一种中药气雾剂新型抛射剂替代可行性研究  

Feasibility Study on Alternative of a New Propellant for Aerosol of Traditional Chinese Medicine

作　　者：陈志祥 董慧滋 张琼 丁江生 CHEN Zhixiang;DONG Huizi;ZHANG Qiong;DING Jiangsheng(College of Traditional Chinese Medicine,Yunnan University of Traditional Chinese Medicine,Kunming 650500,China;Preparation research room,Yunnan Institute of Materia Medica,Kunming 650500,China)

机构地区：[1]云南中医学院中药学院,云南昆明650500 [2]云南省药物研究所制剂研究室,云南昆明650110

出　　处：《中国民族民间医药》2019年第2期36-40,共5页Chinese Journal of Ethnomedicine and Ethnopharmacy

摘　　要：目的:以新型抛射剂反式-1,3,3,3-四氟丙-1-烯(HFO-1234ze (E))替代原有的氢氟碳化合物(HFCs)抛射剂,使替代后的气雾剂与替代前质量一致。方法:对可替代的抛射剂进行筛选,并以喷射速率、喷出总量、内压综合打分进行L_9(3~4)正交分析筛选抛射剂的适宜用量;采用压罐法按筛选的装量灌装气雾剂并对替代抛射剂后的气雾剂进行质量评价。结果:筛选出的最佳工艺条件为A_3B_2,即抛射剂的用量为20 g,配制液的用量为30 g。所生产的气雾剂产品的喷射速率、喷出总量、瓶内压与变更前一致,满足变更前后质量一致性的要求。结论:HFO-1234ze (E)抛射剂可用于气雾剂产品;变更抛射剂后的气雾剂产品质量稳定、安全、有效,与变更前气雾剂产品质量一致。Objective Replacing the original HFCs propellant with a new propellant trans-1,3,3,3-tetrafluoroprop-1-ene(HFO-1234ze(E))to replace the aerosol The agent has the same quality before replacement.Methods The alternative propellants were screened,and the appropriate amount of propellant was screened by L 9(3 4)orthogonal analysis based on the injection rate,total discharge volume,and internal pressure;the filling volume was selected by the pressure tank method according to the selected loading volume.Fog and quality evaluation of aerosols after replacement of propellants.Results The best process condition selected is A 3B 2,ie,the amount of propellant is 20 g,and the amount of preparation liquid is 30 g.The spray rate,total discharge volume,and bottle internal pressure of the produced aerosol product are the same as those before the change,and meet the requirements for consistency of quality before and after the change.Conclusion The HFO-1234ze(E)propellant can be used in aerosol products;the quality of the aerosol product after changing the propellant is stable,safe and effective,and is consistent with the quality of the aerosol product before the change.

关 键 词：抛射剂替代 HFO-1234ze(E) 质量评价 正交试验 

分 类 号：R285.5[医药卫生—中药学]