Ghnassia L T, Yau D F, Kaye K I, Duggin G G
University of Pharmacy, Paris, France.
Am J Health Syst Pharm. 1995 Oct 15;52(20):2204-7. doi: 10.1093/ajhp/52.20.2204.
The stability of cyclosporine in an extemporaneously compounded paste was studied. Cyclosporine oral solution 100 mg/mL was mixed with an adhesive gel to prepare six aluminum-lined ointment tubes containing paste with cyclosporine 9.6 mg/g. Two of the tubes were stored at 37 degrees C, two at 21 degrees C, and two at 2 degrees C. Cyclosporine was extracted from samples taken on days 2, 4, 5, 7, 9, 14, 18, 22, 28, and 31, and the concentration was measured by high-performance liquid chromatography (except for samples obtained on day 2) and fluorescence polarization immunoassay. Throughout the study period, the concentration of cyclosporine remaining in the paste was > 90% of the initial concentration according to both assay methods. Cyclosporine 9.6 mg/g in a paste compounded extemporaneously from cyclosporine oral solution and an adhesive gel was stable for at least 31 days when stored in aluminum-lined ointment tubes at 37, 21, and 2 degrees C.
研究了环孢素在临时配制糊剂中的稳定性。将100mg/mL的环孢素口服溶液与一种粘性凝胶混合，制备了6支铝管内衬的软膏管，其中含有9.6mg/g环孢素的糊剂。其中2支管在37℃储存，2支管在21℃储存，2支管在2℃储存。在第2、4、5、7、9、14、18、22、28和31天从样品中提取环孢素，并通过高效液相色谱法（第2天获得的样品除外）和荧光偏振免疫分析法测量其浓度。在整个研究期间，根据两种测定方法，糊剂中环孢素的残留浓度均>初始浓度的90%。当在37℃、21℃和2℃下储存在铝管内衬的软膏管中时，由环孢素口服溶液和粘性凝胶临时配制的含9.6mg/g环孢素的糊剂至少31天内稳定。
