热毒宁吸入溶液中5种代表性成分递送速率递送总量的批间一致性

目的:对热毒宁吸入溶液中5个代表性成分新绿原酸、绿原酸、隐绿原酸、栀子苷、断氧化马钱苷的含量、递送速率及递送总量进行测定,考察热毒宁吸入溶液各批次间的一致性。方法:将10批热毒宁吸入溶液分别加入雾化杯中,将雾化杯连接呼吸模拟装置,采用BRS2000型呼吸模拟器装置,模拟成人呼吸模式,收集滤膜活性物质,结合高效液相色谱法测定5个代表性成分的含量,计算并比较10批热毒宁5个代表性成分的递送速率、递送总量及各批次间的一致性。结果:10批样品中5个化学成分的含量较为稳定,各成分含量的RSD均小于5%;10批样品递送速率的RSD较大,但均小于10%;递送总量的RSD均小于8%。结论:10批热毒宁吸入溶液具有较好的批间一致性,可为热毒宁吸入溶液的质量控制提供参考。

Inter-batch Consistency in Delivery Rate and Total Delivery Quantity of Five Representative Components from Reduning Inhalation Solution

Objective To investigate the inter-batch consistency of Reduning inhalation solution by determining the contents, delivery rates, and total delivery quantities of neochlorogenic acid, chlorogenic acid, cryptochlorogenic acid, geniposide, and secoxyloganin, five representative components in Reduning inhalation solution.Methods Ten batches of Reduning inhalation solution were separately added into the atomizing cup, which was connected to the BRS2000 respiratory simulator in the adult respiratory mode for collecting the active substances in the filter membrane. The contents of the five representative components were determined by high performance liquid chromatography (HPLC), followed by the calculation of their delivery rates and total delivery quantities and the analysis of the consistency between 10 batches of Reduning inhalation solution.Results Among the 10 batches of Reduning inhalation solution, the contents of the five chemical components were relatively stable, with the RSD of each component less than 5%. The RSD of the delivery rate of each batch was larger, still less than 10%. The RSD of the total delivery quantity was less than 8%.Conclusion The 10 batches of Reduning inhalation solution exhibited good inter-batch consistency, which has provided reference for the quality control of Reduning inhalation solution.