中国药师
中國藥師
중국약사
CHINA PHARMACIST
2015年
2期
340-343
,共4页
梁俊%郑江萍%黄良永%杜士明
樑俊%鄭江萍%黃良永%杜士明
량준%정강평%황량영%두사명
中药饮片%二氧化硫%残留%测定
中藥飲片%二氧化硫%殘留%測定
중약음편%이양화류%잔류%측정
Chinese herb pieces%Sulfur dioxide%Residues%Determination
目的::通过测定我院购入中药饮片的二氧化硫残留量,分析中药饮片二氧化硫残留量的现状,为我院中药饮片的质量控制提供资料,保证临床用药安全。方法:在待入库的中药饮片中,随机抽取100批,其中二氧化硫限量为400 mg·kg-1的10个品种36批和限量为150 mg·kg-1的其他品种64批;依据《中国药典》2010年版和文献报道的方法测定并计算二氧化硫含量。结果:100批中药饮片样品中,二氧化硫残留量超过标准的有14批(大于限量400 mg·kg-1和大于限量150 mg·kg-1各7批),其中限量为400 mg·kg-1的不合格率为19.4%,限量为150 mg·kg-1的不合格率为10.9%。结论:该测定方法操作简单,重复性好,可快速测定中药饮片中二氧化硫的残留量;当前市场上中药饮片二氧化硫残留量超标的问题十分严重,生产厂家需加强对硫磺熏蒸中药材的规范管理,医院应增加入库前二氧化硫残留量定量检测环节,保证临床安全用药。
目的::通過測定我院購入中藥飲片的二氧化硫殘留量,分析中藥飲片二氧化硫殘留量的現狀,為我院中藥飲片的質量控製提供資料,保證臨床用藥安全。方法:在待入庫的中藥飲片中,隨機抽取100批,其中二氧化硫限量為400 mg·kg-1的10箇品種36批和限量為150 mg·kg-1的其他品種64批;依據《中國藥典》2010年版和文獻報道的方法測定併計算二氧化硫含量。結果:100批中藥飲片樣品中,二氧化硫殘留量超過標準的有14批(大于限量400 mg·kg-1和大于限量150 mg·kg-1各7批),其中限量為400 mg·kg-1的不閤格率為19.4%,限量為150 mg·kg-1的不閤格率為10.9%。結論:該測定方法操作簡單,重複性好,可快速測定中藥飲片中二氧化硫的殘留量;噹前市場上中藥飲片二氧化硫殘留量超標的問題十分嚴重,生產廠傢需加彊對硫磺熏蒸中藥材的規範管理,醫院應增加入庫前二氧化硫殘留量定量檢測環節,保證臨床安全用藥。
목적::통과측정아원구입중약음편적이양화류잔류량,분석중약음편이양화류잔류량적현상,위아원중약음편적질량공제제공자료,보증림상용약안전。방법:재대입고적중약음편중,수궤추취100비,기중이양화류한량위400 mg·kg-1적10개품충36비화한량위150 mg·kg-1적기타품충64비;의거《중국약전》2010년판화문헌보도적방법측정병계산이양화류함량。결과:100비중약음편양품중,이양화류잔류량초과표준적유14비(대우한량400 mg·kg-1화대우한량150 mg·kg-1각7비),기중한량위400 mg·kg-1적불합격솔위19.4%,한량위150 mg·kg-1적불합격솔위10.9%。결론:해측정방법조작간단,중복성호,가쾌속측정중약음편중이양화류적잔류량;당전시장상중약음편이양화류잔류량초표적문제십분엄중,생산엄가수가강대류광훈증중약재적규범관리,의원응증가입고전이양화류잔류량정량검측배절,보증림상안전용약。
Objective:To analyze the current situation of sulfur dioxide residues in Chinese herb pieces through determining the residues in Chinese herb pieces purchased by our hospital to provide the information for the quality control of Chinese herb pieces in our hospital and ensure the clinical medication safety. Methods:The methods for the detection of sulfur dioxide residues described in Chi-nese Pharmacopoeia 2010 edition and the relative literatures were adopted. Totally 100 batches of Chinese herb pieces were selected randomly from the storage waiting products, including 10 categories of 36 batches with the limitation of 400 mg·kg-1 and the other categories of 64 batches with the limitation of 150 mg·kg-1 . Results: The sulfur dioxide residues in 14 batches were out of limits, and among them, 7 batches were over 400 mg·kg-1 and the other 7 ones were over 150 mg·kg-1 . The unqualified rate was 19. 4%and 10. 9% for the samples with the limitation of 400 mg·kg-1 and 150 mg·kg-1 , respectively. Conclusion:The detection method is simple, reproducible and rapid in determining sulfur dioxide residues in Chinese herb pieces. The exceeding standard situation of sulfur dioxide residues in Chinese herb pieces is serious, and the management on Chinese herb medicines with sulphur fumigation should be strengthened by manufacturers. Hospitals should implement the determination of sulfur dioxide residues before storage to en-sure drug safety.