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Article Navigation >  Journal of Pharmaceutical Practice and Service  > 2015  >  33(3): 253-254

TAN Qiaoting, YAN Jia, ZHONG Guixiang, SONG Hongtao. Validation for sterility test method of nitroglycerin ointment[J]. Journal of Pharmaceutical Practice and Service, 2015, 33(3): 253-254. doi: 10.3969/j.issn.1006-0111.2015.03.016
Citation: TAN Qiaoting, YAN Jia, ZHONG Guixiang, SONG Hongtao. Validation for sterility test method of nitroglycerin ointment[J]. Journal of Pharmaceutical Practice and Service, 2015, 33(3): 253-254. doi: 10.3969/j.issn.1006-0111.2015.03.016
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Validation for sterility test method of nitroglycerin ointment

doi: 10.3969/j.issn.1006-0111.2015.03.016

  • Department of Pharmacy, Fuzhou General Hospital of Nanjing Millitary Region, Fuzhou 350025, China

  • Received Date: 2014-04-23
  • Rev Recd Date: 2014-09-24
  • 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.
  • [1] 山院飞,冯六泉,张晓元,等. 硝酸甘油软膏联合创灼膏治疗肛裂疗效观察[J].人民军医,2011,54(3):209-210.
    [2] 徐 毅. 硝酸甘油软膏加扩肛与单纯扩肛治疗96例对照观察[J].结直肠肛门外科,2012,18(3):182-183.
    [3] 张 倩,林银花,王 娟,等. 硝酸甘油软膏的制备与质量控制[J].医药导报,2010,29(6):768-770.
    [4] 孔 婵. 复方硝酸甘油软膏和九华膏治疗早期肛裂的疗效对比[J].西部医学,2009,21(9):1540-1541.
    [5] 吴 鑫,陈 希,鄢雷娜. 盐酸特比萘芬乳膏微生物限度检查法的方法学研究[J].中国药事,2013,27(1):48-64.
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Validation for sterility test method of nitroglycerin ointment

doi: 10.3969/j.issn.1006-0111.2015.03.016
  • Department of Pharmacy, Fuzhou General Hospital of Nanjing Millitary Region, Fuzhou 350025, China
  • Received Date: 2014-04-23
  • Rev Recd Date: 2014-09-24

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.

TAN Qiaoting, YAN Jia, ZHONG Guixiang, SONG Hongtao. Validation for sterility test method of nitroglycerin ointment[J]. Journal of Pharmaceutical Practice and Service, 2015, 33(3): 253-254. doi: 10.3969/j.issn.1006-0111.2015.03.016
Citation: TAN Qiaoting, YAN Jia, ZHONG Guixiang, SONG Hongtao. Validation for sterility test method of nitroglycerin ointment[J]. Journal of Pharmaceutical Practice and Service, 2015, 33(3): 253-254. doi: 10.3969/j.issn.1006-0111.2015.03.016
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