Lampiran 1. Sertifikat Pengujian Metoklopramid HCl Baku Pabrik (BP)
Lampiran. Hasil Orientasi Menentukan Perbandingan Fase Gerak dengan Menggunakan Alat KCKT.1. Kromatogram hasil penyuntikan larutan Metoklopramid BP dengan konsentrasi 10 mcg/ml, fase gerak (a) Campuran 1% Asam asetat glasial dalam Air dan, (b) Campuran Asetonitril-methanol (3,7 : 1), dimana a : b = 60:40... Kromatogram hasil penyuntikan larutan Metoklopramid BP dengan konsentrasi 10 mcg/ml, fase gerak (a) Campuran 1% Asam asetat glasial dalam Air dan, (b) Campuran Asetonitril-methanol (3,7 : 1), dimana a : b = 75:5.
.3. Kromatogram hasil penyuntikan larutan Metoklopramid BP dengan konsentrasi 10 mcg/ml, fase gerak (a) Campuran 1% Asam asetat glasial dalam Air dan, (b) Campuran Asetonitril-methanol (3,7 : 1), dimana a : b = 50:50..4. Kromatogram hasil penyuntikan larutan Metoklopramid BP dengan konsentrasi 10 mcg/ml dalam plasma, fase gerak (a) Campuran 1% Asam asetat glasial dalam Air dan, (b) Campuran Asetonitril-methanol (3,7 : 1), dimana a : b = 60:40.
.5. Kromatogram hasil penyuntikan larutan Metoklopramid BP dengan konsentrasi 10 mcg/ml dalam plasma, fase gerak (a) Campuran 1% Asam asetat glasial dalam Air dan, (b) Campuran Asetonitril-methanol (3,7 : 1), dimana a : b = 50:50..6. Kromatogram hasil penyuntikan larutan Metoklopramid BP dengan konsentrasi 10 mcg/ml dalam plasma, fase gerak (a) Campuran 1% Asam asetat glasial dalam Air dan, (b) Campuran Asetonitril-methanol (3,7 : 1), dimana a : b = 30:70.
Lampiran 3. Kromatogram Hasil Penyuntikan Plasma Kosong dari Hewan Percobaan.
Lampiran 4. Perhitungan persamaan regresi dari kurva kalibrasi Metoklopramid BP yang diperoleh secara KCKT Data X Y X Y XY 1 0,0000 0,0000 0,0000 0,0000 0,0000 0,5000 4,830 0,500 1787,851 1,1415 3 1,0000 68,440 1,0000 4684,3074 68,440 4 1,5000 86,7360,500 753,1337 130,1040 5,0000 114,0300 4,0000 1300,8409 8,0600 6,5000 134,8500 6,500 18184,55 337,150 Total 7,5000 446,3410 13,7500 4518,6565 784,875 Rataan 1,500 74,390,917 7530,448 130,811 y = ax + b 51,8734 b = y ax b = 74,390 51,8734 (1,500) b = 74,390 64,8418
b = 9,5484 r = 0,9913 Jadi, persamaannya didapat : Y = 51.8734 X + 9.5484
Lampiran 5. Pengambilan Plasma Untuk Kurva Kalibrasi Metoklopramid HCl Kelinci Dipuasakan minimal 8 jam sebelum percobaan Ditimbang Dicukur bulu telinganya hingga bersih Diambil darah lebih kurang 10 ml Dimasukkan kedalam 5 tabung yang telah berisi tetes heparin Ditambahkan ml TCA 0% Divorteks hingga homogen Disentrifuge pada kecepatan 3000 rpm selama 10 menit Diambil supernatannya Plasma
Lampiran 6. Pembuatan Kurva Kalibrasi Metoklopramid HCl Metoklopramid HCl Larutan Metoklopramid HCl (LIB I) (1000mcg/ml) Ditimbang sebanyak 10 mg Dimasukkan kedalam labu tentukur 10 ml Ditambahkan Aquabidest hingga larut dan cukupkan sampai garis tanda Larutan Metoklopramid HCl (LIB II) (100 mcg/ml) Dipipet sebanyak 1 ml Dimasukkan kedalam labu tentukur 10 ml Ditambahkan Aquadest hingga larut dan cukupkan hingga garis tanda Larutan Metoklopramid HCl (LIB III) (10 mcg/ml) Dipipet sebanyak 1 ml Dimasukkan kedalam labu tentukur 10 ml Ditambahkan Aquadest hingga larut dan cukupkan hingga garis tanda
