虎力散胶囊的质量标准再研究  

Restudy on Quality Standard of HuLiSan Capsule

作　　者：王建平[1] 曾海松[2] 俞洁东[2] 杨云[1] 刘茵[1] 苗春平[1] 颜耀东[1] 

机构地区：[1]空军航空医学研究所附属医院,北京100089 [2]扬子江药业集团有限公司

出　　处：《西部中医药》2015年第7期20-24,共5页Western Journal of Traditional Chinese Medicine

摘　　要：目的:重新建立虎力散胶囊的质量标准。方法:采用显微鉴别法观察虎力散中生药材的显微鉴别特征;采用TLC法对虎力散胶囊中三七、制草乌进行定性鉴别;采用HPLC法对虎力散胶囊中所含生物碱进行限量检查及含量测定,以Sepax-C18(250 mm×4.6 mm,5μm)色谱柱为分析柱,乙腈-四氢呋喃(25∶15)为流动相A,0.1 mol/L醋酸铵溶液(每1 000 m L加冰醋酸0.5 m L)为流动相B,按规定梯度进行洗脱,检测波长为235 nm,柱温25℃,流速1.0 m L/min。结果:显微鉴别特征明显,薄层斑点清晰,阴性对照无干扰;生物碱限量检测及含量测量都在限定的浓度范围内,进样量与峰面积线性关系良好,平均加样回收率分别为98.50%与98.62%,RSD%分别为0.79%与0.80%(n=6)。结论:本方案方法简便,结果准确、可靠,重现性好,可作为虎力散胶囊质量控制的有效方法。Objective： To re-establish quality standard of HuLiSan capsules. Methods： Microstructure features of medicinal herbs in the prescription were observed by microscopic identification; SanQi （Panax Notoginseng） and prepared CaoWu （Radix Aconiti Kusnezoffii Preparata） in HuLiSan capsules were identified qualitatively by TLC method; limit test and content determination of alkaloids contained in HuLiSan capsules were taken by HPLC, chro- matographic column： Sepax-C18 （250 mmx4.6mm, 5 Ixm） as analytical columns, mobile phase A： acetonitrile- te- trahydrofuran （25：15）, mobile phase B： 0.1mol/L ammonium acetate solution （adding glacial acetic acid 0.5 mL each 1000 mL）, gradient elution, detection wavelength was 235 nm, column temperature 25℃, flow rate was 1.0mL/min. Results： The identification was with distinct microscopic features, clear TLC spot and the blank test showed no interference. Limit test and content determination of alkaloids were in the limited ranges of the concentrations, there was good linear relationship between the injection volume and peak areas. Average recovery rates were 98.50% and 98.62%, RSD was 0.79% and 0.80% （n=6）. Conclusion： The method is simple, accurate, reliable and reproducible, which could be an effective method for quality control of HuLiSan capsules.

关 键 词：虎力散胶囊 质量标准 TLC HPLC 制草乌 三七 

分 类 号：R927.11[医药卫生—药学]