保健食品的工艺研究质量标准制定原则.ppt.Convertor

保健食品的工艺研究质量 标准 excel标准偏差excel标准偏差函数exl标准差函数国标检验抽样标准表免费下载红头文件格式标准下载 制定原则.ppt.Convertor 保健食品的工艺研究 质量标准制定原则及评价方法 北京中医药大学药学教授 夏开元 一、保健(功能)食品的基本概念及申报必须 提交的资料 (一)保健食品与药品的区别与联系(工艺及质量要求) 保健食品不是一般的食品，它是为特定人群设计生产的具有特定保健功能的一类食品。保健食品是针对亚健康人群，以调节机体的某种功能:如调节血压、调节血脂、改善睡眠、促进排铅、改善记忆、提高免疫力等，其27个功能(原为22个)均以调节××改善××,进××为名，即不以治疗为目的，而药品则是针对于疾病人群，以治疗为目的。 幻灯片1 在此前提下:保健食品应一方面具有食品特有的口感和色、香、味及相关剂型和包装，同时、HPLC、TLC等。 又具有相应的保健功能。为此:为达到此目的，保健食品在保持食品特色的前提下，大量采用了制药工艺中的精华如喷雾干燥，冷冻干燥，薄膜蒸发，薄膜包衣，造粒等技术，为确保其质量也相应地引入药学领域的检测方法为UV、HPLC、TLC等。 幻灯片1(续) (二)保健食品的发展 近十年来，保健食品发展十分迅速，2003年统计，中国平均增长率为15%，销售额上1000亿元，人类进入“预防医学时代”，保健食品更有广阔的美景。 各国保健食品发展均经历三个价段，第一代为强化食品，第二代是经动物和人群试验证明的某种保健功能，但不知其功能成份，化学结构，功能原理，不能定量测定特有成份。 幻灯片2 第三代是从天然原料中提取功能因子和功效成分，同时可明确其化学结构及含量。许多国家只承认第三代保健食品。认为它可使消费者认同，可以进行监控管理，防止鱼龙混杂。从我国保健食品市场看:只有发展第三代保健食品才能与国际接轨，进入国际市场，在消费者中树立诚信。 幻灯片2(续) (三)申报所需资料: 申报单位应提交: 1( 申请表 食品经营许可证新办申请表下载调动申请表下载出差申请表下载就业申请表下载数据下载申请表 2( 产品配方、依据 3、功能成分，含量及检测方法 4、生产工艺和简图 5(产品质量标准(企标) 6(产品设计包装(含标签) 7( 说明 关于失联党员情况说明岗位说明总经理岗位说明书会计岗位说明书行政主管岗位说明书 书 8(有助于评审的其它资料 幻灯片3 pharmacological action and clinical application of Proton pump inhibitors, pharmacological action and clinical application of gastric mucosa protective agent; II skills requirements: require proper history, written records, conduct a comprehensive physical examination, be familiar with the diagnosis and treatment of diseases of the digestive system regular and master emergency diagnosis and treatment of common diseases of digestive system diseases. Feeding and gastrointestinal decompression, wash stomach, anus exhaust, the abdominal cavity puncture indication and operation and triple cavities tube the indications for use, contraindications and conventional methods of operation. 3. the higher requirements (1) learning content: abdominal tuberculosis (tuberculosis and Tuberculous peritonitis) and chronic diarrhea. (2) clinical knowledge, skills required: ? clinical knowledge: the differential diagnosis of tuberculous peritonitis; the differential diagnosis of intestinal tuberculosis and Crohn's disease; the pathophysiology of chronic diarrhea and diseases; II skills required: gastroscopy and gastric juice extraction, the indication of liver biopsy, contraindications and complications, indication of x-ray examination of the digestive system. (11) endocrine Professional 1. familiar Rotary purpose: basic theory of Endocrinology subject of internal medicine, has a system of academic knowledge. Cultivation of clinical thinking ability, mastering the discipline of clinical skills, be able to handle the subject of common diseases. Understanding: principles of diagnosis and treatment of certain diseases. 2. basic 检测机构出具的报告 1.产品功效试验报告 A.动物实验 B.人群试验 2.稳定性试 验报告 3.理化指标(可以包括在稳定性试验中) A.重金属含量 B.农药成分含量 C.功效成分含量 4(卫生学指标 A.细菌 B.