蛋殼膜做為天然崩散劑的初步評估

Preliminary Evaluation of Eggshell Membrane as a Natural Disintegrant

本研究報告評估蛋殼膜做為崩散劑的初步結果。先用acetaminophen錠劑在純水中的崩散實驗評估蛋殼膜適宜濃度及打錠力量對蛋殼膜活性的影響，進一步在不同的生理條件評估蛋殼膜增進acetaminophen錠劑的崩散及溶離效能，發現蛋殼膜在生理條件下，大大增進錠劑崩散及溶離速率，並且不太受打錠力量的影響。本研究評估蛋殼膜的液體吸取及體積膨脹功能，並與一些常用的合成超級崩散劑比較，它的體積膨脹是小的，也不受酸性環境影響，就像Polyplasdone XL；蛋殼膜大大增進hydrochlorothiazide劑的液體吸取量和速率；一般言之，含蛋殼膜的hydrochlorothiazide錠劑，其液體吸取量與速率比所有含合成超級崩散劑的hydrochlorothiazide錠劑小，尤其在中性環境下更是，但較接近Polyplasdone XL；最後蛋殼膜錠劑吸水照片也與合成超級崩散劑錠劑比較，從上述體積膨脹，液體吸取及照片的比較，蛋殼膜做為崩散劑的功能似乎與Polyplasdone XL較相像，而與Ac-Di-Sol及Primojel較不像。

This study reports the preliminary results of evaluating the eggshell membrane as a disintegrant. The optimal concentration of the eggshell membrane in acetaminophen tablets and the effect of compression force on the activity of the eggshell membrane were first evaluated by the disintegration test in deionized water. Its efficiency in enhancing the disintegration and the dissolution of acetaminophen tablets was further evaluated in different physiological conditions. Eggshell membrane was found to significantly enhance the disintegration and dissolution of the acetaminophen tablets in physiological conditions and its activity was not significantly affected by the compression force. Its function in terms of swelling and liquid uptake was evaluated and compared with those of some commonly used synthetic superdisintegrants. Its swelling volume was small and was not affected by acidic environment like Polyplasdone XL. ESM significantly increases the rate and the extent of liquid uptake of hydrochlorothiazide tablets. In general, the rate and the extent of liquid uptake for eggshell membrane in hydrochlorothiazide tablets are less than those of all the synthetic superdisintegrants compared, especially in the neutral environment. However, they are closer to those of hydrochlorothiazide tablets containing Polyplasdone XL. Finally the pictures of eggshell membrane tablet upon water uptake were taken and compared with those of the synthetic superdisintegrant tablets. From the above swelling volume and liquid uptake studies, and the picture comparison, the function of eggshell membrane as a disintegrant seems more similar to that of Polyplasdone XL than Ac-Di-Sol or Primojel.