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 1;55(17):1804-9. doi: 10.1093/ajhp/55.17.1804.
The stability of five drugs commonly prescribed for use in oral liquids but not commercially available as such was studied. Bethanechol chloride 5 mg/mL, pyrazinamide 10 mg/mL, quinidine sulfate 10 mg/mL, rifampin 25 mg/mL, and tetracycline hydrochloride 25 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 90% of the initial drug concentration was retained for 60 days in the liquids containing bethanechol chloride, pyrazinamide, or quinidine sulfate and for 28 days in the rifampin-containing liquids and the mixture of tetracycline hydrochloride and Ora-Sweet-Ora-Plus at both 5 and 25 degrees C. Tetracycline hydrochloride concentrations of 90% or more of the initial concentration were retained in the liquids prepared with Ora-Sweet SF-Ora-Plus for 10 days at 5 degrees C and 7 days at 25 degrees C and in those prepared with cherry syrup for 7 days at 5 degrees C and 2 days at 25 degrees C. No substantial changes in the appearance, odor, or pH of any liquid were observed. At 5 and 25 degrees C, bethanechol chloride 5 mg/mL, pyrazinamide 10 mg/mL, and quinidine sulfate 10 mg/mL were stable in three extemporaneously compounded oral liquids for 60 days and rifampin 25 mg/mL was stable for 28 days. The stability of tetracycline hydrochloride 25 mg/mL varied with the vehicle.
对五种常用于口服液体制剂但无市售产品的药物的稳定性进行了研究。分别将5mg/mL的氯化贝胆碱、10mg/mL的吡嗪酰胺、10mg/mL的硫酸奎尼丁、25mg/mL的利福平以及25mg/mL的盐酸四环素，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，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。在5℃和25℃下，含氯化贝胆碱、吡嗪酰胺或硫酸奎尼丁的液体中，至少90%的初始药物浓度在60天内保持稳定；含利福平的液体以及盐酸四环素与Ora - Sweet - Ora - Plus的混合物中，至少90%的初始药物浓度在28天内保持稳定。在5℃下，用Ora - Sweet SF - Ora - Plus制备的液体中，90%或更高初始浓度的盐酸四环素浓度可保持10天；在25℃下可保持7天。用樱桃糖浆制备的液体中，在5℃下可保持7天，在25℃下可保持2天。未观察到任何液体的外观、气味或pH有实质性变化。在5℃和25℃下，5mg/mL的氯化贝胆碱、10mg/mL的吡嗪酰胺和10mg/mL的硫酸奎尼丁在三种临时配制的口服液体制剂中60天内稳定，25mg/mL的利福平28天内稳定。25mg/mL盐酸四环素的稳定性随赋形剂而异。
