BbrcBoEoxAEH 14 E EhO nofnq ECK]4.PDF

ffi rssN xypHan 0367-3014 FAffiMAT$IVA www.rusvroch.ru ll,t li'i t::il ;;1,' i:i, :r jj: :: | ,', ,,a,, ,,t ,a.,, ,. rl]i 1'' ti ,:i iii,i ll..:. tr, : -, .1r l-.,: , I I : l,i ;t {, s I ivi r} f i r-: I F} I'1 (] : [-rI f'I I( 14 H A OC HOB w Jr 14 i'r{x:(.lMAfl L}HAR $A P M A i I r, B l ;:.. 14 L{ E M Tosn A'I bTOAE KCT P I/ HA {rcprvtA AuEI4n Ll!4trEl!HA EC t<L4tA p br Fr OE KOq h/ Er!1! rCC I I 14 TAJI bI"IAFI TFAPMAUVIfr 34 PYFEXOIVI E'.C_5 r/ X C P En CT I 65 *-4 **r6 Texnonorre neKopcTBeHHbrx cpeAcrB @ YAK BbrcBoEoxAEH 14 E EhO nofnq 61 l(oaaetog oaropoa, 5.322:582.583.21:61 2016 5.453.41.01 5..4 ECK]4 AKTHBHbTX COEtrUHEHUfiI EKCTPAKTA HME.UP9 IA3- KANCY'I H. E. [eur4Ha*,,qoKTop Qaprvarleerht{ecK4x HayK, npoQeccop, A, Ha,qep, M.H. AnypoBa, KaH.EhAar OapMarleBTilqecKilx HayK, B.B. CrvrnpHoB, K;H.qlt,qar QapvaL-leerhqecKux HayK, A.J4. 6ap,4aroa, KaHAnAar Qaprr,tarleerilqecKhx HayK, v.vl. KrOp QaprvraqeBTnq ecKhx HayK, n pooecco p rocygopcrsgxxrri M,eautllaactcvth yHhBepc',{rer uu.tA.M. Cevexoao; KpacHK)K, flepesri Mocroecrri AO 119991, Mocreo, Tpy5eqron yn., A. 8, crp. 2 llent po6orar - u3YseHue BAuqHuel BuAo <oncyr u co,tn6utnsotopo Ho BHcBa5oKAenue 6uo,qoru,lecKu oKruBHbtx BeaecTB (EAB) oKCT7oKTo ,1M6upfl h3 AeKopcrBeHHon AapMbt. Morepuot u MeroAbt. O6beKroMu t4ccAeAoBoHurt c\yx{k\h )KeAoThHoBbE u rhApot<cunponu\MeruAueAArcAasHae (fnMU) Koncy bt, cyxoil (C3nA), BcnaMoToTeAbHoe BeuJecrBo, npeAcToBAntouJee co6ah Morpuunuu nonnuep, cocTanuJuh h3 SKCTpoKT t4M6upn ^eKopcTBeHHora nothoThteHrAL'lt<ottt 6044, BhHt4N<onpotoK'toMo h Bt4HuAoL,leToTo. B poSore npuBeAeHbt pe3y+broru recro kPocrBopeHhe, c ucnoAb3oBoHkeM cnercpoQorouerpuu. Pe3yfubforbt u o6cyxAeHne. noKo3oH6! conocToBuMbE pe3y\brorbt pocnoAoeMocil4 xeAoruHoaatx u fflMLl Koncy u BbtcBo6or<AeHuu EAB C3kA u3 Ht4x. Bt'teBAeHo y7eAhqeHhe pocTBopt4MocTt4 COkA s QacQorHoM 6yQepe c pH 6,8 B nphcWCrBut4 coaa6unuaoropo, BeeAeHue co\to5t4\t43oTapo cnoca6cTByeT noAHoMy BbrcBa6ot<AeHhn, uepes 45 ttuu e pocrBop nepexa4ut 97,5t3,8',6 oKT^BHbtx coeAuHeHhh et,cTpoKTo hs o6oux runoe xoncyl. 