| 徐鸿,邓继华,于睿,周洋,于新兰,孙磊.国家中药饮片抽验品种冰片质量情况分析与研究[J].中国药事,2022,36(9):1026-1033 |
| 国家中药饮片抽验品种冰片质量情况分析与研究 |
| On the Quality of Borneolum Syntheticum of National Chinese Herbal Pieces |
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| DOI：10.16153/j.1002-7777.2022.09.008 |
| 中文关键词: 国家中药饮片抽验 冰片 质量情况 分析与研究 |
| 英文关键词: sampling test of Chinese herbal pieces borneol quality situation analysis and research |
| 基金项目: |
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| 中文摘要: |
| 目的：通过国家中药饮片抽验专项工作，了解冰片在饮片市场整体质量现状及存在的问题，进一步完善冰片的质量标准，为冰片饮片的质量控制和市场监管提出可行性建议。方法：对42个厂家生产的 116批冰片按法定标准检验，通过关键项目检验和不合格项质量问题的发现，建立解决问题的技术方案。 结果：在116批冰片样品中，有30批次不合格，不合格率高达25.9%；其中，性状不合格率为12.9%，熔点、不挥发物不合格率均为10.3%，樟脑限量检测不合格率为24.1%，龙脑含量测定不合格率为11.2%。 结论：抽验冰片样品的不合格率较高反映出未严格按照工艺生产合成冰片，严重损害了用药群众的切身利益，需要加强对使用单位及生产单位的监管。 |
| 英文摘要: |
| Objective: To understand the present situation and existing problems of the overall quality of borneol in the Chinese herbal pieces market, further improve the quality standard of borneol, and put forward feasible suggstions for the quality control and market supervision of the borneol pieces, through the special work of sampling and testing of Chinese herbal pieces. Method: A total of 116 batches of borneol produced by 42 factories were inspected according to the legal standards, and the technical solutions were established through the inspection of key items and the discovery of the quality problems of unqualified items. Result: Among the 116 batches of borneol, 30 batches were unqualified, so the unqualified rate was as high as 25.9%, and the unqualified rate of properties was 12.9%, so the unqualified rate of melting point and non-volatile was 10.3%, and the unqualified rate of camphor limit was 24.1%, the unqualified rate of borneol content was 11.2%. Conclusion: The high unqualified rate of sampling for Borneolum Syntheticum reflects that the synthetic Borneolum Syntheticum is not produced in strict accordance with the process, which seriously damages the vital interests of the people who use the medicine. It is necessary to strengthen the supervision of the users and the production units. |
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