| 一种新型胃癌治疗性疫苗的无菌检查 |
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| 引用本文： | 毕华,刘兰,范文红,史新昌,丁有学,饶春明.一种新型胃癌治疗性疫苗的无菌检查[J].中国药事,2018,32(2):221-224. |
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| 作者姓名： | 毕华 刘兰 范文红 史新昌 丁有学 饶春明 |
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| 作者单位： | 中国食品药品检定研究院, 北京 100050,中国食品药品检定研究院, 北京 100050,中国食品药品检定研究院, 北京 100050,中国食品药品检定研究院, 北京 100050,中国食品药品检定研究院, 北京 100050,中国食品药品检定研究院, 北京 100050 |
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| 摘 要： | 目的：建立一种新型胃癌治疗性疫苗的无菌检查方法。方法：依据《中国药典》2015年版三部要求，采用薄膜过滤法和吐温80溶解及梯度冲洗的方法进行无菌检查并进行方法适用性试验。结果与结论：通过方法适用性试验说明建立的无菌检查法适用于该疫苗的无菌检查，并对其他黏性供试品的无菌检查具有借鉴意义。
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| 关 键 词： | 胃癌治疗性疫苗 无菌检查 薄膜过滤 方法学验证 |
| 收稿时间： | 2017/2/6 0:00:00 |
Sterility Test of a Novel Gastric Cancer Therapeutic Vaccine |
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| Bi Hu,Liu Lan,Fan Wenhong,Shi Xinchang,Ding Youxue and Rao Chunming.Sterility Test of a Novel Gastric Cancer Therapeutic Vaccine[J].Chinese Pharmaceutical Affairs,2018,32(2):221-224. |
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| Authors: | Bi Hu Liu Lan Fan Wenhong Shi Xinchang Ding Youxue and Rao Chunming |
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| Institution: | National Institutes for Food and Drug Control, Beijing 100050, China,National Institutes for Food and Drug Control, Beijing 100050, China,National Institutes for Food and Drug Control, Beijing 100050, China,National Institutes for Food and Drug Control, Beijing 100050, China,National Institutes for Food and Drug Control, Beijing 100050, China and National Institutes for Food and Drug Control, Beijing 100050, China |
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| Abstract: | Objective: To establish a method for sterility test of a novel gastric cancer therapeutic vaccine. Methods: Membrane fltration method and the method of Tween 80 dissolution and gradient washing were used for sterility test and applicability test according to the relevant requirements of the Chinese Pharmacopoeia 2015 edition, volume III. Results and Conclusion: The applicability test showed that the established method was suitable for sterility test of this vaccine and of reference signifcance to that of other viscosity samples. |
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| Keywords: | gastric cancer therapeutic vaccines sterility test membrane fltration method validation |
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