【摘要】：目的建立一種高效液相色譜分析方法，檢測(cè)癲癇患者拉莫三嗪（Lamotrigine，LTG）血藥濃度，結(jié)合檢測(cè)結(jié)果探討拉莫三嗪血藥濃度與療效及劑量的關(guān)系。 方法利用高效液相（high performance liquid chromatographic，HPLC）建立并驗(yàn)證拉莫三嗪血藥濃度分析方法。以替硝唑?yàn)閮?nèi)標(biāo)，以氯仿作為萃取溶劑，流動(dòng)相為乙腈-0.02mol/LKH2PO4（體積比為25:75），經(jīng)Symmetry-C18WATO54275(250mm×4.6mm,5μ m)色譜柱洗脫、分離，柱溫為室溫，流速為1.0mL min-1，檢測(cè)波長(zhǎng)為210nm。應(yīng)用以上色譜條件檢測(cè)患者LTG血藥濃度，依據(jù)測(cè)得LTG血藥濃度將60例患者分為偏低濃度(1μg/mL4例)、有效濃度（1~8μg/mL49例）及偏高濃度（8μg/mL7例）3組，結(jié)果采用SPSS16.0統(tǒng)計(jì)軟件進(jìn)行分析。 結(jié)果拉莫三嗪血藥濃度在1~8μg/mL范圍內(nèi)線性關(guān)系良好（r=0.9998），最低檢測(cè)限為0.5μg/mL，提取回收率在66.6-70.0%，日內(nèi)、日間精密度均6.93%。60例患者中有49例患者LTG血藥濃度在1~8μg/mL范圍內(nèi)，其中有43例LTG服用劑量為50mg~200mg；血藥濃度在1~8μg/mL時(shí)，LTG治療癲癇療效良好，對(duì)全面性發(fā)作與部分性發(fā)作有效率有顯著差異(P0.05)。 結(jié)論所建立的高效液相色譜法操作簡(jiǎn)便，靈敏度高，經(jīng)濟(jì)廉價(jià)，適用于常規(guī)臨床LTG血藥濃度監(jiān)測(cè)及藥代動(dòng)力學(xué)研究。LTG對(duì)多種癲癇類型有效，給藥劑量在50mg~200mg范圍內(nèi)時(shí)，多數(shù)患者血藥濃度可達(dá)到有效治療濃度，，即1~8μg/mL，LTG對(duì)全面性發(fā)作療效更佳。
[Abstract]:Aim to establish a high performance liquid chromatography (HPLC) method for the determination of lamotriazine (Lamotrigine,LTG) in patients with epilepsy, and to explore the relationship between the concentration of lamotriazine and the therapeutic effect and dose. Methods HPLC (high performance liquid chromatographic,HPLC was used to establish and verify the method for the determination of lamotriazine in human plasma. Tinidazole was used as internal standard, chloroform was used as extraction solvent, acetonitrile-0.02mol/LKH2PO4 (volume ratio was 25:75) was used as mobile phase. The mobile phase was eluted on Symmetry-C18WATO54275 (250mm 脳 4.6 mm, 5 渭 m) column. The column temperature was room temperature and the flow rate was 1.0mL min-1,. The detection wavelength is 210 nm. According to the above chromatographic conditions, 60 patients were divided into three groups: low concentration (1 渭 g / mL4), effective concentration (1 ~ 8 渭 g / mL49) and high concentration (8 渭 g / mL7) according to the serum concentration of LTG. Results the results were analyzed by SPSS16.0 software. Results the calibration curve of lamotriazine was linear in the range of 1 ~ 8 渭 g / mL (r = 0.9998). The detection limit was 0.5 渭 g / mL, and the recovery was 66.6 渭 g / mL,. The inter-day precision was 6.93%. In 49 of the 60 patients, the serum LTG concentration was in the range of 1 ~ 8 渭 g / mL, and 43 of them took 50 mg / mL of LTG. When the plasma concentration was between 1 渭 g / mL and 8 渭 g / LTG, LTG had a good therapeutic effect on epilepsy, and there was a significant difference in the effective rate between comprehensive seizure and partial seizure (P0.05). Conclusion the established high performance liquid chromatography is simple, sensitive, economical and cheap. It is suitable for routine clinical LTG blood concentration monitoring and pharmacokinetic study. LTG is effective for many types of epilepsy, and the dosage of LTG is within the range of 50mg~200mg. The plasma concentration of 1 ~ 8 渭 g / mL,LTG in most of the patients was more effective than that of the control group (1 ~ 8 渭 g / mol) in the treatment of all-round seizure.
【學(xué)位授予單位】：寧夏醫(yī)科大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2014
【分類號(hào)】：R742.1

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