Abstract:
OBJECTIVE To investigate the quality and stability of sofren injection solution under different conditions.
METHODS Sofren injection was diluted by 250 mL 5% glucose injection. The sulutions were respectively placed in room temperature(10-30℃), illumination 4 500 Lx and 40℃ constant temperature. Stability were studied by changes of appearance, pH value, insoluble particles, the contents of effective components(salidroside and tyrosol) in the solutions.
RESULTS The sofren injection solutions remained clear within 24 h, showed no obvious turbidity, sedimentation or change of appearance. The pH value was less affected under different conditions within 12 h and decreased slightly within 24 h. The insoluble particles of sofren injection solutions exceeded the limit in 24 h under irradiation, which accorded with the requirements of Chinese Pharmacopoeia. Other conditions did not exceed the requirements within 24 h. The content of salidroside decreased by 5.34% at 24 h under the influence. Under other conditions, salidroside and tyrosol were stable.
CONCLUSION It is recommended that the solutions should be injected in 12 h as far as possible, and be used cautiously after exceeding 24 h, while avoiding strong light.