Preparation And Pharmacologicalaction Of Salvia Miltiorrhiza F.alba Pills

ObjectiveStudy on the extraction process of Salvia miltiorrhiza f· alba; Study on the preparationtechnology, quality standard, acute toxicity and pharmacological action of Salviamiltiorrhiza f· alba pills. And it is a good theory basis for the experimental research ofSalvia miltiorrhiza f· alba.MethodWith content index of the liposoluble constituents of tanshinone II A and theWater-Soluble Constituents of Lithospennate B, the pharmacopoeia method,60%ethanol,70%ethanol,80%ethanol was optimized.With the preparation of drug fluid and substance,dripping speed and materialtemperature for main investigation factors. The hardness, the tailed degree, the sphericaldegree and the coefficient of heavy variation, and others was applied as the index.The identification of uncaria and the measurement of Salvia miltiorrhiza f· alba pillsin the preparation were made with the TLC and HPLC respectively for the primary qualityevaluation. Study preliminary stability investigation of three batches of Salvia miltiorrhizaf· alba pills for six months under room temperature storage.Method the model was established by injecting isoprenaline. Study on the treatment ofmyocardial infarction of Salvia miltiorrhiza f· alba pills by testing MDA, ROS,CAT, NO,GSH-PXand the cardiac index.In order to get the further information about the safety of Salvia miltiorrhiza f· albapills, mice were employed to investigate the acute toxicityo1.44g by stomach perfusion inorder to observe the death.ResultsThe most proper extraction condition for reflux extraction with heat ethanol was asfollows: the uncaria material was refluxed with eight times of80%alcohol for one timeand it is one hour, concentration temperature was45℃and drying temperature was45℃. The best preparation technology was as follows: the proportion of drug-matrix1:2,the proportion of PEG400-PEG60001:1, dripping speed:28d/min, the condensare wasliquid paraffin, temperature:45℃.The preliminary quality evaluation system was established for the Salvia miltiorrhizaf· alba pills. It was in conformity with Chinese Pharmacopeia (2005)with respect to weightvariation which was30.7mg/pill and diffusion time in37C distilled water which was4minutes. The method of TLC could identify angelica, chuanxiong rhizome and safflower inpreparation. In HPLC, the linear range for tanshinone II A was1.6μg/ml-16μg/ml(r=0.9997), the recoveries for it was102.1%the RSD was1.1%(n=6). The linearrange for Lithospennate B was0.1μg/ml-1.6μg/ml(r=0.9992), the recoveries for it was99.4%the RSD was0.1%(n=6).The characters, identification and content of Salvia miltiorrhiza f· alba pills wassimilar to0month after six months of study.Rats were made into models of myocardial ischemic injury by intraperitonealinjection of isoproterenal(200mg/kg). The Salvia miltiorrhiza f· alba pills was administeredby intragastric injection and the testing indices was qualified that it has good therapeuticeffects on myocardial infarction.Mice were orally administered with Salvia miltiorrhiza f· alba pills with the mosttolerance dose of1.44g. No rats died showed that Salvia miltiorrhiza f· alba pills has notsignificant acute toxicity.ConclusionThe techniques and methodical of quality of Salvia miltiorrhiza f· alba pills areconvenient, stable, feasible and credible. Quality evaluation system can be set up toeffectively control the quality of the dropping pills. The Salvia miltiorrhiza f· alba pills arestable during six months and has not significant toxicity effects.