含CODEINE指示用藥藥品之品質調查   全文下載

An Investigation on the Quality of 'Over the Counter' Drugs (PHARMACY-ONLY) Containing Codeine in Taiwan

於八十六年度自全省各縣、市藥局或藥房價購不同品牌、不同批號含可待因（磷酸鹽）內服液劑指示用藥藥品檢體共26件，計二十二個品牌，分屬國內十三家藥廠產品。依據行政院衛生署83年8月17日衛署藥字第83047660號公告處方含可待因（磷酸鹽）內服液之規定，進行下列項目檢查：一、含可待因（磷酸鹽）內服劑以糖漿劑為限。二、含磷酸可待因糖漿製劑其歸屬指示用藥者，可待因含量應符合下列規定：(1)一日最大配合量感冒糖漿劑為9 mg，鎮咳、袪痰糖漿劑為18 mg；(2)如與EPHEDRINE HYDROCHLORIDE，DLMETHYLEPHEDRINE HYDROCHLORIDE配合時應減量20%。三、成人每次服用量應為五毫升以上，處方單位含量應配合調整。四、零售最大單位包裝不得超過三日用量。五、標籤、仿單、外盒應加印警語「長期使用易致成癮」。並參照本局有關文獻資料，進行可待因（磷酸鹽）之鑑別、含量測定及含糖量等項之檢驗。檢驗結果與規定不符者共8件（計八個品牌，分屬七家藥廠產品），約占31%。其中不符合第一項者1件（該件為液劑），第二項者2件，第三項者1件，第四項者6件，第五項者3件。其中1件檢體不符合規定項目共計四項；2件不符合規定項目二項；其餘5件檢體均各僅一項不符合規定。鑑別及含量測定項則全部合格。

Twenty-six different brand and lot number samples of 'over the counter' drugs (pharmacy-only) containing Codeine Phosphate, were purchased from various areas in Taiwan during 1997.These samples were investigated for the requirements of Announcement No. 8304766 published by the Department of Health Executive Yuan on August 17th 1994 regarding Codeine (Phosphate) containing Oral Liquid Preparations.All samples were investigated with reference to the following requirements;(1) Codeine (Phosphate) containing Oral Liquid preparations prepared as ”Syrup” only. (2) The quantity of Codeine Phosphate in a daily dose should be no more than 9 mg in cold preparation and no more than 18 mg in cough suppressant expectorant preparation. The dose should be decreased 20%, when there preparations with ephedrine hydrochloride or methylephedrine hydrochloride. (3) Oral dosage each time for an adult should be not less than 5ml. (4) The content of each bottle in retail should be no more than the dose required for three days. (5) If the warning remark ”addiction and habitation formed after long-term usage” is printed on the label, instruction sheet and the packing boxes. The samples were identified and assayed for Codeine Phosphate. Sugar content was also determined.The results were that eight samples did not meet the requirements. Among them, one sample, which was liquid preparation, failed to meet the first requirement. Two samples of cough suppressant expectorant preparation, where one contained Methylephedrine Hydrochloride and the other contained Ephedrine Hydrochloride, the quantities of Codeine Phosphate in a daily dose were over the second requirement (maximum quantity is 14.4mg). One sample showed less than 5-ml oral dosage each time for an adult, which violated the third requirement. Six samples showed that the content of each bottle in retail is more than the dose required for three days. These samples failed to meet the fourth requirement. And three samples were without the warning remark, which fails to meet the fifth requirement. All of the samples passed the identification and assay tests.