我国已获批准的国产保健食品及居民使用情况研究
详细信息    本馆镜像全文|  推荐本文 |  |   获取CNKI官网全文
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。
Objectives
     The 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.
     Methods
     The 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.
     Results
     1. 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.
     Conclusions
     1. 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.
     Recommendations
     1. 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.
引文
1.马玉霞,张志强.我国保健食品的现状和管理对策研究[J].中国食品卫生杂志,2002,12(5):12-17
    2.Pszczola D E.Designer foods:An envolving concept[J].Food Tech,2003(3):92
    3.Ensminger M E,王淮洲译.美国食物与营养百科全书(饮食与营养保健卷)[M].北京:农业出版社,1999.182-193
    4.翁新愚.美国、澳大利亚及中国保健食品管理的比较分析[J].国外医学中医中药分册,2004,26(1):3-6
    5.徐贵发、蔺新英,主编.功能食品与功能因子[M】.济南:山东大学出版社.2005
    6.中华人民共和国卫生部.保健食品管理办法【Z】.1996-05-01
    7.Elizabeth Yetley.Regulatory and legal policies:U.S.food and drug perspective[J].Journal of American Dietetic Association.1993,93(4):404
    8.Rosenberg P H.The food label as nutrition policy[J].Nutrition Review,2002,50(2):58
    9.查峰.日本保健用食品管理的启示[J].中国卫生监督杂志,1995,2(2):87
    10.王伟军,李延华,于俊林等.功能性食品的研究进展及发展趋势[J】.通辽师范学院学报,2008,29(10):37-39
    11.刘炳智.保健食品的研究现状与发展[J].食品研究与开发,1999,20(2):50-54
    12.席文娣.我国功能食品生产存在的问题及研发方向[J】.甘肃科技,2008,24(5):57-59
    13.屈平.保健品市场发展综述[J].中国医药科技与市场,2004,4(6):37-38
    14.李毅芳,马天才.保健食品的发展现状【J].中国卫生学检验杂志,2002,12(6):753
    15.中华人民共和国国家标准GB16740-1997保健(功能)食品通用标准【S】
    16.席文娣.功能食品中功能因子及作用[J】.甘肃科技,2008,24(3):64
    17.徐华锋.中国保健食品行业的现状和发展趋势[J].亚太传统医药,2007,(3):14—18
    18.赵仲堂,主编.流行病学研究方法与应用[M】.北京:科学出版社.2000
    19.孙振球,主编.医学统计学[M】.北京:人民卫生出版社.2005
    20.杨磊,秦江梅,井明霞,等.新疆卫生服务调查研究中的抽样与质量控制方法[J】.石河子大学报,2003,7(1):21-24
    21.束云,刘长喜,李连达.我国已获批准的保健食品现状分析[J].现代保健,2006,(30):81-90
    22.李志勇,凌莉,王菊芳.功能食品中的功能因子【J】.食品科学,2005,26(9):622-625
    23.陈仁悙,主编.营养保健食品【M].北京:中国轻工业出版社,2001
    24.郑建仙,编著.功能性食品(第一卷)[M】.北京:中国轻工业出版社,1995
    25.Harrison RA,Holt D,Pattison D J.Are those in need taking dietary supplements.A survey of 21923 adults[J].British Journal of Nutrition,2004,91:617-623
    26.党毅.中国保健食品的整理研究及信息系统的建立[D】.北京:中国协和医科大学,1999
    27.国家药典委员会编.中华人民共和国药典(2005)[M】.北京,化学工业出版社,2005
    28.马冠生,崔朝辉,李艳平,等.中国居民营养补充剂的消费现状[J】.营养学报,2006,28(1):8—10
    29.肖萍.上海市保健食品管理现况及对策研究【D】.复旦大学.2001
    30.Simone Fullagar.Governing the health body:discourses of leisure and lifestyle within Australian health policy[J].SAGE journals,2002,6(1):69-84
    31.饶建兵,丁金龙.认识保健食品之普及篇[J].广东科技,2002,(4):59-62
    32.顾法葛,赵西梅.试述保健(功能)食品及其原则要求[J].山东食品科技,2000,(3):29-31
    33.吴澎,王明林.我国保健食品发展概况及存在的问题[J】.中国食物与营养,2005,11(2):38-39
    34.Kenji Oda,Hisashi Matsuda,et al.Relationship between adjuvant activity and amphipathic structure of soyasapoins[J].Vaccine,2003(21):2145-2151.
    35.赵刚.保健食品的发展与中国的对策[J].中外食品工业信息,2000,(2):13-14
    36.郑琳琳.保健食品的现状及其开发前景[J].食品研究与开发,2008,29(7):191-193
    37.邬时民.保健食品发展历程、现状和前景展望【J】.上海食品药品监管情报研究,2007,10(88):40-41
    38.孔凡真.中国保健食品卫生的监督管理法规[J].杭州食品科技,2009,(1):4-13
    39.陈军.我国保健食品行业发展困境原因探讨及对策[J].产经透视,2009,(4):79-80
    40.张艳,惠伯棣.日本功能性食品发展近况与未来展望[J】.中国食品添加剂,2006,(2):74-78
    41.党毅,彭勇,肖培根,等.21世纪保健食品发展趋势预测[J].中国中医信息杂志:1999,6(12):73-74
    42.胡学智.美国保健食品概况[J】.上海医药,2001,22(1):22-24
    43.肖培根,李连达,刘勇.中药保健食品安全性评估系统的初步研究[J】.中国中药杂志,2005,30(1):9-11
    44.彭军,高小蔷,李琼,等.卫生部批准的795种参类保健食品情况分析【J】.中国食品卫生杂志,2006,18(3):214-220
    45.Beitz R,Mensink G B,Rams S,et al.Use of vitamin and mineral supplements in Germany[J].Bundes Gesundheitsblatt Gesundheitsforschung gesundheitsschutz,2004,47:1057-1065
    46.Radimer K,Binderald B,Hughes J,et al.Dietary supplement use by US adults:data from the national health and nutrition examination survey,1999-2000[J].Am J Epidemiol,2004,160:339-349
    47.Wilt S.Knowledge,attitudes,treatment practices and health behaviors of nurses regarding blood cholesterol and cardiovascular disease.Prev Med1990,19:444-452
    48.Millen A E,Dodd K W,Subar A F.Use of vitamin,mineral,nonvitamin,and nonmineral supplements in the United States:the 1987,1992,and 2000 National Health Interview Survey results[J].J Am Diet Assoc,2004,104:94-950
    49.Kirk S F,Cade J E,Barrett J H,et al.Diet and lifestyle characteristics associated with dietary supplement use in women[J].Br J Nutr,2004,91:617-623
    50.Harrison R A,Holt D,Pattison D J,et al.Are those in need taking dietary supplements.A survey of 21923 adults[J].Br J Nutr,2004,91:627-628
    51.肖硕,王培玉,张玉梅.大豆异黄酮与乳腺癌关系研究进展[J].中国公共卫生,2008,24(5):530-531
    52.于守洋,崔洪斌.中国保健食品的进展[M】.北京:人民卫生出版社,200l:1-18
    53.吴云红,朱亮,初炜,等.保健食品的电子监管模式[J】.中药材,2009,32(3):323-325

© 2004-2018 中国地质图书馆版权所有 京ICP备05064691号 京公网安备11010802017129号

地址:北京市海淀区学院路29号 邮编:100083

电话:办公室:(+86 10)66554848;文献借阅、咨询服务、科技查新:66554700