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[目的]为更好地了解我省保健食品生产企业的生产经营现况,规范我省保健食品生产经营行为。[方法]收集2003年1月至2007年12月,山东省内获得卫生部或国家食品药品监督管理局批准并办理省级卫生许可证的保健食品生产经营单位资料。从保健食品的受理到发证、证件类型、加工方式及保健食品产地与品种分布、功能构成、功效成分、剂型分布、从业人员组成、保健食品GMP审查情况等进行分类统计。[结果]2003~2007年,卫生许可证持有情况呈波浪式发展,加工方式以自加工为主,产地分布以济南、威海、青岛、烟台4市最多,功能构成主要以免疫调节、调节血脂和延缓衰老三大功能为主,有效成分以营养素补充剂、多糖、皂甙、黄酮为主,剂型构成以硬胶囊为主;企业性质以股份制为主,其次是民营和私营企业,国有企业和外资企业较少;固定资产年注册在100万元以上的占76.41%,保健食品企业以10~50人企业为主,占保健食品企业的1/3以上;2003年使用面积1 000 m2以下的较多,占40.00%;2004年保健食品GMP认证后,以1 000 m2以上的较多,占80.24%;目前通过审查取得GMP证书的共有181家,占保健食品生产企业总数的30.52%以上,总评审合格率71.26%。[结论]2004年保健食品GMP认证后,提高了保健食品生产加工企业的准入门槛,保健食品生产企业规模逐渐增大,生产经营行为更加规范,产品标签及说明书标注的内容与批准的保健食品证更加一致,消费者的保护意识逐渐增强,假冒伪劣产品和小作坊式的企业自然淘汰,但保健食品功效成分含量检测水平有待进一步提高。
[Objective] To understand the production and operation status of health food production enterprises in our province better, standardize the production and operation of health food in our province. [Method] The data of health food production and operation units approved by the Ministry of Health or the State Food and Drug Administration in Shandong Province from January 2003 to December 2007 were collected and processed for provincial health permits. From the acceptance of health food to the issuance of certificates, the types of certificates, the processing methods and the distribution of health food origin and varieties, functional composition, efficacy components, dosage form distribution, practitioners’ composition and GMP review of health food products. [Results] From 2003 to 2007, the holding of hygienic license showed a wave development. The processing methods were mainly self-processing. The distribution of origin was the most in Jinan, Weihai, Qingdao and Yantai, and the functional composition mainly consisted of immunomodulatory, And anti-aging three main functions, the active ingredient to nutrient supplements, polysaccharides, saponins, flavonoids, dosage forms consisting mainly of hard capsules; nature of the joint-stock companies, followed by private and private enterprises, state-owned enterprises and foreign investment Fewer enterprises; registered fixed assets in more than 100 million yuan accounted for 76.41%, health food companies to 10 to 50 companies, accounting for more than 1/3 of health food companies; in 2003 the use of area below 1 000 m2 more , Accounting for 40.00%. After GMP authentication of health food in 2004, more than 1 000 m2 accounted for 80.24%. At present, there are 181 GMP certificates through examination, accounting for more than 30.52% of the total number of health food manufacturers, Assessment of the passing rate of 71.26%. [Conclusion] After the GMP authentication of health food in 2004, the access threshold for health food production and processing enterprises was raised, the scale of health food production enterprises gradually increased, the production and operation behaviors were more standardized, the content of product labeling and manual labeling and the approval of health food The evidence is more consistent, consumer protection awareness gradually increased, fake and shoddy products and small workshops of the natural elimination of enterprises, but the health food detection of the content of ingredients to be further improved.