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目的:制备硫酸氢氯吡格雷亚微乳注射液,并对其性质进行考察。方法:以注射用大豆油和注射用中链脂肪酸三酰甘油为混合油相,以蛋黄卵磷脂、泊洛沙姆188和聚山梨酯-80为复合乳化剂,采用高压均质法制备硫酸氢氯吡格雷亚微乳注射液,通过粒度和粒度分布、Zeta电位、pH值、渗透压和含量测定以及稳定性考察等对其性质进行研究。结果:制备的乳剂外观为乳白色,略带蓝色乳光。3批样品的粒径分别为(158±22)、(160±22)和(161±33)nm,平均Zeta电位为(-37.70±0.79)mV,平均pH值为(7.51±0.03),平均渗透压为(279.33±0.58)mmol.kg-1,平均含量为(99.19±1.68)%,在(6±2)和(25±2)℃条件下放置6个月稳定。结论:制备工艺可行,制剂理化性质稳定,符合静脉注射要求。
Objective: To prepare clopidogrel hydrogen sulphate microemulsion injection and investigate its properties. Methods: The mixed oil phase was prepared from soybean oil for injection and medium chain fatty acid triacylglycerol for injection. Egg yolk lecithin, poloxamer 188 and polysorbate-80 were used as emulsifier to prepare hydrogen sulfate Clopidogrel microemulsion injection, through the particle size and particle size distribution, Zeta potential, pH, osmotic pressure and content determination and stability of the study on its nature. Results: The emulsion was milky white with a slight blue opalescence. The average particle size of the three batches of samples was (158 ± 22), (160 ± 22) and (161 ± 33) nm, the average zeta potential was -37.70 ± 0.79 mV and the average pH was (7.51 ± 0.03) The osmotic pressure was (279.33 ± 0.58) mmol.kg-1 and the average content was (99.19 ± 1.68)%. The osmotic pressure was stable at (6 ± 2) and (25 ± 2) ℃ for 6 months. Conclusion: The preparation process is feasible, the physical and chemical properties of the preparation are stable and meet the requirements of intravenous injection.