Studies On Preparation Technology And Quality Standard Of Bushen Jieyu Capsule

Bushen Jieyu Capsule is made of two kinds of herbs(Fructus Psoraleae and Poria). It has a function of warming kidney yang, tonifing spleen Qi, nourshing heart and tranquili-zing the mind. It can be used in depressed syndrome of deficiency of spleen and kidney yang because of deficiency of kidney yang, disfunction transportation of spleen and disfunction nourishing of heart. The manifestation is slow thinking, depression, sleep disorder, anorexia and so on. It can treat depression.With the guidance of the theory of Chinese Traditional Medicine, and with the help of the modern pharmaceutical technology, Bushen Jieyu Capsule has been researched on preparation technology, using various modern analysis techniques ,such as the HPLC and GC, etc, to choose the excellent original medicinal and preparation technology which have optimum process parameters in every link, control product quality, provide the scientific data and basis to realize the industrialized production of Bushen Jieyu Capsule preparation, ensure the quality and clinical effect. The result is showed as follows:Profect the quality standard of Fructus Psoraleae. To establish the method of content determining the total furocoumarine in Fructus Psoraleae with UV spectrophotometry, and establish the method of content determining the psoralen, isopsoralen, bakuchiol in Fructus Psoraleae with HPLC.Profect the quality standard of Poria cocos. To establish the method of content determining the total sugar and polysaccharide in Poria cocos with UV spectrophotometry; using the acetic anhydride as derivatization agent, perform the pre-column derivation of mo-nosaccharide components which compose the total sugar in Poria cocos, establish the pre-column derivation GC to discriminate four monosaccharide components in Poria cocos, which can be used as the quality evaluation method, make up the gaps in the quality control of Poria cocos, which are widely used.Comparative study on Fructus Psoraleae and Poria from different producing area by using the quality analysis method established, finally we selected Fructus Psoraleae from Mengzhou City of Henan Province and Poria from Yingshan County of Hubei Province, which this topic preparation study on. studies on preparation technology.The quality analysis method established applied to the process research of the capsule of tonifing kidney and releasing depression, combined with orthogonal experimental design ,we select the optimal extraction technology which can beneficial to the antide- pressant effective fraction—coumarins in Fructus Psoraleae, optimum extraction process was adding 6 times amount of 50% alcohol and cold leaching for three times, 48mins per time, and it can make the extraction rate of coumarins reached 90%.In order to reduce extract yield of Fructus Psoraleae, using the content of furan coumarins and extract yield as observing indexes, mainly study on purification process of the extract of Fructus Psoraleae, ethanol precipitation technique was finally selected to purify the extract of Fructus Psoraleae, which the extract yield was decreased by 50% and 95% retention rate of effective components was reached.Using the metastasis rate of furan coumarins as observing indexes to overall monitoring production process of Bushen Jieyu Capsule we discovered that in the produc- tion process, the temperature and the polarity of the solvent are the main factors which influenced the retention rate of furan coumarins, in addition it also related to the pH of the solvent.Make the quality standard of the extract of Fructus Psoraleae and Poria and Bushen Jieyu Capsule A prior-column derivation GC method for the identification of sugars in Poria of Bushen Jieyu Capsule has been developed, and it also provides reference for fea- tures discriminant of water-soluble constituents of Poria cocos in the compound.