医院静脉药物配置条件下丹参多酚酸盐输液的不溶性微粒考察

Measurement of Insoluble Particles in Salvianolate Injection in Pharmacy Intravenous Admixture Service

目的测定在医院静脉药物配置条件下注射用丹参多酚酸盐输液中的不溶性微粒,考察各配置条件(浓度、溶媒、静置时间)对其输液的不溶性微粒影响。方法根据统计的处方,在医院静脉药物配置中心完成输液的配置,并采用中国药典2010年版规定的不溶性微粒检查法测定丹参多酚酸盐进入患者体内前输液中不溶性微粒的数量。结果选用5%葡萄糖或0.9%氯化钠注射液作溶媒,输液在8 h内符合中国药典对不溶性微粒数目的要求;输液中的较小微粒(粒径≥2μm)数目明显比较大微粒(粒径≥10μm)的数目多,差异具有统计学意义(P<0.05);配制的高浓度(0.8 g·L?1)输液较低浓度(0.4 g·L?1)输液更易产生较多不溶性微粒。结论医院在配制丹参多酚酸盐输液时应选用5%葡萄糖或0.9%氯化钠注射液作溶媒,在按照说明书规定的用法用量情况下应选择较低的配置浓度(0.4 g·L?1),输液配制完毕后应尽快用完。

OBJECTIVE To determine the insoluble particles in Salvianolate injection in Pharmacy Intravenous Admixture Service（PIVAS） at different drug concentrations, different solvents and different time. METHODS According to the statistics of the prescription, admixed in the PIVAS and measured the quantity of insoluble particles in salvianolate solution by light blockage method specified in Ch.P 2010. RESULTS While 5% glucose or 0.9% sodium chloride injection was used as solvent, the number of insoluble particles conformed to the Ch.P 2010 in 8 h. The number of small particles（size≥2 μm） significantly bigger than the large particles（size≥10 μm）（P〈0.05）. In the high concentration（0.8 g·L-1） solution, the number of insoluble particles was bigger than the lower concentrations（0.4 g·L-1）. CONCLUSION The 5% glucose or 0.9% sodium chloride injection can be used as the solvent, in according to the drug specification low concentration（0.4 g·L-1） should be choosed and the solution should be used for patients as soon as possible.