摘要:
目的 建立硝酸甘油软膏的无菌检查方法,并对方法进行验证。 方法 取预热至45 ℃的供试品10支(15 g/支),每支称取1 g,加至含溶化的司盘80、聚山梨酯80无菌混合物和无菌玻璃珠的锥形瓶中,振摇混匀后,加入45 ℃的 pH 7.0无菌氯化钠-蛋白胨水缓冲液至100 ml,使供试品充分乳化。按薄膜过滤法,细菌、真菌每膜用300 ml pH 7.0氯化钠-蛋白胨缓冲液冲洗,消除抑菌活性。 结果 经方法验证,硝酸甘油软膏供试品组、阴性对照组均无菌生长,试验组各滤器中试验菌与相应对照组比较均生长良好,说明供试品在该检验量和检验条件下无抑菌作用或其抑菌作用可以忽略不计。 结论 薄膜过滤法有效可行,可用于硝酸甘油软膏的无菌检查。
Abstract:
Objective To establish and validate a method of sterility test for nitroglycerin ointment and validate this method. Methods Ten nitroglycerin ointments of 1 g were preheated oven to 45 ℃ for sample, and added to conical flask which containing melted span 80, polysorbate 80 sterile mixture and sterile glass beads, and were shake after mixing, the sample fully emulsified by adding to 100 ml 45 ℃ pH 7.0 sterile sodium chloride-peptone water buffer. According to the method of membrane filtration, bacteria and fungus in each membrane with 300 ml pH 7.0 sterile sodium chloride-peptone water buffer flush, the bacteriostatic activity was eliminated. Results By the method validation, nitroglycerin ointment sample group, negative control group were sterile growth, and test group in each filter of the test bacteria compared with control groups were growing well, so the samples had no inhibitory effect or the antimicrobial effect would not take into account. Conclusion Membrane filtration was reliable, which could be used for sterility test for nitroglycerin ointment.
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