Preparation Of Fructus Schisandrae Sphenantherae Softcapsule And Study On Stability Influence Factors

There are schisandra sphenantheraRehd and schisandrachinensls The literature of schisandra sphenantherarehd is relatively less,some research mostly concentrated in schisandrachinensls at home and abroad,and they are belong to the same plant schisandra from magnoliaceae.It is similar of components and clinical efficacy,but the specific composition and content are greatly different,They were contained separately in the chinese pharmacopoeia.To find the main active parts from schisandra sphenantherarehd in the preliminary work of this project,crude separation of schisandra sphenantherarehd were done according to broad categories.Four parts of the volatile oil,lignans,polysaccharides,organic acids were obtained.The test is subthreshold dose to sleep synergy of pentobarbital sodium and compared the depth of sleep of various parts of the composition.consequently,in the same crude drug doses,lignans show the advantages.At the same time,the mice's spontaneous activities reduced after taking lignans,and it can extend the sleep time,wich further confirmed that lignans are the effective parts.Aim:It is very suitable to choose soft capsule because the lignans is oily.In this study,there are some problems of primary prescription for samples of the fructus schisandrae sphenantherae softcapsule in stability,such as leakage,disintegration slow,adhesion,material migration,hardening and so on.Determination to the amount of amino acids,disintegration,dissolution,differential scanning calorimetry and other methods to explore the mechanism of disintegration retardation,substance migration,adhesion,etc in fructus schisandrae sphenantherae softcapsule.And methods have been proposed to solve the stability problems.From the extraction process of the drug to determine the preparation process and prescription of screening,the stability research through out the entire development process.Methods and relusts:1.By studing the process of extract preparation and separation and purification conditions and the drying process to ensure the stability and reproducibility of the extraction process.Crude drugs in the trial of a preliminary stability study,we obtained that the quality of the API is more stable.2.Initial screen capsule skin prescription and filler prescription,and studied the production of soft capsules conditions,to determine the condition parameters.And start to carry out initial stability test for primary prescription sample.3.Find sample stability factors of primaries prescription for fructus schisandrae sphenantherae softcapsule,and carry out studing of related mechanism.4.According to the factors influencing the stability of soft capsules,we designed to adjust prescriptions,then start a new stability test.Conclusion:Many factors affecting the stability of the soft capsule,such as gelatin quality,the types of additives and usage,the capsule thickness of the skin,the moisture content,the nature of the filler,including carriers,excipients and so on.Innovation:Determination of amino acid content and disintegration time,use the method of DSC to explore the mechanism of disintegration retardation,substance migration,adhesion,etc.For example,the cross-linking reaction of capsule leather has a relationship to amino acids;The high tamperature and light will accelerate the gelatin aging.The small molecule aldehydes in the additives make gelatin cross-linking reaction occurs,such as propylene glycol,titanium dioxide;Capsule skin's moisture state of dynamic equilibrium with the moisture of the filler,and the moisture content too much or too little can cause rupture or hardening of the capsule skin,and may even affect the capsule skin breakdown.This research also studied the interaction of the drug and capsule skin,investigated whether the drug affect the capsule skin.In view of the extract of chinese medicine system has essentially similar physical and chemical characteristics,the skin and contents of the capsule of soft capsules prescription also similar.Thus,it's not only established a research model of study chinese medicine soft capsules stability of the mechanisms and factors,but also should have universal significance for improving the stability of traditional chinese medicine soft capsules.