Construction and application of the project approval evaluation system for traditional Chinese medicine preparation in medical institutions

JU Xiaoyu; ZHAO Liang; ZHAO Yue; TANG He; ZHANG Jingyi; LI Junxue; XUE Yurun; GUAN Shengjiang; CHENG Jie

doi:10.6039/j.issn.1001-0408.2024.10.03

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Construction and application of the project approval evaluation system for traditional Chinese medicine preparation in medical institutions

更新时间：2025-09-25

- Construction and application of the project approval evaluation system for traditional Chinese medicine preparation in medical institutions
- ZHONGGUO YAOFANG Vol. 35, Issue 10, Pages: 1168-1173(2024)
- 作者机构：
  
  1.河北省中医院药学部，石家庄;050011
  2.河北省药品职业化检查员总队（南片区），石家庄　050051
  3.河北省人民医院药学部，石家庄　050054
  4.河北省临床药学重点实验室，石家庄　050054
  5.河北省中医院院长办公室，石家庄　050011
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2024.10.03
  CLC： R943;R288
- Received：14 December 2023，
  
  Revised：2024-04-12，
  
  Accepted：22 April 2024，
  
  Published：30 May 2024
- 稿件说明：
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鞠晓宇,赵靓,赵越,等.医疗机构中药制剂立项评价体系的构建及应用[J].中国药房,2024,35(10):1168-1173.

JU Xiaoyu,ZHAO Liang,ZHAO Yue,et al.Construction and application of the project approval evaluation system for traditional Chinese medicine preparation in medical institutions[J].ZHONGGUO YAOFANG,2024,35(10):1168-1173.
鞠晓宇,赵靓,赵越,等.医疗机构中药制剂立项评价体系的构建及应用[J].中国药房,2024,35(10):1168-1173. DOI： 10.6039/j.issn.1001-0408.2024.10.03.

JU Xiaoyu,ZHAO Liang,ZHAO Yue,et al.Construction and application of the project approval evaluation system for traditional Chinese medicine preparation in medical institutions[J].ZHONGGUO YAOFANG,2024,35(10):1168-1173. DOI： 10.6039/j.issn.1001-0408.2024.10.03.

摘要

目的

以新药转化为导向，构建医疗机构中药制剂备案立项评价体系，以提高医疗机构中药制剂的申报成功率，为后期新药转化奠定基础。

方法

我院研发小组运用文献研究法，采用头脑风暴法列举并整理医疗机构中药制剂立项评价的相关要素，确定初拟指标体系；采用德尔菲法进行专家函询，确定评价指标，根据各指标的重要性评分占比计算权重，赋予具体分值，并采用该指标体系对2023年4－7月我院各科室申请备案的31个中药制剂进行评价。

结果

向17位专家进行了两轮函询，最终确定的医疗机构中药制剂备案立项评价体系包括理论依据、临床研究基础、药学基础、处方、临床价值5项一级指标，以及处方来源、中医理论、临床定位等17项二级指标，其中人用经验为一票否决项。基于上述指标体系，我院进一步完善了医疗机构中药制剂备案立项流程，并从2023年4－7月各科室申请备案的31个中药制剂中，遴选出8个评分≥65分的中药制剂拟进行开发。

结论

本评价体系客观、全面，可操作性强，适用于医疗机构中药制剂研发前的遴选。

Abstract

OBJECTIVE

To establish the project approval evaluation system for traditional Chinese medicine （TCM） preparations in medical institutions guided by new drug conversion， to improve the success rate of approval for TCM preparations in medical institutions and lay the foundation for the later drug conversion.

METHODS

Research and development team used the literature research method and brainstorming method to list and organize relevant elements of project evaluation and determine the initial indicator system. Experts were consulted using the Delphi method to confirm the evaluation index. The weights were calculated based on the proportion of importance scores for each indicator and assigned specific scores to each item. The indicator system was used to evaluate 31 TCM preparations applied for filing by various departments of our hospital from April to July 2023.

RESULTS

After two rounds of 17 experts’ consultation， the final TCM preparation system included five primary indicators， i.e. theoretical basis， clinical research foundation， pharmaceutical foundation， prescription， and clinical value， as well as 17 secondary indicators including prescription source， traditional Chinese medicine theory， clinical positioning and so on. Human experience was considered as the item which would be rejected as one vote. Based on the above indicator system， our hospital further improved the filing and project approval process for TCM preparations in medical institutions. Among the 31 TCM preparations applied for filing by various departments from April to July 2023， 8 TCM preparations with a score ≥65 were selected for development.

CONCLUSIONS

The evaluation system is objective， comprehensive， and highly operable. It is suitable for the selection of TCM preparations in medical institutions before research and development.

关键词

Keywords

references

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