CAJ | 학술논문

目的：了解中药材生产与中药制剂生产的情况，促使《中药材生产质量管理规范》(GAP)和《药品生产质量管理规范》(GMP)相互结合，进一步推动中药材 GAP 实施。方法采取现场走访、与企业座谈及发放调查问卷相结合的方式进行调研，根据调研情况和对问卷的统计分析得出调研结果。结果与结论中药材 GAP 自发布以来已经实施十多年，但在 GAP 认证体系建设、基地建设与政策扶持、推进中药材GAP 进程方面仍有待深入总结研究。调研显示，种植和使用 GAP 药材成本提高导致价格竞争力减弱，挫伤了企业实施中药材 GAP 的积极性；公司与农户合作种植的模式存在农户积极性降低、对农户制约不严、产品溯源性差等弊端；缺乏有效的中药材价格调控机制；GAP 药材的种植管理缺乏一致性。建议参照新修订药品 GMP 的评定方式，对中药材 GAP 种植企业实施可持续性地改进。
목적：료해중약재생산여중약제제생산적정황，촉사《중약재생산질량관리규범》(GAP)화《약품생산질량관리규범》(GMP)상호결합，진일보추동중약재 GAP 실시。방법채취현장주방、여기업좌담급발방조사문권상결합적방식진행조연，근거조연정황화대문권적통계분석득출조연결과。결과여결론중약재 GAP 자발포이래이경실시십다년，단재 GAP 인증체계건설、기지건설여정책부지、추진중약재GAP 진정방면잉유대심입총결연구。조연현시，충식화사용 GAP 약재성본제고도치개격경쟁력감약，좌상료기업실시중약재 GAP 적적겁성；공사여농호합작충식적모식존재농호적겁성강저、대농호제약불엄、산품소원성차등폐단；결핍유효적중약재개격조공궤제；GAP 약재적충식관리결핍일치성。건의삼조신수정약품 GMP 적평정방식，대중약재 GAP 충식기업실시가지속성지개진。
Objective To understand the situation of traditional Chinese material medical production and traditional Chinese preparation production,facilitate the integration of GAP for the traditional Chinese medicinal materials and GMP for drugs and further promote the implementation of GAP for traditional Chinese herbal medicine.Methods Research was carried out by means of on-site visits,discussions with manufacturers as well as statistical analyses based on findings from questionnaires. Results and Conclusion Though GAP has been implemented more than a decade since its release,it still remains to be further explored in the aspects of GAP certification system construction,base construction and policy support and promotion of the process of GAP for traditional Chinese medicinal materials.Researches demonstrate that the rise in the cost of planting and using the GAP medicinal materials leads to weak price competitiveness and dampens the enthusiasm of enterprises to implement GAP for traditional Chinese medicinal materials;drawbacks still exist in the cooperative planting pattern between companies and farmers,such as undermined motivation of the farmers,loose restriction on the farmers and poor product traceability;lack of an effective regulatory mechanism for traditional Chinese herbal medicine prices and the consistency of plantation management of GAP medicinal materials.It is recommended to carry out sustainable improvement for traditional Chinese herbal medicine GAP planting enterprises based on the evaluation methods of the new GMP.