Validation for sterility test method of nitroglycerin ointment

Key words: 
• nitroglycerin ointment /
• sterility test /
• validation of the method

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.