title: 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.
authors.affiliation: College of Pharmacy, Jiangsu University, Zhenjiang, 212013, China.
authors.forename: Hongfei
authors.initials: H
authors.lastname: Liu
authors.affiliation: College of Pharmacy, Jiangsu University, Zhenjiang, 212013, China.
authors.forename: Shuangshuang
authors.initials: S
authors.lastname: Shi
authors.affiliation: Department of Pharmaceutics, Shen Yang Pharmaceutical University, Shen Yang 110016, China.
authors.forename: Weisan
authors.initials: W
authors.lastname: Pan
authors.affiliation: Department of Pharmaceutics, Shen Yang Pharmaceutical University, Shen Yang 110016, China.
authors.forename: Changshan
authors.initials: C
authors.lastname: Sun
authors.affiliation: Department of Pharmaceutics, Shen Yang Pharmaceutical University, Shen Yang 110016, China.
authors.forename: Xiaomian
authors.initials: X
authors.lastname: Zou
authors.affiliation: College of Pharmacy, Jiangsu University, Zhenjiang, 212013, China.
authors.forename: Min
authors.initials: M
authors.lastname: Fu
authors.affiliation: Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing,China.
authors.forename: Yingshu
authors.initials: Y
authors.lastname: Feng
authors.affiliation: College of Pharmacy, Jiangsu University, Zhenjiang, 212013, China.
authors.forename: Hui
authors.initials: H
authors.lastname: Ding
keywords: Biocompatibility; Microsphere; Pharmacology; Toxicology; pH sensitive ion exchange resin