ,π,ηλχ): b HHCJiHTejie - ot MOMeHTa 3apaxeHHa, b 3HaMeHaTejie - ot Hauajia ιιθμθηηη 3/0 5/2 7/4 10/7 npaBbift jieBbiii npaBbiii JieBbiH npaBbiH jieBbiii npaBbifi JieBbifi rjia3 rjiae rjia3 rjia3 rjia3 rjia3 rjia3 rjia3 Tpynna I 3% cycneH3Hfl au,HKJioryaHO-3HHa 1 2 3 4 1.5 1,5 1,0 0,5 1,0 0,5 0,5 0,5 1.5 1,5 0,5 0,5 0 0 0 0 1.0 1,5 0,5 0,5 0 0,5 0 0 1.0 1,0 0,5 0,5 0 0,5 0 0 1,3+0,2 0,6+0,2 0,3+0,3 0,1+0,2 Tpynna 2 37o M33b aiņiKJiOBHpa 5 6 7 8 1.5 1,5 0,5 0,5 0,5 0 0 0 1.5 1,0 0,5 1,0 0,5 0,5 0 0,5 1.5 1,0 1,5 0,5 1,0 0,5 0,5 0,5 1,0 1,0 0,5 0,5 0,5 0,5 0 0 1,2+0,2 0,7+0,3 0,5+0,2 0,2+0,2 Tpynna 3 9 10 II 1.5 1,5 2,0 2,0 2,5 2,0 2,0 2,0 1.5 1,5 1,5 2,0 1,5 2,0 2,0 2,0 1.0 1,0 1,0 1,5 1,5 1,5 0,5 1,0 1.0 1,0 1,5 1,5 2,0 2,0 2,0 2,0 1,2+0,2 1,6+0,3 1,9+0,3 1,7+0,5 LV 10838

