| 头孢地尼胶囊微生物限度检查方法的验证 |
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| 引用本文： | 张丹,卫延明,杨静,赵生奇,杜晶,李春.头孢地尼胶囊微生物限度检查方法的验证[J].安徽医药,2012,16(3):304-306. |
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| 作者姓名： | 张丹 卫延明 杨静 赵生奇 杜晶 李春 |
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| 作者单位： | 陕西省食品药品检验所,陕西,西安,710061;陕西省渭南市食品药品检验所,陕西,渭南,714000;陕西省宝鸡市食品药品检验所,陕西,宝鸡,721000;陕西省商洛市食品药品检验所,陕西,商洛,726000 |
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| 摘 要： | 目的建立头孢地尼胶囊微生物限度的检查方法。方法采用平皿法、稀释法、薄膜过滤法及方法联用对样品进行微生物限度检查,通过比较加入已知阳性对照菌的回收率来确定适宜的检验方法。结果根据回收率实验得出,采用离心薄膜过滤法(500 r.min-1,5 min,100 ml/次,500 ml+1 ml青霉素酶/膜冲洗)进行细菌数测定,采用平皿法进行霉菌和酵母菌数测定,采用联合法离心薄膜过滤法(500 r.min-1,5 min,100 ml/次,500 ml+5 ml青霉素酶/膜冲洗)+培养基稀释法200 ml/瓶]进行控制菌的检查。结论该方法可用于头孢地尼胶囊的微生物限度检查。
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| 关 键 词： | 头孢地尼胶囊 微生物限度检查法 方法验证 |
Microbial limit test method for cefaclor capsules |
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| Institution: | ZHANG Dan1,WEI Yan-ming2,YANG Jing1,et al(1.Shanxi Institute for Food and Drug Control,Xi’an,Shanxi 710061,China; 2.Weinan Institute for Food and Drug Control,Weinan,Shanxi 714000,China) |
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| Abstract: | Objective To establish a method for the microbial limit test for cefaclor capsules.Methods Microbial limit test was carried out by routine,medium dilution method,membane filtration method,and the optimal method for the test on the recovery rate of artificially sprayed bacteria.Results According to results of the recovery rates,medium dilution method was used to determine bacterial numbers and inspection,routine method was used to determine fungus and yeast numbers and combined method was used to control bacteria numbers.Conclusion The method can be used for microbial limit for cefaclor capsules. |
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| Keywords: | cefaclor capsules microbial limit test method method validation |
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