Pharmaceutical And Pharmacodynamic Researches On Jieyushunxin Tablets

Jieyushunxin Tablets are traditional Chinese medicines containing 9 herbs,which have the effect of dispersing the depressed liver-energy,clearing heat and eliminating phlegm,and tranquilizing mind.Jieyushunxin Tablets are beneficial for the treatment of the depressive disorders due to pathogenic fire derived from stagnation of liver-qi and phlegm-heat attacking the heart,with manifestation of deprementia,restlessness,tantrum,gas pain of chest and hypochondrium,palpitation,insomnia,morbid forgetfulness,dreaminess,festless sleep,lassitude,and so on.Under the guidance of TCM theory and according to the State Food and Drug Administration,the article carries out the pharmaceutical and pharmacodynamic research using modern science and technology.1.Study of the preparationAccording to the nature of the active ingredient in the prescription and the literature research,the preparation process was designed.(1)In order to determine the extraction process,we compared the of two extraction methods the traditional decoction and anol reflux extraction,and finally,we adopted reflux extraction method to extract the prescription.(2)The prescription was extracted by reflux method by using salvianolic acid B and tanshinone IIA content as the evaluation index,and do experiments according to L9(34)perpendicular sheet containing four factors-ethanol concentration,extraction time,solvent dosage and extraction frequency.The best water extraction schema is 8 times volume fraction of 60%ethanol reflux extraction 3 times,60 minutes.(3)We choose wet method the to make granula,and do experiments to preffer accessory and corrigent by forming,angle of repose and hygroscopic propery.The best accessory is microcrystalline cellulose,disintegration agent is Carboxyl Methyl Starch(CMS).In order to test the rationality of the preparation,we have research on mid-experiment for three times,and the products are detected according to all the quality control and proved that the preparation process was feasible.2.Quality standards researchIn order to control the quality of the product,the method of thin layer chromatography(TLC)and high performance liquid chromatography(HPLC)were used to establish the quality standard for Jieyushunxin Tablets.TLC method was used to establish a method for the identification of Radix Salviae Miltiorrhizae,Bupleuri Radix and Coptidis Rhizoma.The results show that the spots are clear on the TLC picture and the negative control was non-interference,so we could use it as the qualition identification.HPLC is used to assay Salvianolic acid B,and the regulations of each tablet containing salvianolic acid B shall not be less than at 60.0 mg.It showed that the established method accord with the demands of quantitative analysis;Established HPLC fingerprint of Jieyushunxin Tablets;at the same time difference of tablet weight,disintegration time limit and microbial limits of the general inspection results meet the requirements.3.The study of the stabilityIn order to examine the stability of the medicine,we keep the wrapping material at room temperature and detect three batches of products according to all the indexes from the quality control.4.Preliminary pharmacodynamic studyIn order to verify the efficacy of Jieyushunxin Tablets,open-field test,the effects of forced swimming test in mice and PC 12 cell damage model were used to study the effect of the drug.The results showed that the antidepressant effect of the medicine was good.