Ergotamine Tartrate舌下錠劑的安定性   全文下載

Stability of Ergotamine Tartrate Sublingual Tablets

劑型內高潮濕度對Ergotamine Tartrate舌下錠劑安定性的影響可導致該成品安全問題。由於該成品密封於鋁箔內，在一些儲存環境，錠劑內潮濕水份蒸發及冷凝，可能降級該成品及產生合毒性之副產品，本文針對可能發生之儲存環境，探研此成品一年內之安定性，觀察發現，只要保持穩定的儲存溫度，無論在室溫或冷藏，都不會有安定性問題，可是在不穩定，溫度差異大的儲存情況下，那成品的安定性就會受影響，此儲存環境，應以避免。

The high moisture content of ergotamine tartrate sublingual tablets poses potential stability problems and safety concerns. The finished product is confined in a protective aluminum foil and could degrade to generate toxic by-products during moisture evaporation and condensation within the package under some storage conditions. This study was initiated to examine the stability of ergotamine tartrate sublingual tablets under various simulated storage conditions. The physical and chemical stability of the product was evaluated over a period of 12 months. Results indicated that no stability problems arose when the product was stored at constant temperature, either ambient or sub-ambient. Experimental results indicated that storage in an environment where the temperature fluctuated widely might lead to poor product stability and should be avoided. 劑型內高潮濕度對Ergotamine Tartrate舌下錠劑安定性的影響可導致該成品安全問題。由於該成品密封於鋁箔內，在一些儲存環境，錠劑內潮濕水份蒸發及冷凝，可能降級該成品及產生合毒性之副產品，本文針對可能發生之儲存環境，探研此成品一年內之安定性，觀察發現，只要保持穩定的儲存溫度，無論在室溫或冷藏，都不會有安定性問題，可是在不穩定，溫度差異大的儲存情況下，那成品的安定性就會受影響，此儲存環境，應以避免。