本文選題：中藥　切入點(diǎn)：提取物組合物　出處：《北京中醫(yī)藥大學(xué)》2016年博士論文

【摘要】：目的：通過對(duì)中藥提取物組合物的專利文獻(xiàn)信息進(jìn)行挖掘和分析,探索此類專利的發(fā)展歷史、重點(diǎn)防治的疾病領(lǐng)域和權(quán)利人分布,明確中藥提取物組合物及其專利的內(nèi)在特點(diǎn),為促進(jìn)我國(guó)中藥提取物組合物的科研創(chuàng)新、推動(dòng)中藥提取物組合物的專利發(fā)展和保護(hù)提供思路與參考。方法：本研究以國(guó)家知識(shí)產(chǎn)權(quán)局專利數(shù)據(jù)庫(kù)、中國(guó)專利信息中心、中國(guó)知識(shí)產(chǎn)權(quán)網(wǎng)以及相關(guān)知識(shí)產(chǎn)權(quán)機(jī)構(gòu)作為數(shù)據(jù)信息來源,檢索的時(shí)間范圍為1995年1月1日至2014年12月31日期間申請(qǐng)的中藥提取物組合物的相關(guān)發(fā)明專利為研究對(duì)象,運(yùn)用Excel、Access、 SPSS等軟件,通過簡(jiǎn)單和高階統(tǒng)計(jì)相結(jié)合,理論與實(shí)例相結(jié)合的方法進(jìn)行分析。具體如下：1.簡(jiǎn)單分析與聚類分析相結(jié)合,探索中藥提取物組合物專利的發(fā)展進(jìn)程、病系研發(fā)方向及權(quán)利人分布；2.運(yùn)用頻數(shù)分析、聚類分析和因子分析相結(jié)合的方法,探索重點(diǎn)防治病系的中藥提取物組合物的藥物及科類的組合規(guī)律；3.根據(jù)重點(diǎn)防治病系的藥用植物科類的頻數(shù)分析結(jié)果,以有效專利中所涉及的高頻科類及其所含中藥為研究對(duì)象,對(duì)其藥理作用及活性成分進(jìn)行對(duì)比,結(jié)合以藥性為研究參數(shù)的模糊聚類分析結(jié)果,探索同科中藥的相似性；4.根據(jù)權(quán)利人分布的研究結(jié)果,以高頻權(quán)利人的中藥提取物組合物有效專利為研究對(duì)象,對(duì)其有效專利的劑型、活性成分結(jié)構(gòu)以及用途等進(jìn)行簡(jiǎn)單統(tǒng)計(jì),結(jié)合理論分析,為現(xiàn)代中藥企業(yè)專利網(wǎng)的構(gòu)建提供借鑒；5.基于對(duì)中藥提取物組合物的組合規(guī)律和特點(diǎn)的分析結(jié)果,以理論聯(lián)系案例的方法探討此類發(fā)明的可專利性判斷。結(jié)果：1.中藥提取物組合物相關(guān)創(chuàng)新成果的專利保護(hù)發(fā)展于近二十年,發(fā)展速度于2004年開始具有明顯提升；2015年以前國(guó)內(nèi)中藥提取物組合物有效發(fā)明專利中,職務(wù)發(fā)明占78.11%；高頻專利權(quán)人主要包括現(xiàn)代中藥企業(yè)、高校以及以技術(shù)開發(fā)、技術(shù)轉(zhuǎn)讓等為核心經(jīng)營(yíng)范圍的技術(shù)企業(yè)；防治內(nèi)科疾病中的心系病與肝系病的中藥提取物組合物有效專利所占比例較大。2.防治心系病的中藥提取物組合物涉及高頻中藥為丹參、人參和三七等,高頻科為五加科、豆科、唇形科以及傘形科；常用中藥組合單元為人參+麥冬,丹參+降香,人參+五味子等；常用科類組合單元為五加科+百合科,唇形科+豆科,五加科+五味子科等。3.防治肝系病的中藥提取物組合物涉及高頻中藥為丹參、黃芪、川芎等,高頻科類為傘形科、唇形科、菊科等；常用中藥組合單元為梔子+黃芩、柴胡+甘草、白芍+當(dāng)歸；常用科類組合單元為茜草科+唇形科、傘形科+豆科、毛茛科+傘形科。4.各科均有一些在有效成分及藥理作用方面具有相似性的中藥,依據(jù)模糊聚類分析結(jié)果,對(duì)各類中藥進(jìn)行對(duì)比發(fā)現(xiàn),各科屬于同類的中藥在藥理作用和活性成分上更為接近。5.天士力制藥集團(tuán)股份有限公司含有丹參的中藥提取物組合物的專利網(wǎng)基本構(gòu)建完全,該專利網(wǎng)主要圍繞丹參提取物十三七提取物十冰片這一組合物展開,在核心權(quán)利獲得保護(hù)的基礎(chǔ)上,通過對(duì)組合物單元進(jìn)行替換、細(xì)化組合物配比范圍等核心技術(shù)的延伸,形成具有更大保護(hù)力度和更加穩(wěn)固的防御體系。結(jié)論：1.中藥提取物組合物發(fā)明專利在近二十年中歷經(jīng)四個(gè)增長(zhǎng)階段,整體處于上升趨勢(shì),其增長(zhǎng)與國(guó)家法律法規(guī)及重大戰(zhàn)略的推動(dòng)、中藥提取物的產(chǎn)業(yè)化趨勢(shì)、近年來豐碩的中藥提取物組合物的科研成果等因素密切相關(guān)；有效專利的職務(wù)發(fā)明比例在整個(gè)中藥復(fù)方領(lǐng)域具有明顯優(yōu)勢(shì),高頻權(quán)利人以現(xiàn)代中藥企業(yè)居多；中藥提取物組合物有效專利所述用途,以心系病與肝系病的防治居多。2.