盐酸溴己新3种注射剂型静脉滴注时药物含量的变化

目的比较盐酸溴己新注射液(水针,liquid injection)、注射用盐酸溴己新(粉针,solid injec-tion)和盐酸溴己新葡萄糖注射液(葡萄糖输液,glucose infusion)3种制剂在配制与注射过程中药物含量的变化。方法粉针、水针分别加至葡萄糖注射液中静脉滴注,与葡萄糖输液比较配制与注射过程中滴出液中盐酸溴己新含量的变化。结果粉针、水针与葡萄糖注射液混合振摇10 min与振摇1 min药物含量差异没有统计学意义;粉针、水针经输液器输注过程中,出现药物含量下降,在每分钟30滴的滴速下,粉针含量质量分数下降最高达9.2%,水针含量质量分数下降最高达19.8%,输液药物含量在输注过程中没有下降;粉针、水针在滴速为每分钟15滴时,药物含量下降多于每分钟30滴和60滴。药物滴完后,测定滴管内的药物残留量,发现输液器内有药物残留,比较不同厂家生产的8种输液器,其均有不同程度的药物残留,导致粉针、水针输注到患者体内的药量明显减少。结论冻干粉针、小水针在滴注过程中出现输液器对药物的吸附问题,注射速度越慢,药物进入患者体内的量越少,药物的含量质量分数最高损失可达标示量的20%。提示临床用药时注意!

Effect of injectable formulation on the content of bromhexine hydrochloride during injection

Objective To compare the change of the drug contents of three injectable formulations of bromhexine hydrochloride:glucose injection,solid injection,liquid injection in the preparation and the injection process.Methods Solid injection and liquid injection were added to the 50 g · L-1 glucose injection respectively,together with the bromhexine hydrochloride glucose injection,and dropped through injector respectively,the flow out liquid was collected and the content of bromhexine hydrochloride was determined by HPLC method.Results There were no difference on the drug contents of solid injection,liquid injection and glucose injection when mixed by shaking for 10 min or 1 min.Drug content appeared to decline during the process of infusion by solid injection and liquid injection.The content of solid injection was decreased by 9.2%,and that of liquid injection was decreased by 19.8%,drug content of glucose injection did not decline in the infusion process;drug contents of solid injection and liquid injection were decreased more with the dripping speed of 15 drop · min-1 than that with 60 drop · min-1.Further more,when the residue of bromhexine hydrochloride was determined in the injector after infusion,it was discovered that the drug content nearly equal to the lost of bromhexine hydrochloride during infusion.The results showed that all the different injector appeared the adsorption to the drug.Conclusions Bromhexine hydrochloride is lost during the injection of bromhexine hydrochloride and bromhexine hydrochloride injection.And the lost drug can be adsorbed by the injector,the slower of the drug drips,the more of the drug loses.