The Pharmaceutical Research Of Zhigui Tablets

The tablet of Zhigui is comprised of Cassiae Semen, Angelica Dahuricae and Angelica sinensis etc. It has the effect of blood-raising and wind-dispelling and catharsis, so it is mainly for slow-transit constipation and mixed constipation.In the study of Cassiae Semen and Angelica Dahuricae extraction process, the factors were the concentration of ethanol, solvent ratio, extraction time and times and the investigation indexes were chrysophanol, aurantio-obtusin and Imperatorin extraction rate and the yield of extract. The optimal refluxing conditions of medicinal materials were extracted with10times volume of80%ethanol for2times and2h. The extract rate of anthraquinone and imperatorin and the yield rate of extract content were adopted. The ethanol extract and water precipitation, chitosan precipitation, adsorption method by macroporous resin, and acid-alkali method were compared. The acid-alkali method showed good extract rate and yield rate. Comparing with several purification methods, the acid-alkali method was selected for purification. The final purification process was as follows:adjusting to pH6.0with20%lime milk, standing for2h, then filtered and dried under reduced pressure.In the study of volatile oil extraction process, the supercritical extraction technology was used. Using three indexes, including the using amount and ratio of volatile oil to β-cyclodextrin(v/w), inclusion temperature and stirring time as the investigation factors, to comprehensively evaluate oil utilization efficiency and inclusion yield, the optimal inclusion procedure was as follows:the inclusion time is2h, The inclusion temperature is50℃and the proportion of oil and β-cyclodextrin is1:8.The central composite design-response design was used to optimize the formulation of Zhigui tablets. In the formulation design using response surface methodology plus central composite design, independent variables included the proportion of lactose, CMS-Na and CaHPO4content in ethanol absolute. Disintegration time of tablets and hardness were taken as dependent variable. Finally, predicted responses were verified. The quantitative relationship between three factors and two evaluation indexes were characterized. Optimal formulation was proposed to contain8.73%～9.26%lactose and3.63%～4.23%CMS-Na. The critical relative humidity of particles was67%, so the pressure were needed in the environment of the humidity below67%, and package film-cloth.The quality standard of TLC was established in the identification of Cassiae Semen, Angelica Dahuricae and Angelica sinensis. The conten of chrysophanol, aurantio-obtusin and imperatorin was measured by HPLC. The standard methods are simple, specific, and reproducible.