地龙饮片质量分析的研究.docVIP

地龙饮片质量分析的研究 　　[摘要]目的 评价市售地龙饮片的质量状况，分析不合格项发生的原因，为临床用药和药品监管提供参考。方法 按照《中国药典》2010年版一部、2015年版一部对10批次市售地龙饮片的杂质、水分、总灰分、酸不溶性灰分和水溶性浸出物进行测定。结果 10批次地龙饮片均存在质量问题，不合格项主要是杂质、总灰分、酸不溶性灰分和水溶性浸出物。结论 本地区市售地龙饮片杂质超标问题严重，未严格按照标准除去地龙体内的内脏、泥沙等异物。建议地龙生产和经营企业严格控制饮片质量，药品监管部门加强监管力度，确保地龙用药安全、有效。 　　[关键词]地龙；杂质；水分；总灰分；酸不溶性灰分；水溶性浸出物；质量分析 　　[中图分类号] R282.74 [文献标识码] A [文章编号] 1674-4721（2017）09（c）-0076-03 　　[Abstract]Objective To evaluate the quality of Lumbricus in the market and analysis the reason of unqualified items as a reference for clinical medication and drug supervision.Methods Referring to the Chinese Pharmacopeia （2010 and 2015 Editions，part 1），impurity，moisture，total ash，acid-insoluble ash and water-soluble extract of the 10 batches of samples were determined.Results Some quality problems existed in these samples，impurity，total ash，acid-insoluble ash and water-soluble extract were the main unqualified items.Conclusion The problems of excessive impurity in Lumbricus decoction pieces are serious in this region.The harvesting and processing enterprises of Lumbricus do not remove its viscus，sediment，foreign matters completely，which should be strictly performed in accordance with the quality standard.It is suggested that these enterprises strictly control the quality of Lumbricus decoction pieces.The drug administration ought to strengthen inspection and supervision in order to ensure the safe and effective in clinical medication. 　　[Key words]Lumbricus；Impurity；Moisture；Total ash；Acid-insoluble ash；Water-soluble extract；Quality analysis 　　地??，别名蚯蚓干，为常用中药，其药用历史已逾数千年。始载于《神农本草经》，列为下品。具有清热息风、通络、平喘、利尿等功效[1-6]。《中国药典》收载的地龙为钜蚓科动物参环毛蚓Pheretima aspergillum（E.Perrier）、通俗环毛蚓Pheretima vulgaris Chen、威廉环毛蚓Pheretima guillelmi（Michaelsen）或栉盲环毛蚓Pheretima pectinifera Michaelsen的干燥体[7-8]。前一种习称“广地龙”，后三种习称“沪地龙”。上述标准规定地龙饮片应满足：杂质不得超过6.0%，水分不得超过12.0%，总灰分不得超过10.0%，酸不溶性灰分不得超过5.0%，水溶性浸出物不得少于16.0%。根据近几年本地区检验数据统计发现，部分市售地龙饮片存在杂质严重超标的问题，笔者曾经检查过杂质含量高达60%的地龙饮片样品[9]。临床上使用如此劣质的地龙饮片，不仅发挥不了其药效，反而延误治疗，甚至加重患者病情。为深入探讨地龙饮片的质量状况、保