柴胡总皂苷提取物制剂前的评价  

Evaluation on Pre-Preparation of Total Saponins Extract from Bupleuri Radix

作　　者：封传华[1] 张国松[2] 罗晓健[1,2] 胡鹏翼[1] 何秀菊[2] 王跃生[1,3] 

机构地区：[1]江西中医学院,南昌330004 [2]中药固体制剂制造技术国家工程研究中心,南昌330006 [3]中国中医科学院中药研究所,北京100700

出　　处：《中国实验方剂学杂志》2011年第18期12-15,共4页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：重大新药创制专项(2009ZX09103)

摘　　要：目的:对柴胡总皂苷提取物进行制剂前研究,为设计合理的剂型提供依据。方法:采用分光光度法和高效液相色谱法研究柴胡总皂苷提取物的表观溶解度、油水分配系数、稳定性及初步考察柴胡总皂苷提取物对胃黏膜的刺激性。结果:柴胡总皂苷提取物在水中的表观溶解度为0.145 g.L-1;在pH 5.0的缓冲液中,油水分配系数为34.72;在pH 9.0的缓冲液中,油水分配系数为60.36;高湿度试验结果不符合规定;刺激性较大。结论:柴胡总皂苷提取物的表观溶解度小,在碱性溶液中的油水分配系数大于酸性溶液中的分配系数,稳定性较好,但具有一定的吸湿性,具有较大的胃黏膜刺激性。Objective：To study on pre-preparation of total saponins extract from Bupleuri Radix and provide a basis for rational design of dosage forms.Method：Using spectrophotometry and high performance liquid chromatography to investigate of the appraent aqueous solubility,oil-water partition coefficient,stability and preliminary gastric irritation of extracts of total saponins extract from Bupleuri Radix.Result：The appraent aqueous solubility in water was 0.145 g·L-1.In buffer of pH 5.0,oil-water partition coefficient was 34.72;In buffer of pH 9.0,oil-water partition coefficient was 60.36,High-humidity test results didn＇t meet requirements;Had greater irritating.Conclusion：Appraent aqueous solubility of total saponins extract from Bupleuri Radix was small,oil-water partition coefficient in alkaline solution was greater than in acidic solution,had good stability,but with a certain degree of hygroscopicity,and had a large irritation to gastric.

关 键 词：柴胡 总皂苷 制剂前评价研究 

分 类 号：R283.6[医药卫生—中药学]