The Study On Preparation Process And Quality Standards Of Yuqin Jiedu Pills

Objective:To research the preparation technology and establish the qμality standards of Yuqin Jiedu pills.Methods:(1)To determine the optimal water extraction process parameters by baicalin,chlorogenic acid content and total polysaccharides as index.(2)To investigate the parameter of shaping process of Yuqin Jiedu pills by single factor experiment.(3)Thin layer chromatography was used to qualitatively identify all species of medical materials of Yuqin Jiedu pills.(4)To determine the contents of baicalein and paeonol of Yuqin Jiedu pills by HPLC,Chromatographic conditions:baicalin mobile phase was methanol-0.4%phosphoric acid(47:53),detection wavelength was 280 nm。the paeonol mobile phase was methanol-1%acetic acid(55:45),detection wavelength was 274nm,the column temperature were 30 C,flow were of 1.0mL/min.The injection volume were10μL.Result:(1)The optimum water extracting technology was as follows:10 times the amount of water extracted three times,each time 1 hour.(2)The best pills molding technological conditions for:thick paste the relative density was 1.35(60℃),powder fineness was 100 mesh,thick paste and powder use ratio was 1.5:1,drying temperature was 70℃,dry time for 48 hours;(3)To set up the qualitative differentiation with the method of TLC of Scutellaria baicalensis,Cortex moutan,Houtttuynia cordata,this method strong specificity,TLC spots were faily clear;(4)Assay results showed that baicalin in 0.070～0.704mg/mL within a good linear relationship(r=0.9997),with an average recovery was 102.44%,RSD was 0.93%.Paeonol in 9.52～152.32μg/mL within a good linear relationship,r=0.9998,average recovery was 95.52%,RSD was 0.22%。Conclusion:The extraction technology was stable,simple and feasible.this study set up quality standard were was reliable and accurate,and can effectively control the quality of the preparations.