Study On The Quality Control, Pharmacodynamics And Toxicology Of Zhimaikang Dispersible Tablets

Objective:The purpose of this study is to establish quality control standards for the main effective parts in Zhimaikang dispersible tablets. Examining the efficacy and safety of drugs by pharmacodynamics and toxicology experiments, it provides the basis for the clinical application of research and development for new drugs.Methods And Results:1. Quality control studies about the Zhimaikang dispersible tablets:Using the HPLC assay the content of the effective parts (polydatin and resveratrol) in Zhimaikang dispersible tablets. According to the drying sample, the content of the effective parts must not be less than19.0mg/piece, in which polydatin shall not be less than18.4mg/piece. Thin layer chromatography((abbreviated as TLC) was used to identify polyd-atin, resveratrol and emodin in Zhimaikang dispersible tablets. The results show:there are the same colorful spots of polydatin, resveratrol and emodin at the same site by comparison of chromatography of reference substance.2. the main pharmacodynamic studies about the Zhimaikang dispersible tablets:Through the establishment of two different hyperlipidemia model: experimental rat model and high fat diet sex rabbit atherosclerosis model,the lipid-lowering effect of Zhimaikang dispersible tablet was evaluated. In the experimental rat fatty model, investigates the effects of the different dose Zhimaikang dispersible tablet on experimental rats hyperlipidemia prevention function and the in vitro thrombotic influence; In the diet sex rabbit atherosclerosis model, a series of experiments were carried out to observe its resistance to atherosclerosis effect and platelet aggregation rate and blood rheological effect.The results show that the middle and high doses of Zhimaikang dispersible tablet has a significant lipid-lowering, anti-atherosclerotic role and antibody outside thrombosis effect, and can better improve the blood of strong adhesive state, inhibit platelet gathering. 3. The safety evaluation of Zhimaikang dispersible tablets:General pharmacology study, Through the investigation on general pharmacology index of mice and normal anaesthetic dogs, found that Zhimaikang dispersible tablet have no obvious influence on animal normal physiological activities;Toxicology research the acute toxicity of mice, rats and dogs long-term toxicity test, the results show that all the toxicology test indexes no abnormalities are found, and learned about toxic reaction of target organ damage and the reversibility, determine the non-toxic reaction dose range, for clinical dose safety worked to provide the reference. Various safety research results show that:The Zhimaikang dispersible tablets within the recommended human dose of medication is safe.Conclusion:The quality of Zhimaikang dispersible tablets is controllable. The content of polydatin and resveratrol can be assayed by HPLC and identified by TLC obviously also.Study results show that the methods is simple, reproducible and can be used as determination methods for the quality control of Zhimaikang dispersible tablets.By studies of the main pharmacodynamic and general pharmacology and The toxicology of Zhimaikang dispersible tablets have shown that: Compared with the Xuezhikang capsule of the commonly used drugs in clinical, Zhimaikang dispersible tablets can be used to improve the blood concentration sticky state, even more efficacy and safety. so it can become a kind of high safety of new traditional Chinese medicine effective parts cholesterol-lowering drugs.