UJI TOKSISITAS ORAL AKUT DAN SUBKRONIK FORMULA POLIHERBAL GALAKTAGOG ASIMOMMY® YANG MENGANDUNG DAUN KATUK (Sauropus androgynous), BIJI KLABET (Trigonella foenum-graceum), DAN DAUN KELOR (Moringa oleifera)

ZULKHAH NOOR, Prof. Dr. Mustofa, Apt., M.Kes; drh. Dwi Liliek Kusindarta, M.P., Ph.D.

2023 | Disertasi | DOKTOR ILMU KEDOKTERAN DAN KESEHATAN

Latar Belakang Masalah: Keberhasilan pemberian ASI eksklusif dan penyempurnaan penyusuan hingga 2 tahun memerlukan kebijakan, berbagai dukungan, training, dan galaktagog. Kapsul Asimommy® (500 mg) terdiri dari S. androgynus Folium (300 mg), T. foenum graceum (150 mg), dan M. oleifera Folium (50 mg) dipersiapkan sebagai fitofarmaka galaktagog perlu bukti keamanan sebelum digunakan pada manusia. Tujuan Penelitian: Penelitian ini bertujuan untuk mengetahui toksisitas Asimommy® dengan uji toksisitas akut oral dan subkronik oral 90 hari. Metode Penelitian: Protokol uji toksisitas mengikuti BPOM tahun 2014. Uji toksisitas akut oral menggunakan 25 ekor Rattus norvegicus strain Sprague Dawley dibagi 5 kelompok dosis tunggal (0/plasebo, 50 mg/kgBB, 300 mg/kgBB, 2000 mg/kgBB, 5000 mg/kgBB). Uji toksisitas subkronik 90 hari pada 70 ekor tikus SD dibagi menjadi 7 kelompok dosis (0; 52,5; 500;1000) mg/kg BB, klabet tunggal dosis 27 mg/kg BB, satelit kontrol, dan satelit dosis 1000mg/kgBB), dan 12 ekor kelinci selandia baru (Oryctolagus cuniculus) betina dibagi 3 kelompok (placebo, 54,6mg/kgBB, 109,2mg/kgBB). Efek toksisitas akut dipantau selama 14 hari, sedangkan toksisitas subkronik berupa tanda klinik, berat badan, konsumsi pakan dan minum dipantau setiap hari, hematologi dan kimia darah dipantau di awal, tengah, dan akhir perlakuan serta perubahan patologi dan histopatologi organ. Analisis statistik data menggunakan uji oneway anova atau Kruskal Wallis. Hasil: Uji toksisitas akut tidak menemukan kematian dan tanda klinik abnormal. Patologis paru ditemukan berupa perubahan warna bitnik dan bercak merah. Perubahan histopatologi ditemukan tersebar pada semua kelompok (p>0.05). Uji Toksisitas subkronik pada tikus dan kelinci tidak menyebabkan kematian, tanda klinik abnormal. Perubahan nilai hematologi dan kimia darah sebagian besar dalam rentang normal meskipun ada perbedaan bermakna. Perubaban persentase ukuran organ tidak berbeda antar kelompok (p>0.05), perubahan histopatologi organ paru dan lainnya tidak berbeda signifikan antar kelompok (p>0.05). Kesimpulan: LD50 formula poliherbal Asimommy® diatas 5000mg dan dikategorikan sebagai sediaan tidak beracun dan No Observed Adverse Effect Level (NOAEL) yang tinggi.

Background: The success of exclusive breastfeeding and improvement of breastfeeding for up to 2 years requires policies, various supports, training, and galactagogues. Asimommy® capsules (500 mg) consisting of S. androgynus Folium (300 mg), T. foenum graceum (150 mg), and M. oleifera Folium (50 mg) are prepared as a galactagogue phytopharmaca and need proof of safety before being used in humans. Objectives: This study aims to determine the toxicity of Asimommy® with 90-day oral acute and sub chronic oral toxicity tests. Research Methods: Toxicity test protocol following BPOM 2014. Oral acute toxicity test using 25 Rattus norvegicus Sprague Dawley strain divided into 5 single dose groups (0/placebo, 50 mg/kg, 300 mg/kg, 2,000 mg/kg, 5,000 mg /kgBB). Subchronic toxicity test 90 days on 70 SD rats divided into 7 dose groups (0; 52.5; 500; 1000) mg/kg BW, single clabet dose 27 mg/kg BW, control satellite, and satellite dose 1000mg/kgBW), and 12 female New Zealand rabbits (Oryctolagus cuniculus) divided into 3 groups (placebo, 54.6 mg/kg, 109.2 mg/kg). The effects of acute toxicity were monitored for 14 days, while sub chronic toxicity in the form of clinical signs, body weight, food and drink consumption were monitored every day, haematology and blood chemistry were monitored at the beginning, middle and end of treatment as well as changes in pathology and histopathology of organs. Statistical analysis of the data used the one-way ANOVA or Kruskal Wallis test. Result: Acute toxicity test found no death and abnormal clinical signs. Lung pathology was found in the form of bitnik discoloration and red spots. Histopathological changes were found to be scattered in all groups (p>0.05). Sub chronic toxicity test in rats and rabbits did not cause death, abnormal clinical signs. Changes in haematological and blood chemistry values were mostly within the normal range although there were significant differences. Changes in percentage of organ size did not differ between groups (p>0.05), histopathological changes in lung and other organs did not differ significantly between groups (p>0.05). Conclusion: The LD50 of the Asimommy® polyherbal formula is above 5000mg and is categorized as a non-toxic preparation with a high No Observed Adverse Effect Level (NOAEL).

Kata Kunci : Polyherbal-galactagogue, acute toxicity, sub chronic