Study on the Improvement of Quality Standard of Jianpi Zhixiening Granules / 中国药房

ABSTRACT

OBJECTIVE:To improve the quality standard of Jianpi zhixiening granules. METHODS:TLC was applied for qual-itative identification of Scutellaria baicalensis,Crategi Fructus,Lonicerae japonicae,Codonopsis Radix,Nelumbo nucifera,Copti-dis Rhizoma. The contents of berberine hydrochloride and baicalin were determined by HPLC. The determination was performed on Shimadzu VP-ODS column with mobile phase consisted of methanol-acetonitrile-water (463042,V/V/V,berberine hydrochlo-ride))(0.1% sodium dodecylsulphate,0.1% phosphoric acid,methanol-0.4% phosphoric acid(5050,V/V,baicalin)at the flow rate of 1.0 mL/min. The detection wavelengths were set at 265 nm (berberine hydrochloride) and 280 nm (baicalin). The column temperature was 30 ℃,and sample size was 10 μL. RESULTS:TLC spots of S. baicalensis,Crategi Fructus,L. Japonicae,Co-donopsis Radix,N. nucifera,Coptidis Rhizoma were clear and well-separated without negative interference. The linear ranges of berberine hydrochloride and baicalin were 6.67-33.34 μg/mL(r=0.9998)and 7.7-38.7 μg/mL(r=0.9999). RSDs of precision,sta-bility and reproducibility tests were all lower than 1.0% . The recoveries were 96.5% -99.9%(RSD=1.2% ,n=6)and 101.1%-102.9%(RSD=0.6%,n=6). CONCLUSIONS:Improved standard can be used for quality control of Jianpi zhixiening granules.