Lampiran 6. (lanjutan) Larutan Metoklopramid HCl (LIB III) (10 mcg/ml) Dipipet sebanyak 0,05 ml, 0,1 ml, 0,15 ml, 0, ml dan 0,5 ml Diencerkan dengan plasma hingga 1 ml Diinjekkan ke alat KCKT pada panjang gelombang 73 nm Hasil
Lampiran 7. Perlakuan Pada Hewan Percobaan dengan Pemberian Tablet Metoklopramid HCl Kelinci Dipuasakan minimal 8 jam sebelum percobaan Ditimbang Dicukur bulu telinganya hingga bersih dan diambil 1 ml darah untuk blanko Diberikan Tablet Metoklopramid HCl dengan dosis 10 mg secara peroral Dibilas spuit dengan heparin dan diambil darah sebanyak 1 ml pada waktu 10 menit setelah pemberian obat, kemudian 0, 30, 45, 60, 90, 10, 180, 300, dan 40 menit Dimasukkan kedalam tabung sentrifuge yang telah berisi tetes heparin Cuplikan Darah Hasil Ditambahkan TCA 0% sebanyak 1 ml Divorteks hingga homogeny Disentrifuge pada kecepatan 3000 rpm selama 10 menit Diambil supernatan Diukur pada alat KCKT pada panjang gelombang 73 nm
Lampiran 8. Kadar Metoklopramid Bahan Tambahan Sari Tape (BTST) dalam Plasma Pada Kelinci Jantan Setiap Waktu Pengambilan Sampel Hewan Uji waktu (menit) I II III IV V VI Area Kadar Area Kadar Area Kadar Area kadar Area Kadar Area Kadar Rata-rata Kadar ± SD (mcg/ml) 10 58.55643 0.94476 58.47541 0.9430 63.35810 1.03733 57.0463 0.91870 5.88734 0.83548 5.90 0.867 0.9170±0.079 0 60.88715 0.98969 79.34096 1.34544 79.34090 1.34543 60.88014 0.98956 61.5069 1.00191 61.35101 0.99864 1.11178±0.181 30 79.96545 1.35748 87.75655 1.50767 85.17495 1.45791 91.1939 1.57443 86.57891 1.48497 74.7057 1.5608 1.43976±0.114 45 95.59378 1.65876 110.5919 1.94147 98.95189 1.7349 107.49596 1.8880 96.16418 1.66975 97.46774 1.69488 1.7676±0.1 60 110.73630 1.95067 1.64136.18017 11.44984 1.98370 96.0149 1.66683 103.8399 1.8174 104.58865 1.8316 1.90516±0.175 90 90.1039 1.5590 115.5043.03769 116.184.05566 90.1039 1.5590 97.46774 1.69488 96.16418 1.66975 1.76063±0.9 10 86.54416 1.48430 104.18548 1.8439 109.50915 1.9701 86.3647 1.48083 70.1040 1.1694 88.76334 1.5708 1.56884±0.7 180 63.88715 1.04753 85.09465 1.45636 97.89897 1.7030 78.00673 1.3197 69.49679 1.15567 86.9370 1.4916 1.3635±0.39 300 59.5089 0.96301 64.69456 1.06309 87.4794 1.5033 63.7500 1.0449 63.90189 1.04781 63.6945 1.04381 1.11083±0.195 40 5.81454 0.83407 58.511 0.94391 63.967 1.03485 60.76060 0.9875 54.04371 0.85777 58.50344 0.94374 0.93360±0.76
Lampiran 9. Gambar Konsentrasi (C) vs Waktu ( t ) Metoklopramid BTST (Bahan Tambahan Sari Tape) pada Plasma Kelinci, n=6 ekor
