文章摘要
王丹丹,谭红略,张虹.感染外用中药复方专利的申请情况及用药规律分析[J].安徽医药,2024,28(5):1050-1055.
感染外用中药复方专利的申请情况及用药规律分析
Patent application and the medication rules of external anti-infective traditional Chinese medicine compound
  
DOI:10.3969/j.issn.1009-6469.2024.05.042
中文关键词: 抗感染药  中草药  外用  中药复方专利  用药规律
英文关键词: Anti-infection agents  Drugs, Chinese herbal  External  Patent for traditional Chinese medicine compound prescrip-tion  Medication rule
基金项目:NSFC-河南联合基金项目( U1804189)
作者单位E-mail
王丹丹 河南省洛阳正骨医院河南省骨科医院科研与知识产权部河南洛阳 471002  
谭红略 河南省洛阳正骨医院河南省骨科医院科研与知识产权部河南洛阳 471002  
张虹 河南省洛阳正骨医院河南省骨科医院科研与知识产权部河南洛阳 471002 lyzgzh2008@163.com 
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中文摘要:
      目的分析抗感染外用中药复方专利的申请授权情况,挖掘外用抗感染中药复方的用药规律。方法通过国家知识产权局专利检索系统,下载提取 2000年以来外用抗感染中药复方专利数据,录入 Excel表分类汇总授权专利数量、年份、申请人类型、地区、治疗疾病分布、剂型等信息,复方方剂录入“中医传承辅助平台”利用“方剂分析”功能进行复方用药的频数分析、关联规则分析、聚类分析等。结果共筛选出 102项外用抗感染的中药专利复,方,专利申请数量整体不足且近年来下滑明显,以个人名义申报占比 78.43%,药物剂型涵盖 11种剂型,常见膏剂、散剂、洗剂、搽剂等,主要用于治疗外伤、皮肤病等,多数进行了简单的疗效评价和安全性考察。所选处方用药分散、药味共计 285种,其中出现 10次以上的高频药味 20种,多为清热凉血、活血化瘀药,主归肝、心、肾经,强关联药对有乳香 -没药、白及 -黄柏、白及 -地榆、黄连 -黄柏、地榆 -黄柏等,聚类分析出 14个核心药物组合和 7个新处方。结论外用抗感染中药复方专利申请数量和质量都有待提高,主要用于治疗外伤和皮肤病,常用黄柏、大黄、冰片、地榆等清热凉血、活血化瘀类药材,体现了清热解毒以祛邪、补益心脾以扶正的整体治疗观念;乳香、没药、白及、黄柏、地榆、黄连等不仅是高频药物,也是强关联药物,是临床外用抗感染的核心药群所在。
英文摘要:
      Objective To analyze the patent application and authorization status of anti-infective external Chinese herbal compound, and explore the medication rules of the selected compound.Methods Through the patent retrieval system of the China National Intel-lectual Property Administration, the patent data of compound anti-infective TCM for external use since 2000 were downloaded and ex-tracted, the number of authorized patents, year, applicant type, region, treatment disease distribution, dosage form and other informationwere classified and summarized into the Excel table, the compound prescription entered into the Traditional Chinese Medicine Inheri-tance Auxiliary Platform (V2.5), and the frequency analysis, association rule analysis, cluster analysis, etc of compound prescriptionswere used by "prescription analysis" function.Results A total of 102 patent compounds of TCM for external use and anti-infection have been selected. The overall number of patent applications was insufficient and declined significantly in recent years, with 78.43% reported in the name of individuals. The drug dosage forms included 11 dosage forms, including common plasters, powders, lotions, lini-ments, etc., mainly used for the treatment of external injuries, skin diseases, etc. Most of them had undergone simple efficacy evaluationand safety evaluation. The selected prescriptions had a total of 285 types of drugs with scattered medication and a total of 20 types ofdrug flavors, including more than 10 high-frequency drug flavors, most of which were drugs for clearing heat and cooling blood, promot-ing blood circulation and resolving stasis, mainly targeting the liver, heart, and kidney meridians. Strong correlation drug pairs includedOlibanum-Myrrha, Bletillae Rhizoma-Phellodendri Chinensis Cortex, Bletillae Rhizoma-Sanguisorbae Radix, Coptidis Rhizoma-Phello-dendri Chinensis Cortex, Sanguisorbae Radix-Phellodendri Chinensisi, and so on. Cluster analysis had identified 14 core drug combina-tions and 7 new prescriptions.Conclusions The number and quality of patent applications for external anti-infective traditional Chi-nese medicine prescriptions need to be improved, with the prescriptions mainly used for treating trauma and skin diseases. The com-monly used herbs such as Phellodendri Chinensis Cortex, Rhei Radix et Rhizoma, and Sanguisorba officinalis are used to clear heat,cool blood, promote blood circulation, reflecting the overall treatment concept of clearing heat and detoxifying to dispel pathogenic fac-tors, tonifying the heart and spleen to strengthen the body. Olibanum, Myrrha, Bletillae Rhizoma, Phellodendri Chinensis Cortex,Sangui-sorbae Radix, Coptidis Rhizoma are not only high-frequency drugs, but also strongly related drugs, and are the core group of anti-infec-tive drugs for clinical external use.
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