Process And Quality Standard Of Nuclear Tablet Milk Preparation

[Objective]Ruhe dispersible tablets is consisted of Salvia miltiorrhizae,Bupleurum chinense,Paeonia lactiflora,Citrus reticulate,Cyperus rotundus,Angelica sinensis,Prunella vulgaris and about fourteens so on.It has the blood circulation and huayu sanjie efficacy,be used to breast hyperplasia and breast lumps,breast bruising,the nipple water or bleeding embolism. Use of the modern traditional Chinese medicine preparation of the new technology. In This study,the basic pharmaceutical research of dispersible tablets was achieved, together with the selection of manufacturing techniques, establishment of quality standards, the appraise of preliminary stability. In general, my aim is to make further choice for the patients orin clinic.[Methods](1) The total weight of volatile oils was used to evaluate the extraction process.The process condition was studied by determing the utilization ratio of volatile,saturated water solution method and grinding method analyzed and compareded.The optimum condition were investigated by the orthogonal design. While the inclusion rate of volatile oils was used to evaluate the inclusion process.Orthogonal design was applied. with the ingredients of hesperidin, paeoniflorin as the evaluation index, Orthogonal design was applied to chose the optimum extraction process;The optimum ethanol extracting technology was selected with the content and extraction efficiency of tanshinone ⅡA through the orthogonal test;(2) With the ingredients of hesperidin and paeoniflorin as the evaluation index, ethanol precipiaton methods was used to choose the optimize purification process; To clarify the ethanol extracts by using chiosan,the content and extraction efficiency of tanshinone ⅡA as the evaluation index.(3) Normal pressure drying and vacuum drying were used to treat with the content by water extracts and ethanol extracts.(4) The disintegration time was observed to formulate the best preparation technology of RuHe dispersible tablets by uniform experimental of statistics.(5) The contents of hesperidin and paeoniflorin acid were determined through HPLC, five drugs were evaluated by TLC methods.(6) To investigate the stability of prescription,observing the remain specimen was done.[Results](1) The optimum extraction condition was to add six times amount of water into the mixture of crude drugs,to soak for2.5h,heat up to boiling and reflux8h;The optimum inclusion condition was to mix volatile oils with β-CD in proportion of1:10,the inclusion temperature was at45℃with the inclusion time of2h; The optimum extraction process by ethanol was adding70%ethanol which was6or4times the quantity of medicine and extracting twice(the first time for one hour,and the second time for half an hour). The optimum extraction process was adding water by16times,14times,14times,exteacting for3times and for2h,1.5h,1.5h. (2) The optimum process conditions were alcohol precipitation, The specific method was the relative density of the water to be condensed to1.20, adding ethanol to60%of ethanol concentration and depositing12hours;The optimizing conditions of extraction by ethanol were concentrated solution voume was1:6,added0.5%acetic acid solution of chitosan,standing12h.(3) The optimized drying methods was vacuum drying in60℃,and drying12h.(4) The optimized formulation of RuHe dispersible tablets was38%Extract powder、47%MCC、8%L-HPC.4%CMS-Na、2%PVPP、1.0%Gum Arabic selected as lubracan.(5) RuHe dispersible tablets was a brown solid.lt could disintegrate within2minutes.The content of hesperidin should not be lower then0.16%, paeoniflorin acid should not be lower then0.4%.the method was sensitive and specific.(6) Three blocks of RuHe dispersible tablets all measured up with the quality standard.[Conclusion]Studies had shown:under the guidance of clinicalmedicine,it was proved to be feasible to make Ruhe dispersible tablets,quality was steady and controllable. It provided a valuable reference for the research of dispersible tablets.The project goals were achieved.