The Quality Standard Investigation Of Guanxindanshen

There are three dosage forms of Guanxindanshen preparation in clinical application at present. Tablet, capsule and drop pill. They are all made up of danshen,notoginseng and dalbergiae odoriferae. Clinical research indicates: Guanxindanshen preparation can promote blood flow and regulate qi to alleviate pain. It can cure thoracic obstruction and cariac blood stasis It has evident therapeutic action to cardiopathia and breast pang. It has been reported that Guanxindanshen drop pill has total effective rate is 93.3%. Guanxindanshen tablet has total effective rate is 86.7%.Guanxindanshen tablet was recorded in 2000 Pharmacopeia.and capsule was recorded in 2005 Pharmacopeia. Drop pill is a new Chinese drugs preparation that goes on market in recent years. There are no assaying in quality specification of Guanxindanshen tablet in Pharmacopeia.Tanshinoneâ…¡A is quality control target of capsule's liposoluble constituent (Tanshinoneâ…¡A is not few from 0.30mg every pill) But water solubility component, such as phenolic acid is not spoken.For consummating quality specification of Guanxindanshen preparation, providing reference and ensuring clinical therapeutic effect. The HPLC procedure was used to determine the contents of salvianolic acid B,notoginseng saponin R1 in Guanxindanshen Capsules , Guanxindanshen Drop pills and Guanxindanshen Tablets.The result of salvianolic acid B is 0.3146%,0.1164% and0.5033% notoginseng saponin R1 is 0.5868%,0.5122% and 0.5014%.The oar method was used to determine the vitro-dissolution rate of salvianolic acid B,notoginseng saponin R1 in Guanxindanshen Capsules,Guanxindanshen Drop pills and Guanxindanshen Tablets.Then draw the stripping curve. The consequence indicates the dissolution rate of salvianolic acid B,notoginseng saponin R1 in the three dosage forms is: drop pills >capsules>tablets. Salvianolic acid B t50 is 15.42min,2.66min and 1.88min, notoginseng saponin R1 t50 is 23.8min,5.9min and 3.16min.The difference preparation has great effect to dissolution and it is necessary to evaluate TCM solid dosage form.