Research on Technology Development of Traditional Chinese Medicine Extraction Based on Patent Information

Objective To understand the development status of traditional Chinese medicine extraction technology,so as to provide a reference for enterprises and scientific research institutions to determine the direction of technological innovation.Besides,the government can formulate scientific and technological innovation strategies.Methods Based on patent information,statistical methods were applied to analyze the development of traditional Chinese medicine extraction technology.Then,the core technology was identified by constructing a patent citation network.Finally,the main path analysis method was applied to discover the technological evolution path.Results and Conclusion The extraction technology of traditional Chinese medicine is still in the growth stage.At present,its R&D is based on enterprises,supplemented by scientific research institutions.The core technologies are ultrasonic extraction and enzymatic extraction.The main path represented by enzymatic extraction technology reveals the evolution process of traditional Chinese medicine extraction technology.Based on this,relevant suggestions are put forward.Firstly,technological innovation cooperation should be strengthened to explore new models of achievement transformation and cooperation.Secondly,key enterprises of technology clusters should be cultivated to accelerate breakthroughs in core technologies.Thirdly,combined technologies can achieve high-efficiency enzyme-assisted extraction and open up new ways of extracting traditional Chinese medicine.Fourthly,traditional techniques should be improved to develop innovative modern techniques.

Prescribing Chinese patent medicines without traditional Chinese medicine training is now banned in China

On July 1, 2019, the website of the National Health Commission of the People’s Republic of China issued the “Notice on printing and distributing the first batch of national key monitoring and rational drugs (chemicals and biological products)”(National Health Office Medical Letter [2019] No. 558)[1], where the third article stipulates:“Other types of physicians, after not less than one year of systematically studying Chinese medicine professional knowledge and passing the examination, in accordance with the basic principles of syndrome differentiation, can issue prescriptions for Chinese patent medicine”.

Quality Control for Traditional Medicines–Chinese Patent Medicines

Ji Shen: Dr.Ma Shuangcheng,Director of Institutes for Control of Chinese Traditional Medicines and Ethnic Medicine,National Institutes for Food and Drug Control,is a long-term researcher on the quality standards of Chinese materia medica,Chairman Member of the Risk Assessment of the Pharmacopoeia of People's Republic of China ,and is also the Director Member of the Professional Committee of Drug Risk,China Pharmaceutical Association,and the Director Member of the Directors Committee of Chinese Materia Medica Quality and Safety.He has long been engaged in the control of the quality and safety of Chinese materia medica,and has also been included in the National 10000 Talent Plan.Let's invite Dr.Ma to give a report.Thank you.

Ultrasonic Nebulization Extraction Coupled with Gas Chromatography-Mass Spectrometry for Analysis of Volatile Components in Traditional Chinese Patent Medicine

The ultrasonic nebulization extraction（UNE） was developed and applied to the extraction of volatile components from traditional Chinese patent medicine Xiaoyao Pills. Several parameters of ultrasonic nebulization extraction including the sample particle size, solvent volume, extraction time and ultrasonic power were studied and selected. As a result, 2.4 g of sample with particle size of 80 mesh was extracted with 15 mL of n-hexane for 20 min at an ultrasonic power of 35 W. The volatile components were analyzed by gas chromatography-mass spectrometry （GC-MS） under the optimal conditions and 57 compounds were identified. The precision, repeatability and stability of the proposed method were also studied. Compared with ultrasonic-assisted extraction（UAE） and hydrodistillation（HD） extraction, the proposed method is more efficient, faster and easier to be operated at room temperature with smaller sample and energy consumption. It is suggested that the ultrasonic nebulization extraction can be used as a novel alternative method for the extraction of volatile components from traditional Chinese patent medicine.

