To establish a quality standard for Reduning Inhalation Powder Mist.Methods:The preparation process for Reduning Inhalation Powder Mist was optimized through experiments.The contents of chlorogenic acid,gardenoside,and artemisinin in Reduning Inhalation Powder Mist were determined by high performance liquid chromatography(HPLC).The particle size distribution of Reduning Inhalation Powder Mist was determined using a laser particle size analyzer,and a quality standard for Reduning Inhalation Powder Mist was established in accordance with the requirements of the pharmacopoeia and relevant regulations.Results:A toal of 15 g of Flos Lonicerae and 12 g of Herba Artemisiae Annuae were extracted in three times the volume of water solution for six hours to obtain the optimal amount of volatile oil.Under the conditions of six times the volume of water,pH of 2.5,and extraction time of 240 min,the optimal yield of chlorogenic acid and extract could be obtained.Under the conditions of ethanol concentration of 70%,extraction time of 180 min,and addition ratio of six times,the optimal alcohol extraction rate of Gardenia jasminoides was obtained.The spray drying was carried out under the conditions of temperature at 80 ℃,wind speed at 600 L/h,and dosage of 3 mL/min.It was found that the optimal condition was when the ethanol content was 60%,the volume percentage of particle size distribution in the range of 1 to 5 μm was 67.6%.The powder yield was 71.2%.The spray powder was stored at 25 ℃ for one month and three months.The degradation of the drug was 0.25% and 2.13%,and the moisture increase was 0.02% and 0.05%,respectively.There was no obvious change in the conditions of no light and normal light.The content of chlorogenic acid,artemisinin,and gardenoside in Redunng Spaying and Inhalation Powder Mist shall not be less than 5.0%,3.2%,and 6.8% respectively.The total colony count in Redunng Spaying and Inhalation Powder Mist was less than 1 000 cfu/g.The fungi and yeast were less than 100 cfu/g,and Escherichia coli was not detected.Conclusion:The optimized process is reliable,and the precision,accuracy,and repeatability of content determination all meet the methodological requirements,which can be used for the production and quality control of Reduning Inhalation Powder Mist.