Study on Quality Standard of Chailing Hugan Granules / 中国药房

ABSTRACT

OBJECTIVE:To establish the quality standard of Chailing hugan granules. METHODS:TLC was used for qualitative identification of Radix bupleuri,Atractylodes macrocephala and Glycyrrhiza uralensis. The content of total flavonoids (by rutin) in preparation was determined by UV-visible spectrophotometry. The moisture, dissolubility and granularity of preparation were determined. RESULTS:TLC spots of R. bupleuri ,A. macrocephala and G. uralensis were clear and well-separated without interference from negative control. The linear range of rutin was 0.050-0.300 mg/mL(r＝0.999 8). RSDs of precision, stability and reproducibility tests were all lower than 2%. The recoveries were 97.89%-100.01%(RSD＝0.68%,n＝9). The content of samples were 1.920-2.018 mg/g. The contents of moisture in 3 batches of samples were 1.54%,1.62% and 1.57%;all samples dissolved within 5 min. The sum of granules not passing through No.1 sieve and passing through No.5 sieve were 2.13%, 2.51%,2.38%,which were all in line with the requirements of Chinese Pharmacopeia (2015 edition,Vol Ⅳ). CONCLUSIONS:The content of total flavonoicle in Chailing hugan granules should be no less than 1.57 mg/g (by rutin). Established quality standard is simple,rapid,accurate and reproducible,and can be used for quality control of Chailing hugan granules.