To produce ⁶⁸Ga and automatically synthesize ⁶⁸Ga-labeled drugs based on low-energy medical cyclotron solid target system.

⁶⁸Zn was electroplated on the surface of the target by electrodeposition. According to the principle of ⁶⁸Zn(p, n)⁶⁸Ga nuclear reaction, ⁶⁸Zn was irradiated by the 10 MeV medical cyclotron solid target system (30 μA, 30 min) to produce ⁶⁸Ga, and the activity, nuclear purity, half-life and content of metal impurities of purified product were determined. ⁶⁸Ga-prostate specific membrane antigen (PSMA)-11 and ⁶⁸Ga-1, 4, 7, 10-tetraazacyclododecane-1, 4, 7, 10-tetraacetic acid-D-Phe1-Tyr3-Thr8-octreotide (DOTATATE) were synthesized automatically using ⁶⁸Ga respectively, and the quality control analyses of drug properties, concentration, pH, radiochemical purity, sterility and bacterial endotoxin were carried out.

The electroplating mass of ⁶⁸Zn was (43.71±0.87) mg (n=35), the yield of ⁶⁸Ga after irradiation was (10.96±0.67) GBq (n=35), and the measured half-life was (67.64±0.06) min (n=7). Only 511 keV energy peak was detected by the gamma spectrometer. After purification, (6.85±0.12) GBq (n=35) of pure ⁶⁸Ga was obtained, and the purification efficiency was (62.46±0.96)% (non-attenuated correction, n=35). The metal impurity contents of Zn and Fe were (0.18±0.06) and (1.25±0.43) μg/GBq (n=5), which met the requirements of European Pharmacopoeia. Three batches of ⁶⁸Ga-PSMA-11 and ⁶⁸Ga-DOTATATE were automatically synthesized, with the yield, concentration and radiochemical purity of (3.54±0.14) and (2.74±0.20) GBq, (294.97±11.58) and (228.17±16.32) GBq/L, (99.73±0.11)% and (99.45±0.25)%, respectively. Both sterility and bacterial endotoxin were qualified.

High-yield and qualified nuclide ⁶⁸Ga and ⁶⁸Ga-labeled drugs are successfully prepared through the low-energy medical cyclotron solid target system and the automated purification and synthesis module, which provide a strong guarantee for clinical practice.

Cyclotrons; Solid target; Gallium radioisotopes; Isotope labeling; Quality control