根據(jù)防治心系病和肝系病的中藥提取物組合物的組合規(guī)律研究結(jié)果,高頻中藥大多屬于高頻科類,且常用的中藥組合單元與常用科類組合單元基本一致；高頻科類及常用科類組合單元對(duì)新的中藥提取物組合物研發(fā)具有一定的提示作用；中藥提取物組合物的組合規(guī)律研究,在激勵(lì)自主研發(fā),促進(jìn)專利申請(qǐng)等方面具有一定應(yīng)用價(jià)值。3.本研究中所涉及的同科中藥,藥性相似者在化學(xué)成分與藥理作用方面具有更明顯的共性；相關(guān)領(lǐng)域科研人員應(yīng)辨證運(yùn)用同科中藥的相似性,適當(dāng)繞開熱點(diǎn)研發(fā)藥物,對(duì)低頻中藥的化學(xué)成分及藥理作用進(jìn)行深入研究,進(jìn)而展開新組合物的研究,為促進(jìn)單位創(chuàng)新成果的產(chǎn)出,構(gòu)建和完善專利網(wǎng)等方面提供可能。4.現(xiàn)代中藥企業(yè)應(yīng)以核心技術(shù)的專利權(quán)利獲取為基礎(chǔ),圍繞一類具有相似功效的產(chǎn)品,展開中藥提取物組合物的外圍研發(fā)與專利網(wǎng)構(gòu)建,同時(shí)注重研發(fā)方向的多樣化,根據(jù)不同技術(shù)路線有針對(duì)性的申請(qǐng)專利,以豐富專利網(wǎng)的構(gòu)建路線,提高專利網(wǎng)的系統(tǒng)性,促進(jìn)專利網(wǎng)的可持續(xù)發(fā)展；重視專利申報(bào)質(zhì)量與申請(qǐng)時(shí)機(jī),以提高專利網(wǎng)構(gòu)建的成功率。5.對(duì)中藥提取物組合物的可專利性判斷應(yīng)將專利法與中醫(yī)藥理論相結(jié)合,主動(dòng)引用中藥領(lǐng)域權(quán)威單位的實(shí)驗(yàn)室檢定數(shù)據(jù)或?qū)＜业囊庖姡晃覈?guó)專利審查標(biāo)準(zhǔn)中應(yīng)盡快增設(shè)專門針對(duì)中藥領(lǐng)域發(fā)明的章節(jié)。建議：1.政府層面：以完善適用于中藥提取物組合物發(fā)明的專利保護(hù)政策為主要任務(wù)。在現(xiàn)行專利審查標(biāo)準(zhǔn)中,盡快增設(shè)專門針對(duì)中藥領(lǐng)域發(fā)明的章節(jié),提高可專利性判斷的客觀性與準(zhǔn)確性；倡導(dǎo)多樣化的知識(shí)產(chǎn)權(quán)激勵(lì)政策,以促進(jìn)創(chuàng)新成果的產(chǎn)出。2.企業(yè)層面：以完善中藥提取物組合物專利戰(zhàn)略為主要任務(wù)。重視專利研發(fā)戰(zhàn)略,協(xié)助專利戰(zhàn)略的制定；圍繞核心專利展開自主創(chuàng)新,加強(qiáng)防御性專利戰(zhàn)略構(gòu)建；多樣化研發(fā)方向,提高專利網(wǎng)的系統(tǒng)性和完整性。3.科研層面：以提高創(chuàng)新成果的可專利性及促進(jìn)產(chǎn)品轉(zhuǎn)化為主要任務(wù)�？蒲袉挝粦�(yīng)合理利用專利文獻(xiàn)信息,結(jié)合自身研發(fā)領(lǐng)域,加強(qiáng)基礎(chǔ)研究,提高創(chuàng)新成果的可專利性；創(chuàng)辦專門針對(duì)現(xiàn)代中藥制劑研發(fā)的協(xié)同創(chuàng)新發(fā)展中心,加強(qiáng)校企合作,構(gòu)建對(duì)現(xiàn)代中藥的科學(xué)研究及專利申報(bào)的全程跟進(jìn)制度,促進(jìn)創(chuàng)新成果的產(chǎn)出并及時(shí)投入企業(yè)生產(chǎn),實(shí)現(xiàn)創(chuàng)新成果快速轉(zhuǎn)化。
[Abstract]:Objective : To explore the development history of the traditional Chinese medicine extract composition , focus on the disease field and the distribution of the rights , clarify the inherent characteristics of the traditional Chinese medicine extract composition and provide the thought and reference for the patent development and protection of the traditional Chinese medicine extract composition . The method is as follows : 1 . The research is based on the combination of simple and high - order statistics , the development process of the traditional Chinese medicine extract composition patent , the development direction of the disease system and the distribution of the right person .
