新型冠状病毒肺炎中药预防代煎剂稳定性研究  

Study on Stability of Chinese Medicinal Substitute Decoction for Preventing Coronavirus Disease 2019

作　　者：于兆海 王丽 董萍 殷瑞华 YU Zhaohai;WANG Li;DONG Ping;YIN Ruihua(West Coast New District People’s Hospital of Qingdao,Qingdao 266400,China)

机构地区：[1]青岛西海岸新区人民医院,山东青岛266400

出　　处：《山东中医药大学学报》2022年第4期533-538,共6页Journal of Shandong University of Traditional Chinese Medicine

摘　　要：目的:考察新型冠状病毒肺炎中药预防代煎剂在不同温度和时间下放置的稳定性,为中药防疫制剂的使用提供基础研究支撑。方法:根据山东省《冠状病毒肺炎密切接触者中医药预防方案(第二版)》制备中药预防代煎剂。处方药物采用自动煎药机代煎并封装成袋,考察其在冷冻(-18℃)、冷藏(4℃)、常温(20℃)以及高温(30℃)四组条件下,避光放置最长28 d下多个时间段的黄芩苷、沉淀量、微生物限量以及pH值的变化。结果:在四组条件下,黄芩苷含量均未发生变化,而沉淀量从第7天时均显著增高(P<0.05,P<0.01),以冷冻组最高。微生物限量不合格出现在第28天的常温组和高温组。高温组pH值的变化最大,第7天明显降低(P<0.05),常温组在第21天、冷藏组在第28天pH值才降低(P<0.05),冷冻组pH值则没有显著变化。结论:中药预防代煎剂的最佳保存条件是4℃冷藏,最长保存时间是21 d,常温条件下最长保存14 d,但不宜置于冷冻和高温条件下保存。Objective:To investigate the stability of Chinese medicinal substitute decoction for preventing coronavirus disease 2019(COVID-19)in different storage temperatures and time,and provide basic support for the use of anti-epidemic preparation of traditional Chinese medicine(TCM).Methods:The Chinese medicinal substitute decoction were prepared according to Traditional Chinese Medicine Prevention Program for Close Contacts of COVID-19(Second Edition)in Shandong Province.The prescribed medicines were decocted by an automatic decoction machine and packaged into bags.Under the four conditions of freezing(-18℃),refrigeration(4℃),normal temperature(20℃)and high temperature(30℃),placed out of the sun for maximum 28 d,baicalin,precipitation amount,microbial limit and pH value were investigated in multiple time periods.Results:In the four groups,the content of baicalin did not change while the precipitation amount increased significantly from the 7th day(P<0.05,P<0.01),especially in freezing group.The unqualified microbial limit appeared in the normal temperature and high temperature groups on the 28th day.The greatest influence on pH value was the high temperature group and the pH value decreased significantly from the 7th day(P<0.05).The pH value of the normal temperature group decreased on the 21st day and the refrigerated group on the 28th day(P<0.05)while there was no significant effect on pH value in the freezing group.Conclusions:The best storage conditions for Chinese medicinal substitute decoction are refrigerated at 4℃,and the longest storage day is 21 d.It can be stored for up to 14 days under normal temperature conditions,but should not be stored under freezing and high temperature conditions.

关 键 词：新型冠状病毒肺炎 中药预防代煎剂 黄芩苷 温度 时间 PH值 微生物限量 稳定性 

分 类 号：R289.5[医药卫生—方剂学]