臺灣地區市售四環素類製劑之力價調查

Investigation on the Potency of Tetracycline Antibiotic Drugs in Taiwan

林玉珊(Yu-Shan Lin) ； 柯燕珍(Yann-Jen Ko) ； 邱進益(Jin-Yi Chiou)

《藥物食品檢驗局調查研究年報》 13號 (1995/09) Pp. 260-264

https://doi.org/10.6946/ASRNL.199509.0260

摘要

於民國八十二年由全省各縣市抽購國產及進口四環素類製劑共122件，國產品35家廠牌共112件，進口4家廠牌共10件，其中鹽酸四環素(Tetracycline HCl)101件，鹽酸氣四環素(Chlortetracycline HCl)9件，鹽酸挫四環素(Oxytetracycline HCl)12 件。依據美國藥典第二十二版(USP XXII)及日本抗生物質醫藥品產準解說1993年版(MRAP 1993)上記載之HPLC方法及光學標準曲線法測定其力價，結果約符合公定書之合格標準(90~120%)，合格率100%。

關鍵字

四環素 ； HPLC

並列摘要

In an attempt to determine the quality of tetracycline antibiotic drugs after the implementation of GMP, a total of 122 samples were purchased from Taiwan area in 1993. Among these samples 112 represented domestic products manufactured by 35 drug companies and the remaining 10 were importes and distributed by 4 companies. 101 out of 122 samples were tetracycline HCl, while the remaining were 9 chlortetracycline HCl and 12 oxytetracycline HCl, respectively. The high performance liquid chromatography (HPLC) method in USPXXII and the optical standard response line method in MRAP (1990) were employed to test these samples. The results showed thst all the samples meet the potency requirement (90~120%).