Preparation And Evaluation "Ranae Oviductus And Fritillaria Ussuriensis Maxim" Soft Capsules

Objective:To prepare a health food with the function of enhancing immunity use Ranae oviductus and Fritillaria ussuriensis Maxim,to determine the prescription and preparation technology conditions,to establish the quality standard of preparation and evaluate healthcare function.Method:1.Choose the total alkaloids transfer rate as the evaluation index,the extraction parameters as ethanol concentration,material-liquid ratio and extraction time were optimized through the design of orthogonal test.2.Choose the base adsorption and sedimentation rate as the evaluation index,the best medicament preparation index of soft capsules were determined through single-factor test and orthogonal test.3.Use TLC to identify,Use the acid dye colorimetry method to determine the content of the total alkaloids,Use HPLC to determine the content of the 1-Methyl Hydantoin and establish quality standard.4.Use the ratio of visceral organ and body weight,ellular immune function,humoral immune function,mononuclear macrophage and NK cell activity as the evaluation index to contribute the enhancement of immunity function evaluation.Results:1.The optimum extraction technology of total alkaloids include 80%ethanol as extractant,extract for 2 times,ratio of material-liquid on 1:10and1:8,and extraction time by 2h and 1h.2.The best prescription for the soft capsule is the ratio of medical powder and soybean oil is 1:1.5;beeswax 1.5%;tween80 0.5%;3.The result of TLC identification is that sample and control sample in chromatography or control position medicinal chromatography corresponding show the same color spots or fluorescent stripe and negative control without corresponding spots;The peimine kept a good linearity relation in the concentration range of 4.08?20.40?g·mL-1in the acid dye colorimetry method,r = 0.9908;The 1-Methyl Hydantoin kept a good linearity relation in the concentration range of 0.4?1.0ug·mL-1in the HPLC,r ?0.9998.The average contents of total alkaloids and 1-Methyl Hydantoin in 3 samples were 17.61?g.g-1,8.56?g·g-1.4.The middle dosage groups and high dosage groups were respectively oral fed with the soft capsule content according to 10,30 times of the recommended dose for human body,the negative control groups were fed with equivalence oil.after Continuous oral fed 30 days,compared with negative control group the ratio of T lymphocytes CD69+/CD3+ in mice peripheral blood of high dosage group and phagocytic index for fluospheres in mice peritoneal macrophages of middle dosage group all had significant difference(P<0.05);the spleen lymphocyte transformation efficiency and the ratio of NK cell CD69+/NKG2D+ in mice spleen of middlie dosage group had a very significant difference(P<0.01).Meanwhile,the ratio of visceral organ and body weight,delayed type hypersensitivity,antibody-producing and monocyte-macrophage carbon clearance ability has no apparent effect.Conclusion:The optimized extraction process is stable and feasible;soft capsule forming process is simple and reasonable,the prepared content have a good liquidity and stability;The quality standard have a good repeat ability and can be used for quality control of the preparation;Health food prepared by the above method can help to strengthen immunity function.