复方血竭跌打膏的制剂工艺、指纹图谱及含量测定研究

Study on Preparation Technology,Fingerprint and Content Determination of Fufang Xuejie Dieda Ointment

目的制备复方血竭跌打膏,建立高效液相色谱(HPLC)指纹图谱并对其主要成分进行定量分析。方法制备O/W型乳膏剂,结合星点设计-效应面法(CCD-RSM)优化药膏基质处方,并进行中试放大验证;采用HPLC建立指纹图谱并检测三七、续断指标成分含量。结果优选出最佳基质处方为:硬脂酸10.7 g、单硬脂酸甘油酯6.0 g、十二烷基硫酸钠1.0 g、羊毛脂3.3 g;并基于此进行了中试放大验证实验,相对误差为2.66%,结果显示上述基质处方科学合理,稳定可行。HPLC指纹图谱显示11批样品中有19个共有峰,相似度>0.9;建立了三七皂苷R_(1)、人参皂苷Rg_(1)、人参皂苷Rb1及川续断皂苷Ⅵ含量测定方法。结论用优选得到的基质处方制备出的软膏均匀细腻、稳定性好,高效液相色谱方法检测结果可靠,可用于质量标准的研究。

Objective To prepare Fufang Xuejie Dieda Ointment,to establish HPLC fingerprint and quantitatively analyze its main chemical components.Methods O/W cream was prepared,the ointment matrix formulation was optimized by central composite design-response surface methodology(CCD-RSM)and then verified by pilot samples.HPLC was used to establish fingerprint and detect the contents of Notoginseng Radix et Rhizoma and Dipsaci Radix.Results The optimal ratio of the matrix is as follows:10.7 g stearic acid,6.0 g glycerin monostearate,1.0 g sodium dodecyl sulfate and 3.3 g lanolin.The relative error according to the pilot-plant test was 2.66%,which illustrated that the matrix formulation was reasonable and stable.HPLC fingerprint showed that there were 19 common peaks in 11 batches of samples,and the similarity was above 0.9.Meanwhile,the method for determining content of Notoginsenoside R_(1),Ginsenoside Rg_(1),Ginsenoside Rb1 and Akebia saponin D was established.Conclusion The ointment prepared with the optimal matrix formulation is uniform,fine and stable.The detection results of the HPLC method is reliable,which could be used in the further research on quality standard.