丹参注射液与临床常用输液配伍的稳定性研究

Study on the Stability of the Compatibility of Danshen Injection with Common Clinical Infusion

目的探讨丹参注射液与临床常用输液0.9%氯化钠注射液(0.9%NS),5%葡萄糖注射液(5%GS),10%葡萄糖注射液(10%GS),葡萄糖氯化钠注射液(GNS),转化糖注射液及果糖注射液配伍后的稳定性。方法按说明书中推荐剂量,将丹参注射液与常用溶媒配置的成品输液,在光照与遮光的环境下,分别置于常温(10~30℃)、高温(35~37℃)、低温(4~8℃)下,考察成品输液8 h内配伍溶液的外观、pH、不溶性微粒及主要有效成分的含量变化情况。结果丹参注射液与6种溶媒配伍后的成品输液外观、pH均无明显改变(RSD≤1%)。20 mL丹参注射液与100 mL 5%GS配伍的高浓度成品输液及与250 mL 5%GNS、0.9%NS、转化糖注射液配伍的常规浓度成品输液,不溶性微粒超出药典(2015版)标准,时间、温度对不溶性微粒的影响差异有统计学意义(P<0.01或P<0.05);且低温与高温、低温与常温条件下的不溶性微粒数有差异,差异有统计学意义(P<0.01或P<0.05),高浓度成品输液在高温8 h时原儿茶醛含量最大下降约14%,丹参素钠含量变化<2.5%,在其余溶媒中丹参素钠、原儿茶醛含量较稳定,含量变化不超过2.7%。结论丹参注射液与溶媒配伍的成品输液浓度较高时,温度、光照和时间对其质量有一定影响,应尽量避免在高温和阳光直射的环境中输注,且应在6 h内使用。非病情必须,不推荐大剂量、高浓度输注该品的成品输液。

Objective To explore Danshen injection and common clinical infusion 0.9%sodium chloride injection(0.9%NS),5%glucose injection(5%GS),10%glucose injection(10%GS),glucose sodium chloride injection(GNS),the stability of the compatibility of invert sugar injection and fructose injection.Methods According to the recommended dosage in the instructions,the finished product of Danshen injection and common solvents were infused under light and shading environment,respectively,at room temperature(10-30℃),high temperature(35-37℃),and low temperature(4-8℃),the appearance,pH,insoluble particles and the content of the main active ingredients of the compatible solution of the finished infusion solution within 8 h were investigated.Results There was no significant change in appearance and pH of the finished product infusion after Danshen injection and 6 kinds of solvents(RSD≤1%).The high-concentration finished infusion of 20 mL Danshen injection compatible with 100 mL 5%GS and the regular-concentration finished infusion compatible with 250 mL 5%GNS,0.9%NS,and invert sugar injection.Insoluble particles exceed the standards of the Pharmacopoeia(2015 edition).There were statistically significant differences in the effects of time and temperature on insoluble particles(P<0.01 or P<0.05);and the differences in the number of insoluble particles between low temperature and high temperature,low temperature and normal temperature was statistically significant(P<0.01 or P<0.05).Protocatechuic aldehyde content of high-concentration finished infusion solution at high temperature for 8 h will decrease by about 14%,and the content of danshensu sodium will change less than 2.5%.In other solvents,the content of danshensu sodium and protocatechuic aldehyde was relatively stable.The change did not exceed 2.7%.Conclusion When the concentration of the infusion of the finished product of Danshen injection and solvent is high,temperature,light and time have certain effects on its quality.It should be avoided in the environment of high temperature and direct sunlight,and should be used within 6 h.It is not necessary for the condition,and it is not recommended to inject the finished infusion of this product in large doses and high concentrations.