正交试验法优选硝英洗剂制备工艺研究

Study on the Optimization of the Extraction Technology for Xiaoyin xiji by Orthogonal Experiment

摘要: 目的：以盐酸小檗碱为考察指标建立硝英洗液正交试验优化工艺。方法：采用HPLC法，以Wonda Sil C18 (250 mm × 4.6 mm, 5 μm)色谱柱，乙腈-0.1%磷酸溶液(50:50)为流动相，流速为1.0 mL/min，检测波长为265 nm，柱温为30℃；用正交试验法优化对硝英洗剂的提取工艺优化。结果：盐酸小檗碱在0.078125 mg/mL~0.125 mg/mL范围内，线性关系良好，回归方程y = 19947x − 8.6951，R2 = 1；盐酸小檗碱平均加样回收率(n = 6)为99.19% (RSD = 1.45%)；正交试验结果为加水12倍量水，煎煮3次，每次45 min。结论：本实验建立以盐酸小檗碱为最佳工艺的硝英洗液提取工艺，该工艺方法合理、工艺可靠，可以作为大生产的提取条件。

Abstract: Objective: To establish the orthogonal test optimization process of Xiaoyin xiji with the small sacilline hydrochloride as the inspection index. Methods: Using HPLC method, the color column of Wonda Sil C18 (250 mm × 4.6 mm, 5 m) was used, and the acetylene-0.1% phosphoric acid solution (50:50) for the flow phase, flow rate of 1.0 mL/min, detection wavelength of 265 nm, column temperature of 30 degrees C, with orthogonal test method to optimize the extraction process of Xiaoyin xiji. Results: Small carbapenum hydrochloride at 0.078125 mg/mL to 0.125 mg/mL range, the linear relationship is good, and the regression equation y = 19947x − 8.6951, R2 = 1. The average sample recovery was 99.19% (n = 6), RSD was 1.45%. Conclusion: In this experiment, the Xiaoyin xiji extraction process with hydrochloric acid as the best process is es-tablished, which is reasonable and reliable, and can be used as the extraction condition for large-scale production.