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目的本实验旨在建立一种检定铜绿假单胞菌注射液生物活性的体外实验方法和检定标准,用以替代目前具有局限性的动物抑瘤实验。方法研究中利用铜绿假单胞菌注射液有效成分PA-MSHA菌株的抗原性和促有丝分裂原性,将PA-MSHA在体外直接作用于BALB/c小鼠的脾细胞,通过MTT比色法检测其刺激小鼠脾细胞增殖的能力,以刺激指数(SI)作为指标,评价铜绿假单胞菌注射液的生物活性。通过对各项实验条件的摸索,建立了一套完整的实验体系,并对十批铜绿假单胞菌注射液成品进行了3次重复检测。结果检测结果显示,铜绿假单胞菌注射液稀释度为1∶200时,所有SI均大于2.0,且批间变异系数为0.039~0.052。结论该方法稳定性好,精密度高,而且具有操作简便,节约成本和时间等优点。通过对检测数据的统计分析,最终确定了铜绿假单胞菌注射液成品的检定合格标准。
Objective The purpose of this experiment is to establish an in vitro experimental method and assay standard for the determination of the biological activity of Pseudomonas aeruginosa injection, which can replace the currently limited animal antitumor experiment. In the study, the antigenicity and mitogenicity of PA-MSHA, the active ingredient of Pseudomonas aeruginosa injection, were used to study the effect of PA-MSHA on the splenocytes of BALB / c mice in vitro and MTT colorimetric assay Its ability to stimulate mouse spleen cell proliferation, the stimulation index (SI) as an indicator to evaluate the biological activity of Pseudomonas aeruginosa injection. Through the exploration of various experimental conditions, a complete set of experimental system was established, and three batches of Pseudomonas aeruginosa injections were tested repeatedly. Results The test results showed that when the dilution of Pseudomonas aeruginosa injection was 1: 200, all the SIs were greater than 2.0 and the coefficient of variation (CV) was between 0.039 and 0.052. Conclusion The method has good stability and high precision, and has the advantages of simple operation, cost saving and time saving. Through the statistical analysis of the test data, the qualified standard of the finished Pseudomonas aeruginosa injection product was finally determined.