| Health food has a long history in our country, which could be also well proved by homology theory of food and medicine since time immemorial in China. Thus using food only or combination of food and medicine to achieve nutritional healthcare and recovery were very common in Chinese traditional medicine science. As conventional health food, propolis and royal jelly were widely used. This paper discussed production process of compound soft capsule made from propolis and royal jelly, while analyzing hazard and critical control point in each process step based on quality control system. This paper started from extraction of raw material - propolis, investigating effect of factors during lead removing process on lead content in propolis. The best extraction process was, soaking 100g propolis with 2L 75% alcohol for 48h and separating supernatant. The lead content in propolis was 0.189mg/kg. According to orthogonal design study results on alcohol amount, alcohol concentration, soaking time, extraction times with propolis extraction rate as goal, optimum extraction conditions were quantity ratio between propolis raw material and alcohol 1:6, extracting 3 times and soaking 48h, which got 11.00% flavonoids content and 55.6% exact yield.For large-scale production, ratio of propolis, royal jelly, PEG400, safflower oil and beeswax were studied, using settlement rate as a main measure index. The final recipe was fixed as propolis, royal jelly, PEG400, safflower oil and beeswax 20:25:50:10:4.Then used uniform design method and U5(53) uniform design table, fixing gelatin dosage as 10 times, to explore effect of ratio between gelatin, glycerol and PEG on dissolution rate of capsule shell. Regression equation got from multiple regression analysis is: Y=-16.96+50.96* X1-30.80* X12+0.013* X22 ; N=5,s=0.044,F=269.77(P<0.05). The euation was significant.Disintegration time of soft capsule was influenced by different temperatures and humidity. We found drying time 20-24h, drying temperature 22±2℃were best conditions. When relative humidity was 20±2%, moisture content in capsule shell was low, which results in shortest disintegration time. Moreover, this paper also researched how sorbitol, mannitol, citric acid, L- cysteine, fumaric acid, PEG, sorbitan mixture affected disintegration time of soft capsule. The best dosages were as follow: 8%-10% sorbitol, 4%-5% mannitol, 6% citric acid, 5% L- cysteine, 1% fumaric acid, 5% PEG, 6%-8% sorbitan mixture.Based on above research, various process parameters were discussed. Via preliminary stability test shelf life of product was recommended as 24 months.Product functions of anti-aging and blood-lipid regulation were verified in the light of functional assessment procedure and test methods of health food. Acute toxicity test, mutagenicity test and high dose-fed rat trial were completed too. It was shown that, propolis and royal jelly capsule can enhance activity of SOD and GSH-Px obviously in rat serum as decreasing MDA content, which indicating its anti-aging function. Analyzed blood lipid after continuous gavage for 30 days .The results showed that, high and medium dose groups have higher HDL-cholesterol concentration than control group, the increasing extents were 50.0% and 31.6% respectively. Triglycerides in rat serum of high, medium and low dose group were lower than that of control group, the decreasing extents were 47.6%,45.7%,42.1%. Cholesterol in rat serum of high, medium and low dose group were also lower than control group obviously, the decreasing extents were 57.9%,54.3%,42.0%. It stated that propolis and royal jelly capsule can regulate blood lipid. Acute toxicity grade of this product belonged to non-toxic class, results of Ames, bone marrow micronucleus and mice sperm abnormality test were all negative. It means this product had no mutagenesis to mammal somatic cells and male germ cells no matter in vivo or vitro. 30 days continuous fed trial on rat found that (equal to 8, 32, 128 times the human consumption dosage), rat body weight and food utilization rate at different time in 30 days were not influenced by dosages of capsule. This suggests tested product didn't bring about visible impact on growth and food utilization of rat.In the final part of this paper, according to significant hazards affirmed in hazard analysis list, combining product characteristics and production experience, critical control points and limits were determined Three critical control points for propolis and royal jelly capsule production: acceptance test, materials weighing and homogeneous mixed. The critical limits were: among raw materials, acid value of safflower oil (count as fat)≤30.0; peroxide (count as fat)≤12.0, total plate count≤1000 cfu/g, pathogens negative; heavy metals in propolis (count as Pb, mg/kg)≤1.0, heavy metals in royal jelly freeze dry powder (count as Pb,%)≤0.001, 10-HDA≥4.0%; during materials weighing, balance accuracy: sensitivity weight: 60kg electronic scale 5g, 1kg electronic scale 0.5g; During homogeneous mix, mixing time 30min, temperature≤40℃.
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