| 许玮仪,左甜甜,王莹,李耀磊,金红宇,马双成.大黄配方颗粒质量分析及标准建议[J].中国药事,2019,33(6):670-674 |
| 大黄配方颗粒质量分析及标准建议 |
| Quality Analysis and Standard Suggestions for Rhubarb Granules for Prescriptions |
| 投稿时间：2019-01-11 |
| DOI：10.16153/j.1002-7777.2019.06.010 |
| 中文关键词: 大黄配方颗粒 标准比较 质量差异 统一标准 |
| 英文关键词: rhubarb granules for prescriptions standard comparison quality difference unified standard |
| 基金项目:国家十二五“重大新药创制”课题“中药质量安全检测和风险控制技术平台”（编号2014ZX09304307-002） |
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| 中文摘要: |
| 目的：比较目前市场上不同厂家的大黄配方颗粒企业标准和全检结果，对质量差异进行分析，并对质量标准和市场监管提出建议。方法：对比各企业间大黄配方颗粒质量标准的差异，采用企业标准，对9家企业109批大黄及炮制品配方颗粒进行全检。结果与结论：各企业大黄配方颗粒批间质量稳定，但不同企业间质量差异较大；建议在全国范围内，统一中药配方颗粒质量标准，加强监管。 |
| 英文摘要: |
| Objective:To compare the enterprise standard and the total inspection results of rhubarb granules for prescriptions of different manufacturers in the market, analyze the quality differences, and put forward suggestions for quality standards and market supervision. Methods:The quality standards of rhubarb granules for prescriptions among different enterprises were compared. 109 batches of rhubarb granules in 9 enterprises were fully inspected by using enterprise standards. Results and Conclusion:The quality of rhubarb granules for prescriptions was stable among different batches, but the quality difference among different enterprises was large. It is suggested that the quality standards of the traditional Chinese medicine granules for prescriptions should be unified and the supervision should be strengthened nationwide. |
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