3orcNoqenue. fla ocuoeuaM not<o3oreAqM - pocnoAoeMocru u aarcao6ox<4euhn - KoncyAbr u3 xeAoThHo u TnMLI 6\usKu ,r cooraercrBytoT QopMoKoneuHbtM Tpe5aBoHueM. n3y'lqoeMoe BCnoMoroTeA6Hoe BeurccrBa. B<AoqeHHoe B rpoHy bt c cyxtlM ot(crpoKTaM uM6upn aercctpcraenuoro o^o3dBoel noAoKilreADHoe B^r14dhe io AUHoMhKY BbtC8060^AeHhet 6uaaoThceCru o^tuaHbu CoeAkHeHhu tn Koncy\upoBout-toh neropcraeauou 6oauat. KAloqeabte ctogo: co\to6t4Ak3o4uri. noBHLueHue pocrBaphMocTh, hM6uph AeKopcrBeHH6til, Zingiber af'ficinole Roscoe , Koncy\bt. *E-mail: diomina. nb@vandex. ru B BOAHbIX Cpenax BeX{eCTBaM. 3rO UOXer qBnrrrbc{ np[- rrnHoii Hr{3Koii 6noAocrynsocrx r,r repaneBruqecKoit BBEAEHI4E e@Serrlrnuocrr{ lpenaparoB tlM6upq. u6upr,rerapcrneHulrii (Zingiber fficinale Roscoe.) c.rlpeBHocrr{ t{3BecreH He ro-[bKO KaK npflHOCTb, HO U KaK neKapCTBeHHOe paCTeHHe. Mouorpa@lrr{ Ha cbrpbe <<nopotrroK KopHeBr.rxl nu6v14 HacrorzKu L{3 Hefo BKr}oqeHbr B OapMaKoneu Enponlr, Kyrafl., -fnoHr.ll uVInp.nv. pq neKapcrBeHHoro)> []. Kopuenurqe nu6upr o6nanaer rxr,rpoKr{M crreKTpoM 6uonofr,rqec Ko ii aKTr4BHocTI,t : oKa3brBaer npoTlr BOBOCfIaJIUTeJIbHOe, ilpOTuBOKaIlr.IeBOe, aHTUynbuepo- reHHoe, cIa3MorrrHTHqecKoe aeiacrnne, cTr,rMynt{pyeT fl[rr{eBapeHr4e. 9aue scero r,rN46l,{pb npuMeHqroT KaK IIpOTI,TBOpBOTHOe CpenCTBO, B qacTHOCTH rrpil TOrrrHOTe B frocreonepauuoHHoM rrepr{oAe, B rlepBbre Mecqubr 6epeveriHocrv, npv <MopcKofr 6o,rerstr> r,{ xHMI4orepailnn. Vcranon:reuo, qro npornBopBoruufi :@Qexr vM6Hp tL npaKrtlqe cKu paBeH e$$e xry MeroK,{o B noc-nenHne roAbr oco6uii r{Hrepec Bbr3brBaror Sap- MaueBTnuecKue pa3pa6oTKu TexHonofr.rii rroBbrrrreHr,nr pacrBopr{Mocrr,r aKrr{BHbrx cy6craHunri. Oco6eHuo ero aKTyanbHo &rls TBepabIX nepopa,rrbHbrx neKapcTBeHHbrx @oprtr, rrocKonbKy r{MeHHo oHH AeMoHcrpr{p}Tor Hr{3Kyro 6lro4ocrynHocrb B cn) {ae nrgpo$o6urrx cy6crasqufi. Culnarcr, qro Hau6onee npocrbrM TexHo,rroruqecKr4M perueHueM Bonpoca Mo)KeT oKa3aTbcq BBeAeHr{e B neKapcrBeHH)aro Oopuy BcrroMorarerlbHblx BeulecrB - co,'rlo6n,rr.r:aropon. Ile,rt Hacro.suer} pa6ortl - H3] {eHue B,rII4qHuq conrc6llrlu3aropots Ha srtc so6o)KleHr,re 6noxofr,rqecKr4 aK- rllBHbrx Ber[ecrB (BAB) 3KcrpaKra uxr6upx r{3 nepopa-rluoii reKapcrBeHHofr Sopun. 6uo,'Iolr4.{ecKoro KoMruteKca aKTuBHL,IX MATEPIIAII U METOXbI O6lexraltu r.{cc,'re.4oBaH vg cn]rlxvjruxenart{HoBbIe t,r rrupoKcr{rporr{,'rueJr,'rnno3Hbre (f IIMII) rcancy,ru No 0, cLlennHeHr4ri uu6ttpx neKapcrBeHHoro rJraBHbrMtr KoMfloHeHTaM14 cvlttarcr Qeuo,rlbHble coeAl{HeHli.s, Koropble, HaIOJ'IHeHHble rpaHynl{poBaHHbIM CTaHAapTI{3OBaHHbIM cyxuM 3KcrpaKroM utr6vpx neKapcrBeHHoro (CgI,IJI) c KaK LI3BeCTHO, OTHOCqTCfi K OfpaHI4rIeHHO paCTBOpHMbrM 5 Vo trpaMr4 - Aa [2, 3). B cocrase 42 co lepxaHHeM IuHIepo,'IoB. Watsqaagww2ol6, r. 65, Ne4 Texnonorrs neKopcrBeHHbrx cpeAcrB Tecr <.Pacreope Hre>> rrpoBoAr,rn14 Ha npn6opc DT600 Erweka GmbH. Cpeaoii cny.xvn $ocOarHsrii 6y(rep c pH 6,8, o6rev cpenbr - 800 ,r,{,l, cK0pocrb Bpau.