The Research Report On The Quality Standard For Raw Medicine And Intermediates Of Kangai Injection

Kangai injection is a traditional anti-cancer injection which made from Ginseng,,Astragalus and Flavescens as the main raw materials.Kangai injection has inhibiting tumor growh,and can protect and even enhance the immune function of the body during radiotherapy and chemotherapy.This subject comes from National standardization project of traditional Chinese Medicine of Changbai Mountain company——The quality.standard of Kangai preparation(ZYBZH-C-JL-23.In order to control the quality and insure the security and effeciency of Kangai injection,we studied the quality standard of raw medicine—Ginseng Pieces,Astragalus Pieces and intermdiate-Ginseng Extract?Astragalus Extract of Kangai injection in production.First of all,according to the requirements of the first part of the 2015 edition of the Chinese Pharmacopoeia,the following researches are focus on Ginseng Pieces and Astragalus Pieces in production of Kangai injection:1 Different batches of Ginseng Pieces and Astragalus Pieces have been identified by using thin-layer chromatography(TLC)Just as standard products,the samples showed the same stripe at the same location on the silica gel plate and the degree of separation was better by using above method.2 And established the examination of Ginseng Pieces and easily mixed herhs.3.Detection method for moisture has been established,according to the results,formulate the moisture of Ginseng Pieces should be not less than 12%;the moisture of Astragalus Pieces has moisture should be not less than 9%.4 In the production of Kangai injection,the content of Ginseng Pieces and Astragalus Pieces have been determined:This product is calculated according to the dry product,the total content of ginsenoside Rgi and ginsenoside Re in the Ginseng Pieces was 0.33?0.81%,and the content of ginsenoside Rbi ranges from 0.21 to 0.72;the content of astragaloside ?was 0.05?0.20%and the content of calycosin was 0.031?0.056%.5 The fingerprints of Ginseng Pieces and Astragalus Pieces have been established by HPLC,determined the characteristic chromatographic peak of Ginseng Pieces:ginsenosideRgi,ginsenoside Re,ginsenoside Rf,ginsenoside Rbi,ginsenoside Rc,ginsenoside Rb2ginsenoside Rd;determined the characteristic chromatographic peak of Ginseng pieces:calycosin-7-O-?-D-glucoside,Formononetin-7-O-?-D-glucoside,9,10-Dimethoxyptrcarpan-3-O-?-D-glucosid e,2'-Dihydroxy-3',4'-dimethoxyisoflavan-7-O-Beta-D-glucoside,Formononetin.Secondly,the paper based on the quality control of the production of Kangai injection,the following studies were conducted on Ginseng Extract and Astragalus Extract:1 The detection of total solids content:the total solid content of Ginseng Extract was 478.03?672.19 mg/mL,and the total solid content of Astragalus Extract was 402.57?777.3 mg/mL.2 In the production of Kangai injection,the content of intermediates have been determined by HPLC:the total content of ginsenoside Rgi and ginsenoside Re is in the range of 13.07?34.16 mg/mL;the range of astragaloside IV was 0.30-0.66 mg/mL.3 The fingerprints of Ginseng Extract and Astragalus Extract have been established,the result showed that this method was stable and feasible,and provided scientific basis for the control and evaluation of Kangai injection in production.This report is based on the results of a series of research on the main raw material in the production of Kangai injection.It will improve the control and supervision of the source of Kangai injection.The key research results of Ginseng Extract and Astragalus Extract have been applying in production and guiding significance for ensure the stability and effectiveness of Kangai preparations.