Study on the Compatibility Stability of Shuganning Injection

OBJECTIVE To investigate the quality and stability of different concentrations of Shuganning injection solution under different conditions. METHODS Shuganning injections were diluted by 10% glucose injection and were divided into low concentration group and high concentration group. The sulutions were respectively placed in room temperature, illumination 4 500 Lx and 40℃ constant temperature. Stability were studied by changes of appearance, pH value, insoluble particles, the contents of effective components (chlorogenic acid, geniposide, baicalin) in the solutions. RESULTS The Shuganning injection solution remained clear within 24 h, showed no obvious turbidity, sedimentation or change of appearance. The pH value was less affected by room temperature and illumination, but the pH value of the low concentration group and high concentration group exposed to 40℃ decreased slightly with time. The insoluble particles of Shuganning injection solutions didn't exceed the limit in 24 h under different conditions, which accorded with the requirements of Chinese Pharmacopoeia. At room temperature for 12 h, the contents of chlorogenic acid, geniposide and baicalin in low and high concentration solutions didn't change. The contents of three components decreased at 24 h under irradiation and 40℃, and 40℃ had greater influence on them. CONCLUSION The stability of Shuganning injection is different in different environments. The contents of effective components (chlorogenic acid, geniposide, baicalin) are more stable at room temperature than under illumination and 40℃. Therefore, Shuganning injection solutions shall be placed at room temperature, while avoiding strong light. It is recommended that the solutions be injected into the 12 h as far as possible, and be used cautiously after exceeding 24 h.