基于Microtox技术的银杏内酯注射液质量控制初步研究

Microtox assay for the quality control of Ginkgolide Injections

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 how microtox assay is applied to the quality control of Ginkgolide injections. Methods： Based on the optimal detection system of microtox assay for TCM injections established by our laboratory and freshly prepared Vibrio fischeri,we evaluated the luminous biological effect and the quality control of 7 batches of Ginkgolide injections and their vehicle. Results： The luminescence intensity of Vibrio fischeri decreased with the time prolonged,then tended to be stable state from 15 to 60 minutes. IC50 values of 3 batches of ginkgolide vehicles were：（ 5. 60 ± 0. 39） %,（ 5. 42 ± 0. 22） %,（ 5. 59 ± 0. 10） % respectively,there was no significant difference among these batches（ P〈0. 05）. IC50 values of 7 batches of ginkgolide injections 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） %,（ 1. 39 ± 0. 11） % respectively,differences were significant comparing Batch 0815808 with other 6 batches（ P〈0. 05 or 0. 01）; differences among Batch 0816310,0815807,0815806 and Batch 0815701 were obviously（ P〈0. 05 or 0.01,table1）. Conclusion： There is a significant concentration-effect relationship of ginkgolide injections,and IC50 values of some batches are significant different. Our data suggested that microtox assay could be applied to not only the biological effect of ginkgolide injections,but also the quality control of medicine products.