摘要
目的：通过对丁酸氯维地平静脉脂肪乳各指标进行检测,对所制备的丁酸氯维地平静脉脂肪乳的质量进行评价,确保制剂的稳定、安全、有效。方法：制备静脉脂肪乳剂,通过测定制剂含量、粒径、电位、pH值、过氧化值、游离脂肪酸值、甲氧基苯胺值等指标对制剂进行质量评价。结果：丁酸氯维地平的峰面积（Y）与浓度（X）在0.1~100μg.mL-1范围内具有良好线性关系,Y=51801X＋17659,R2=0.9999（n=3）,检测限为0.8ng,所制备的丁酸氯维地平静脉脂肪乳剂的平均含量为97.06%,平均粒径243.2±2.08nm,zeta电位-36.2±0.25,pH 7.03±0.11,过氧化值0.01 mL,游离脂肪酸值0.20±0.01,甲氧基苯胺值2.08±0.07,渗透压306±8.96 mOsmol.Kg-1。结论：所制备丁酸氯维地平脂肪乳的含量符合要求,标示含量在90.0%-110.0%的限度范围,渗透压及pH均与人体血液环境相接近,平均粒径小且分布集中,过氧化值、游离脂肪酸值及甲氧基苯胺值均较低,制备的乳剂性质稳定、重复性好,能够达到国外进口同种制剂的标准。
Objective： To evaluate the quality of clevidipine butyrate emulsion for intravenous injection by detecting each indicator of it, in order to ensure the stability safety and validity of the emulsion. Methods： High pressure homogenization method was used to prepare clevidipine butyrate emulsion for intravenous injection, the quality of clevidipine butyrate emulsion was evaluated by the determination of the content, the mean particle size~ zeta potential, pH value, peroxide value, acid value, and osmotic pressure of clevidipine butyrate emulsion. Results： The peak area of clevidipine butyrate （Y） and concentration （X） in the 0.1-100 μg. mL^-1 range has a good linear relationship within the framework Y=51801X±17659 R2=0.9999（n=3）, the detection limit of clevidipine butyrate was 0.8 ng. The mean con- tent of Clevidipine butyrate emulsion was 97.06 %, the mean particle size, Zeta potential, pH value, peroxide value, acid value, anisidine value and osmotic pressure was 243.2± 2.08 nm, -36.2± 0＇.25, 2.08± 0.07, 7.03± 0.11, 0.01mL, 0.501± 0.06, and 306± 8.96 mOsmol. Kg^-1 respectively. Conclusion： The content of the clevidipine butyrate emulsion was in the 90.0%-110.0 % range, the osmotic pressure and pH were close to human blood environment, the mean particle size was small and its distribution was concentrated, the peroxide value, free fatty acid value and anisidine value were low, the emulsion prepared was stable, and have good reproducibility, it can reach the standard of the same kind of preparations imported.
出处
《现代生物医学进展》
CAS
2013年第7期1272-1277,共6页
Progress in Modern Biomedicine
关键词
丁酸氯维地平
静脉脂肪乳
质量评价
Clevidipine butyrate
Intravenous injection
Evaluation
