【作者】 王楠；

【导师】 蔺新英； 陈永祥；

【作者基本信息】 山东大学 ， 营养与食品卫生学， 2009， 硕士

【摘要】 目的:本研究通过对从我国保健食品实行审批制度以来,获得批准的国产保健食品进行全面系统分析以了解我国保健食品的一般状况和规律;通过对北京市居民保健食品使用情况调查,了解居民使用保健食品基本情况,探讨影响居民使用保健食品的因素;旨在为各级保健食品管理部门制定相关法律法规和监督管理提供数据支持和依据,为保健食品生产企业研发、生产和销售提供参考。方法:本研究涉及我国已审批的国产保健食品基本情况和北京市居民保健食品使用基本情况。前者主要应用流行病学回顾性研究方法,利用卫生部保健食品证书和产品说明证书汇编材料和国家食品药品监督管理局保健食品数据库对1996年～2008年期间获得批准的国产保健食品进行研究。研究内容包括:(1)产品一般情况(包括各年度的批准数目,产品申报单位的地域,功能声称,产品剂型等),(2)中药原料应用情况(按照《卫生部关于进一步规范保健食品原料管理的通知》卫法监发[2002]51号附件中关于保健食品中药原料的分类进行统计),(3)功能因子应用情况(包括功能因子涉及功能、原料来源、产品含量及每日食用量)。后者主要应用流行病学现场调查的研究方法,调查采用多阶段整群随机抽样法,第一阶段从北京市抽取西城、宣武、昌平及密云4个区县,第二阶段每个区县抽取15个乡镇/居委会,第三阶段采用随机整群抽样方法,从每个乡镇/居委会各抽取1个村/社区抽取100户家庭,以家庭中的所有常住人口为调查对象。共调查家庭6000户,居民21000人。其中获得有效问卷20409份。研究内容包括:(1)对北京市居民保健食品使用基本情况进行描述性分析,(2)对北京市居民保健食品使用可能产生影响的因素进行单因素分析,(3)应用Logistic回归模型找出影响居民保健食品使用的因素。结果:1.本研究分析了我国1996年～2008年获得批准的8932个国产保健食品,结果显示1996年获得批准的数目最少,仅为57个,占批准产品总数的0.64%,2004年获得批准的数目最多,达1501个,占批准产品总数的16.80%,其他每年批准的产品数量在400～1000之间波动。2.产品的地区分布不平衡,主要集中在北京、广东、山东、浙江、江苏等东部沿海经济发达省市,而保健食品原料资源丰富的西部地区省份产品较少。3.产品的声称功能主要集中在“增强免疫力(免疫调节)”、“缓解体力疲劳(抗疲劳)”和“营养素补充剂”3类产品,占批准产品总数的62.41%,而“促进泌乳”、“改善微循环”、“防龋护齿”3类保健食品获得批准的数目均不超过10个;营养素类补充剂主要有补充维生素、矿物质、脂肪酸和氨基酸4类,其中以补钙类产品最多,达584个。4.以胶囊、片剂和口服液等非传统食品形态为主,分别占获得批准的产品总数的41.50%、20.34%、11.58%,而剂型采用传统食品的形态如饮料、醋等的产品较少,仅占0.27%和0.21%。5.我国使用的保健食品中药原料主要为卫法监发[2002]51号文件附件1“既是食品又是药品的物品”和附件2“可用于保健食品的物品”。其中附件1中枸杞使用频次最高,达1524次。白扁豆花、枳实子、黑胡椒和榧子4种原料至今未被使用过;附件2中西洋参使用频次最多,为944次。人参、黄芪的使用也超过了800次。而平贝母、泽兰、厚朴花、荜茇、湖北贝母、蒲黄和酸角至今未被作为国产保健食品原料使用过;已审批的国产保健食品均未声称使用过禁用物品名单内的原料。6.对2004年～2008年获得审批的国产保健食品的功能因子按照化学结构分类进行统计分析,包括8大类、21小类的功能因子,其中酚类化合物类最多,批准的产品数量为1550,占获得批准的产品总数的35.90%;其次为萜类化合物类,产品数量达到1373,占总数的31.80%;有机酸类产品相对较少,仅有48个,占获得批准产品总数的1.3%。7.含总皂甙、粗多糖、总黄酮的保健食品声称功能分布广,原料来源丰富。产品中功能因子含量及每日推荐食用量范围差异较大。8.北京居民保健食品使用率为8.90%,89.07%的居民通过电视/收音机/网络途径获得保健食品知识,超过90%的居民通过多种途径获得保健食品知识,北京市居民最喜欢的保健食品宣传形式是广播电视网络,占49.56%;其次是健康知识讲座。居民对保健食品知识了解的程度主要集中在“中等”(占45.08%)、“好”的比例较低,仅占14.76%。居民对保健食品相关管理政策了解情况和保健食品管理评价情况不容乐观。广大居民对保健食品的广告和标签信任度较低。9.影响居民保健食品使用情况的单因素分析显示:城市居民的使用率高于农村居民;随着年龄的增长,保健食品的使用率在增加;随着受教育程度的增加,居民保健食品的使用率也在增加;农民工相对于其他行业居民保健食品使用率较低;经济收入水平越高,保健食品使用率越高;良好健康行为习惯的居民保健食品使用率较高,而不良饮食行为习惯的居民保健食品使用率高于健康饮食行为习惯的居民;自我感觉身体健康的居民保健食品使用率最低;居民对保健食品的了解越多,保健食品的使用率越高;居民对保健食品的管理状况评价越高,保健食品的使用率越高。10.多项式Logistic回归模型显示:经济收入、保健食品知识了解情况、自报健康水平显著影响居民对保健食品的使用。11.居民使用保健食品的目的以增加体质为多,依据以批准文号为多,使用保健食品的功能居前三位的是:“营养补充剂”、“辅助降血脂”、“增加免疫力”,剂型居前三位的是:“胶囊”、“口服液”、“片剂”。结论:1.我国获得审批的国产保健食品数量大,产品地域分布广泛,产品功能种类较多。中药原料资源和功能因子种类丰富。但是保健食品结构不够合理,同质化集中现象比较突出:产品地区分布不均,功能和剂型主要集中在少数种类上,中药原料的使用种类集中在51号文附件1和附件2所列名单,部分原料使用频次较高,而一些原料尚未在我国已审批的保健食品中使用过。国产保健食品中应用的功能因子种类丰富,在保健食品中的应用处于稳步上升阶段。但分布极不平衡,以结构和成分复杂、来源广泛的酚类化合物和萜类化合物两大类别为主,其中又以总皂甙、粗多糖和总黄酮最为常见。同一功能因子在不同功能的产品中的含量和每日推荐摄入量范围相差较大。2.与发达国家相比,我国居民保健食品使用率偏低。居民通过多种途径获得保健食品相关知识,但主要以电视/收音机/网络为主。居民保健食品知识了解情况不容乐观,应进一步加强相关知识的宣教。经济收入、保健食品知识了解情况、自报健康水平是影响居民对保健食品的使用的显著因素。建议:1.加强功能因子的基础研究,制定保健食品功能因子的卫生标准和确定功能因子每日推荐摄入量。2.简化审批程序,创新管理体制。3.政府主管部门加强对保健食品生产企业指导。4.加强保健食品科学知识宣传普及工作,避免保健食品价格虚高,引导正确消费。更多还原

【Abstract】 ObjectivesThe study analyzed native functional food approved systematically and comprehensively in order to know Chinese functional food status and rules. The study also investigated the usage of functional food of Beijing residents to learn the common status on functional food usage of residents and to discover the factors affecting the functional food usage . The study aims at providing numerical support and accordance for establishing laws, rules and supervision. Also reference for research, production and distribution.MethodsThe study involved evaluation status of Chinese native functional food and usage status of residents in Beijing. The former took the epidemiological retrospection method by using collection materials from Ministry of Health and database of State Food and Drug Administration. Contents consisted