不同增溶剂对鱼金注射液稳定性的影响  

Effect of Different Solubilizer on Stability of Yujin Injection

作　　者：何俊婷 张芳侠 曹爱兰 王景峰 惠选柱 He Junting;Zhang Fangxia;Cao Allan;Wang Jinffeng;Xi Xuanzhu(Medbine Research Institute of Shaanxi Pharmaceutical Holding Group C0.,Ltd.,Xi＇an,Shaanxi,China 710075;Shaanxi Chinese Medbirw Institute,Xi＇an,Shaanxi,China 710075;Shaanxi Pharmaceutical Holding Shanhaidan Pharmaceutical C0.,Ltd.,Xi＇an,Shaanxi,China 710075;Engineering Research Center of Extraction Separation and Preparation Technology of Traditional Chirwse Medicbw in Shaanxi Provbwe,Xi＇an,Shaanxi,China 710075)

机构地区：[1]陕西医药控股医药研究院有限公司,陕西西安710075 [2]陕西省中药提取分离与制剂工艺工程研究中心,陕西西安710075 [3]陕西中药研究所,陕西西安710075 [4]陕西医药控股山海丹药业有限公司,陕西西安710075

出　　处：《中国药业》2018年第21期9-11,共3页China Pharmaceuticals

基　　金：陕西省科学技术研究发展计划项目[2015SF2-06]

摘　　要：目的考察不同增溶剂制备的鱼金注射液的稳定性。方法分别以羟丙基-β-环糊精、磺丁基-β-环糊精、甲基-β-环糊精为增溶剂制备鱼金注射液,以外观、不溶性微粒、可见异物、p H及甲基正壬酮、乙酸龙脑酯、芳樟醇含量为评价指标,考察鱼金注射液稳定性的影响因素试验(光照、高温、低温、冻融)及40℃加速试验。结果羟丙基-β-环糊精、甲基-β-环糊精制备的鱼金注射液外观、可见异物及不溶性微粒均符合规定,甲基正壬酮、乙酸龙脑酯及芳樟醇含量无明显变化;磺丁基-β-环糊精制备的鱼金注射液经6个月加速试验后,不溶性微粒增多,溶液有乳光产生。结论羟丙基-β-环糊精、甲基-β-环糊精具有优良的增溶效果,制备的鱼金注射液稳定性良好,但磺丁基-β-环糊精不适用于鱼金注射液的增溶。Objective To investigate the stability of Yujin Injection prepared with difl^rent solubilizer. Methods Yujin Injections were prepared with hydroxyprow1 - β - cyclodextrin, sulfobutyl - β - cyclodextrin or methyl - β - cyclodextrin as solubilizers respectively. The appearance, insoluble particles, visible foreign matter, pH, methyl-n- nonanone, bornyl acetate and linalool were taken as evaluation indexes to investigate the influencing factors of Yujin Injection（light, high temperature, low temperature, freezing and thawing） and accelerate sta- bility at 40 ℃. Results The appearance, visible foreign matter and insoluble particles of Yujin Injections prepared by hydroxyprowl- β- cyclodextrin and methyl- β- cyclodextrin were in line with the provisions. There was no significant change in metbyl n- nonyl ketone, bornyl acetate and linalool content. After six months of accelerated test, the insoluble particles of Yujin Injection prepared by sulfobutyl- β-cyclodextrin were increased, the solution turned slightly milky white. Conclusion Hydroxypropyl- β-cyclodextrin and methyl- β- cyclodextrin have good solubilization eflect, the Yujin Injections prepared with them have good stability. However, sulfobutyl- β- cyclodextrin is not suitable for the solubilization of Yujin Injection.

关 键 词：羟丙基-Β-环糊精 磺丁基-β-环糊精 甲基-β-环糊精 影响因素试验 加速稳定性 鱼金注射液 

分 类 号：R932[医药卫生—生药学] R283.2[医药卫生—药学]