Study Of Chemical Ingredients And Quality Control Methods Of Suger In Danshen Injection

Danshen injection is water-soluble Salvia preparation.It has the efferciency of regulating qi and resuscitation,activating blood and removing blood stasis,clearing away heart-fire and eliminating annoy.In clinic,it was widely used for the treatment of coronary heart diseases,angina pectoris,myocardial infarctions and cerebrovascular diseases.Danshen injection is the infusion summarize,the osmotic pressure of which must keep consistent with the blood osmotic pressute.Too high or too low of the osmotic pressure is harmful to human health.Hypotonic solution would cause hemolysis,and hypertonic solution would cause vascular embolization.The sugar of the preparation,especially glucose as excipient,which never be found to have bioactivity,has great influence on the osmotic pressure.So,it is important to control the sugar of danshen injection.The sugar of danshen injection had been studied by phytochemical researches and spectroscopic analysis.Four compouds were isolated and identified on the basis of spectroscopic data(1H-NMR,13C-NMR)as follow:fructose,glucose,mannotriose and stachyose.On the basis of chemical studies,we had researched the quality standard of danshen injection.The method to determine contents of fructose,glucose and total sugar was established.The result is that:the content of fructose is 560?935 mg;the content of glucose is 92.0?108.0%;the content of total sugar is 11.8?16.0 g.In order to control the quality well,the HPLC characteristic spectrum of sugar in danshen injection and Salvia were also studied.The standard characteristic spectrum has been established from 10 batches of sample.At the same time,the effect of water extracting-alcohol precipitating and ultrafiltration on the sugar of Salvia miltiorrhiza Bunge had been researched.The result showed that water extracting-alcohol precipitating could effectively remove polysaccharide.Ultrafiltration had no effect on the sugar of samples.However,ultrafiltration could effectively remove endotoxin to guarantee the safety of the preparations.