霉菌 幻灯片3(续) 二、保健食品工艺研究 功能类别—处方—工艺—原料处理剂型选择制作过程—产品 机械粉碎 原植物 超微(细胞级)粉碎 水提 原料 化学方法 醇提 双提(含挥发成份) 提取物 CO2超临界萃取(SFE) 物理方法 膜分离技术 纳米技术 幻灯片4 固体型食品 颗粒剂 固体 胶囊剂 片剂 产品剂型 袋泡剂 口服液 液体 液体饮品 软胶囊 幻灯片4(续) 三、制定生产工艺及简图 (一) 原则:生产工艺流程必须按照“管理办法”18条规定，即“?保健食品的生产过程，生产条件必须符合相应的食品生产企业卫生规定或其它有关卫生要求;?选用的工艺应能保持功效成份的稳定性;?加工过程中功效成分不损失，不破坏，不分解和不产生有害的中间体。 (二)内容: 制定生产工艺(文件)应满足“保健食品评审技术规程”第16条规定:即 1) 生产工艺合理(按办法18条规定) 2)生产工艺应包括各组份的制备，成品加工过程及主要技术条件。并按生产实际情况编pharmacological action and clinical application of Proton pump inhibitors, pharmacological action and clinical application of gastric mucosa protective agent; II skills requirements: require proper history, written records, conduct a comprehensive physical examination, be familiar with the diagnosis and treatment of diseases of the digestive system regular and master emergency diagnosis and treatment of common diseases of digestive system diseases. Feeding and gastrointestinal decompression, wash stomach, anus exhaust, the abdominal cavity puncture indication and operation and triple cavities tube the indications for use, contraindications and conventional methods of operation. 3. the higher requirements (1) learning content: abdominal tuberculosis (tuberculosis and Tuberculous peritonitis) and chronic diarrhea. (2) clinical knowledge, skills required: ? clinical knowledge: the differential diagnosis of tuberculous peritonitis; the differential diagnosis of intestinal tuberculosis and Crohn's disease; the pathophysiology of chronic diarrhea and diseases; II skills required: gastroscopy and gastric juice extraction, the indication of liver biopsy, contraindications and complications, indication of x-ray examination of the digestive system. (11) endocrine Professional 1. familiar Rotary purpose: basic theory of Endocrinology subject of internal medicine, has a system of academic knowledge. Cultivation of clinical thinking ability, mastering the discipline of clinical skills, be able to handle the subject of common diseases. Understanding: principles of diagnosis and treatment of certain diseases. 2. basic 写 幻灯片5 (三) 实例: 如××减肥降脂茶。组方为乌龙茶、决明子、泽泻 、首乌、山渣、陈皮。 各组分制备为:乌龙茶、决明子、陈皮粉碎成40目;首乌、泽泻 、山渣用粗提物(干浸膏要求10:1)，然后按比例混合，造粒,包装，灭菌后即为成品(袋泡茶剂)。 主要技术条件包括:袋泡茶:3g/袋，包装盒尺寸及贮存，运输条件。 加工过程应按工艺流程表述各工序操作过程及技术要求. (四) 按工艺流程画出方框图，使繁琐工艺一目了然。 幻灯片5(续) (五) 真菌类保健食品 真菌类保健食品如灵芝、酿酒酵母、红曲霉对生产工艺有专门技术要求。应按照“卫生部关于真菌类保健食品评审规定”执行。 1(真菌类保健食品生产企业应具有良好的生产规范(GMP)，及逐步危害 分析 定性数据统计分析pdf销售业绩分析模板建筑结构震害分析销售进度分析表京东商城竞争战略分析 关键控制质量保证体系(HACCP)。 2(必须具备中试规模，即每天至少生产500L3的能力，并以中试生产报批，以防止作坊式生产漫延。 幻灯片5(续) 四、保健食品的企业标准 (一)制定原则:按“保健食品评审技术规程”第17条规定，同时应按标准化部门要求，按标准文本格式制定企业质量标准。 (二)标准文本格式包括 1(范围 2(引用标准 3(产品规格 4(技术要求 5(试验方法 6(检验规则 7(检查包装、运输、贮存及有效期 幻灯片6 (三)企业标准应符合国家有关标准，只能高于而不能低于国家标准，仍以“××降脂减肥茶”为例:国家标准中重金属含量为 pb?2.0(mg/kg) As?1.0(mg/kg) Hg?0.3(mg/kg) 生产减肥茶企业标准中pb、As、Hg含量必须符合上述规定，如企业技术优越可定为pb?1.0(mg/kg)是可行的，而pb含量超过2.0mg/kg即不可行。 幻灯片6(续) (四)企业标准对产品原料，辅料的来源，品质作出规定。 