非類固醇抗發炎藥(piroxicam)及抗生素(cefaclor)口服製劑之品質監測

Monitoring the Quality of NSAIDs and Oral Antibiotics: Taiwan

吳珍瑗(Chen-Yuan Wu)；黃秋羽(Chiu-Yu Huang)；黃昱綺(Yu-Chi Huang)；林美智(Mei-Chi Lin)；陳玉盆(Yu-Pen Chen)；周秀冠(Hsiu-Kuan Chou)；陳惠芳(Hwei-Fang Cheng)

非類固醇抗發炎藥 ； 抗生素 ； 膠囊劑型 ； piroxicam ； cefaclor ； non-steroid anti-inflammatory drug ； antibiotics ； piroxicam ； cefaclor

食品藥物研究年報

6期（2015 / 12 / 01）

159 - 164

繁體中文

103年度藥品品質監測計畫以風險評估為原則，配合藥政管理政策，選定非類固醇抗發炎藥(non-steroid anti-inflammatory drug, NSAIDs)(含Piroxicam成分)及抗生素(含Cefaclor成分)膠囊劑型之市售品進行品質監測，於1至9月間委由全國各縣市衛生局，前往轄區內醫院、診所、藥局、藥商及製藥廠抽驗市售檢體，共抽得Piroxicam檢體27件(均為國產)，Cefaclor檢體7件(均為國產)參照中華藥典第七版及美國藥典36版進行外觀、平均重量、主成分鑑別、溶離度、單位劑量均一度、水分、類緣化合物及含量測定之檢驗。檢驗結果Piroxicam成分之檢體2件溶離度試驗不合格，1件水分含量不合格，Cefaclor成分之檢體均合格。相較於81、87年進行Piroxicam口服製劑之品質調查及95年進行Cefaclor膠囊製劑之品質調查結果，兩種成分之市售品品質均有改善。

Surveillance and vigilance systems for marketed medications is imperative to maintain the regulated standard of post marketed NSAIDs (non-steroids anti inflammatory drugs) and oral antibiotics in Taiwan. In this study, 34 samples of prepared piroxicam and cefaclor were acquired from various counties and cities in Taiwan from January to September of 2014. Samples were analyzed using methods described in Ch. P. 7/USP 36 with authorized specifications. Appearance, average weight, identifcation, assay, dissolution, uniformity of dosage units, water content and percentage of related compounds were the elements taken into consideration for analysis. The results showed that two samples failed to meet the specification of dissolution; one of which had failed to meet the specification of water contetnt.