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LAMPIRAN I PERHITUNGAN UJI HOMOGENITAS DAN RATA-RATA DATA SANGAN DARI AREA BAWAH KURVA (AUC) f5ERHITUNGAN U J I HOHOGENITAS D A N RATA-RATA ( AREA DI BACJAH EURVA ) : NU. ,:A ):=A : ,:H : : 964.57 1014.5 914.22 1116.7 1088.4 DATA HERPASANGAN x2b : : D = >:H-;:A D2 ................................................................ 1 ! 1415.0 2002451.12 2 ! 1331.0 1771629.94 3 : 1556.4 2422435.12 4 : 1218.7 1485267.71 5 : 1242.2 1545263.07 : : 930409.96 : -450.55) 1029370.7 : -316.44 835798.29 : -642.19 1247191.0 ! -101.93 1184804.3 ! -153.79 ................................................................ T O T A L ! 6763.5 9225046.98 5098.6 5227574.1 : -1664.8 ................................................................ 5 r, : 5 5 PIEAN S1) : : 1352.7 137.84 I I ! 1019.7 ! . 84.181 1 : 202952. 100138. 412417. 10371.4 23552.5 749552. -7-7 ,.,\L. 97 220.900 .................................................................. PROSEDUR P E N G U J I A N HONOGENITAS ( U J I DlJA V A R I n N S ) ................................................ PROSEUUK P E N G U J I A N : 1. H o : S2A = SzH; A r t i n y a , kedrra h a s i l p e n g u k u r a n ~ n e m h e r i k a nv a r l a r l s yang t i d a k b e r b e d a s e e a r a s i g n i f i k a n . ti: S Z A # S'H; h r t i n y a , kedua h a s i l p r n g u h u r a n memberikan v a r i a n s yang b e r b e d a s e c a r a s i g n i f i k a n . 2. Fo = varians terbesar ------------------ 3. T b r n f s i g n i f i k a n s i = C1.10 dbl = 4 db2 = 1 , 4. 137.845823 = ----------- var-ians t e r k r c i l 84.1919045 = , F tabel = BERPA- 6.19 I:e.-i.mpulan: k a r e n a F o b s e r v a s i < F t a b e l , maka Ho d i t r r i m a dan I-la d i t o l a k . J a d i l : e d ~ ~ ha a s i l p e n g u k u r a n memberli.:an v a r i a n s yang t i d a k b e r b e d a s e c a r a s l g n i f i l , e n . - LANJUTAN PKOSEDUR PENGUJIAN: ------------------- I MAI.:SIMUM 1. t o : uD = 0:. tidal: add perbrdaan r a t a - r a t e a n t a r a p e r l a k u a n A d e n g a n p e r l a k u a n H. tia : LID # 0; a d a p e r b e d a a n r a t a - r a t a a n t a r a perlakuan A dengan p e r l a k u a n H . 2. u j i - t , d i m a n a d b . = n t ( . 0 5 / 2 ) = 2.776 - 1 = 4 3. M e n c a r i t o b s e r v a s i ( t o ) : ...................... 3. Kesimpulan : Karena / t abcervasi / = 3.370 > t( . 0 5 / 2 ) ma&.a Ho d i t o l a k d a n Ha d i t e r i m a . J a d i p a d a t a r a f c i g n i f i k a n s i 5% d i s i m p u l k a n bahwa a d n perbedaan yang s i g n i f i k a n a n t a r a kedua p e r l a k u a n . LAMPIRAN 11 PERHITUMGAN UJI HOMOGENITAS DAN RATA-RATA DATA BERPASANGAN DARI.WAKTU OBAT MENCAPAI KONSENTRASI MAKSIHUM DALAM DARAH ( T m a k s ) FERHITUNGAN U J I HOMOGENITAS DAN RATA-RATA DATA BEFiPASANG61.I ( WAETU WENCAPCLI I:ONSENTRASI HAKSIMUPI ) ................................................................ NO. : A I ):=A : xB : 91.050 90.61 90.37 90.316 92.596 : : x'b D = >:B-):A D" ................................................................ : : 68.581 75.477 54.055 68.055 b4.273 505.855 228.989 592.389 495.529 802.225 TOTGL: 340.44 23266.2821 : 454.94 41398.431 : 114.498 ................................................................ rt : 5 5. ................................................................ 2723.99 : : : 4703.47700 5696.86810 4103.2t081 4631.61915 4131.05709 : : : 8290.2563 8210.1721 8166.7369 8157.0701 8574.1958 : : : : 22.469 15.1324 26.3153 22.2505 28.3235 1 2 3 4 5 : MEAN SD : : 69.089 4.5274 ------ : - c I : 90.988 0.9444 .................................................................. PROSEDUR PENGUJ IAN : ------------------- : 22.8997 5.1:1495:. - -- - - .-. 