大陸中藥品質調查

INVESTIGATION ON THE QUALITY OF MAINLAND CHINESE HERBAL PREPATIONS

本調查於80年07月至08月間於台北地區抽購大陸藥品檢體計八大類（58件），分別進行重量差異、成分比對、摻加西藥分、重金屬檢查、標示檢查及外觀檢查。各項驗結果，在每一製劑重量與平均重量之差異試驗方面，由於大部份檢體均未標示其理論重量，故僅觀察每一製劑（丸、錠或膠囊）之重量與平均重量之差異，經檢驗45件丸劑，錠劑或膠囊檢體，有17件其差異超過±15%。各類檢體經薄層層析檢驗比對，結果發現感冒鎮咳類2件，健胃整腸類1件，外用膏粉類1件及其他類1件，其檢體處方分別未標示黃柏及黃連藥材，但結果顯現黃柏及黃連特有之螢光斑點。其他類2件檢體，其處方標示有當歸藥材，但結果卻未顯現當歸特有之螢光斑點。另1件其他類檢體，其處方未標示含防腐劑，但卻檢出對羥本甲酸乙酯（Ethyl paraben）防腐劑。在在摻加西藥成份方面，風濕鎮痛類乙件檢體檢出Hydrochlorothiazide。另補腎滋養類乙件檢體檢出Caffenine，外觀檢查有兩件有發霉之情事。而重金屬方面，分別槍測鉛、銅、鎘、汞及砷等重金屬，結果有2件檢體檢出銅含量介於150-200ppm之間，而汞測定部份，其中2件汞含量達2791ppm及2139ppm，另1件為735ppm且砷含量為49ppm，砷測定部份，則有2件砷含量達2772ppm及941ppm。在檢體標示檢查方面，未標示廠者，未標示任何大陸衛生機關藥品字號者，未標示製造批號者，未標示任何大陸衛生機關藥品字號及製造批號者，未標示處方成分者，處方成分標示不全者分別佔此次抽購檢體之8.6%、55.2%、36.2%、34.5%、8.6%及41.4%。

Fifty-eight samples were taken from the Taipei market during the period from July, 1991 to August, 1991. These samples were classified into eight categories, for which the tests on weight variation, TLC, adulteration with synthetic chemical drugs, heavy metal, labeling and external appearance were performed. The results showed that: (1) There were 17 samples with weight variations (differences between the individual dosage units and the average weights) exceeding the range of ±15%. (2) In cmparing the TLC patterns of the samples, it was found that six samples individually showed up with the characteristic fluorescent spots of coptis, phellodendri and ethyl paraben in their TLC patterns, but the package labelings did not indicate inclusion of the components coptis rhizoma, phellodendri cortex and preservative in their compositions. Two other samples didn't show up with the characteristic fluorescent spots of angelicae radix in the TLC patterns, despite the labeling of this component in their composition. (3) One sample of the antirheumatic and analgesic category contained hydrochlorthiazide as an adulterant, and two samples of the renal tonic category were adulterated with caffeine. (4) With regard to heavy metals, the Cu contens of two samples fell within 150-200ppm, the Hg contents of two sampies were individually 2791ppm and 2139 ppm, and the contents of As were 2772 ppm and 941ppm in another two samples. (5) Of the 58 samples, 20(34.5%) were found to bear no labeling on drug permit number and lot number, 5(8.6%) had no labelings of prescription, and 24 (41.4%) had incomplete labelings. (6) There were two samples found to have mold growth.