The Study Of Jiangzhibao Capsules

Objectives:The purpose of the research is to establish foundation for the development of a new preparation of the compound traditional Chinese medicine for hyperlipidemia.According to the study of new pharmaceutical preparation,this project before clinical trial includes four important sections:to study preparation technology,to establish the quality standard,to study the stability of the preparation,to study the main pharmacodynamics and the acute toxicology.Methods:①The preparation technology of Jiangzhibao Capsules was determined.The pre-process of Black Currant seed and the influence factor of stability of its powder were studied.The alcohol extracting procedure of Fructus Crataegi and the water extracting procedure of Glycyrrhiza and Fructus Crataegi which had been extracted by alcohol and the clarifying procedure of water extrac solution were separately screened by means of optimal experiment designs.The formulation procedure was screened by means of single-factor experiment design.②The quality standard of Jiangzhibao Capsules was established.Black Currant seed was identified by Microscopy.Fructus Crataegi and Glycyrrhiza was separately identifed by TLC.The content ofγ-1inolenic acid in Jiangzhibao Capsules was determined by GC.③Accelerating and long-term tests were conducted according to guidelines regarding the experiments of stability of medicine from the Chinese Pharmacopoeia(Edition 2005) to evaluate the stability of the product.④Xuezhikang Capsules used as reference preparation, the main pharmacodynamics was studied by observing the effect of the product on serum lipid and atherosclerotic plaque in experimental hyperlipidemia rats,mice and quails, respectively.The acute toxic reaction of mice was observed after they took Jiangzhibao Capsules orally.Results:①The pre-process of sterilization and comminution of Black Currant seed and packing material and storage condition of its powder were determined. The frequency and the time of extraction and the concentration and the volume of alcohol in the alcohol extracting procedure of Fructus Crataegi were determined.The frequency and the time of extraction and the volume of water in the water extracting procedure of Glycyrrhiza and Fructus Crataegi which had been extracted by alcohol were determined. The optium clarifiying procedure was determined.In the form of granule made by spray-drying process,the best formula of preparation and the best proportion of excipients were determined.②The quality standard of Jiangzhibao Capsules can practicably control the quality.③There was no obvious change with all indicators of the samples in the experiments monitored through the 3-month peried of accelerating and long-term tests.④The results of the statistical analysis showed that test drugs can not only lower the lever of TC,TG and LDL-C in serum and reduce the formation of atherosclerotic plaque in experimental hyperlipidemia animals,but also significantly better than reference preparation in quails except the lever of TG in serum(P＜0.01).With test drugs,the maximum tolerance dosage of mouse was as 2448 times as everyday dosage of adult according to body weight per kilo.Conclusions:①The preparation process is stable and suitable for new pharmaceutical preparation.②The quality standard of the preparation is feasible and contrlollable.③The initial stability of the preparation is sound and provides evidence for the feasibility of technology and packing material.④The results of the experiments showed that the preparation for hyperlipidemia is effective and safe.