Study on dissolution test of Xinkeshu capsule / 中国生化药物杂志

ABSTRACT

Objective To establish a method of the dissolution test of Xinkeshu capsule and study the dissolution behavior of sodium Danshensu, protocatechuic aldehyde, salvianolic acid B and puerarin in Xinkeshu capsule.Methods Using the dissolution determination first law of Chinese Pharmacopoeia 2010 II edition, according to the dissolution test conditions in Japan′s“quality of medical drugs information set”, different Xinkeshu capsule were inspected in pH 1.2 solution,pH 4.0 acetate buffer, pH 6.8 phosphate buffer and water.The HPLC gradient elution method was adopted to determine the dissolution of sodium Danshensu,protocatechuic aldehyde,salvianolic acid B and puerarin in Xinkeshu capsule.ResuIts Dissolution of sodium Danshensu, protocatechuic aldehyde, puerarin and salvianolic acid B of Xinkeshu capsule sample from each manufacturer were in good condition, 45min dissolution were 80% and dissolution uniformity.ConcIusion The method is simple, accurate and reproducible for the dissolution determination of this capsule .