葫芦素脂肪乳剂成型性影响因素考察

Factors that influence the formation of cucurbitacin lipid emulsion

目的 了解影响葫芦素脂肪乳荆成型性的因素。方法 以葫芦素脂肪乳的外观、粒径、药物含量及稳定性为指标,分别考察渗透压、高压乳匀、pH、空气置换刑及灭菌等因素对乳剂成型性的影响。结果 等渗调节剂甘油对乳剂粒径没有影响;高压乳匀可降低乳剂粒径,适当压力下多次乳匀可获得粒径小、均匀性好的乳剂;pH可影响乳剂中药物含量;使用空气置换刑的乳剂在37℃放置3个月后稳定性良好,而充空气的乳剂发生破裂;高压灭 菌时,升温速度对乳刺的稳定性亦有影响。结论 控制和掌握好高压乳匀、pH、空气置换剂及灭茼等因素,就可获得粒径大小适宜、粒度均匀、性质稳定、供静脉注射的葫芦素脂肪乳剂。

OBJECTIVE To determine the factors that influence the formation of cucurbitacin lipicl emulsion. METHODS To investigate the influence of osmotic pressure, homogenizing, pH, nitrogen gas and autoclaving on (he formation of the emulsion, the appearance, particle size, drug content and stability of cucurbitarin lipid emulsion were used as guidelines. RESULTS The amount of glycerol had no effect on the particle size of the emulsion, which could he reduced through repetitive homogenizing. pH values influenced the drug content of the emulsion, Saturated with nitrogen gas, the emulsion was stable after 3 months at 37℃ , while it cracked when saturated with air The rate of temperature ascending in autoclaving influenced the stability of the emulsion, too. CONCLUSIONS Cucurbitacin intravenous lipid emulsion with appropriate, uniform particle size and stable quality can be maintained if such factors as homogenizing. pH. nitrogen gas and autoclaving can be well controlled.