摘要
目的:制备复方异丙嗪栓,并评价其质量。方法:采用热熔法制备复方异丙嗪栓,以栓剂溶出度作为指标考察6种不同栓剂基质,筛选最优基质并制备栓剂。按中国药典2015年版第四部栓剂项下规定检查其性状外观、重量差异和融变时限等指标,建立HPLC法测定盐酸异丙嗪、咖啡因的含量。结果:SUPPOCIRE BS2X PELLETS为最优基质,以此基质制备的栓剂为乳白色鱼雷型栓剂,重量差异、融变时限和溶出度均符合规定。盐酸异丙嗪、咖啡因分别在0.5~100.0μg·ml^-1(r=0.9999),4.0~800.0μg·ml^-1(r=0.9998)浓度范围内线性关系良好。盐酸异丙嗪、咖啡因回收率平均值分别为99.84%(RSD=1.57%),99.08%(RSD=0.97%)(n=6)。结论:以最优基质SUPPOCIRE BS2X PELLETS制备复方异丙嗪栓的制备工艺简单易行,建立的HPLC含量测定方法适合于该栓剂的质量控制。
Objective:To prepare compound promethazine suppositories and evaluate the quality.Methods:Compound promethazine suppositories were prepared by hot-melt method,and the dissolution rate of suppositories was used as an index to examine 6 different suppository bases,and the optimal suppository base was selected and the suppositories were prepared.In accordance with the requirements of suppository in the Fourth Part of Chinese Pharmacopoeia(2015 edition),the appearance,weight difference and melting time limit were checked,and the dissolution rate was measured.The contents of promethazine hydrochloride and caffeine were determined by HPLC.Results:The best base was SUPPOCIRE BS2X PELLETS,and the suppositories were with milky white torpedo appearance.The weight difference,melting time and dissolution were controllable.The linear range of promethazine hydrochloride and caffeine was 0.5-100.0μg·ml^-1(r=0.9999)and 4.0-800.0μg·ml^-1,and the average recovery of promethazine hydrochloride and caffeine was 99.84%(RSD=1.57%)and 99.08%(RSD=0.97%)(n=6),respectively.Conclusion:The preparation method of the suppositories is rapid,simple and accurate,and the quality control method is reliable.
作者
盖守昌
沈歆
张景淇
徐大鹏
张彬彬
何韧
霍晓东
王庆伟
高建义
刘雪英
Gai Shouchang;Shen Xin;Zhang Jingqi;Xu Dapeng;Zhang Binbin;He Ren;Huo Xiaodong;Wang Qingwei;Gao Jianyi;Liu Xueying(Department of Medicinal Chemistry,School of Pharmacy,Air Force Military Medical University,Xi’an 710032,China;No.79 Army Group Hospital of People’s Liberation Army;Department of Pharmacy,Tangdu Hospital,Air Force Military Medical University;China Astronaut Research and Training Center)
出处
《中国药师》
CAS
2020年第9期1837-1839,1854,共4页
China Pharmacist
基金
国家自然科学基金面上项目(编号:8177070350)
2017年度军队后勤科研重点项目(编号:BWS17J028)。
关键词
盐酸异丙嗪
咖啡因
晕动病
栓剂
质量评价
Promethazine hydrochloride
Caffeine
Motion sickness
Suppositories
Quality evaluation
