DEVELOPMENT OF A TABLET FORM OF LIU WEI DI HUANG EXTRACT

摘要

Objective: Develop an effective and stable tablet form of Liu Wei Di Huang (LWDH). Methods: LWDH extract was obtained by decoction (TC) and reflux with water (WR). Extracts were concentrated and analyzed by HPLC-PDA using loganin as the bioactive marker. Adsorbents, tablet strength and friability, and tablet quality and stability were evaluated. Results: Extraction of LWDH formula from raw materials using WR yielded higher concentrations of loganin than TC. The best formulation of LWDH tablets included Avicel ? PH101, corn starch, purified talcum, magnesium stearate and Cab-osil ? with about 97.40% of the label amount of active marker. Excluding moisture from the product reduced marker degradation, suggesting a product shelf life 12+months. Finished tablets were uniform in weight, friability, disintegrated in<30 min, had good microbial and heavy metal contamination safety profiles and was stable. Conclusions: Extraction of LWDH formula using reflux with water produces higher yields than decoction. A suitable tablet formulation consists of dried water extract (38.83%), corn starch (29.13%), Avicel ? PH101 (29.13%), purified talcum (0.97%), magnesium stearate (0.97%) and Cab-osil ? (0.97%) prepared by wet granulation. Excluding moisture from the product reduces product degradation, suggesting a shelf life of 12+months. LWDH tablets avoid traditional formulation problems (high dosages, unacceptable taste and odor, lack of product uniformity, contamination with microorganisms and heavy metals), and are a good alternative for patients and TCM practitioners. Keywords : Liu Wei Di Huang, Chinese Traditional medicine, Tablets, Quality, Stability.