甘草抗郁原位凝胶的制备及质量标准研究
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摘要
研究制备甘草抗郁凝胶,初步制订可行、可控的质量标准。采用正交试验设计法考察凝胶基质比例、保湿剂对凝胶效果的影响,优化处方工艺;采用薄层色谱法、高效液相色谱法对凝胶中的抗郁成分进行定性鉴别及含量测定。结果表明:甘草抗郁凝胶的最佳处方为泊洛沙姆P407、P188分别为16%、4%,甘油3%,磷酸盐缓冲液76.98%,尼泊金乙酯0.01%;平均胶凝温度33.8℃;载药量为99.4μg?mL~(-1);薄层色谱鉴别斑点清晰,阴性无干扰;凝胶p H符合鼻腔黏膜用药要求;甘草查尔酮在10.0～1 000μg?mL~(-1)范围内具有良好的线性关系(r=0.999 9),平均回收率为99.8%。建立了准确、有效的甘草抗郁凝胶制备及质量控制分析方法。
To prepare licorice antidepressant in-situ gel and study its quality standard,the preparation process was optimized by using orthogonal experiment,TLC and HPLC were used to identify anti-depression components and determinate their content.The optimum prescription of the gel was determined as follows:poloxamer P407 16%,poloxamer P188 4%,glycerol 3%,phosphate buffer 76.98%and ethylparaben 0.01%.The average gelatinization temperature was 33.8℃.The content of licochalcone was 99.4μg·mL~(-1).The TLC spots were clear,without interference.The gel pH met the requirements of nasal mucosal medication.The linear range of licochalcone was10.0～1 000μg·m L~(-1)(r=0.999 9),the average recovery was 99.8%.The effective,accurate and reasonable quality control analysis method of licorice antidepressant in-situ gel was established.
To prepare licorice antidepressant in-situ gel and study its quality standard,the preparation process was optimized by using orthogonal experiment,TLC and HPLC were used to identify anti-depression components and determinate their content.The optimum prescription of the gel was determined as follows:poloxamer P407 16%,poloxamer P188 4%,glycerol 3%,phosphate buffer 76.98%and ethylparaben 0.01%.The average gelatinization temperature was 33.8℃.The content of licochalcone was 99.4μg·mL~(-1).The TLC spots were clear,without interference.The gel pH met the requirements of nasal mucosal medication.The linear range of licochalcone was10.0～1 000μg·m L~(-1)(r=0.999 9),the average recovery was 99.8%.The effective,accurate and reasonable quality control analysis method of licorice antidepressant in-situ gel was established.
引文
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[2]李海芳.甘草苷抗抑郁作用的主要药效及机制研究[D].北京中医药大学,2008.
[3]黄世敬,张颖,潘菊华,等.甘草抗抑郁研究与应用[J].世界中医药,2015,13(8):1288-1291.
[4]张明发,赵迎春,沈雅琴.甘草及其黄酮类化合物的神经保护作用[J].抗感染药学,2013,10(3):170-175.
[5]邓树海,巩洪刚,常建晖.智能化凝胶控释黏膜给药系统应用研究进展[J].中国医药技术经济与管理,2008,2(9):34-40.
[6]William M,Pardridge.Drug targeting to the brain[J].Pharmaceutical research,2007,24(9):1733-44.
[7]王平,王晨,楼一层.冰片、川芎对复方舒郁健脑方剂透过血脑屏障的作用研究[J].湖北中医药大学报,2011,13(5):21-22.
[8]王峰,蒋新国.鼻粘膜作为脑内递药途径的研究进展[J].药学学报,2001,36(8):636-640.
[9]Cao SL,Ren XW,Zhang QZ,et a1.In situ gel based on gellan gum as new carrier for nasal administration of mometasone furoate[J].Int JPharm,2009,365(12):109-115.
[10]赵宁,王黎,李伟泽,等.酸枣仁鼻用温敏凝胶的制备研究[J].应用化工,2016,45(7):1290-1292.
[11]国家药典委员会.中华人民共和国.四部[S].北京:中国医药科技出版社,2015,77-78:176-185.