两种市售中药保健品功效安全的对比评价及相关问题探讨

Comparative evaluation on functions-safety of two TCM healthy foods on sale and discussion of relevant problems

目的通过低营养亚健康小鼠模型及益损指数-累计积分(BDI-GS)方式对市售两种中药保健品A、B胶囊的实际保健功效及安全性进行对比综合评价,并进行保健品相关问题的探讨。方法实验用生长期健康ICR雄性小鼠,通过玉米低营养饲料和0.25%、0.50%、0.75%3个剂量保健品掺和饲料喂养12d,记录小鼠体质量,解剖后统计9项脏器系数及其BDI、GS等指标,以及血清生化指标。结果胶囊A中、高剂量组表现一定的保健功效,而低剂量组存在轻微负面效应,体现在GS值上;胶囊B在3个剂量均对机体主要脏器组织产生不同程度的损害,体现在多脏器的系数BDI<1.0,GS<9.0。结论目前市售的中药保健品种组成相近,但内在质量差异较大,甚至部分产品还存在有一定不良反应,其功效及安全性并未能得到充分保障。通过BDIGS体系评价,可提高保健品的市场准入标准,以提高保健品的功效及安全水平。

Objective To conduct the comparative comprehensive evaluation on the actual healthy effects and safety of two kinds of healthy foods capsule A and B made of Chinese medicinal herbs on sale through the low-nutritional sub-health mice model com-bined with the benefit-damage index-general score（BDI-GS） approach ,and to perform the discussion on the relevant problems a-round healthy foods .Methods The experimental healthy ICR male mice during growth period were fed with maize low-nutritional feed and the mixed feed with 3 doses of 0 .25% ,0 .5% ,0 .75% healthy foods for 12 d and the mice body masses were recorded .Af-ter dissection ,9 items of the organ index and their BDI ,GS and serum biochemical indicators were performed the statistics .Results In the capsule A ,the medium and high dose groups manifested certain health-promoting effect ,while the slight negative effect exis-ted in the low dose group ,which was expressed in the GS values ;but in the capsule B ,3 doses all caused the damage to main internal organs in different degrees ,which was expressed in BDI＆lt;1 .0 and GS＆lt;9 .0 .Conclusion At present ,despite of possessing similar ingredients ,Chinese medicinal healthy foods in market are of greater differences in intrinsic qualities ,and even partial products have some adverse effect ,the healthy functions and safety are not enough to be fully ensured .Through the systematic evaluation of the BDI-GS system ,the criteria of marketing threshold for healthy foods will be increased so as to enhance their effects and safety level .