北京生物醫(yī)學(xué)工程

羥丁基殼聚糖護(hù)創(chuàng)敷料無菌檢查方法的建立

Establishment of the sterility test method for hydroxybutyl chitosanprotective dressings

作者：張娟李夢玉劉思敏岳衛(wèi)華

單位：北京市醫(yī)療器械檢驗所（北京101111）

關(guān)鍵詞：羥丁基殼聚糖護(hù)創(chuàng)敷料; 無菌檢查；薄膜過濾法；抑菌性；方法適用性檢查

分類號：R318

出版年·卷·期（頁碼）：2020·39·2（165-168）

摘要：

目的建立羥丁基殼聚糖護(hù)創(chuàng)敷料的無菌檢查方法，為該類產(chǎn)品的無菌檢查提供參考依據(jù)。方法根據(jù)《中國藥典》2015年版無菌檢查法（四部通則1101）相關(guān)要求，采用薄膜過濾法進(jìn)行方法適用性檢查，以2~8 ℃的0.1%蛋白胨水作為稀釋液和沖洗液，將樣品溶解并將供試液全部過濾后，用2~8 ℃的0.1%蛋白胨水沖洗濾膜，沖洗量為500 mL（每膜每次沖洗量不超過100 mL），培養(yǎng)基用量為100 mL。結(jié)果與對照組相比，實驗組中藥典規(guī)定的6種陽性菌株均生長良好，說明該測試品的該檢驗量在該檢驗條件下抑菌作用已被有效消除。結(jié)論所建立的方法能用于羥丁基殼聚糖護(hù)創(chuàng)敷料的無菌檢查。

Objective To establish a sterility test method for hydroxybutyl chitosan protective dressings and provide reference for such kind of products. Methods According to the relevant requirements in the 2015 version of Chinese Pharmacopoeia(General Rule 1101, Volume IV), the method applicability test was carried out by membrane filtration method and used 2-8℃ 0.1% sterile peptone solution as dilute solution and rinse solution. After the sample was dissolved and the testing liquid was filtrated , we used 2-8℃ 0.1% sterile peptone solution to rinse the membrane with the rinsing amount of 500 mL per membrane (no more than 100 mL per membrane each time), and the medium dosage was 100 mL. Results In comparison with the control group, six kinds of positive control test strains required by Chinese Pharmacopoeia (2015 Version) grew well in the experimental groups, indicating that the antimicrobial activity of hydroxybutyl chitosan could be eliminated effectively. Conclusions The method can be used in the sterility test for hydroxybutyl chitosan protective dressings.

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