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 detecting residual n-butanol and to optimize the process for eliminating n-butanol in active composition of LW-PSB. Methods We detected the residual n-butanol in active compositions of LW-PSB by gas chromatography(GC)，and optimized the process condition for the elimination of n-butanol with residual n-butanol as the indexes and by using the orthogonal experimental design. Results The recovery of residual n-butanol was 99.62 ％ with RSD being 2.05 ％. The optimal process for eliminating n-butanol was adding 0.5-fold water every time and reduced-pressure distillation at 80 ℃ for three times，and the obtained residual n-butanol level was in accordance with the pharmacopeial limit. Conclusion The method for detecting residual n-butanol in active composition of LW-PSB is accurate and reliable. The optimal technique is convenient and practical，and will lay a good foundation for the product development.

R284.1

国家自然科学基金项目(81374072)。