1. Ho : mA = me, t i d a k . e d a perbedaan r a t a - r a t a a n t a r a p e r l a k u a n A dengan p e r l a k u a n B. Ha : mA # mu, ada p e r b e d a a n r a t a - r a t s a n t a r a perl a k u a n A dengan p e r l a k u a n B. 2. u j i - t , d i m a n a d b l = dbZ = n-1 = t ( .05/2)= 2.776 4 3. t i e n c a r i t o b s e r v a s i ( t o ) : A : BASIS ~t~/a ---------- ===---------- B : BASIS a/m ============= - = --------c >: X n = 90.90386 n = .- 5 .- --. LANJUTAN / / ( SzA/nA + SzR/nH) V wl. t l + w2. t 2 ' Eesimpulan : Karena / t o ' / < d a r i t i t i k k r i t i s maka Ho d i t e r i m a dan Ha d i t o l a k . J a d i t i d a k a d d p e r b e d a a n y a n g s i g n i f i k a n a n t a r a Cedua p e r l a k u a n . -- . - PROSEDUK i . . ..- . - PENGUJIAN: ------------------- , / . 1. Ho : LID = 0:. t l d a k add p e r b e d a a n r a t a - r a t a a n t a r a p e r l a k u a n A dengan p e r l a k u a n R. Ha : uD # 0; ada p e r b e d a a n r a t a - r a t a a n t a r a perl a k u a n A dengan p e r l a k u a n H. = n 2. u j i - t , dimana db. t ( . 0 5 / 2 ) = 2.776 3. Mencar1 t r b s e r v a s l .I.. ...................... - 1 = 4 (to): I..:osimpulan : karena / t observael / = 10.14 :; t ( .05/2j maka No d i t o l a k dan Ha d i t e r i m a . J a d i yada t a r d f s i g n i f i b . a n s i 5% d i s i m p u l k a n bahwa add perbenaan yang s i g n i f i k a n a n t a r a Cedua p e r l a k u a n . I LAMPIRAN I11 PERHITUNGAN U J I IiOHOGENITAS DAN RATA-RATA DATA BERPA-SANGAN DARI KADAR OBAT MAKSIMUM DALAM DARAH PERHITUNGAN U J I HOMOGENITAS DAN HAT&-RAT& DATA HERPASANGGN ( KONSENTRASI MAP.SIMUfl ) ................................................................ NO. n : wA : : 5 : ,:B - . 5 w A ' x"b - 8.4067 : 5.6751 1.6757 : 0.8143 ................................................................ NEAN SD : : D" 5 I : : : D = ,:B-xA -2.5316 2 -30394 PROSEDUR PENFUJIAN HOMOGENITAS ( V J I DUA VARIANS) PROSEDUR PENGUJIAN: I . Ha: SxA = S28: A r t i n y a , kedua h a s i l p e n q u k u r a n memberikan v a r i a n s yang t i d a k b e r b e d a s r c a r a s i g n i f i k e n . Ha: S'G # S"H; A r t i n y a , kedua t i a s i l penqul.uran memherikan v a r i a n s yanq b e r b e d a s e c a r a s i g n i f i l , + n . 2. Fo = varians terbesar -----------------varians terkecil 7 . Taraf dbl = . s l g n ~ f i k a n s i= 4 dt-2 = 1..1757':1756 = <1.814;62':lC. ' ----------- = 0.10 4 . F tzbel = 6.39 4. Kesimpu 1 an : k:arena F u b s e r v a s i < F t a t j r l tla d i t o l a l : , J a d i kedua h a s i l ma1 a I l o d l t e r i n a darl pcngul:urarx member-iban v a r i a n s yang t i d a b h e r b e d a s e c i r a s i g n i f i l : . a n . - LANJUTAN PROSEDUR PEP4GUJ IAN: ------------------- I MAbSIMUM 1. Ho : uD = 0:. t l d a k add perbedaan r a t a - r a t a a n t a r a perlakuan A dengan perlakuan R . tin : LID # 0: ada perbedaan rata-rata Iakuan A denqan p e r l a k u a n B . 2 . u j i - t , dimana d b . = n t(.05/2)= 2.776 - 1 = antara per- 4 3 . Mencari t o b s e r v a s i (to): 3. Kesimpulan : k'.arena / t o h s e r v a s i / = 2.457 C t ( . 0 5 / 2 ) maka H u d i t e r i m a dan H a d i t o l a k . J a d i pada t a r a f s i g n i f i k a n s i 5% d i s i m p u l k a n bahwa t i d a l ada perbedaan yang s i g n i f i k a n a n t a r a kedua p e r l a k c ~ a n . ! LAMP1RAN IV DISTRIBUSI t PADA BEBERAPA LEVEL PROBABILITAS scr rr- 5," .,b.,, ,..,.... 7.. >,I c> ..., ..<,", o. I * 1 ,.:d ,,., :. .,, ..,.r,t,.,...,l.,....II v",,.:,.r<:. .....:,. . I... l..h.. I . , 1.. L LAMPIRAN V DISTRIBUSI F PADA BEBERAPA LEVEL PROBABILITAS o*nrl I . l"8. ld" *I, I*"*$", T I %any-lhl.n -4- . ; _ .. . t h-1 0 vs v,. , CI.ll , I 1 2 I 1 I * 1 7 1 9 sn *#I 11 10 I1 ,. -.,,.., 16 I1 10 m a 344 *a s u 2.8 m z n r ~ 1 4 1 *tu .ma . . 14 j0 40, *a* su4 xsa nt. -6 l * , M tS.W ,,,St 4 4 s W.01 n . J T t9JS 18.30 1B.U 2924 I S m 2SJa 13le.40 19.41 1S.41 lS.41 lt44 IS.4S 2*.U U.U U.41 W.41 W.41 U . 4 4 U L S W . U W.47 W.28 W P W 3 9924 .*Y *>I 1Q.tl S<.II rr.4 ~ 3 8 2x7 us, m a a r *,&I 9JS *.I1 *,el 9.M hCd U 4 J SLS I n . 