Đánh giá độc tính cấp và độc tính bán trường diễn của chế phẩm CB-02 trên động vật thực nghiệm=Evaluation of acute and sub-chronic toxicity of CB-02 formulation in experimental animals

0 Người đánh giá. Xếp hạng trung bình 0

Tác giả: Lan Hiệp Hoàng, Đình Nhân Nguyễn, Hoàng Ngân Nguyễn, Nhật Minh Nguyễn

Ngôn ngữ: vie

Ký hiệu phân loại:

Thông tin xuất bản: Tạp chí Y dược lâm sàng 108, 2024

Mô tả vật lý: tr.157-165

Bộ sưu tập: Metadata

ID: 244956

Thêm vào giỏ

Đánh giá độc tính cấp và độc tính bán trường diễn trên động vật thực nghiệm của chế phẩm CB-02. Đối tượng và phương pháp: Đánh giá độc tính cấp được thực hiện theo phương pháp Litchfield-Wilcoxon trên chuột nhắt trắng chủng Swiss. Độc tính bán trường diễn được đánh giá trên chuột cống trắng thuần chủng Wistar theo Hướng dẫn của Bộ Y tế và Tổ chức Y tế Thế giới về đánh giá hiệu lực và an toàn thuốc. Kết quả: Chưa xác định được LD50 của chế phẩm CB-02 ở mức liều cao nhất có thể cho chuột uống (17,5g/kg thể trọng). Chế phẩm CB-02 liều 336mg/kg/24giờ và 1680mg/kg/24giờ, uống liên tục trong 90 ngày không làm ảnh hưởng đến tình trạng chung, trọng lượng cơ thể của chuột cống
các chỉ số huyết học: số lượng hồng cầu, hemoglobin, hematocrit, bạch cầu và tiểu cầu
các chỉ số đánh giá hủy hoại tế bào gan (nồng độ enzym GOT, GPT), chức năng thận (creatinin) và cholesterol toàn phần thay đổi không có ý nghĩa thống kê (p>
0,05) giữa nhóm sử dụng thuốc và nhóm chứng. Hình ảnh mô bệnh học gan, thận và lách chuột cống đều trong giới hạn bình thường ở các lô nghiên cứu. Kết luận: Chế phẩm CB-02 không gây độc tính cấp trên chuột nhắt trắng và không làm thay đổi chức năng tạo máu, hủy hoại tế bào gan, chức năng thận và hình thái gan, thận, lách trên chuột cống trắng thực nghiệm.To evaluate the acute and sub-chronic toxicity of the CB-02 formulation in experimental animals. Subject and method: The acute toxicity of CB-02 formulation was evaluated on Swiss mice by the Litchfield-Wilcoxon’s method and the sub-chronic toxicity was evaluated on Wistar white rats according to Vietnam Health Ministry’s regulations and WHO guidelines on the effectiveness and safety of the medicine. Result: The LD50 of the CB-02 formulation was not identified at the highest dose that mice could drink for 24 hours (17.5g/kg BW). The CB-02 formulation at 336mg/kg per day and 1680mg/kg per day for 90 consecutive days did not affect the body weight and the hematology indicators like red blood cells, hemoglobin, hematocrit white blood cells and platelets
the liver cell destruction assessment indicators (GOT, GPT), kidney functions (creatinin) and cholesterol total
the changes were not statistical significance (p>
0.05) between the research group and control group. The pathological images of rats’ livers and kidneys were within the normal limits. Conclusion: The CB-02 formulation did not have acute toxicity, did not change the functions of hematopoiesis, and did not destroy the liver cells, the kidney functions, the form of kidney, liver and spleen on experimental white rats.

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