2 . The combination of frequency analysis , cluster analysis and factor analysis was used to explore the combination of medicine and medicine of traditional Chinese medicine extract composition with emphasis on prevention and control of diseases .
3 . Based on the results of the frequency analysis of the medicinal plants of the disease - prevention department , the pharmacology and active ingredients of the high - frequency family and the Chinese medicine contained in the effective patent are compared , and the similarity of the same Chinese medicine is explored with the result of the fuzzy clustering analysis of the drug properties as the research parameters ;
4 . According to the research result of the distribution of the right person , the effective patent of the traditional Chinese medicine extract composition of the high - frequency right person is the research object , the dosage form , the active ingredient structure and the application of the effective patent are simply counted and combined with the theoretical analysis , so as to provide reference for the construction of the patent network of the modern Chinese medicine enterprise ;
5 . Based on the analysis results of the combination rule and characteristics of the traditional Chinese medicine extract composition , the patentability judgment of the invention is discussed by the method of theoretical contact case . The result is that 1 . Patent protection of the related innovative results of the traditional Chinese medicine extract composition is developed in the last two decades , and the development speed is obviously improved in 2004 ;
In the effective inventor ' s patent of Chinese traditional Chinese medicine extract composition before 2015 , the invention occupies 78.11 % ;
The high - frequency patent holder mainly includes modern Chinese medicine enterprises , colleges and technology enterprises with the core business scope such as technology development and technology transfer ;
The traditional Chinese medicine extract composition for preventing and treating cardiovascular diseases relates to a traditional Chinese medicine extract composition for preventing and treating cardiovascular diseases , and relates to a traditional Chinese medicine extract composition for preventing and treating cardiovascular diseases , which relates to a high - frequency traditional Chinese medicine as red sage root , ginseng and notoginseng , etc .