7 1 ~ J ~I Z ¶Id7 I n.49 ~ a.11 .Jt l l Z l 1P.W 1S.S. a I 4.p. m ~ L ?rn I wu t.8 1.11 I 4 m m - MI 841 3.z uu I.11 ns np 1.n s.14 . 1 . S.59 I . s.az . 4.74 4.a 11.26 111 S.IZ I0.M 4.26 l.02 1ld 4.10 *.I4 1.71 1.89 rrm n,n n.u UI 1.3 #.la I.W 1 - COO S . l 1.01 1.W IS.(# ICU 1111 l W l I 4 Y 14." I 4 Y I4.41 14.37 ILI ad* LII 1.11 10.8 8.w *Y (81 4.71 4.74 l6.lS 13.27 1Z.W 1139 1O.W 10.61 10.48 I 0 2 7 I 4 1 6 1O.W I 114 n.11 834 1.1r.69. n.sa 4.1.64 &IS.17 * *.U *.SS 4.- 4.e.47 2 4.14 I 7 1 M I.%I (.IS I 7 . 7 7.7 7 . Y I.= 2.91 1.2 7 <.IS 4.1% 3.97 1.1 3>7 1 0 J.lS.S.71 I I 1.6" ¶.W 3.W 1.37 1.11 a,<*' 1.4, a.s 1.41 0 1 a s 41* *.as S.01 ..*I 8 4 7 8 S 3.v a.2v *.la 3.t" 2.0, 1 M 8.l7 III 2.10 6.3" 3.07 1.61 a,,, *.." s . s us <.m 1,s. >.*I 2.89 11, 6.- 3.w 1.w 6.1) S.12 3.4" S.OT. 4.91 4.10 1 1 4.m 1.62 4.01 u4 dm a.41 I.2' . . us 6.27 am s.10 ~ . J J 3.a~ 1.11 IS 2- I W srw uw ua uu ur* uu I.62 sw m au S, .ut 0. ou 19.41 W.47 19.4s 11.0 21.4s 1S.S 1S.IO WAS WAS W.4. W.49 , ' . S I nY .r.IO 1.60 n . ~ 8.S nm 1.17 I S 1- W S.U n z ~q n n.14 n.nr S J I I J 4 6.M 1 7 1 1.14 1.11 1.10 1.6.U 1.61 1 1 4 ICI4 14.11 14.01 $,;I I W 13.14 1I.W llLl II.I1 IUI I3.U ::1: 4.7s 7 4.~1 LO, YSZ 4m -.- - , 4.12 id7 ..!I I- CLP <.<a 4.44 4.12 4.4e S,M 9- V2< 1.11 9.U **I '5.71 3.84 2 . ~ 6 a,?: 1.7, *m I P l a,). l.34 1,SZ 929 10., L z.0, 2.m I P .S.<l 3.- S 8 Y.?Z 2.m Y m a*. 4.n 9.04 s.02 ~ $ 9 I." I.-x u I.U 2.m 3.25 3.94 2.U S.00 3.r,% x~ ,.>: 2.x *.a r r sr rrr rtn a . 1 ~ a!: 431 - - . .-.. I.63 - . S C ,st. x.m 1.56 . 1.11 . .<r (.Y 9.m s.S1 1.7% ,.to 1.93 z.73 I.#! O X rn z., rm 7,z 4 ...- --. . 3 s,m 1.6s x.3 4*. .,,,, 4.(8 LAHPIRAN V I SURAT PERNYATAAN P E R S E T U J U A N D A R I T I A P SUKARELAVAN Svyo yang AL\W : ii~ura t e n ~ a n di bcrtondo habrh : ini T O B I ~ ~ Umur LIYAS I.IAPltOXBN, yurrt: Nrp :' 2443089018 Alomut : jl. soya ra yenc I.dupun vduiah 1. yand Mcrrjeluni pclncrikxr.bn d&r.ch u n t u k bioyo . cu- I . d i julunl : klilliz 1 ~ 1 c n a r 1 k s n k e ~ e h u t u r i zrcy; 10 ml tcta jrlur~l. p e ~ i c l l L I r ~ r rycire: ~ c b u ~ n t lr r i k u t t i ( l c . 1 ~ di11,rap- i , l ~ o s ~ - . i u r;*t a u i l i u r ~ nvyh proacdur kc3c:nputun u n t u k m y - ~ ~ r n11;p i ; - i n s efeh rnuneki~l t l ; r ~ b u l d u n pcnclitluu : Surabayo p e n j c l a ~ v n dsn I~ngunaun I;oproxcn, lion 10a Dinoyo rncndrpatkotr olch di1uhukr.n doktci urltuk i r ~ e n ~ r r c b ii l. . l r r - k i 1 . a gun diperl!inr d i t r n e ~ u n e ole) olch d l l:.horotorium pencliti- p ~ - ~ - dun LANJUTAN I - - 2. liowoncoro, rueliputi noh dideritu, hioaoon 3. rorknn, merokok sebclum 4. rikayut Puaae- - semulom . dek Dotong u1c1.ci mcnjclrne uioupun tempet tuknn woktunyo selamv waktu penyokit ysne tert~udopohot, kc- wsktu -- minu~ri obot pcnellti~n dan tllain satu minegu dun sort pennlitlan berlungnung. penelition bcruda tclrh diten- temput pcnclitisn 5. Dlambll sun111el d*z.vh aebunyuk 7.0 ml podo wsktu dun yang dl terval penelltiun. 0, 15. 30, 45, 60, ini auyn bunt 30, in- 120, 150, 180, 240 mcnit. Dernlkinn keaodvron don -. pcr- . loirl-lnin. dan penelltien ke riwnyut pernyotran tunpv puksobn plhuk-pihrk denean penuh luirr. ,- _I LANJUTAN Suya yang bertondo : HF17-d. G U T W T o Umur : rl S h n : S.- bodan aedio ~nenjodi a u k ~ r t l r ~ a d n ~ l o ~ pn e n e l l t i o n LIYAS BkFROXEN, yong I T : i i / ~ d e n g ~ n s e a u n g ~ u h n y a , bstrda Kcnyutnkun ini kg 1 01@0Y0 : Alotnot bnhnh di Hntss Bernt j tandon tloiriu : H Nrp : 244309901 8 Alumat : jl. dilukukun oleh i / sryu bcrPLZNGARUH 1 i 1 : & Dinoyo Surrbaya 100 I Pernyotoon auyo peraetujuvn mendupotkon nanyrken hol-ha1 kcgununrl Knproxen, hun ra penelition addlab ybng saya mengerti sc,r~ping yrng efcL den sctel~~h In-- tentang t i d a k dihorep- pros-dur a t n u t z t e arya okurr proscdur buut lrcaelnputrn urltuk drrr belum y@nl; n