三妙丸工艺的优化及工艺验证
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摘要
目的针对三妙丸制丸过程中易出现丸药开裂的情况,优化了三妙丸的制丸工艺参数,并进行了工艺验证。方法首先制得三妙丸粉,然后以丸药外观、水分、溶散时限为评价指标,通过考察不同丸径及干燥温度,优化三妙丸的制丸工艺参数,并进行三批次工艺验证。结果三妙丸制丸工艺参数条件优化为,丸径控制为5.0±0.25mm,泛制成丸,70℃干燥。结论工艺简单可行,产品各项指标稳定。
OBJECTIVE According to the phenomenon of so easy cracking of Sanmiao pills,To optimize the preparative parameters of Sanmiao Pills,and to validate the process.METHODS The powders of Sanmiao Pills were prepared firstly.Then the appearance,humidity and disintegration time of pills were selected as evaluation indexes to optimize the process parameters of Sanmiao Pills.The technology was validated by 3 batches afterwards.RESULTS The process parameters of Sanmiao Pills were optimized as follows:The diameter of pills was controlled as 5.0±0.25 mm,and drying under the 70℃.CONCLUSION The process technology is simple and feasible.The quality of pills is stable.
OBJECTIVE According to the phenomenon of so easy cracking of Sanmiao pills,To optimize the preparative parameters of Sanmiao Pills,and to validate the process.METHODS The powders of Sanmiao Pills were prepared firstly.Then the appearance,humidity and disintegration time of pills were selected as evaluation indexes to optimize the process parameters of Sanmiao Pills.The technology was validated by 3 batches afterwards.RESULTS The process parameters of Sanmiao Pills were optimized as follows:The diameter of pills was controlled as 5.0±0.25 mm,and drying under the 70℃.CONCLUSION The process technology is simple and feasible.The quality of pills is stable.
引文
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[4]陆继宏.中药内服外用治疗痛风性关节炎42例临床观察[J].中国保健营养,2015,25(15):351-352.
[5]陈杰.三妙丸加味治疗痛风性关节炎临床观察[J].中国中医急症,2014,23(3):532-533.
[6]朱晓勤.二妙丸类方抗湿热证痛风物质基础与生物效应的相关性研究[D].南京中医药大学,2008.
[7]李祥.中药复方三妙丸的物质基础和药代动力学研究[D].第二军医大学,2013.
[8]李欣,尹莲,段金廒,等.二妙丸类方抗湿热证痛风有效部位群乙酰化GC指纹图谱比较研究[J].世界科学技术:中医药现代化,2009,11(1):44-47.
[9]陈福星.高效液相色谱法测定三妙丸中盐酸小檗碱的含量[J].海峡药学,2007,19(6):51-53.
[10]蔡俊安.三妙丸中盐酸小檗碱的含量测定[J].中国药业,2011,20(6):38-39.
[11]李祥,赵亮,吕磊,等.三妙丸及其组方药材的化学成分、质量控制及临床应用[J].药学服务与研究,2013,13(4):274-277.
[12]高祖新.医药数理统计方法(第五版)[M].北京:人民卫生出版社,2011.
[13]单玮.三妙丸类方及川牛膝对急性痛风性关节炎大鼠炎症反应的作用机制研究[D].上海中医药大学,2011.
[14]吴娟.应用大鼠急性痛风性关节炎和高尿酸血症模型研究三妙丸方中牛膝“引药下行”作用[D].安徽医科大学,2015.
[15]尹莲,李欣,徐立,等.应用指纹图谱研究类方方剂配伍物质基础--二妙丸物质基础在配伍类方中的变化研究[J].世界科学技术:中医药现代化,2009,11(1):179-183.