Sartnurak S, Christensen J M
Am J Hosp Pharm. 1982 Apr;39(4):627-9.
The stability of valproate sodium syrup repackaged in three types of unit dose containers was studied. Two-millimeter samples of commercial valproate sodium syrup 250 mg/5 ml (of valproic acid) were packaged in polypropylene oral syringes, glass oral syringes, and glass vials (126 of each type). These were stored at 4, 25, or 60 degrees C and assayed for valproic acid concentration using gas chromatography at 0, 5, 10, 20, 30, 90, and 180 days. Polypropylene syringes that were stored for 180 days at 4 and 25 degrees C were rinsed and put in chloroform 50 ml; valproic acid concentration was determined daily for 12 days. Valproate sodium syrup repackaged in glass oral syringes and glass vials retained 95% of valproic acid label claim after storage at 4 and 25 degrees C for 180 days, while valproate sodium syrup repackaged in polypropylene oral syringes did not retain 90% of label claim after storage for 20 days at 4 or 25 degrees C. All samples stored at 60 degrees C had greater loss than those stored at lower temperatures. An average of 86% of the drug lost from the polypropylene syringes was recovered in 12 days during the desorption experiment (range 80-92%). Repackaging valproate sodium syrup in unit dose glass vials or glass syringes resulted in retention of 95% of valproic acid label claim after storage for 180 days at 4 and 25 degrees C. Repackaging of this drug product in polypropylene oral syringes is not recommended.
研究了重新包装在三种单位剂量容器中的丙戊酸钠糖浆的稳定性。将市售的250mg/5ml（丙戊酸）丙戊酸钠糖浆的2毫米样品分别包装在聚丙烯口服注射器、玻璃口服注射器和玻璃瓶中（每种类型126个）。将这些样品分别储存在4℃、25℃或60℃下，并在0、5、10、20、30、90和180天时使用气相色谱法测定丙戊酸浓度。在4℃和25℃下储存180天的聚丙烯注射器用50ml氯仿冲洗，并在12天内每天测定丙戊酸浓度。重新包装在玻璃口服注射器和玻璃瓶中的丙戊酸钠糖浆在4℃和25℃下储存180天后保留了95%的丙戊酸标签声称量，而重新包装在聚丙烯口服注射器中的丙戊酸钠糖浆在4℃或25℃下储存20天后未保留90%的标签声称量。所有储存在60℃下的样品损失都比储存在较低温度下的样品大。在解吸实验的12天内，从聚丙烯注射器中损失的药物平均有86%被回收（范围为80-92%）。将丙戊酸钠糖浆重新包装在单位剂量玻璃瓶或玻璃注射器中，在4℃和25℃下储存180天后可保留95%的丙戊酸标签声称量。不建议将该药品重新包装在聚丙烯口服注射器中。
