The Pharmaceutical Research Of Guishen Erzhi Tablet

Erzhi pill was putted crushed medicinal plants with refined honey into pill. The process was easy and its quality standards were unexcellent. Large dose, dysphagia, not preserve well and easy metamorphism were all defects. Guishen erzhi tablet was on the basis of TCM theory, combined with Erzhi pill from Pharmacopoeia, which coordinate traditional prescription with angelica and salvia miltiorrhiza of contribute to this prescription. To develop the major functions of the tablet were irregular menstruation and amenorrhea. In the study, the purification and extraction of angelica, Ligustrum lucidum, eclipta prostrate, salvia miltiorrhiza, preparation techniques, the preliminary stability of tablet and quality control criteria were systematically investigated.In the ethanol extraction process of Guishen erzhi tablet, according to the different property of medicinal substances, Ligustrum lucidum, angelica, eclipta prostrate were extracted by alcohol. With the orthogonal experiment, the extraction rate of specnuezhenide, ferulic acid and wedelolactone and the recovery rate determined the optimum conditions of the alcohol extraction. The extraction rate of specnuezhenide, ferulic acid and wedelolactone were respectively85%,93%and73%. Recovery rate was22.2%. The content of ferulic acid, specnuezhenide and wedelolactone were0.41%,9.01%and0.23%respectively.In the procedure of purification of extraction of ethanol extraction, HPD-100resin was selected to purificate the extraction, Static and Dynamic saturated adsorption, effection of velocity and concentration of solutin across macroporous adsorption resin was investigated, the leak curve and elution curve and elution rate of alcohol at different concentration were determined, the recovery rate of the dry extract ion decreased to4.54%. The content of specnuezhenide, ferulic acid and wedelolactone in the dry extraction after purification were15.69%,5.68%and3.48%respectively.In the study of salvia miltiorrhiza, using the orthogonal experiment, the optimum conditions of extraction were determined with the extraction rate of salvianolic acid B and the recovery rate of the dry extraction. Through the comparation of three kinds of methods, HPD-100resin, Silica gel column chromatography and Water extraction and alcohol precipitation method. To purificate the extraction of salvia miltiorrhiza selected water extraction and alcohol precipitation. The recovery rate decreased to20.1%. The content of salvianolic acid B after purification was8.25%.In the preparation procedure of tablet, using the single-factor experiment and central composite design-response surface method for the kind of accessories. Using central composite design, The disintegration time and hardness to select dosage of accessories determined optimum conditions of preparation process of tablet.The tablets which were made through the above-mentioned prescription, quality control criteria was studied, including properties, identification, the method for detection of content and disintegration time. Controllable quality assessment was established and provided a theoretical foundation. The result of preliminary stability indicated that properties, identification, the method for detection of content and disintegration time were rational and feasible.