A Research Of Soft Capsules On Sleep Improvement

As the mode of modern life is changing and the pace of modern life is speeding up,the incidence of sleep disorder becomes larger.We have to pay more attention to this problem.According to the latest research from Chinese Sleep Research Society,the incidence of insomnia among Chinese adults is as high as 38.2%.As the head of sleeping disorders,insomnia generally accompanied by the following performances:early awakening,hard to settle into sleep, discontinuous sleeping,unable to sleep after waking.Affected by a variety of reasons mentioned,the crowd who suffer from insomnia tend to be lassitude,upset,confused,headache,hypomnesis and take more risks of psychosomatic disease,which lead to severe affects of people’s quality of life, working efficiency and increase the incidence of accidents. To enhance the quality of sleep of people, this article developed a preparation.Its prescription is composed of three Chinese herbs such as lotus seeds, fruit of Chinese magnoliavine and platycladi seed.This preparation is helpful to improve people’s quality of life and work efficiency and then promote social harmony and stability.We choose the soft capsule as dosage form, in this paper the production technology, quality standards,stability and pharmacodynamics of the soft capsule were studied.The results are as follows:1.Selection of production processExtraction process:As the principal component of schisandra,lignans includes schisandrin and schisantherin A,which have the pharmacological effects such as hypnosis and calm.The efficiency of platycladi seed and lotus seed to enhance the quality of sleep is based on platycladi seed oil and liensinine.Alcohol extraction is an effective way to extract those effective components because of the low cost,simple process and easiness for volume-production.We proposed to adopte orthogonal test to seek the best way to extract schisandra, lotus seed,and arborvitae seed alcohol,and then we determine the optimal extraction conditions as follows: ethanol concentration in 70%, extraction times in 3, add amount of alcohol in 4 times, extracting time in 3h.Pharmaceutics Technology:Through prescription screening,we choose corn oil as the solvent of the soft capsule,beeswax as the suspending agent of the soft capsule,adding remedium cardinale and excipients to complete the preparation of soft capsule preparation.2.Quality StandardThe research of soft capsule quality standard refer to the specific requirements of the 2010 edition of "Chinese pharmacopoeia".Using High Performance Liquid Chromatography(HPLC) to quantitative analyse schizandrin and liensinine,the indicators of the soft capsule,and developing a quality standard.The experimental results show that the method of using High Performance Liquid Chromatography(HPLC) for content determination of the capsule has strong specificity,good reproducibility and high sensitivity.3.Stability testThis research adopted the accelerated test and normal temperature to inspect the stability of the sleep ameliorating soft capsule.By testing the properties,load difference,disintegration time,content and microbial limit of the soft capsule.Results show that there were no obvious changes of the five indicators.The stability of the sleep ameliorating soft capsule is good.4.Pharmacodynamics testICR mice were used as experimental animals to complete the related research of the function of the soft capsule. By observing the sleeping time and the incidence of sleep of the ICR mice after gavage administration,we can determine the soft capsule is helpful to ameliorate sleep.