- 期刊
廣告類中藥製劑之品質調查－補腎、保肝及壯筋骨類
Investigation on the Quality of Commerical Chinese Herbal Preparations-Liver and Kidney Supplement and Skeleton-strengthing Formula
摘要
本品質調查之檢體係於民國九十四年二月至八月間由各縣市衛生局抽查所得之65件檢體，依各產品原查驗登記規格與方法包括：外觀、平均重量、重量差異、崩散度、乾燥減重、總灰分、酸不溶性灰分、成分比對等予以檢驗及標示之檢查。檢驗結果，65件檢體中有7件不符規定，佔10.8%，其中平均重量及總灰分不符者各3件(4.6%)，外觀、重量差異及酸不溶性灰分不符者各2件(3.1%)。檢體65件分屬46家藥廠，包括18家GMP藥廠、28家非GMP藥廠，而檢驗不符規定之檢體，分屬6家藥廠，其中5家為非GMP藥廠。上述檢驗結果，均逐案函覆原送地方衛生機關依法處理。
並列摘要
This study analyzed 65 samples taken from Feb. 2005 to Aug. 2005 by region health authorities, based on the registered specifications and testing methods、appearance、average weight、weight variation、disintegration、dry loss、total ash、acid-insoluble ash、identification and labeling. The results showed that three samples (4.6%) failed to meet the requirements of average weight and total ash determination. Two samples (3.1%) failed to meet the appearance, weight variation and acid-insoluble ash requirement. The samples were manufactured by 46 pharmaceutical plants, including 18 GMP and 28 non-GMP plants. The 7 samples that did not comply with the requirements were manufactured by 6 different pharmaceutical factories, 5 of these are not GMP compliant.
延伸閱讀
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