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目的:测定磷酸川芎嗪透皮贴中川芎嗪(2,3,5,6-tetramethylpyrazine,TMP)含量均匀度及释放度。方法:建立HPLC法测定贴剂中川芎嗪含量均匀度;按照中国药典附录ⅩD释放度测定法第三法测定贴剂的释放度。结果:HPLC法测定川芎嗪含量的准确度和精密度良好。3批中试样品的含量均匀度均符合药典规定。贴剂释药曲线符合Higuchi方程;通过测定6批中试样品的释放度,确定本品在2、12和24 h的释放限度应分别为标示量的8%~30%、40%~75%和60%以上。贴剂体外释放度与体内吸收分数具有良好的相关性。结论:磷酸川芎嗪透皮贴制备工艺重演性好;建立的含量均匀度和释放度测定方法可用于贴剂的质量控制。
Objective: To determine the content uniformity and release of tetramethylpyrazine (TMP) in ligustrazine phosphate transdermal patch. Methods: HPLC method was used to determine the content uniformity of ligustrazine in the patch preparation. The release of patch preparation was determined by the third method in accordance with the appendix XD of Chinese Pharmacopoeia. Results: The accuracy and precision of determination of tetramethylpyrazine by HPLC were good. The content uniformity of three batches of pilot samples are in accordance with Pharmacopoeia regulations. The drug release curve of the patch was in accordance with the Higuchi equation. By determining the release of six test samples, the release limit of the patch at 8 h, 12 h and 24 h should be 8% -30%, 40% -75% % And 60% or more. The in vitro release of the patch has a good correlation with the in vivo absorption fraction. Conclusion: The tetramethylpyrazine phosphate transdermal paste preparation process reproducibility is good; the content uniformity and release determination established method can be used for the quality control of the patch.