基于微量量热法的连花清瘟胶囊质量一致性评价方法的建立

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目的考察连花清瘟胶囊(LQC)对绿脓杆菌Pseudomonas aeruginosa生长代谢的影响,建立评价LQC质量一致性的新方法。方法采用微量量热法测定不同质量浓度LQC对绿脓杆菌的生长代谢的影响,得到热谱曲线及相应的热动力学参数,如生长峰达峰时间(T)、生长期发热量(Q)、生长期最大发热功率(P)、生长期生长速率常数(k)等。以LQC质量浓度(C)为横坐标,T、P、Q、k为纵坐标进行回归分析,根据相关系数优选最佳参数,计算抑菌有效率(antibacterial effective rate,E)。以E作为评价LQC抗菌活性指标,分别检测11个批次市售LQC以及经特殊处理后的LQC样品对绿脓杆菌生长代谢的影响。结果 LQC质量浓度在10.00~47.68 mg/m L时对绿脓杆菌生长代谢具有明显的抑制作用,且具有质量浓度依赖性。通过回归分析得出的4个热动力学参数中,相关性最好的参数为T,r=0.990,其变化可以直观评价LQC对绿脓杆菌生长代谢的影响,且该参数稳定性较好,故选择指数生长期的T计算E。结果表明不同批次LQC样品E无明显差异,样品放于潮湿或高温环境中其E发生明显变化。结论该方法具有灵敏度高、重现性好的特点,可以区分不同质量LQC的抗菌生物活性,为LQC质量的一致性评价提供了一种参考方法,并为其他大复方中药制剂质量评价提供了参考依据和方法学借鉴。 Objective To investigate the effect of Lianhua Qingwen Capsule (LQC) on the growth and metabolism of Pseudomonas aeruginosa and to establish a new method to evaluate the consistency of LQC quality. Methods The effects of different concentrations of LQC on the growth and metabolism of Pseudomonas aeruginosa were determined by microcalorimetry. The thermograms and corresponding thermodynamic parameters were obtained, such as the peak growth time (T), the caloric value (Q) , Maximum heating power (P) in growth phase, growth rate constant (k) in growth phase and so on. Regression analysis was performed using LQC concentration (C) as abscissa and T, P, Q and K as ordinate, and the optimal parameters were optimized according to the correlation coefficients to calculate the antibacterial effective rate (E). Using E as an index for evaluating the antibacterial activity of LQC, the effect of LQC on 11 batches and LQC after special treatment on the growth and metabolism of Pseudomonas aeruginosa was examined. Results LQC concentration of 10.00 ~ 47.68 mg / m L on the growth and metabolism of Pseudomonas aeruginosa has a significant inhibitory effect, and has a concentration-dependent. Among the four thermodynamic parameters obtained by regression analysis, the best correlation coefficient was T, r = 0.990. The change of the parameters could directly evaluate the effect of LQC on the growth and metabolism of Pseudomonas aeruginosa, and the stability of this parameter was good. Therefore, the choice of index growth period T calculation. The results showed that there was no significant difference between different batch LQC samples E, and the samples had obvious changes of E in humid or high temperature environment. Conclusion The method has the characteristics of high sensitivity and good reproducibility, and can distinguish the antibacterial biological activity of LQC with different mass. It provides a reference method for the consistency assessment of LQC quality and provides a reference for the quality evaluation of other large Chinese herbal preparations. Basis and methodology learn from.
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