颠胃酸口服液的制备与质量控制

目的：建立颠胃酸口服液的制备工艺及质量控制方法。方法：用溶胀溶解法制备颠胃酸口服液；用酸碱滴定法测定其盐酸含量；以HPLC法测定该制剂中东莨菪碱的含量。色谱柱为Diamonsil—C18柱（250mm×4．6mm，5μm）；流动相为0．25％十二烷基硫酸钠溶液（用磷酸调pH为2．5）-乙腈（60：40），流速1．0ml·mn^-1，检测波长210nm，进样量20μl，柱温30℃。结果：东莨菪碱在2．6—130．0μg·ml^-1。范围内线性关系良好（r=0．9995），回收率为97．3％（mD=0．93％，n=6）。结论：所拟制备方法可行，制剂质量稳定，所建立质量控制方法实用、便捷。

Preparation and Quality Control of Dianweisuan Oral Liquid

To establish the preparation and quality control methods for Dianweisuan oral liquid. Method： Dianweisuan oral liquid was prepared by swelling-dissolving method. The content of HC1 was determined by acid-base titration and the content of scopolamine was determined by HPLC. The column was DiamonsiL-Cls （250 mm×4. 6 ram,5 μm） ,the mobile phase was 0. 25% sodium dodecyl sulfate solution （pH adjusted to 2.5 by phosphoric acid）-acetonitrile （60： 40） ,the flow rate was 1.0 ml.min^ -1 ,UV detection Wavelength was at 210 nm,the injection volume was 20μ1 and the column temperature was 30℃. Result： The content of scopolamine was linear within the range of 2. 6-130. 0 μg· ml ^- 1, and the average recovery was 97. 3 % with RSD of 0. 93 % （ n = 6 ）. Conclusion： The preparation technology of Dianweisuan oral liquid was feasible and stable, and the quality control method was simple and practical.