Murray K M, Erkkila D, Gombotz W R, Pankey S
Immunex Corporation, Seattle, WA 98101, USA.
Am J Health Syst Pharm. 1997 Nov 15;54(22):2588-91. doi: 10.1093/ajhp/54.22.2588.
The stability of thiotepa in a new formulation of the drug was studied. Vials of Thioplex (Immunex), a relatively new lyophilized formulation of thiotepa, were reconstituted with sterile water and diluted with 0.9% sodium chloride injection in polyvinyl chloride infusion bags to thiotepa concentrations of 0.5, 1, and 3 mg/mL. The solutions were stored at 8 and 25 degrees C in ambient light and analyzed at 0, 8, 24, and in most cases 48 hours for thiotepa concentration and chloro-adduct formation by stability-indicating high-performance liquid chromatography. Thiotepa 1 and 3 mg/mL was stable for 48 hours at 8 degrees C and for 24 hours at 25 degrees C. Thiotepa 0.5 mg/mL was not stable at either temperature. Storage at 8 degrees C slowed but did not prevent chloro-adduct formation and loss of potency. The pH tended to increase with time; turbidity remained low. Thiotepa (lyophilized) 1 and 3 mg/mL in 0.9% sodium chloride injection was stable for 48 hours at 8 degrees C and for 24 hours at 25 degrees C; the drug was unstable when diluted to 0.5 mg/mL and stored under the same conditions.
研究了噻替派新制剂的稳定性。用无菌水复溶噻替派（免疫ex）的小瓶，噻替派是一种相对较新的冻干制剂，并用0.9%氯化钠注射液在聚氯乙烯输液袋中稀释至噻替派浓度为0.5、1和3mg/mL。溶液在8和25℃下于自然光下储存，并在0、8、24以及大多数情况下在48小时时通过稳定性指示高效液相色谱法分析噻替派浓度和氯加合物的形成。噻替派1和3mg/mL在8℃下稳定48小时，在25℃下稳定24小时。噻替派0.5mg/mL在这两个温度下均不稳定。在8℃下储存减缓了但并未阻止氯加合物的形成和效力损失。pH值随时间趋于升高；浊度保持较低。在0.9%氯化钠注射液中1和3mg/mL的冻干噻替派在8℃下稳定48小时，在25℃下稳定24小时；当稀释至0.5mg/mL并在相同条件下储存时，该药物不稳定。
