Xinmai Capsule's Effect On The Treatment Of Hyperlipidemia And The Improvement Of Its Quality Standards

Xin Mai Capsule is being developed six categories of new drugs by Jiangsu Kanion Parmaceutical Co.,Ltd,which is clinical experience prescription from the Chinese medicine master Zhou Zhong-ying in the treatment of hyperlipidemia,composed of hawthorn,Ginkgo biloba,rhubarb,seaweed wine,and garlic.Patent number:ZL031322867.Solvent extraction was used to separate Xin Mai Capsule into different polar fractions.Mice hyperlipidemia model by intraperitoneal injection of 75%Egg Yolk Emulsion Method was use to screen the active site of Xin Mai Capsule.The fingerprints of the active site and the relevant fractions of its herbs were configured by HPLC analysis.The correlation was evaluated with retention time.Twenty-eight characteristic peaks were obtained in the fingerprint of active site in Xin Mai Capsule with good separation.The method was stable with great reproducibility.Twenty-seven characteristic peaks of HPLC fingerprint were confirmed to the three component herbs respectively.And on the basis of preliminary research about the analysis and identification of the composition of the capsule,to analysis the chemical components of the active site of Xin Mai Capsule by UPLC/Q-TOF-MS technology.The result showed that the main active chemical components were rhubarb anthraquinones compounds,Ginkgo biloba terpenes,flavonoids.In the meantime,23 fingerprint main peaks were identified.This study discussed the material basis for the efficacy of treating hyperlipidemia on Xin Mai Capsule,but also provided a theoretical basis for research on improving its quality standard.On the basis of the original quality standard of Xin Mai Capsule,in order to further improve the product quality control,the study combined with the analysis results of screening active site and the ingredients to increase the determination method of terpene lactones in another main herb Ginkgo biloba L.leaf.The method is accurate and feasible for proving an important reference value on quality standard promotion.Meantime a method for fingerprint determination of effective component in Xin Mai Capsule was established and the 16 main peaks were identified in order to control the intrinsic quality of the product more fully.In addition,this study established the quality control method of two main herbs hawthorn and Ginkgo biloba leaf in Xin Mai Capsule prescription,then compared active ingredient content and fingerprint similarity of different areas,batches of hawthorn and Ginkgo biloba leaves.The origin of the two herbs were confirmed to ensure the stability of product quality.