中草药制剂回收乙醇质量研究.docVIP

中草药制剂回收乙醇质量研究[摘要] 目的：分析中草药制剂回收乙醇的质量情况，为净化处理提供依据。方法：采用对比法，取乙醇配制成与中草药制剂回收乙醇相近的浓度，按乙醇质量标准检验比较其质量差异。结果：中草药制剂回收乙醇的外观、酸度、易氧化物、不挥发物等项目均不符合规定。结论：中草药制剂回收乙醇被带入了某些中药成分的杂质，必须通过处理后才能再应用，以利于保障制剂质量。 [关键词] 中草药制剂；回收乙醇；质量分析 [中图分类号]TQ461 [文献标识码]A [文章编号]1673-7210（2008）03（b）-032-02 Quality analysis in recycled ethanol of medicinal herb preparations MO Ming-xiu1, ZENG Zhi-jian2, JIANG San-yuan3, ZHANG Xiao-ying 1, ZHANG Jian-min3, GUO Hui 2 (1.Xinhui People′s Hospital, Jiangmen 529100, China; 2. Jiangmen Institute for Drug Control, Jiangmen 529000, China; 3. Xinhui Hospital of Traditional Chinese Medicine, Jiangmen 529100, China) [Abstract] Objective:To analysis the quality in the recycled ethanol of medicinal herb preparations and to provide the basis of the purification disposal. Methods: The recycled ethanol was compared with the fresh ethanol that had the same concentration as the recycled ethanol according to the quality standard of ethanol to find the difference between them. Results: The recycled ethanol of medicinal herb preparations did not accord with stipulations at aspect, acidity, readily oxidizable substance, non-volatile substance and etc. Conclusion: The recycled ethanol of medicinal herb preparations is brought into some impurities in the medicinal herbs. It can′t be used because there are impurities in the recycled ethanol until it is treated eligibly. [Key words] Medicinal herb preparations; Recycled ethanol; Quality analysis 随着我国中医药事业的快速发展，中草药制剂不断增加。在中草药制剂生产中，如注射剂、片剂、口服液、颗粒剂等不少剂型的中草药制剂均采用水提醇沉法，以除去中草药中一些非药用成分，达到提纯精制、提高制剂质量、保证临床疗效之目的。制剂生产中用的乙醇作为一种处理溶媒，其质量有严格的规定[1]。本着节约资源、减少浪费，回收乙醇应该再利用，但是回收乙醇质量如何，是否符合质量标准，目前尚未见报道。因此，本文对不同中草药制剂生产的回收乙醇进行了系统的质量分析，为探讨除去回收乙醇中杂质的方法，提供有效的参考依据。 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：070510）；感冒退热冲剂的回收乙醇（批号；生骨片的回收乙醇（批号；养阴生脉片的回收乙醇（批号：070424）；病毒清口服液的回收乙醇（批号：071011）；咳喘清口服液的回收乙醇（批号：070225）。所用试剂均为分析纯。 2方法与结果 2.1 样品的制备与采集 2.1.1 乙醇对照品溶