4种常用中药注射液不同浓度对不溶性微粒的影响

Effects of Different Concentrations of 4 Traditional Chinese Medicine Injections on Insoluble Particles

目的:考察4种常用中药注射液与0.9%氯化钠注射液不同浓度配伍的不溶性微粒数变化,为临床选择药物浓度提供参考。方法:将复方苦参注射液、疏血通注射液、鹿瓜多肽注射液、注射用红花黄色素用0.9%氯化钠注射液制成低浓度和高浓度溶液,按照中国药典2015版第四部通则0903不溶性微粒检查法测定其配伍前与配伍后0,2,4,5 h的不溶性微粒数。结果:4种中药注射剂原液和0.9%氯化钠注射液不溶性微粒符合要求;4种中药注射剂不同浓度下≥25μm不溶性微粒数量都很少,几乎不随时间变化;4种中药注射剂≥10μm不溶性微粒数总体呈现高浓度输液中的微粒数略多于低浓度,随时间变化趋势各不相同。结论:高浓度中药注射剂输液中≥10μm不溶性微粒数较低浓度中药注射剂输液略多,建议临床按照说明书规定的浓度进行药物稀释,并尽快使用。

Objective： To investigate the change of insoluble particles in 4 traditional Chinese medicine injections at difterent con- centrations in 0.9% NaC1 injection. Methods： Fnfang Kushen injection, Shuxuetong injection, Lugua Duotai injection and Honghua Huangsesu injection were diluted by 0.9% sodium chloride injection to obtain low concentration and high concentration solutions. The insoluble particles number of initial injections and dilutions at different time points（0,2,4, and 5 h） was detected according to the in- soluble particles test described in the fourth principle 0903 of China Pharmacopoeia （2015 edition）. Results：The number of insoluble particles in 4 traditional Chinese medicine injections and 0.9% sodium chloride injection met the requirements. The insoluble particles （≥25 μm） in 4 traditional Chinese medicine injec.tions at different concentrations were few and ahnost stable with time, the insoluble particles（ ≥10 μm） showed an increasing trend in a concentration-dependent manner and varied with time. Conclusion： The insoluble particles（≥ 10 μm） in traditional Chinese medicine injections at high concentration are more than those at low concentration, which suggests that the concentration of traditional Chinese medicine injections should be restricted strictly according to the prescriptions and used up as soon as possible.