辅酶Q10的溶解度测定及稳定性考察

Investigation of basic physico-chemical properties of coenzyme Q10

目的测定辅酶Q10的溶解度,并考察其稳定性,为开发可改善辅酶Q10生物利用度和药效的新剂型及新剂型的体内外评价奠定基础。方法采用HPLC法测定辅酶Q10表观油水分配系数及在不同介质中的溶解度。在强酸破坏、氧化、高温破坏、光照环境下,考察辅酶Q10的稳定性。结果辅酶Q10在维生素E中溶解度最大,为371.34mg·g-1。在水中的溶解度小于1μg·L–1;聚山梨酯80对辅酶Q10对的增溶作用较强,可达824.69mg·L-1;辅酶Q10的表观油水分配系数(P)为4286.5(lgP=3.63)。辅酶Q10经强酸性破坏、氧化及高温破坏后未出现降解产物峰,在碱性及光照环境下,辅酶Q10峰明显减小,且出现降解产物峰。结论辅酶Q10的脂溶性强,水溶性差,增溶剂对其增溶作用不明显,且辅酶Q10在光照及碱性环境下不稳定。

Objective To determine the solubility of coenzyme Q10 in various solvents , its partition coefficients for the n-octanol-water system and to investigate the stability of its solution exposed to acid, alkali, oxygen, heat and light. Methods A high performance liquid chromatography method was established to detect the concentration of coenzyme Q10 in various media, and monitor the change of content. The partition coefficient for the n-octanol-water system of coenzyme Q10 was determined by shaking flask method. Results The solubility of coenzyme Q10 in vitamin E was 371.34 mg·g-1 and in water was less than 1μg·L-1 . Polysorbate 80 was good solubilizer for coenzyme Q10, it could raise the solubility in water up to 824.69mg·L-1. Apparent n-octanol-water partition coefficient of coenzyme Q10 was 4 286.5(lgP=3.63). Conclusions Coenzyme Q10 is a hydrophobic drug .The alkali and light are the major factors that affect the stability of coenzyme Q10 solution.