A Research Of Alleviation Constipation Soft Capsule

The constipation is a quite common kind of complex symptom on a clinical,Mainly refers to the bowel movement number of times reduction and excrementquantity being few, excrement is dry and hard, bowel movement hard sledding. Theabove symptoms exist simultaneously in two or more kinds may be diagnosed as symptoms ofconstipation. Usually take the bowel movement frequency reduction primarily, general every2-3day either longer time bowel movement one time (or each week <3time) as the constipation. Themodern society along with the influence of change and stress disorder and social factor people dietstructure, the constipation disease incidence rate has the trend of markup. Based on this, thisarticle has researched and developed an alleviation constipation soft capsule, this soft capsule isthe pure Chinese traditional medicine preparation, comprised of the Huomaren, the shu Dahuangand the Muxiang three materials for the medicine, is mainly used to alleviate the constipation.The purpose of this project is to study the soft capsule production process conditions, qualitystandards and efficacy. Select soft capsule dosage form as the preparation, their preparationprocess, quality standards, stability and pharmacodynamics were investigated, and specific resultsare shown below:A. Supercritical Fluid processTakes the extract weight or banks rose hydrocarbon lactone and dehydrogenation banks rosehydrocarbon lactone total quantity as the target, has studied huomaren, shudahuang and muxiangsuper critical fluid extraction craft. By the orthogonal experiment, take the extract pressure, theextract temperature and the CO2current capacity as the inspection factor, carries on3factor3levels the orthogonal experiments, the distinction optimal raw material for medicine best extractcraft.B. The preparation procedureInvestigate the preparation and production of soft gelatin capsules: choose the bestaccessories and concluded that the best preparation process.C. The quality standards studyUsed the TLC law to carry on the qualitative distinction to the Shudahuang. The results showed that the spots on the chromatograms were reproducibility, clear, characteristicwithing no interference by negative materials. The methods are considerable tocontrol the standards of soft capsule foam.Using HPLC method to detect Costunolide and Dhydrocostuslctone content. Results showthat the method in the study of linear, precision, stability, reproducibility and the recovery rate isgood. Stipulated that in this each soft capsule the banks rose hydrocarbon lactone and totalquantity of dehydrogenation banks rose hydrocarbon lactone can not be less than5.75mg.D. The stability researchUsed the normal temperature experiment and the acceleration test separately inspected thepreparation stability, To the preparation character, only the content, the qualitative distinction, thecontent determination and the microorganism limit five items carry on the inspection. The normaltemperature experiment and the acceleration test inspect separately for3months, not obviouslychanges, showing the stability of the foam was good.E. Pharmacodynamic studyThe pharmacodynamics test result indicated: This soft capsule has the function of certainauxiliary bowel movement.The results show that this bowel movement soft capsule formulation fabricating process isreasonable, the quality is controllable, the stability is good, has the curative effect of certainauxiliary bowel movement.