ΟΤΕΡΑΤΥ PA 1. Andreeva O.T., Lidak M.Yu., Zhuk R.A. et al. Study of antiviral properties of acyclovir. - B kh.: y Me3KflyHapo,ņHb[H cnMno3nyM coiļnajiHCTHqecKHx CTpaH "Ahthbh-pycHbie Beui,ecTBa". Te3ncw. Pnra, 6-8 ceHTH6pfl 1982 r., c. 36. 2. Βοτηκοβ B.H., AH^peeBa O.T., BjiaflbiKO Γ.Β. η ,π,ρ. ripoTHBOBnpycHbie CBOficTBa ηοββιχ aHajioroB ryaH03HHa. - B kh.: "Hyoeo3Hflbi, npon3BOflHbie dHiļHKJiorenTaHa h a,ņa-MaHTa, flpyrne aHTHBHpycHbie BemecTBa". MaTepnajībi 3aceflaHHH προόΛβΜΗΟίί komhcchh "Xh-MHOTepariHH H XHMHOnpO$HJiaKTHKa BHpyCHblX ΗΗφβΚΙ1ΗΗΜ Η οδ'ΒββΗΗβΗΗΟΗ HayiiHOfl CeCCHH npo6jieMHOH komhcchh, EeHopyccKoro HHH θπηαθμηολογηη η μηκρο6ηολογηη h BejiopyccKO-ro HayMHoro MeflHiļHHCKoro o6mecTBa μηκρο6ηολογοβ, θπηαθμηολογοβ h napa3HTOJioroB. Mhhck, 1-2 fleKadpn 1981 r;, Mhhck, 1981, c.31-35. 3. AHflpeeea O.T., Ky30BKHHa H.A., UlaBpoBa E.H. h flp. HMMyHOJiorHuecKaH peaKTHB-HOCTb ΓφΗ 3KCnepHMeHTaJIbH0ii repneTHHeCKOH ΜΗφβΚφΙΗ B yCJIOBHHX ΓφΗΜΘΗΘΗΗΗ npOTHBO— BHpyCHblX CpeflCTB. - B KH.: "ΠροδΛβΜΜ H nepCneKTHBbl H3yHeHHH HyKJie03Hfl0B, 6HI1HKJIO-remaHa, aflaMaHTaHa h flpyrHx npoTHBOBHpycHbix οοθαηηθηηη b θκοπθρημθητθ b κληηηκθ". MaTepHaJIbl 3aCeflaHHH Πρ00ΛΘΜΗ0Η KOMHCCHH "XHMHOTepanHH H XHMHOnpO$HJiaKTHKa BHpyctwx ΗΗφβΚρΗΗ" Η οδ'ΒθβΗΗΘΗΗΟΗ HayHHOfl CeCCHH ΓφΟδΛβΜΗΟΗ KOMHCCHH, BeJ10pyCCK0r0 HHH 9ΠΗ— ΑΘΜΗΟΛΟΓΗΗ Η ΜΗΚροδΗΟΛΟΓΗΗ H BeJIOpyCCKOrO HayUH0r0 MeflHIļHHCKOrO odmeCTBa ΜΗΚροδΗΟ-jiotob, snHfleMHOJioroB h napa3HTOJioroB. Mhhck, 1982, c.115-116. 4. AHflpeeBa O.T., Ky30BKHHa H.A., lūaBpoea E.H. h flp. Βληηηηθ προτΗΒΟΓΘρπβτΗΗβ-ckhx BeiiļecTB Ha ημμ^ήοκομπθτθητηηθ κλθτκη opraHHSMa. ΟοοδηβΗΗβ I. Η3μθηθηηθ $yHK-IļHOHaJIbHOH aKTHBHOCTH JIHM$OlļHTOB ΗΗΤΒΚΤΗΜΧ ΚΗΒΟΤΗΜΧ nOfl BO3fle0CTBHeM πρΟΤΗΒΟΓβρΠΘ-τηηθοκηχ BemecTB. - B kh.: "AHTHBHpyHbie BemecTBa". MaTepHaJIbl 3ace,a,aHHH προόΛβΜΗΟΗ komhcchh "XHMHOTepanHH η χΗΜΗΟπροφιυΐΒκτΗΚΒ BHpycHbix ΗΗφβκφΐΗ, oco6o onacHbie H Mefl-jieHHbie (BHpycHbie) ΗΗφβκμΗκ" η ο6τ>θαηηθηηοη HayuHOH ceccHH npoČJieMHofi komhcchh, Be-jiopyccKoro HHH θπηαθμηολογηη η μηκρο6ηολογηη h EeΛopyccκoΓO HayuHoro μθαηι^ηηοκογο o6ņecTBa μηκρο6ηολογοβ, θπηαθμηολογοβ h napa3HTOJioroB, Mhhck, 1983, c.IOO. 5. AHflpeeea O.T., Ky30BKHHa H.A., AcTaneHKO A.C. h ,ņp. Βληηηηθ npoTHBorepneTH-ηθοκηχ BemecTB Ha ημμ^οκομπθτθητημθ κλθτκη opraHHSMa. Coo6meHHe 2. Χθμοτοκοηηθο-KaH aKTHBHOCTb HMMyHOKOMnOHeHTHblX ΚΛΘΤΟΚ npH 3KCnepHMem^bH0M repneTHUeCKOM 3ΗΙ1Θ-φθΛΗΤΘ B yCHOBHHX CneiļH$HHeCKOH ΧΗΜΗΟΤθρθΓΙΗΗ. - TaM *e, C.I02. 6. BHpycHbie BaKiļHHbi h npoTHBOBHpycHue npenapaTbi. ļooafl HayHHOii rpynnbi B03, cep.τθχηηηθοκηχ flotcnaflOB 693. B03. leHeea, 1985, c.78. 7. IlaHKaMa A. Ηοβμθ βθηηηη b pa3BHTHH oa3Hbix npenapaTOB. - B kh.: MaTepnajībi CHMno3HyMa "Κληηη^θοκοθ πρημθηθηηθ b οφτβΛΒΜΟΛΟΓΗΗ npenapaTOB rpynnbi "ΟφτΕΗ"". M., 06.04.84, 1984, c.69-76. 8. Brigden D., Whiteman P. The mechanism of action, pharmacokinetics and toxicity of acyclovir - a veview. /Acyclovir A symposium held at the Royal Free Hospital, Hampsted London Nki^, November 1982, on Behalf of the British Society for the study of Infection// J.Infect.- 1983. - VG, suppl.1 - p.3-9. 9. Falcon M.G., Acyclovir in herpes simplex keratitis - inbid., p.37-40. 10. Kolioponlos J. Acyclovir - a promising antivirai aģent: A review of the preciinical and clinical data in ocular herpes simplex management/ Ann.Ophtalmol. 1984. - V.16, No. 1. - p.19-24. 11. Zovirax. Ophthalmic intment. Instruction to the medical and pharmaceutical professions /Wellcome Foundation LTD // 4494/e/f/g. - Dartford, England. - 1981. 4 p.p. 12. Ejihhob Η.Π. HenoTopbie MHKpobHbie nojincaxapHflbi h ηχ πρβκτΗΜβοκοβ πρημθηθηηθ "Υοπθχη MHKpo6nojiornn", Μ., 1982, τ.Ι7, c.158-177. 13. Ejihhob Η.Π. ΜκκροόΗΜθ nojiHcaxapHflbi η nepcneKTHBbi HcnoJib30BaHHH ηχ β $apMa Ρθβτηηθοκοη npaKTHice. - Β κη.: MaTepHajībi Π BcepoccHiicKoro ci>e3fla $apMapeBTOB. Μ., 1969, c.91-92. 14. MojiflaBep E.fl., ΓγρβΒΗΗ H.fl., ToHHapoBa H.E. h ap. Πολ^θηηθ h cbohctbo cycneH3HH cy^b$aHHJiaMHflHbix ripenapaTOB Ha οοηοβθ ay6a3HflaHa. - B kh.: HaynHbie Tpy-flbi BHΗΗΦ, T.2I, M., 1983, c.88-94. LV 10838

