Study On The Quality Standard For Shuxiong Tablet

ObjectivesWith the acceleration of the rhythm of people's lives and increasing work pressure,the amount of the patients with cardiovascular diseases in our country is rising.Shuxiong tablet which is included in the Chp 2015 of The first part of Traditional Chinese Medicine(TCM)preparations.Shuxiong tablet is composed of Radix Notogingseng(100g),Flos Carthami(100g),Rhizoma Chuanxiong(200g),the effect of which is to promote blood circulation,remove blood stasis,free network vessels and stop pain.The clinical application of Shuxiong tablet is chest stuffiness and pains,coronary heart disease and angina pectoris.As one of the most common proprietary Chinese medicine treatment,Shuxiong tablet has a good prospect.In recent years,traditional Chinese medicine safety incidents have repeatedly broke out,the Chinese medicine safety issues pushed on the cusp,such as in the year of 2015,poor quality Cork,Puhuang,Corydalis and other Chinese herbal medicines were found using illegal dyeing industrial amine O.The effectiveness and safety of traditional Chinese medicine is particularly important to the people's livelihood.the current quality standards of Shuxiong chest radiographs included in "the China Pharmacopoeia" 2015 edition(a)still exist shortcomings: Firstly,the current standard only contains thin layer identification method of the Panax,safflower and the determination method of the content of indicator components of Panax notoginseng,the method of measuring the content of the Chuanxiong and the Safflower is still missing.Secondly,the tablet contains the original powder of pseudo-ginseng,however,there exist no method of safety control of pesticide residues and heavy metals and harmful elements currently.Thirdly,safflower is an expensive Chinese medicine,some may illegally dye,however,the current standard did not establish a corresponding inspection methods to detect illegal dyeiny.Methods:1.The research for determination method of multicomponent content,the CAPCELL PAK MG(250nm×4.6nm,5um)was used.The mobile phase,consisting of acetonitrile-0.05%phosphoricacid solution,was programmed for a gradient elution.To establish a method for the determination of hydrosafflower yellow A,ferulic acid,ginsenoside Rg,ginsenoside Rb1,ginsenoside Re,and notoginsenoside R,in Shuxiong tablets.2.The research for adulteration dye in Shuxiong tablets: establish detection methods of the adulteration dye with TLC,HPLC,and HPLC-MS were used for verification.3.The research for pesticide residues and heavy metals and harmful element in Shuxiong tablets: establish detection methods of pesticide residues with GC-MS-MS.A simultaneous determination method of 5 heavy metals,in Shuxiong tablets by ICP-MS combined with microwave digestion was established.Results1.The method for the content determination of Shuxiong tablets is established.2.The method for detection methods of the adulteration dye is developed,which makes up the blank of determination method about adulteration dye in Shuxiong tablets.3.The method for pesticide residues and heavy metals and harmful element in Shuxiong tablets is developed,which filled the void of detection methods about pesticide residues and heavy metals and harmful element in Shuxiong tablets.