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인삼사포닌의 소장내 최종대사산물인 IH-901의 수용액중 가용화
권오승,정연복 한국약제학회 2004 Journal of Pharmaceutical Investigation Vol.34 No.5
The purpose of the present study was to formulate the aqueous solution of 20-O-β-D-glucopyranosyl-20(S)-protopanaxadiol (IH-901), an intestinal bacterial metabolic derivative from Ginseng protopanaxadiol saponin. For this pur-pose, the effects of various solubilization agents such as cosolvents [ethanol, propylene glycol (PG), polyethylene glycol 300 (PEG 300). polyethylene glycol 400 (PEG 400), glycerin], surfactants (Tween 80, Cremophor RH40, Cremophor?EL, Poloxamer 407, Poloxamer 188) and a complexation agent [hydroxypropyl-β-cyclodextrin (HPBCD)], on the solubility of IH-901 in aqueous solution were evaluated. The solubility of IH-901 in water was under 1 μg/ml at 20℃. Cosolvents such as ethanol, PG, PEG 300, PEG 400 and glycerin did not enhance the solubility of IH-901 at the 0 - 40% concentration range. The solubility of IH-901 was significantly elevated by the addition of cosolvents over the 80% concentration range. On the other hand. tween 80, Cremophor" EL, Cremophor" RH40 and HPBCD showed enhanced effects on the solubility of IH-901. The enhanced effects of Poloxamer 407 or Poloxamer 188 on the IH-901 solubility were less pronounced compared with Cremophor" EL or Cremophor' RH40. As a results. Cremophor"' aqueous solution was selected as an optimum solvent system. The aqueous solutions containing 10% Cremophor EL and 7% Cremophor' RH40 were formulated as dosing solutions containing 5.0 mg/ml of IH-901 for its intravenous and oral administration, respectively. The formular showed physical stability after stored for 7 days at 4℃.