特殊医学用途配方食品干法混合工艺研究及其与湿法工艺的对比
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摘要
针对特殊医学用途配方食品(foods for special medical purposes,FSMP)干法混合工艺关键步骤,同时将其与湿法和干-湿法工艺进行对比分析,旨在为相关进行干法混合工艺的生产企业提供理论和实践依据。通过分析干法混合工艺的关键控制点,确定从物料添加顺序、混合时间和混合转速及工艺稳定性对其混合工艺均匀性进行分析。最终确定生产工艺条件:混合工艺1的流程添加物料,总混时间为20 min,总混频率为20 Hz(约14 r/min);在该工艺条件下,不同位置的维生素A和维生素B1相对标准偏差分别为4.37%和2.52%,与验证工艺的检测结果接近,说明产品混合均匀且工艺稳定,且各检测值符合法规和设计要求;最后,同湿法工艺和干湿法工艺对比后,干法混合工艺也表现出一定的优势。因此,该工艺可以满足特医食品全营养配方食品的干法生产。
In order to provide theoretical and practical basis of dry mixing technology for relevant manufacturers,the key steps of dry mixing process of formula food for special medical purposes and its comparison with wet and dry methods were evaluated.By analyzing the key control points of the dry mixing process,the material addition order,mixing time,mixing frequence and process stability were analyzed to investigate their influence on the uniformity of the mixed process.The final production process conditions were as follow:materials were added in the process of mixed process 1,a total mixing time was 20 min,a total mixing frequence was 20 Hz.Under these conditions,the relative standard deviation of vitamin A and vitamin B1 in different positions were 4.37% and 2.52%,respectively.It was close to the test results of the verification process,indicating that the product was mixed uniformly and the process was stable,and the test values were in accordance with the regulations and design requirements.Compared with the wet process and the dry and wet process,the dry mixing process also showed certain advantages.Therefore,this process can meet the requirements of the dry production of the special medical food formula.
In order to provide theoretical and practical basis of dry mixing technology for relevant manufacturers,the key steps of dry mixing process of formula food for special medical purposes and its comparison with wet and dry methods were evaluated.By analyzing the key control points of the dry mixing process,the material addition order,mixing time,mixing frequence and process stability were analyzed to investigate their influence on the uniformity of the mixed process.The final production process conditions were as follow:materials were added in the process of mixed process 1,a total mixing time was 20 min,a total mixing frequence was 20 Hz.Under these conditions,the relative standard deviation of vitamin A and vitamin B1 in different positions were 4.37% and 2.52%,respectively.It was close to the test results of the verification process,indicating that the product was mixed uniformly and the process was stable,and the test values were in accordance with the regulations and design requirements.Compared with the wet process and the dry and wet process,the dry mixing process also showed certain advantages.Therefore,this process can meet the requirements of the dry production of the special medical food formula.
引文
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[2]赵文利,闫洁,杨秀花,等.膳食营养指导及适量肠内营养补充对Ⅳ期神经母细胞瘤患儿营养不良改善效果分析[J].中国食物与营养,2016,22(8):85-88ZHAO Wen-li,YAN Jie,YANG Xiu-hua,et al.Dietary nutritional guidance and a moderate amount of enteral nutrition supplement on phase of malnutrition in childrenⅣwith neuroblastoma improvement effect analysis[J].Chinese Food and Nutrition,2016,22(8):85-88
[3]Boelens P G1,Heesakkers F F,Luyer M D,et al.Reduction of postoperative ileus by early enteral nutrition in patients undergoing major rectal surgery:Prospective,randomized,controlled trial[J].Ann Surg,2014,259(4):649-655
[4]Davidson P,Kwiatkowski C A,Wien M.Management of hy-perglycemia and enteral nutrition in the hospitalized patient[J].Nutr Clin Pract,2015,30(5):652-659
[5]殷继永,黄建,霍军生.特殊膳食用食品膳食补充剂全球概况[N].中国食品报,2009YIN Ji-yong,HUANG Jian,HUO Jun-sheng.Global overview of dietary supplements for special dietary foods[N].China Food Daily,2009
[6]王承忠.实验室间比对的能力验证及稳健统计技术[J].理化检验(物理分册),2004,40(10):533-538WANG Cheng-zhong.Proficiency testing and robust statistical techniques for interlaboratory comparisons[J].Physical and Chemical Testing(Physical),2004,40(10):533-538
[7]刘姗姗.安宫牛黄丸生产过程混合均匀度及牛黄药材鉴别研究[D].北京中医药大学,2014LIU Shan-shan.Study on the mixing uniformity during the production of Angong Niuhuang pill and the identification of Niuhuang medicine[D].Beijing University of Chinese Medicine,2014
[8]张天博,宋晓青,杨凯,等.婴儿配方乳粉中营养成分均匀性分析[J].中国乳品工业,2018,46(3):19-20ZHANG Tian-bo,SONG Xiao-qing,YANG Kai,et al.Analysis of nutrient uniformity in iinfant formula milk powder[J].China Dairy Industry,2018,46(3):19-20
[9]朱天钢,刘尧,苗瑞华.一种粉剂型全营养配方食品及其生产工艺:中国,CN104839718A[P]2015-08-19ZHU Tian-gang,LIU Yao,MIAO Rui-hua.A powder formulation of whole nutrition formula and its production process:China,CN104839718A[P]2015-08-19
[10]张人明,许飒,胡瑞标.一种全干混婴幼儿配方奶粉及其制备方法:中国,CN104757123A[P]2015-07-08ZHANG Ren-ming,XU Sa,HU Rui-biao.A completely dry and mixed infant formula and its preparation method:China,CN104757123A[P]2015-07-08
[11]齐晓彦,苏米亚,郭本恒,等.含益生菌的婴儿配方奶粉,制备方法及其储存方法:中国,CN103651857A[P]2014-03-26QI Xiao-yan,SU Mi-ya,GUO Ben-eng,et al.Infant formula containing probiotics,preparation and storage methods:China,CN103651857A[P]2014-03-26
[12]贾宏信,刘振民,徐致远,等.一种含益生菌的新生儿配方乳粉及其制备方法:中国,CN106720347A[P]2017-05-31JIA Hong-xin,LIU Zhen-min,XU Zhi-yuan,et al.Anew-born formula milk powder containing probiotics and its preparation method:China,CN106720347A[P]2017-05-31
[13]贾宏信,刘振民,徐致远,等.一种新生儿配方乳粉及其制备方法:中国,CN106720369A[P]2017-05-31JIA Hong-xin,LIU Zhen-min,XU Zhi-yuan,et al.A new infant formula milk powder and its preparation method:China,CN106720369A[P]2017-05-31
[14]Jiang J J,Zeng Q X,Zhu Z W.Chemical and sensory changes associated Yu-lu fermentation process-A traditional Chinese fish sauce[J].Food Chemistry,2007,104:1629-1634
[15]赵双春,赵红菊.美国FDA混合均匀性取样和评价指南对我国制药混合设备及工艺验证的意义[J].机电信息,2015,14:1-3ZHAO Shuang-chun,ZHAO Hong-ju.Significance of FDAmixed uniformity sampling and evaluation guidelines for the validation of pharmaceutical mixing equipment and process in China[J].Mechanical and Electronic Information,2015,14:1-3
[16]钟芳,王璋,许时婴.喷雾干燥条件对豆粉速溶性的影响[J].食品工业科技,2003,12:17-20ZHONG Fang,WANG Zhang,XU Shi-ying.Effect of spray drying conditions on the solubility of soybean powder[J].Food Industry Technology,2003,12:17-20