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Acute Oral Safety Profile of GA: SPI-Encapsulated Holothuria atra as a Candidate Antimalarial: An Integrated Clinical, Biochemical, and Histopathological Evaluation in Wistar Rats | ||
| Archives of Razi Institute | ||
| مقالات آماده انتشار، پذیرفته شده، انتشار آنلاین از تاریخ 27 مهر 1405 اصل مقاله (2.42 M) | ||
| نوع مقاله: Original Articles | ||
| شناسه دیجیتال (DOI): 10.66224/ari.2026.374008.4311 | ||
| نویسندگان | ||
| Prawesty Diah Utami* 1؛ Herin Setianingsih2؛ Erlyana Trianita Putri3؛ I Nyoman Aditya Pramana3؛ Dewi Ratih Tirto Sari4 | ||
| 1Department of Parasitology, Faculty of Medicine, Hang Tuah University, Surabaya, Indonesia | ||
| 2Department of Anatomy and Histology, Faculty of Medicine, Hang Tuah University, Surabaya, Indonesia | ||
| 3Undergraduate Medical Student, Faculty of Medicine, Hang Tuah University, Surabaya, Indonesia | ||
| 4Department of Pharmacy, Faculty of Health Science, Ibrahimy University, Situbondo, Indonesia | ||
| چکیده | ||
| Introduction: Malaria remains a significant challenge to public health, reinforcing the importance of identifying new antimalarial candidates with an adequately defined preclinical safety profile. Previous studies have shown antimalarial activity and hepatorenal protective effects of encapsulated Holothuria atra, but its safety after a single oral exposure has not yet been comprehensively established. Accordingly, this study evaluated the acute oral toxicity of a 4:1 gum Arabic–soy protein isolate/GA-SPI microencapsulated formulation of H. atra in male Wistar rats. Materials & Methods: Thirty-five animals were assigned to one vehicle-control group and four treatment groups that received a one-time oral administration of 5, 50, 300, or 2,000 mg/kg body weight and were monitored for 14 days. Evaluations included clinical and behavioral observations, food consumption, body weight, hematological indices, serum biochemical markers, absolute organ weights, and histopathology of the heart, brain, liver, and kidneys. Results: Food consumption did not show progressive suppression with increasing dose, and changes in body weight were not significantly different among groups. Hematological findings were generally stable, whereas biochemical responses varied across parameters without a uniform dose-related trend. Clinical and behavioral changes were more apparent at higher exposures, particularly at 2,000 mg/kg. Histopathological scores differed among groups for all examined organs and were consistently greatest at 2,000 mg/kg. Conclusion: Taken together, acute exposure to encapsulated H. atra was associated with generally maintained systemic tolerability, although the highest dose produced more evident clinical and microscopic tissue changes. Repeated-dose and toxicokinetic studies are needed to delineate the therapeutic safety window more precisely. | ||
| کلیدواژه‌ها | ||
| Acute oral toxicity؛ Antimalarial candidate؛ Histopathology؛ Holothuria atra؛ Microencapsulation | ||
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