毛細管電泳法定量風濕鎮痛類中藥製劑中摻加西藥成分之探討   全文下載

Study on the Adulterated Chemical Drugs in Rheumatic and Analgesic Traditional Chinese Medicine by MEKC

本研究利用毛細管電泳儀分析探討，經常於風濕鎮痛類中藥製劑中檢出之西藥成分，包括非固醇類鎮痛消炎劑acetaminophen, aminopyrine, bucetin, ethoxybenzamide, indomethacin, ketoprofen, mefenamic acid, phenylbutazone及diclophenac sodium九種；類固醇dexamethasone及prednisolone二種；肌肉鬆弛劑chlorzoxazone；鎮靜安眠劑diazepam；中樞神經興奮劑caffeine等十四種西藥成分。本法利用pH9.0之0.02M硼酸鈉及磷酸二氫鈉溶液（含0.15M 十二烷基硫酸鈉鹽）為緩衝液，上述成分可於25分內得到良好之分離。分析數據顯示，各成分之相關係數介於r=0.9987-0.9998間，顯示線性關係良好。添加於獨活寄生湯濃縮散之回收率為92.1%至102.5%，顯示準確性佳。利用上述方法分析由地方衛生局消費者服務中心送驗之風濕鎮痛中藥丸兩種sample A及B，結果sample A檢出acetaminophen, caffeine, phenylbutazone及prednisolone四種西藥成分。其含量百分比及每粒中藥丸之含量依序為0.9、0.4、4.7及0.3%；4.9、2.2、26.6及1.5mg，各成分之同日間及異日間之相對標準偏差依序為3.1、2.3、2.4及2.2%（同日間）；4.1、5.1、3.5及2.9%（異日間）。Sample B檢出aminopyrine, caffeine及ethoxybenzamide三種西藥成分。其含量百分比及每粒中藥丸之含量依序為2.1、1.0及0.6%；11.8、5.6及3.6mg，各成分之同日間及異日間之相對標準偏差依序為3.5、2.0及3.4%（同日間）；4.7、2.4及4.5%（異日間）。顯示毛細管電泳法用於上述中藥摻加西藥之分析應屬可行。"

A micellar electrokinetic capillary chromatography was developed to identify adulterants in rheumatic and analgesic traditional Chinese medicine. This chromatographic technique was carried out using a buffer of (pH 9.0) 0.02M sodium tetraborate and sodium dihydrogenphosphate (contain 0.15 M sodium Iauryl sulfate). This method was applied to simultaneously analyze 14 synthetic chemical drugs adulterated in tradition) Chinese medicine within 25 minutes. They represented five pharmacological categories: antipyretic analgesics, glucocorticoids, CNS stimulants, muscle relaxants and sedatives, and included: acetaminophen, aminopyrine, bucetin, diclophenac sodium, ethoxybenzamide, indomethacin, ketoprofen, mefenamic acid, phenylbutazone, dexamethasone, prednisolone, chlorzoxazone, diazepam, and caffeine. The recovery of synthetic chemical drugs add to Dwu-Hwo-JihSheng- Tang(獨活寄生湯)ranged from 92.1 to 102.5%. This method was used to assess two traditional Chinese medicines sold by distributors of Chinese natural drugs . collected by the consumer centers of local health bureaus from Oct. 1991 to Jun. 1992. In sample A, acetaminophen, caffeine, phenylbutazone, prednisolone were found, and their content in each pill were measured at 4.9, 2.2, 26.6 and 1.5mg, respectively. The relative standard deviation ranged between 2.2-3.1 %(intraday) and 2.9-5.1%(interday). In sample B, aminopyrine, caffeine and ethoxybenzamide were found, and their content of each pill were measured at 11.8, 5.6, and 3.6mg, respectively. The relative standard deviation ranged between 2.0-3.5%)(intraday) and 2.4-4.7%(interday). MEKC was found to be an efficient and sensitive chromatographic technique with which to measure adulterants in samples of rheumatic and analgesic traditional Chinese medicine.