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5种输液调配的生脉注射液成品输液稳定性考察

         

摘要

Objective To explore the compatible stability of Shengmai injection with 5% glucose injection (5%GS),10% glucose in-jection (10%GS),0.9% sodium chloride injection (0.9%NS),glucose and sodium chloride injection (GNS)and sodium lactate Ringer's injection (SLR).Methods At room temperature,Shengmai injection was mixed with the above 5 infusion solutions,and then the appearance,pH value,insoluble particle and the content of Schisandrin were observed within 8 h under clean conditions.Results No significant changes were found in the appearance,pH value and the content of Schisandrin of all mixed solutions within 8 h;the number of insoluble particles in the mixture of 5% GS,0.9% NS,10% GS and GNS conformed to the standard of Chinese Pharmaco-peias within 4h.Conclusion Shengmai injection should be mixed with 5% GS ,0.9% NS,10% GS or GNS and be used within 4 h.%目的:考察生脉注射液用5%葡萄糖注射液(5%GS)、10%葡萄糖注射液(10%GS)、0.9%氯化钠注射液(0.9%NS)、葡萄糖氯化钠注射液(GNS)和乳酸钠林格注射液(SLR)调配后成品输液的稳定性。方法洁净条件下,生脉注射液用上述5种输液调配为成品输液,室温(25℃)8 h 内观察成品输液的性状、pH、不溶性微粒数及 HPLC 法检测五味子醇甲的含量变化。结果5种成品输液的外观、pH 及五味子醇甲含量均无明显变化;用5%GS、10%GS、0.9%NS 和 GNS 调配的成品输液,4 h 内不溶性微粒符合2010年版《中国药典》一部规定,但用 SLR 调配的成品输液不溶性微粒不符合其规定。结论生脉注射液可以用5%GS、10%GS、0.9%NS 或 GNS 调配为成品输液,并在4 h 内使用。

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