苦参碱立方液晶纳米粒的制备及质量控制的研究Preparationand Quality Controlof Matrine Cubic Crystal Nanoparticles
田圆,吴伟刚,王家平,李宝红,彭新生
TIAN Yuan,WU Weigang,WANG Jiaping,LI Baohong,PENG Xinsheng
摘要(Abstract)：
目的采用改良的高压均质法制备苦参碱立方液晶纳米粒,并建立其质量控制方法。方法以单油酸甘油酯(GMO)为载体材料,洛泊沙姆(F127)为稳定剂,通过高速剪切和超声粉碎制备立方液晶纳米粒。采用高效液相色谱法测定苦参碱的含量。结果苦参碱检测浓度在11.125~178μg/m L范围内,浓度和峰面积线性关系良好。苦参碱立方液晶纳米粒在3个浓度水平下测得的平均回收率分别为102.1%、102.6%、100.5%,RSD分别为1.9%、1.9%、2.1%(n=3);包封率为68%,RSD为2%;实验方法精密度良好。结论该制备工艺简单易行,质量控制方法简单、准确。
OBJECTIVE To prepare matrine cubic crystal nanoparticlesbyhigh pressure homogenization method,and to establishits quality control methods. METHODS The glycerol monooleate( GMO) was used as the carrier material,poloxamer( F127) as stabilizer,cubic crystal nanoparticles were preparedby high-speed shearing and sonication. The contentofmatrinewas determined by HPLC. RESULTS The linear range of matrine was 11. 125- 178 μg / m L. The average recoveries of matrine cubic crystal nanoparticles measured at 3 different concentrations were 102. 1% with RSD = 1. 9%,102. 6% with RSD = 1. 9%,and 100. 5% with RSD = 2. 1%,respectively. The encapsulation efficiency was 68% with RSD = 2%. The precision of this test method was good.CONCLUSION The established preparation process in simple,the method of quality control is simple and accurate.
关键词(KeyWords)：
苦参碱立方液晶纳米粒;高效液相法;质量控制
matrinecubosomes;HPLC;quality control
基金项目(Foundation): 国家自然科学基金项目(81001643);; 广东省及东莞市科技计划项目(2011B031700058,2011108102020);; 广东省医学科研基金立项课题编号:(A2012424,B2012265);; 广东省中医药局科研项目(20122081);; 东莞市科技计划重点项目(201210815200358);东莞市科技计划重点项目(201110825200102)
作者(Author):
田圆,吴伟刚,王家平,李宝红,彭新生
TIAN Yuan,WU Weigang,WANG Jiaping,LI Baohong,PENG Xinsheng
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