盐酸溴己新注射剂配伍稳定性考察

Compatibiliy Stability of Bromhexine Hydrochloride Injection

目的 考察注射用盐酸溴己新、盐酸溴己新注射液与不同溶媒配伍后的成品输液稳定性。方法 将注射用盐酸溴己新、盐酸溴己新注射液分别与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(NS)及葡萄糖氯化钠注射液(GNS)配伍,考察各成品输液于室温下放置24 h的外观、不溶性微粒、pH值、渗透压、盐酸溴己新含量及有关物质。结果 注射用盐酸溴己新分别与5%GS 50 mL、5%GS 100 mL、5%GS 250 mL及NS 250 mL配伍;盐酸溴己新注射液分别与5%GS 50 mL、5%GS 100 mL、5%GS 250 mL、NS 100 mL、NS 250 mL及GNS 100 mL配伍后,各成品输液外观、不溶性微粒、pH值、渗透压、盐酸溴己新含量及有关物质在24 h内相对稳定。注射用盐酸溴己新与10%GS 100 mL、GNS 100 mL及NS 100 mL配伍0 h后不溶性微粒数目不符合要求,与NS 100 mL和GNS 100 mL配伍2 h后百分含量分别下降至71.81%和72.32%;盐酸溴己新注射液与10%GS 100 mL配伍在6 h内百分含量下降至94.54%。结论 注射用盐酸溴己新与NS配伍时,成品输液稳定性可能与配伍剂量有关,其适宜配伍剂量为0.016 mg·mL^(-1)。加强盐酸溴己新注射剂各成品输液配伍稳定性研究,有利于盐酸溴己新及其他静脉输液的临床合理用药。

Objective To investigate the infusion stability of bromhexine hydrochloride for injection and bromhexine hydrochloride injection after mixing with different solvents.Methods Bromhexine hydrochloride for injection and bromhexine hydrochloride injection was mixed with 5%glucose injection(5%GS),10%glucose injection(10%GS),0.9%sodium chloride injection(NS),and glucose sodium chloride injection(GNS),respectively.The appearance,insoluble particles,pH value,osmotic pressure,bromhexine hydrochloride content,and related substances of the infusions were investigated after they were placed at room temperature for 24 h.Results For bromhexine hydrochloride for injection,5%GS 50 mL,5%GS 100 mL,5%GS 250 mL,NS 250 mL should be selected as the solvent for injection,and bromhexine hydrochloride injection should choose 5%GS 50 mL,5%GS 100 mL,5%GS 250 mL,NS 100 mL,NS 250 mL or GNS 100 mL as the solvent.According to the appearance,insoluble particles,pH value,osmotic pressure,bromohexine hydrochloride content and related substances of the finished infusions prepared were relatively stable within 24 h.However,the number of insoluble particles of bromhexine hydrochloride for injection did not meet the requirement after 0 h combination with 10%GS 100 mL,GNS 100 mL,and NS 100 mL,and the percentage of bromhexine hydrochloride decreased to 71.81%and 72.32%after 2 h combination with NS 100 mL and GNS 100 mL,respectively.The percentage of bromhexine hydrochloride injection combined with 10%GS 100 mL decreased to 94.54%at 6 h.Conclusions When bromhexine hydrochloride for injection is compatible with NS,the stability of infusion may be related to the compatible dose and the appropriate compatible dose is 0.016 mg·mL^(-1).More studies on the stability of the infusion compatibility of bromhexine hydrochloride injections would be beneficial to the clinical rational use of bromhexine hydrochloride and other intravenous fluids.