含Codeine指示藥品之品質調查   全文下載

Investigation on the Quality of 'Over the Counter' Drugs Containing Codeine in Taiwan

於八十七年度自全省各縣、市藥局或藥房價購不同品牌、不同批號含可待因（磷酸鹽）內服液劑指示藥品檢體共30件，計23個品牌，分屬國內15家藥廠產品。依據行政院衛生署八十三年八月十七日衛署藥字第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9mg，鎮咳、祛痰糖漿劑為18 mg；(2)．如與Ephedrine Hydrochloride, DL-Methylephedrine 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。檢查／檢驗結果與規定不符者共7件（計7個品牌，分屬7家藥廠產品），約占23%。其中不符合第一項規定者1件，第二項者1件，第三項者2件，第四項者6件，第五項者2件。另外有2件檢體為同一品牌卻有不同外包裝，故不予判定。鑑別及含量測定項則全部合格。"

Thirty different brand and lot number samples of 'over the counter' drugs (pharmacy-only) containing Codeine (Phosphate), were purchased from various areas in Taiwan during 1998.These samples were investigated for the requirements of Announcement NO.83047660 published by the Department of Health Executive Yuan on August 17 1994 regarding Oral Liquid Preparations containing Codeine (Phosphate).All samples were investigated with reference to the following requirements: (1) Oral Liquid Preparations containing Codeine (Phosphate) prepared as ”Syrup” only. (2) The quantity of Codeine Phosphate in a daily dose should be no more than 9 mg in cold preparations and no more than 18 mg in cough suppressant expectorant preparations. The dose should be decreased 20%, when the preparations are combined with Ephedrine Hydrochloride or DL-Methylephedrine Hydrochloride. (3) Each time oral dosage for an adult should be not less than 5 mL. (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 showed that seven samples did not meet the requirements. Among them, one sample, the sugar content was 28.3% w/v, which violated the first requirement that sugar content should not be less than 55.0% w/v. One sample, cough suppressant expectorant preparation contained Pseudoephedrine Hydrochloride, the quantity of Codeine Phosphate in a daily dose was 18mg, over the second requirement (maximum quantity is 14.4 mg). Two samples 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 was more than the dose required for three days. These samples failed to meet the fourth requirement. Two samples were without the warning remark, which failed to meet the fifth requirement.. The others passed the identification and assay tests.