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Article Title

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

Abstract

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.

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