u n ~ k i l l t i n i b u l 1,dbpun 1. penjelanon ysng su:iu i l l i efi- jalani. ! , c ~ i r l i t i p n yci.6 aka12 d ij u l u n i actcg~l beri~ut : i . . c ~ ~ j ~ l u npic ~ n c r i k a u b f l i . l i r l i a ,rlemerikau 10 m l kcaellvLuii d c ~ . c t i untu;. SI.J, dblr di,,rr,lkau olch dokLcr uritul. ~ i i r n ~ u i o1t ~k i r u - 1 . i r cli 1. bur . t o r l u m u d.m - LANJUTAN -bioyr 2. ditenggung Wawoncaro, noh 3. Puosn duk meliputi dideritu, biosoan olrli semnlorn merokok don Dotang ke tuknn penyakit alergl perke- lain-lnin. moupun tempvt ysng terhedop obet, ~ncr~jelongwrktu sebelum penelition 4. riwayot riwaynt Inakun, peneliti. minunr obat penelitinn dun tilnin sotu rnincp,u don soat penalition berlungnunfi. penelition noktt~nyo dan tcleh ditcn- di tempat penelitiarl 5. Diombll salnpel dkrvh sebnnyok 2,0 ml pado aeloma woktu terval 180, wnktu 240 Dcmikion kesodoran don berudo yony penelltian. 15, 0, 70, 45, 60, 90. in- 120. menit. pernyetron tonpn ini pokseun sayo bunt pihnk-pihsk dengon penuh lrirr. I- Surrboyr, Hormrt Ijrr. UMI 150, ATIIIJAII, KC nay*, LANJUTAN -- Svya - - yang bcrtvnda --- - -- -- tan,:on di Iinlrla : lWATAi-7 SUKAHADI Umur : 2B W-n Derat Alamet : 3L.MOJO .I / Menyatukan aedia derlgsn menjudi PENAMUAIIAN ;I ulna ALUNIIiIUPI B : Pernyatnan auya hol-ha1 kegunrorl I<rproxeri, re hdapun adalah 1. olch dcrr beluro efeh s::v Ler- i'EI;GIJ<C!i ~ s y o lnengcrt.1 jang don says ten:&n& atou t ~ t sck- ~olcni. y n r ~ g ahur. d i Ju1ur.i : pctserik~unn k l i l ~ l s 01th IIICIOCI'~~JY keaeLa~L,~i ~ r r y v untuX set cluh t i d h ; ~d i h o r u p - p1.08-dur petlclitirrl tarlkut bust keac:nputcn u n t u k - s r - svmpiriy &Lon proscdul' duroh . : aoya i l t i Mcnjalunl 10 m l - - ysni: yung aebagal : It y u r ~ roungkir~ ~ ti:rrlul penelition SURAQAY4 f dilukukvn penjelvaan nanyoksn kcn ~ d~larn !)cnelitiun persetujurn mandupotkon - HIU~~OIUITJATSRliBDfiP UIOXVAILALI- yurri; I T Ini beach n e a u n g g u h n y ~ , balria aukureluwan NAPFiGXEN, LIZ'AS -- k9. 52- : badon - . . -.- \lull doktcr untuk a c n & a t r D i l L11.u-1iir.u dipcrik~u dl l ~ b o r u t o r i u t nd r n , LANJUTAN . -. bioyo 2. ditonggung Wowoncara, noh biosaan riwvyot riwuynt moknn, - ole11 peneliti. meliputi dlderitu, - don penyokit olere1 yang per- tcrh~dopobut, ke- 10111-lain. 3. P u a ~ o semnlam tr~enjelong woktu penelltian den tidok I merokok sebelum penelition 4. Datong ke tuknn rnoupun minual tempot woktunge aelun~o woktu , 5. Dlombll 100, 240 Dernikion kesaderan don loin penelition don berodm yon3 dl teloh tempat UklI diten- penelltian penelition. 0, 15, sebur~ynk 7.0 1111 podo In- , 45, 150, ini suya 60. 90. 120, menit. pernyutuan tanpa paksaon bunt pihok-pihak Nsr~~etahui Dru. setu minegu dan seat penalition herlongnung. somgel d u r u h terval woktu obot ATIIIJAII, 14:; LR. Il<'riAK dendon perlull loin. ,. LANJUTAN I Soya yong bertonda tsn~an di I(OU0 : Hcndrnkus A s k t ~ i Umur : z z th I Berot : So k y , : badou Alarnat Menyotakon ' aedio lnenjedi Ph'1;AFBAIlkN LITAS Dsooyo "7 dengun seaun&guhnyn, auksrelvwsn ALUMIIiIUH NAPROXEN, Namo : R N ~ P : 2443089018 Alumat : jl. T svya nanyoksn ysng kegurioar~ Noproxen, kon rs yrng Aduy)un vdolah 1. yvng oleh asyo i l l 1 soya lncneerti sr:an says l i Lcr1k.t : t terrtorlg t i d u k dlhurupcu- jrlani. y u ~ l a~l [ r r ~ I lnernerlkso k c s e l i r ~ t s r l any2 untuk sctcluh p r o ~ e d u rs t u u t i t s don p c ~ n e r i k ~ r o nk l i ~ ~ i os l c h drrsh buat d s r ~ keacrnpatan u n t u k 111r- Hcnjplvni 10 m l ?EI:GILP.UE : ~ u m p l n g yang efeh pronndur. aebngsi pcnelltion Suruboya belurn r n u n e k i ~ ~t i n L u l penelition soya ber- I* 108 pcnjclaaan hal-hai bohwa : A peraetujuvn mnndopatkun in1 TERIihDhP BIOLVAILAbI- dilokulcvn Dlnoyo Pernyotron dololn i!IUhOi(SIDA yong I bahrh dokter di Jul&rrL ~ntt~ii d ~ n ilirn;&.r.bil kiru-ki1.u diperiksu dl l + t ~ o r