复方黄柏温敏凝胶的制备和连翘苷含量测定

Preparation and forsythin content determination of compound Phellodendron thermosensitive gel

目的:筛选复方黄柏温敏凝胶的最优处方,建立测定其中连翘苷含量的HPLC法。方法:以泊洛沙姆407(P407)和泊洛沙姆188(P188)为基质制备复方黄柏温敏凝胶,通过相变温度和黏度筛选最佳处方。HPLC法测定所用色谱柱:Hypersil ODS2-C18柱(150mm×4.6mm,5μm),流动相为乙腈∶水(22∶78),流速为1.0 ml/min,检测波长277nm,柱温30℃。结果:最优处方为P407∶P188=18∶1作为基质,相变温度为27.17℃,黏度为15.31Pa·s。建立的HPLC法回收率、精密度和稳定性良好,测得3批复方黄柏温敏凝胶中连翘苷含量为(0.74±0.05)mg/g(n=3)。结论:复方黄柏温敏凝胶符合临床应用要求。建立的HPLC法准确、稳定、专属性强,可用于复方黄柏温敏凝胶中的连翘苷含量测定。

Objective： To screen the optimal formula of compound Phellodendron thermosensitive gel and establish a HPLC method for content determination of forsythin in it. Methods： Compound Phellodendron thermosensitive gel was prepared using poloxamer 407（P407） and poloxamer 188（P188） as matrix. The optimal formula was chosen according to the phase transition temperature and viscosity. The HPLC method was applied on a Hypersil ODS2-C18 analytical column（150 mm× 4. 6 mm, 5 μm） ,with the mobile phase consisting of acetonitrile-water（22 ： 78） at a flow rate of 1.0 ml/min. Detection wavelength was 277 nm and the column temperature was 30 ℃. Results： The optimal formula was using P407 ： P188（18 ： 1） as matrix. The phase transition temperature was 27.17℃ and the viscosity was 15.31 Pa · s. Recovery,precision and stability of the HPLC method were all good. Content of forsythin determined in the three batches of compound Phellodendron thermosensitive gel were （0.74±0.05） mg/g（n= 3）. Conclusion： The compound Phellodendron thermosensitive gel conforms to the requirements of clinical application. The HPLC method is accurate,stable,specific and can be used for forsythin content determination of com- pound Phellodendron thermosensitive gel.