替利定药物树脂混悬剂初步质量研究

The preliminary research of the quality of tilidine-resin suspension

目的对制备的替利定药物树脂混悬剂进行初步的含量测定和溶出度检测方法的质量研究。方法采用HPLC，用依利特spherisorb C8色谱柱（20cm×4．6mm，5μm）；以甲醇-0．2％碳酸铵溶液（75：25）为流动相；检测波长254nm；柱温30℃；流速1mL／min。结果依照上述方法进行含量测定，试验结果显示，在浓度为0．005-5mg／mL范围内，具有良好的线性范围（r=0．9998），平均回收率100．2％、100．1％和100．0％；溶出度检测结果显示，在0．005-0．1mg／mL浓度内（r=0．9997），浓度与峰面积呈良好的线性，平均回收率较高。结论该法简单可行，质量可控，为替利定药物树脂混悬剂的质量标准的建立提供了依据。

Objective To determine the methods of the tilidine-resin suspension about the content determination and dissolution test. Methods The analysis was carried out using HPLC, a C8 column（20cm×4.6mm,5μm）. The mobile phase was a mixture of methanol and 0.2% ammonium bicarbonate（70：30）, The detection wavelength was 254nm. The column temperature was 30℃. The flow rate was lmL/min. Results Experimental results show that the content of the concentration of 0.005 to 5mg/mL range, has a good linear range（r=0.9998）, the average recoveries were 100.2%, 100.1% and 100.0%; Dissolution test results showed that within 0.005-0.1mg/mL concentration （r=0.9997）, the concentration had good linear with peak area, the average recoveries were higher. Conclusion This method is simple, feasible, and quality controllable, it was providing the basis to the establishment of the mixed suspension of quality standard.