舒肝宁注射液配伍稳定性的考察

Study on the Compatibility Stability of Shuganning Injection

关键词:  舒肝宁注射液  成品输液  不溶性微粒  高效液相色谱法  绿原酸  栀子苷  黄芩苷

Key words:  Shuganning injection  infusion  insoluble particles  HPLC  chlorogenic acid  geniposide  baicalin

摘要:

目的 考察不同浓度舒肝宁注射液配制后成品液在不同条件下的质量及稳定性。方法 将10 mL或20 mL舒肝宁注射液与250 mL 10%葡萄糖溶液配伍后，放置于室温、光照（4 500 Lx）、40℃恒温环境下，在不同时间点考察舒肝宁注射液的性状、pH值、不溶性微粒、有效成分（绿原酸、栀子苷和黄芩苷）的含量。结果 舒肝宁注射液成品液在放置过程中性状无明显变化。室温和光照对pH值的影响较小，40℃恒温时低浓度和高浓度溶液随着时间的延长，pH值略有下降。舒肝宁注射液成品液在室温、光照和40℃恒温条件下不溶性微粒24 h内没有超限，符合药典规定。舒肝宁注射液在室温下放置12 h，低浓度和高浓度溶液中3种成分绿原酸、栀子苷、黄芩苷含量变化均不大；24 h光照和40℃恒温条件下3种成分含量均有下降，而40℃恒温对其影响更大。结论 舒肝宁注射液在光照和40℃恒温条件下绿原酸、栀子苷和黄芩苷含量均有下降，室温时比较稳定、下降较少。因此配制后的舒肝宁注射液应放置在室温条件，避免强光照射；建议成品液尽可能在12 h内输注；超过24 h后谨慎使用。

Abstract:

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.