Studies On The Optimization Technology And Quality Criterion Of Xin Yue Shu Tablet By Powder Property

There are some common problems,such as unstable of volatile oil volatile,hygroscopic and poor liquidity of powder in the compound preparation of traditional chinese medicine.Xin Yue Shu tablet is a new compound preparation of Traditional Chinese Medieine,which is composed of Angelica,Cinnamon and Stauntonia Chinensis.It has the function of qi to relieve pain and warm through removing blood stasis.Thus,it can be used to cure women primary dysmenorrheal in clinical practice.The extraction rate was high.If the accessories were added into the extract directly to prepare tablets,it was difficult for clinical use because of a large single dose.So it was necessary to process extract using spray method.However Xin Yue Shu spray drying powder was hygroscopic with poor liquidity,which was not conducive to the subsequent preparation processing.Because it contained large volatile oil of Angelica and Cinnamon,the prepared tablets occurrenced lobes and oil spills,resulting in unstable product quality.On the basis of the function of the presecription and the characters of the components of the herbs,we used powder modified technique and curing volatile oil technique and optimized preparing procedure and carried out the quality standards with the guidance of the theories of the Traditional Chinese Medieine.Using the orthogonal design,we optimized the extraetion proeess.Then we optimized the preparing procedure of Xin Yue SHu tablet.Finally we obtained the feasible and comparative detailed producing technology conditions:Onhogonal design has been applied to seleet the optimum technique conditions for extraction,and the relevant technique parameters have been fixed,which were as follows:Angelica and Cinnamon with 12 fold water to soak flos lonicerae for 1 h,distill the strong aromatie water for 5 hours to get the essentialoils,solidify it with colloidal silicon dioxide,keep the solidified power for use.The dregs of the two drugs mentioned above and Stauntonia Chinensis were extracted with water twice with 10-fold water,each time for 2 hour,then the extract was ineorporated together and vacuum concentrated till the density of which reached 1.10(60?).The extract was made into extraet sicea by spray drying method.Then the spray dryied power was blended with developed compound excipient and solidified power of volatile oil,microcrystalline cellulose,and made into granule product by fluidized-bed spray granulator.Grains was tabletted.After that the qualitys tandard of the Xin Yue Shu tablet was finished,the contents of ferulic acid and cinnamic aldehyde were determined using high performance liquid hromatography(HPLC)as indieators of internal quality control.TLS method was utilized to identify Angelica,Cinnamon,Stauntonia Chinensis.