感康灵喷雾剂质量标准研究

Study on quality specifications of Gankangling aerosol

目的:通过定性和定量两方面为建立感康灵喷雾剂质量标准提供技术参考。方法:薄层色谱法鉴别复方中药中的金银花、黄芩、虎杖、柴胡、广藿香和薄荷等成分。高效液相色谱法测定绿原酸和黄芩苷的含量,色谱柱均为 Kromasil(250mm×4.6mm,5μm)。测定绿原酸的流动相为:乙腈-0.4%磷酸溶液(13∶87),检测波长327nm;黄芩苷的流动相为:甲醇-水-磷酸(40∶60∶0.2),检测波长280nm。结果:在 TLC 中均能检出金银花、黄芩、虎杖、广藿香、柴胡和薄荷。绿原酸在0.2～1.0μg范围内具有良好的线性关系(r=0.9999),平均回收率(n=5)为100.5%(RSD 为0.98%);黄芩苷在0.22～1.1μg范围内具有良好的线性关系(r=0.9999),平均回收率(n=5)为99.53%(RSD 为1.3%)。结论:该定性定量方法准确可行,重复性好,可作为感康灵喷雾剂的质量标准基础。

Objective： To develop a technical reference for the establishment of quality control standard of Gankangling aerosol. Method： TLC identification was developed for components in a TCM compound Gangkangling： Flos Lonicerae, Radix Scutellariae, Rhizoma Polygoni Cuspidati, Radix Bupleuri, Herba Pogostemonis, and Herba Menthae. The contents of the main pharmacological constituents in the medicine, chlorogenic acid and baicalin were determined by HPLC ,with acetonitrile -0. 4% phosphoric acid（ 13：87 ） and methanol - water - phosphoric acid（40： 60：0. 2）as mobile phases at a flow rate of 1.0 mL · min^-1 and room temperature,detected at 327 nm and 280 nm for chlorogenic acid and baicalin, respectively. Results： The TLC spots of the above - mentioned TCM were distinctive and coincident with the respective standards. By using our chromatographic conditions, chlorogenic acid and baicalin could be baseline separated with other constituents in the sample, determined with satisfactory accuracy and precision,with average recovery of 100. 5% and 99. 53% for chlorogenic acid and baicalin,respectively. The RSD （n =5 ）of chlorogenic acid and baicalin were 0. 98% and 1.3% ,respectively. The linear ranges of chlorogenic acid and baicalin were 0. 2 - 1.0μg （ r = 0. 9999 ） and 0. 22 - 1.1 μg （ r - 0. 9999 ）, respectively. Conclusion： The research on Gankangling aerosol quality specifications can be the basis for quality control of the medicine.