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研究生:龔朝峰
研究生(外文):Kung, Chao-Feng
論文名稱:Diclofenacsodium緩釋劑型相等性試驗之研究
論文名稱(外文):Bioequivalence study of diclofenac sodium sustained-release formulations: Staren SR and Voltaren SR
指導教授:蘇聖芳蘇聖芳引用關係
指導教授(外文):Jing-Jane Tsai
學位類別:碩士
校院名稱:國立成功大學
系所名稱:臨床藥學研究所
學門:醫藥衛生學門
學類:藥學學類
論文種類:學術論文
論文出版年:1996
畢業學年度:84
語文別:中文
論文頁數:74
外文關鍵詞:diclofenacsustained release
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目的 本試驗的目的是在比較兩種皆含diclofenac sodium 100mg緩釋劑
型之藥品,是否具有生體相等性。 試驗藥品為臺灣南光化學製藥公司的
Staren SR膠囊,參考藥品為瑞士汽巴嘉基藥廠的Voltaren SR錠劑。方法
本試驗為一多劑量雙向交叉試驗。12名健康受試者(21至26歲)於每天用完
固定早餐後15分鐘口服Staren SR 100mg或Voltaren SR 100mg維期七天,
停藥間斷為七天。血液收集是在每天給藥前零時間及第七天給藥後的24小
時內。血液中diclofenac濃度以高層液相層析儀(HPLC)分析。其次,為了
解兩藥品在不同酸鹼值(pH)的溶離情況,以範圍在pH=1到pH=7.5的五種溶
媒來做兩藥品的溶離度試驗。結果 經統計分析後顯示兩藥品第七天24
小時的濃度時間曲線下面積(AUC0*24 )並不相等,Staren SR相對於
Voltaren SR的diclofenac生體可用率為71%。口服Starn SR所產生的
diclofenac最高血中濃度(Cpeak)為452±133 ng/mL(平均值±標準差)與
Voltaren SR的955±471 ng/Ml也具有顯著的差異。但是若比較
diclofenac血中最高濃度出現的時間(Tpeak),兩藥品卻是很接近(Staren
SR為4.3±1.1小時,Voltaren SR為4.6±1.5小時)。在溶離試驗的結果發
現在pH=2.5到pH =7.5的範圍內兩藥品的溶離率隨pH的增加而增高。而比
較兩藥品在不同溶媒的相似因子(similarity factor,f2)後發現兩藥品
具有相似的溶離曲線;但若進一步以變異數分析兩藥品的溶離相等性時,
則可發現兩藥品在pH = 2.5與pH = 4.5溶媒的溶離率(達溶離穩定狀態時)
存有差異。結論 根據以上結果顯示Staren SR與Voltaren SR無論在吸
收量或吸收速率(如Cpeak之差異性)皆有顯著的差異存在,故兩藥品並不
具有生體相等性。而兩藥品在溶離試驗中具有差異性或許是其生體可用率
不相等的原因之一。

Purpose The objective of the study was to compare the
bioavailability of diclofenac sodium for the sustained-released
formulation developed in Taiwan (Staren SR 100mg capsule) to
that for the innovator formulation produced by Ciba-Geigy
Limited(Voltaren SR 100mg tablet). Method Twelve healthy
volunteers (21-26 years old) were administered 100 mg each of
the two preparations every 24 hours over seven days in a two-way
crossover fashion. A standardized breakfast was finished 15
minutes before drug administration. Blood samples were collected
following each dosing and over 24 hours on the seventh day.
Plasma concentration of diclofenac were determined by high-
performance liquid chromatography (HPLC). For realizing the
dissolution profile of the two formulations in various pH, the
dissolution test was carried out in five media.Results The
extent of the drug available from the two formulations were not
the same as the mean AUC0*24 values were significantly
different. The mean bioavailability of diclofenac from Staren SR
was 71% relative to that of Voltaren SR. The Cpeak for Staren SR
(452±133 ng/mL, mean±sd) was significantly much lower than
that for Voltaen SR (955±471 ng/mL). However, the Tpeak for
Staren SR (4.3±1.1 hr) was similar to that for Voltaren SR
(4.6±1.5 hr). The percentage dissolved versus pH plot showed
that the percent of the two drugs dissolved increased with pH in
the range of pH2.5-pH7.5. And according to the comparison of the
similarity factor (f2), the dissolution revealed that similar
dissolution profiles for the two formulations. By ANOVA
(Analysis of Variance), however, the significant differences
were determined on the steady state of dissolution profiles in
the pH 4.5 and pH 2.5 buffer media.Conclusion The results have
demonstrated that Staren SR was not equivalent to Voltaren SR
with respect to both the extent and rate (e.g. Cpeak). And the
significant differences in dissolution may be one of reasons for
the conclusion in vivo.

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