TOKSISITAS KRONIS SAMPEL DLBS2411 PADA TIKUS GALUR WISTAR TINJAUAN TERHADAP PARAMETER KIMIA DARAH

FEBRIANTI TRI PUSPITASARI, Dr. Arief Nurrochmad, M.Si., M.Sc., Apt. ; Irfan Muris Setiawan, M.Sc., Apt.

2014 | Skripsi | FARMASI

Sampel DLBS2411 merupakan salah satu alternatif gastroprotector dengan mekanisme proton pump inhibitor (PPI) dan pengurangan sintesis pompa proton. Tujuan dari penelitian ini adalah mengetahui gejala klinis yang muncul, perubahan berat badan, asupan makanan, asupan minuman, perubahan parameter biokimia darah yang meliputi kolesterol total, protein total, albumin, glukosa darah, kreatinin total, bilirubin, SGPT, dan SGOT akibat pemberian berulang sampel DLBS2411 selama 180 hari, serta hubungan dosis pemberian DLBS2411 dengan wujud efek toksik ditinjau dari parameter kimia darah. Penelitian ini dilakukan berdasarkan pada protokol uji toksisitas kronis Guideline OECD 452. Pengujian dilakukan terhadap tikus Wistar, yang dibagi dalam kelompok kontrol dan kelompok perlakuan dimana tiap kelompok terdiri dari 20 ekor tikus. Kelompok kontrol negatif dipejani Na-CMC 0,5% p.o dan kelompok perlakuan dipejani sampel DLBS2411 40 mg/kgBB, 200 mg/kgBB, dan 1000 mg/kgBB p.o. Gejala toksik dianalisis secara kualitatif. Analisis kuantitatif dilakukan terhadap kematian hewan uji, purata kenaikan berat badan per hari (PKBP), asupan makanan, asupan minuman, dan kadar kimia darah. Data ditampilkan dalam bentuk purata±SEM (Standard Error Mean). Datad ianalisis secara statistik dengan ANOVA Test dilanjutkan Tukey Post Hoc Test dan Pairedsamples T Test untuk data parametrik. Data nonparametrik dianalisis dengan Kruskal Wallis Test dilanjutkan Mann Whitney Test dan Wilcoxon Test. Taraf kepercayaan sebesar 95% digunakan dalam analisis ini. Perubahan parameter kimia darah kelompok perlakuan dibandingkan dengan kelompok kontrol dan literatur. Hasil pengujian menunjukkan bahwa pemberian berulang sampel DLBS2411 tidak menimbulkan gejala toksik, perubahan parameter kimia darah melebihi normal dan tidak menimbulkan perbedaan signifikan pada asupan makanan dan minuman tikus jantan (p>0,05). Dosis 200 mg/kgBB menyebabkan perbedaan signifikan pada PKBP, asupan makanan dan minuman tikus betina (p<0,05). Dosis 1000 mg/kgBB menyebabkan perbedaan signifikan pada PKPB tikus jantan dan betina (p<0,05). Tidak ada hubungan antara dosis dengan wujud efek toksik ditinjau dari parameter kimia darah.

The DLBS2411 sample is one of gastroprotector alternative that have proton pump inhibitor (PPI) and proton pump synthesis reduction mechanism. The research was aimed to know clinical symptoms, alteration of body weight, food and water intake, and clinical biochemistry (total cholesterol, total protein, glucose, albumin, total creatinin, bilirubin, SGPT, and SGOT) that were caused by repeated dose 180-days oral administration of the DLBS2411 sample, and to know dose-toxic effect manifestation relationship in terms of clinical biochemistry. This research was conducted based on the chronic toxicity test protocol OECD Guideline 452. The test was carried out on Wistar rats, which were divided into a control group and three treatment groups in which each group consisted of 20 rats. The negative control group was administered by 0.5% Na-CMC p.o and treatment groups were administered by DLBS2411 sample 40 mg/kg, 200 mg/kg, and 1000 mg/kg p.o. Toxic symptoms were analyzed qualitatively. Quantitative analysis was performed to test the animals death, average of weight gain per day (AWGD), food and water intake, and clinical biochemistry levels. Data are shown as mean ± SEM (Standard Error Mean). The parametric data were statistically analyzed by ANOVA followed Tukey Post Hoc test and Paired-samples T test. The nonparametric data were analyzed by the Kruskal-Wallis test followed Mann Whitney test and Wilcoxon test. Confidence level of 95% was used in this analysis. Changes in clinical biochemistry parameters of the treatment groups were compared with the control group and the literature. The test results indicated that repeated administrations of DLBS2411 sample did not cause toxic symptoms, change in blood chemistry parameters exceed normal in both male and female rats and did not cause a significant difference in the intake of food and water of male rats (p> 0.05). Dose of 200 mg/kg caused a significant difference in AWGD, food and water intake of female rats (p <0.05). Dose of 1000 mg/kg caused a significant difference in both male and female rats AWGD (p <0.05). There was no relationship between the dose to form toxic effects in terms of clinical biochemistry parameters.

Kata Kunci : DLBS2411, uji toksisitas kronis, kimia darah, tikus Wistar