橙皮苷栓剂的研制及质量评价
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摘要
目的:制备一种主药为橙皮苷的栓剂,同时建立质量控制体系,并对其进行质量评价。方法:以橙皮苷为原料药,聚乙二醇400、聚乙二醇6000和甘油为基质,热熔法制备栓剂,并对其外观、药物含量均匀度、融变时限、重量差异进行评价。结果:橙皮苷栓剂外观呈棕色,室温下硬度较好,含量均匀度、重量差异、融变时限均符合栓剂要求。结论:本法制备的橙皮苷栓质量符合栓剂质量要求,适合作为橙皮苷的新剂型开发。
Objective: To prepare hesperidin suppository and establish a quality control method. Methods:Hesperidin was used as an active ingredient. Polyethylene glycol 400, polyethylene glycol 6000 and glycerol were chosen as substrates. Fusion method was applied to prepare the hesperidin suppository. The content uniformity, appearance, melting time and weight variation were evaluated. Results: The hesperidin suppository showed brown appearance and desirable hardness at room temperature. The content uniformity, weight variation and melting time of hesperidin suppository prepared by this method met the requirements of quality control. Conclusion: The hesperidin suppository prepared by this method meet the quality requirements of suppository and may be developed as a new formulation of hesperidin.
Objective: To prepare hesperidin suppository and establish a quality control method. Methods:Hesperidin was used as an active ingredient. Polyethylene glycol 400, polyethylene glycol 6000 and glycerol were chosen as substrates. Fusion method was applied to prepare the hesperidin suppository. The content uniformity, appearance, melting time and weight variation were evaluated. Results: The hesperidin suppository showed brown appearance and desirable hardness at room temperature. The content uniformity, weight variation and melting time of hesperidin suppository prepared by this method met the requirements of quality control. Conclusion: The hesperidin suppository prepared by this method meet the quality requirements of suppository and may be developed as a new formulation of hesperidin.
引文
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[10]任盛静,马燕玲,陈勇,等.痔血安合剂治疗湿热下注型老年痔出血临床疗效观察[J].上海中医药杂志,2017,51(2):58-60.
[2]陈克莉,陈道鸽,张玉宾,等.橙皮苷提取方法的研究进展[J].食品工业,2016,37(12):204-207.
[3]张恒,饶坤林,向韩.橙皮苷药理活性研究进展[J].中南药学,2016,14(10):1097-1100.
[4]李雪飞,江洪.橙皮苷药理学作用机制及研究进展[J].海南医学,2016,27(14):2337-2340.
[5]崔福德.药剂学[M].7版.北京:人民卫生出版社,2011:301-307.
[6]国家药典委员会.中华人民共和国药典[M].2015版.北京:中国医药科技出版社,2015:通则10.
[7]张芮绮,姜晓晔,刘永琼,等.橙皮苷-PEG4000固体分散体溶出度的测定[J].医学新知杂志,2016,26(5):357-359.
[8]刘磊,屈云云.中药栓剂的概况及应用进展[J].黑龙江医药,2010,23(1):98-100.
[9]张媛,赵宝明.近十年来国内肛肠病中药栓剂研究概况[J].辽宁中医药大学学报,2014,16(2):169-172.
[10]任盛静,马燕玲,陈勇,等.痔血安合剂治疗湿热下注型老年痔出血临床疗效观察[J].上海中医药杂志,2017,51(2):58-60.