| 第 51 卷第 2 期 |  | Vol. 51 No. 2 | | 2021 年 4 月 | Apr 2021 |
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所属栏目：医药及中间体
盐酸头孢他美酯原料药微生物限度检查方法研究 |
| 何军芳1，彭 欢1，任党培1*，朱南兵1，阳学文1，吴 兴2，3*
（1. 浙江普洛得邦制药有限公司，浙江 东阳 322118；2. 横店集团控股股份有限公司，浙江 东阳 322118；3. 浙江普洛家园药业有限公司，浙江 东阳 322118） |
| 摘 要：对盐酸头孢他美酯原料药的微生物限度计数检查方法和控制菌检查方法进行研究并确认。盐酸头孢他美酯原料药，1∶100供试品溶液1 mL加不少于60万单位头孢菌素酶消除抑菌性，采用平皿法进行需氧菌总数检查；1∶10供试液1 mL采用平皿法进行盐酸头孢他美酯原料药霉菌酵母菌总数检查；1∶10供试液10 mL采用“薄膜过滤+冲洗+头孢菌素酶中和”的方法，进行控制菌（大肠埃希菌）检查。 |
| 关键词：盐酸头孢他美酯；平皿法；薄膜过滤法；头孢菌素酶 |
| 中图分类号：TQ460.6 文献标识码：A 文章编号：1009-9212（2021）02-0046-04 |
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| Microbial Limit Test of Cefetamet Pivoxil hydrochloride |
| HE Jun-fang1, PENG Huan1, REN Dang-pei1*, ZHU Nan -bing1, YANG Xue-wen1, WU Xing2,3*
(1. Zhejiang Apeloatospo Pharmaceutical Co.,Ltd., Dongyang 322118, China; 2. Hengdian Group Holding Co.,Ltd., Dongyang 322118, China; 3. Zhejiang Apeloa Jiayuan Pharmaceutical Co.,Ltd., Dongyang 322118, China) |
| Abstract：The microbial limit count test method and control bacteria test method for Cefetamet Pivoxil hydrochloride were presented in this paper. Conclusions were made as followings: for Cefetamet Pivoxil hydrochloride, 1 mL of 1∶100 test solution and no less than 600 000 units of cephalosporin enzyme were added to eliminate the bacteriostasis, and the plate method was used to check the total aerobic bacteria; 1 mL of 1∶10 test solution was used to check the total number of molds and yeasts; 10 mL of 1∶10 test solution was used to check the total number of molds and yeasts; 10 mL of 1∶10 test solution was used to check the total number of molds and yeasts. A process including membrane filtration , washing,and cephalosporin enzyme neutralization was adopted to check the control bacteria (Escherichia coli). |
| Key words：cefetamet pivoxil hydrochloride; plate method; membrane filtration; cephalosporinase |
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作者简介：何军芳（1972—），女，浙江东阳人，工程师，主要从事药物研究和生产（E-mail：junfang.he@apeloa.com）。
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联 系 人： 任党培，工程师，主要从事药物研究和生产（E-mail:dangpei.ren@apeloa.com）；吴兴，高级工程师，主要从事药物研究和生产（E-mail：john.wu@hengdian-group.com）。
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收稿日期：2021-03-12
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