根黄分散片的含量测定及制剂稳定性研究

摘要

The study aimed to establish a method for determining Baicalin in Genhuang dispersible tablets and inspection for the preparation of stability. RP-HPLC method was adopted and the C18 column(150 mm×4. 6 mm, 10μm)was used. The mobile phase was methanol-water-phosphoric acid(47:53: 0. 2%), with the flow rate of 1 mL/min. The detection wavelength was at 280 nm and the column temperature was 30 ℃. Under the high-light exposure experiment, accelerating experiment and room temperature storage observation, the results showed that the product was basically stable. The calibration curve of Baicalin was linear in the range of 1. 018 to 50. 90 μg/mL, r=0. 9999(n=6) , the average recovery rate was 97. 27% , RSD=0. 75% (n=9). The method was simple, sensitive and accurate with good repeatability, which can be used for the quality control of Genhuang dispersible tablets, and the preparation of good stability.%本试验旨在建立根黄分散片中黄芩苷的含量测定方法以及考察该制剂的稳定性,为制定该制剂质量标准中含量测定方法及保质期提供依据.采用反相高效液相色谱(RP-HPLC)法,色谱柱为YWG-C18 (150 mm×4.6 mm,10 μm),流动相:甲醇:0.2％磷酸水溶液(47:53),流速:1 mL/min,检测波长:280 nm,柱温:30℃,进样量:10μL;根据药典,采用强光照射试验、加速试验及部分长期稳定性试验考察分散片中黄芩苷的稳定性.结果表明,黄芩苷的含量在1.018～50.90 μg/mL范围内与峰面积呈良好的线性关系,r=0.9999(n=6),平均加样回收率为97.27％,RSD为0.75％(n=9);强光照射试验、加速试验及部分长期稳定性试验结果表明该产品基本稳定;此方法简便、灵敏、重现性好,可用于根黄分散片中黄芩苷的含量测定,且该制剂的稳定性良好.