大株红景天注射液配伍稳定性考察

Study on the Compatibility Stability of Sofren Injection

关键词:  大株红景天注射液  配伍  稳定性  不溶性微粒  高效液相色谱法

Key words:  sofren injection  compatibility  stability  insoluble particles  HPLC

摘要:

目的 考察大株红景天注射液配制后溶液在不同条件下的质量稳定性。方法 将10 mL大株红景天注射液与5%葡萄糖注射液250 mL配伍后，放置于室温（10~30℃）、光照（4 500 Lx）、40℃恒温环境下，在不同时间点考察大株红景天注射液的性状、pH值、不溶性微粒和有效成分（红景天苷和酪醇）的含量。结果 大株红景天注射液配伍溶液在放置过程中性状无明显变化，12 h内pH值几乎无变化，24 h内略微下降。光照条件下，溶液在24 h微粒数超出药典规定；其他条件在24 h内微粒数均未超过药典规定。红景天苷含量受光照影响在24 h时下降了5.34%，在室温和40℃恒温条件下放置24 h比较稳定。酪醇24 h内在以上条件下均比较稳定。结论 建议配制后的大株红景天溶液在12 h内输注完毕，超过24 h后需谨慎使用，同时应该避免强光直射。

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.