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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。
OBJECTIVE: To test paracetamol nasal drops and determine its quality standard, content determination method, storage conditions, expiration date, safety and effectiveness. Methods: Spectrophotometry, stability experiment, pharmacology experiment and clinical observation. Results: The average recovery was 99.146%, the standard deviation was S = 0.611, the coefficient of variation was CV = 0.62%. There was a significant difference between rabbits with fever and control group (P <0. 05) .01), there was a significant difference (P <0.05) when compared with the tablet group at 15 min. Conclusion: Paracetamol nasal drops have obvious antipyretic effect, its effect is faster than tablets, safe to use. Paracetamol nasal drops content determination method is reliable, the preparation should be stored in the environment below 25 ℃, valid for 22.5 months.