Lampiran 10. Kadar Metoklopramid HCl merek dagang (Primperan ) dalam Plasma Kelinci Jantan Setiap Waktu Pengambilan Sampel waktu (menit) Hewan Uji I II III IV V VI Area Kadar Area Kadar Area Kadar Area kadar Area Kadar Area Kadar Rata-rata Kadar ± SD (mcg/ml) 10 41.45054 0.61500 4.6945 0.63898 43.8981 0.6618 4.33117 0.63198 4.33107 0.63197 5.7313 0.8347 0.66876±0.08 0 43.8981 0.6618 5.11689 0.806 46.93919 0.7081 45.33553 0.68989 6.61388 1.098 59.99448 0.9748 0.81483±0.15 30 59.63763 0.96561 59.19817 0.95713 60.80913 0.98819 63.7907 1.04566 63.5960 1.04185 60.7693 0.9874 0.99764±0.038 45 65.978 1.08687 65.3106 1.07497 63.101 1.0338 69.84731 1.164 97.38391 1.6937 79.86343 1.35551 1.344±0.5 60 86.0167 1.4741 8.58674 1.40801 74.09116 1.444 103.97738 1.8037 109.655 1.995 8.8330 1.4175 1.5481±0.67 90 70.84679 1.18169 66.88767 1.10537 96.7188 1.68033 74.06435 1.437 107.54356 1.8891 74.0674 1.4369 1.39065±0.316 10 68.56066 1.1376 63.06636 1.03170 95.59378 1.65876 63.19400 1.03416 86.3643 1.48080 65.951 1.08733 1.3840±0.66 180 63.0584 1.03155 56.65568 0.9081 63.017 1.03467 6.90361 1.0857 63.19555 1.03419 61.31639 0.99797 1.00584±0.049 300 43.74991 0.65933 44.81764 0.67991 46.6700 0.7156 45.4449 0.68814 57.017 0.91865 59.63940 0.96564 0.7711±0.134 40 41.6057 0.61799 41.5600 0.61711 45.4449 0.66814 44.0761 0.6656 4.36843 0.6369 46.818 0.71836 0.6533±0.413
Lampiran 11. Gambar Konsentrasi ( C ) vs Waktu (t) Primperan dalam Plasma Kelinci Jantan, n = 6 ekor
Lampiran 1. Parameter Bioavailabilitas Tablet Metoklopramid Bahan Tambahan Sari Tape (BTST) pada 6 ekor kelinci jantan dengan dosis 10 mg. Kelinci BB (Kg) Ka (menit ) t1/ a (menit) Tmaks (menit) Cmaks (mcg/ml) Vd (ml) AUC0- (mcg/ml menit) Kel (menit ) t1/ e (menit) I 1.8 0.06 11,55 58,65 1.53 617,00 971,95 0.00 346.5 II 1.9 0.05 13.86 67,07.11 488.51 971.59 0.00 346.5 III.1 0.05 13,86 67,07.13 470.04 1170.95 0.00 346.5 IV. 0.06 11,50 58,65 1.88 49.47 1015.75 0.00 346.5 V 1.9 0.05 13,86 67,07 1.7 5446.6 918.5 0.00 346.5 VI.0 0.07 9.9 5.9 1.85 505.13 995.75 0.00 346.5 Rata-rata 1.98 0.06 1,43 61,80 1.86 5013.98 1007,37 0.00 346.5 SD 0.15 0.01 1,68 6, 0.3 709,1 86,53 0 0
Lampiran 13. Parameter Bioavailabilitas Metoklopramid Merek Dagang (Primperan ) pada 6 ekor kelinci jantan dengan dosis 10 mg. Kelinci BB (Kg) Ka (menit ) t1/ a (menit) Tmaks (menit) Cmaks (mcg/ml) Vd (ml) AUC0- (mcg/ml menit) Kel (menit ) t1/ e (menit) I 1.8 0.04 17,33 78,84 1.7 6949,61 650,39 0.00 346.5 II 1.9 0.05 13,86 67,07 1.14 8049,86 787,85 0.00 346.5 III.1 0.04 17,33 78,84 1.6 7083,76 637,6 0.00 346.5 IV. 0.07 9,90 5,9 1.4 7613,97 783,78 0.00 346.5 V 1.9 0.05 13,86 56.68 1.78 5534,7 679.48 0.003 31 VI.0 0.03 3,10 113.8 1.16 7658.78 93.64 0.001 693 Rata-rata 1.98 0.05 15,89 74,58 1.37 7148,38 745,3 0.00 385 SD 0.15 0.01 4,48,13 0.6 887,58 11,61 0.001 157,80
Lampiran 14. Contoh Perhitungan Parameter Bioavailabilitas Secara Manual Waktu (t) Konsentrasi (C) A.e K el t Residual (menit) (mcg / ml) (mcg/ml) (mcg/ml) 10 0,94 1,59 /0,65/ ln R = lnb- K a.t 0 0,99 1,56 /0,57/ = 0,3911 0,06t 30 1,36 1,5 /0,16/ R = B.e -K a. t 45 1,66 = 1,479 e -0,06t 60 1,95 r = -0,9 90 1,55 10 1,48 ln CE = ln A-K el.t 180 1,05 = 0,4816-0,00t 300 0,96 CE = A.e -K el.t 40 0,83 = 1,6187e -0,00 t r = -0,9 K el = 0,0017 menit -1 T 1/ el = 0,693 0,00 = 346,5 menit K a = 0,06 menit -1 T 1/ ab = 0,693 0,06 = 11,5 menit AUC (Area Under the Curve) C AUC 0-t = { 1 xt 1 } + { ( C t1 + C1) x( t ) } +.. { ( Cn + Cn 1) x( tn tn 1) } AUC 0-40 = { (0,94)(10) }+{ ( 0,94 + 0,99)(0 10) }+ ( 0,99 + 1,36)(30 0) ( 1,36 + 1,66)(45 30) { }+{ }+
