目的:建立八味益肾丸制备中的回收乙醇的质量控制方法.方法:以乙醇中杂质、提取药材主成分的残留和安全性限量为综合评价指标,检测循环使用的回收乙醇的质量.结果:在八味益肾丸的制备中,回收乙醇循环使用20次内,其含有的杂质、提取药材主成分残留和安全性限量均符合要求.结论:本方法可用于八味益肾丸制备中的回收乙醇的质量控制,并可确定回收乙醇的循环使用次数.%Objective:To establish the method for quality control of recycled ethanol from preparation of Baweiyishen pills.METHODS: Impurities in the ethanol,residue of extraction of medicinal materials principal components and security of limited extracts were set as indicators to determine the quality of recycled ethanol.RESULTS: During the preparation process of Baweiyishen pills,the impurities in the ethanol,residue of extraction of medicinal materials principal components and security of limited extracts in recycled ethanol all met the requirements within twenty times.CONCLUSIONS: This method is can be used for quality control of recycled ethanol from preparation of Baweiyishen pills,and can ensure the recycled application times of recycled ethanol.
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