| 银杏二萜内酯葡胺注射液与中性硼硅玻璃安瓿的药物相容性试验研究 |
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| 引用本文： | 李雪峰,李峰,刘莉莉,韦迎春,吴云,萧伟.银杏二萜内酯葡胺注射液与中性硼硅玻璃安瓿的药物相容性试验研究[J].世界科学技术-中医药现代化,2014,16(12):2676-2680. |
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| 作者姓名： | 李雪峰 李峰 刘莉莉 韦迎春 吴云 萧伟 |
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| 作者单位： | 江苏康缘药业股份有限公司 连云港 222001；中药制药过程新技术国家重点实验室 连云港 222001;江苏康缘药业股份有限公司 连云港 222001；中药制药过程新技术国家重点实验室 连云港 222001;江苏康缘药业股份有限公司 连云港 222001；中药制药过程新技术国家重点实验室 连云港 222001;江苏康缘药业股份有限公司 连云港 222001；中药制药过程新技术国家重点实验室 连云港 222001;江苏康缘药业股份有限公司 连云港 222001；中药制药过程新技术国家重点实验室 连云港 222001;江苏康缘药业股份有限公司 连云港 222001；中药制药过程新技术国家重点实验室 连云港 222001 |
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| 基金项目： | 科学技术部国家重大新药创制项目（2013ZX09402203）：现代中药创新集群与数字制药技术平台，负责人：王振中。 |
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| 摘 要： | 目的：通过对银杏二萜内酯葡胺注射液与中性硼硅玻璃安瓿的药物相容性试验研究，确定中性硼硅玻璃安瓿作为银杏二萜内酯葡胺注射液内包装材料的可行性。方法：根据《药品包装材料与药物相容性试验指导原则》，进行以中性硼硅玻璃安瓿为包装材料的银杏二萜内酯葡胺注射液相容性研究。结果：中性硼硅玻璃安瓿与银杏二萜内酯葡胺注射液之间无迁移及吸附等质量变化，中性硼硅玻璃安瓿与银杏二萜内酯葡胺注射液具有较好的药物相容性。结论：中性硼硅玻璃安瓿可以作为银杏二萜内酯葡胺注射液的包装材料。
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| 关 键 词： | 相容性 银杏二萜内酯 包装材料 中性硼硅玻璃安瓿 |
| 收稿时间： | 2013/12/18 0:00:00 |
| 修稿时间： | 2014/2/27 0:00:00 |
Study on Drug Compatibility between Ginkgolides Meglumine Injection and Neutral Borosilicate Glass Ampoule |
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| Li Xuefeng,Li Feng,Liu Lili,Wei Yingchun,Wu Yun and Xiao Wei.Study on Drug Compatibility between Ginkgolides Meglumine Injection and Neutral Borosilicate Glass Ampoule[J].World Science and Technology-Modernization of Traditional Chinese Medicine,2014,16(12):2676-2680. |
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| Authors: | Li Xuefeng Li Feng Liu Lili Wei Yingchun Wu Yun and Xiao Wei |
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| Institution: | Jiangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China; State Key Laboratory of New-tech for Chinese Medicine Phar maceutical Process, Lianyungang 222001, China;Jiangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China; State Key Laboratory of New-tech for Chinese Medicine Phar maceutical Process, Lianyungang 222001, China;Jiangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China; State Key Laboratory of New-tech for Chinese Medicine Phar maceutical Process, Lianyungang 222001, China;Jiangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China; State Key Laboratory of New-tech for Chinese Medicine Phar maceutical Process, Lianyungang 222001, China;Jiangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China; State Key Laboratory of New-tech for Chinese Medicine Phar maceutical Process, Lianyungang 222001, China;Jiangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China; State Key Laboratory of New-tech for Chinese Medicine Phar maceutical Process, Lianyungang 222001, China |
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| Abstract: | This article was aimed to determine the feasibility of neutral borosilicate glass ampoule as the inner packing material of Ginkgolides meglumine injection by studying the drug compatibility between Ginkgolides meglumine injection and neutral borosilicate glass ampoule. On the basis of the Pharmaceutical Packaging Materials and Drug Compatibility Test Guidance Rules, the study was carried on the compatibility between Ginkgolides meglumine injection and neutral borosilicate glass ampoule for packaging materials. The results showed that no migration or adsorption quality of change between the Ginkgolides meglumine injection and neutral borosilicate glass ampoule. It had good compatibility between neutral borosilicate glass ampoule and Ginkgolides meglumine injection. It was concluded that neutral borosilicate glass can be used as the packing materials of Ginkgolides meglumine injection. |
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| Keywords: | Compatibility ginkgolides packaging materials neutral borosilicate glass ampoule |
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