Based on the national patent database to explore the rule of traditional Chinese medicine in the treatment of hyperlipidemia

Objective:To explore the medication law of traditional Chinese medicine compound patent for hyperlipidemia,and to provide reference for the research and development of traditional Chinese medicine new drugs for clinical treatment of hyperlipidemia.Methods:All compound TCM patents related to the treatment of hyperlipidemia were searched and extracted from the national patent database(http://epub.sipo.gov.cn)from the establishment of the database to 10st,March 2021.The data was established by the TCM Inheritance Support System(V2.5)and Microsoft Excel 2010 Softwore,and used to conduct TCM syndromes,frequency statistics,four nature and five flavors of traditional Chinese medicine,meridian attribution statistics.IBM SPSS statistics 20 software was used for drug clustering analysis,IBM SPSS modeler 18.2.2 software was used for association rules and web visualization analysis.Results:Totally 284 compound TCM patents were included,involving 577 kinds of Chinese medicine,and the most common syndrome was Yin deficiency of liver and kidney syndrome(74 times,accounting for 26.06%).The most ten common Chinese materiamedica was Hawthorn,Salvia miltiorrhiza,Alismaorientalis,Cassia seed,Polygonummultiflorum,Licorice,Poriacocos,chinese rhubarb,dried tangerine peel,Radix Paeoniae Alba.The top three appeared frequently in drug categories were tonifying deficiency medicine,activating blood-circulation and dissipating blood-stasis medicine,and heat-clearing medicine,respectively.The top two of its drug properties were warm and cold;the top three drug tastes were sweet,bitterness and pungent;the top two meridians were liver and spleen meridian,respectively.Seven drug groups were obtained by cluster analysis,and 16 were obtained by association rule analysis,including 5 drug pairs and 11 three drug groups.Conclusion:Through the data mining of the patent of traditional Chinese medicine compound prescription for regulating and treating hyperlipidemia,it is concluded that the fundamental pathogenesis of the disease is deficiency of viscera function and obstruction of phlegm and blood stasis.The clinical methods are tonifying the liver and kidney,activating blood circulation and removing stasis,resolving phlegm and removing dampness.Traditional Chinese medicine is mostly used for tonifying deficiency,activating blood circulation,removing stasis,resolving phlegm and removing dampness.This paper provides a reference for the research and development of traditional Chinese medicine for hyperlipidemia.

Analysis of the rule of medication of compound Chinese traditional patent medicine for digestive system tumors based on data mining

Objective:Based on the data mining method,explore the medication rules of Chinese patent medicines for the treatment of digestive system tumors.Method:Based on the"Chinese Traditional Medicine Prescription Database"in https://db.yaozh.com/,collect Chinese patent medicines for the treatment of digestive system tumors,establish an Excel table,and use the ancient and modern medical case cloud platform(V2.2.1)to perform frequency statistics,association rules,and drugs on the data Clustering and complex network analysis.Results:A total of 36 Chinese patent medicines for the treatment of digestive system tumors were screened.The medicinal properties were mainly warm and cold,the taste was bitter and sweet,and the meridians were mainly liver and spleen meridians.High frequency Chinese medicine include Astragalus,Scutellaria-barbata,Ginseng,Curcuma,Triangle,Atractylodes,Hedyotis diffusa,etc.Correlation analysis obtained 17 drug combinations,High-frequency drug pairs include Scutellaria-barbata-Astragalus,Ginseng-Astragalus,Curcuma-Astragalus,Scutellaria-barbata-Curcuma,etc.Cluster analysis found 3 types of drugs.The core drug network is composed of 27 drugs,and the core compatibility network consists of 3 groups of drugs.Conclusion:The Chinese patent compound medicine for the treatment of digestive system tumors has the characteristics of combining cold and warming,replenishing and reducing treatment,and treating the liver and spleen at the same time.The medicine is mainly used to replenish qi and invigorate the spleen,promote blood circulation and remove blood stasis,and clear away heat and detoxification.Replenish qi,nourish yin,invigorate blood,and detoxify are mainly compatible with each other,reflecting the pathogenesis characteristics of"deficiency,stasis,and toxin"in digestive system tumors.Data mining can provide references for the prescription and compatibility of Chinese patent medicines.

