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目的:考察利福喷丁的溶解性及其稳定性,为开发其新剂型奠定基础。方法:采用紫外分光光度法测定利福喷丁在11种溶剂中的溶解度及研究4种增溶剂对其的增溶作用;考察其在正己烷和正辛醇中的表观油水分配系数及在高湿、高温、光照条件下的稳定性。结果:利福喷丁在三氯甲烷中溶解性较好,溶解度为13.076 mg.L-1,在水中溶解性较差,为3.046 mg.L-1;吐温-80对其增溶作用较强,溶解度达到823 mg.L-1;在正己烷和正辛醇中的表观油水分配系数分别为4.778±0.41、17.441 2±2.79;稳定性指标中色泽和主药含量在考察期内均有变化。结论:利福喷丁的脂溶性强、水溶性差,合适的增溶剂对其有一定的增溶作用,其在高温、高湿、光照条件下不太稳定。
Objective: To investigate the solubility and stability of rifapentine and lay the foundation for the development of new dosage forms. Methods: The solubility of rifapentine in 11 solvents was determined by ultraviolet spectrophotometry and the solubilization of 4 solubilizers was studied. The apparent partition coefficients of oil and water in n-hexane and n-octanol were also investigated. Wet, high temperature, light conditions of stability. Results: The solubility of rifapentine in trichloromethane was better, its solubility was 13.076 mg.L-1, and its solubility in water was poor, which was 3.046 mg.L-1. The solubilization of rifapentine was better than that of tween -80 And the solubility of 823 mg · L-1 was obtained. The apparent water-oil partition coefficients in n-hexane and n-octanol were 4.778 ± 0.41 and 17.441 ± 2.79, respectively. Variety. CONCLUSION: Rifapentin has strong liposolubility and poor water solubility, and suitable solubilizer has certain solubilization effect on it. It is not stable under high temperature, high humidity and light conditions.