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目的:观察ELE与LIP乳化栓塞剂不同配制比的物理稳定性,释放速率及乳粒大小,考证其临床适用性。方法:将MMC溶解于ELE或60% UR中,采用“二泵一间隔”法与40% LIP混合成不同配制比,静置于室温下,观察并记录油水分层时间。用显微镜观察不同时间油水分层和乳粒变化及特征,并用EIE乳粒定标测定不同比例的乳粒大小。用ZKS- 4智能溶出仪以浆叶法测定MMC含量,计算释放累积百分率,用紫外法测定其吸收值并与不同浓度进行线性回归,求其标准曲线方程,按PKBP- N1程序中威布尔公式计算释放参数。结果:LME4∶1和5∶1分层慢,完全分层时间为13.5 h 和8 h,乳滴稳定,大小为20～100 um ,其中4∶1 药物释放速度慢,释放半衰期长,为本实验最佳乳化比,5∶1次之。LMU5∶3 比也有理想结果。结论:乳化剂的选择与配制比例影响药物的释放速度和物理稳定性,LME4∶1和5∶1 比具有“双载体”微栓的多重作用,是肿瘤血管的理想栓塞剂。LMU5∶3比也具有理想结果,供临床应用时借鉴
OBJECTIVE: To observe the physical stability, release rate and size of granules of ELE and LIP emulsifying embolic agents and to verify their clinical applicability. Method: Dissolve MMC in ELE or 60% UR, use “two-pump-one-space” method and 40% LIP to mix into different formulation ratios, statically place at room temperature, observe and record the time of oil and moisture layer. Observe the change and characteristics of the oil-moisture layer and the milk at different times using a microscope, and determine the size of the milk particles in different proportions using EIE milk calibration. ZKS-4 intelligent dissolution apparatus was used to determine the content of MMC by paddle method, and the cumulative percentage of release was calculated. The absorption value was measured by UV method and linear regression was performed with different concentrations to find the standard curve equation, according to the Weibull formula in PKBP-N1 procedure. Calculate release parameters. Results: LME 4:1 and 5:1 delamination were slow, the complete stratified time was 13.5 h and 8 h, the emulsion was stable, and the size was 20-100 um, of which the 4:1 drug release was slow and the release half-life was long. The optimal emulsification ratio was 5:1. The LMU 5:3 ratio also has ideal results. Conclusion: The selection and formulation ratio of emulsifiers affect the release rate and physical stability of the drug. LME 4:1 and 5:1 ratios have multiple effects of “two-carrier” microthrombi and are ideal embolic agents for tumor vessels. LMU 5:3 ratio also has ideal results for reference in clinical applications