The Research Of Compound Semen Cassiae Chewable Tablets

With the accelerated pace of society,people put more and more energy into the work,the immune system has been destroyed,health is a serious threat.More work or study will lead to asthenopia,as the asthenopia has seriously affected people's work and life,reducing people's work efficiency a lot.As the number of patients with asthenopia increased,the study of relieving asthenopia caused widespread concern,It is an urgent task to make full use of traditional Chinese medicine resources to developed health food,which can relieve asthenopia.We have carried out the relevant research and toxicological evaluation,based on looking up,researching and analysing of relevant literature,test methods and results of the formulation are as follows:The extraction of active ingredients in medicinal herbs is carried out by using orthogonal test design method.The contents of active ingredients were extracted,and the contents of chrysophanol?emodin?physcion?obtusifolin and aurantio-obtusin are investigated.We ultimately determine the optimum extraction conditions: with soaked 60 min,extracted three times,five times the amount of water,five hours once time.And based as aboved research,we research pharmaceutical formulations process.To establish relevant quality standards of formulation,selecting thin layer chromatography(TLC),a rapid and accurate method for the determination of betaine in wolfberry is established.The method of determination on the chewable tablets is established by high performance liquid chromatography(HPLC),the appropriate liquid chromatography conditions and sample processing method are selected,establishing a appropriate method to determine the active ingredients content of chrysophanol emodin physcion obtusifolin and aurantio-obtusin of chewable tablets as inspecting the project indicators.the line arrange are: 0.00136-0.00680 mg/m L(r=0.9995);0.00065-0.00325mg/m L(r=0.9993);0.00013-0.00065 mg m L(r=0.9991);0.00096-0.00480mg/m L(r=0.9991);0.00054-0.00270mg/m L(r=0.9991);The average recoveries are: 99.73%(RSD=0.14%),99.53%(RSD=0.24%),99.31%,(RSD=0.39%),99.69%(RSD=0.15%)? 99.33%(RSD=0.17%);The results show that there is a good linear relationship between mass concentration and peak area in the above range,which indicates that the method is simple and accurate,and has good separation and high sensitivity.It can be used as a quality standard for the compound Semen Cassiae chewable tablets.The results of the stability study show that the stability is good and the related properties are basically stable.In order to ensure the safety of the product,we make the toxicological evaluation.The acute toxicity of the sample was non-toxic according to the acute toxicity rating of the rat.The results of the three genotoxicity test(Ames test,mouse bone marrow cell micronucleus test,mouse sperm abnormality test)is negative;through the 30-day feeding test,it doesn't indicate toxic side effects in the test dose range of the sample.