Investigation of Systematic Stability of Danshen Capsules / 中国实验方剂学杂志

ABSTRACT

Objective:To prepare Danshen extract and Danshen capsules, and study on its stability under high humidity, high temperature and light conditions.To determine the hygroscopicity of Danshen capsules and its intermediates. Method:The contents of danshensu, rosmarinic acid, lithospermic acid and salvianolic acid B in Danshen extract and Danshen capsules were determined by UPLC, the detection wavelength was 280 nm and the mobile phase was 0.05% phosphoric acid aqueous solution(A)-acetonitrile(B)for gradient elution(0-2 min, 93% -79.2% A;2-6 min, 79.2% -75% A;6-9 min, 75% -65% A;9-10.5 min, 65% -10% A;10.5-11 min, 10% -93% A).The critical relative humidity(CRH) was calculated and hygroscopic isothermal curve was drawn by determining the moisture absorption and weight gain of Danshen capsules and its intermediates. Result:The fluctuation of contents of these four phenolic acids in Danshen extract and Danshen capsules was within±10% and no significant change trend after placing at temperature of 40℃, relative humidity of 75% and 92.5%, light intensity of (4 500±500) Lx for 10 days.The change rates of danshensu in Danshen extract and Danshen capsules under 60℃ were 47.45% and 32.24%, and change rates of salvianolic acid B were -6.39% and -9.64%, respectively.The hygroscopic investigation showed that CRH of starch-based pellets was 58.5%, CRH of Danshen extract was 72.34%, CRH of coated pills was 72.85%, and CRH of Danshen capsules was 73.55%. Conclusion:High temperature has effect on stability of phenolic acids in Danshen extract and Danshen capsules, in order to ensure the quality of them, high temperature environment should be avoided.In order to prevent excessive moisture absorption of Danshen capsules and its intermediates, the relative humidity in the production and storage environment should be controlled below the corresponding CRH.