肠安口服液的质量标准研究

Study on the Quality Standard of Changan Oral Liquid

目的：制定肠安口服液的质量标准。方法：采用薄层色谱法定性鉴别黄芩、芍药和甘草，用高效液相色谱法测定制剂中黄芩苷的含量。以C18化学键合硅胶为固定相，以甲醇-水-磷酸（50：50：0．3）为流动相，检测波长为280nm。结果：定性鉴别色谱特征明显，重现性好。黄芩苷在9．6～57．60μg／mL范围内呈良好的线性关系，r=0．9998，平均回收率为98．70％，RSD=3．10％。结论：上述方法可靠、实用，可有效地控制该制荆的质量。

Objective ：To establish the quality standard of Changan Oral Liquid. Methods ：Radix Scutellariae, Radix Paeoniae Alba and Radix Glycyrrhizae were identified by TLC. The content of baicalin was determined by HPLC, with Cls chemical bonded silica gel as solid phase and methanol- water- phosphoric acid （50： 50： 0.3）as mobile phase. UV detection wavelength was at 280nm. Results ： The characteristics for identification by TLC were distinct. The linear range was 9.6 - 57.61μg/mL, r = 0. 9998. The average recovery of baicalin was 98.70%. RSD was 3.10%. Conclusion ：The methods above - mentioned were reproducible and realizable, and can effectively control the quality of Changning Oral Liquid.