NGHIÊN CỨU ĐÔNG KHÔ BEVACIZUMAB VÀ ĐÁNH DẤU VỚI TC-99M ĐỂ CHỤP HÌNH MIỄN DỊCH PHÓNG XẠ UNG THƯ=Study freeze-dried of bevacizumab and labeling with 99mTc for tumor radioimmunoscintigraphy

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Tác giả: Hồ Hồng Quang Đặng, Thanh Bình Nguyễn, Thanh Nhàn Nguyễn, Thị Khánh Giang Nguyễn, Thị Ngọc Nguyễn, Thị Thu Nguyễn, Thành Minh Phạm

Ngôn ngữ: vie

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Thông tin xuất bản: Tạp chí Điện quang và Y học hạt nhân Việt Nam, 2024

Mô tả vật lý: tr.13-19

Bộ sưu tập: Metadata

ID: 486841

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Mục tiêu: Bevacizumab, kháng thể đơn dòng nhân hoá kháng VEGF, được nghiên cứu đông khô và đánh dấu với 99mTc để tạo thành 99mTc-bevacizumab dùng trong chụp hình khối ung thư. Mục đích của nghiên cứu là phát triển công thức và quy trình đông khô thuốc bevacizumab.Phương pháp: Bevacizumab được khảo sát đông khô theo hàm lượng các chất, pH, nhiệt độ và thời gian. Hợp chất đông khô được kiểm tra tính ổn định, đánh dấu với đồng vị phóng xạ 99mTc, kiểm tra độ tinh khiết hoá phóng xạ và độ bền.Kết quả: Kết quả nghiên cứu cho thấy, bevacizumab được đông khô tạo thành dạng khô xốp, màu trắng, ở các điều kiện tối ưu như đệm phosphat 0,5 M, pH 7,4 ở nhiệt độ -40oC và thời gian 24 giờ. Bevacizumab đông khô ổn định sau 6 tháng theo dõi. Độ tinh khiết hóa phóng xạ của 99mTc-bevacizumab đạt hơn 98 %, đạt vô khuẩn và nội độc tố vi khuẩn.Kết luận: Bevacizumab đã được điều chế dạng đông khô, có thể dùng để đánh dấu với 99mTc, đạt các chỉ tiêu về thuốc phóng xạ và có thể dùng trong các nghiên cứu tiền lâm sàng.Objective: Bevacizumab, a humanized monoclonal antibody against VEGF was lyophilized and labeled with radioisotope 99mTc using in tumor radioimmunoscintigraphy. The purpose of the study is to develop a formulation and process for lyophilization of bevacizumab.Methods: Bevacizumab was studied on the lyophilization at the difference of buffers, pH, temperature and time. The antibody lyophilized compound was tested on the stable with time, radiolabeled with 99mTc radioisotope, radiochemical purity examination and stability of radioimmunoconjugates.Results: The results of the study showed that bevacizumab was lyophilized to form a white porous dry form under optimal conditions, as a phosphate buffer 0.5 M, pH 7.4 at - 40°C and a time of 24 hours. The lyophilized bevacizumab was stable after 6 months of follow-up. Radiochemical purity of 99mTc-bevacizumab has been reached more than 98% and passed the test for sterility, bacterial endotoxin.Conclusion: Bevacizumab was prepared in a lyophilized formulation, can be used for radiolabeling with 99mTc, which met radiopharmaceuticalcriteria, and could be used in preclinical evaluations.

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