大株红景天注射液在PIVAS集中配置后合理使用时间的研究

Study on the Reasonable Using Time of Sofren Injection After Drug Allocation in PIVAS

关键词:  大株红景天注射液  静脉用药集中调配中心  合理使用时间  高效液相色谱法

Key words:  Sofren injection  PIVAS  the reasonable using time  HPLC

摘要:

目的 研究大株红景天注射液与5%葡萄糖注射液和0.9%氯化钠注射液2种溶媒在静脉用药集中调配中心（pharmacy intravenous admixture services，PIVAS）集中配置后的合理使用时间。方法 将大株红景天注射液与5%葡萄糖注射液和0.9%氯化钠注射液在PIVAS集中配置后，观测其在常温下0~6 h内外观、pH值、不溶性微粒的变化。利用高效液相色谱法测定其主要成分红景天苷、酪醇在0~6 h内的稳定性。结果 大株红景天注射液与5%葡萄糖注射液和0.9%氯化钠注射配伍后，在常温下0~6 h内其外观、pH值、不溶性微粒均符合中国药典2015年版的要求。其主要成分红景天苷和酪醇的含量在0~6 h内稳定。结论 大株红景天注射液与5%葡萄糖注射液和0.9%氯化钠注射液2种溶媒在PIVAS集中配置后的合理使用时间为6 h。

Abstract:

OBJECTIVE To investigate the reasonable using time of Sofren injection with 5% glucose injection and 0.9% sodium chloride injection after drug allocation in pharmacy intravenous admixture services(PIVAS). METHODS Sofren injection was allocated with 5% glucose injection and 0.9% sodium chloride in PIVAS, and the changes were evaluated in appearance, pH values and insoluble particle in 6 h at room temperature. The stability of salidroside and tyrosol which were the main components of Sofren injection in 6 h was determined by HPLC. RESULTS After the allocation of Sofren injection with 5% glucose injection and 0.9% sodium chloride injection, its appearance, pH values and insoluble particles met the requirements of the Chinese Pharmacopoeia 2015 Edition within 6 h at room temperature. Salidroside and tyrosol were stable within 6 h. CONCLUSION The reasonable using time of Sofren injection with 5% glucose injection and 0.9% sodium chloride injection after drug allocation in PIVAS is 6 h.