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目的制备醒脑静注射乳剂并对其物理性质进行初步考察。方法用激光电泳-粒度测定仪、可见分光光度计、高分子渗透压计、酸度计、乌氏黏度计等仪器分别测定醒脑静注射乳剂的粒径及分布、Zeta电位、稳定性参数(Ke)、渗透压、pH值、黏度等;观察室温留样乳剂的粒径及输液配伍的稳定性。结果醒脑静注射乳剂的Nicomp分布强度重量径为(176.8±24.0)nm,Zeta电位为–27.49 mV,稳定性参数(Ke)为2.9%,渗透压稍偏高,pH值为7.20,黏滞系数为1.243 cp;醒脑静注射乳剂留样6个月粒径稍增大,与5%葡萄糖、生理盐水配伍10 h内稳定。结论醒脑静注射乳剂各项指标基本符合静脉注射制剂的要求。
Objective To prepare Xingnaojing injection emulsion and preliminary study of its physical properties. Methods The particle size and distribution of Xingnaojing injection emulsion, Zeta potential and stability parameter (Ke) were measured by laser electrophoresis - particle size analyzer, visible spectrophotometer, macrophage osmometer, pH meter and Ubbelohde viscometer, respectively ), Osmotic pressure, pH value, viscosity and so on; observe the stability of the emulsion size and infusion compatibility at room temperature. Results The weight distribution of Xingnaojing injection emulsion was (176.8 ± 24.0) nm, the zeta potential was -27.49 mV, the stability parameter (Ke) was 2.9%, the osmotic pressure was slightly higher, the pH value was 7.20, Coefficient of 1.243 cp; Xingnao intravenous emulsion sample remaining 6 months slightly increased, with 5% glucose, saline compatibility within 10 h stability. Conclusion Xingnaojing injection of the emulsion indicators basically in line with the requirements of intravenous preparations.