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目的:在胃乐宁片现有质量标准的基础上,增加总氮量限度控制,并建立HPLC法测定腺苷的含量,以便更加有效的控制胃乐宁片的质量。方法:利用自动定氮仪测定胃乐宁片中总氮量;色谱柱为Li-chrospher C18(250 mm×4.6 mm,5μm),以乙腈-0.04 mol.L-1磷酸二氢钾溶液(2∶98)为流动相,检测波长为260 nm,流速为1.0 mL.min-1。结果:选取的16批胃乐宁片中氮的含量为13.8～15.6 mg.g-1;腺苷在1.06～106.0μg.mL-1范围呈良好的线性关系(r=0.999 9);平均回收率为96.7%。结论:增加胃乐宁片中总氮量及腺苷的含量测定,可以更好的控制胃乐宁片的质量。
OBJECTIVE: To increase the total nitrogen limit control based on the existing quality standards of Weleinning tablet, and establish the HPLC method for the determination of adenosine content in order to more effectively control the quality of Welein tablets. Methods: The total nitrogen in Weilening tablet was determined by automatic nitrogen analyzer. The column was Li-chrospher C18 (250 mm × 4.6 mm, 5 μm) with acetonitrile-0.04 mol·L-1 potassium dihydrogen phosphate solution (2 : 98) as the mobile phase at a detection wavelength of 260 nm at a flow rate of 1.0 mL.min-1. Results: The content of nitrogen in the 16 batches of Weileinning tablets was 13.8-15.6 mg.g-1, and the linearity of adenosine was in the range of 1.06-106.0 μg.mL-1 (r = 0.999 9). The mean recovery The rate is 96.7%. Conclusion: Increasing the content of total nitrogen and adenosine in Weleinning tablet can better control the quality of Welening tablet.