ΦΟΡΜΥΛΑ M30EPETEHM5I

AeKapcTBeHHaii KOMno3nuMfl δλη λθηθημη repneTnsecKnx KepaTMTOB m KepaTOKOHbiOHKTMBMTOB Ha ocHoee aum<AoryaH03MHa, OTAUHaiomancfl τθμ, hto, C UeAblO nOBbllUeHMfl δΜΟΔΟΟΤγΠΗΟΟΓΜ, TOHHOCTM Δ03ΜΡ0ΒΚΜ M yAo6cTBa npM npHMeHeHMM, OHa ΔΟΠΟΛΗΜΤΘΛΒΗΟ ΟΟΔθρΧΜΤ ayČa3MAaH, 6opHyiO KMCAOTy, HMnarmH, nponMAnapaoKCM6eH3oaT m AHCTMAAMpoBaHHyio BOAy ripu CAeAyiouieM cooTHOLueHMM ΜΗΓρβΔΜθΗτοΒ, %(Macc): 1,0-5,0 0,3 -1,0 1,6-2,0 0,07-0,14 0,03 - 0,06 ocraAbHoe

aUMKA0ryaH03MH ay6a3MAaH 6opHan KMCAOTa HMnarklH

nponnAnapaoKcn6eH3oaT Β0Δ3 AMCCTUA. s

Claims (1)

1. Ārstnieciska kompozīcija uz acikloguanozīna bāzes herpētisko keratītu un keratokonjunktivītu ārstēšanai, kas atšķiras ar to, ka, biopieejamības un dozēšanas precizitātes palielināšanas, ka arī ērtākas pielietošanas nolūkā, tā papildus satur aubazi-

   dāņu, borskabi, nipagīnu, propilparahidrofcšibenzoātu un destilētu ūdeni sekojošās ingradientu attiecībās, masas %:· acikloguano'zīns 1,0-5,0 aubaz idāns 0,3-1,0 borskābe 1,6-2,0

   nipagīns 0,07-0,14 propilparahidroksibenzoāts 0,03-0,06 destilēts ūdens pārējais