Allen L V, Erickson M A
College of Pharmacy, University of Oklahoma Health Sciences Center, Oklahoma City 73117, USA. loyd-allen@uokhsc
Am J Health Syst Pharm. 1996 Oct 1;53(19):2304-9. doi: 10.1093/ajhp/53.19.2304.
The stability of drugs commonly prescribed for use in oral liquid dosage forms but not commercially available as such was studied. Labetalol hydrochloride 40 mg/mL, metoprolol tartrate 10 mg/mL, verapamil hydrochloride 50 mg/mL, and spironolactone 5 mg/mL plus hydrochlorothiazide 5 mg/ mL were 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 (Paddock Laboratories), and cherry syrup and placed in polyethylene terephthalate bottles. The sources of the drugs were tablets. Six bottles were prepared per liquid; three were stored at 5 degrees C and three at 25 degrees C, all in the dark. A sample was removed from each bottle initially and at intervals up to 60 days and analyzed for drug concentration by stability-indicating high-performance liquid chromatography. At least 91% of the initial drug concentration was retained in all the oral liquids for up to 60 days. There were no substantial changes in the appearance or odor of the liquids, or in the pH. Labetalol hydrochloride 40 mg/mL, metoprolol tartrate 10 mg/mL, verapamil hydrochloride 50 mg/mL, plus hydrochlorothiazide 5 mg/ mL in three oral liquids compounded extemporaneously from sweetened vehicles and tablets were stable for up to 60 days when stored without light at 5 and 25 degrees C.
对常用于口服液体制剂但无市售产品的药物稳定性进行了研究。将40mg/mL盐酸拉贝洛尔、10mg/mL酒石酸美托洛尔、50mg/mL盐酸维拉帕米以及5mg/mL螺内酯加5mg/mL氢氯噻嗪分别用Ora - Sweet和Ora - Plus(帕多克实验室)的1:1混合物、Ora - Sweet SF和Ora - Plus(帕多克实验室)的1:1混合物以及樱桃糖浆配制,并置于聚对苯二甲酸乙二酯瓶中。药物来源为片剂。每种液体配制6瓶;3瓶储存于5℃,3瓶储存于25℃,均置于暗处。最初以及每隔一段时间直至60天从每个瓶子中取出一份样品,通过稳定性指示高效液相色谱法分析药物浓度。在长达60天的时间里,所有口服液中至少保留了91%的初始药物浓度。液体的外观、气味或pH值均无实质性变化。由甜味赋形剂和片剂临时配制的三种口服液中,40mg/mL盐酸拉贝洛尔、10mg/mL酒石酸美托洛尔、50mg/mL盐酸维拉帕米加5mg/mL氢氯噻嗪在5℃和25℃避光储存时,长达60天都是稳定的。