A Research Of Soft Capsules On Sleep Improvement

Insomnia is a sleep disorder, which main performance is falling asleep hardly,sleeping fitfully, or waking up early, even can’t continue to sleep after wake up. Hewill have the feeling of lack of sleep and fatigue. it belongs to the nerve abnormalitiesresulting in a superexcitation of cerebral cortex and appearing a kind of pathologicalsymptoms. Most symptoms are affected by poor health, pain, unwell feeling,interrupting circadian rhythm, sleep environment and so on. In addition, the pace oflife is becoming more and more quickly and also gradually improves the livingstandards, which will make people’s life stress is more and more increased toindirectly effect the people’s quality of sleep. So insomnia has become a commonproblem in today’s society. In view of this phenomenon, this paper developed a softcapsule that can improve sleep. The capsules are composed of Schisandra Chinensis,Semen Ziziphi Spinosae and Semen Platycladi, mainly to improve sleep and sedativeeffect.This thesis mainly studies the production technology of the soft capsule, qualitystandard and efficacy. We Choose the soft capsule as dosage form and study theproduction process, quality standard, stability, and efficacy. The specific results are asfollows:1.the study of production technologyThe main component of Schisandra Chinensis is lignan, which includeSchisandrin and Schisantherin, which have pharmacological effects in sedation and hypnosis. Alcohol extraction can effectively extract the effective components, whichhas advantage in simple process, convenient operation, low cost, and better conditionof mass production. We use orthogonal test L9(34) to do the orthogonal experiment,to seek the optimum process conditions of extracting the effective components ofSchisandra chinensis in alcohol extraction. And determine the optimal extractionconditions is ethanol concentration in80%, extraction times in2, and amount ofalcohol in6times, extracting time in3h.Platycladi seed oil is the main functional component of Semen Platycladi inimproving sleep. Using CO2supercritical fluid extraction technology to extract theeffective components have more advantages than other extraction methods, such asfast extraction speed, no residual organic solvents, simple process, easy to operate.The4factors3levels orthogonal test determine the optimal extraction conditions:extraction temperature in50℃, extraction times in2,30Mpa extraction pressure,supercritical fluid CO2volume flow for medicinal powder in10times.2. quality standardWe do the study on quality standard of the soft capsule with reference to the2010edition of China pharmacopoeia requirements. Methods Thin LayerChromatography (TLC) is used to identify Semen Ziziphi Spinosae. The results showthat there is the spot in the corresponding position, indicating the good reproducibilityand the strong characteristic. Methods High Performance Liquid Chromatography(HPLC) analysis the major component Schisandrin of Schisandra Chinensis in softcapsule and develop the quality standard. The results showed that: using HPLC fordetermination content of the soft capsule has good reproducibility, high sensitivity,strong specificity. 3. stability testAdopted the normal temperature test and accelerated test to study the stability ofthis soft capsule on the trait of soft capsule, disintegration time, qualitativeidentification, content determination and microbial limit respectively in3months.There were no obvious changes, showing the stability of this product is good.4. pharmacodynamic testThe examine in pharmacodynamics research through the study of the softcapsule in animal experiment, show that the preparation can improve sleep.