Grogan L J, Jensen B K, Makoid M C, Baldwin J N
Am J Hosp Pharm. 1979 Feb;36(2):205-8.
The stability of reconstituted penicillin V potassium (PVK) when stored in 6-ml plastic oral syringes at various temperatures and protected from light was studied. One batch of PVK was reconstituted with distilled water according to manufacturer's directions (label claim: 125 mg/ml). Samples of 5 ml were stored in plastic oral syringes at 4 C, 25 C, 41 C, 60 C or 75 C and assayed spectrophotometrically and microbiogically at various times. From an initial concentration of 113% of label claim, PVK stored at 4 C (refrigerated) reached 90% of manufacturer's label claim in 11.5 days (95% confidence level). PVK stored at 25 C (room temperature) was unstable after storage for less than 37 hours. PVK degradation followed a first-order process. No significant difference was found between the spectrophotometric and microbiological assay (p less than 0.05). Manufacturer's stability data for storage of reconstituted PVK in the original bulk container should not be applied to PVK repackaged in plastic oral syringes. The pharmacy department developed guideliness designed to prevent the administration of subpotent PVK.
研究了复溶后的青霉素V钾（PVK）在不同温度下避光保存在6毫升塑料口服注射器中的稳定性。按照制造商的说明，用蒸馏水复溶一批PVK（标签声明：125毫克/毫升）。将5毫升样品保存在塑料口服注射器中，分别置于4℃、25℃、41℃、60℃或75℃，并在不同时间进行分光光度法和微生物学测定。从初始浓度为标签声明的113%开始，保存在4℃（冷藏）的PVK在11.5天内（95%置信水平）降至制造商标签声明的90%。保存在25℃（室温）的PVK在储存不到37小时后就不稳定了。PVK的降解遵循一级过程。分光光度法和微生物学测定之间未发现显著差异（p<0.05）。制造商关于复溶后的PVK保存在原装大容量容器中的稳定性数据不适用于重新包装在塑料口服注射器中的PVK。药剂科制定了指南，旨在防止使用效力不足的PVK。
