| 基于“组分结构理论”的丹参注射剂的 “多维结构过程动态”质量控制 |
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| 引用本文： | 胡绍英,封亮,张明华,顾俊菲,贾晓斌. 基于“组分结构理论”的丹参注射剂的 “多维结构过程动态”质量控制[J]. 中国中药杂志, 2013, 38(24): 4375-4378 |
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| 作者姓名： | 胡绍英 封亮 张明华 顾俊菲 贾晓斌 |
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| 作者单位： | 南京中医药大学, 江苏 南京 210046;江苏省中医药研究院 国家中医药管理局中药释药系统重点研究室, 江苏 南京 210028;南京中医药大学, 江苏 南京 210046;南京中医药大学, 江苏 南京 210046;南京中医药大学, 江苏 南京 210046;南京中医药大学, 江苏 南京 210046;江苏省中医药研究院 国家中医药管理局中药释药系统重点研究室, 江苏 南京 210028 |
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| 基金项目： | 江苏省中医药领军人才项目（2006） |
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| 摘 要： | 从丹参原药材到丹参注射剂制剂成型过程中，涉及工艺复杂，影响质量安全因素较多，需要对其进行有效性和安全性的整体质量控制。该文基于“组分结构理论”，结合丹参注射剂物质基础，探讨该制剂的多维结构过程动态质量控制技术，以达到对丹参注射剂安全性和有效性物质基础的质量控制，为丹参注射剂生产质量规范提供新的思路和方法。
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| 关 键 词： | 丹参注射剂 组分结构理论 物质基础 质量控制 |
| 收稿时间： | 2013-06-13 |
Multi-dimensional structure quality control over Salvia miltiorrhiza injection based on component structure theory |
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| HU Shao-ying,FENG Liang,ZHANG Ming-hu,GU Jun-fei and JIA Xiao-bin. Multi-dimensional structure quality control over Salvia miltiorrhiza injection based on component structure theory[J]. China Journal of Chinese Materia Medica, 2013, 38(24): 4375-4378 |
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| Authors: | HU Shao-ying FENG Liang ZHANG Ming-hu GU Jun-fei JIA Xiao-bin |
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| Affiliation: | Nanjing University of Chinese Medicine, Nanjing 210046, China;Key Laboratory of New Drug Delivery System of Chinese Meteria Medica under State Administration of Traditional Chinese Medicine, Academy of Traditional Chinese Medicine of Jiangsu Province, Nanjing 210028, China;Nanjing University of Chinese Medicine, Nanjing 210046, China;Nanjing University of Chinese Medicine, Nanjing 210046, China;Nanjing University of Chinese Medicine, Nanjing 210046, China;Nanjing University of Chinese Medicine, Nanjing 210046, China;Key Laboratory of New Drug Delivery System of Chinese Meteria Medica under State Administration of Traditional Chinese Medicine, Academy of Traditional Chinese Medicine of Jiangsu Province, Nanjing 210028, China |
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| Abstract: | As the preparation process from Salvia miltiorrhiz herbs to S. miltiorrhiz injection involves complicated technology and has relatively more factors impacting quality safety, the overall quality control is required for its effectiveness and safety. On the basis of the component structure theory, and according to the material basis of S. miltiorrhiz injection, we discussed the multi-dimensional structure and process dynamic quality control technology system of the preparation, in order to achieve the quality control over the material basis with safety and effectiveness of S. miltiorrhiz injection, and provide new ideas and methods for production quality standardization of S. miltiorrhiz injection. |
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| Keywords: | Salvia miltiorrhiz injection component structure theory substance base quality control |
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