Partial response to Chinese patent medicine Kangliu pill for adult glioblastoma: A case report and review of the literature

BACKGROUND Glioblastoma is the most common type of brain tumor and is invariably fatal,with a mean survival time of 8-15 mo for recently diagnosed tumors,and a 5-year survival rate of only 7.2%.The standard treatment for newly diagnosed glioblastoma includes surgery followed by concurrent chemoradiotherapy and further adjuvant temozolomide.However,the prognosis remains poor and longterm survival is rare.This report aimed to demonstrate a new therapeutic strategy for the treatment of glioblastoma.CASE SUMMARY A patient was referred to the Department of Neurosurgery with an intracranial space-occupying lesion with a maximum diameter of approximately 5 cm.The tumor was compressing functional areas,and the patient accordingly underwent partial resection and concurrent chemoradiotherapy.The imaging and pathological findings were consistent with a diagnosis of glioblastoma with oligodendroglioma differentiation(World Health Organization IV).The patient was finally diagnosed with glioblastoma.However,the patient discontinued treatment due to intolerable side effects,and was prescribed Kangliu pill(KLP)7.5 g three times/d,which he has continued to date.Significant shrinkage of the tumor(maximum diameter reduced from about 3.5 to about 2 cm)was found after 3 mo of KLP therapy,and the tumor was further reduced to about 1 cm after 3 years.The patient’s symptoms of headache,limb weakness,and left hemiplegia were relieved,with no side effects.CONCLUSION KLP has been a successful intervention for glioblastoma, and the current caseindicates that traditional Chinese medicine may offer effective alternativetherapies for glioblastoma.

Clinical practice guideline on traditional Chinese medicine in the treatment of influenza (2021)

Influenza is a serious public health problem that endangers the health of the global human population.Traditional Chinese medicine(TCM)is rich in theory and practical experience regarding the treatment of influenza,and TCM treatments have shown good curative effects,but there is a dearth of standardized clinical guidance.It is necessary to formulate a clinical practice guide based on evidence-based medicine.To this end,the Specialty Committee of Emergency,China Association of Chinese Medicine(Beijing,China)organized a team of clinical experts,methodological experts,and other multidisciplinary experts to develop a guideline with integrated research methods in the first place of TCM.This guide includes 23 recommendations.The prescription section contains 16 recommendations,including 5 recommendations for mild cases,5 recommendations for severe cases,3 recommendations for critical cases,and 4 recommendations for the recovery period;the portion covering proprietary Chinese medicines forms a total of 7 recommendations.This guide aims to provide the best evidence for clinicians and related practitioners to make decisions about influenza diagnosis and treatment in Chinese medicine.

医务人员及患儿家长对儿童使用中成药风险的KAP调查研究

目的 调查医务人员及患儿家长对儿童使用中成药风险的知识-态度-行为(KAP)现状,分析两类人群对中成药知识掌握程度、用药态度及用药行为的异同,并通过“医-患”两个角度分析中成药用药风险的影响因素,以期更好地指导临床工作。方法 2023年7月至2023年11月,以首都儿科研究所附属儿童医院(以下简称“我院”)及外院医务工作人员,以及在我院就诊过且服用过中成药的患儿家长为调查对象,通过问卷星发放并回收问卷,分析医务人员及患儿家长对儿童使用中成药风险KAP得分情况,采用Logistic回归对使用中成药KAP得分的影响因素进行分析,并通过Spearman分析探讨中成药用药知识、态度、行为之间的相关性。结果 医务人员版问卷共收集有效问卷339份(有效回收率98.83%),医务人员中成药用药知识、态度和行为评分优秀者分别占16.22%、7.08%和83.19%。患儿家长版共收集有效问卷336份(有效回收率98.82%),患儿家长中成药用药知识、态度和行为评分优秀者分别占25.87%、3.57%和30.65%。Logistic回归分析显示,不同医院所在地、受教育程度是医务人员KAP的重要影响因素,患儿家长的年龄、受教育程度、工作状况、职业和月收入是患儿家长KAP的重要影响因素(P<0.05)。Spearman相关分析结果显示用药知识、态度和行为3个维度之间呈显著正相关(P<0.01)。结论 医务人员和患儿家长的中成药用药知识和用药态度均有待进一步提高,患儿家长需特别注意规范用药行为,从而降低儿童使用中成药的风险。医师和药师可结合本研究结果针对患儿家长开展适宜的中成药知识普及和科普宣传工作。