(e rrHrr Kop- 100 o6/uHH, reMnepalypa - 37+9,5"6. Ko.,rr.r_ nepeuenuefo B pacTBop 3KCTpaKTa OtIpeAe.rrfln14 npl,voli cnerrpotforonrerpneil Ha cneKTposorolrerpe <Specord 250> Analytik Jena B KloBere rorriuuHor4 cno.s i cu npn EryrHe Bo,rrHbr 280+2 Hrl [4]. flpe.4aapure,rrHo 6rlro ycrauoBneHo orc),TcrBl,re aacop6quu pacrnopar.l.r 3I,IHKr.r qecTBo - bHbrx BeruecTB, rrpt{c),"TcTB}.rou{ux B cocTa Be neKapcrBesgori @oputr v caMwx Karrcylr. BCIION{OfaTe,rr PE3yJI bTATbI I,I B pesyltrare 3Kc n epr{M e OE CyXIEHI4 HTttJ'rbH oro _ E Llr,..trc Hrrs BIrLrg - nus conro6trnu3aropoB Ha pacrBoplrMocrb C9I,{JI ycra_ HoBJIeHo Irono)KI,ITeJ.IbHoe Aefi crgue BcfloMorareJl bHoto BeruecrBa, npe.qcraBn_arclI1ero co6oti uarplruutui ilont{_ Mep, cocro{wvn v3 rro;rrr3TtrJTeHrJruKo;rr 6000, eunN_rr_ KanponaKraMa v Br4rulrauerara. B xole 3Kcnepr4MeHTa BbrqBneHo ):BenltqeHHe pacrBopuMocrll COI4,fI e Soc@ar_ uou 6y$epe c pH 6,8 B npr4cyrcrBrru pa3ni.rqHbrx KoHueH- rpaqlrfi colrc6rarusaropa. C pocroM 4onlr co:rrc6vl:z3a_ ropa pacrBopr{Mocrb C9LII }'BeruquBaercs x Aocruraer 128,0+4)% npu \{accoBoM coorHorxeuuu l:4 (plrc.l). B Bore oqnuleHHoH Bnn_sHtre co,rrc6u,rH3aropa cHJTbHee, raK npu coorHotueHtrr C3l4JI:co,rn6u,rn:arop ( l:4) rroKa3aHo froBbrtleHHe pacrBopr{},{ocru Ha 66,2+3,5%. rfoplroii n,'ul 3KcrpaKra r.rl,16npl eu_ ,flercapcraeHHoii 6pautt Kancy,'Ibl, noro t43) reHul 6notpapMaueBTr,rqecKr4x rroKa3are,teii Ka(recrBa xeJ'rarr.{HoBbrx u f|IMII Ka[cyn, Harror.tHeH_ rrbrx cl4ecblo rpaHynr4poBaHHofo C9VI.II (200 ur) c co_ .'rro6uirr..r:alopoM (100 lrr). IlexapcrneHHorl @opllori cpaBHeHrl, CIty)r.L/tnv Kaflcynbr, Hano,rIHeHHbIe rpaHy_ J.rHpoBarrHbtv C314JI 6e: corrc6uJrrr,r3aropa. OnHca_ Hr{e rexHolor'r411 r.paHynnpoBatufl Cgl4JI ony6nzro_ naHo [7J. OcuosH ll N,t n o Ka3a'rcr e M, n ri M r4Tr.{pyrcur{M rrpouecc nltceo6o)KleLrufl 113 Kzlrrcy;r, rrBrlercl pacnaAaeMocrt. flpu onpeaerreHl/.:/. pacnanae Mocrr4 KancyJt o6oHX BI!