市售Piroxicam膠囊之溶離度品質調查   全文下載

Evaluation on Dissolution Qualty of Piroxicam Capsules from Taiwan District

為瞭解現階段市售piroxicam膠囊之溶離度管制狀況，於民國八十六年十一月十八日函請臺北市政府衛生局、高雄市政府衛生局、臺灣省各相關縣市衛生局就轄區內藥廠及輸入代理商惠予抽樣，共獲piroxicam檢體45件，其中膠囊檢體43件、錠劑檢體1件、凝膠檢體l件，因錠劑及凝膠劑藥典未收載且非本次調查之劑型，故就43件膠囊劑參考美國藥典第XXIII版所載方法進行溶離度試驗，結果43件檢體中，不符合藥典規定者6件，不合格率為14%。

Forty-three samples of piroxicam capsules imported or manufactured by local pharmaceutical factories in Taiwan were randomly collected via local health authorities. These samples were analyzed to evaluate their qualityby virtue of dissolution testing. The analysis included four tests according to the methods of United States Pharmacopoeia XXII The results showed that all samples met requirements for weight variation test. Fourteen percent of the samples failed to pass the dissolution test.Factors which affect the dissolution were analyzed on piroxicam capsules formulated and produced in this laboratory. It was shown thatexcipients have certain degree of effect on the dissolution. The dissolution rate was reduced if the capsule contains more than 5% of magnesium stearate. This may be due to the lamination and subsequent adhesion of piroxicam to the dry agglomerate. The mixing time of magnesium stearate didnot have a significant effect on dissolution. It was also found that 0.75% and 1.56% of sodium lauryl sulfate increased the dissolution rate of piroxicam capsules. Higher concentration of sodium lauryl sulfate(3.12%) decreased the dissolution rate. However, sodium lauryl sulfate is not recommended for oral formulation.