蒲地蓝消炎片质量控制与评价研究

Study on Quality Control and Evaluation of Pudilan Xiaoyan Tablets

关键词:  蒲地蓝消炎片  质量控制与评价  探索性研究

Key words:  Pudilan Xiaoyan tablets  quality control and evaluation  exploratory research

摘要:

目的 对蒲地蓝消炎片的现行质量标准和质量现状进行分析和评价，为其标准和质量提高提供依据。方法 依据现行法定标准检验中发现的问题，结合原药材炮制和制剂生产工艺，从药品真实性、安全性和有效性3个方面开展探索性研究，建立和完善薄层色谱鉴别、黄芩苷/汉黄芩苷峰面积比值测定、重金属及有害元素检查及多指标成分含量测定等检测和评价方法。结果 有3家企业可能存在低质投料、少投料、原药材炮制工艺不规范问题，有1家企业存在人为添加黄芩苷指标成分行为，有部分企业样品存在较高水平的砷残留。结论 蒲地蓝消炎片总体质量状况一般，标准和工艺亟待提高完善。

Abstract:

OBJECTIVE To analyze and evaluate the current quality standards and quality status of Pudilan Xiaoyan tablets for providing evidence for its standard and quality improvement production. METHODS According to the problems found in the standard test, combined with the original medicinal material processing and preparation production process, exploratory research was carried out from the three aspects of authenticity, safety and effectiveness of the drug. Detection and evaluation methods including thin-layer chromatography, baicalin/wogonoside peak area ratio, heavy metals and harmful elements, and determination of the content of multi-index components were established and improved. RESULTS Three companies might have problems such as low-quality feeding, less feed, and irregular processing technology of the original medicinal material, one company had artificially added baicalin index components, and some samples had high levels of arsenic residue. CONCLUSION The overall quality status of Pudilan Xiaoyan tablets is normal. The standards and processes need to be improved.