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研究生:郭嘉翎
研究生(外文):Chia-Ling Kuo
論文名稱:Fluorouracil與Leucovorin配伍之微粒數目評估
論文名稱(外文):The Compatibility of Fluorouracil with Leucovorin on Particulate Evaluation
指導教授:詹道明詹道明引用關係
指導教授(外文):Thau-Ming Cham
學位類別:碩士
校院名稱:高雄醫學大學
系所名稱:藥學研究所碩士在職專班
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:2005
畢業學年度:93
語文別:中文
論文頁數:72
中文關鍵詞:FluorouracilLeucovorin微粒
外文關鍵詞:ParticlesFluorouracilLeucovorin
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Fluorouracil (5-Fu)與Folinic acid (Leucovorin)合併使用仍是治療大腸直腸癌的第一線首選。醫療人員有時會為了給藥的便利而將2種藥物混合在同一瓶大瓶稀釋液中,再加上醫療器材的進步,病患已經不需要住院就可以進行多天連續性的藥物注射。然而,有研究顯示這兩個藥物是有配伍禁忌,所以並不適合配製在一起。且已經有研究發現注射劑內的微粒對於人體是有相當程度的危害。各國藥典大多已對大型輸注液的微粒含量做出規範,美國藥典最近也規範了小型注射劑的微粒含量,但其所使用的是HIAC®法。而中華藥典並尚未對小型注射劑的微粒含量做出規範。
本篇研究是以Coulter Counter®測定用生理食鹽水稀釋5-Fu與Leucovorin於同一瓶大瓶點滴中所產生的各粒徑間的微粒數量。5-Fu與Leucovorin的濃度以臨床上使用的各治療劑量為範圍,並測定配製後4小時及第2到7日的微粒數量。
結果在某些情況下根據「五分之一理論」合併以中華藥典對於大型輸注液的微粒規範,這些微粒數量是合理且人體可以承受的。如此一來,則可增加醫療人員給藥的便利性,也可以減少病患的住院次數及天數。最終目標是希望醫療人員能很有效率的提供更高層次的醫療服務,病患也能接受更有品質的照顧。
The combination of Fluorouracil (5-Fu) and Folinic acid (Leucovorin) is the first line regiment for colorectal caner. Sometimes these two drugs are mixed in the same container for the convenience of using in our hospital. In addition, patients can be treated with multiple days continuous infusion without hospitalized, because of the progressing medical supplies. However, the study has shown that these two drugs are physically incompatible. Furthermore, more studies have showed that the particles of injections are potentially harmful for body. The pharmacopoeias in many countries have made a precise standard for the particles in large volume parenterals (LVPs). The U.S.P. also has made a precise standard for small volume parenterals (SVPs) recently, but it is performed by HIAC® method. Meanwhile, the Chinese pharmacopoeia does not make up a standard for SVPs yet.
The aim of this study was to detect the particulate contaminant of samples by Coulter Counter®. The concentrations of 5-Fu and Leucovorin were based on the clinical dosage. The data of the particulate count were collected after four hours of preparing and determination of the count of particles was carried out from second day to seventh day.
According to the assumption of “One-Fifth Theory” and the standard for LVPs in Chinese pharmacopoeia, patients can endure the consequence in particular situation. Moreover, medical staffs can care their patients more effectively and patients’ hospitalization both frequency and duration can be reduced. Finally, the goal of this study is that medical staffs can provide high efficiency medical service and patients can have a higher quality of medical attention.