The common Chinese medicinal composition is Ginseng Radix , Radix Ophiopogonis , Saviae Miltiorrhizae Radix , Lignum Dalbergia Odoriferae , Ginseng Radix and Fructus Schisandrae , etc . ;
The traditional Chinese medicine extract composition for preventing and treating hepatic diseases relates to a traditional Chinese medicine extract composition for preventing and treating liver diseases , and relates to a traditional Chinese medicine extract composition for preventing and treating liver diseases , which relates to a high - frequency Chinese medicine as salvia miltiorrhiza , astragalus root , Szechwan rhizome and the like .
The common Chinese medicinal composition comprises Fructus Gardeniae , Scutellariae Radix , Bupleuri Radix , Glycyrrhrizae Radix , Radix Paeoniae Alba and Radix Angelicae Sinensis ;
The invention discloses a traditional Chinese medicine extract composition , which comprises the following components in parts by weight : 1 , the traditional Chinese medicine extract composition has four growth stages , the whole is in an ascending trend , the growth of the traditional Chinese medicine extract composition is promoted by the national laws and regulations and the major strategy , and the industrialization trend of the traditional Chinese medicine extract is closely related ;
The proportion of the job invention of the effective patent has obvious advantages in the whole traditional Chinese medicine compound field , and the high - frequency right person is the most modern Chinese medicine enterprise ;
according to the combination rule of the traditional Chinese medicine extract composition for preventing and treating cardiovascular diseases and liver diseases , the high - frequency traditional Chinese medicine is mostly high - frequency family , and the common traditional Chinese medicine combination unit is basically consistent with the conventional medicine combination unit ;
the high - frequency family and the commonly used medicine combination unit have certain prompting effect on the research and development of the new traditional Chinese medicine extract composition ;
The combination rule of traditional Chinese medicine extract composition has certain application value in stimulating independent R & D , promoting patent application and so on .
In order to promote the output , construct and perfect the patent network , the research of the traditional Chinese medicine should be based on the patent rights of the core technology , and the development direction should be diversified . According to different technical routes , the patent network should be patented , so as to enrich the construction route of the patent network , improve the systematicness of the patent network and promote the sustainable development of patent network .
Pay attention to the quality of the patent application and the timing of the application to improve the success rate of the patent network construction . 5 . The patentability judgment of the traditional Chinese medicine extract composition should combine the patent law with the theory of Chinese medicine to actively refer to the laboratory verification data or expert opinion of the authoritative unit in the field of traditional Chinese medicine ;
in that current patent review standard , a special section specially for the invention in the field of traditional Chinese medicine is added as soon as possible to improve the objectivity and accuracy of the patentability judgment ;
Promote the diversification of intellectual property incentive policies to promote the output of innovative results . 2 . Enterprise level : to improve the patent strategy of traditional Chinese medicine extract composition as the main task . Pay attention to patent development strategy and assist in the formulation of patent strategy ;
Develop independent innovation around core patent , strengthen defensive patent strategy construction ;
In order to improve the systematicness and completeness of the patent network , the scientific research level : to improve the patentability of the innovative results and to promote the transformation of the products into the main tasks . The scientific research units should use patent document information reasonably , strengthen the basic research and improve the patentability of the innovation results in combination with the research and development field .
Establish a collaborative innovation development center specially for the development of modern Chinese medicine preparation , strengthen cooperation of the school and enterprise , construct the whole process follow - up system for scientific research and patent application of modern Chinese medicine , promote the output of innovative results and put into the enterprise production in a timely manner , and realize the rapid transformation of innovative results .

【學(xué)位授予單位】：北京中醫(yī)藥大學(xué)
【學(xué)位級(jí)別】：博士
【學(xué)位授予年份】：2016
【分類號(hào)】：R284;G306
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本文編號(hào)：1726449