Nghiên cứu độc tính cấp và bán trường diễn của sản phẩm HemoShield trên động vật thực nghiệm=Assessment acute and subacute toxicity of HemoShield in experimental animals

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Tác giả: Thị Nhung Dương, Khánh Hòa Nguyễn, Thị Thanh Hương Nguyễn, Tường Anh Nguyễn, Thanh Thúy Tô

Ngôn ngữ: vie

Ký hiệu phân loại:

Thông tin xuất bản: Tạp chí Nghiên cứu y học (Đại học Y Hà Nội), 2024

Mô tả vật lý: tr.282-294

Bộ sưu tập: Metadata

ID: 244755

Thêm vào giỏ

Nghiên cứu này đánh giá độc tính cấp và bán trường diễn của sản phẩm hỗ trợ điều trị sốt xuất huyết HemoShield (HS) của công ty Dược Phẩm Vĩnh Phúc (VPO Pharco.) trên chuột nhắt trắng bằng phương pháp thử nghiệm độc tính rút gọn theo hướng dẫn của Bộ Y tế và OECD, độc tính bán trường diễn trên chuột cống trắng theo hướng dẫn của Bộ Y tế. Liều được dùng cho đánh giá độc tính cấp là 5,0 g/kg thể trọng
hai liều được dùng đánh giá độc tính bán trường diễn là 1120,56 mg/kg thể trọng/ngày và 3361,68 mg/kg thể trọng/ ngày. Kết quả thử nghiệm độc tính cấp cho thấy liều 5,0 g/kg thể trọng không gây chết trên chuột nhắt. Kết quả đánh giá độc tính bán trường diễn không phát hiện tác dụng gây hại của sản phẩm HS ở liều cao tới 3361 mg/ kg/ngày lên các chức năng tạo máu, miễn dịch, chức năng gan, thận của chuột cống. Về số lượng tiểu cầu, tuy không có sự khác biệt giữa lô dùng HS liều thấp (1120,56 mg/kg/ngày) và liều cao (3361,68 mg/kg/ngày) so với lô chứng ở các thời điểm nghiên cứu nhưng có sự giảm nhẹ số lượng tiểu cầu ở lô dùng HS liều cao sau 4 tuần uống so với trước khi uống. Các kết quả thu được cho thấy sản phẩm có thể tiếp tục được nghiên cứu để sử dụng trên người nhưng cần thận trọng khi sử dụng liều cao tương đương 3361,68 mg/kg/ngày trên chuột.The study aimed to evaluate the acute and subacute toxicity of the HemoShield (HS) - a product of Vinh Phuc Pharmaceutical Company (VPO Pharco.) on mice and rats. Study the on the acute toxicity of the water extract on mice using the acute and subacute toxicity test methods according to the guidelines of the Ministry of Health and the OECD. Study the acute and sub acute toxicity of capsules on rats according to the instructions of the Ministry of Health. Research results show that with a dose of 5.0 g/kg of mouse body weight, no mouse died. HemoShield extract (1120.6 mg/kg mouse body weight/day) and dose 3 times the clinical dose of human (3360.7 mg/kg mouse body weight/ day) for 4 consecutive weeks of taking the HS. All monitoring indicators of general condition, weight, hematopoietic function, liver function and kidney function are within normal limits, liver and kidney histopathology have no obvious differences compared to control group (p >
0.05). The number of platelets in mice taking high doses of the drug after 4 weeks decreased significantly compared to the control group but no bleeding symptom appeared in the tissues. Therefore, the HemoShield product is safe and can be used for further human studies at a dose not exceeding 171 mg/kg body weight.

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