目的 研究雾化器压力对双黄连吸入溶液（Shuanghuanglian inhalation solution，SHL-IS）体外雾化特性影响。方法 采用呼吸模拟器和新一代微粒撞击器，以SHL-IS为模型药物，通过测定雾化器不同压力雾化后的递送剂量均一性和空气动力学分布，将压力与递送剂量信息组和压力与粒径信息组进行相关性分析和多元线性回归分析。结果 压力与质量中值空气动力学粒径（mass median aero-dynamic diameter，MMAD）具有强负相关性，压力与微细粒子分数（fine particle fraction，FPF）、递送速率、递送总量和呼出总量有强正相关性，提取出相关性显著变量，建立回归模型，用于预测压力、FPF、MMAD、递送速率和递送总量。结论 雾化器压力对SHL-IS的体外雾化特性和临床疗效均有影响，建议严格雾化器标准并规范雾化器的使用。

Objective To study on the influence of atomizer pressure on the in vitro atomization characteristics of Shuanghuanglian inhalation solution (SHL-IS). Methods The uniformity of delivery dose and aerodynamic distribution of SHL-IS after atomization under different pressures were measured by a respiratory simulator and a new generation of particle impactor. The correlation analysis and multiple linear regression analysis between information groups of delivery dose and aerosol particle size was investigated. Results There was a strong negative correlation between pressure and mass median aero-dynamic diameter (MMAD) and a strong positive correlation between pressure and fine particle fraction (FPF), delivery rate, delivered amount and total outgoing amount. Significant variables of correlations were extracted and regression models were established to predict pressure, FPF, MMAD, delivery rate and delivered amount. Conclusion The atomizer pressure affects the in vitro atomization characteristics of the inhaled solution and its clinical efficacy. It is suggested that the atomizer standard should be strictly followed and the use of the atomizer should be standardized.

R283.6

广东省省级科技计划项目（2020A050515006）