羟基喜树碱凝胶的制备及其质量控制

发布时间：2018-03-08 23:10

本文选题：羟基喜树碱　切入点：凝胶　出处：《中国医院药学杂志》2017年20期 　论文类型：期刊论文

【摘要】：目的:制备羟基喜树碱凝胶并建立质量控制方法。方法:采用正交设计法,以凝胶的成型性、涂展性、pH和黏度为指标,对基质处方进行优化;对HPLC检测羟基喜树碱进行方法学考察并检测羟基喜树碱在制剂中的含量。结果:羟基喜树碱凝胶最佳基质处方为(质量体积比):卡波姆-934 0.5%、甘油15%、月桂氮芯卓酮2%、三乙醇胺0.3%,此处方制备的凝胶均匀、细腻、易于涂布,测得其pH为6.90,黏度为35 Pa·s;羟基喜树碱在0.187 7~117.3μg·mL-1范围内线性关系良好(R2=0.999 8),精密度和准确度良好,重复性和稳定性的相对标准偏差为1.96%和1.95%,80%、100%和120%,制剂的加样回收率分别为(95±1)%,(96±2)%,(94±1)%。3批样品中羟基喜树碱的平均含量分别为标示量的104.8%、105.0%和100.6%。结论:采用卡波姆为基质制备羟基喜树碱凝胶工艺简单、质量可控,凝胶的水性基质可以增加患者的依从性,具有良好的开发前景。
[Abstract]:Objective: to prepare hydroxycamptothecin gel and establish a quality control method. The method for the determination of hydroxycamptothecin by HPLC and the content of hydroxycamptothecin in the preparation were investigated. Results: the best matrix formulation of hydroxycamptothecin gel was (mass / volume ratio: Carbome-934 0.5g), glycerol 15, lauryl azependone. (2) triethanolamine 0.3%, the gel prepared here is uniform, The results showed that the pH value was 6.90, the viscosity was 35 Pa 路s, the linear range of hydroxycamptothecin was 0.187 7 ~ 117.3 渭 g 路mL-1, and the precision and accuracy of hydroxycamptothecin were good. The relative standard deviations of reproducibility and stability were 1.96% and 1.95 respectively. The recoveries were 95 卤1 and 96 卤2, respectively. The average contents of hydroxycamptothecin in the samples were 104.8% and 100.60.Conclusion: hydroxycamptothecin was prepared with Carbomer as the substrate. The technology of ketocamptothecin gel is simple, The quality can be controlled and the hydrogel substrate can increase the compliance of patients. It has a good prospect of development.
【作者单位】：华中科技大学同济医学院附属同济医院;德宏州第二人民医院;
【分类号】：R943

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