神经酸干乳制剂制备工艺及质量评价  

Preparation Technology and Quality Evaluation of Nervonic Acid Dry Emulsion Preparation

作　　者：陈文静 闫雪生[2] 孙丹丹[2] 于蓓蓓[2] 生立嵩[2] 王平[2] 江丽慧 蔡成龙 付加雷[2] CHEN Wenjing;YAN Xuesheng;SUN Dandan;YU Beibei;SHENG Lisong;WANG Ping;JIANG Lihui;CAI Chenglong;FU Jialei(Shandong University of Traditional Chinese Medicine,Jinan 250355,Shandong,China;Shandong Academy of Chinese Medicine,Jinan 250014,Shandong,China;Shangdong Vocational College of Science and Technology,Weifang 261053,Shandong,China;Affiliated Hospital of Jining Medical College,Jining 272000,Shandong,China)

机构地区：[1]山东中医药大学,山东济南250355 [2]山东省中医药研究院,山东济南250014 [3]山东科技职业学院,山东潍坊261053 [4]济宁医学院附属医院,山东济宁272000

出　　处：《辽宁中医药大学学报》2022年第10期62-67,共6页Journal of Liaoning University of Traditional Chinese Medicine

基　　金：中央引导地方科技发展专项基金(YDZX2021117);山东省中医药科技发展计划(2019-0290,M-2022175);山东省重点研发计划(科技示范工程)(2021SFGC1205)。

摘　　要：目的研究神经酸干乳制剂的制备工艺,并对其进行质量评价。方法利用冷冻干燥法将神经酸口服乳剂冷冻,以干乳制剂的外观、再分散性、复溶后粒径大小为考察指标,利用单因素法优选出适宜的支撑剂及冻干工艺。结果采用7.5%的乳糖作为支撑剂,预冻4 h,主干燥60 h、终末干燥10 h制得的神经酸干乳制剂外观平整结实,为均一乳白色,再分散性较好,复溶后平均粒径为207.83 nm,多分散系数(PDI)为0.228,电位为-30.95 mV,平均载药量为44.3201 mg/g,体外溶出度明显提高,室温及4℃环境下放置30 d外观及含量变化不大,稳定性较好。结论该制备工艺稳定可行,制得的神经酸干乳制剂稳定,符合要求。Objective To study the preparation process of nervonic acid dry emulsion preparation and to evaluate its quality. Methods The nervonic acid oral emulsion was frozen by freeze-drying. The appearance,redispersibility and particle size after reconstitution of the dry emulsion preparation were used as the inspection indicators. The single-factor method was used to select a suitable proppant and freeze-drying process. Results Using 7.5% lactose as proppant,pre-freezing for 4 hours,main drying for 60 hours,and final drying for 10 hours,the nervonic acid dry emulsion preparation had a smooth and firm appearance,uniform emulsiony white,good redispersibility,and average grain size after reconstitution. The diameter was 207.83 nm,the polydispersity coefficient(PDI)was 0.228,the potential was-30.95 m V,and the average drug loading was 44.320 1 mg/g. The in vitro dissolution rate was significantly improved. It was placed at room temperature and 4 ℃ for 30 d,with little change in appearance and content,and good stability. Conclusion The preparation process is stable and feasible,and the prepared nervonic acid dry emulsion preparation is relatively stable and meets the requirements.

关 键 词：神经酸 干乳制剂 制备工艺 质量评价 

分 类 号：R284[医药卫生—中药学]