RESUMO
OBJECTIVE：To optimize the inclusion technology of volatile oil from Ganmao qingre granules. METHODS ： Guided by the concept of “quality by design ”，taking volatile oil inclusion rate and inclusion complex yield as key quality attribute，comprehensive score of above two indexes after weighting as response value ，inclusion temperature ，inclusion time ，the ratio of β-CD to volatile oil as key technology parameters ，Box-Burman response surface design was adopted to establish the design space of key technology parameters and key quality attributes. The design space was optimized and verified by 95％ confidence interval. The stability of inclusion complex was investigated preliminarily. RESULTS ：The optimal design space ，i. e. the optimal technology parameters rang ，included inclusion temperature 35-40 ℃，inclusion time 1.8-2.0 h，the ratio of β-CD to volatile oil 9.5∶1- 10∶1（g/mL）. The results of 3 validation tests showed that the volatile oil inclusion rates were all over 62％，the yields of inclusion complex were all over 75％，and the comprehensive scores were all over 80 point. The results of preliminary stability showed that the inclusion rate of volatile oil ，the yield of inclusion complex and the comprehensive score did not change significantly. The difference in evaluation indicators within 7 days was within 5％. CONCLUSIONS ：The optimized inclusion technology is feasible ， and the obtained inclusion complex is stable.
RESUMO
OBJECTIVE:To establish a method for simultaneously determination of glycyrrhizic acid and glycyrrhetinic acid in Yaotongning capsule. METHODS:HPLC was performed on the column of Agilent TC-C18 with mobile phase of methanol-0.2 mol/L ammonium acetate(gradient elution) at a flow rate of 1.0 ml/min;detection wavelength was 250 nm and column temperature was 25 ℃ and injection volume was 10 μl. RESULTS:The linear range was 0.007 1-0.178 0 mg/ml(r=0.999 8)for glycyrrhizin acid and 0.354 8-8.720 0 μg/ml of glycyrrhetinic acid(r=0.999 8);RSDs of precision,stability and reproducibility tests were no more than 1.74%,average recoveries were 95.49%-100.62%(RSD=1.98%,n=9)and 96.80%-102.26%(RSD=1.83%,n=9),respec-tively. CONCLUSIONS:The method is simple,reproducible,accurate and reliable,and can be used for the simultaneous determi-nation of glycyrrhizic acid and glycyrrhetinic acid in Yaotongning capsule.