of: (1) general information (number, area, function claims and dosage type); (2) application of Traditional Chinese Medicine raw materials(classification according to Available Materials in Functional Food listed in No.51 Files annex issued by MOH); (3) application of functional factors (function, materials source, product content and recommended daily intake). The latter employed the epidemiological field investigation method. The multistage stratified cluster sampling method was applied. First, Xicheng, Xuanwu, Miyun and Changping were randomly chosen. Second step, 15 towns/communities were randomly chosen from each one. Third step, stratified cluster sampling method was employed, 100 families were selected randomly from each village/resident commission also randomly opted. 6000 families and 21000 residents were investigated. The survey got 20409 valid questionnaires finally. Research contents included as follows: (1) descriptive analysis on general status of Beijing residents functional food usage, (2) single factor analysis on probably affecting factors of Beijing residents functional food usage, (3) multifactors analysis by Logistic regression model on affecting residents functional food usage.Results1. The study analyzed 8932 native approved functional food from 1996 to 2008. Results suggested that there was a great difference in numbers between years, and the most was in 2004 whereas the least was in 1996, with the number of 57 and 1501 and the percentage of 0.64% and 16.80% respectively. The number in other years ranged from 400 to 1000.2. The distribution of areas was not even, mainly in developed areas such as Beijing, Guangdong, Shandong, Zhejiang, Jiangsu ; whereas fewer in western areas rich in functional food resources.3. The functions claimed concentrated on products of regulating immunity, antifatigue and nutrient supplements, accounting 62.41%, however, the number of three kinds of products of stimulating latex, regulating microcirculation and antidecayed tooth were all below 10. There are 4 kinds of supplements containing vitamins, minerals, fatty acid and amino acid; the most was the calcium supplements, with the number of 584.4. The main dosage type were capsule, troche and oral liquid, accounted 41.50%, 20.34% and 11.58%. While the percentage of traditional food type such as drinks and vinegar were fewer, only 0.27% and 0.21 %.5. Functional food Chinese Traditional Medicine raw materials were mainly 87 kinds of raw materials in Food and Medicine Materials List and 114 kinds of raw materials in Available Materials in Functional Food listed in No.51 Files annex issued by MOH. The most frequently used was wolfberry with the number of 1397. However, four kinds of raw materials in No.51 Files annex l(dolichos flowers, immature bitter orange, black pepper and Chinese torreya) have not been used so far; American ginseng were 944 times used, ginseng and astragalus were used more than 800 times respectively, however, seven kinds of raw materials in No.51 Files annex 2(fritillaria, Japan bogorchid, flos magnolias officinalis, fructus peperis longi, Hubei fritillaria, cattail pollen and tamarindus indica linn ) have not been used so far. There was no products claimed to use the raw materials in No.51 Files annex 3.6. The functional factors in native functional food approved from 2004 to 2008 were categorized according to chemical structure, including 8 categories and 21 sub-categories. The number of compounds with terpene structure was over 1550, accounting for 35.90%; Subsequently, the number of products with hydroxybenzene structure was 1373, accounting for 31.80%. There were just 48 products with the organic acid structure.7. The functional food containing total