鹽酸配西汀注射液在不同安瓿中之安定性研究

鹽酸配西汀長久以來被廣用為止痛劑，並具有良好的安定性。但由於其化學結構中含有酯鍵，在水溶液中會進行水解反應，產生meperidinic acid分解物，使溶液之含量及pH值受到影響，因而鹽酸配西汀製備成注射液的安定性頗值得探討。基於此，本研究將鹽酸配西汀注射液充塡至無色與琥珀色透明安瓿中，熔封後進行40℃，60℃，80℃加速試驗與儲存試驗，以評估其在兩種不同安瓿中的安定性情形。結果顯示鹽酸配西汀注射液在兩種安瓿中經40℃加速試驗與儲存六個月樣品之外觀、透光率、pH值和含量均未呈明顯變化；加速試驗60℃者於15週開始pH值有明顯下降，此外，外觀、透光率與含量均未呈明顯變化；而加速試驗80℃者於15週之外觀與透光率雖未呈明顯變化，但其含量與pH值均明顯下降，表示有分解反應發生。然而貯於兩種安瓿之降解反應變化程度經評估並無顯著差異，此結果顯示鹽酸配西汀注射液在兩種安瓿中的安定性無顯著差異。

關鍵字

安定性；鹽酸配西汀注射液；安瓿

並列摘要

Meperidine hydrochloride is used extensively as an analgesic agent. Although it is generally stable, it is not uncommon that the hydrolysis to meperidinie acid rendered this ester drug to a decrease in pH value. Therefore the stability of Meperidine HC1 injection is of pharmaceutical concen. The objet of the present research is to assess the decomposition of Meperidine HC1 in sealed injection packaged in colorless or in amber ampules. Accelerated tests as well as storage tests were executed at 40℃, 60℃ and 80℃ for both ampule types. No differences in transparency, pH change or quanty of meperidine were observed either in accelerated tests at 40℃ or storage test for six months. Nevertheless, a decrease in pH value without significant changes of transparency and meperidine content was observed in accelerated tests at 60℃ after storage for 15 weeks. The pH value and meperidine content decrease significantly in both types of ampules when subjected to accelerated tests at 80℃ for 15 weeks. Since the decreases of meperidine content were found to be similar for both types of ampules, the stability of meperidine is not correlated with ampule type.

並列關鍵字

Stability ； Meperdine HC1 injection ； ampule

國際替代計量

鹽酸配西汀注射液在不同安瓿中之安定性研究

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