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目的:探索Microtox技术应用于银杏内酯注射液质量控制检测。方法:参照本实验室建立的中药注射剂微毒测试技术平台和方法,首次以新鲜培养的费氏弧菌为测试菌种,对7个不同批次银杏内酯注射液及其溶媒进行发光生物效应检测和生物质量控制研究。结果:费氏弧菌发光强度随着时间变化呈现先降低后稳定的特点,在平衡后的15min~60min处于相对平稳状态。银杏内酯注射液溶媒3个批次的IC_(50)值分别为(5.60±0.39)%,(5.42±0.22)%,(5.59±0.10)%,各批次比较差异无显著意义,银杏内酯注射液7个批次的IC_(50)值分别为(2.25±0.46)%,(3.77±0.65)%,(3.56±0.55)%,(2.49±0.40)%,(2.73±0.30)%,(2.95±0.55)%,(1.39±0.11)%,不同批次比较统计差异有显著意义。结论:银杏内酯注射液对费氏弧菌的发光效应存在显著的浓度-效应关系,部分批次之间IC_(50)值具有显著性差异,提示Microtox技术不仅可以用于检测银杏内酯注射液综合生物效应大小,同时对于产品质量控制也有很好的应用前景。
Objective: To explore the application of Microtox technology in the quality control test of ginkgolide injection. Methods: With reference to the platform and method for testing microtoxin in traditional Chinese medicine injection established in our laboratory, the freshly-cultured Vibrio fischeri was used as the test strain for the first time. Seven different batches of ginkgolide injection and its vehicle were irradiated with bio-effect Testing and Biological Quality Control. Results: The luminous intensity of Vibrio fischeri decreased first and then stabilized with time, and remained relatively stable at 15min ~ 60min after the equilibration. The IC50 values of three batches of ginkgolide injection solution were (5.60 ± 0.39)%, (5.42 ± 0.22)% and (5.59 ± 0.10)%, respectively. There was no significant difference between the batches The IC 50 values of the seven batches of ester injection were (2.25 ± 0.46)%, (3.77 ± 0.65)%, (3.56 ± 0.55)%, (2.49 ± 0.40)%, (2.73 ± 0.30)%, (2.95 ± 0.55)% and (1.39 ± 0.11)%, respectively. There was significant difference between different batches in statistics. CONCLUSION: Ginkgolide injection has a significant concentration-effect relationship with the luminescence of V. fischeri. The IC 50 value of some batches has a significant difference, suggesting that Microtox can not only be used to detect ginkgolides Liquid biological effect of the size of the same time, for product quality control also has good prospects.