T/TPPA 0001-2022 Evaluating Allergic Reactions of Chinese Herbal Injection by RBL-2H3 Degranulation Method: Operating Procedures

Scope

Main technical content: The technical content of this document includes the inspection principles, experimental reagents, instruments, cell lines, and key technical indicators for operations such as reagent preparation, drug solution preparation, etc. The main content includes cell culture, subculturing, growth curve determination, and the detection of degranulation and biological active substances such as histamine and β-glucosidase release rate. Specifically, it includes the detection of mast cell degranulation by staining methods (neutral red staining and toluidine blue staining), histamine, and β-glucosidase release rate, as well as statistical analysis of the data. The content of this document also includes the statistical analysis and processing of data. For each test group, the degranulation of RBL-2H3 cells and the release rate of histamine and β-glucosidase in each test group were compared with the negative PBS control group. If the comparison results between groups were P > 0.05, it indicated that the drug did not pose an allergy risk. If any comparison results of degranulation rate, histamine release rate, or β-glucosidase release rate were P < 0.05, it indicated that there was a significant difference compared with the PBS control group, indicating that the drug tested in this group posed an allergy risk. This document also stipulates the concentration range of the positive drug C48/80 in the test method, its reproducibility, precision, and the linear relationship between the allergenicity of the positive drug. It also specifies the details that should be considered when implementing this document.

Development Information

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