r t o r i u r ndun LANJUTAN bioyo 2. Wowoncoro, nnh i i ditonggung oleh. peneliti. nleliputi riwayot diderito, riwoyot hiosoan muknn, don penyokit yone per- o l e r ~ i terhodop obot, kc- loi11-1f~in. 3. Pumso aemulorn l~~enjelongwoktu penelition dun tidak merokok innupun sebelum penelition 4. Dotong ternput ke tuknn woktunyo selomu woktu 180, Demikion loin pcnelitiun ynng berudo di teloll tempot deroh penelition 0, 15, scbunyok 2.0 a11 pado 30, 45, 60, pernyotoan tonpo ini paksarn soya bunt pihok-pihek 1.iengetohui : L. UI4I diten- 90. In- 120, 150, menit. kesodaron dan Drr. satu minegu penelltion. wnktu 240 obat don shot penslition berlongaung. don 5. Diombll aompel terval minurn - loin. ,- P '** ATIIIJAIi, Tembimbing dengon penuh I MS DR. I K Y R L pcnonggun& S&kWq jowob medl3 LANJUTAN Menyetoken acdin menjrdi PEKAbIBAIiAN LITAS d e n g ~ n xenunijgulsny~, brt~wa nryv L r r sukvl.eluuan A L U M I ~ ; I U ~ HIDIIOKSIGA NAPROWN, ynng N ~ P :' 2 4 4 3 0 0 9 0 10 Alnmat : hnl-ha1 ltegunrnn Brproxen, efeh rnungkin ti;nbul ken rs yeng ndalah 1. yany p e n c l i t i o r ~ yrng hdopun aernpins untuk ~nengerti ysng IIIC- tcnterig t i d e k dihnr.apcu- Jalani. yci.d alcnr. dijul~lli : pelnerikaoon dersh scteleh pr.o~cdurstvu t r t a says klirtis 181emeriksa k c a c h a t u r ~ s n y s 10 r n l suya dun buat k c s e : n p u t ~ nu n t u k penrlitiprr ~ e b e e n i barikut : aoya dun brlurn rhun proscdur Ncnjolvni ini penjclaaon nunyoksn oleh Surubnyn 108 pcrsetujuvn mendapotken PENCARUIi TERHADAP 5IOhVAILAbI- clilnkukon Dinoyo jl. Pernyrtuon aryo drlu~n penslition don dipcrikau oleh dokter untuk ~ s c f i ~ ~ ~Is. .bi rlul- l ~ i ~ . o di 1 r . h o r u t o r i u r a dun LANJUTAN - bioyo 2. ditenggung Wowencoro, noh 3. Puoso dok riwoyot moknn, merokok den penelition aelomo woktu i 5. vlergi Diombll Demikion kesodaron don yrrrg pcr- tcrhadop obat, ke- penelitinn don ti- obat lain ~ v t urninggu don avot penalition herlungnung. don berado di tempat penelition penelitian. omp pel terval woktu - -- loin-lain. Inoupun atinurn t u k ~ n woktunyo -- - penyokit semoloin rnenjelone woktu aebalum : - -.-. olel: peneliti. nreliputi riwayrt diderite, hiosoon ; -. .- . doroh 0. 15. pernyotnan tunpo scbonyok 2.0 rnl 30, in1 puksabn 45, 60, auyo bunt pihok-pihak pndo 90. in- 120, 1 5 0 , dengan perruh lain. ,- Dru. UMI ATkIIJAH, 145 liR . IlLiiAfi penunzgune SETIXOUDI juwob media I LAHPIRAN V I I H A S I L PEHERIKSAAN LABORATARIUH D A R I TIAP SUKARELAWAN . I ..-- IABORATORIUM M W I S ' . , MOJOPAIIITU ~4s" / ; I it 2 ---. ---- ' APJ -.----- i . : --A. tgl.u(cul : a. ............................................. : ................... ....................... : .............................................. .a :: ............................................ ml mg% m p U Mu/ml ..:.............................................. . : ............................................ p% ..........................................p% : ; .. .' .......!2.:.................... /0. ............................................. ., ............................................. 8 ' ,............................................ . : : ,-.. ! i .................. :......................... U/I U/I gr% gr% U/I *. .a. .,*. NORMAL >13d ( < 0.50 ma% ( < l.Wmg% ( ( 0.5,Ou 6-8p% 0.3 - mrsS ,"9 ) ( 1 ) ( Prla 11 50 U/I 1 ( Wanlu7 ) - : 0.6 Pria Jurnlah Urine . Clcnrancc/menit : rngx -jam ..... Wantla: 0.5 - 32 U/I I ) : - Uric A c i d : 1.5 mg % - 1.3 mg% -ml - mg % -- m . . . . . . - zo m g % ) ( 20 - 10 mg 7; ) :2.5 - 7.0 m (: ( lo m.% Uriurn Darah - ml /mcnit 1 1,75/rnz / S A 12. 4. U. N. , wanita < 31 ~ /) l ': W a d u < 31 U/l ) . / I 1 NORMAL J. . a < 37 U/I ( o p t 3 7 ' ~P r h < 40 U/1 ( 2-3@. ( 4.5@ ' " HASlL : i i FAAL - GINJAL Crcatioioc I 1 : I i U s Ab. Crcatinine I .I ) ( 15 69 mU/ml ( 0.9 ( o p t 3743 m - -- ) t1DS A g <mum .......19........... .-.I,.