如上述例子中:“减肥降脂茶”中所用中药(决明子、泽泻、首乌、陈皮、山渣)应符合《中国药典》规定;茶叶应符合茶叶生产标准(GB9679——88)。 食品包装用纸应符合GB11680标准规定。 (五)原则上应制定特异功效成份指标，并附定性、定量标准。 保健食品管理办法第4条规定“„配方的组成及用量必须有科学依据，具有明确的功效成份，如在现有技术条件下，不能明确功效成份的，应确定与保健功能有关的主要原料pharmacological action and clinical application of Proton pump inhibitors, pharmacological action and clinical application of gastric mucosa protective agent; II skills requirements: require proper history, written records, conduct a comprehensive physical examination, be familiar with the diagnosis and treatment of diseases of the digestive system regular and master emergency diagnosis and treatment of common diseases of digestive system diseases. Feeding and gastrointestinal decompression, wash stomach, anus exhaust, the abdominal cavity puncture indication and operation and triple cavities tube the indications for use, contraindications and conventional methods of operation. 3. the higher requirements (1) learning content: abdominal tuberculosis (tuberculosis and Tuberculous peritonitis) and chronic diarrhea. (2) clinical knowledge, skills required: ? clinical knowledge: the differential diagnosis of tuberculous peritonitis; the differential diagnosis of intestinal tuberculosis and Crohn's disease; the pathophysiology of chronic diarrhea and diseases; II skills required: gastroscopy and gastric juice extraction, the indication of liver biopsy, contraindications and complications, indication of x-ray examination of the digestive system. (11) endocrine Professional 1. familiar Rotary purpose: basic theory of Endocrinology subject of internal medicine, has a system of academic knowledge. Cultivation of clinical thinking ability, mastering the discipline of clinical skills, be able to handle the subject of common diseases. Understanding: principles of diagnosis and treatment of certain diseases. 2. basic 名称，并按成分功能作用顺序排列”。 幻灯片6(续) 例如:“金果浓缩银杏叶口服液”原料为银杏叶,其功效成份为银杏黄酮，可定量测定。 降低血脂用的“绞股兰片”原料为绞股兰„„绞胶兰皂苷，可定量测定。 珍珠、大枣、杜仲、对功效成份认同和检测在当前技术条件下尚有困难。 上述例子“减肥降脂茶”其功能成份尚不十分明确，可按规定将主要原料列上即可(按功效作用顺序即按决明子、首乌、泽泻、山楂、陈皮排列即可。)。在质量控制上可测总黄酮。 幻灯片6(续) 五、保健食品质量评价方法: (一) 关于质量标准(企标)文件的审查:其中应用范围引用标准，技术要求，测定方法是否符合国家标准和标准化要求，是否与生产实际相一致。 (二)关于功能成份资料的审查和评价 幻灯片7 可测:红景天胶囊 „„红景天 苷( 0.3mg/片) 1(单一功效成份产品 不可测:如杜仲茶、乌梅钦 幻灯片7(续) 3(现有技术条件下不能明确功效成份的产品 上述减肥茶及1.2.中不可测项 可测:强力神(抗疲劳)„„ 牛磺酸、锌、绞股兰皂苷 2(多组分产品 不可测:如抗疲劳作用的青春补液 成分为狗鞭、蚕蛹、鹿鞭。 幻灯片7(续) (三)关于稳定性评价 按照“保健食品评审技术规程”评价 1.目的:核定产品的保质期 2.方法:用加速实验的方法:在温度37-40。C,相对湿度(75%)条件下，于潮湿箱中放置产品3个月，每月检测一次，3月后如指标稳定即相当于产品可保存2年。 3(指标:在稳定性试验中选取所有代表产品内在质 量指标均应检测，应注意直接与产品接触的包装材料对产品稳定性的影响。 指标一般为功效成份，全部理化指标 4(样品:测试样品至少对3批样品进行观察 幻灯片8 (四)关于卫生学评价(按“保健食品通用卫生要求”) 1( 目的:保健食品系口服食品，因此，卫生学指标必须合格 2( 指标: 1)检测项目为:菌群总数、大肠菌群、致病菌、霉菌、酵母。 2) 对液态食品与固态或半固态食品有不同要求。 