目的 建立可用于丙泊酚脂肪乳注射液质量控制的乳粒检测方法。方法 以4%氯化钠溶液为介质将得普利麻和利泊芬2种丙泊酚脂肪乳注射液稀释成不同浓度, 以库尔特计数法测定各浓度下乳粒平均粒径, 寻求该法的最佳测定浓度。以水为分散介质, 在大约10%的遮光度条件下测定上述2种脂肪乳注射液的粒度分布, 比较2种方法的优缺点。通过加入氯化钙溶液不同程度地破坏上述脂肪乳注射液, 分别用库尔特计数法和激光散射法考察各质量指标的变化以寻求能反应质量变化的关键指标。结果 库尔特计数法测定丙泊酚脂肪乳注射液有最佳浓度条件, 得普利麻为15 μg·mL^-1, 利泊芬为6 μg·mL^-1。库尔特计数法不能测得脂肪乳完整的粒径分布, 但可以监测其中大粒子数, 通过考察大于0.6 μm乳粒的比例可监测该注射剂的质量变化。激光散射法可测得脂肪乳注射液的完整的粒径分布和平均粒径, 但对其中痕量大粒子的检测不灵敏, 注射液破坏时, 各参数变化不明显。结论 库尔特计数法在合理的测定条件下, 测定关键指标, 可有效的对丙泊酚脂肪乳注射液进行质量控制。

OBJECTIVE To establish a method to determine the droplet size of propofol fat emulison injection for quality control. METHODS Coulter counting and light diffraction were employed respectively to determine the droplet size of Diprivan and Lipuro, and the two METHODS were compared for their advantages and disadvantages. The optimal determining condition was built through investigating the influence of concentration. Demulsification was carried out by adding electrolyte, then several parameters were measured. According to the results, the optimal condition and the key parameter for determination of the droplet size were established. RESULTSThe optimal concentrations for droplet size determination by coulter counting were 15 μg·mL^-1 for Diprivan and 6 μg·mL^-1 for Lipuro, respectively. Coulter counting method could not provide the whole size distritbution of the emulsion, but could monitor the large droplets in the injection. Additionally, the change of the quality of the emulsion could be monitored by measuring the portion of the droplets larger than 0.6 μm. Light diffraction could offer the whole size distribution and the mean size of the emulsion. But it was not sensitive to measure large droplets in trace amount. And the detection RESULTScould not reflect the change when the emulsion was destructed. CONCLUSION The quality of propofol fat emulsion can be effectively controlled by determining the key parameters with coulter counting under reasonable conditions.