复方天门冬多糖注射液的稳定性试验  

Stability analysis of compound Asparagus cochinchinensis polysaccharide injection

作　　者：尹丹[1] 黄明[1] 胡庭俊[1] 潘贵珍[1] 施君[1] 杨膺白[1] 何家康[1] 谢丽丽[1] 廖黎黎[1] 

机构地区：[1]广西大学动物科学技术学院,南宁530005

出　　处：《南方农业学报》2014年第1期127-132,共6页Journal of Southern Agriculture

基　　金：广西自然科学基金项目(2010GXNSFD013022)

摘　　要：【目的】研究复方天门冬多糖注射液的稳定性,为其申报生产、运输及贮存等提供科学依据。【方法】以苯酚—硫酸法测定复方注射液中天门冬多糖含量、高效液相色谱法(HPLC)测定三七总皂苷含量,分别通过光加速试验和温度加速试验探讨贮存过程中复方注射液天门冬多糖、三七总皂苷含量的变化规律,并观测样品的pH和澄明度,以评价复方注射液的稳定性。【结果】复方注射液中可添加1%吐温-80,但不适宜添加焦亚硫酸钠、亚硫酸钠或维生素C作为抗氧化剂。在4500±500 lx的光照条件下贮存,对复方注射液中天门冬多糖含量和pH无明显影响,但对三七总皂苷含量的影响较大。复方注射液按照市售包装后在温度(40±2)℃、相对湿度(75±5)%的条件下放置6个月,其天门冬多糖含量、三七总皂苷含量、pH及澄明度的变化均在有效范围之内。【结论】复方天门冬多糖注射液可选用1%吐温-80作为助溶剂,确保密封避光,其在温度(40±2)℃、相对湿度(75±5)%的条件下至少可贮存6个月。[Objective]The stability of compound Asparagus cochinchinensis polysaccharide （ACP） injection was studied to provide necessary scientific references for its application for production, transport and storage. [ Method ]ACP content was determined using phenol-sulfuric acid method, and the content of Panax notoginseng saponins （PNS） was determined by HPLC. Light and temperature acceleration tests were used to study the change rule of ACP and PNS, pH and clarity so that the stability of compound ACP injection could be evaluated. [ Result ]Tuwen-80 （1%） additive could be added to the compound injection, however sodium pyrosulfite, sodium sulfite or vitamin C was not suitable to be used as antioxidants. Light conditions of 4500±500 lx had no obvious effects on content and pH, but great effects on PNS content. After compound ACP injection was packaged as products in market and stored in the conditions of temperature of （40±2）℃ and relative hu- mid of （75±5）% for six months, ACP content, PNS content, pH and clarity changed within the effective range. [Conclusion] The compound injection can be stored for at least six months using 1% Tuwen-80 as cosolvent, no-light sealing, and at （40±2） ℃ and relative humid of （75±5）%.

关 键 词：复方天门冬多糖注射液 天门冬多糖 三七总皂苷 稳定性 PH 澄明度 

分 类 号：S853.732[农业科学—临床兽医学]