Studies On The Preparation Process, Quality Standard And Primary Evaluation On The Main Pharmacodynamics Of Guanxindanshen Soft Capsules

Guanxindanshen Soft Capsules(GXDSSC)are a compound Chinese Medicinal Material preparation developed on the base of a clinically proved recipe,which contains three kinds of medicinal materials,such as Salvia miltiorrhiza Bge.,Panax notoginseng(Burk)F.H.Chen,Dalbergia odorifera T.chen.The prescription was proved to be of remarkable curative effect when it was applied to treat coronary artery disease.In this paper the preparation process and quality standard of the compound preparation were studied so as to establish the foundation and preliminary evaluation of their pharmacodynamics for the further study on treating coronary artery disease with Chinese Medicine.In the studies on its preparation process,comparison test was applied to select the proportion and type of the auxiliary materials.The Panax notoginseng(Burk) F.H.Chen were crashed into fine powder.The Salvia miltiorrhiza Bge.were crashed into middle powder and were extracted with 8-fold 90%alcohol by percolation,then collected the percolate.The percolate were reclaimed the alcohol and should be concentrated into dense extractum;The gruffs of the Salvia miltiorrhiza Bge were decocted with 8-fold water for 2 times,1 hour per time; The extracted solution should be concentrated into extractum.The fine powder of the Panax notoginseng(Burk) F.H.Chen and the extractum should be misced bene.Then it was prepared granule, dried and crashed the fine power.Adding into the oil of Dalbergia odorifera T.chen. and 2%glycerin monostearate,then the soybean oil added to full dose.Finally it was prepared to soft capsules.In the studies on its quality standard,the thin layer chromatography(TLC) method was established to identify Salvia miltiorrhiza Bge.,Panax notoginseng(Burk) F.H.Chen,Dalbergia odorifera T chen.The high performance liquid chromatography (HPLC)method was established to determine the content of salviolⅡ_A in Salvia miltiorrhiza Bge.Guanxindanshen Soft Capsules of three batches of samples left at room temperature for a preliminary inspection 6 months of stability test.The studies on its quality standard indicated that the TLC for identifying Salvia miltiorrhiza Bge., Panax notoginseng(Burk)F.H.Chen,Dalbergia odorifera T.chen.is simple and practicable.A good linear relationship between the concentration and peak area of salviolⅡ_A was found within the range of 0.084μg/ml～0.420μg/ml,the average recovery was 99.60%,RSD=1.30%.The three animal models were established including normal hypoxia mice,auricle microcirculation in mice and acute myocardialischemia in rat.The survival time was calculated to appraise the protective effect of Guanxindanshen capsule on animal model of ischemia and hypoxia injury.Guanxindanshen soft capsules(1g·kg^-1,2 g·kg^-1)could prolong the survival time of mice who bear hypoxia of or dinary pressure,and oppose blood stasis in mice induced by Dextran,improve microcirculation,protect myocardial ischemia induced by ligation of aeteria coronaria.