Studies On Preparation Technology And Quality Standard Of Anti-rheumatoidarthritis Effective Parts From Caulophyllum Robustum

Caulophyllum robustum Maxim belongs to the family of Berberidaceae.The officinal part of the plant was roots and rhizome which can cultivated.The herb is a folk medicine that has been utilized widely to cure many diseases such as rheumatoid arthritis,bellyache fracture injuries and menstruate disorder etc.due to its strong and wide biological activities.In order to better explore the medicinal value of Caulophyllum robustum Maxim as a new anti-rheumatoid arthritis drug,the topic on extraction technology?purification technology and quality standards of effective site have been studied.The research was aimed to explore new anti-RA drug with well-defined ingredient and high efficiency.Specific methods and results are as follows:1 We set the limitation of saponin content through UV analysis,using Cauloside C as analysis subject.The minimum of saponin content was 5.3%.Refer to Chinese Pharmacopoeia under the 2010 version of an appendix IX methodologies,water was not more than 12%,total ash was not more than 6%and acid insoluble ash should not exceed 2%.Based on the investigation to the 3 batches of medicinal materials,medicinal quality standard has been preliminarily established.2 The extraction process was screened by combination of single factor experiments and orthogonal design.The optimal extraction process was as fllows:The herb was soaked in 70%ethanol for two hours with two extraction.AB-8 macroporous resin was selected to be the suitable resin by dynamic adsorption and desorption test.The final purification process was optimized by orthogonal design using the combination of content on saponin and 6 index components as composite index.After concentrating to 1.0 mg·mL-1,the extract was loaded to macroporous resin column in the speed of 2 BV·h-1.After 4 h of adsorption,the column was eluted with water for 4BV,70%ethanol for 5 BV in the speed of 3 BV·h-1.The elute of 70%ethanol was dried then yielded intermediate.3 3 batches of intermediate were prepared by using the selected process.The quality of intermediate can be measured by the total saponin.Through the analysis of different batches,content limitation of tatal saponin was formulated as 41.64%.Content determinition of 6 index components in effective parts was selected by HPLC-UV method,HPLC-ELSD method and more than one test evaluation.Because of the saponins for end absorption in the UV detector,content of index components is low in HPLC-UV method.More than one test evaluation method is suitable for using in case of lack of reference.Content determinition of index components was selected by HPLC-ELSD.The quality of intermediate can be measured by Cauloside H.Leonticin D?Cauloside G?Cauloside D?Cauloside B and Cauloside C.Through the analysis of 3 batches,content limitation of them were formulated as 4.35%,3.60%,20.22%,7.13%,2.58%,1.58%.The effective parts of the TCL and inspection was Studied.Water was not more than 5%,residue on ignition was not more than 6%.Above-mentioned study and the results lay tne foundation on further development and utilization of the effective parts for the new drug innovation.