-, - - - . - - CIY- HASIL 1 :. . ...->..-- . :.y ,'l.pnua- HATI FAAL Gross Hcyman v/d bcrgh dlrccl ec,... (,oul, 1 Xhymol Tur bldiry Test Alkali Phasphatuc . &rum Protein Gamma Globulin t 1S. G. 0. T. Y S. G. P. T . j %rum Globulin : krumrUbumin Gamma 'G.T. ;.: . 2 : - No. ~ b m t o r i ~ n: . ~ottcrpcnlirim .-- ... S u n b a ................... ~ Z.: ...:. :.: 1 NO. 1. S U & ~ -eCndc.iu I Pria W a n i i a : 1.5 - 6.0 mp% - - ... ..-L- LANJUTAN - r. ... -...... -. _....... IABORATORIUM MEDlS MOJOPAHIT XI Jab Moiopohil No. , No. -durn : . mkwrpndrim i -.-....-- --..-"fix--.----...-.-.-.-...- ,~.-ri- : td..C(L..I : OUM 3 ; _ ( > 13ml ( < 0.50 mg% lndircc! (total) ( Gamma Globulin ( 0-5.OU :: ( 15 69 mU/ml ....................................... aY . : .............. 3: ...................... ............................................ Scrum Globulin : Serum Albumin : Gamma G.T. ............................................. -:&.:-.*..... .-......-.-.. .......................:.................... ) 1 1 1 < 1.00 mp% :' i: w. G. 0 . T. 4.G. P. T. " --..- NORMAL ............................................m l ............................................mg% ............................................. mg% ............................................U ............................................Mulml ! .: ............................................gr96 : ............................................gr96 Gross : Heyman v/d bcrgh dlrm :' , p y m o l Tur bidity T a t ' ................-- HAT1 HASIL . .. ............ ---- --....-- i. . . : ". ...... .L .J ! . I FAAL : , Alkali Phorpharase ; . SCNI~ Proccin . . .!:";$ Sumbay..................................... 19 fi?%tP ---_l-c i . ..?.., .. ,: 2. lu ~ v npnderiu r . - . U/I ( 6-8@ ) ( 0.3 0 9 mL9L ) ( opt 3?c m < 37 U/I w m t u c 31 U/I U/I ( opt 37'~ Prla < 40 U/l Wanlta c 31 U/I ) gr96 gr96 ( 2-3@ ) ( 4-5( Prla 11-5OU/I ) ) - u/I - j ( WanIu 7 32 U/I ............................................. : ............................................ W Ds A g HUsAb. 1 I . I __ _ 1; , I ~ .. ~ FAAL GINJAL . I ... .... :I -I I HASIL ' I <Serum Creariaine ' /, 0 : Uriae Creatiaiae : 1 i Jumlah Urine : --jam Clcnraoce/meoit : I I I ! ' . NORIMAL Crcatinine I 1 ..... .... /El. U. N. mg .- 8 U ~ i u r nDarah : Uric Acid : m Wanirn: 0.5 :0.6 Pria 1,s mg% 1.3 m:% X -m l ml [mcait! 1.731 m 2 / S A -- !WX (10-20 m g x ) mg % - 40 rn;::) Pria : 2.5 - 7.0 m p X Wxnita: 1.5 - 6.0 mg% ms;: ' (20 1 LANJUTAN I-. , ! . I WORATORIUM MEDIS MOJOPAIIIT11 I&" Mojo&ic No. 2. s",.bq. N=mapc?dcda : No. bbancorium : Dakcer pcn%rim : /$. #c.&;~ ........l.... 3 . . . . ....... .. .... . 19 .-............ S u n b a y.......................................... . rll.pcnerimun : :..-iL ..--.. . . .... .. . /h.r. -. I ............................................ : ............................................ Gross : " NORMAL ( > 1.3 ml ( < 0.50 mg% ( < 1.00 mg% ( 0 5.0 U ml -- - ' ) - ) ) ( 0.3 ) - 0.9 ng% ( opt 374: Ptia < 37 U/I W m l u c 3 1 U/l ) opt 37% Prla < 40 U/l Wanlu c 3 1 U/I ) ( 2-3gr% ) ( 4-5g% ) ( Prla 11 . 5 0 U/I ) ! I i GIKJAL NORMAL HASIL Prin L' m~.:; Uriac Crcntioinc : Jumlnh U r i n e : Clcsrnnce[ rncnit : B. U. N. . Urium Darah : Uric Ac~d . -- I! :0.6-1.5mg% agn;rn:~,j-~.lm:% ',' _ ml rno =,o -- .ism - rnl !mcnir 1 l , i ~ / m ~ / S A 4. . ma:; - ( 1 0 - 2 U m:%) me 7: mp:: ! ) ( 6.8prs6 ( i ) ( 15 69 mU/ml Crcarininc . I 1 ---FAAL /Strum Crcarlninc ; .......................... ......................................... Heyman v/d bergh dlrcci me% lndlrcct (total) ............................................. ms% n l y m o l Tur bidity Test : ............................................ U Nknli Phosphziue : ............................................ Mu/ml Scmln Prolcin ............................................. fi Gainma Globulin ............................................. fi 4.%. ..........