Astragalus Stomach Floating Chip Fabrication Process And Quality Standards

Objective:To study Huang Qi floating tablets extraction and the confectioning technology,as well as its new preparation suitable for clinical practice,and the establishment of its quality specification.Methods:(1)According to the physico-chemical properties of the active ingredients in Astragalus,chose eligible extraction method,and optimized the extraction process by orthogonal experiment.(2)According to nature of the excipients and the need for floating,appropriate excipients were chosen by single factor consideration,whose proportion is later optimized by orthogonal experiment.The desiccation time and pressure of the preparation were evaluated by vitro floatation performance.Then on the basis of the determined prescription and preparation technics,Huang Qi floating tablets were obtained by wet granulation,tabletting.(3)TLC qualitative distinction was used;the content determination of astragalosideⅣand astragalus polysaccharides were established through methodology investigation. (4)A new apparatus was used to evaluate vitro floatation performance,and the datas were simulated to equation,which could forecast the floationg time.Results:(1)Extraction process of Astragalus was determined:to extract with 12-time water for 3 times,each time for 1.5h.(2)The eligible dosage was:HPMC E50 16.5g/100 tablets,Na2CO3 3.3g/100 tablets,HEC 3.3g/100 tablets. The desiccation time was 24h.The pressure of the preparation was 3～5Kg.(3)Quality specification of Huang Qi floating tablets was established.The methodology consideration result indicated that:the precision,the stability,the reproduction quality and application of sample recovery rate can meet the requirement. (4)Curve regression for test data showed the change of buoyancy by time was logarithmic linear equation,which is significant.Floating time was 5～9 minutes by 95% confidence interval.Conclusion:Extraction process of each ingredients in a prescription was reasonable,the data was reliable;the confectioning process improved the vitro floatation performance.Huang Qi floating tablets conformed to regulations of the tablet item in 2005 edition of Chinese Pharmacopoeia.The experiment provided experiences for the preparation of floating tablets with TCM extraction.