Study On Anti-fatigue Dispersible Tablets Of Compound Rhodiola Crenulata(Hook.f.et Thoms.) H. Ohba

With the development of economy and fast lifestyle,there are an increasing number of people who suffer from chronic fatigue syndrome.Although it cannot result in direct and sudden death like cancer or heart disease,it is regarded as an invisible killer to modern people's health and has greatly affected their work and life, getting the number of sub-healthy people increased.Having recognized the seriousness of the problem,lots of experts and researchers at home or abroad begin to divert their attention to the field of improving the symptoms of chronic fatigue syndrome and have made a great deal of researches on medicine sources and health-care food which can relieve fatigue.Hongjingtian was first recorded in Pharmacopoeia of the People's Republic of China(Edition.1977,Volumn I) in which its functions are described as follows: clearing heat-toxicity,dispelling pathogenic wind and removing dampness.It was originally employed to treat lung and infectious disease as well as limb swelling. Hongjingtian product is available as a bablet or capsule drug.Mordern pharmacology researches demonstrate that Hongjingtian has the effects of anti-fatigue,anti-hypoxia and enhancing immune,with reliable treatment efficiency and less side effects.In order to improve its stability and efficiency as well as drug taking convenience,this study designed and developed a tablet fast releasing dosage form for Hongjingtian. This research includes the following steps:First,an exploration about extraction methods of Hongjingtian was conducted. After many experiments,extraction techniques of Hongjingtian were finally determined:extraction solvent 40%ethanol,extraction liquid ratio 1:15,extraction time 60min,extraction duplication twicely.Condensed pharmacognostic extract with 5 g^-1(20℃) relative density was gotten after these above mentioned steps.Second,prescription and the preparation technology of compound recipe Hongjingtian dispersible tablets were decided by single factor analysis and orthogonal design.In this step,the degree of influence of different disintegrants,fillers,and drug-loading rate on the disintegration time of Hongjingtian dispersible tablets was first tested.According to the testing results,alcohol and MCC erythritol as the filler, PVPP,L-HPC and CMS-Na were selected as disintegration agents,Then,L₉(3⁴) orthogonal experiment was applied to determine the effects disintegrants amount on tablet disintegration time and finally optimal proportion of disintegrants was got.drug loading is 30%.Optimal Prescription of Compound recipe Hongjingtian dispersible tablets is as follows:Rhodiola extract 30%,microcrystalline cellulose 20%,erythrite 18%,low-substituted hydroxypropyl cellulose is 12%,PVPP 9%,CMS-Na 9%, magnesium stearate 1%and Talc powder 1%.Third,Quality standards of Compound recipe Hongjingtian dispersible tablets were defined,which included the main indicators such as characteristics, identification,examination and assaying.Qualitative identification of Salidroside, ferulic and acid liquiritin in Hongjingtian dispersible tablets was made.by HLPC. Then,HLPC was used again to measure the content,accuracy,stability and recovery rate of glycyrrizin.Salidroside,ferulic acid and content,accuracy,stability and recovery rate of glycyrrizin.These methods were proved to be accurate and fast in quantitative and qualitative tests of Hongjingtian dispersible tablets,which can be applied to the quality control of the preparation to ensure rationality,security, effectiveness.Fourth,the stability of Compound recipe Hongjingtian dispersible tablets in normal atmospheric temperature was examined.After being laid for 6 months,there were no significant changes for characteristics,identification,examination and assaying of Hongjingtian dispersible tablets,demonstrating that the product is stable in inspection phase.Finally,preliminary pharmacodynamics of compound recipe Hongjingtian dispersible tablets was tested by load swimming test,determination of blood urea nitrogen and liver glycogen and so on.The results showed Compound recipe Hongjingtian dispersible tablets had obvious effectiveness of relieving fatigue. Subsequently,pharmaco-toxicological tests of Compound recipe Hongjingtian dispersible tablets were studied,which showed Compound recipe Hongjingtian dispersible tablets hadn't toxic reaction and oral drug administration was secure.In summary,the compound recipe Hongjingtian dispersible tablets is stable and its quality is controllable in production,reaching the designed objectives and requirements.