-. ...... , G. 0 . T. : ................. U/I do . Ids. G. P. T. ............................................. ufl Scrum Clobulin ............................................. fi , . Serum Albumin ,............................................. pr% Gamma C.T. ............................................. U/I -. - : CIum HATI FAAL HASIL I ._ ...................... 1d.Yl-i (20 - 40 me::) : 2.5 - i,G m p X Wanira : 1.5 6.0 m p % Pr13 - . LANJUTAM ~ . ~ ~ - . /.IABOIWTORIUM MEDIS h r o J o P n r r r r 11 j I I , j ! j. ~ : /Tn. A&. ".."....... No. bbancarium ': k k t n pcndrim .......--.-"-..."-" ?.$: -...-...... 1 I - : GUM r . " : ............................................ ............................................ : ........................................... : ............................................ ( > 1.3 ml ) ( < 0.50 mg% ) Indirect (total) lllymol Tur bidity Tcst Nkali P l ~ o r p h a l u e m U Mu/ml ( c 1.00 mg% ( 0-5,Ou ) ( 15 69 mU/ml ) ( 6-8@ 1 . ......................................... : ............................................ gr% : ............................................ w% 43. ........................................... U/I : ................. .................... U/L : ........................................... : ..................... :..................... gr% : U/I - ............................................ ii ! iI ) 1 ) ( 0.3 0.9 d ( o p t 37% Prla < 37 U/I Wanlta < 31 U/l ) ( o p t 3 7 ' ~Prla < 40 U/l Wanlu c 31 U/I ) : ( ( 4.58% ( Prla 11 -5OU/I - ! I 1 ) 2-3pr% [ i m~ mg% 1 [ i ) j ( Wanlu 7 3 2 U/I IILIs Ag. IIlls Ab. i ~ NORMAL H A S I L I . t ~ross : lliyman v/d bcrgh dlrccr : S C N Protcin ~ Gamma Globulln ! "S. G. 0 . 1 . /s. G. P. T. Scrum Globulin Serum Albumin Gamma G.T. . HAT1 F A A L 1 -~ -* : -.-..-...........- s ! ... ~- . . - . -. . .. S u n b a p...................... :.................. . . 19 . ,.,. ....... i . ,&,. pourirnun -., --. I. . ,&,. -1..----;..=I 1 "-.. ....- Jalur Hoiophir No. 1. Sumby Nmmr pendcnu . ~ t i j ~ ............................................. : ........................... -.-............... I i I I i ! I 1 i .. ............. -................... . . . FAAL I i NORIVAL Crcarininc Pria : U r i x Crcatioinc : J u n l n h Urine : Clcaiancr/meoir : 4.U. N. 7' L : 0.6 - 1.5 mgz - 1.3 m:% Wani:a: 0.5 mg:; mf -- ---___) GINJAL HASIL ~ S c r u mCrcarinioc :: rnl j3m m l /menit! 1,731 m 2 / S . A 9 : U r i u m Darah : . Uric Acid : - m;: - mg% mg>i 1: - 20 rng % ) ( 2 0 - 40 mf::) Pria :2.5 - 7.0 rn:% Wanila : 1.5 - 6.0 rng% . ( 10 LANJUTAN .~ . -.-I W O R A T O R I U M MEDIS lrrOJOPAHlT n Moiop3lil No. 1. sunbm N-a pcndcriu : ....Y : ... tpl.vkvi D-klcr pcngirim cautln HAT1 FAAL HASIL ........................................... : ............................................ : Hcyman v/d bcrgh dlrcct Indirect (total) Thymot Tur bidity Tcst Alkali Phorphatasc S C N I Protein ~ Gamma Globulin - '5. G. 0. T. S. G. P. T. Scrum Globulin Scruin hlbumin Gamma G.T. NORMAL > 1.3d ( < 0.50 ma% ml mg% ( mg% ( < 1.00 mg% ............................................ U ........................................... Mu/ml ............................................. fl ............................................. fl /o. ............................................. - : : ............................................. /'.j IllJs Ab. '/ : U/r V/l ( opt 3 7 ' ~Prla < 40 U/l Wanlu < 31 U/I ) ( 2-3g% ) ( Waniu7-32U/I ) mmgo; j%m Clc2rnoc:/ : Uric h o d ) NORhlhL :0.6 - 1.S mg% W a n $ ( = :0,s - 1 . 3 rn;% ml ml \m:ni[ '3. , 1 ) : : - 0.9 mr% ( 4-5896 J u m l ~ hUrine .- ) ( Pria 11 . 5 0 U/I .-....-... mg;; Urium Dnrah ! 1 "/I . -.... -. meall ) srss rJr;zc Crcntininc 5. U. N. ! ) Pria v Strum Crcalioinc 1 ( 6 - 8 f l . 