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目的:优选天舒滴丸正丁醇去除最佳工艺,并对其中间体浓缩液进行正丁醇残留量检测。方法:采用正交试验设计,运用气相色谱法测定正丁醇残留量,并以正丁醇残留量为正交试验考察指标,优选最佳工艺。结果:最佳去除工艺为80℃旋转蒸发3次,每次加入0.25倍量水,正丁醇残留量检测方法回收率为101.13%,RSD 1.10%,符合药典规定限量标准。结论:优选得到的去除工艺稳定可行,正丁醇残留量检测方法简便,重复性好,可作为该产品的企业内控质量标准之一。
OBJECTIVE: To optimize the removal of n-butanol from Tianshu pills and to detect the n-butanol residues of its intermediate concentrates. Methods: Orthogonal design was used to determine the content of n-butanol by gas chromatography. The n-butanol content was determined by orthogonal test, and the optimum process was optimized. Results: The best removal process was rotary evaporation at 80 ℃ for 3 times. Each time adding 0.25 times the amount of water, the detection limit of n-butanol was 101.13% and the RSD was 1.10%, which was within the limit of Pharmacopoeia. Conclusion: The optimal removal process is stable and feasible. The detection method of n-butanol residue is simple and reproducible. It can be used as one of the quality standards for the internal control of the product.