Study on Quality Standard of Danshen Capsules / 医药导报

ABSTRACT

Objective To establish a new quality control standard for danshen capsules. Methods The qualitative identification of danshen capsules was characterized by ultraviolet fluorescence and thin-layer chromatography( TLC ). The contents of tanshinoneⅡA,cryptotanshinone,salvianolic acid B,danshensu and protocatechuic aldehyde in danshen capsules were determined by high performance liquid chromatography(HPLC)on a C18 column. The flow rate was 1 mL·min-1,and the column temperature was 35 ℃. Results The HPLC linear ranges of tanshinone ⅡA,cryptotanshinone,salvianolic acid B, danshensu and protocatechuic aldehyde were 2. 046-40. 92 μg · mL-1 ,1. 482 25 -59. 29 μg · mL-1 ,1. 502 55 -60. 102 μg·mL-1 ,11. 49-459. 582 μg·mL-1 ,and 0. 617 4-24. 696 μg·mL-1 ,respectively,and r values were 0. 999 9. The average recoveries were 99. 66%(RSD of 0. 91%)for tanshinoneⅡA,99. 26%(RSD of 0. 88%)for cryptotanshinone,99. 09%(RSD of 0. 76%)for salvianolic acid B,100. 51%(RSD of 0. 62%)for danshensu,and 100. 62%(RSD of 0. 82%)for protocatechuic aldehyde,respectively. The contents of the tanshinoneⅡA,cryptotanshinone,salvianolic acid B,danshensu showed a certain high level in the 3 batches of danshen capsule samples,but protocatechuic aldehyde was low by comparison. Conclusion The HPLC method is proven to be sensitive,accurate,repeatable,and can be used for quality control of the danshen capsules.