Studies On Salviae Miltiorrhizae And Ligustrazine For Injection

Salviae Miltiorrhizae and Ligustrazine for Injection is composed of total salvianolic acids and Ligustrazine Hydrochloride. It can improve microcirculation, protect the heart from cardiac ischemia and cardiac infarct,inhibit lipid peroxidation, scavenge hydroxyl radical, inhibit thrombosis formation and so on. It was developed from Salviae Miltiorrhizae and Ligustrazine injection. A series of research mainly including the preparative process, the content determination and chromatographicfingerprints has been carried on.Firstly the method of preparating the total salvianolic acids was explored. To research the craft of extract salvianolic acids from Salviae Miltiorrhizae radix, a scheme of L₉(3⁴) orthogonal experiments were adopted. Four factors were consisted with granularity of material, soaking time, percolating volume and the menstruum pH . Each factor set three levels. The best craft was determined while taking the index of extracting ratio of salvianolic acids. To purify the extracted liquid, the solution was taken to pass through a big bore resin pillar. Firstly using 0.01M HCL to wash off the material which was not adsorbed. Secondly using 25% alcohol to wash off the impurities with bigger polarity. Thirdly the solution of 40% alcohol was collected and decompression inspissated. Finally the inspissated liquid was freeze-dried. So the total salvianolic acids with the purity over 80% were obtained. Through the enlarged experiment, it was proved that the craft was suitable for the industrial manufacturing.Secondly the study on the pharmaceutical craft of Salviae Miltiorrhizae and Ligustrazine for Injection was carried on. HPLC method was used to investigate the stability of salvianolic acid B in different pH conditions and the best pH condition was selected. The dosage of active carbon was chosen by investigating content change of salvianolic acid B and Ligustrazine Hydrochloride; the suitable support agent was selected to ensure the good form and resolvability; the best pharmaceutical craft was chosen after various different freeze-drying conditions were tested.Thirdly the method of content determination was established. Spectrophotometry was used to determinate the content of total salvianolic acids while taking salvianolic...