pharmacological action and clinical application of Proton pump inhibitors, pharmacological action and clinical application of gastric mucosa protective agent; II skills requirements: require proper history, written records, conduct a comprehensive physical examination, be familiar with the diagnosis and treatment of diseases of the digestive system regular and master emergency diagnosis and treatment of common diseases of digestive system diseases. Feeding and gastrointestinal decompression, wash stomach, anus exhaust, the abdominal cavity puncture indication and operation and triple cavities tube the indications for use, contraindications and conventional methods of operation. 3. the higher requirements (1) learning content: abdominal tuberculosis (tuberculosis and Tuberculous peritonitis) and chronic diarrhea. (2) clinical knowledge, skills required: ? clinical knowledge: the differential diagnosis of tuberculous peritonitis; the differential diagnosis of intestinal tuberculosis and Crohn's disease; the pathophysiology of chronic diarrhea and diseases; II skills required: gastroscopy and gastric juice extraction, the indication of liver biopsy, contraindications and complications, indication of x-ray examination of the digestive system. (11) endocrine Professional 1. familiar Rotary purpose: basic theory of Endocrinology subject of internal medicine, has a system of academic knowledge. Cultivation of clinical thinking ability, mastering the discipline of clinical skills, be able to handle the subject of common diseases. Understanding: principles of diagnosis and treatment of certain diseases. 2. basic 3) 对液态食品与固态或半固态食品中蛋白质含量不同的产品也有不同要求。详见“保健食品通用卫生要求”。 幻灯片9 3.样品:用三个不同批号(生产期相隔一个月)产品进行检测，在进行卫生学评价同时，应对产品按标准进行感官测定，即色泽、气味、组织形态;不得有异味、杂质或腐败变质现象。供儿童、孕产妇用保健食品不得检出有激素类物质。 (五)关于测试样品有关的规定 最近国家食品药品监督管理局(FDA)要求:申报保健食品生产厂除送样测试外(占50%)还要由有关部门从生产厂抽取样品、同时进行测试(占50%)，以防止生产与送样不一致. 幻灯片9(续) 六、几个问 题 快递公司问题件快递公司问题件货款处理关于圆的周长面积重点题型关于解方程组的题及答案关于南海问题 的讨论 1(工艺中的幅照灭菌问题，以原植物粉碎直接制成产品，必需使C060灭菌(中成药亦如此)，否则细菌超标。按食品卫生法规定幅照食品应在包装上注明，但均未执行。 2(纳米技术的应用问题，药用植物细胞粒径即可;对大分子(链状)，其形成等法以纳米粒径衡量,多为商业炒作。 3 (产品功能成份测定的进展，SFC、指纹图谱、多种HPLC，及多成份一次检出技术。 4(GMP要求与工艺及质量关系。GMP要求生产厂具备30万级净化间及分析室按工艺要求进行品质管理。 幻灯片10 制作保健食品的新技术新工艺 一、粉体工程 1.超微细胞及粉碎 2.复合化包覆技术 3.喷雾干燥微囊化技术 4.实例 A.天然维生素E胶囊与片剂 B.提高黄酮类化合物的溶解度 C.“千金美容方”的产品生产 幻灯片11 5 . CO2—SFE应用实例 A.沙棘籽、月见草、葡萄籽油的提取 B.保健食品品功效成分提取 C.去除银杏叶中的毒害成份 D.去除产品中的农药残留及溶剂残留 幻灯片11(续) 二、CO2超临界萃取(SFE) 1.超临界流体的概念和性质 2.选择性溶解及规律(沸点、极性、分子量) 3.工艺流程简图 4.CO2—SFE的特点 A.低温提取，保持全成份 B.无溶剂残留，无公害 pharmacological action and clinical application of Proton pump inhibitors, pharmacological action and clinical application of gastric mucosa protective agent; II skills requirements: require proper history, written records, conduct a comprehensive physical examination, be familiar with the diagnosis and treatment of diseases of the digestive system regular and master emergency diagnosis and treatment of common diseases of digestive system diseases. Feeding and gastrointestinal decompression, wash stomach, anus exhaust, the abdominal cavity puncture indication and operation and triple cavities tube the indications for use, contraindications and conventional methods of operation. 