2003-2007年山东省保健食品生产企业现状分析与对策研究

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1000m^2以下的较多，占40．00％；2004年保健食品GMP认证后，以1000m^2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。

Analysis of Business State and Explore of Countermeasures of Health Food Production Enterprises in Shandong Province from 2003 to 2007

Objective]To be better to know the status of production and operation in health food enterprises in Shandong province and standardize the behavior of production and management in the province, Methods]Data of the health food production and management enterprises approved by the Ministry of Public Health or FDA and with hygienic license of provincial level in Shandong province from January,2003 to December,2007. Data of handling of health food samples and deliver of hygienic license, type of the license, processing mode, producing area, distribution, function, composition, the status of employees,GMP check-up were statistically classified. Results]The curve of hygienic license was wave-style from 2003 to 2007. The main processing way was self-processing,most of the enterprises were in Ji＇nan, Weihai, Qingdao and Yantai; the main function was immunity regulation, blood fat regulation and anti-aging. Most of the effect composition was nutrient supplement agent, polyhexose, saponin and flavone in capsule, Most of them were share-holding company, collective-owned and private-owed enterprises. Fewer of them were state-owed and foreign enterprises. 76.41% of them had yearly fixed capital of over 1 million More than 1/3 of the companies had 10 to 50 employees,40% of them had the floor area of under 1 000 m2 in 2003. While 84.24% of them had the floor area of more than 1 000 m2 in 2004 after the implementation of GMP. 181 companies passed GMP check-up, accounting for 50% and 70.17% of the total check-up rate. Conclusion]After the implementation of GMP in 2004, the examination and approval system for health food production and processing enterprises was strengthened, the scale of health food production enterprises was gradually expanded, the behavior of production and management was standardized, the label and manual were in accord with the certificate approved, the protective consciousness of the consumers was gradually improved, fake and inferior commodities and small workshop were naturally eliminated,but the ex