我国大豆异黄酮保健食品的概况分析

General situation of soy isoflavone health food in China

目的探讨目前我国大豆异黄酮保健食品在原料配伍、使用剂量及保健功能等方面的特点以及可能存在的问题，为进一步完善大豆异黄酮类产品的审批提供参考和依据。方法通过查询国家食品药品监督管理局保健食品审评数据库以及查阅相关注册审评档案，对我国2006年底以前批准的大豆异黄酮保健食品的注册审批情况进行描述性统计分析，分析其原料、剂型、保健功能、食用量、功效成分／标志性成分及质量标准、检验方法等有关信息。结果共分析127个大豆异黄酮保健食品，产品涉及91种原料和9项保健功能；96．1％的产品是由大豆异黄酮／大豆提取物与其他原料配伍而成的，3味及以上原料配伍的产品占总产品的89．0％；增加骨密度、抗氧化／延缓衰老两项功能占全部功能总数的60％（106／175）。产品中大豆异黄酮摄入量范围为0．02～220．80mg／d。均值为56．88mg／d。剂型以片剂（28．3％）、胶囊（66．1％）为主。结论我国大豆异黄酮保健食品具有大豆异黄酮摄入量范围较大、保健功能范围较广、原料配伍较为复杂、产品剂型较为单一的特点。这与国内外无统一的大豆异黄酮原料标准、生产工艺、功效作用、食用剂量及检测方法等有关。应尽快制定大豆异黄酮或大豆提取物行业标准和／或国家标准。

Objective To learn general situation of soy isoflavone health food in China, and try to provide reference and evidence for licensing new products. Methods Data of soy isoflavone health food authorized before 2007 were collected. Ingestion dose of isoflavone, the raw materials used, the functions claimed, and other related information were analyzed. Results Ninety - one sorts of raw material and 9 kinds of functions were involved in all of the authorized soy isoflavone health food. 96.1% of products were composed of soy isoflavones/soybean extract with other raw materials. The functions of increasing bone density and antioxidation occupied 60.6% （ 106/175 ） of all functions. The intake of soy isoflavones in products was in the range of O. 02 - 220.80 mg/d, with average of 56.88 mg/d. The main dosage forms were tablets （28.3%） and capsules （66.1% ）. Conclusion The soy isoflavone health food in China were characteristic of wide range of ingested dose, various function claims, complicated raw materials and simple forms of product. It could be attributed to short history of using soy isoflavone and lack of guidelines of raw material, manufacture process, health claim, recommended dose and even methods for measuring soy isoflavone.