Shut Phellodendron Phellodendron Chinense Quality Standards

Cortex Phellodendri is derived from the plants of genus Phellodendron of Rutaceae family.The genus Phellodendron contains 4 species,2 species and 1 variety in which have found in China,which are P.amurense Rupr,P.chinense Schneid.and P.chinense Schneid.var.glabriusculum Schneid.The P.amurense Rupr.and the P. chinense Schneid.were once recorded in pharmacopoeia of P.R.China both as sources of Cortex Phellodendri.Because of the differences in content of the chemical composition,in Pharmacopoeia of P.R..China(2005 edition).P.amurense Rupr.was recorded as the source of Cortex Phellodendri Amurensis and P.chinense Schneid.was recored as the scourse of Cortex Phellodendri Chinensis.But as Traditional Chinese Medicine they are used in the same way in clinical application.Concerning the quality standard of Cortex Phellodendri Amurensis and Cortex Phellodendri Chinensis,the content of berberine is the only content mensuration evaluating indicator.In Pharmacopoeia of P.R.China(2005 edition),it's prescribed that the content of berberine can't be lower than 3%in Cortex Phellodendri Chinensis and can't be lower than 0.6%in Cortex Phellodendri Amurensis.At the same time,in the Pharmacopoeia the two commonly used processed products——'stir-baked Cortex Phellodendri with salt solution' and 'stir-baked Cortex Phellodendri' are listed but not be provided the content mensuration.The berberine is not only existed in Cortex Phellodendir but also in Rhizoma Coptidis,Radix Berberidis and Mahonia fortunei,etc.For berberine is not a characteristic composition in Cortex Phellodendri,as amending of 2010 edition of the Pharmacopoeia,the task was given that amending the content mensuration of Cortex Phellodendri Amurensis and Cortex Phellodendri Chinensis,and defining the standard of the processed products.As a part of this task,this study developed a more scientific and objective quality evaluation criteria of Cortex Phellodendri Amurensis and Cortex Phellodendri Chinensis, through the research on determination of active ingredients,standard limit and routine examination.In this dissertation,the following results were chieved.1.A HPLC method was established to determine the the content of jatrorrhizine, palmatine,berberine and obacunone in Cortex Phellodendri Amurensis and Cortex Phellodendri Chinensis,as well as in their processed products.According to the method validation,this new method have a good resolution and accuracy,can be used in the quality control of Cortex Phellodendri Amurensis,Cortex Phellodendri Chinensis and their processed products.2.The contents of jatrorrhizine,palmatine,berberine and obacunone in all the 95 samples,including Cortex Phellodendri Amurensis,Cortex Phellodendri Chinensis and their processed products,were determined.Through statistical analysis of the results,a more reasonable evaluation of the contents was provided.3.The contents of water,extractive,ash and acid-insoluble ash in all the 95 samples, including Cortex Phellodendri Amurensis,Cortex Phellodendri Chinensis and their processed products,were determined.Through statistical analysis of the results,the control standard was put forward and the quality standard was improved.4.Completed the drafting and the notes of drafting of the quality standard of Cortex Phellodendri Amurensis,Cortex Phellodendri Chinensis and their processed products...