论文部分内容阅读
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 the preparation of total saikosaponin before formulation and provide the basis for designing a reasonable dosage form. Methods: The apparent solubility, oil-water partition coefficient and stability of total saikosaponin extract were determined by spectrophotometry and HPLC. The irritation to gastric mucosa of Bupleurum chinense saponin extract was also investigated. Results: The apparent solubility in water of Bupleurum chinense extract was 0.145 gL-1; the partition coefficient of oil-water was 34.72 in the buffer of pH 5.0; the partition coefficient of oil-water in the buffer of pH 9.0 was 60.36; the high humidity Test results do not meet the requirements; irritation larger. Conclusion: The apparent solubility of the extract of Bupleurum sativum total saponins is small. The oil-water partition coefficient in alkaline solution is larger than the partition coefficient in acidic solution. The stability is good, but it has some hygroscopicity and large gastric mucosal irritation Sex.