| Objective: To study the quality control methods of clinical adverse reactions(allergic reactions)with Xueshuantong injection(lyophilized)from the aspects of chemical composition and cell bioactivity,and to establish a quality control method for the clinical adverse reactions(allergic reaction)Xueshuantong injection(lyophilized)clinical basis for clinical drug use and basis.Methods: 1 Xueshuantong injection(lyophilized)adverse reaction samples:use the method of not interfere with clinical medication,focused on monitoring method of multi center,hospital,discovery,Xueshuantong injection(lyophilized)the collection and evaluation of adverse reactions,to determine the normal samples and the adverse reaction of the samples,which laid the foundation for the further study.2 Xueshuantong injection(lyophilized)chemical component analysis: use the e UPLC method to establish Xueshuantong Injection(lyophilized)effective component fingerprint;use UPLC-TQ/MS technology to determine of Xueshuantong injection(lyophilized)chemical composition content information.3 Xueshuantong injection(lyophilized)resulted in the release rate of RBL-2H3 cell beta hexosaminidase of biological evaluation method:To establish an allergic evaluation model of RBL-2H3 cell;Among them,Compound 48/80 was positive drug,and the release rate of beta hexosaminidase as evaluation index;Determined the release rate of the beta hexosaminidase in samples and sample without adverse reactions.Results: 1 The adverse reactions of Xueshuantong(lyophilized)Injection.New adverse reactions: sweating,skin allergic purpura,eye bleeding,periorbital edema,weakness,chest pain,anxiety,hypotension,hypertension,numbness,tinnitus;The adverse reactions were found to involve multiple system damage,mainly manifested as allergic reactions.On the occurrence of adverse reactions were relevance evaluation and monitoring the 29 batch of Xueshuantong injection(lyophilized).Among them,the 9 batch of drugs is likely to produce adverse reactions of the sample,the 5 batch of samples may be adverse reactions,no adverse reactions in the sample of the 15 batches.2 The UPLC fingerprint of Xueshuantong injection(lyophilized)was established and 13 common peaks were identified.Among them,the similarity between the 20 batches of Xueshuantong injection(lyophilized)was more than 0.98;The contents of Sanqi saponins R1,ginsenoside Rg,ginsenoside Re,ginsenoside Rb1,ginsenoside,ginsenoside Rd and ginsenoside were determined in the samples of Xueshuantong injection.The results showed that there was no regularity between the samples and the samples with no adverse reaction,and there was no regularity between adverse reactions of samples and normal samples.3 RBL-2H3 degranulation method can be used in vitro to evaluate allergic reactions,95% confidence interval in the 5 mg group of normal 95% confidence interval [1.692,2.4277],95% confidence interval for adverse events [4.1371,6.2175];normal group in 1 mg group 95% Confidence interval [1.3844,2.1563],95% confidence interval for adverse events [3.774,4.899];95% confidence interval in the normal group of 100 μg group [0.6724,1.6107],95% confidence interval for adverse events [2.2487,3.6023];measured normal samples and abnormal samples were significantly differentConclusion: 1 The adverse reaction of Xueshuantong(lyophilized)is mild and can be recovered rapidly.The anaphylactoid reactions were the main adverse reactions.2 Xueshuantong(lyophilized)which has Sanqi saponins is complex,from several chemical components and the determination of the content of the total saponins of the Sanqi can not be a good control its safety.3 The evaluation method of RBL-2H3 cell beta-glucosidase release rate can be used to evaluate the safety of traditional Chinese medicine.4 Study on the biological evaluation method for Xueshuantong injection(lyophilized)clinical adverse reactions provide the basis.The RBL-2H3 method can evaluate the degranulation of anaphylactoid reaction in vitro,which can distinguish the adverse reactions of samples and normal samples. |
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