盐酸赛洛唑啉鼻用温敏凝胶的处方筛选及含量测定  

Formulation screening and content determination of nasal thermosensitive gel xylometazoline hydrochloride

作　　者：孙静秋[1] 兰曦[1] 汪细和 张莉[3] 

机构地区：[1]武警后勤学院附属医院药材科,天津300162 [2]武警湖南总队医院,湖南长沙410006 [3]武警后勤学院救援医学系生药学与药剂学教研室,天津300309

出　　处：《武警后勤学院学报（医学版）》2017年第2期127-130,共4页Journal of Logistics University of PAP（Medical Sciences）

摘　　要：【目的】制备盐酸赛洛唑啉鼻用温敏凝胶并筛选出最佳处方。【方法】以泊洛沙姆407和泊洛沙姆188为凝胶材料,制备盐酸赛洛唑啉温敏凝胶,考察凝胶材料比例对胶凝温度的影响;建立高效液相色谱法(high performance liquid chromatography,HPLC)法测定凝胶中盐酸赛洛唑啉的含量,并对其进行专属性、精密度、准确度、稳定性验证。【结果】以20%P407和1%P188制备的0.1%盐酸赛洛唑啉温敏凝胶的胶凝点在(32.6±0.33)℃。盐酸赛洛唑啉浓度在0.4~1.2μg/ml范围内线性关系良好,线性方程为A=85452C-10118,r=0.9999。日内、日间精密度相对标准偏差(relative standard deviation,RSD)值分别为1.3%、1.7%,低、中、高3种质量浓度的加样回收率为100.11%、97.19%、99.06%,RSD值分别为2.1%、4.4%、2.4%(n=3)。凝胶含量测定结果为(1.00±0.05)mg/ml。【结论】通过调整温敏凝胶材料比例可制得性状优良的鼻用温敏凝胶剂,所建立的HPLC检测方法灵敏度高,专属性好,准确性高,稳定可靠,可用于盐酸赛洛唑啉制剂的质量控制。[Objective] To prepare the nasal thermosensitive gel xylometazoline hydrochloride and screen the optimum formulation. [ Methods] Poloxamer 407 and 188 were used to prepare the thermosensitive gel xylometazoline hydrochloride. The effect of gel matrix ratio on gelatinization temperature was explored. High performance liquid chromatograph （HPLC） method was established to determine the content of xylometazoline hydrochloride in the gel. The specificity, precision, accuracy and stability were verified. [ Results] The thermosensitive gel of 0.1% xylometazoline hydroehloride was perpared with 20% poloxamer 407 and 1% poloxamer 188, and its gelatination temperature was （32.6 ± 0.33） ℃. There was a good linear relationship between peak area and xylometazoline hydroehloride concentration in the range of 0.4- 1.2 μg/ml, and the linear equation was A=85452C-10118, r = 0.9999. The relative standard deviation （RSD） values of intra-day and inter-day precision were 1.3% and 1.7% respectively and the sample recovery values of xylometazoline hydrochloride in low, middle and high concentrations were 100.11%, 97.19% and 99.06%, with the RSD values of 2.1%, 4.4% and 2.4% （n=3）. The concentration of xylometazoline hydrochloride was （1.00 ± 0.05） mg/ml. [Conclusion] Thermosensitive gel of xylometazoline hydrochloride with qualified characteristics could be prepared through adjusting the proportion of gel matrix. The established HPLC method is sensitive, specific, accurate and stable. Therefore it can be applied for the quality control of xylometazoline hydrochloride preparation.

关 键 词：盐酸赛洛唑啉 温敏凝胶 鼻腔用药 胶凝温度 高效液相色谱法 

分 类 号：R943[医药卫生—药剂学]