正交试验优选金蕾滴丸的提取及成型工艺
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摘要
目的优选金蕾滴丸的最佳提取工艺及成型工艺。方法以干膏率、当药黄素和当药醇苷的含量为综合评价指标,采用正交试验法优选金蕾滴丸的提取工艺;采用滴制法制备金蕾滴丸,以滴丸的丸重变异系数、圆整度和溶散时限为综合评价指标,采用正交试验法优选金蕾滴丸的成型工艺。结果金蕾滴丸的最佳提取工艺为:加8倍量70%的乙醇提取2次,每次1 h。金蕾滴丸的成型工艺为:以聚乙二醇(PEG)-6000∶PEG-4000(2∶1)作为复合基质,液体石蜡作为冷却剂,药材提取物与基质配比为1.0∶1.5,滴制温度65℃,冷却柱柱长60 cm。结论该提取工艺简便、稳定,滴丸的制备工艺具有良好的重复性,为金蕾滴丸的生产提供了重要的试验依据。
Objective To optimize the best extraction process and forming technology of Jinlei Diwan( 金蕾滴丸). Methods With the content of dry extract yield,swertisin and swertianolin for overall evaluation indexes,the orthogonal experiments were used to find the optimal extraction process of Jinlei Diwan;using dropping method for the preparation of Jinlei Diwan,with pill weight coefficient of variation,roundness and time-limit of dissolution for overall evaluation indexes,the orthogonal experiments were used to find the optimal formation technology of Jinlei Diwan. Results The extraction process of Jinlei Diwan: adding 8 times the amount of 70% ethanol to extract twice,1 h each time. The forming technology of Jinlei Diwan: using PEG-6000 and PEG-4000 as compound substrates with the ratio of 2 ∶ 1,using liquid paraffin as a coolant,the ratio of herbal extract to compound substrates was 1.0 ∶ 1.5,the dropping temperature was at 65 ℃ and the length of the cooling column was 60 cm.Conclusion The extraction process is simple and stable,the forming technology of Diwan has good repeatability,which provides an important experimental basis for the production of Jinlei Diwan.
Objective To optimize the best extraction process and forming technology of Jinlei Diwan( 金蕾滴丸). Methods With the content of dry extract yield,swertisin and swertianolin for overall evaluation indexes,the orthogonal experiments were used to find the optimal extraction process of Jinlei Diwan;using dropping method for the preparation of Jinlei Diwan,with pill weight coefficient of variation,roundness and time-limit of dissolution for overall evaluation indexes,the orthogonal experiments were used to find the optimal formation technology of Jinlei Diwan. Results The extraction process of Jinlei Diwan: adding 8 times the amount of 70% ethanol to extract twice,1 h each time. The forming technology of Jinlei Diwan: using PEG-6000 and PEG-4000 as compound substrates with the ratio of 2 ∶ 1,using liquid paraffin as a coolant,the ratio of herbal extract to compound substrates was 1.0 ∶ 1.5,the dropping temperature was at 65 ℃ and the length of the cooling column was 60 cm.Conclusion The extraction process is simple and stable,the forming technology of Diwan has good repeatability,which provides an important experimental basis for the production of Jinlei Diwan.
引文
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[2]芦彦兆,景明,卢年华,等.藏药湿生扁蕾提取物对四氯化碳致小鼠急性肝损伤的保护作用研究[J].甘肃中医药大学学报,2018,35(1):1-5.
[3]张旭东,芦彦兆,柳娜,等.复方湿生扁蕾提取液镇痛、抗炎及急性毒性研究[J].药学研究,2017,36(11):627-629.
[4]荣立新,鲁爽,张保献.中药滴丸剂研究概况[J].中国实验方剂学杂志,2013,19(20):325-329.
[5]国家药典委员会.中华人民共和国药典(一部)[M].北京:中国医药科技出版社,2010:附录9,附录71.
[6]舒予,李小芳,苏娟,等.星点设计-效应面法优化桂甘滴丸的制备工艺研究[C]∥“好医生杯”中药制剂创新与发展论坛论文集(上).成都:中华中医药学会中药制剂分会、世界中医药学会联合会中药药剂专业委员会,2013:9.
[7]刘琳娜,张琰,徐媛,等.正交试验法优选小柴胡汤滴丸制备工艺[J].中国实验方剂学杂志,2011,17(9):44-47.
[8]杨明.中药药剂学[M].北京:中国中医药出版社,2012:319.
[9]邱颖,朱玲,孙晓英.星点设计-效应面优化法与正交设计和均匀设计的比较及其在药剂研究中的应用[J].海峡药学,2011,23(2):18-20.