四磨汤口服液治疗功能性消化不良临床综合评价

目的以药品临床价值为导向,对四磨汤口服液治疗功能性消化不良开展临床综合评价,为四磨汤口服液的合理定价、合理用药以及药品目录遴选提供科学依据。方法基于当前可获得数据以及调研数据,围绕四磨汤口服液与两种对照药治疗功能性消化不良的有效性、安全性、经济性、创新性、适宜性和可及性6个维度开展临床综合评价。结果有效性方面,四磨汤口服液可提高临床有效率,药理作用机制明确。安全性方面,未见毒性反应,不良反应较轻,预后良好。经济性方面,日均费用略高于对照药,具有一定成本效果优势。创新性方面,获中国专利授权,并作为中药创新药上市。适宜性方面,方便服用,在药物技术特性和药品使用方面都具有较好的适宜性。可及性方面,医院覆盖较广,产能充足,患者负担较低,长期应用无较大环境风险。3种中成药的综合价值分数从高到低依次为四磨汤口服液(92.01分)>对照药A(85.11分)>对照药B(77.51分)。专家组推荐意见为A类(21/23),建议可直接转化为决策使用。结论四磨汤口服液治疗功能性消化不良的临床综合价值较高,可为药品合理定价、合理用药以及药品目录遴选提供参考依据。

基于数据挖掘探析国家专利中药复方治疗PACG的用药规律

目的基于数据挖掘探析国家专利中药复方治疗原发性闭角型青光眼(PACG)的用药规律。方法纳入建库至2022年12月31日中国专利公布公告网站中治疗PACG的中药复方专利。采用Excel软件对中药复方建立数据库并进行数据处理,运用R语言进行频数统计、功效归类、性味归经、关联规则及聚类分析。结果(1)一般情况:共纳入专利160项,共涉及药物510味,药物累计频次2,055次。(2)性味归经:四气为寒性药最多,共27味(49.09%);五味以甘味药最多,共71味(47.97%);归经以肝经最多,共38味(25.00%)。(3)高频中药使用频次:使用频次>10次的中药(高频中药)有55味,使用频次最高为枸杞子(46次,28.75%),其次为熟地黄(42次,26.25%)、菊花(41次,25.63%)、甘草(39次,24.38%)、决明子(38次,23.75%)。(4)高频中药功效归类分析:排名前5位为清热药(14味,25.45%)、补虚药(12味,21.82%)、解表药(8味,14.55%)、平肝息风药(5味,9.09%)、利水渗湿药(4味,7.27%)。(5)关联规则分析:高频药对排名前5位分别为:菊花-枸杞子(21次,9.21%)、茯苓-枸杞子(20次,8.77%)、决明子-菊花(20次,8.77%)、泽泻-菊花(18次,7.89%)、熟地黄-菊花(18次,7.89%)。(6)聚类分析:共得到6类有效组合。第Ⅰ类功效为清热泻火,疏肝解郁;第Ⅱ类功效为祛风解表,凉血解毒;第Ⅲ类功效为活血祛瘀,通经止痛;第Ⅳ类功效为滋肾养阴,平肝潜阳;第Ⅴ类功效为滋补肝肾,化痰泻火;第Ⅵ类功效为滋补肝肾,祛风化火。结论国家专利中药复方治疗PACG有规律可循,多从肝、肾、脾入手,组方寒温并用,虚实兼顾,标本兼治,主要针对风、火、痰、虚、郁、瘀六类致病因素。

基于国家专利的中药复方调治失眠用药规律研究

目的对治疗失眠中药复方专利进行数据挖掘,分析其用药配伍及组方规律。方法检索CNIPR(China Intellectual Property Right Net)专利信息服务平台(http://search.cnipr.com/)自建库至2020年10月7日治疗失眠的中药复方专利,将数据录入中医传承辅助平台(V2.5)进行药物频次统计、性味归经统计、关联规则分析,并挖掘潜在新处方。结果共纳入78首治疗失眠的中药复方专利,涉及中药231味,高频药物为酸枣仁、远志、甘草、茯苓、首乌藤等;药性分布:平>温>凉>寒,药味分布:甘>苦>辛>酸;主要归心、肝、肺经;药物组合以酸枣仁为核心;新处方有白芍+阿胶+黄连+熟地黄+当归+山茱萸、白芍+黄芩+黄连+鸡子黄等5首;最常见中医证型为肝火扰心证(34.1%)。结论本文运用数据挖掘技术,对中药复方专利治疗失眠的用药模式进行客观分析,有助于指导新方新药研发及临床处方优化。

