Development of a novel quality standard of Indigoplant

蓼大青叶质量标准的研究（英文）

Traditional Chinese medicine （TCM） has been widely used in China for thousands of years, and has received more and more recognition worldwide. Indigoplant （Folium Polygoni Tinctorii）, a TCM, has been used in various diseases. In our study, we established a quality standard of Indigoplant according to the European Pharmacopoeia, and this standard has passed the early audit stages of the European Pharmacopoeia Commission. The lndigoplant samples were identified with high performance thin layer chromatography （HPTLC）, qualified with RP-HPLC quantitation, and analyzed with a series of quality tests. An accurate, reliable and robust HPLC method with gradient elution for quantitation was developed and validated with a one-variable-at-a-time （OVAT） robustness approach. Several tests, including the loss on drying, total ash and ash insoluble in hydrochloric acid of Indigoplant, were performed for quality analysis. Furthermore, six batches of the Indigoplant samples were appraised with this quality standard. In conclusion, the established quality standard was more internationally normative and applicable for the quality control of Indigoplant in practical application.

中药在我国的广泛应用已有几千年历史,也越来越多地得到世界范围的认可。蓼大青叶是一种传统中药,广泛应用于多种疾病的治疗。本研究根据欧洲药典规范,建立了蓼大青叶的质量控制标准,该标准现已通过欧洲药典委的初期审核。本研究对蓼大青叶药材进行了高效薄层色谱法鉴别,反相高效液相色潽法含量测定及系列检查。高效液相色谱含量测定方法准确、可靠、耐用;用梯度洗脱色谱条件,并采用单因素循环法对该含量测定方法进行了耐用性验证。对蓼大青叶干燥失重、总灰分和酸不溶灰分进行了系列检查。按此质量标准对六批药材进行了评价。结果表明,该质量标准更具有国际规范性,适用于实际应用中蓼大青叶的质量控制。