Allen L V, Erickson M A
Department of Medicinal Chemistry and Pharmaceutics, College of Pharmacy, University of Oklahoma Health Sciences Center, Oklahoma City 73117, USA.
Am J Health Syst Pharm. 1998 Sep 15;55(18):1915-20. doi: 10.1093/ajhp/55.18.1915.
The stability of five drugs commonly prescribed for use in oral liquid dosage forms but not commercially available as such was studied. Alprazolam 1 mg/mL, chloroquine phosphate 15 mg/mL, cisapride 1 mg/mL, enalapril maleate 1 mg/mL, and hydralazine hydrochloride 4 mg/mL were each prepared in a 1:1 mixture of Ora-Sweet and Ora-Plus (Paddock Laboratories), a 1:1 mixture of Ora-Sweet SF and Ora-Plus, and cherry syrup and placed in 120-mL amber clear polyethylene terephthalate bottles. Three bottles of each liquid were stored at 5 degrees C and three at 25 degrees C, all in the dark. Samples were taken initially and at various times up to 60 days for analysis by high-performance liquid chromatography and assessment of appearance and odor; pH was measured. A mean of at least 91% of the initial drug concentration was retained for 60 days in the alprazolam, chloroquine phosphate, cisapride, and enalapril maleate liquids. The hydralazine hydrochloride liquids retained more than 90% of the initial concentration for only one day at 5 degrees C when prepared with Ora-Sweet-Ora-Plus and two days when prepared with Ora-Sweet SF-Ora-Plus and for less than a day in these preparations at 25 degrees C and in cherry syrup at 5 and 25 degrees C. No substantial changes in the appearance, odor, or pH of any liquid were observed. Alprazolam 1 mg/mL, chloroquine phosphate 15 mg/mL, cisapride 1 mg/mL, and enalapril maleate 1 mg/mL were stable in three extemporaneously compounded oral liquids for 60 days at 5 and 25 degrees C; hydralazine hydrochloride 4 mg/mL was stable at 5 degrees C for one day in Ora-Sweet-Ora Plus and for two days in Ora-Sweet SF-Ora-Plus.
研究了五种常用于口服液体制剂但尚无市售产品的药物的稳定性。分别将1mg/mL的阿普唑仑、15mg/mL的磷酸氯喹、1mg/mL的西沙必利、1mg/mL的马来酸依那普利和4mg/mL的盐酸肼屈嗪制备于Ora-Sweet和Ora-Plus（帕多克实验室）的1:1混合物、Ora-Sweet SF和Ora-Plus的1:1混合物以及樱桃糖浆中，并置于120mL琥珀色透明聚对苯二甲酸乙二酯瓶中。每种液体取三瓶于5℃储存，另三瓶于25℃储存，均置于暗处。最初以及在长达60天的不同时间取样，通过高效液相色谱法进行分析，并评估外观和气味；测量pH值。阿普唑仑、磷酸氯喹、西沙必利和马来酸依那普利液体在60天内至少保留了初始药物浓度的91%。盐酸肼屈嗪液体在5℃用Ora-Sweet-Ora-Plus制备时仅在一天内保留了超过90%的初始浓度，用Ora-Sweet SF-Ora-Plus制备时保留了两天，在25℃的这些制剂中以及在5℃和25℃的樱桃糖浆中保留时间不到一天。未观察到任何液体的外观、气味或pH值有实质性变化。1mg/mL的阿普唑仑、15mg/mL的磷酸氯喹、1mg/mL的西沙必利和1mg/mL的马来酸依那普利在三种临时配制的口服液体制剂中于5℃和25℃下60天内稳定；4mg/mL的盐酸肼屈嗪在5℃用Ora-Sweet-Ora Plus时稳定一天，用Ora-Sweet SF-Ora-Plus时稳定两天。
