還少丹軟膠囊製程與分析技術開發   全文下載

The Development of Manufacturing and Analytical Method of Hwan-Shio-Dan Softgel

本研究開發還少丹現代化軟膠囊劑型之製程及分析品管技術。於製程方面，從還少丹組成藥材之選材，煎煮萃取，離心過濾，薄膜濃縮，噴霧乾燥，粉末拌油到膠囊充填等已完成其試製。於分析品管方面，則針對還少丹內含Loganin和s-Asarone之指標成分，建立高效液相層析定量方法（HPLC），以此應用於還少丹之安定性試驗，結果顯示還少丹軟膠囊之外觀安定性良好，指標成分中Loganin有逐月遞減之趨勢，此遞減趨勢又會隨著儲存溫度上升而加劇，但s-Asarone則顯示相當安定。 The HPLC analytical method and manufacturing process of Hwan-Shio-Dan Softgel were developed in this study. First, Chinese crude drugs contained in Hwan-Shio-Dan were purchased and selected. They were then processed by a decoction extractor, centrifugal filter, centrifugal thin-film vacuumed evaporation machine, and spray dryer. Finally, the dry powder from the spray dryer was homogenized with an oil substance and sealed in a softgel form. At the same time, a HPLC analytical method for loganin and β-asarone constituted in Hwan- Shio-Dan was developed to evaluate the stability of Hwan-Shio-Dan softgel. The results showed that the appearance of Hwan-Shio-Dan softgel was good. Although one of the marker substances, loganin, slowly decayed with time and the tendency of the degradation became obvious with an increase in the storage temperature, the other maker substance, β-asarone, was quite stable during the accelerated stability study."

The HPLC analytical method and manufacturing process of Hwan-Shio-Dan Softgel were developed in this study. First, Chinese crude drugs contained in Hwan-Shio-Dan were purchased and selected. They were then processed by a decoction extractor, centrifugal filter, centrifugal thin-film vacuumed evaporation machine, and spray dryer. Finally, the dry powder from the spray dryer was homogenized with an oil substance and sealed in a softgel form. At the same time, a HPLC analytical method for loganin and β-asarone constituted in Hwan- Shio-Dan was developed to evaluate the stability of Hwan-Shio-Dan softgel. The results showed that the appearance of Hwan-Shio-Dan softgel was good. Although one of the marker substances, loganin, slowly decayed with time and the tendency of the degradation became obvious with an increase in the storage temperature, the other maker substance, β-asarone, was quite stable during the accelerated stability study.