The Studies On The Pilot Tests And The Quality Standards Of Temperature-sensitive Nanogels In The Blood-vascular Embolization Therapy

Liver cancer is one of the most common malignancy in China and other Asiancountries and it’s seems that more people would suffer this disease in the future.Nowadays, interventional therapy has been recognized as the preferred therapy foradvanced liver cancer because it’s minimally invasive, good effect and low side effects.And the key of the interventional therapy is the choice of embolic agents for the vessel.Temperature sensitive nanogel has been studied well for the embolization therapy of livercancer in our previous works. In order to implement the industrial production of nanogels,the studies on the pilot test technology, the quality standards and biocompatibilities werecarried out in the thesis. The main results were as follows:(1) The improvement of the synthesis process of p(N-isopropylacrylamide-co-butylmethacrylate)(PIB) nanogel. The influence of the SDS amount on the nanogel size wasstudied. When the feeding amount of SDS was between0.2～0.65mmol g/L, thenanogel size was in the range of150and300nm. The factors of the synthesis processwere studied, and the preliminary study was carried out on the amplification process.(2) A HPLC method was established to determinate N-isopropylacrylamide (NIPAM)and a GC method to determinate Butyl-methacrylate (BMA). The MS-LC method wasestablished in order to determinate the trace amounts of NIPAM, BMA and MBA. Thetechnology to remove these monomers from PIB nanogel was found. After purification,the amounts of all residual monomers were less than50ppb.(3) The quality standards of PIB nanogels was established for the blood-vascularembolization therapy of liver cancer, and the pilot process route of PIB nanogels wasfound including the synthesis, post-treatment, mixing with Iohexol and filling process.