站内搜索
最新录用更多>>
活性炭对于眼氨肽滴眼液抑菌剂的吸附性研究
投稿时间:2019-10-18  修订日期:2019-11-27  点此下载全文
引用本文:
摘要点击次数: 86
全文下载次数: 0
作者单位E-mail
覃婷婷 天津市药品检验研究院 57213467@qq.com 
中文摘要:建立一种检测眼氨肽滴眼液中抑菌剂含量的HPLC法,使用Diamonsil C18(4.6×250 mm,5 μm )色谱柱,以1%三乙胺溶液(用磷酸调节pH值至 3.0)为流动相A,甲醇为流动相B进行梯度洗脱,检测波长为256 nm,柱温40 ℃,流速1.0 mL/min。在该条件下羟苯甲酯、羟苯乙酯和醋酸氯己定三种抑菌剂分离度良好,各抑菌剂在0.1~80 μg/mL浓度范围内,峰面积与浓度呈良好线性关系(r>0.9991),回收率分别为97.2%~104.1%,RSD为0.8%~1.2%。用该法检测的5批市售眼氨肽滴眼剂抑菌剂含量均低于处方量的10%,经考察发现生产工艺中使用的活性炭对于抑菌剂有强吸附作用,温度越低、活性炭浓度越高对抑菌剂的吸附越强,其中活性炭对不同抑菌剂的吸附能力分别为:醋酸氯己定>羟苯乙酯>羟苯甲酯。结果表明,建立的HPLC法,操作简便,灵敏度高,重复性好,可用于快速准确测定眼氨肽滴眼液中抑菌剂含量;此外,本研究首次揭示了眼氨肽滴眼液生产中除杂工序对抑菌剂的影响,该品种不适宜在添加尼泊金酯类和醋酸氯己定抑菌剂前使用活性炭除杂质,为其生产质量监控与提升提供了新的指导依据。
中文关键词:眼氨肽滴眼液  活性炭  抑菌剂  尼泊金酯类  醋酸氯己定
 
Adsorption of activated carbon on bacteriostat in Ocular Extractives Eye Drops
Abstract:To establish a high performance liquid chromatography (HPLC) method to determine the content of bacteriostat s in the Ocular Extractives Eye Drops, Diamonsil C18(4.6×250 mm,5 μm)column was used, with gradient elusion by 1% triethylamine solution (pH3.0) (mobile phase A) and methanol (mobile phase B). The detection wavelength was 256 nm, the column temperature was 40 ℃, and the flow rate was 1.0 mL/min. Under these conditions, the three bacteriostats of methylparaben, ethylparoben and chlorhexidine acetate have good resolution. The bacteriostats have good linear relationship between the peak area and the concentration in the concentration range of 0.1~80 μg/mL(r>0.9991).The recoveries were 97.2% to 104.1%, and the RSD was 0.8% to 1.2%. The content of bacteriostats in five batches of Ocular Extractives Eye Drops were all less than 10% of the prescription amount. It was found that the activated carbon used in the production process has strong adsorption effect on the bacteriostat, and the lower the temperature, The higher the concentration of activated carbon, the stronger the adsorption of bacteriostatic agent. The adsorption capacity of activated carbon for different bacteriostatis is: chlorhexidine acetate > ethylparoben > methylparaben. The results show that the established HPLC method is easy to operate, high sensitivity and good repeatability. It can be used to quickly and accurately determine the content of bacteriostat in Ocular Extractives Eye Drops. In addition, this study reveals for the first time the effect of the impurity removal process on the bacteriostat in the production of Ocular Extractives Eye Drops. It is not suitable for the use of activated carbon to remove impurities before adding parabens and chlorhexidine acetate bacteriostats. It provides a new guiding basis for its production quality monitoring and improvement.
keywords:Ocular Extractives Eye Drops  activated carbon  bacteriostat  nipagins  chlorhexidine acetate
  查看/发表评论  下载PDF阅读器
相关附件:   介绍信扫描件.jpg  审稿意见回复
分享按钮