含丹参的中药注射液中过敏性杂质的检测_胡昌勤.pdf

518 Acta Pharm aceutica Sin ica 2008, 43( 5): 518- 522 1* 1 1 1, 2 1 1 1 胡昌勤 , 许明哲, 马 越, 于风平 , 李 进, 王 晨, 崔生辉 ( 1. , 100050; 2. , 255000) : , ( 4% ) , ; (ASA) ( PCA) , , ( ELISA ); , 008~ 512 - 1 2 - 1 - 1 g mL (r = 0990 6), 008g mL 04 g mL 308 , 35( 114% ) ; , ELISA , : ; ; ; ; : R917 : A : 0513- 4870(2008) 05- 0518- 05 D eterm ination of the allergic impurities in the parenteral injection of Chinese traditional m edicines containing Sa lvia m iltiorrh iza 1* 1 1 1, 2 HU Chang-qin , XU M ing-zhe, MA Yue, YU Feng-ping , 1 1 1 LI Jin , WANG Chen , CUI Sheng-hui (1. N a tional Institutef or the Control of Pharm aceutical and B iolog ical P roducts, B eij ing 100050, China; 2. Z i o Institute of D rug Control, Z i o 255000, China) Abs tract: he residual protein m ixture ( the content is 4% , approxmi ately ), called Salvia m iltiorrhiza antigen, was extracted from the Salvia m iltiorrhiza cruel materials by m mi icking the alcohol- deposit extracts process. Both rabbits and guinea pigs sensitized by Salvia m iltiorrhiza could produce specified antibodies. Large molecular antigenic mi puritieswere extracted from the D anshen injection and X iangdan injection using the centrifugal filtering method. he test results of active system ic anaphylaxis (ASA) and passive cutaneous anaphylaxis ( PCA) in guinea pigs confirmed that the extracted antigenic mi purities could induce the anaphylaxis reaction in the anmi als wh