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目的建立六味生物制剂有效部位正丁醇残留量的检测方法,确定六味生物制剂有效部位残留正丁醇的最佳去除工艺。方法运用气相色谱法测定正丁醇残留量,以正丁醇残留量为考察指标,结合正交试验设计,优选最佳的残留正丁醇去除工艺。结果正丁醇残留量检测方法平均回收率为99.62%,RSD为2.05%。六味生物制剂有效部位残留正丁醇的最佳去除工艺为每次加入0.5倍量水,80℃旋转蒸发3次,测得正丁醇残留量符合《中国药典》规定限量标准。结论本试验所建立的正丁醇残留量检测方法准确可靠,优选的正丁醇去除工艺简便可行,为后续产品研发奠定基础。
Objective To establish a method for the determination of n-butanol in effective part of Liuwei biological preparation and to determine the optimum removal process of n-butanol in the effective part of Liuwei biological preparation. Methods Gas chromatography was used to determine the n - butanol content. Using the n - butanol content as the index, combined with orthogonal experimental design, the optimal n - butanol removal process was optimized. Results The average recovery of n-butanol residue was 99.62% and the RSD was 2.05%. The optimum removal process of residual n-butanol at the effective site of Liuwei biological preparation is that 0.5-fold amount of water is added into each of the effective parts of the Liuwei biological preparation and is rotary-evaporated three times at 80 DEG C, and the residual amount of n-butanol is measured in compliance with the limited standard of Chinese Pharmacopoeia. Conclusion The method for the determination of n-butanol residue established in this experiment is accurate and reliable, and the preferred n-butanol removal process is simple and feasible, laying the foundation for subsequent product development.