附圖目錄..........................................II
附表目錄..........................................III
中文摘要..........................................VI
英文摘要(Abstract)...............................VII
緒論..............................................1
一.藥物簡介.......................................1
二.Fluorouracil-Leucovorin合併使用的治療..........6
三.注射劑內的異物微粒.............................9
四.研究目的與動機.................................12
材料、儀器及實驗方法..............................14
一.材料及儀器.....................................14
二.實驗方法.......................................17
結果與討論........................................21
一.pH測定值.......................................21
二.微粒測定.......................................22
三.討論..........................................55
結論..............................................65
建議繼續探討之計畫重點............................67
參考文獻..........................................68

附圖目錄
圖 一.Fluorouracil (5-Fu)化學結構圖................2
圖 二.Leucovorin® (Folinic acid)化學結構圖.........2
圖 三.葉酸代謝路徑.................................3
圖 四.Fluorouracil作用機轉(一).....................4
圖 五.Fluorouracil作用機轉(二).....................5
圖 六.Continuous Infusor...........................8
圖 七.Vertical Laminar Air Flow正面、側面圖........15
圖 八.Coulter Counter®全貌.........................15
圖 九.Coulter Counter® Sampling Stand..............16
圖 十. >2m微粒分佈圖...............................45
圖 十一. >5 �慆微粒分佈圖..........................46
圖 十二. >10 �慆微粒分佈圖..........................47
圖 十三. >25 �慆微粒分佈圖..........................48
圖 十四. Total微粒分佈圖............................49
圖 十五. 各組每日>2 m微粒數.........................50
圖 十六. 各組每日>5 m微粒數.........................51
圖 十七. 各組每日>10 m微粒數........................52
圖 十八. 各組每日>25 m微粒數........................53
圖 十九. 各組每日Total微粒數........................54

附表目錄
表 1. Composition of 5-Fu and Leucovorin in Normal Saline…19
表 2. 各組樣本每日pH測定值及其平均值及標準偏差……..21
表 3. Group A sample 1 第1-7日各粒徑間的微粒測定數目...22
表 4. Group A sample 2 第1-7日各粒徑間的微粒測定數目..23
表 5. Group A sample 3 第1-7日各粒徑間的微粒測定數目...24
表 6. Group B sample 1 第1-7日各粒徑間的微粒測定數目...25
表 7. Group B sample 2 第1-7日各粒徑間的微粒測定數目...26
表 8. Group B sample 3 第1-7日各粒徑間的微粒測定數目...27
表 9. Group C sample 1 第1-7日各粒徑間的微粒測定數目...28
表 10. Group C sample 2 第1-7日各粒徑間的微粒測定數目...29
表 11. Group C sample 3 第1-7日各粒徑間的微粒測定數目...30
表 12. Group D sample 1 第1-7日各粒徑間的微粒測定數目...31
表 13. Group D sample 2 第1-7日各粒徑間的微粒測定數目...32
表 14. Group D sample 3 第1-7日各粒徑間的微粒測定數目...33
表 15. Group E sample 1 第1-7日各粒徑間的微粒測定數目...34
表 16. Group E sample 2 第1-7日各粒徑間的微粒測定數目...35
表 17. Group E sample 3 第1-7日各粒徑間的微粒測定數目...36
表 18. Group A 各sample在1-7日各粒徑間的微粒測定數目之平均值及標準偏差(n=6).37
表 19. Group B 各sample在1-7日各粒徑間的微粒測定數目之平均值及標準偏差(n=6).38
表 20 Group C 各sample在1-7日各粒徑間的微粒測定數目之平均值及標準偏差(n=6).39
表 21 Group D 各sample在1-7日各粒徑間的微粒測定數目之平均值及標準偏差(n=6).40
表 22 Group E 各sample在1-7日各粒徑間的微粒測定數目之平均值及標準偏差(n=6).41
表 23 Group A 在1-7日各粒徑間的微粒測定數目之平均值及標準偏差(n=18)........42
表 24 Group B 在1-7日各粒徑間的微粒測定數目之平均值及標準偏差(n=18)........42
表 25 Group C 在1-7日各粒徑間的微粒測定數目之平均值及標準偏差(n=18)........43
表 26 Group D 在1-7日各粒徑間的微粒測定數目之平均值及標準偏差(n=18)........43
表 27 Group E 在1-7日各粒徑間的微粒測定數目之平均值及標準偏差(n=18)........44
表 28 Group A、B、C、D、E每日微粒數以ANOVA檢驗所得的F值(濃度變化).......55
表 29 Group A、B、C、D、E每日微粒數以ANOVA檢驗所得的F值(經時變化).......55
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