鋁鹽吸著疫苗製劑滅菌檢查之探討

STERILITY TESTING OF ALUMINUM ADSORBED VACCINES METHOD COMPARISON OF DISPOSABLE MEMBRANE FILTRATION SYSTEM AND DIRECT INOCULATION SYSTEM

除B型肝炎疫苗外，含有氫氧化鋁或磷酸鋁等鋁鹽吸著之製劑尚有吸著白喉類毒素、吸著破傷風類毒素、吸著破傷風白喉混合類毒素、吸著百日咳破傷風白喉混合疫苗等。目前各國藥典及國家檢驗基準中使用之滅菌檢查方法，分別是直接接種法及微孔濾膜法。為了評估現行滅菌檢查方法，並探討影響鋁鹽吸著疫苗製劑之滅菌檢查因素。本計劃以兩種菌種不同的菌數，用0.5mg/ml之aluminum hydroxide當稀釋液，分別以直接接種法及微孔濾膜法進行試驗。結果當檢液10ml含細菌數量20-50CFU之高時，其陽性檢出率在微孔濾膜法檢出率高達100%，在直接接種法檢出率則高達74%。而含菌數在1-2.5CFU之微時，其陽性檢出率在微孔濾膜法約為33.33%，在直接接種法檢出率約為17.5%。但在鋁鹽存在下使培養基混濁，會造成偽陽性或偽陰性之誤判，故必須加以次培養鑑別，再小心觀察判定以免誤判。

The aluminum adsorbed vaccines contain Hepatitis B vaccine, Adsorbed diphtheria toxoid, adsorbed tetanus toxoid, Adsorbed diphtheria-pertussis-tetanus combined vaccine, Adsorbed diphtheria-tetanus combined vaccine. There are two methods of sterility test: membrane filtration method and direct transfer method. We compared the two methods in order to understand the sensitivity of sterility testing in aluminum adsorbed vaccine. We used 0.5mg aluminum hydroxide/ml as diluent to prepare Bacillus subtilis and Candida albican cell suspension. The result show that the bacteria number interfere the result of sterility test.