本文關(guān)鍵詞：瑞他莫林軟膏的微生物限度檢查適用性試驗(yàn)　出處：《中國(guó)現(xiàn)代應(yīng)用藥學(xué)》2016年05期 　論文類(lèi)型：期刊論文

  更多相關(guān)文章： 瑞他莫林 微生物限度檢查 適用性試驗(yàn) 薄膜過(guò)濾法

【摘要】：目的建立瑞他莫林軟膏的微生物限度檢查方法,并進(jìn)行適用性實(shí)驗(yàn)。方法用十四烷酸異丙酯溶解后,按照中國(guó)藥典2015年版第四部通則1105和1106對(duì)瑞他莫林軟膏進(jìn)行微生物限度檢查適用性實(shí)驗(yàn)。需氧菌總數(shù)計(jì)數(shù)、真菌和酵母菌總數(shù)計(jì)數(shù)采用降低取樣量后薄膜過(guò)濾,并在水相沖洗液中加入乳化劑聚山梨酯80,控制菌檢查采用培養(yǎng)基稀釋法。結(jié)果需氧菌總數(shù)計(jì)數(shù)、真菌和酵母菌總數(shù)計(jì)數(shù)適用性實(shí)驗(yàn)中的回收率比值均在0.5~2內(nèi);控制菌檢查適用性實(shí)驗(yàn)中未檢出金黃色葡萄球菌,檢出銅綠假單胞菌。結(jié)論瑞他莫林軟膏具有較強(qiáng)的抑菌性且基質(zhì)特殊,按照中國(guó)藥典2015年版規(guī)定,本試驗(yàn)建立的方法可作為瑞他莫林軟膏的微生物限度檢查方法。
[Abstract]:Objective to establish a microbiological limit test method for Ritamurin ointment and to test its applicability. Methods the method was dissolved with isopropyl 14 alkanoate. According to the 2015 edition of Chinese Pharmacopoeia, 4th general rules 1105 and 1106 were used to test the applicability of the microbial limit test of Ritamurin ointment. The total number of aerobic bacteria was counted. The total number of fungi and yeast was filtered by thin film after reducing the sampling amount, and the emulsifier polysorbate 80 was added to the washing liquid of water phase. The culture medium dilution method was used to control the bacteria. Results the total number of aerobic bacteria was counted. The recovery ratio of the total count of fungi and yeasts was within 0.5 ~ 2; No Staphylococcus aureus and Pseudomonas aeruginosa were detected in the applicability test of control bacteria. Conclusion Ritamorin ointment has strong bacteriostasis and special matrix according to the Chinese Pharmacopoeia 2015 edition. The method established in this study can be used as a microbiological limit test method for Ratamurin ointment.
【作者單位】： 浙江省食品藥品檢驗(yàn)研究院;
【分類(lèi)號(hào)】：R927.1
【正文快照】： 瑞他莫林是一種半合成的短截北風(fēng)菌素類(lèi)抗菌藥物,其軟膏主要用于治療金黃色葡萄球菌和化膿鏈球菌感染的皰疹病[1]。該軟膏具有較強(qiáng)的抑菌性,且由較特殊的輔料基質(zhì)組成,目前尚無(wú)確切的微生物限度檢查方法。本研究根據(jù)該品種的特殊性質(zhì)建立了微生物限度檢查方法,并按照中國(guó)藥典2

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本文編號(hào)：1429176