{OB n Soc@arHorrl 6y$epe pH 6,8 yc-r.aHoBJreHo, rtro xe,TaruHoBbie Kancynbr pacna4arorcs za 320+40 c, KancyJ,tbr r,r3 |IIMII - 2a265+35 c. flo,ry.reHHbre 3HaqeFruu 6,ru:ru, coorBercrByror rpe6onauu.sN{ f(D XIll u He 6y4yr orca_ 3hlBarb cyrqecrBeHHoro B,'rHqHua Ha npo$raJrrb BblcBo_ 6oxIeHu-s KarrcynlrpyeMbrx BertlecrB. OxcnepuveuranbHo ycraHoBneHo, vro eucno6oxAeHue $euo,rsulrx coeanHeHnii COI,IJI n rpocSarHsrii 6y0ep He 3aBHcHT or rxrla fic[o,rrb3oBaHHbrX Kitnc]:.r, 3 onpeAeJ'I_sercq ronbKo cocraBoM coAep)Kl{Mofo. Tax, nu_ cno6oxnenre Kar pr:eecrHo, % 140 120 80 60 40 KaK cbrpbe xtrBorHoro nponcxoxneHn-q N,roxer 6srrl 20 Hocr4Te,rreM :a6o.qeeaHltir x}reoruttx, c[oco6uHX rrpl{_ Hecru Bpe.u 3nopoBblo qeJ.roBeKa. Kpoue roro, r4Merorc.s 0 qeH n'I np l 100 ocHoBHbrM Marepl{zL,roM An.q r43ro_ ToB,rIe Hlr-lt Kancyn flBjrfler cx xeJIarHH. Onuaxo xe,rtarl{H 14 o6pa:qoB, conepxauux rpaHynr{po_ TaK KaK oHu or,rllrqalorc_s Ml4HHMlr\,IoM OapMarlesruqecKr.rx @arropon, cnoco6ntrx orpuuarenbHo Blrurrrb ua elrcno6oxneHue co.qep)KllMoro. o f pa H u: LI 14 C ft On b3 o Ba H I,{ I4 )Ker'I aTHH a nJIfl On p e _ 'i{. "[eJ'r HHIIX rare rop l.rfi norpe 6nre,re ri ( rereraprr aHr{br r.{ HeKoropbre penr4ruo3Hbte vnw srHlrrrecKr,re rpynnu). e llo:rouy B nocneAHne roAbr BeAercf rroucK ,=:l :: aJ,IbreD- HaTI,IBHbIX MaTepI{ar,-IOB l{_rl-s I,t3rO- TOB,rteHHf Kancyn, B qacTHocTU K TaKIIM MaTepl{a-flaM, r I'{ApO K C X I] p :a (ffIMIl), oTHOCt4TCfl 120 Koropa-s uupoKo r{c- \o -:100 O rI l{,rl M eTI4I Ue,,-Lq }O,'I O a Qapvauenrrlqecroii Ilpo}lbrIxneHHocTH B KaqecTBe noxplrruli ua ra6,terxn lr ocHoB Infl tst3KoftJ'IacrI,IqHbIX $opvr : re,reil u Kper,roB. fnMU xopouo coBN{eCTHMA C I{3BCCTHbIMI,{ BCIIOMOfATeIbHbII,lX BetUeCTBalvILt U HMeer nolo6uue xe-tarllHV caoiicrsa rroJTb3yercs Ero x60 o-" -**- TAV co lu 20 O6pa:eu I O6pa:eu 2 30 Bpelu, vltrr t5, 6l B Hacroqureii pa6ore npnBoD,qTCfl pe3ynbTaTbr cpaBHLrTenb_ W,*ttgs*a,aqbeg4 L zot 6, r. 65, Ne4 ii: |:: , 43 Texronorrs neKopcrBeHHbrx cpeAcrB nauurrri 3KcrpaKT 6e: co,rrc6r,r-tr,r3aropa, He aocrr{faer @aplraxoner?ulrx rpe6onannh'. za45 uuu u3 neKapcrBeHuori Qopr,ru B pacrBop nepexoar4r,ruurl 63,3*3,}Vo BAB r.r3 )KeJrarr.{HoBbrx Karrcyt n 64,5+3}% vz fflMU rcan- cyr. Boslroxuo, rpurruHa HenorrrHofo nlrcgo6oxneHHq - He TO,TILKO HH3Kat, HO I{ 3aMe.4neHHag paCTBOpl.{MOCTb 3KcrpaKTa. BeeAeHl.Ie co,rro6lrqx:aropa cnoco6cro-ver npaKTl{qecKx no-rrHoMy ssrceo6oxtreHH}o. T.e. peKoMeH gyenoli $apuaxoneaMr4 HopMbr (757o) nora3arerrb rocrufaer pKe 3a 10 lrr.lH, a qepe3 45 l,ruu B pacrtsop nepeXO.Uur 9 7, 5 * 3,8Vo axrnsubrx coenllH e rr u r.i e rcc |pax'r'a N r o6oux rr{rroB Kancyn. llpoSu,ur Kpr{Bbrx slrcno6o)Kne u: ffiMII H Hq 6A8 3KcrpaKra Kaflcyn npr.rBeAeHbl ua puc. 2. 