凝乳酶效价测定方法研究

发布时间：2018-06-17 11:29

本文选题：凝乳酶 + 效价　；参考：《中国生化药物杂志》2015年10期

【摘要】：目的考察凝乳酶效价测定方法的影响因素,改进凝乳酶效价测定方法;考察凝乳酶国家标准品稳定性、适用性。方法考察不同奶粉底物和酶浓度对凝乳酶效价测定的影响;建立3×3量反应平行线法,并对多批样品进行测定,结果与绝对法、单点相对法进行比较;使用绝对法和统计分析对凝乳酶标准品稳定性进行考察;通过量反应平行线法考察凝乳酶标准品的适用性。结果不同奶粉底物对绝对效价的测定有显著性影响;酶浓度与凝乳时间呈幂函数关系;与绝对效价比较,相对效价在不同实验室间结果重现性更好;3×3量反应平行线法测定剂量为0.35、0.44、0.55 U/m L,可信限率小于5%;凝乳酶国家标准品(140712-201302)2015年效价测定结果与2013年结果无统计学意义;在一定剂量范围内,凝乳酶国家标准品与复合凝乳酶或羔羊胃提取物的剂量-反应呈直线关系,2直线平行。结论凝乳酶效价测定影响因素多,通过标准品测定相对效价可以消除不同底物、不同人员操作、终点判断等因素对测定的影响,使实验室之间结果具有可比性;3×3量反应平行线法的实验设计可以更好的控制实验误差;凝乳酶国家标准品(140712-201302)稳定性良好,适用于复合凝乳酶和羔羊胃提取物的凝乳效价测定。
[Abstract]:Objective to investigate the factors influencing the determination of the titer of coagulase, to improve the method of determination of the titer of coagulase, and to investigate the stability and applicability of the national standard of coagulase. Methods the effect of different milk powder substrate and enzyme concentration on the determination of the titer of condensate enzyme was investigated, 3 脳 3 reaction parallel line method was established, and many batches of samples were determined. The results were compared with absolute method and single point relative method. Absolute method and statistical analysis were used to investigate the stability of curd standard and the applicability of curd standard was investigated by parallel line method of throughput reaction. Results different milk powder substrates had significant influence on the determination of absolute titer, the relationship between enzyme concentration and curd time was power function, and compared with absolute titer, The reproducibility of the relative titer in different laboratories was better. The dose measured by the parallel line method of 3 脳 3 dose reaction was 0.35 渭 m / L, the confidence limit was less than 5%, the national standard of condensate enzyme was 140712-201302) the results of 2015 titer were not statistically significant compared with the results of 2013. In a certain range of dosages, the national standard of clotting enzyme is parallel to the dose-response of compound coagulase or lamb gastric extract in a straight line. Conclusion there are many factors influencing the determination of the titer of coagulase, and the influence of different substrates, different operators, and terminal point judgment can be eliminated by the determination of relative titer of coagulase. The experimental design of parallel line method of 3 脳 3 dose reaction between laboratories can better control the experimental error, and the national standard of clotting enzyme (No. 140712-201302) has good stability, which is suitable for the determination of the titer of condensed milk with compound coagulase and lamb stomach extract.
【作者单位】：中国食品药品检定研究院;
【分类号】：R392-33

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