Biocompatibility Research of a Novel pH Sensitive Ion Exchange Resin Microsphere.

Abstract

The main objective of this study was to investigate biocompatibility and provide in-vivo pharmacological and toxicological evidence for further investigation of the possibility of pH sensitive ion exchange resin microsphere for clinical utilizations. Acute toxicity study and general pharmacological studies were conducted on the pH sensitive ion exchange resin microsphere we prepared. The general pharmacological studies consist of the effects of the pH sensitive ion exchange resin microsphere on the nervous system of mice, the functional coordination of mice, the hypnosis of mice treated with nembutal at subliminal dose, the autonomic activities of tested mice, and the heart rate, blood pressure, ECG and breathing of the anesthetic cats. The LD50 of pH sensitive ion exchange resin microsphere after oral administration was more than 18.84 g·Kg(-1). Mice were orally administered with 16 mg·Kg(-1), 32 mg·Kg(-1) and 64 mg·Kg(-1) of pH sensitive ion exchange resin microsphere and there was no significant influence on mice nervous system, general behavior, function coordination, hypnotic effect treated with nembutal at subliminal dose and frequency of autonomic activities. Within the 90 min after 5 mg·Kg(-1), 10 mg·Kg(-1), 20 mg·Kg(-1) pH sensitive ion exchange resin microsphere was injected to cat duodenum, the heart rate, blood pressure, breathing and ECG of the cats didn't make significant changes in each experimental group compared with the control group. The desirable pharmacological and toxicological behaviors of the pH sensitive ion exchange resin microsphere exhibited that it has safe biocompatibility and is possible for clinical use.