醇提取乙醇套用问题

小米饭

用乙醇提取中药材一般回收的乙醇会继续套用，但是怎样验证可以套用多少次？套用次数过多会有什么影响？

poemhw2008

中药没有化药那么严格，查查GAP的相关相关规定啊

玻璃杯

我们是生物原料药，无限循环使用，每个独立的容器全检（50T一罐），定期补充新酒精。
这个自己企业规定即可，拿出证据不影响产品质量和稳定性，任何检查也不会有问题的。

kkcljj

完全可以啊，但应有管理文件规定，最好有数据支持。

FDA Guidance for Industry
Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients
Draft - Not for Implementation



E. Control of Recovered Solvents, Mother Liquors, and Second Crops

Written procedures should be established for the recovery of solvents, mother liquors, second crops or other materials. These should include adequate tests and controls to ensure that recovered materials are suitable for use in manufacturing processes and do not adversely affect the quality of APIs and intermediates.

Solvents may be recovered and reused in the same process or in different processes, provided that the recovery procedures are validated to ensure that recovered solvents meet appropriate standards before reuse or commingling with other approved materials. The quality of solvent mixtures should be monitored at suitable intervals.

Mother liquors may be reused provided that the quality of the API or intermediate is not adversely affected by their reuse. Procedures for secondary recovery of reactants, intermediates, or the API should ensure that these recovered materials meet specifications suitable for their intended use.

The use of recovered solvents, mother liquors, and other recovered materials should be adequately documented in batch production records.

youngzhou

论坛里有很多关于乙醇回收的讨论，查查看

yuansoul

那要看你监测方法，气相测定含量还是酒精比重计。但无论怎样，反复套用后，乙醇分子会出现酯化，这种酯化物去除，不是一般企业可以自己做的

freeman132

这个应该移到提取浓缩版去，不过那里已经有了这个帖子，楼主可去看看https://www.ouryao.com/forum.php? ... &extra=page%3D1

蠡怡良

路过学习，谢谢

囍4768b2b6

首先根据风险评估，评估出最大使用次数，比如套用50次，再根据这50次乙醇的检验数据做出风险分析，然后将套用次数定为40次， 前提是你套用的乙醇检测全部合格。