复方黄芩温敏凝胶的制备与质量标准研究  

Studies on the Preparation and Quality Standard of Compound Huangqin Temperature Sensitive gel

作　　者：何丽芳[1] 万东华[2] 潘旭东[1] 林唯[3] 刘锋[1] 

机构地区：[1]福建中医药大学附属人民医院,福州350004 [2]福州大学化学化工学院药物化学与制药工程研究所,福州350108 [3]福建中医药大学药学院,福州350108

出　　处：《海峡药学》2014年第11期60-63,共4页Strait Pharmaceutical Journal

摘　　要：目的制备复方黄芩温敏凝胶,并建立了温敏凝胶中黄芩苷含量测定的质量标准。方法以泊洛沙姆作为凝胶材料,考察含有不同泊洛沙姆407（Pluronic F127）和泊洛沙姆188（Pluronic F68）浓度配比的处方对凝胶胶凝温度的影响。采用高效液相色谱法测定凝胶中黄芩苷的含量：色谱柱为Acclaim 120 C18柱（4.6mm×250mm,5μm）;流动相为甲醇-水-磷酸（57∶43∶0.2）,流速1.0m L·min^-1;检测波长280nm,柱温30℃。结果选择胶凝温度为29.5℃的凝胶基质：22%P407/8%P188。黄芩苷在0.0253~0.1508（mg·m L^-1）范围内线性关系良好,平均加样回收率为103.74%,RSD为1.26%。结论泊洛沙姆温敏凝胶的制备工艺简便易行,筛选得到的凝胶处方适于临床皮肤给药。所建立的质量标准结果准确,可靠,重现性好,可用于复方黄芩温敏凝胶的质量控制。OBJECTIVE To prepare the preparation of compound Huangqin temperature sensitive gel,and to establish the quality control standard to determine the content of baicalin temperature sensitive gel. METHODS Bo Losham was choosed as gel material,the influence of different concentration ratio of Bo Losham 407（Pluronic F127）and Bo Losham 188（Pluronic F68） on the prescription on the gel temperature was investigatal. HPLC method was established for determination of Baicalin in gel： the chromatographic column was Acclaim 120 C18column（4. 6mm ×250mm,5μm）; the mobile phase of methanol water phosphoric acid（57∶ 43∶ 0. 2）,the flow rate was 1. 0m L·min^-1;the detection wavelength was 280 nm and the column temperature was 30℃. RESULTS The gelation temperature was 29. 5℃ gel matrix： 22% P407 /8% P188. Baicalin in 0. 0253 ~ 0. 1508（mg·m L^-1） the linear relationship is good,the average recovery was 103. 74%,RSD was 1. 26%. CONCLUSION The poloxamer temperature sensitive gel preparation process is simple,the prescription screening gelobtained is suitable for clinical skin medication. The quality standard is accurate,reliable,reproducible and can be used for quality control of compound Huangqin temperature sensitive gel.

关 键 词：黄芩苷 制备 质量标准 HPLC 

分 类 号：TQ460.4[化学工程—制药化工] R927.11[医药卫生—药学]