四川麦冬质量评价研究

Study on Quality Evaluation of Ophiopogonis Radix in Sichuan

目的：对四川地区生产、流通和临床应用的麦冬药材质量进行综合评价,为四川地区麦冬药材质量监控提供理论依据。方法：收集四川地区不同产地、市场、饮片厂、药店的麦冬药材样品105份,采用药典方法对水分、总灰分、浸出物、麦冬总皂苷、重金属及有害元素、农残和二氧化硫含量进行测定,采用HPLC法对麦冬皂苷D、甲基麦冬黄烷酮A和甲基麦冬黄烷酮B的含量进行测定。结果：105份麦冬药材样品的水分含量在5.7%~17.9%,总灰分含量在0.9%~3.4%,浸出物含量在68.7%~95.1%,总皂苷含量在0.12%~0.57%,二氧化硫超标率为23.81%,重金属及有害元素均符合限量要求,3种有机农药均未检出,麦冬皂苷D的含量在0.04~0.30 mg/kg,甲基麦冬黄烷酮A的含量在0.0170~0.0837 mg/kg,甲基麦冬黄烷酮B的含量在0.0049~0.0370 mg/kg。结论：105份麦冬药材样品均符合中国药典的规定,但法定标准不健全,特别是在安全性监控方面尚缺乏标准,建议四川地区根据实际生产情况加强安全性方面的控制,保证临床用药安全有效。

Objective： To evaluate the quality of Ophiopogonis Radix from produce area,circulation link and clinical application in Sichuan,and to provide the theoretical basis for the quality control of Ophiopogonis Radix in Sichuan. Methods： 105 samples were collected from different produce area,market,factory of decoction pieces,drugstore in Sichuan. The content of moisture,total ash,extractum,total saponin,heavy metal,harmful element,pesticide residues,sulfur dioxide were measured by the methods which recorded in Chinese pharmacopoeia. The content of ophiopogonin D,methylophiopogonanone A,methylophiopogonanone B were measured by HPLC. Results： The content of moisture,total ash,extractum,total saponin in 105 samples Ophiopogonis Radix in Sichuan were at 5. 7%~ 17. 9%,0. 9% ~ 3. 4%,68. 7% ~ 95. 1%,0. 12% ~ 0. 57%,respectively. Over standard rate of sulfur dioxide was 23. 81%. The content of heavy metal and harmful element was conform to the limitation requirement of Chinese pharmacopoeia. Three kinds of organic pesticide had not been checked out. The content of ophiopogonin D,methylophiopogonanone A,methylophiopogonanone B were at 0. 04~ 0. 30 mg/kg,0. 0170 ~ 0. 0837 mg/kg,0. 0049 ~ 0. 0370 mg/kg,respectively. Conclusion： The quality of 105 samples are up to the requirement with the provisions of the Chinese pharmacopoeia. Actually,the mandatory standard was not perfect,especially lack of standard in security. It is suggested that strengthening supervision of sulfur dioxide and paclobutrazol residual according to the actual situation for ensuring the safe and effective of Ophiopogonis Radix in clinical application.