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六味地黄丸(浓缩丸)微波干燥工艺的验证
引用本文:卢鹏伟,杨晨华,单雯,何颖,宋丽丽,范丙义.六味地黄丸(浓缩丸)微波干燥工艺的验证[J].河南大学学报(医学版),2005,24(2):31-33.
作者姓名:卢鹏伟  杨晨华  单雯  何颖  宋丽丽  范丙义
作者单位:河大制药厂,河南,开封,475001;河大制药厂,河南,开封,475001;河大制药厂,河南,开封,475001;河大制药厂,河南,开封,475001;河大制药厂,河南,开封,475001;河大制药厂,河南,开封,475001
摘    要:目的对六味地黄丸(浓缩丸)的微波干燥工艺进行验证。方法采用同步验证,以干燥药丸的水分、溶散时限、微生物限度为指标,考察其干燥、灭菌效果的稳定性。结果微波干燥后,不同取样位置的药丸微生物限度指标良好。干燥后药丸的水分和溶散时限均符合质量标准,但是水分和溶散时限指标却存在差异。结论微波干燥工艺的灭菌效果稳定、可靠。应采取一定措施改善干燥药丸的水分、溶散时限指标的差异。

关 键 词:六味地黄丸  微波干燥  工艺  验证
文章编号:1672-7606(2005)02-0031-03
修稿时间:2005年2月22日

Validation on microwave-dryness technology of Liuwei Dihuang Pills(condensed)
LU Peng-wei,YANG Chen-hua,SHAN Wen,HE Ying,SONG Li-li,FAN Bing-yi.Validation on microwave-dryness technology of Liuwei Dihuang Pills(condensed)[J].Journal of Henan University,2005,24(2):31-33.
Authors:LU Peng-wei  YANG Chen-hua  SHAN Wen  HE Ying  SONG Li-li  FAN Bing-yi
Abstract:Objective: To validate microwave-dryness Technology of Liuwei Dihuang pills(condensed).Methods: Isochronous validation was conducted, the effects of dryness and sterilization were observed using the moisture, time-limit of dissolution and limit of microorganism as quality index. Results: Limit of microorganism of the pills dried by microwave in different positions was very good. Both moisture and time-limit dissolution of dried pills were complied with quality standard. However, there existed some difference in the moisture and time-limit dissolution.Conclusion: The sterilization effects of microwave-dryness technology are stable and reliable. Some measures should be taken to decrease the difference of moisture and time-limit of dissolution.
Keywords:Liuwei Dihuang Pills  microwave-dryness  technology  validation
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