Study On Biological Toxicity Evaluation And Quality Control Of Traditional Chinese Medicine Injection

The present research studied the new in vitro and ex vivo biological activity evaluation method, especially microtox biological toxicity test technology and its application. Established a toxicity test for bacteria toxicity evaluation method in vibrio fischeri phhotobacteria. And applied the new method to test the comprehensive toxicity of tiaditional Chinese medicine injection and used to assist in the quality control of traditional Chinese medicine injection, it can make a role model foe Bioassay method used in traditional Chinese medicine injection’s quality control. At the same time, based on the traditional Chinese medicine injection (safflower injection) antigenic impurities and the quality control of research, explore the relationship with the occurrence of adverse reactions of TCM injection, provides a basis for improving the quality standard of traditional Chinese medicine injections.1. Establishment of Luminescent Bacteria Toxicity Assessment and in Houttuynia cordata injection, safflower injection toxicity evaluation.This research has established a luminescent bacteria of biological toxicity evaluation which used fischeri bacteria. System optimum detection time is 15min, light intensity of optimal 15min is 500-1000, the optimal pH is 5.0-9.0,and the experiments show that under this system, repeatability and intermediate precision was good, the relative deviation of<15%. Evaluation of the use of luminescent bacteria for biological toxicity method proposed in this paper, Some products were determined the biological toxicity which include 10 batches of Houttuynia cordata injection products from A factory,3 batches of Houttuynia cordata injection semi-finished products,2 batches with Houttuynia cordata injection solvent from A factory,10 batches of ethylene plant of Herba Houttuyniae Injection products as well as the 10 batches of safflower injection (safflower injection clinical positive samples the adverse reaction of the sample) and 10 batches of safflower injection of negative samples (i.e.no adverse reaction of safflower injection in clinical samples) toxicity, found that the comprehensive toxicity are very different from the various manufacturers, as well as each batch of samples, the safflower injection samples positive for EC50 were lower than those safflower injection of negative samples, and has significant difference.2. Research of the antigen-active of impurities Safflower injection and quality controlThis research based on the protein content determination about 10 batches of clinical adverse reactions of safflower injection sample (i.e. positive samples) and no adverse reaction of safflower injection samples and 10 clinical (i.e. negative samples), positive samples were found positive protein content was higher than that of negative samples. Based on the research,we imitated the process of the "water extraction and alcohol precipitation" which used to prepare the safflower injection, prepare the highly heterogeneous safflower residue protein mixture from safflower, as safflower antigen. Using ultrafiltration method to separate macromolecular antigen activity impurities and small molecular antigenic impurities from safflower injection. Use active allergic reaction model in guinea pigs (ASA) and passive cutaneous anaphylaxis (PCA) model in rat, the results show the extracted antigenic impurities may cause the hypersensitivity which caused by anaphylaxis of safflower injection or safflower antigen. The result of this research shous that Safflower (safflower residue protein mixture) may be one of the causes of clinical allergic reaction, so we suggested that existing inspection standards for protein detection should changed from qualitative to quantitative detection detection.