| Sleeping is closely related to our life,however,with the rapid development of society,insomnia has gradually become a common phenomenon under the increasing pressure.In addition,insomnia may be accompanied by anxiety,depression and other symptoms.At present,due to the rapid onset and strong efficiency,western medicine treatment was widely used in clinical.However,because of high addiction,low safety and other shortcomings,people tend to more safe and natural medicine treatment.In this study,in order to alleviate the symptoms of insomnia and improve the quality of sleeping,we choose different Chinese herbal medicines(Ziziphi Spinosae Semen,nature medicine B and C)with medicine and food homologous,to research and develop an effective functional food.Part One: ReviewsThis part mainly reviewed the research progress of natural medicine treatment in insomnia,as well as the development.Additionally,the research status of Ziziphi Spinosae Semen(ZSS),as well as its active ingredient,pharmacological mechanism and new research hotspot were also describe in this section.Moreover,the topic basis and research approach were presented,thus providing a foundation for the development of the work.Part Two: Screening of active ingredient for sleep improvementThis section applied two evaluating indicators(prolonging sleeping time and shortening sleep latency induced by pentobarbital sodium)to optimize the extraction condition of Chinese herbal medicines by orthogonal design experiment.In addition,the combination of the obtained extracts was evaluated by a uniform design method and comprehensive regression analysis was performed with reference to the experimental results of positive control drugs.The results showed that the optimum extraction conditions of ZSS were determined as follows : liquid-solid ratio of 10:1,extraction 2.5h with 70% ethanol at 90℃.B herbes with water as the extraction solvent and the optimum extraction conditions were liquid-solid ratio 16:1,one time by 2 hours at 90℃.The optimum extraction conditions of C herbs were confirmed as : liquid-solid ratio of 10:1,2 times,2 h per time with 70 % ethanol.The results of uniform design showed that the best compatibility comdition of ZSS,B and C herbs was ZSS extract: B extract: C extract = 15:5:5.The efficacy of different doses study found that the dose of 3g/kg has significant sleep function.Part Three: Research on preparation technology of pelletsIn this section,we used the extrusion-roll method to prepare pellets.And applied four evaluating indicators(yield of particle size distribution,roundness,angle of repose and soft material situation)to optimize conditions about preparation process by single factor and orthogonal design experiments.The pellets of sleep improvement were successfully prepared,and the optimum prescription conditions were confirmed as: MCC as an excipient with 50% drug loading,8% ethanol(wetting agent)with dosage ratio of 1:0.6.Moreover,the optimal parameters were determined as follows: Extrusion speed of 35 Hz,roll speed 45 Hz and round time by 6 min.The reproducibility results showed that the pellets of different batches are less different and have better shape,as well as its yield of 20-30 mesh up to 84%.Pellets are brown and no visible foreign impurities.Part Four: preliminary chemical composition analysis and content detection ofthe pelletsThis part mainly focuses on the preliminary chemical composition analysis and content detection of the pellets.And it contains saponins,flavonoids,alkaloids through the detection of chemical composition in the pellets.The thin layer chromatography(TLC)showed that the pellets contained jujube saponins.Moreover,the content of saponins of pellets was analyzed by UV spectrophotometry and high performance liquid chromatography(HPLC).According to the results of methodological analysis,the UV spectrophotometry is easy to make the experimental results produce errors because of low accuracy and instability.Therefore,we finally choose HPLC with high precision and recovery rate,to determine the content of pellets.The results of content test demonstrated that the content of jujuboside A of pellets was about 0.457mg/g..Part Five: Efficacy evaluation of pelletsIn this section,the insomnia mice model was established by PCPA induced,and evaluate the effect of the pellets through experiments of prolonging sleeping time and shortening the sleep latency induced by pentobarbital sodium.In addition,the efficacy of the pellets was further investigated by observing the spontaneous activity of the mice after administration.The results of model test demonstrated that the mice were quieter and the symptoms of insomnia were relieved after treatment with pellets.And in the sleep experiment induced by pentobarbital sodium,the pellet group siginificantly reduced the sleep latency and prolonged sleep time compared with the blank group,and the efficacy is higher than the extraction composition and BLM groups.This result indicating that the pellets could alleciate the insomnia symptoms of mice and improve sleeping.On the other hand,through the independent activity of mice,it was found that the pellet group of the number of movement and distance of the mice were significantly lower than blank group.This result suggesting that the pellets play a sedative and hypnotic effect. |
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