( 1,66 + 1,95)(60 45) ( 1,95 + 1,55)(90 60) { }+{ }+ ( 1,55 + 1,48)(10 90) ( 1,48 + 1,05)(180 10) { }+{ }+ ( 1,05 + 0,96)(300 180) ( 0,96 + 0,83)(40 300) { }+{ } = 477,775 mcg / ml menit AUC 40- Ctn = Kel = 0,83 0,0017 = 488,35 (mcg / ml) menit AUC 0- = AUC 0-40 + AUC 40- = 477,775 + 488,35 = 966,01 (mcg/ml) menit Vd = = = = 6089,39 ml T maks =,303 log Ka ke Ka Ke
=,303 0,06 = 58,65 menit log 0,00 0,06 0,00 Ka.( Dosis) ke. tmaks C maks = e Vd( Ka Kel) = 1,5 mcg / ml
Lampiran 15. Contoh Perhitungan Pengujian Hipotesis Perhitungan Cmaks No Metoklopramid BTS Primperan 1 1,54 1,0,11 1,14 3,13 1,6 4 1,88 1,4 5 1,7 1,78 6 1,85 1,16 X 1,86 1,35 SD 0,3 0,7 Ho: σ 1 = σ H1: σ 1 σ Pengujian Hipotesis f = S 1 / S 0,3 f = 0,7 = 0,73 dibandingkan dengan nilai kritis : f α/, v1, v f tabel = f α/, v1, v f tabel = f 0,05, 6, 6 = 4,8 f hitung < f tabel
Bila f hitung < f kritis (diterima), maka harga kedua variansi tersebut adalah sama, maka uji selanjutnya dalam membedakan dua mean menggunakan uji t. Ho : µ 1 = µ H1: µ 1 µ Pengujian hipotesis t = ( y y / s 1/ r1 + 1 r ) 1 / Lampiran 15, (lanjutan) s= r1 r1 y1 i i 1 i= 1 y 1i \ r r / r1 + y i y i / r / 1 i 1 1 i= ( r + r ) atau s = = = 0,5 t = ( y y / s 1/ r1 + 1 r ) 1 / t = 1 1 ( 1,86 1,35 / 0,5 + ) 6 6 t = 0,51 / 0,14 t = 3,54 nilai t hitung hasil pengujian statistik ini, kemudian dibandingkan dengan nilai kritis ( t tabel) yaitu : t tabel = ± t α/, (r1+r-) t tabel = ± t 0,05, (6+6-)
t tabel = ± t 0,05, 10 t tabel = ±,8 t hitung > t tabel (bermakna, p < 0,05) Kesimpulan : Ho ditolak (Hipotesis Ditolak), karena terdapat perbedaan yang bermakna antara konsentrasi maksimum (Cmaks) kedua sediaan tersebut
Lampiran 16. Data Statistik Kadar Metoklopramid BTST dan Primperan dalam Plasma Tiap Waktu Pengambilan pada 6 ekor Kelinci Menggunakan Statistik Independent T-Test. 16.1 Waktu Pengambilan 10 menit Descriptive Statistics Metoklopramid BTST waktu (10 menit) 6.87 1.0373.9170.079353 Descriptive Statistics Primperan waktu (10 menit) 6.6150.835.668763.081640 Group Statistics Perlakuan N Mean Std. Deviation Std. Error Mean waktu (10 menit) Metoklopramid BTST 6.91703.0793510.033949 Primperan 6.668765.0816416.0333301 Independent Sample Test Levene's Test for ity of Variances t-test for ity of Means 95% Confidence Interval of the Difference F Sig. t df Sig. (- Mean Std. Error tailed) Difference Difference Lower Upper waktu (10 menit).019.894 5.341 10.000.48583.0464793.1446961.351806
Levene's Test for ity of Variances t-test for ity of Means 95% Confidence Interval of the Difference F Sig. t df Sig. (- Mean Std. Error tailed) Difference Difference Lower Upper waktu (10 menit) not.019.894 5.341 10.000.48583.0464793.1446961.351806 5.341 9.99.000.48583.0464793.1446847.351830 16. Waktu Pengambilan 0 menit Descriptive Statistics Metoklopramid BTST waktu (0 menit) 6.9896 1.3454 1.111778.1810571 Descriptive Statistics Primperan waktu (0 menit) 6.66 1.030.81489.1596 Group Statistics Perlakuan N Mean Std. Deviation Std. Error Mean waktu (0 menit) Metoklopramid BTST 6 1.111780.1810579.0739166 Primperan 6.81487.1596.06173
