银杏叶胶囊辅助降血脂功能人体试食研究  

Human Feeding Trial of Ginkgo Folium Capsules for Evaluation of Auxiliary Lipid-lowering Function

作　　者：周丹英[1] 章越 姜慧洁 ZHOU Dan-ying;ZHANG Yue;JIANG Hui-jie(Zhejiang Institute of Traditional Chinese Medicine Co.,Ltd.,Hangzhou 310023,China)

机构地区：[1]浙江省中药研究所有限公司,浙江杭州310023

出　　处：《食品与药品》2024年第2期186-189,共4页Food and Drug

摘　　要：目的观察银杏叶胶囊在推荐剂量下辅助降血脂作用的安全性和有效性。方法筛选出符合标准的高脂血症患者110人,随机分为试食组(55例)和对照组(55例)。试食组每天2次,每次1粒,服用银杏叶胶囊,对照组服用安慰剂。结果试食前后各项安全检测指标,如血压、血象、心率、排泄物、血糖浓度、肝脏和肾脏功能等平均数值均处于正常范围,试食过程中未出现过敏情况及不良反应。试食组服用银杏叶胶囊60 d后血清高密度脂蛋白胆固醇(HDL-C)水平低于对照组,差异无统计学意义(P>0.05);低密度脂蛋白胆固醇(LDL-C)、甘油三酯(TG)、血清总胆固醇(TC)的水平明显降低,自身试食前后及组间对比差异均具有统计学意义(P<0.05);试食组临床观察的总有效率(84.9%)明显高于对照组(44.2%),差异具有统计学意义(P<0.05)。结论银杏叶胶囊对受试者健康无明显损害,且在试验剂量下具有辅助降血脂功效。Objective To observe the safety and effectiveness of Ginkgo Folium Capsules at the recommended dose in human feeding trial for evaluation of auxiliary lipid-lowering function.Methods 110 patients with hyperlipidemia who met the test criteria were selected and randomly divided into trial group(55 cases)and control group(55 cases).The patients in trial group took one capsule twice daily,while the patients in control group took placebo.Results Before and after the trial,the average values of various safety indexes,such as blood pressure,hemogram,heart rate,excrement,blood sugar concentration,liver and kidney function,were all within the normal range,and no allergy or adverse reactions occurred during the trial.After administration of Ginkgo Folium Capsules for 60 days,the serum high density lipoprotein cholesterol(HDL-C)level of the trial group was lower than that of the control group,and the difference was not statistically significant(P>0.05).The levels of low-density lipoprotein cholesterol(LDL-C),triglyceride(TG)and serum total cholesterol(TC)decreased significantly,and the differences between the levels of the indexes before after the trial and the differences between the levels of the indexes of the trial group and the control group were all statistically significant(P<0.05).After the trial,the total effective rate of clinical observation of the trial group(84.9%)was significantly higher than that of the control group(44.2%),and the difference was statistically significant(P<0.05).Conclusion Ginkgo Folium Capsules show no obvious harm to the health of the subjects,and has auxiliary lipid-lowering effect at the experimental dose.

关 键 词：银杏叶胶囊 人体试食试验 安全性 降血脂 

分 类 号：TS218[轻工技术与工程—粮食、油脂及植物蛋白工程]