| 摘要 |
Technetium 99m (V)-dimercaptosuccinic acid (DMSA) is a diagnostic imaging agent with clinical application in the diagnosis of myeloid thyroid carcinoma, of bone and soft tissue tumors and breast tumors. Furthermore, significant retention in bone metastases has been reported. The invention concerns a standardized formulation of a freeze-dried kit for the single-step preparation of the radiopharmaceutical pentavalent technetium-<99m>Tc(V)-dimercaptosuccinic acid only by the reconstitution of the freeze-dried kit content by adding an appropriate volume of injectable solution of sodium Pertechnetate-<99m>Tc. Consequently, the kit formulation is developed to contain all necessary constituents in a stable in vitro composition which enables the kit storage for three months. The vial content - lyophilized dry powder - is sterile and pyrogen free. The method of the kit preparation comprises the mixture of two DMSA solutions (A and B) of different compositions and acidity. The final solution is prepared by adding solution B to solution A; Lyophilization is taking place at zero degrees Celsius for 24 hours, whereas vials are sealed inside the lyophilization chamber under dried and sterile nitrogen 99.999% pure. The whole procedure must be run under aseptic conditions. The cold kit should be stored in the freezer. The kit labeling with technetium-99m is achieved with the reconstitution or total dissolution of the kit content by adding 2.5 ml of sodium pertechnetate-Tc99m injectable solution of total radioactivity between 0.74 - 2.96 GBq (20-80 mCi). The method of labeling is therefore performed simultaneously with the kit reconstitution. Therefore the preparation of the pentavalent technetium 99m(V)-dimercaptosuccinic acid is a very simple procedure, easy-to-use, efficient and pharmaceutically safe. The prepared solution of pentavalent technetium 99m(V)- dimercaptosuccinic acid may be used for 2.5 hours after labeling when kept in the refrigerator (preservation conditions) conforming to the rules of protection against radiation. |
