制约中药企业做大做强关键要素研究

通过文献研究及调查研究发现，中药企业发展过程中存在着中药材质量难保证、中药材资源难持续、同质化现象严重、中药产品临床定位不清，适应证不明确、产品缺乏有利的循证医学及药物经济学数据支持、缺乏系统的安全性评价研究等制约因素。为促进中药企业健康发展，提出应保证中药材质量及资源可持续发展；系统地开展循证药物经济学研究，明确临床定位；系统地开展安全性评价，完善说明书；完善以临床有效性为导向的质量标准。

Study on Restrictive Critical Factors and Research of Traditional Chinese Medicine Enterprises Become Bigger and Stronger

The literature study and survey revealed existed problems and factors such as the difficulties to maintain quality of traditional Chinese medicine (TCM), sustainable development, homogenization and indeterminacy of clinical orientation diagnosis, lack of favorable evidence-based medicine and pharmacoeconomics data to support, lack of evidence of safety evaluation, which restrict the development of TCM enterprises. Based on problems and factors mentioned above, recommendations were made on the healthy development of TCM enterprises, which include guarantee of the quality of TCM herbs and the sustainable development of its resource; conduct systematic evidence-based pharmacoeconomic research, identify the clinical orientation; carry out safety assessment systematically, improve the specification; improve clinical effectiveness-oriented quality standards.