基于中医理论用新体系评价中药归脾丸新剂型的补益及健康效应  

Replenishing and Healthy Sanatory Effects Evaluation of Guipi pills Pills in New Dosage Formnovel dose-form Evaluated by Novel System Based on Traditional Chinese Medicine Theory

作　　者：郜文[1] 王浩[2] 徐平湘[1] 靳瑾[2] 于培红[1] 沈秀[2] 龙伟[2] 周则卫[2] 

机构地区：[1]首都医科大学药物研究所,北京100069 [2]中国医学科学院北京协和医学院放射医学研究所,天津300192

出　　处：《药品评价》2014年第16期15-18,46,共5页Drug Evaluation

基　　金："传统中药功效评价体系研究"。中国医学科学院北京协和医学院放射医学研究所发展基金项目;编号:SF1337

摘　　要：目的:本研究通过BDI-GS新体系结合玉米低营养小鼠模型,在常规给药剂量下评价中药归脾丸水丸新剂型的补益及健康效应,并以此检验该体系在中药功效评价中应用的实用性。方法:实验选用生长期健康ICR小鼠,设立玉米低营养饲料空白对照组,以及0.225%、0.45%和0.90%3个剂量的归脾丸药物掺和饲料组;连续喂养12天,隔天称取体重1次,于第12天称体重后,取血并处死、剖取9项脏器器官及组织并称重,计算脏器系数、BDI及GS值,并测试血清生化指标。结果:常规剂量下归脾丸水丸具有良好养心功效,符合其主治功效。并表现出较好的降酶(AST及ALT)保肝功效,以及对肾脏功能指标肌酐(CREA)和尿素氮(BUN)降低的功效,可用于相关疾病的辅助治疗。药物对主要脏器组织损伤较轻,表现在脏器BDI值均在0.80以上,机体能够耐受。9项指标累计GSW值均略低于9.0;而GSI也接近9.0的基本值,综合负效应较轻。结论:本研究表明归脾丸水丸对心脏健康十分有益。在常规剂量下连续用药副作用较轻,不会导致机体脏器组织严重的健康损害。Objective： To study the replenishing and sanatory effects of Chinese medicinal Guipipills in novel water- pill dosage form under common intake dosages by using BDI-GS system combined with maize low-nutritional mice model, and to testify the practical value of the system in the evaluation of Chinese medicinefunctions. Methods： The healthy ICR mice during growth period were selected. Mice in the control group were fed with maize low-nutritional diets, and mice in the tested group were fed with spiking diets with 0.225%, 0.45% and 0.90% of Guipipills. The mice were fed continuously for 12 days, weighed once every other day. At the 12th day, blood samples were taken andall mice were executed. Statistical analysis was performed on animal weights and indexes of 9 organs or tissues, BDI and GS values. Serum biochemical indicators were also measured. Rosults： The Guipi water-type pills in common dosage forms showed well replenishing function in heart, and it is in agreement with its major curing effects. It lowered liverenzymes （AST and ALT）, creatinine （CREA） and blood urea nitrogen （BUN） which were indicators of kidney funtion, which suggested helpful in assistant therapy of relevant diseases. Lighter damages on major organs or tissues of body, expressed in the BDI values of organs all above 0.80, were observed which were tolerable. The accumulated GSW values are just slightly below 9.0, the basic point, and GSI values are all close to 9.0 point, with lighter overall adverse effects. Conclusion： The study suggestted thatGuipiwater- type pills was beneficial for heart health. The adverse side effects were slight in the course of continuous intake in common doses, and no serious healthy damage occurred.

关 键 词：BDI—GS体系 低营养模型 归脾丸 功效安全评价 

分 类 号：R259[医药卫生—中西医结合]