Independent Samples Test Levene's Test for ity of Variances t-test for ity of Means 95% Confidence Interval of the Difference F Sig. t Df Sig. (- Mean Std. Error tailed) Difference Difference Lower Upper Waktu (0 menit) not.73.415 3.074 10.01.969533.0965876.081747.511640 3.074 9.715.01.969533.0965876.0808836.513031 16.3 Waktu Pengambilan 30 menit Descriptive Statistics Metoklopramid BTST waktu (30 menit) 6 1.561 1.5744 1.439757.1145675 Descriptive Statistics Primperan waktu (30 menit) 6.9571 1.0457.99764.0377383
Group Statistics Perlakuan N Mean Std. Deviation Std. Error Mean waktu (30 menit) Metoklopramid BTST 6 1.439757.1145683.046773 Primperan 6.997643.0377390.0154069 Independent Samples Test Levene's Test for ity of Variances t-test for ity of Means 95% Confidence Interval of the Difference F Sig. t Df Sig. (- Mean Std. Error tailed) Difference Difference Lower Upper Waktu (30 menit) not 5.049.048 8.978 10.000.441133.049445.333897.5518369 8.978 6.07.000.441133.049445.319639.5668 16.4 Waktu Pengambilan 45 menit Descriptive Statistics Metoklopramid BTST waktu (45 menit) 6 1.6588 1.9415 1.7673.11548
Descriptive Statistics Primperan waktu (45 menit) 6 1.034 1.6933 1.3435.53515 Group Statistics Perlakuan N Mean Std. Deviation Std. Error Mean waktu (45 menit) Metoklopramid BTST 6 1.76758.110695.049464 Primperan 6 1.3437.53511.103019 Independent Samples Test Levene's Test for ity of Variances t-test for ity of Means 95% Confidence Interval of the Difference F Sig. t df Sig. (- Mean Std. Error tailed) Difference Difference Lower Upper Waktu (45 menit) not.409.15 4.65 10.001.58517.114650.73934.7831199 4.65 7.186.00.58517.114650.597388.7973045 16.5 Waktu Pengambilan 60 menit Descriptive Statistics Metoklopramid BTST waktu (60 menit) 6 1.6668.180 1.905158.175394
Descriptive Statistics Primperan waktu (60 menit) 6 1.44 1.993 1.5481.665183 Group Statistics Perlakuan N Mean Std. Deviation Std. Error Mean waktu (60 menit) Metoklopramid BTST 6 1.905158.175375.071577 Primperan 6 1.54813.665164.1088049 Independent Samples Test Levene's Test for ity of Variances t-test for ity of Means 95% Confidence Interval of the Difference F Sig. t Df Sig. (- Mean Std. Error tailed) Difference Difference Lower Upper waktu (60 menit) not 1.86.06.741 10.01.3570350.130374.0668479.6471.741 8.645.04.3570350.130374.060569.6535071 16.6 Waktu Pengambilan 90 menit Descriptive Statistics Metoklopramid BTST waktu (90 menit) 6 1.559.0557 1.760630.9134
Descriptive Statistics Primperan waktu (90 menit) 6 1.1054 1.8891 1.390653.316451 Group Statistics Perlakuan N Mean Std. Deviation Std. Error Mean waktu (90 menit) Metoklopramid BTST 6 1.760630.910.0935754 Primperan 6 1.390653.31644.191797 Independent Samples Test Levene's Test for ity of Variances t-test for ity of Means 95% Confidence Interval of the Difference F Sig. T Df Sig. (- Mean Std. Error tailed) Difference Difference Lower Upper waktu (90 menit) not 1.188.301.319 10.043.3699767.1595109.014564.75389.319 9.114.045.3699767.1595109.00987.730161
