巿售雙氧水品質調查

QUALITY INVESTIGATON ON THE MARKETING HYDROGEN PEROXIDE TOPICAL SOLUTION

本調查係為了解市面所銷售的幾種家庭常備外用消毒清潔液之品質概況而選定進行抽購調查的品目之一。過氧化氫液為一種強氧化劑，一般家庭常用者為3%水溶液，通稱雙氧水，主要利用其接觸到組織即釋出氧分子之特性，將死組織及菌囊分離而達到清潔消毒之目的。由於其性質相當不安定，極易受氧化性有機物、部份金屬及鹼性所破壞，降低有效氧之含量而失去效用；而濃度過高時，施用於皮膚及黏膜上則會引起刺激性灼燒，產生白色焦痂；因此，雙氧水中過氧化氫含量需加以控制，藥典中規定其含量以2.5%至3.5%（W/W）為準。乃於七十六年上半年分赴北部地區：包括宜蘭縣市、基隆市、台北縣、市及桃園市各藥局及藥房抽購了分屬七家製造廠製造的雙氧水檢體共五十件，依美國藥典第二十一版收載之HYDROGEN PEROXIDE TOPICAL SOLUTION 品目下之鑑別及含量測定方法進行檢驗分析。結果發現，五十件檢體中有十件不符合藥典規定之H202含量應在2.5%~3 .5%（W/W）的合格範圍，占全部檢體之20.0%；合格檢體則占80.0%（見表一）。經分析各廠檢體含量分佈頻率，發現不合格檢體主要集中於編號C、D兩家製藥廠所產製者，共九件。經檢視該二廠之檢體標示，其批號均不確實，各自分別印刷同一批號，而由有關資料顯示，該二廠均尚未確定其實施GMP──優良藥品製造標準之意願。由市場占有率幾達二分之一的 G 廠所抽驗之廿一件檢體中，有一件不符規格，惟同時於同地區另一藥局所購得之同批號產品，其檢驗結果則合格。推測此差異形成之原因，可能是銷售者儲存不當所致。

To understand the quality of topical disinfectant preparations on market, fifty samples of commercial topical solutions of Hydrogen Peroxide in Taiwan area were purchased and analyzed. The method used is according to the monograph in the USP XXI, p. 510. The results indicate that 20% of the samples do not meet the standard requirement which is between 2. 5% and 3.5% of the H20 2 content. It was found that the failed preparations were produced by two pharmaceutical manufacturers which still have not implement the GMP (Good Manufacture Practice) system in their factories. Two conclusions were obtained as follow: 1. Consumers should consider if the drug maker is a GMP manufacturer. 2. It is important to educate the seller how to avoid the degradation of H2O2 preparations.