【作者】 赵晶；

【导师】 李红玉；

【作者基本信息】 兰州大学 ， 药学·药学（专业学位）， 2017， 硕士

【摘要】 本文主要研究在现行专利制度下,如何对传统中成药进行专利再保护,探索传统中成药专利再保护的实践途径。本文分为五章。第一章是文献综述。首先对中成药相关概念进行界定;其次对传统中成药的专利保护现状及其成因进行了系统分析,进而提出了对传统中成药进行专利再保护的可行性策略:剂型改良、研发新适应症、新炮制方法等,最后阐述了传统中成药专利再保护的必要性、意义以及难点。第二章阐述了剂型改良对传统中成药进行专利再保护的途径。通过对传统中成药专利无效宣告大数据的分析,结果显示剂型改良是传统中成药专利再保护最为有效的途径之一,论文接下来重点研究了剂型改良中辅料选择、辅料配比及工艺的选择是如何满足专利法授权条件,如何实现对传统中成药专利再保护的实践途径。最后通过对复审、无效案例的分析以及对复方丹参方剂型改良专利申请实践分析,为剂型改良对传统中成药实施专利再保护提供了建议。第三章阐述了研发新适应症对传统中成药进行专利再保护的途径。首先分析了传统中成药功能主治的局限性及传统中成药新适应症可专利性,论文接下来通过对高通量筛选技术在传统中成药新适应症专利中的应用以及复方丹参方新适应症专利申请实践分析,为新适应症对传统中成药进行专利再保护提供了建议。第四章阐述了新炮制方法对传统中成药进行专利再保护的途径。首先分析了传统炮制方法的局限性及传统中成药新炮制方法的可专利性,从现代先进技术在开发新炮制方法以及质量控制和检验方法中的应用入手,研究了新炮制方法对传统中成药进行专利再保护的实践途径。接下来通过对微波技术和生物冶金技术作为新炮制方法对传统中成药专利申请实践分析,为新炮制方法对传统中成药进行专利再保护提供了建议。第五章结论与展望。更多还原

【Abstract】 This dissertation mainly studied how to implement patent protection for the Traditional Chinese Patent Medicine under the current patent system,and how to explore implementation path of patent re-protection for the Traditional Chinese Patent Medicine.This dissertation was composed of five chapters.The first chapter is the literature review.Firstly,related concepts of the Traditional Chinese Patent Medicine were introduced.Secondly,the reasons of the present situation of patent protection for the Traditional Chinese Patent Medicine were analyzed,and the strategies of re-protection of the Traditional Chinese Patent Medicine were introduced.Finally,the necessity,significance,problems and difficulties of patent re-protection of the Traditional Chinese Patent Medicine were elaborated.The second chapter elaborated the way to improving the dosage forms for patent re-protect of Traditional Chinese Patent Medicine.According to the analysis of the invalidation data of Traditional Chinese Patent Medicine,the results showed that the improvement of dosage form is an effective way to patent re-protect of Traditional Chinese Patent Medicine.Dissertation mainly focused on how to select excipients,the ratio of excipients and the choice of process can conform to the condition of patent authorization,and how to realize the practical way of patent re-protection of Traditional Chinese Patent Medicine.The chapter analyzed the retrial,invalid case and the case of Compound Danshen Prescription to provide the advices for the patent re-protect of Traditional Chinese Patent Medicine by improving the dosage forms.The third chapter elaborated discoveries of new indications for patent re-protect of Traditional Chinese Patent Medicine.The limitation of function of Traditional Chinese Patent Medicine and the patentable of new indications to patent re-protect of Traditional Chinese Patent Medicine were analyzed.Then dissertation introduced the application of high-throughput screening technology in the patent application of new indications of Traditional Chinese Patent Medicine and new indications of Compound Danshen Prescription.Finally,a recommendation for new indications of patent re-protection with Traditional Chinese Patent Medicine was provided.The fourth chapter elaborated new medicinal processing for patent re-protect of Traditional Chinese Patent Medicine.Firstly,according to analyzed the shortcomings of the traditional processing methods and the patentable of new methods of medicinal processing,and explored how to develop new processing to patent re-protection of Traditional Chinese Patent Medicine through the application of modern advanced technology in medicinal processing and quality control.Secondly,dissertation analyzed the cases which used new methods such as microwave technology and bioleaching.And the advices for the patent re-protect of Traditional Chinese Patent Medicine by application of new medicinal processing were provided.The fifth chapter is Summary and Prospect.更多还原