The Preparation Technology And Quality Standard Of Zhibai Dihuang Wan (Concentrated Pill)

Zhibai Dihuang Wan (concentrated pill) appeared in Chinese traditional patent formulation NO.7, standard code: WS3-B-1357-93, is made from eight traditional Chinese medicine including Rhizoma anemarrhenae, Cortex Phellodendri amurensis, Radix rehmanniae preparata, Fructus corni, Cortex moutan, Rhizoma alismatis, Poria and Rhizoma dioscoreae. It is effective in nourishing yin to lessen fire, can be used in treating asthenic yin causing excessive pyrexia, hectic fever and night-sweat, dry mouth and swallow, tinnitus and spermorrhea, oliguria with reddish urine. In the thesis, a systematic study was carried out to investigate the preparation technology and quality standard of Zhibai Dihuang Wan (concentrated pill).Fructus corni is a principal drug in Zhibai Dihuang Wan. In the thesis, loganin was extracted in Fructus corni with ethanol, isolated repeatedly by column chromatography on silica gel, purified in methanol. The purity of loganin exceeded 98%.Under the guidance of the theories of TCM, its preparation technology was studied and optimized with modern methods. The quality standard was improved. In the experiment of quality standard, we have identified five drugs by TLC, which were Rhizoma anemarrhenae, Cortex Phellodendri amurensis, Radix rehmanniae preparata, Fructus corni, Cortex moutan. In the assaying experiment, we have chosen the active component including loganin, Paeoniflorin, berberine, Palmatine, paeonol as determination index. In the 238nm, loganin and Paeoniflorin have been determined simultaneously by HPLC; In the 265nm, berberine, Palmatine and paeonol have been determined simultaneously by HPLC. The quantitation control method has been established. As a result, Zhibai Dihuang Wan (concentrated pill) has satisfactory effects with reasonable and stable preparation technology and controllable quality standard. The quality control methods have many effects with convenience, accuratissime, repetition, and so on.