| 第 51 卷第 2 期 |  | Vol. 51 No. 2 | | 2021 年 4 月 | Apr 2021 |
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所屬欄目：醫藥及中間體
鹽酸頭孢他美酯原料藥微生物限度檢查方法研究 |
| 何軍芳1，彭 歡1，任黨培1*，朱南兵1，陽(yáng)學(xué)文1，吳 興2，3*
（1. 浙江普洛得邦制藥有限公司，浙江 東陽(yáng) 322118；2. 橫店集團控股股份有限公司，浙江 東陽(yáng) 322118；3. 浙江普洛家園藥業(yè)有限公司，浙江 東陽(yáng) 322118） |
| 摘 要：對鹽酸頭孢他美酯原料藥的微生物限度計數檢查方法和控制菌檢查方法進(jìn)行研究并確認。鹽酸頭孢他美酯原料藥，1∶100供試品溶液1 mL加不少于60萬(wàn)單位頭孢菌素酶消除抑菌性，采用平皿法進(jìn)行需氧菌總數檢查；1∶10供試液1 mL采用平皿法進(jìn)行鹽酸頭孢他美酯原料藥霉菌酵母菌總數檢查；1∶10供試液10 mL采用“薄膜過(guò)濾+沖洗+頭孢菌素酶中和”的方法，進(jìn)行控制菌（大腸埃希菌）檢查。 |
| 關(guān)鍵詞：鹽酸頭孢他美酯；平皿法；薄膜過(guò)濾法；頭孢菌素酶 |
| 中圖分類(lèi)號：TQ460.6 文獻標識碼：A 文章編號：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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作者簡(jiǎn)介：何軍芳（1972—），女，浙江東陽(yáng)人，工程師，主要從事藥物研究和生產(chǎn)（E-mail：junfang.he@apeloa.com）。
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聯(lián) 系 人： 任黨培，工程師，主要從事藥物研究和生產(chǎn)（E-mail:dangpei.ren@apeloa.com）；吳興，高級工程師，主要從事藥物研究和生產(chǎn)（E-mail：john.wu@hengdian-group.com）。
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收稿日期：2021-03-12
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