Atkins Julia R, Lull Melinda E, Decker Andrew S, Hutchinson David J
Wegmans School of Pharmacy, St. John Fisher College, Rochester, New York.
Golisano Children's Hospital, University of Rochester Medical Center, Rochester, New York.
Int J Pharm Compd. 2018 Jul-Aug;22(4):326-328.
The stability of extemporaneously prepared sodium benzoate oral suspension in cherry syrup and Ora-Sweet was studied. Oral solutions of 250-mg/mL sodium benzoate were prepared in either cherry syrup or Ora-Sweet. To a beaker, 50 grams of Sodium Benzoate Powder USP was dissolved and filtered, the solution was divided equally into two parts, and each aliquot was added into two separate calibrated 100-mL amber vials. In the first vial, cherry syrup was added to make a final volume of 100 mL. In the second vial, Ora-Sweet was added to give a final volume of 100 mL. This process was repeated to prepare three solutions of each kind and all were stored at room temperature. A 250-µL sample was withdrawn immediately after preparation and again at 7, 14, 28, 60, and 90 days for each sample. At each time point, further dilution was made to an expected concentration of 0.25 mg/mL with sample diluent, and the samples were assayed in triplicate by stability-indicating high-performance liquid chromatography. Stability was defined as the retention of at least 90% of the initial concentration. At least 92% of the initial concentration of sodium benzoate in cherry syrup and at least 96% of the sodium benzoate in Ora-Sweet remained throughout the 90-day study period. There were no detectable changes in color and no visible microbial growth in any sample. Extemporaneously compounded suspensions of sodium benzoate in cherry syrup or Ora-Sweet were stable for at least 90 days when stored in a 4-oz amber plastic bottle at room temperature in reduced lighting.
研究了临时配制的苯甲酸钠口服混悬液在樱桃糖浆和Ora-Sweet中的稳定性。分别在樱桃糖浆或Ora-Sweet中制备250 mg/mL苯甲酸钠的口服溶液。将50克美国药典苯甲酸钠粉末溶解并过滤到一个烧杯中，将溶液平均分成两份，每份分别加入两个单独校准的100 mL琥珀色小瓶中。在第一个小瓶中加入樱桃糖浆，使最终体积达到100 mL。在第二个小瓶中加入Ora-Sweet，使最终体积达到100 mL。重复此过程以制备每种溶液各三份，并将所有溶液储存在室温下。每种样品在制备后立即以及在第7、14、28、60和90天再次取出250 μL样品。在每个时间点，用样品稀释剂进一步稀释至预期浓度0.25 mg/mL，并通过稳定性指示高效液相色谱法对样品进行三次测定。稳定性定义为保留至少90%的初始浓度。在整个90天的研究期间，樱桃糖浆中苯甲酸钠的初始浓度至少保留92%，Ora-Sweet中苯甲酸钠的初始浓度至少保留96%。任何样品均未检测到颜色变化，也没有可见的微生物生长。当在室温下、光线较暗的环境中储存在4盎司琥珀色塑料瓶中时，临时配制的苯甲酸钠在樱桃糖浆或Ora-Sweet中的混悬液至少稳定90天。
