儿科低剂量红霉素：20 毫克硬胶囊的配方和稳定性。
Low-dose erythromycin in pediatrics: Formulation and stability of 20 mg hard gelatin capsules.
机构信息
Service central de la qualité et de l'information pharmaceutiques (SCQIP), Pharmacy Department, AP-HM, Marseille, France.
CNRS, Institut de Chimie Radicalaire ICR, UMR 7273, Equipe de Pharmaco-Chimie Radicalaire, Aix Marseille Univ, Marseille, France.
出版信息
PLoS One. 2023 Feb 24;18(2):e0282164. doi: 10.1371/journal.pone.0282164. eCollection 2023.
OBJECTIVE
Erythromycin is a macrolide antibiotic that is also prescribed off-label in premature neonates as a prokinetic agent. There is no oral formulation with dosage and/or excipients adapted for these high-risk patients.
METHODS
Clinical studies of erythromycin as a prokinetic agent were reviewed. Capsules of 20 milligrams of erythromycin were compounded with microcrystalline cellulose. Erythromycin capsules were analyzed using the chromatographic method described in the United States Pharmacopoeia which was found to be stability-indicating. The stability of 20 mg erythromycin capsules stored protected from light at room temperature was studied for one year.
RESULTS
20 mg erythromycin capsules have a beyond use date not lower than one year.
CONCLUSION
20 milligrams erythromycin capsules can be compounded in batches of 300 unities in hospital pharmacy with a beyond-use-date of one year at ambient temperature protected from light.
目的
红霉素是一种大环内酯类抗生素，也被超说明书用于早产儿作为促动力剂。目前没有适合这些高危患者的剂量和/或赋形剂的口服制剂。
方法
综述了红霉素作为促动力剂的临床研究。将 20 毫克红霉素胶囊与微晶纤维素混合。采用美国药典中描述的色谱法对红霉素胶囊进行分析，该方法具有稳定性指示作用。研究了避光保存在室温下的 20 毫克红霉素胶囊的稳定性，为期一年。
结果
20 毫克红霉素胶囊的有效期不低于一年。
结论
可以在医院药房中以 300 个单位的批次配制 20 毫克红霉素胶囊，在避光的室温下有效期为一年。
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