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目的:测定葛根素的饱和溶解度,并探讨不同表面活性剂及高分子材料对其溶解特性的影响。方法:选择表面活性剂十二烷基硫酸钠(SDS)、泊洛沙姆188(F68)、高分子材料聚维酮K30(PVP K30)、甲基纤维素(MC)、系列羟丙甲基纤维素(HPMC K_(-100M)、K_(15M)、K_(4M)、E_(15)、E_5、E_3),配成系列浓度的溶液,采用HPLC法测定葛根素在以上溶液中的最大溶解度。结果:考察物质的质量浓度在0.2~1.5mg·mL~(-1)范围内,葛根素的最大饱和溶解度分别为:4.04mg·mL~(-1)[ρ(SDS)=0.2mg·mL~(-1)],5.32mg·mL~(-1)[ρ(PVPK30)=0.2mg·mL~(-1)],4.91mg·mL~(-1)[ρ(F68)=0.5mg·mL~(-1)],5.73mg·mL~(-1)[ρ(HPMC E3)=0.2mg·mL~(-1)],4.51mg·mL~(-1)[ρ(MC)=1.0mg·mL~(-1)],4.94mg·mL~(-1)[ρ(HPMC E_5)=0.5mg·mL~(-1)],4.72mg·mL~(-1)[ρ(HPMC E_(15))=1.5 mg·mL~(-1)],4.87mg·mL~(-1)[ρ(HPMC E4M)=1.5mg·mL~(-1)],4.46mg·mL~(-1)[ρ(HPMC E_(15M))=1.5mg·mL~(-1)],4.27mg·mL~(-1)[ρ(HPMC E_(100M)100M)=1.5mg·mL~(-1)]。结论:葛根素为水中溶解度较低的药物,在葛根素溶液中加入0.2mg·mL~(-1)的HPMC E_3或0.2mg·mL~(-1)PVP K30可能通过抑制葛根素结晶,使其增溶效果更好。
Objective: To determine the saturated solubility of puerarin and investigate the effect of different surfactants and polymeric materials on its dissolution characteristics. Methods: The surfactant sodium dodecyl sulfate (SDS), poloxamer 188 (F68), polymer material Povidone K30 (PVP K30), methylcellulose (MC) Cellulose (HPMC K_ (-100M), K_ (15M), K_ (4M), E_ (15), E_5, E_3) were dubbed into series solutions. The maximum solubility of puerarin in the above solution . Results: The maximal saturated solubility of puerarin in the range of 0.2-1.5 mg · mL -1 of the tested substance was 4.04 mg · mL -1 [ρ (SDS) = 0.2 mg · mL -1 5.32 mg · mL -1 [ρ (PVPK30) = 0.2 mg · mL -1], 4.91 mg · mL -1 [ρ (F68) = 0.5 mg · ML -1, 5.73 mg · mL -1 [ρ (HPMC E3) = 0.2 mg · mL -1], 4.51 mg · mL -1 [ρ (MC) = 1.0mg · mL -1], 4.94mg · mL -1 [ρ (HPMC E_5) = 0.5mg · mL -1], 4.72mg · mL -1 [ρ (HPMC E_ (15)) = 1.5 mg · mL -1, 4.87 mg · mL -1 [ρ (HPMC E4M) = 1.5 mg · mL -1] and 4.46 mg · mL -1 Ρ (HPMC E_ (15M)) = 1.5 mg · mL -1, 4.27 mg · mL -1 [ρ (HPMC E 100M) 100M) ~ (-1)]. CONCLUSION: Puerarin is a low solubility drug in water. Adding 0.2mg · mL -1 HPMC E 3 or 0.2 mg · mL -1 PVP K30 to puerarin solution may inhibit the crystallization of puerarin Its solubilization effect is better.