This paper was aimed to establish a new method for evaluating the
anaphylactoid reaction of 15 batches of Zushima Injection from different manufacturers in vitro. Basophilic
leukemia cell line RBL-2 H3 cells were cultured in vitro and
Compound 48/80 was selected as positive
drug. Real-time cell analysis(RTCA) system was used to detect the changes of cell index(CI) value after
drug intervention. The degranulation of RBL-2 H3 cells was verified with the
toluidine blue staining technology by observing the changes of cell morphology and skeleton. Clustering method was used to analyze the CI values of 15 batches of Zushima Injection on RBL-2 H3 cells. The results showed
Compound 48/80(20 μg·mL~(-1)) significantly changed the cell morphology and cytoskeleton, with obvious degranulation. After adding
Compound 48/80, CI value decreased rapidly within 30 minutes, then decreased slowly, suggesting that RTCA system can be used for rapid and sensitive evaluation of RBL-2 H3 cell degranulation. The results of cluster analysis showed that Zushima Injection from different manufacturers had different effects on RBL-2 H3 cells. S1-S8 and
Compound 48/80 groups were grouped into one cluster, which suggesting that the sample might have potential clinical
anaphylaxis. S9-S15 and the normal control group were grouped into one cluster, suggesting there was no
anaphylactoid reaction in the sample. In this study, a rapid in vitro
anaphylaxis evaluation technique based on RTCA system and pattern recognition method was established, which can be used for rapid in vitro evaluation of
anaphylaxis for
traditional Chinese medicine injection.