應用於藥物、化粧品、塑膠醫療器材、食品及食品添加物之局部刺激性試驗法

Current Developed Methods for Detecting Local Lrritation in Drug, Cosmetics, Medical, Plastic Devices, Food and Food Additives

杜先覺(Shian-Jyue Du)

《藥物食品檢驗局調查研究年報》 9號 (1991/09) Pp. 1-26

https://doi.org/10.6946/ASRNL.199109.0001

摘要

藥物、化粧品、塑膠醫材、食品及食品添加物的安全性逐漸受到人們之重視。在毒理學上，局部刺激性試驗是一高度受到重視的試驗法，除可供為產述前物之局部刺激原及其官能基檢測外，尚可用於鑑定工業廢污。常用於試驗的活體標的器官組織有，皮膚、黏膜、肺臟細胞、肌肉、及關節腔；其試驗項目含括，皮膚刺激性試驗、黏膜刺激性試驗、肺臟細胞刺激性試驗、肌肉刺激性試驗、及關節腔內刺激性試驗；而其評估標準，約以表格記述。文中所列的方法，約為現今毒理學之研之趨勢，雖然某些方法並未普遍施行。深信當有更多的毒物資料與更進步的技術時，人類之使康將更形有保障。

關鍵字

關節腔 ； 氣管肺泡 ； 角膜及結膜 ； 消化道 ； 耳翼 ； 肺 ； 肌肉 ； 皮膚 ； 胃毒性 ； 局部刺激性試驗

並列摘要

For the progress and development of industry in decades, there are varieties of products being found, applied and manufactured for living. There is no exception for drug, cosmetics, medical plastic devices, food and food additives. As a result of the flowering chemicals, the importance of safety of these materials are being recognized. Among so many versatile methods being applied in toxicology, the local irritation tests are well established methods to assess the causative agents of local irritation for drug, cosmetics, medical plastic devices, food and food additives, as well as the industrial pollutants and dumping-wastes. For most of the performed methods in the local irritation tests, the target tissues availed in in vivo tests include skin, mucosa, alveolar cells, muscle as well as articular cavity, and the test items applied involve skin irritation test, mucosa irritation test, lung alveolar cell irritation test, muscle irritation test as well as articular cavity irritation test. The evaluation criteria for detecting local irritation were also available in the tables of the text. All of the methods described in this article purport to the contemporary trend and the development of toxicology, although a few of the methods (e.g., detection of vasopermeability and ear surface temperature, gastroepithelial cell uptake radioactive thymidine test, broncho-alveolar lavage and lung macrophage function test, and Hsu's plasma creatinine phosphokinasetest) are yet applied in general. As more information concerning the toxicity of these substances is obtained and as technology becomes more advanced, it is believed that the health of human will be assured.

並列關鍵字

Articular cavity ； Broncho-alveolar ； Cornea and conjunctiva ； Digestive tract ； Ear flap ； Lung ； Muscle ； Skin ； Gastrotoxicity ； Local irritation test