1 !,75!m2,'S.i mz;; ( lo - rn:;; (20 m2.L Pria - : 2.5 W ~ n i t n: 1.5 2u rng 9, 40 rng",) - 7.0 m n f < - 6.0 mg% I ) 1 HJ.SIL /; " ( o p t 37% Prla < 3 7 U/I Wanlu c 3 1 V/I) .............................................fl Crcntininc " ( 0 5.0 U ( I S 19 mU/ml ( 0.3 ............................................. ............................................. HDs Ag. .- ,gl. pcncrimvn : NO. I-abon<orius : Gross . ..:...I9........... ........"............................... .......... : ............I ; :. . -...... . ....... Sunbaya....................... . . . . . ." ......?!-:.,.!!?! i ! i ! i LAMP I RAN Vl 11 S E R T I F I K A T ANALISIS BAHAN BAKU NAPROXEN G~~Oflff kaQ@ @ff B,iiIAMAS CHEdlCAL DlVlSlON P. 0. BOX F-2430 FREEPORT, BAHAMAS L/C NO. 005.201/0131/USANCE PROUUCT: NAPROXEN PHARMACEUTICAL GRADE CODE NC: 401033 ANALYSIS NO: 00014872 SPEC RO: 5-100-4 BATCH NO: 2AY152 LOT NO:B2-JA-021 Thix material has been analyzed and has been found to meet all appllcabla speclflcatlons. Ue have permanent records In our control laboratory vhlch constltute ObjectlVe evldence to afflrm the above statement. .' RESULT SPECIFICATION APPEARANCE OF SOLIDS DESCRIPTION PASS WHITE TO OFF UNITE CRYSTALLINE ' POWDER ODOR DETERMINATION ODOR PASS ALMOST ODORLESS CRYSTALLINE POWDER SOLVBILITY SOLUDILITY PASS PRACTICALLY INSOLUBLE IN WATER FREELY SOLUBLE IN CHLOROFORM AIlD ETHANOL INFRARED ANALYSIS SCAN COMPARES TO REF SAME AS REFEREI!CE STANDARD SIMILARLY MEASURED ZI.YSIS NAP3OXEN UV ASSAY X REL TO REF LAMBDA MAX SCAN OF TIIE SAMPLE IS THE SAME AS THE REF SIMILARLY MEASURED, %RELATIVE TO REF IS BETWEEN 97 -AND 103% C.ND LAMDBA HAX IS BETWEEN 269 AND 273 NU SPEZIFIC ROTATION SPECIFIC ROTATION IS BETWEEN . 63.0 AND 68.5 DECREES A VG NOT HORE THAN 0.5% HAXIHUH LOSS ON DRYING % liT LOSS NOT MORE THAN 0.5% OF ANY ONE FRS AND NOT HORE THAN 2.0% TOTAL FRS -. 'NOT MORE THAN 0.1% RESIDUE ON IGNITION NAPROXEN TLC TOTALFRS IIlD FRS RESIDUE 011 IGNITION RESIDUE NOT UORE THAN 2OPPH TANABE SPEC NOT HORE THAN 10 PPH IIEAVY HETALS HEAVY HETALS PAGE - 1 LANJUTAN BAHAMAS CHEMICAL DIVISION P.0.BOX F.2430 FREEPORT. BAHAMAS PRODUCT: NAPROXEN PHARMACEUTICAL GRADE CODE NO: 401033 ANALYSIS NO: 00014872 SPEC NO: 5-100-4 BATCH NO: 2AYl52 LOT NO:B2-JA-021 This materlal has been analyzed and has been found to meet all applicable speciflcatlons. We have permanent records in our control laboratory vhlch constltute objective eVldenCe to afflrm the above statement. A. ;YSIS RESULT RESIDUAL BASE RES BASE (0 SPECIFICATION NOT MORE THAN 0.01% .01'. PARTICLE SIZE X(25OU % (75U NOT LESS THAN 95% IS LESS THAN 250 MICRONS AND NOT LESS THAN 80% IS LESS THAN 7 5 MICRONS NAPROXEN ASSAY MEAN NOT LESS THAN 98.5% ON THE DRIED BASIS MELTItiG RANGE INITIAL TEMP FINAL TEMP 154.0 156.5 MELTS BETWEEN 152.0 AND 158.0 DEGREES CENTIGRADE WITHIN A RANGE OF 3 DEGREES CLARITY OF SOLUTION CLARITY PASS SUBSTANTIALLY CLEAR AND FREE OF FOREIGN MATTER - DATE OF MANUFACTURE (HONTHIYEA RELEASED BY: COPIED BY: I#- a I (1 1992 DATE RELEASED: PAGE - 2 \f mawn %?,I , , ! . i ! 1 X RECOVERY YANG DIDBPAT DARI FREKUENSI EKSTRAKSI YANG BERBEDA Recovery No. Konsentrasi (ppm) B A Konsen- Recove- Konsen- Recovetrasi trasi ry ry > (P P ~ (% > > (P P ~ (X> 1. 0,5 0,231 62,O 0,46 92,O 2. 1,o 0,63 63,O 0,96 96,O 3. 1,5 0,90 60,O 1,41 94,O 4 2,o 1,33 66,5 1,91 95,5 5. 3,O 1,82 60,7 2,78 92,7 f=62,44 A : sampel plasma ?=94,04 yang d i e k s t r a k s i s a t u kali yang d i e k s t r a k s i t i g a kali dengan p r o s e d u r ) B : sampel plasma (sesuai LBHPIRAN X %RECOVERY YANG DIDAPAT DARI WAKTU EKSTRAKSI YANG BERBEDA Recovery No. Konsentrasi (ppm) B A Konsen- Recove- Konsen- Recovetrasi trasi ry ry (PP~) (XI (P P ~ (%I > 1. 0,5 0,46 92,O 0,47 94,O 2. 1,o 0,93 96,O 0,95 95,O 3. 1,5 1,41 94,O 1,39 93,O 4 2,o 1,91 95,5 1,88 94,O 5. 3,O 2,78 92,7 2,82 94,O , X=62,44 F=94,00 L Reterangan A = sampel plasma yang d i e k s t r a k s i t i g a w a k t u 15 m e n i t B = sampel plasma yang d i e k s t r a k s i t i g a w a k t u 15 m e n i t , 10 m e n i t , 5 m e n i t . kali dengan kali dengan