以 0.9% 氯化鈉為稀釋溶液的異丙酚中／長鏈三酸甘油酯在 CRYOVAC(R) 非聚氯乙烯軟袋容器中於不同貯藏條件下安定性之探討   全文下載

Stability of Propofol Medium Chain Triglyceride/Long Chain Triglyceride (MCT/LCT) in 0.9% NaCl Solution with CRYOVAC(R) Non-PVC Soft Bag Containers

本研究針對異丙酚中／長鏈脂肪乳劑在 CRYOVAC(R) 非聚氯乙烯軟袋容器中，於不同的溫度及光照條件下進行相容性研究。以 0.9% 氯化鈉溶液為稀釋液配製 2.0 和 2.5 mg/mL 之異丙酚中 ／ 長鏈脂肪乳劑，裝填在CRYOVAC(R) 非聚氯乙烯軟袋容器內並儲存於（i）常溫（25 ± 2°C）及正常光線環境中；（ii）常溫及黑暗環境中；（iii）於 2 - 8° C 及黑暗環境中 5 天。利用高效液相層析法分析不同條件下異丙酚含量變化。此外，在長期試驗中，分別進行儲放時間達 8 天及 15 天的異丙酚含量分析。結果顯示，在三種測試條件下，異丙酚中 ／ 長鏈脂肪乳劑皆能穩定儲存達 5 天。異丙酚含量在儲放於第 8 天和第 15 天（i）在常溫及正常光線環境中分別下降 8 - 12%和 15 - 23%，（ii）在常溫及黑暗環境中分別下降 3 - 9% 和 10 - 13%，（iii）在 2 - 8° C 及黑暗環境中下降約 2 - 8%。結論，以 0.9% 氯化鈉溶液為稀釋液配製 2.0 和 2.5 mg/mL 之異丙酚中 ／ 長鏈脂肪乳劑，裝填在 CRYOVAC(R)非聚氯乙烯軟袋容器能穩定存放 5 天。異丙酚儲存在常溫下相較於 2 - 8° C不穩定也較易受光照影響。此外，利用高效液相層析法定量分析鄰苯二甲酸二（2-乙基己基）酯其最低偵測極限值於 5 ppm 試驗中並未在本研究使用的非聚氯乙烯軟袋容器中檢驗出鄰苯二甲酸二（2-乙基己基）酯。因此， CRYOVAC(R) 非聚氯乙烯軟袋是一個異丙酚中 ／ 長鏈脂肪乳劑合適的裝填容器。

The compatibility of propofol MCT/LCT with non-PVC soft bag was investigated in this study. Solutions of 2.0 and 2.5 mg/mL propofol MCT/LCT in 0.9% NaCl solution were filled into CRYOVAC(R) containers. The studied samples were grouped and stored at ambient temperature (25 ± 2°C) in the light, at ambient temperature in the dark, and at 2-8°C in the dark for 5 days. At indicated sampling time, propofol was assayed by high-performance liquid chromatography. For long-term study, propofol samples were analyzed at day 8 and at day 15. The results showed that all studied samples were stable for 5 days. Propofol contents decreased by 8-12% and 15-23% when stored in the non-PVC bag at ambient temperature in the light for 8 days and 15 days, respectively. Studied samples in non-PVC bag stored at ambient temperature in the dark showed 3-9% decrease when stored for 8 days, whereas 10-13% decrease for 15 days. Propofol concentration in non-PVC bag stored at 2-8°C in the dark showed approximately 2-8% decrease at both day 8 and day 15. In conclusion, the 2.0 and 2.5 mg/mL propofol MCT/LCT in 0.9% NaCl solution with CRYOVAC(R) container stored at all conditions were stable for 5 days. It is found that samples stored at ambient temperature were more labile as compared to those at 2-8°C; moreover, propofol sample was vulnerable to light exposure. In addition, DEHP additive was not detected in the CRYOVAC(R) soft bag container by HPLC with a quantitation limit at 5 ppm. Therefore, CRYOVAC(R) non-PVC soft bag is a suitable container system for propofol MCT/LCT emulsion.