正交试验优化青藤外敷贴的制备工艺  

Preparation Technology Optimization of Sinomenine Topical Paste by Orthogonal Test

作　　者：李陈雪 曲炳楠 曹赢[1] 杨玉赫 郭玉岩[1] 李永吉[1] 王锐[1] 

机构地区：[1]黑龙江中医药大学药学院,哈尔滨150040

出　　处：《中国药房》2016年第22期3112-3114,共3页China Pharmacy

基　　金：黑龙江省自然科学基金资助项目(No.H201472)

摘　　要：目的:优化青藤外敷贴的制备工艺。方法:以"初黏力""持黏力""剥离强度"的综合评分为指标,以加热搅拌时间(A,h)、加热温度(B,℃)和各组分(软化剂、空白基质和青藤碱)加入顺序(C)为影响因素,设计正交试验优化青藤外敷贴的制备工艺并进行验证;同时采用高效液相色谱法测定青藤碱含量。结果:青藤外敷贴的最优制备工艺为先加入空白基质与青藤碱,再加入软化剂,80℃加热搅拌1 h;验证试验中3批样品综合评分的RSD=2.09%(n=3),药物含量平均值为6.7 mg/g,符合不低于6.0 mg/g的质量要求。结论:优化的青藤外敷贴制备工艺设计合理、稳定、可行,所制敷贴黏附性较好、药物含量合格。OBJECTIVE：To optimize the preparation technology of Sinomenine topical paste. METHODS：Using＂initial viscous force＂,＂holding viscous force＂and＂peeling strength＂as index,heating and stirring time（A,h）,heating temperature（B,℃）and the sequence of adding composition（softening agent,blank matrix and sinomenine）（C）as influential factors,the preparation technology of Sinomenine topical paste was optimized by orthogonal test and verified. At the same time,the content of sinomenine was determined by HPLC method. RESULTS：The optimal preparation technology of Sinomenine topical pasta was as follows as adding blank matrix and sinomenine,and then adding softening agent,heating at 80 ℃,stirring for 1 h. In verification test,RSD of comprehensive score for 3 batches of samples were 2.09%（n=3）;average contents of samples were 6.7 mg/g,which was in line with the requirement of ≥6.0 mg/g. CONCLUSIONS：The optimal preparation technology of Sinomenine topical pasta is reasonable,stable and feasible. The paste shows good adhesiveness and is qualified in content.

关 键 词：青藤外敷贴 制备工艺 黏附力指标 正交试验 青藤碱 含量测定 高效液相色谱法 

分 类 号：R285.2[医药卫生—中药学]