| 王赵,李耀磊,李静,许玮仪,金红宇,马双成.金银花配方颗粒评价性抽验结果分析与建议[J].中国药事,2019,33(5):528-533 |
| 金银花配方颗粒评价性抽验结果分析与建议 |
| Analysis and Suggestions to the Sampling Inspection Results of Jinyinhua Formula Granules |
| 投稿时间：2018-11-30 |
| DOI：10.16153/j.1002-7777.2019.05.006 |
| 中文关键词: 中药饮片 金银花配方颗粒 企业标准 质量分析 监管建议 |
| 英文关键词: prepared slices of Chinese medicines Jinyinhua formula granules standards of manufacturers quality analysis regulatory suggestions |
| 基金项目: |
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| 摘要点击次数: 1241 |
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| 中文摘要: |
| 目的：通过开展金银花配方颗粒评价性抽验，比较分析不同厂家金银花配方颗粒的质量情况，并提出监管建议。方法：收集各企业金银花配方颗粒质量标准，依据企业标准进行法定检验。结果：共抽验117批金银花配方颗粒，涉及9家生产企业。按各自企业标准进行检验，总体合格率为100%。但是各企业之间金银花配方颗粒含量差异较大且每克颗粒相当的药材（饮片）量不同，转移率不同。结论：通过本次抽验发现金银花配方颗粒的整体质量较高，但是不同厂家之间所用原料药材及生产工艺存在一定差异，导致最终产品质量参差不齐。因此，有必要规范中药配方颗粒生产工艺，尽快统一标准，加强监管。 |
| 英文摘要: |
| Objective:To compare and analyze the qualities of Jinyinhua formula granules from different manufacturers through the nationwide sampling inspection of Jinyinhua formula granules, and to propose some regulatory suggestions. Methods:Quality standards of Jinyinhua formula granules from different manufacturers were collected, and the statutory inspection was carried out according to standards of the manufacturers. Results:A total of 117 batches of Jinyinhua formula granules were collected from 9 manufacturers. The overall pass rate of the inspections carried out according to standards of the manufacturers was 100%. However, the content of chlorogenic acid and cynaroside in the Jinyinhua formula granules varied greatly among different manufacturers and the amount of medicinal prepared slices (yinpian) equivalent to one gram granule was different. The transfer rate was also different. Conclusion:The overall qualities of the Jinyinhua formula granules are proved good through the sampling inspection. But there are some differences in raw materials and production process among different manufacturers, resulting in the uneven qualities of final products. Therefore, it is necessary to standardize the production process, unify the standards of Chinese medicinal formula granules as soon as possible, and strengthen the regulations. |
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