3. the higher requirements (1) learning content: abdominal tuberculosis (tuberculosis and Tuberculous peritonitis) and chronic diarrhea. (2) clinical knowledge, skills required: ? clinical knowledge: the differential diagnosis of tuberculous peritonitis; the differential diagnosis of intestinal tuberculosis and Crohn's disease; the pathophysiology of chronic diarrhea and diseases; II skills required: gastroscopy and gastric juice extraction, the indication of liver biopsy, contraindications and complications, indication of x-ray examination of the digestive system. (11) endocrine Professional 1. familiar Rotary purpose: basic theory of Endocrinology subject of internal medicine, has a system of academic knowledge. Cultivation of clinical thinking ability, mastering the discipline of clinical skills, be able to handle the subject of common diseases. Understanding: principles of diagnosis and treatment of certain diseases. 2. basic C.高效率，低能耗 幻灯片12 CO2瓶 冷凝 高压泵 加热 萃取器 流量计 分离? 分离? 出料B 出料A CO2、 SFE流程图 幻灯片13 三、纳米技术浅谈 1.基本概念 2.溶剂更换和反萃取 3.进展概况 幻灯片14 pharmacological action and clinical application of Proton pump inhibitors, pharmacological action and clinical application of gastric mucosa protective agent; II skills requirements: require proper history, written records, conduct a comprehensive physical examination, be familiar with the diagnosis and treatment of diseases of the digestive system regular and master emergency diagnosis and treatment of common diseases of digestive system diseases. Feeding and gastrointestinal decompression, wash stomach, anus exhaust, the abdominal cavity puncture indication and operation and triple cavities tube the indications for use, contraindications and conventional methods of operation. 3. the higher requirements (1) learning content: abdominal tuberculosis (tuberculosis and Tuberculous peritonitis) and chronic diarrhea. (2) clinical knowledge, skills required: ? clinical knowledge: the differential diagnosis of tuberculous peritonitis; the differential diagnosis of intestinal tuberculosis and Crohn's disease; the pathophysiology of chronic diarrhea and diseases; II skills required: gastroscopy and gastric juice extraction, the indication of liver biopsy, contraindications and complications, indication of x-ray examination of the digestive system. (11) endocrine Professional 1. familiar Rotary purpose: basic theory of Endocrinology subject of internal medicine, has a system of academic knowledge. Cultivation of clinical thinking ability, mastering the discipline of clinical skills, be able to handle the subject of common diseases. Understanding: principles of diagnosis and treatment of certain diseases. 2. basic