酥制蛤蚧炮制工艺及质量标准研究

Research on processing method and quality standard of crispy Gejie

目的:以酥制蛤蚧的厂家炮制工艺为基础,结合《中国药典》2020年版四部炮制通则的要求明确具体的相关工艺参数,优化炮制工艺;遵循药材和饮片检定通则,制订质量标准。方法:收集样品,确定考察因素,将酥制蛤蚧的工艺进行优化。以《中国药典》2020年版一部蛤蚧的质量标准为基础,通过方法学考察,制订性状、鉴别和浸出物的质量标准和限度;增加聚合酶链式反应法、重金属及有害元素、黄曲霉毒素三项检验项目。结果与结论:经过生产企业验证,酥制蛤蚧的炮制工艺可行,更加规范化;新制订的质量标准能够有效控制酥制蛤蚧饮片的质量。

Objective:To clarify the relevant process parameters and optimize the processing process based on the manufacturer's processing process of crispy Gejie and the requirements of the Chinese Pharmacopoeia 2020.VolⅣ.To establish the quality standards by following general of determination for the traditional Chinese material medicine and Chinese prepared slices.Methods:Samples were collected and the factors to be examined were identified,the process of crispy Gejie was optimized based on the quality standards of the Chinese Pharmacopoeia 2020.VolⅠ.Through methodological investigations,quality standards,traits,identification and limits for leachables were developed.t Tests of heavy metals and harmful elements,and aflatoxin were added.Results and Conclusion:The processing process of crispy Gejie verified by production enterprises is feasible,more normalized.This quality standards can effectively control the quality of crispy Gejie.