3AKTIOT{EHUE flo ocnosF{lrM noKa3are,'IqM - pac[anaeMoc-tv u rr,rcso6o)KneHlrto - Karrcynbl ri3 )Ke,.rarr,lHa n |IIMU 6 tuzrcu l{ coorBercroyrcr Qapuaxoneft utru rpe6onanl.r qN,{. BcnoNrorarenbHoe Berr{ecrBo, BKrroqeHHoe B rpaHynbr c c1a<lrM 3KcrpaKToM uwr6upx reKapcrBeHHoro, OKA3bIBAET TO,qO)KI,ITC,TIbHOC cno6oxlenuq B,rU4-gH I,{C HA Ah HAMHKY B bI - 6l.ro;roruq ecKlr aKTHBHbrx coenrlnenuri H3 KancynrpoeaFrHorl neKapcrBeHuori @oplru. N cpeAcrB, 2015: 4 (13):82-90. [Volchihino O.Yu , Diomino N 8.. Noder A Ginger rhizome os o promising plonl moteriol to creote medicines. Development ond registroiion of medicines, 2015:4 (13) 82-90) (in Russion) 2. Boger S., Ovesen L. Assessmenl repol on Zingiber offictnole Roscoe, rhizomo. Londonr Europeon Medicines Agency, 2012: 49 3. A service of the U.S. Notional Institutes of Heotth UMCCOP 02-01 Ginger in Treoting Nouseo ond Vomiting in Poilents Receiving Chemoiheropy for Concer (lRB 2003 55'1) URL: hftps://clinicoltriats gov/ ct2i show/NCT0006427 2 (dote of occess 20.09.20 1 5). 4. L1{enov<rHo O.lO., [evnro H.6., )Koroeo A.A. r.r 4p. Onpe4eneuze 6r.ronoru.recr<tz or<TtBHblx Beu1ecrB B cyxoM 3l(crpoKTe t M6Api neKopcTBeHHoro (Zingiber officlnole Roscoe). Po3po6orKo 14 perhcrpcur4q Aet(opcrBeHHbrx cpeAcrB, 2415 2: 160-166 (Shepochkino O.Yu,, Diomino N,8., Gogovo A,A., Anurovo N.M., Votchihino O.Yu.. Noder A. Determinotion of biologicoily octive substonces in the dry extroct of Zingiber officinole (Zngiber officinole Roscoe). Development ond registrotion of medicines, 2015:2:160-166 (in Russion). 5. Quoli-V Hypromellose copsules Hondbook, 41 crp.,aaeopt2012. 6. AeM[Ho H.6., AeMhH M,C, Pospo6orKo TexHonon4l4 npo/3BoAcrBo KoncynbHbrx Qopr',r neropcreeHHbtx npenoporos I l(H.: @opuoqeerwecKol po3po6oTKo. KoHqenLUg ta npot<Tr4LlecKte peKoMeHAoql.ltl. M,. raA. f1epo, 2015: 19G236. [Diomino N.8., Demin M,S., Development of lechnology for production of dosoge forms in copsules, Phormoceuticol developmenl. The concept ond procticol recommendoiions. Moscow: Pero 2015; 169-236) (jn Russion). 