摘要
目的：对扑热息痛滴鼻剂进行试制，确定其质量标准、含量测定方法、贮存条件、有效期、安全性和有效性。方法：分光光度法、稳定性实验、药理学实验及临床观察。结果：平均回收率为99．146％，标准差S＝0．611，变异系数CV＝0．62％；兔发热用药组和对照组（生理盐水）之间有极显著性差异（P＜0．01），和片剂组之间比较在用药15min时有显著性差异（P＜0．05）。结论：扑热息痛滴鼻剂有明显的退热作用，其起效比片剂快，使用安全。扑热息痛滴鼻剂含量测定方法可靠，其制剂应在低于25℃的环境中贮存，有效期为22．5个月。
AIM:To make trial preparation of paracetamol nose drops and define its quality standard,assay method of content,storage requirement,period of validity,safety and effectiveness. METHOD: Spectrophotometry determination, stability test, pharmacolo- gical experiment and clinical observation. RESULTS: The average recovery was 99. 146 % with a standard difference of 0. 611 andvariation coefficient CV = 0. 62 %. Experiment on pyrexial rabbits induced by peptone injection showed that there were significantdifferences between nose drops group and normal saline group (P<0.01) as well as between nose drops group and tablet group(P<0.05).CONCLUSION:The paracetamol nose drops possess obvious antipyretic effect,the onset of which is earlier with nose dropsthan with tablet.The assay method of content is reliable.The preparation should be stored below 25t with a period of validity of22. 5 months.
出处
《中国药房》
CAS
CSCD
1998年第3期107-108,共2页
China Pharmacy
关键词
扑热息痛
滴鼻剂
制备
含量
测定
稳定性
药理
paracetamol
nose drops
preparation
content determination
stability test
pharmacological experiment
clinical observation
