Study on the Preparation and the Quality Standards in Naotai Tablets
|School||Hunan University of Traditional Chinese Medicine|
|Keywords||Preparation Process Orthogonal design Alcohol precipitation Separate drying Mixed dry Quality standards|
Objective: To study brain Thai film preparation process and quality standards , on the basis of the preparation and quality control for the treatment of cardiovascular and cerebrovascular diseases preparing a new film coating formulations . Methods : analysis and extraction route filtering through prescription , to determine the extraction process route to tetramethylpyrazine , ferulic acid , the total amount of flavonoids leaching indicators preferred influence leaching factors ; compared by single factor , total flavonoids retention rate indicators , preferably alcohol precipitation process conditions ; comparative experiments investigated alcohol extract separate drying and mixing and drying , and vacuum drying under different temperature conditions tetramethylpyrazine and ferulic acid content ; disintegration indicators , combined with the pelleting process tabletting process parameters, preferred brain Thai piece molding process conditions ; to do qualitative identification using thin layer chromatography ; content was determined by high performance liquid chromatography (HPLC) , and methodological study . Results: Chuanxiong extracted with ethanol , the astragalus , A, B , water extraction . Alcohol extract optimum conditions were : 40% ethanol , heated to reflux extracted two times , plus the amount of alcohol , respectively, to 10,8 times , extraction time were 2,1.5 hours . Water extraction , the optimum conditions of : extracting 3 times, water addition was 10 times that of herbs , eight times , eight times , and extraction time were 2.0 hours , 1.5 hours , 1.5 hours . Reminder water extracting solution was concentrated to a relative density of 1.20 , adding 95 % ethanol , so that liquid containing an alcohol content of 60% , after standing for 24 hours , filtered , and dried with the alcohol extract solution was vacuum 70 ° C mixed . Molding process conditions : drug fine powder : lactose: soluble starch = 14:3:3,3 % PVP ( K30 ) , 95 % ethanol solution as a binder , 0.5% micronized silica gel as a glidant , and 1 % of stearic acid magnesium as a lubricant . Astragalus, Chuanxiong The TLC of negative interference , A and B, TLC of the double negative interference , tetramethylpyrazine and ferulic acid determination method is feasible and reproducible . Conclusion : The preparation process is feasible , reliable and quality standards , and can be used in industrial production .