大陸藥品品質調查

INVESTIGATION ON THE QUALITY OF MAINLAND CHINESE HERBAL PREPARATIONS

本調查於77年10月至12月間於台北地區抽購大陸藥品檢體計六大類102件，分別進行重量差異、崩散度試驗、薄層層析比對、摻加西藥成分試驗、重金屬檢查、含醇量、標示檢查及急性毒性試驗。各項檢驗結果，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，經檢驗結果大部份在±5～±15%範圍內。崩散度試驗結果，檢體均在J.P.XI所規定之120分鐘內崩散。各類檢體經薄層層析檢驗比對，結果發現同廠商出品之同一產品會有呈現不同圖譜之情形。風濕鎮痛類中有2件雖然處方標示有黃連藥材，但經薄層層析檢驗結果未顯示黃連特有的螢光斑點。在摻加西藥成份方面，風濕鎮痛類有1件檢體檢出Acetaminophen, Diazepam及Caffeine（然處方未含茶葉），補腎滋養類2件檢體檢出Caffeine（然處方未含茶葉）。而重金屬檢查方面，風濕鎮痛類及其他類檢體均未檢出砷、鎘及鉛等重金屬。藥酒含醇量測定，結果13件檢體其含醇量為18.8%～57.9%，而測定甲醇含量結果有5件未檢出甲醇，另8件甲醇含量均低於100ppm。在檢體標示檢查方面，未標示任何大陸衛生機關藥品字號者、未標示製造批號者及未標示任何大陸街生機關藥品字號及製造批號者分別佔此次抽購檢體之44.1%，47.1%及33.3%。而有標示大陸衛生機關藥品字號及製造批號者則佔此次抽購檢體之41.2%。至於急性口服毒性試驗中，2件檢體可能有亞急性或慢性毒性。

One hundred and two samples were taken in Taipei from Oct. 1988 to Dec. 1988. These samples were classified into six categories ' and weight variation, disintegration ' TLC ' adulteration of synthetic chemical drugs ' heavy metal ' alcohol content ' labeling and toxicity tests were performed. The results showed that: (l)The weight variation between the individual dosage units and the average weights mostly fell within ± 5-± 15% (2)All Samples met the requirement of J. P. XI on disintegration to be accomplished in 120 mins. (3)In comparing the TLC patterns of the samples, it was found that different Samples of the same product manufactured by the same manufactory had different TLC patterns. Two other samples of the anti-rheumatic and analgesic category didn’t show up the characteristic fluorescent spots of coptis in the TLC patterns, despite the labeling of the component of coptis Rhizoma in their compositions. (4)One sample of the antirheumatic and analgesic category contained the adulterations of acetaminophen, diazepam and caffeine, and two samples of the renaltonic category had the adulteration of caffeine. (5)The heavy metals, As, Cd and Pb were negative in the antirheumatic and analgesic preparations on the other preparations. (6)The alcohol contents of 13 samples fell within 18.8-57.9% (v / v), and methanol was not detected in 5 samples, or was present in less than 100 ppm in another 8 samples. (7)Trhirty four of the 102 samples (33.35%) were found to bear no labeling on drug permit number and lot. number. (8)Two samples probably had subacute toxicity and chronic toxicity.