纳米齐墩果酸注射用灭菌粉末质量标准的研究  

A Study of the Quality Standard of the Sterilized Powder of Oleanolic Acid Nanoparticles (OLA-NP) for Injection

作　　者：陈倩[1] 易以木[1] 刘亚妮[1] 

机构地区：[1]华中科技大学同济医学院药学院药剂教研室,武汉430030

出　　处：《医药导报》2005年第6期524-526,共3页Herald of Medicine

摘　　要：目的对纳米齐墩果酸注射用灭菌粉末进行含量测定,并对其质量标准作出评价。方法采用高效液相色谱(HPLC)法进行含量测定,流动相为水∶甲醇(用冰醋酸、三乙胺调节pH值至5.8),检测波长210nm,流速:1mL·min1,柱温:室温。结果线性范围Y=0.182X-0.0998,r=0.9998,平均回收率100.07%,RSD值0.48%。测得齐墩果酸纳米粒的平均粒径320.3nm,平均包封率96.47%。结论该测定方法有效,所测实验室冻干注射用灭菌粉末制剂质量合格。Objective To determine the content of oleanolic acid (OLA) in the sterilized powder for injection and to assess the quality standard of the powder. Methods The content of OLA in the powder was determined with HPLC. The mobile phase was composed of methanol and water, the pH value being adjusted to 5.8 with glacial acetic acid and triethylamine. The detection wavelength was set at 210 nm and the column kept at room temperature. The flow rate was 1 mL·min -1. Results The linear range was Y=0.182X-0.099 8(r=0.999 8). The average recovery rate was 100.07% with an RSD of 0.48%. The average diameter of the OLA-NP was 320.3 nm and the average encapsulation rate, 96.47%. Conclusion The method was shown to be effective and the quality of the freeze-dried sterilized powder for injection up to standard.

关 键 词：齐墩果酸 纳米 质量标准 高效液相色谱法 

分 类 号：R286[医药卫生—中药学] R927.11[医药卫生—中医学]