| 丹参川芎嗪注射液细菌内毒素检查法研究 |
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| 引用本文： | 张 馨,梅 群,肖植国.丹参川芎嗪注射液细菌内毒素检查法研究[J].医学信息,2018,0(24):139-141,186. |
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| 作者姓名： | 张 馨 梅 群 肖植国 |
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| 作者单位： | 曲靖市食品药品检验检测中心生测室，云南 曲靖 655000 |
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| 摘 要： | 目的 建立丹参川芎嗪注射液细菌内毒素检查法。方法 依据《中国药典》2015年版四部（通则1143）细菌内毒素检查法，通过预干扰预试验和干扰试验，确定丹参川芎嗪注射液最大无干扰的浓度，并进行方法学验证。结果 将丹参川芎嗪注射液稀释20倍，对细菌内毒素检测法无干扰作用。结论 丹参川芎嗪注射液内毒素检查法可用于检查丹参川芎嗪注射液。
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| 关 键 词： | 丹参川芎嗪注射液 细菌内毒素检查 凝胶法 干扰试验 |
Study on Bacterial Endotoxin Test of Salviae Miltiorrhizae and Ligustrazine Hydrochloride |
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| ZHANG Xin,MEI Qun,XIAO Zhi-guo.Study on Bacterial Endotoxin Test of Salviae Miltiorrhizae and Ligustrazine Hydrochloride[J].Medical Information,2018,0(24):139-141,186. |
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| Authors: | ZHANG Xin MEI Qun XIAO Zhi-guo |
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| Institution: | Department of Bioassay,Qujing Food and Drug Testing Center,Qujing 655000,Yunnan,China |
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| Abstract: | Objective Establish a bacterial endotoxin test for Salviae Miltiorrhizae and Ligustrazine Hydrochloride. Methods According to the Chinese Pharmacopoeia's 2015 edition of the four-part (General Rule 1143) bacterial endotoxin test, the maximum interference-free concentration of Salviae Miltiorrhizae and Ligustrazine Hydrochloride was determined by pre-interference pre-test and interference test, and the methodological verification was carried out. Results The Salviae Miltiorrhizae and Ligustrazine Hydrochloride was diluted 20 times, which had no interference effect on the bacterial endotoxin test. Conclusion The endotoxin test of Salviae Miltiorrhizae and Ligustrazine Hydrochloride can be used to check Salviae Miltiorrhizae and Ligustrazine Hydrochloride. |
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| Keywords: | Salviae Miltiorrhizae and Ligustrazine Hydrochloride Bacterial endotoxin test Gel method Interference test |
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