16.7 Waktu Pengambilan 10 menit Descriptive Statistics Metoklopramid BTST waktu (10 menit) 6 1.1694 1.970 1.568840.719414 Descriptive Statistics Primperan waktu (10 menit) 6 1.0317 1.6588 1.38396.656578 Group Statistics Perlakuan N Mean Std. Deviation Std. Error Mean waktu (10 menit) Metoklopramid BTST 6 1.568838.71948.11100 Primperan 6 1.38395.656607.1084555 Independent Samples Test Levene's Test for ity of Variances t-test for ity of Means 95% Confidence Interval of the Difference F Sig. T Df Sig. (- Mean Std. Error tailed) Difference Difference Lower Upper Waktu (10 menit) not.045.836.19 10.059.3304433.155034 -.0153713.676580.19 9.995.059.3304433.155034 -.676836.0153969
16.8 Waktu Pengambilan 180 menit Descriptive Statistics Metoklopramid BTST waktu (180 menit) 6 1.0475 1.703 1.36348.38909 Descriptive Statistics Primperan waktu (180 menit) 6.9081 1.0347 1.005844.0498470 Group Statistics Perlakuan N Mean Std. Deviation Std. Error Mean waktu (180 menit) Metoklopramid BTS 6 1.36350.38909.0975317 Primperan 6 1.005845.0498471.003500 Independent Samples Test Levene's Test for ity of Variances t-test for ity of Means 95% Confidence Interval of the Difference F Sig. t Df Sig. (- Mean Std. Error tailed) Difference Difference Lower Upper waktu (180 menit) not 8.96.013 3.578 10.005.3565050.099631.1345109.5784991 3.578 5.435.014.3565050.099631.1064310.6065790
16.9 Waktu Pengambilan 300 menit Descriptive Statistics Metoklopramid BTST waktu (300 menit) 6.9630 1.503 1.11089.1950437 Descriptive Statistics Primperan waktu (300 menit) 6.6593.9656.77114.1344505 Group Statistics Perlakuan N Mean Std. Deviation Std. Error Mean waktu (300 menit) Metoklopramid BTST 6 1.11088.1950433.079661 Primperan 6.77115.1344509.0548894
Levene's Test for ity of Variances t-test for ity of Means 95% Confidence Interval of the Difference F Sig. t Df Sig. (- Mean Std. Error tailed) Difference Difference Lower Upper waktu (300 menit) not.08.781 3.51 10.006.3396133.0967117.1416.5551005 3.51 8.877.007.3396133.0967117.103715.558855 16.10 Waktu Pengambilan 40 menit Descriptive Statistics Metoklopramid BTST waktu (40 menit) 6.8341 1.0349.933599.076156 Descriptive Statistics Primperan waktu (40 menit) 6.6171.7184.656653.041594 Group Statistics Perlakuan N Mean Std. Deviation Std. Error Mean waktu (40 menit) Metoklopramid BTST 6 1.0491.409365.0983619 Primperan 6.65665.041609.0168447
Independent Samples Test Levene's Test for ity of Variances t-test for ity of Means 95% Confidence Interval of the Difference F Sig. t Df Sig. (- Mean Std. Error tailed) Difference Difference Lower Upper waktu (40 menit) not 3.331.098 3.690 10.004.368600.0997938.1459055.5906145 3.690 5.93.013.368600.0997938.1159449.605751
