Research&Development Of Complex Probotics Product And Health Function Study

We put forward a creative viewpoint of combining probiotics complex(lactobacillusacidophilus+bifidobacterium lactis) with prebiotics(xylooligosaccharide), and succeeded inachieving a health food probiotics complex granule(Junior). The new product has optimisticmarketing potential and meaningful social benefits. The health function of probioticscomplex(lactobacillus acidophilus+bifidobacterium lactis) and application in the juniorwere studied and the results could be a support to develop and prepare for a functionalprobiotics complex product. The research and development results are showed as follow:It’s natural source for lactobacillus acidophilus and bifidobacterium lactis used in theproduct. Lactobacillus acidophilus as one kind of bacillus lactis, bifidobacterium lactis as onekind of bacillus bifidus, there are many researching background and perfect studies andclinical reports for them. Both are formulated together and complemented each other. Theproduct has the health function of regulating gastrointestinal tract flora and enhancingimmunity. The product is also formulated with xylooligosaccharide, which can selectivelyenhance the activity of bacillus bifidusand extending the function of probiotics. Formulatedtogether for lactobacillus acidophilus, bifidobacterium lactis and xylooligosaccharide couldachieve the health function of regulating gastrointestinal tract flora and enhancing immunity.The stability of product functional ingredients could be ensured by using matureprocessing of dry mixing powder based on a mass of studies, it can effectively ensure. Drypowder mixing and forming directly was chosen as product type after optimizing product type.The variety and dosage of excipients, suitable humidity&temperature conditions foroperation workshop were determined, and did some experiments on the flowability andevenness of mixed materials. After a series of experiments the process and parameters wereobtained and showed as follows: the temperature was18-26℃, the related humidity was lessthan30%for the operation workshop, and the mixing time is about20minutes. The producttype is granule with dry powder directly mixing and filling. The formula and process of theproduct was reasonable and practical, and all indexes were well conformed to the qualitystandards after verified by stability test.Through the results of the oral acute toxicity test, three inheritance toxicity testsincluding Ames test, bone marrow cell micronucleus test, mice sperm abnormality test, andthirty days feeding studies, the health food of probiotics complex granule(Junior) product wascertified to be practically nontoxic substance for its MTD﹥20.0g/kg·BW. There was no teratogenic and mutagenic action to the treatment animals.Result of the health function study of probiotics complex on regulating juniorgastrointestinal tract flora function indicated that all dosage groups before and after oral fedby probiotics complex showed the significant increases ingrowth of intestinal lactobacillusand bifidobacterium lactis (P<0.05) during14days’ animal test. It’s certified by the animaltest that the product had the health function of regulating gastrointestinal tract flora. Theclinical test result showed: the testing groups could enlarge the quantity number of intestinallactobacillus and bifidobacterium lactis very significantly(P<0.01) compared with the controlgroup after15days’ human clinical test. According to "Technical standards for testing&assessment of health food-Method for the assessment of clinical test of regulatinggastrointestinal tract flora function", it’s certified that the product had the health function ofregulating gastrointestinal tract flora. Both the animal test and clinical test showed the producthad the function of regulating gastrointestinal tract flora.The result of health function study on enhancing junior immunity indicated: Both arepositive for the test of mice delayed hypersensitivity induced by SRBC and conversionproliferation reaction of mice splenic lymphocyte after4weeks mice(SPF grade fromKunming) test with daily dosage of0.25、0.50、1.50g/kg·BW(comparatively as5,10,30timesof recommended human daily dosage) by oral. It ’s certified that the product could enhancethe cell immunity (P<0.05); The product could enhance NK cell activity very significantly(P<0.01)) since the NK cell activity test result was positive. According to "Technicalstandards for testing&assessment of health food-Method for the assessment of enhancingimmunity function", the product had the health function of enhancing immunity.The health food license of probiotics complex granule(Junior) had been approved andreleased by SFDA in Feb.2012. The health function of the product was regulatinggastrointestinal tract flora and enhancing immunity.