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作者中文名	作者英文名	单位中文名	单位英文名	E-Mail
辛洁萍	XIN Jie-ping	北京中医药大学中药学院/北京市中药品质评价重点实验室，北京102488	School of Chinese Materia Medica，Beijing University of Chinese Medicine/Beijing Key Laboratory for Quality Evalution of Traditional Chinese Medicine，Beijing 102488，China
王海丽	WANG Hai-li	北京中医药大学中药学院/北京市中药品质评价重点实验室，北京102488	School of Chinese Materia Medica，Beijing University of Chinese Medicine/Beijing Key Laboratory for Quality Evalution of Traditional Chinese Medicine，Beijing 102488，China
王敏	WANG Min	北京中医药大学中药学院/北京市中药品质评价重点实验室，北京102488	School of Chinese Materia Medica，Beijing University of Chinese Medicine/Beijing Key Laboratory for Quality Evalution of Traditional Chinese Medicine，Beijing 102488，China
白玉莹	BAI Yu-ying	北京中医药大学中药学院/北京市中药品质评价重点实验室，北京102488	School of Chinese Materia Medica，Beijing University of Chinese Medicine/Beijing Key Laboratory for Quality Evalution of Traditional Chinese Medicine，Beijing 102488，China
徐文娟	XU Wen-juan	北京中医药大学中药学院/北京市中药品质评价重点实验室，北京102488	School of Chinese Materia Medica，Beijing University of Chinese Medicine/Beijing Key Laboratory for Quality Evalution of Traditional Chinese Medicine，Beijing 102488，China
徐新房	XU Xin-fang	北京中医药大学中药学院/北京市中药品质评价重点实验室，北京102488	School of Chinese Materia Medica，Beijing University of Chinese Medicine/Beijing Key Laboratory for Quality Evalution of Traditional Chinese Medicine，Beijing 102488，China
魏锋	WEI Feng	中国食品药品检定研究院，北京100050	National Institute for Food and Drug Control，Beijing 100050，China	魏锋，博士，研究员，研究方向：中药质量控制；Tel：（010）67095432，E-mail：weifeng@nifdc.org.cn
李向日	LI Xiang-ri	北京中医药大学中药学院/北京市中药品质评价重点实验室，北京102488	School of Chinese Materia Medica，Beijing University of Chinese Medicine/Beijing Key Laboratory for Quality Evalution of Traditional Chinese Medicine，Beijing 102488，China	李向日，教授，研究方向：中药炮制及质量控制；Tel：（010）84738616，E-mail：lixiangri@sina.com

基金项目:国家药品标准提高项目（2018Z009）；国家重点研发计划（2019YFC1711500）

中文摘要:目的：针对《中华人民共和国药典》（2015年版）苦杏仁标准中存在的显微鉴别不全面、水分项缺失以及炒苦杏仁限度不合理等问题，通过实验研究，为建立更为完善的质量标准提供参考。方法：采用5%氢氧化钾解离，稀甘油装片，显微观察苦杏仁外种皮细胞；比较甲苯法和烘干法测定水分的差异，并进行水分测定；HPLC测定苦杏仁苷的含量。结果：苦杏仁中存在多边形的外种皮细胞；采用甲苯法测定苦杏仁及其饮片的水分，20批苦杏仁的平均水分为3.6%，燀苦杏仁的平均水分为3.5%，炒苦杏仁的平均水分为3.2%；所测20批市售燀苦杏仁样品中苦杏仁苷的平均质量分数为3.0%，炒苦杏仁的平均质量分数为3.4%。结论：建议《中华人民共和国药典》标准进行相应修订，苦杏仁外种皮细胞呈类圆形或多边形；采用四部通则0832第四法测定苦杏仁及其饮片的水分，水分限度定为苦杏仁不得超过7.0%、燀苦杏仁不得超过7.0%、炒苦杏仁不得超过6.0%；炒苦杏仁中苦杏仁苷的质量分数不得少于2.4%。

中文关键词:苦杏仁显微鉴别水分含量测定质量标准

Quality Standards Improvement of Medicinal Materials and Cut Crude Drugs of Bitter Almond

Abstract:Objective：There are some problems in the standard of bitter almonds in the Pharmacopoeia of the People′s Republic of China （2015 edition），such as incomplete microscopic identification，lacking of the standard of moisture and unreasonable content limit standard of stir-fried bitter almonds. The object of this study was to establish a more comprehensive quality standard of bitter almonds through experiment. Methods：The bitter almonds was dissociated with 5% potassium hydroxide，the seed coat of bitter almonds was put on the glass slide with dilute glycerol，and the microscope was used to observe the exotestal cells. In this experiment both toluene method and drying method are used to determine the water content；The content of amygdalin was determined by high performance liquid chromatography. Results：Polygonal epidermal cells exist in bitter almonds；The moisture content of medicinal materials and cut crude drugs of bitter almond was measured by toluene method. The average moisture of 20 batches of bitter almonds was 3.6%，the scalded bitter almonds was 3.5%，and the stir-fried bitter almonds was 3.2%. The average content of amygdalin was 3.0% in 20 batches of commercially available scalded bitter almonds，and the stir-fried bitter almonds was 3.4%. Conclusion：It is suggested to revise the pharmacopoeia standard as follows：The exotestal cells of bitter almonds are round or polygonal；The moisture content of medicinal materials and cut crude drugs of bitter almond are determined by the fourth method of General Rule 0832. The moisture limit is set to be no more than 7.0% in bitter almonds and scalded bitter almonds，no more than 6.0% in stir-fried bitter almonds；The content of amygdalin in stir-fried bitter almonds should not be less than 2.4%.

keywords:bitter almond microscopic identification moisture content determination quality standard

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