Zhang Y, Trissel L A, Johansen J F, Kimball C L
Division of Pharmacy, The University of Texas, M.D. Anderson Cancer Center, Houston, TX.
Int J Pharm Compd. 1998 Jan-Feb;2(1):89-91.
The purpose of this project was to evaluate the short-term shelf-life stability of an extemporaneously compounded mechlorethamine hydrochloride 0.01% topical ointment stored at room temperature. Mechlorethamine hydrochloreide injection 10-mg vials were reconstituted with 1 mL of dehydrated alcohol injection, USP, yielding a 10-mg/mL solution. One milliliter of the reconstituted liquid was incorporated by spatulation into 100 g of Aquaphor ointment base, yielding an ointment containing mechlorethamine hydrochloride 0.01%. The ointment was packaged in screw-cap ointment jars and stored at 23 deg C. Chemical stability was evaluated over a 90 day-period using derivatization and a stability-indicating high-performance liquid chromatographic analytical method. Decomposition of the intact drug occurred at a mcuh slower rate than that observed in aqueous solutions. The loss appeared to be biphasic, occurring more rapidly during the first week and proceeding much more slowly thereafter. Mechlorethamine hydrochloride solubilized with dehydrated alcohol injection and incorporated into Aquaphor ointment base at a concentration of 0.01% lost 10% potency in seven days when stored at 23 deg C.
本项目的目的是评估室温下临时配制的0.01%盐酸氮芥外用软膏的短期货架期稳定性。将10毫克装的盐酸氮芥注射液用1毫升美国药典规定的无水乙醇注射液复溶，得到10毫克/毫升的溶液。用刮勺将1毫升复溶后的液体加入100克凡士林软膏基质中，制成含0.01%盐酸氮芥的软膏。该软膏包装在带螺旋盖的软膏瓶中，于23℃储存。使用衍生化和稳定性指示高效液相色谱分析方法，在90天内评估其化学稳定性。完整药物的分解速度比在水溶液中观察到的要慢得多。损失似乎呈双相，在第一周内发生得更快，此后则慢得多。当在23℃储存时，用无水乙醇注射液溶解并以0.01%的浓度加入凡士林软膏基质中的盐酸氮芥，在七天内损失了10%的效力。
