半边旗口服微乳剂的质量控制及稳定性研究  

Studies on Quality Control and Stability of PsL Oral Microemulsion

作　　者：吕应年[1,2] 何宇辉[2] 田乐[2] 牟伯中[1] 

机构地区：[1]华东理工大学化学与分子工程学院,上海200203 [2]广东医学院广东天然药物研究与开发重点实验室,广东湛江524023

出　　处：《时珍国医国药》2014年第12期2899-2901,共3页Lishizhen Medicine and Materia Medica Research

基　　金：广东省科学自然基金(No.S2012010008163);粤港合作自然科学基金(No.GHP/022/06)

摘　　要：目的建立半边旗抗癌二萜5F口服微乳剂的质量标准并考察稳定性。方法采用液相色谱-紫外检测法测定口服微乳剂中有效成分5F的含量,色谱条件为Hypersil C18（4.6 mm×250 mm,5μm）色谱柱,流动相为甲醇∶水∶醋酸（55∶45∶0.045,V/V）流速1.0 ml·min^-1,柱温35℃,检测波长242 nm。采用4 000 r/min离心5 h及10 000 r/min高速离心20 min考察微乳剂的稳定性,采用长期静置法考察温度及光照对口服微乳剂稳定性的影响。结果高效液相色谱法测定5F的含量在0.12~2.4μg·ml^-1范围内线性关系良好,平均回收率为92.9%。高速离心对微乳稳定性无影响,温度及光照条件下半边旗5F口服微乳稳定性良好,未出现破乳、分层或析出现象。结论实验建立的分析方法灵敏可靠,可作为半边旗口服微乳剂的质量控制方法,半边旗口服微乳剂稳定性好。Objective To establish the quality standard of PsL oral microemulsion containing mainly 5F（ ent - 11 α - hydroxy - 15 - oxo - kaur - 16 - en - 19 - oic - acid）, and to evaluate its stability. Methods The content was determined by HPLC. The col- umn was Hypersil C18 （4.6 mm×250 mm,5μm） , the mobile phase was the mixture of methanol -water- acetic acid （55：45：0. 045, V/V） with a flow rate of 1.0 ml·min^-1 , the detective wavelength was 242 nm, and the column temperature was main- tained at 35℃. The factors such as centrifuge, temperature and light were adopted to evaluate the stability of the oral microeul- sion. Results The linearity for 5F was obtained over the range of 0.12 -2.4 μg·ml^-1 （r2 = 0. 9988 ）, the average recovery of 5F was 89.8%. The microemulsion was stable with no demulsification or delamination after centrifugation at 4000 r/min for 5h or 10000 r/min for 20 min, and it was also stable with a period of store under different temperature or microemulsion. Conclusion the method of HPLC - UV was sensitive and reliable that can be used as quality control method of PsLSF oral microe- mulsion. The stability of the oral microemulsion was good.

关 键 词：半边旗 二萜 口服微乳剂 含量 稳定性 

分 类 号：R283[医药卫生—中药学]