[Determination of the allergic impurities in the parenteral injection of Chinese traditional medicines containing Salvia miltiorrhiza].

The residual protein mixture (the content is 4%, approximately), called Salvia miltiorrhiza antigen, was extracted from the Salvia miltiorrhiza cruel materials by mimicking the alcohol-deposit extracts process. Both rabbits and guinea pigs sensitized by Salvia miltiorrhiza could produce specified antibodies. Large molecular antigenic impurities were extracted from the Danshen injection and Xiangdan injection using the centrifugal filtering method. The test results of active systemic anaphylaxis (ASA) and passive cutaneous anaphylaxis (PCA) in guinea pigs confirmed that the extracted antigenic impurities could induce the anaphylaxis reaction in the animals which were sensitized by the Salvia miltiorrhiza antigen. Using the specified antibody produced from rabbits which were sensitiyed by Salvia miltiorrhiza, ELISA test method was developed to test the residual Salvia miltiorrhiza antigenic materials contained in the parenteral Chinese traditional medicines. Calculated as residual protein, the linear range was 0.08-5.12 microg x mL(-1) (r2 = 0.9906), the detection limit and quantization limit are 0.08 microg x mL(-1) and 0.4 microg x mL(-1), respectively. 308 batches of parenteral Chinese traditional medicines containing water-soluable components of Salvia miltiorrhiza were tested, and the Salvia miltiorrhiza antigenic impurities were spotted in 35 (11.4%) batches of samples. The test results show that the extracting process currently used can not remove the Salvia miltiorrhiza antigenic impurities completely, and this may be one of the reasons for anaphylactic reaction in clinics. The proposed ELISA method can be used for improving the manufacture process and for routine quality control of drug products.