热毒宁吸入粉雾剂的制备与质量标准研究  

Preparation and Quality Standards of Reduning Inhalation Powder Mist

作　　者：房玉良 霍雨佳 刘博 许彦来 FANG Yuliang;HUO Yujia;LIU Bo;XU Yanlai(Graduate School of Qingdao University,Qingdao 266003,China;Department of Traditional Chinese Medicine,Navy Qingdao Special Service Recuperation Center,Qingdao 266000,China;Department of Pharmacy,Qingdao Central Hospital,Qingdao 266000,China)

机构地区：[1]青岛大学研究生院,青岛266003 [2]海军青岛特勤疗养中心中医科,青岛266000 [3]青岛市中心医院药剂科,青岛266000

出　　处：《世界中医药》2024年第4期464-468,共5页World Chinese Medicine

基　　金：全军中医药服务能力培育与提升专项计划面上项目(2021ZY017)。

摘　　要：目的:建立热毒宁吸入粉雾剂的质量标准。方法:通过实验对热毒宁吸入粉雾剂进行制备工艺优化,采用高效液相色谱法(HPLC)测定热毒宁吸入粉雾剂中绿原酸、栀子苷和青蒿素的含量。运用激光粒度仪测定热毒宁吸入粉雾剂的粉末粒径分布,结合药典和相关法规的要求,制定热毒宁吸入粉雾剂的质量标准。结果:15 g金银花和12 g青蒿在3倍体积的水中提取6 h,可以获得最佳的挥发油提取量,在6倍水体积,pH=2.5的条件下,提取240 min可以获得最优的绿原酸和浸膏得率。在乙醇浓度为70%,提取时间180 min, 6倍加液条件下,获得最佳的栀子醇提物得率。在温度80℃、风速600 L/h,进药量3 mL/min的条件下进行喷雾干燥,发现乙醇含量为60%时为最优条件,其粒径分布在1~5μm的体积百分数为67.6%,且得粉率为71.2%。喷雾微粉在25℃条件下储存1个月和3个月,药物分别降解0.25%和2.13%,水分分别增加0.02%和0.05%,且在避光和正常光照条件下无明显变化。热毒宁喷吸入雾剂中绿原酸含量不低于5.0%、青蒿素含量不低于3.2%、栀子苷含量不低于6.8%。热毒宁喷吸入雾剂中总菌落数低于1 000 cfu/g,真菌和酵母低于100 cfu/g,未检出大肠杆菌。结论:该优化后工艺可靠,含量测定的精密度、准确性、重复性均符合方法学要求,可用于热毒宁吸入粉雾剂的生产和质量控制。Objective: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 5μm 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 1000 cfu/g.The fungi and yeast were less than 100 cfu/g,and Escherichia coli was not

关 键 词：热毒宁吸入粉雾剂 质量标准 绿原酸 栀子苷 青蒿素 高相液相色谱法 

分 类 号：R286.0[医药卫生—中药学]