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| 三七伤药片质量评价与研究 | |
| 引用本文： | 胡晓茹,杨美丽,王明娟,刘静,戴忠,马双成.三七伤药片质量评价与研究[J].中国药学杂志,2015,50(4):299-304. |
| 作者姓名： | 胡晓茹 杨美丽 王明娟 刘静 戴忠 马双成 |
| 作者单位： | 1.中国食品药品检定研究院,北京 100050; 2. 保定市药品检验所, 河北 保定 071051 |
| 基金项目： | 国家十二五“重大新药创制”专项(2014ZX09304307-002) |
| 摘 要： | 目的 通过三七伤药片的评价性抽验结果进行分析,对其质量现状进行评价。方法 依据标准检验中发现的问题,结合原药材的质量现状,从与药品真实性、有效性、安全性等方面进行探索性研究,对三七伤药片的质量状况进行全面分析与评价。结果 标准检验合格率为98.8%;探索性研究结果表明,部分企业可能存在投料不足、制法与标准不一致、染色、重金属及有害元素超标,过度辐照等问题。结论 三七伤药片总体质量状况较好,质量标准有待进一步提高。 |
| 关 键 词： | 三七伤药片 质量分析 国家评价性抽验 |
| 收稿时间： | 2015-03-09; |
Quality Evaluation of Sanqi Shangyao Tablets |
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| HU Xiao-ru,YANG Mei-li,WANG Ming-juan,LIU Jing,DAI Zhong,MA Shuang-cheng.Quality Evaluation of Sanqi Shangyao Tablets[J].Chinese Pharmaceutical Journal,2015,50(4):299-304. | |
| Authors: | HU Xiao-ru YANG Mei-li WANG Ming-juan LIU Jing DAI Zhong MA Shuang-cheng |
| Institution: | 1. National Institutes for Food and Drug Control, Beijing 100050,China; 2. Baoding Institute for Drug Control, Baoding 071051, China |
| Abstract: | OBJECTIVE To evaluate the quality status of Sanqi Shangyao tablets. METHODS Based on the results of statutory inspection and exploratory research, the quality evaluation regarding authenticity, effectiveness, and safety, was carried out. RESULTS The qualified rate of inspection was 98.8%. Some problems, such as inconsistency of preparation process of standards and illegal dying, were discovered in some samples. CONCLUSION In general,the overall quality of Sanqi Shangyao tablets is good. Some deficiency in the quality standards deserves further concern. |
| Keywords: | Sanqi Shangyao tablet quality analysis national evaluation sampling |
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