7. Ho4ep A., Bonl,]|4xuHo O.fO., AHypoBo M,H., AeM/Ho H.E. BnorooxrusrsiapoBoHHoe fpoHyntapoBoHt,le hM614pe 3t(crpor(To cyxoro. Pcapo6orKo, l4cc^eAoae{t4e / MopKeT/Hr HoBoh QopMoqeBTt4qecKoi npoAyKLlt4r. C6. HoyvHurx rpy4os, esrn. 70. l-lnrirropcr<; Pl4A l(MB. 2015; 13G-3 (Noder A.. Votchihino O,yu.. Anurovo M,N , Diomino N.B, Blogoustroeno gronuloiion ginger dry extroct. Development, reseorch ond morketing of new phormoceulicol products. Collection of scientific popers, issue 70. Pyotigorsk RIA hTEPATPA/REFERENCES l(MV 2015; 130-3) (in Russion). 1. Bonu..ll,4xr1Ho O.fO , [evr.+ro H.6., HaAep A. l(opHeBhu.ie /M6Ape, koK nepcneKTr4EHoe pocTt4Tenbsoe cbtpbe Mq co3aoHtlrl AeKopcrBeHHbtx cpeAcrB. Po3po6orKo h perficrpot_lt4r AeKopcrBeHHbtx Ilocmynuta 30 noadpa 2015 e. RELEASE OF BIOLOGICALLY ACTTVE COMPOUNDS OF GINGER (Zingiber fficinale Roscoe.) EXTRACT FROM CAPSULES Professor N.B. Demina, PhD; A. Nader; M.N. Anurova, PhD; V.V. Smirnov, PhD; A.I. Bardakor PhD; Professor I.I.Iftasnyuk, PhD LM. Sechenov First Moscow State Medical [Jniversity; 8, Trubetskaya St., Build. 2, Moscow 119991 SUMMARY Obieclive: to investigote ihe effect of the type of copsules cnd o solubilizer on the releose of biologicolly oclive substonces (BAS) of ginger (Zngiber officinoie Roscoe.) extroct from its dosoge form. Moteiols ond methods. Gelotin ond hydroxypropylcellulose (HPC) copsules, dry ginger exlroct (DGE), ond the excipient thot is o motrix polymer comprising of polyethylene glycol 6000. vinyl coproloctom. ond vinyl ocetote were the subjects of the investigotion. The poper gives the results of the test (Solution) using spectrophotometry Resu/ls ond discussion. The comporoble results of disintegrotion of gelotin ond HPC copsules cnd relecse of BAS of DGE from them were shown. The solubility of DGE wos found to increose in phosphote buffer ot pH 6.8 in the presence of solubilizer. The incorporotion of the solubilizer contributes to compleie releose; following 45 min, 97.5t3.8% of ihe octive ingredients of ihe extroct from both types of copsules convert to o solution, Conclusion.In terms of the moin indicotors (disintegrolion ond releose). gelotin ond HpC copsules ore close ond comply with the phormocopeio requiremenfs. The excipient solubilizer incorporoted into the gronules with DGE hos c positive effect on the dynomics of BAS releose from copsules Key words; solubilizotioni enhoncement of solubility; ginger, Zinglber officinate Roscoe , copsules. 44 @mpwaaaffiffi2o16, r. 65, Ns4