八十年度大陸中藥品質調查報告

INVESTIGATION OF THE QUALITY OF HERBAL PREPARATIONS PRODUCED IN MAINLAND CHINA

本項品質調查係於83年06月至84年02月間於坊問蒐購及民眾送驗之大陸藥品檢體103件，依其用途計分十一類，檢體未登錄於前四個年度所調查之新品目者列為甲部份，前已收載之舊品目，但同品名不同批產品，或不同廠牌同品名者，亦加以蒐集予以比對者，列為乙部份、甲部份計60件分別進行重量差異試驗、成分比對、摻加西藥成分、重金屬檢查、標示檢查及外觀檢查，結果如次：一、重量差異試驗之48件檢體中，有11件其差異超過平均重量之±15% 。二、甲部份39件檢體之組成藥材比對，結果有4件檢體與標示處方藥材成分不符，分別為未檢出芍藥、桂枝、冰片及生地黃等藥材。三、摻加西藥成分方面，60件檢體中計2件檢出摻加西藥成分，分別為風濕鎮痛類1件，檢出乙醯基氨基苯（acetaminophen）、咖啡鹼（caffeine）、氯若沙宗（chlorzoxazone）、二氮平（diazepam）、氫氯苯噻（hydrochlorothiazide）、吲哚美洒辛（indomethacin）、維他命Bl（thiamine disulfide）等西藥成分及己二烯酸（sorbic acid） 防腐劑成分。補腎滋養類1件，檢出acetaminophen西藥成分。四、重金屬方面，60件檢體經分別檢測鉛、銅、鎘、汞及砷等項目，其中有四件之砷含量偏高，分別為187、2306、10885及21490ppm，另有兩件檢體所含前述之五種重金屬含量合計超出100ppm。五、檢體之各項標示檢查方面，未標示任何大陸衛生機關藥品許可字號者，未標示製造日期或批號者，未標示任何大陸衛生機關藥品許可字號及製造日期批號者，未標示有效日期或保存期限者，未標示處方成分者及處方成分標示不全者，各分別佔此次抽購檢體之21.7%、21.7%、15.0%、90.0%、13.3%及68.3%。另乙部份檢體計43件係針對同一品名、同一廠牌中不同批號或不同製造廠所製造之檢體，就標示及處方組成內容加以比較並檢驗，結果發現有廠牌相同、處方標示相同而成分比對之薄層層析圖譜相異之情形。至於檢體標示檢查方面，未標示任何大陸衛生機關藥品許可字號者、未標示製造日期或批號者，未標示任何大陸衛生機關藥品許可字號及製造日期批號者，未標示有效日期或保存期限者，未標示處方成分者及處方成分標示不全者各分別佔此次抽購檢體之46.5%、53.5%、44.2%、97.7%、9.3%及44.2%。

A total of one hundred and three samples were purchased from Taipei area or received from consumers during the period from June, 1994 to February, 1995. The first group consisted of 60 samples which were new items. Another 43 drugs which had been collected in our previous surveys, but belonged to different lot constituted the second group. The first group of samples were classified into eleven categories, for which the test on weight variation, TLC tests for components, a test for adulteration with synthetic chemical drugs, another test for heavy metals and finally an examination of labeling and external appearance were conducted. The variation of TLC patterns and labelings were carried out for the samples of the second group. The results revealed that: (1) There were 11 out of a total of 48 samples with weight vanat1on which exceeded the range of average weight ± 15%. (2) In comparison of the TLC pattern of the samples, it was found that three samples did not yield the characteritic spots of Paeoniae Radix, Cinnamomi Ramulus and Rehmanniae Radix respectively, and one sample did not yield the spots for both Rehmanniae Radix and borneol in the TLC patterns, despite the labeling of ingredients. (3) One sample of the antirheumatic and analgesic category contained acetaminophen, caffeine, chlorzoxazone, diazepam, hydrochlorothiazide, •indomethacin, thiamine disulfide and sorbic acid as adulterants, and another sample of the nourishing category was adulterated with acetaminophen. (4) With regard to heavy metals, the As contents in four samples were 187, 2306, 10885 and 21490 ppm respectively, and the total contents of Pb, Cu , Cd, Hg, As were over 100 ppm in another two samples. (5) 0f the 60 samples in the first group, 21.7% were found to bear no labeling for drug permit number; 21.7% had no labeling of manufacture date or lot number; 15.0% had no labeling of drug permit number, as well as manufacture date arid lot number; 90% had no labeling for expiration date or shelf life; 13.3% had no labeling of the formulas, and 68.3% had incomplete labeling of the formulas. Of the 43 samples in the second group, 46.5%, 53.5%, 44.2%, 97.7%, 9.3% and 44.2% had defaults in the same categories of test no. as for the first group.