針灸針生物學檢驗方法之建立

THE ESTABLISHMENT OF THE BIOCOMPATIBILITY TESTS FOR ACUPUNCTURE NEEDLES

中國以針作為治療用醫療器具，已有兩千年以上之歷史，千百年來其療效及醫學理論不斷被開發研討，但針灸針之品質及衛生狀況卻較少見探討。針灸針屬衛生署公告應辦理查驗登記取得許可證之醫療器材之一，但遍尋各國相關藥典均未列載針灸針之各項生物學檢驗規格與方法。本實驗是參照一般注射針之相關檢驗資料，依據兩種檢驗方法，就市面上抽購之28件國產針灸針和5件大陸製針灸針進行急性毒性試驗、皮內刺激試驗及熱原試驗等三項生物學檢驗。檢驗結果顯示對33件檢體所作之三項試驗均合格，而依據兩種不同檢驗方法所得之結果間亦無顯著差異。但因針灸針刺入人體常以按、提、捻、搖、擺、盤、留等手法治療，停留在人體的時間一般而言較注射針為長，建議以較嚴格，及較高溫度之萃取方式來制定生物學之檢驗規格及方法。

Biological tests' methods--safety test, intractaneous test and pyrogen test of the acupuncture needles are not described in any existing pharmacopoeia. In the present study, we set out to establish these methods for the safety evaluation of commercially produced acupuncture needles according similar methods used for injection needles. Twenty-five cases of domestically produced samples and 5 cases of samples produced in mainland China were subjected to testing. The methods (systemic injection test, intra-cutaneous test and pyrogen test) adopted refer to the methods for injection needle listing in Japanese Guideline to the Test Method of Medical Devices and international Standard (ISO). The results show the sampled acupuncture needles passed the test methods and no significant difference was found between two different methods. The methods with more restricted standsards are suggested to evaluate the safety of acupuncture needles.