Lampiran 17. Data Statistik Parameter Bioavailabilitas Metoklopramid BTST dan Primperan Menggunakan Statistik Independent T-Test. 17.1 Data Statistik Waktu Maksimum ( ) Descriptive Statistics Metoklopramid BTST Tmaks 6 5.900 67.0700 61.800000 6.6007 Descriptive Statistics Primperan Tmaks 6 5.900 113.8000 74.586667.176186 Group Statistics Perlakuan N Mean Std. Deviation Std. Error Mean Tmaks Metoklopramid BTST 6 61.800000 6.6007.5403661 Primperan 6 74.586667.176186 9.033565 Independent Samples Test Levene's Test for ity of Variances t-test for ity of Means 95% Confidence Interval of the Difference Sig. (- Mean Std. Error F Sig. t df tailed) Difference Difference Lower Upper Tmaks 3.547.089-10.03-9.3839603-8.10999 1.363 1.7866667 33.695433
Independent Samples Test Levene's Test for ity of Variances t-test for ity of Means 95% Confidence Interval of the Difference Sig. (- Mean Std. Error F Sig. t df tailed) Difference Difference Lower Upper Tmaks 3.547.089-10.03-9.3839603-8.10999 1.363 1.7866667 33.695433 not - 5.786.4-9.3839603-1.363 1.7866667 35.9559344 10.386011 17. Data Statistik Konsentrasi Maksimum ( ) Descriptive Statistics Metoklopramid BTST Cmaks 6 1.500.1300 1.865000.353508 Descriptive Statistics Primperan Cmaks 6 1.1400 1.7800 1.365000.65833
Group Statistics Perlakuan N Mean Std. Deviation Std. Error Mean Cmaks Metoklopramid BTST 6 1.865000.353508.0960816 Primperan 6 1.365000.65833.107199 Independent Samples Test Levene's Test for ity of Variances t-test for ity of Means 95% Confidence Interval of the Difference F Sig. T df Sig. (- Mean Std. Error tailed) Difference Difference Lower Upper Cmaks.333.577 3.473 10.006.5000000.1439560.179460.807540 not 3.473 9.88.006.5000000.1439560.17878.81718 17.3 Data Statistik Area Di Bawah Kurva (AUC) Descriptive Statistics Metoklopramid BTST AUC 6 918.500 1170.9500 1007.369167 86.5348554
Descriptive Statistics Primperan AUC 6 637.600 93.6400 745.33333 11.605758 Group Statistics Perlakuan N Mean Std. Deviation Std. Error Mean AUC Metoklopramid BTST 6 1007.369167 86.5348554 35.377068 Primperan 6 745.33333 11.605758 45.9711083 Independent Samples Test Levene's Test for ity of Variance s t-test for ity of Means 95% Confidence Interval of the Difference Sig. (- tailed Mean Std. Error F Sig. t df ) Difference Difference Lower Upper AU.94.355 4.5 10.001 6.135833 57.97749 13.95399 391.317737 C variance 1 3 7 5 s 4.5 9.37.001 6.135833 57.97749 131.78414 39.487541 variance 1 9 3 7 7 9 s not
Lampiran 18. Formula Metoklopramid Bahan Tambahan Sari Tape R/ Metoklopramid HCl 10 mg Sari Tape Padat (Brem) 7 mg Corn starch 7 mg Avicel 54 mg LH-11,5mg Aspartam 5 mg Mg. Stearat 1,5 mg Talkum add 150 mg
Lampiran 19. Gambar Alat yang Digunakan Pada KCKT a. Alat KCKT (Agilent) b. Sonifikator (Branson 1510)
c. Pompa Vakum (Gast DO A-PG04-BN) dan alat penyaring fase gerak. d. Degasser (DGU 0 AS)
Lampiran 19. (lanjutan) e. Vial Agilent
Lampiran 0. Gambar Alat Tambahan Untuk Penentuan Bioavailabilitas a. Neraca Analitik b. Alat Sentrifuge
c. Alat Vorteks
Lampiran 1. Gambar Hewan Percobaan dan Proses Pengambilan Darah a. Kelinci b. Proses Pengambilan Darah
c. Tabung Reaksi dan Rak Tabung