saponins, total coarse polysaccharide and total flavonoids claimed wider range function, and their raw materials came from rich source. Contents and recommended daily intake of functional factors had great difference in range.8. Beijing residents functional food usage rate was 8.90%, 89.07% of whom learned functional food knowledge via TV/radio/web, over 90% got functional food knowledge in more than two ways. 49.56% of Beijing residents thought that TV/radio/web was favourite way to learn functional food knowledge, the subsequent way was health knowledge lecture. Residents understanding about functional food management policy and evaluation about supervision and inspection were not optimistic. Most residents had low trust in advertisements and labels of functional food.9. The single factor affecting residents functional food usage analysis indicated that: the functional food usage rate of citizens was higher than farmers; the functional food usage rate was increasing with age and education enhancing; Fewer migrant workers utilized functional food than residents with other careers; the rate of residents with good health behavior was higher; the rater of residents with bad diet health behavior was higher than the ones with good diet health behavior; the usage rate of residents with self-health awareness was lower; the more residents knew about functional food, the higher the usage rate was; the higher residents evaluation about functional food management, the higher the usage rate was.10. Logistic regression model suggested that: income, functional food knowledge, self-health awareness three factors affect the residents functional food usage dramatically.11. The main purpose of residents using functional food was to build up bodies. Approved numbers was the main reference. Nutrient supplements, regulating blood lipid, improving immunity were the top three functions claimed that residents chose. Capsules, oral liquid, tablets were the top three dosage types residents opted.Conclusions1. The native functional food approved had great quantities, wide areas distribution, many functional kinds. The TCM raw materials and functional factors were various. However, the structure of functional food was not proper, homogeneity phenomenon was obvious, areas distribution was not even, functions and dosage types focused on only a few kinds, so it is with TCM raw materials. Functional factors was various, but main kinds were the ones with terpene and hydroxybenzene structure. The functional factors such as total saponins, total coarse polysaccharide and total flavonoids were common. Contents and recommended daily intake of functional factors had statistical difference in range.2. Chinese residents functional food usage rate was lower than the ones in developed countries. Residents gained related knowledge of functional food via many ways. TV/radion/web was the chief ones. The propaganda and education of functional food should be strengthened for the reason that the situation of residents learning functional food knowledge was not optimistic. Economic income, self-health awareness and functional food knowledge were radical affecting factors of functional food usage. Recommendations1. Fundamental research of functional factors should be strengthened, hygiene standards and recommended daily intake of functional factors should be established.2. The procedures of evaluation should be predigested and optimized management system.3. Government departments in charge should give guidance to functional food manufacturing enterprise.4. Functional food knowledge propaganda and permeation should be strengthened. The price should be controlled to avoid too high so that residents consume rationally.更多还原