川芎嗪眼用乳剂制备工艺研究  

Study on Preparation Technology of Tertramethylpyrazine Ophthalmic Emulsion

作　　者：甘良春[1] 彭熙琳[2] 郭丹丹[3] 李元波[2] 刘晏春[2] 

机构地区：[1]四川省食品药品安全监测及评审认证中心,成都市610017 [2]扬子江药业集团四川海蓉药业有限公司,都江堰市611830 [3]四川省人民医院皮肤病性病研究所,成都市610031

出　　处：《中国药房》2011年第7期608-610,共3页China Pharmacy

摘　　要：目的:制备川芎嗪(TMP)眼用乳剂。方法:通过单因素试验,考察油相浓度、乳化剂浓度、投药量、乳化时间和高压匀质工艺、灭菌工艺,以确定最佳处方和制备工艺;通过测定pH值、粒径、Zeta电位、包封率、TMP含量评价其质量。结果:选取的油相浓度为15%、乳化剂的浓度为1.5%、投药量为每100mL乳剂投300mgTMP、乳化时间为5min,高压匀质工艺为15000psi压力下匀质5次,灭菌条件为121℃、15min热压灭菌;制得的样品pH平均值为6.8,平均粒径为(273±2)nm,平均Zeta电位为(-26.6±0.4)mV,平均包封率为(59.9±1.3)%,TMP平均含量为(2.98±0.01)mg·mL-1。结论:优选的处方合理,制备工艺可行。OBJECTIVE： To prepare Tertramethylpyrazine （TMP） ophthalmic emulison. METHODS： The concentration of oil phase and emulsifier, amount of drugs, emulsification time, high-pressure homogeneization process and sterilization process were investigated by single factor test to establish the optimal formulations and preparation technology. The quality of TMP emulsion was evaluated by determining the pH value, particle size, Zeta electric potential, entrapment efficiency and content. RESULTS： The concentration of oil phase and emulsifier were 15% and 1.5%. 300 mg TMP was used to prepare 100 mL emulison. The emulsification time were 5 min. The homogeneization process was 15 000 psi for 5 times. The sterilization condition was 121℃ for 15 min. The pH value of preparation was 6.8. The average particle size, Zeta electric potential, entrapment efficiency and concentration of three samples were （273 ± 2） nm, （ 26.6 ± 0.4） mV, （59.9 ± 1.3）% and （2.98 ± 0.01） mg·mL^-1, respectively. CONCLUSION： The optimized formulations and preparation technology are reasonable and feasible.

关 键 词：川芎嗪 眼用乳剂 制备工艺 

分 类 号：R284.2[医药卫生—中药学] R283.62[医药卫生—中医学]