中草药制剂回收乙醇中杂质去除方法探析.docVIP

中草药制剂回收乙醇中杂质去除方法探析[摘要] 目的：探讨中草药制剂的回收乙醇中杂质的去除方法。方法：将回收乙醇进行初步的除杂质实验，选择较好的除杂质方法，再以正交法对其进行优选，并对优选方法加以验证。结果：每1 000 ml 回收乙醇中加入5%高锰酸钾溶液6 ml，静置30 min，然后加入活性炭6 g，再静置30 min，滤过，蒸馏，收集蒸馏液作相应的检验，各项指标均能达到规定要求。结论：该方法可有效除去中草药制剂回收乙醇中的杂质，提高其质量。 [关键词] 中草药制剂；回收乙醇；除杂质方法 [中图分类号]TQ461 [文献标识码]A [文章编号]1673-7210（2008）02（b）-033-02 Study on the removal of impurities in recycled ethanol of medicinal herb preparations JIANG San-yuan1, ZENG Zhi-jian2, LIN Chuan-hui3, LUO Hao-zhang2,LIANG Yong-guang1 (1. Xinhui Hospital of Traditional Chinese Medicine, Jiangmen 529100, China; 2. Jiangmen Institute for Drug Control, Jiangmen 529000, China;3. Siqianzhen Hospital of Xinhui Jiangmen Guangdong, Jiangmen 529159, China) [Abstract] Objective: To discuss the method about how to remove the impurities in recycled ethanol of medicinal herb preparations. Methods: The initial test was carried out to remove the impurities in recycled ethanol and the better method was chosen which would be verified by orthogonal test. Results: 1 000 ml of recycled ethanol liquor solution was put in 6 ml of 5%KMNO4, standing for 30 min and 6 g of activated carbon, standing for 30 min again. Then it was filtrated and distilled, and the distilled ethanol was collected to make corresponding tests. All indexes of ethanol tests had reached regulary request. Conclusion: This method can remove the impurities in recycled ethanol of medicinal herb preparations. The quality of recycled ethanol is improved. [Key words] Medicinal herb preparation; Recycled ethanol; Removal of impurities 在中草药制剂生产中，常用水提醇沉法除去中草药中一些非药用成分的杂质，以达到提纯精制、提高制剂质量、保证临床疗效之目的，因此就需用大量的乙醇。这些乙醇作为一种溶媒回收时，难免带入一些中草药成分的杂质，从而影响回收乙醇溶媒的质量。医药用乙醇有着严格的质量标准[1]，中草药制剂的回收乙醇如何才能达到标准，我们查阅了相关资料尚未见对其杂质的去除方法的报道。为了使回收乙醇符合制剂生产用的质量要求，保障制剂质量与临床疗效，本文对中草药制剂中的回收乙醇进行了去除杂质的方法研究。本研究建立了用加入5%高锰酸钾溶液和活性炭，滤过，再蒸馏的方法，可有效去除中草药制剂回收乙醇中的杂质。 1 仪器与材料 pH计（上海雷磁仪器厂）；酒精计（体积浓度，浙江余姚仪表二厂生产）。乙醇（广东省广宁县顺宁葡萄糖药业有限公司，批号；多种制剂混合回收乙醇；热感冲剂的回收乙醇（批号；感冒退热冲剂的回收乙醇（批号；生骨片的回收乙醇（批号：20