基于数据挖掘、网络药理和分子对接分析中药组方专利治疗奶牛乳房炎的作用机制

旨在分析专利中复方中药治疗奶牛乳房炎的用药规律及作用机制。筛选并建立相关中药组方专利的数据库,进行频次、性味、归经、关联规则和高频药物聚类分析。通过在线数据库和相关文献获得核心药对活性成分和奶牛乳房炎的相关靶点。采用STRING数据库构建蛋白-蛋白互作信息网络,应用DAVID数据库进行基因本体(GO)功能和京都基因与基因组百科全书(KEGG)通路富集分析。将获得的核心药物和核心靶点进行分子对接验证。结果:共纳入178个专利组方,药性以寒、温为主,药味以苦、甘、辛为主,归经主入肝、肺、胃经,关联规则分析出14组药物组合,聚类分析将药物分为4类。核心药对蒲公英-紫花地丁和奶牛乳房炎共同靶点28个,主要富集于56条GO和72条KEGG信号通路。分子对接结果显示6个核心靶点与5种活性成分均具有结合的可能性。专利组方治疗奶牛乳房炎主要以清热解毒、益气活血调经、行气止痛等治法为主。核心药对可通过磷酸酯酶与张力蛋白同源物(PTEN)、V-rel网状内皮细胞病毒癌基因同源物A(RELA)、白细胞介素-6(IL-6)、白细胞介素-1β(IL-1β)、白细胞介素-2(IL-2)和γ干扰素(IFNG)等靶点调控白细胞介素-17(IL-17)、肿瘤坏死因子(TNF)、核因子κB(NF-κB)、PI3K-Akt和NOD样受体等信号通路,发挥抗炎、免疫调节等作用来防治奶牛乳房炎。

治疗糖尿病中成药的用药规律研究

目的 基于数据挖掘技术分析治疗糖尿病中成药的用药规律。方法 收集2020年版《中华人民共和国药典》《中华人民共和国卫生部药品标准中药成方制剂》《新编国家中成药》《国家中成药标准汇编》《新药转正标准》中治疗糖尿病的中成药,筛选并建立数据库,使用中医传承计算平台(V 3.0)进行用药频次统计、中药属性统计、中药功效统计、关联规则分析、聚类分析,探讨组方用药规律。结果 共纳入68个治疗糖尿病的中成药处方,涉及113味中药,使用频次最高的中药包括黄芪、天花粉、生地黄、人参、五味子、麦冬、葛根、山药、茯苓、黄连等。中药药性以寒性最多,药味以甘、苦为主,主要归肺、肾、脾经,药物功效以补虚和清热为主,利水渗湿药和活血化瘀药也占有一定的比例。关联规则分析得到23个最常用药物组合和9味核心药物,聚类分析得到3个潜在新方。结论 治疗糖尿病的中成药处方以益气养阴清热为基本治法,配以利水渗湿、活血化瘀等。

国家中药复方专利治疗肾结石的用药规律分析

目的 通过对治疗肾结石中药复方专利的挖掘,研究其配伍用药规律,为临床治疗肾结石的遣方用药及新药开发提供参考。方法 检索2013年至2023年国家专利数据库治疗肾结石的中药复方专利,运用中医传承计算平台(V3.0),对复方中药物的药性、药味、功效及中药频次进行统计,通过关联规则和聚类分析等方法分析中药复方的配伍规律。结果 共纳入治疗肾结石中药复方153首,涉及中药554味,使用频次前6位分别为金钱草、车前子、海金沙、鸡内金、滑石、牛膝。涉及药物药性以寒为主,其次为平、温;药味以甘居多,其次为苦、辛;功效以利尿渗湿类为主,其次为补虚类、清热类;金钱草-鸡内金药对组合出现频次最高,关联组合“鸡内金,滑石→金钱草”的置信度最高;聚类分析得到治疗肾结石的4组核心类方。结论 现代医家治疗肾结石用药灵活,以利尿通淋为核心,辅以补肾益气、活血化瘀,常用三金排石汤、八正散等经典名方为基础方加减治疗。

基于数据挖掘和网络药理学探讨治疗抑郁症的中药复方专利用药规律及机制

目的基于数据挖掘、网络药理学方法,分析探讨治疗抑郁症的中药复方专利用药规律以及核心药物的分子作用机制。方法通过中国专利公布公告网检索获得治疗抑郁症的中药复方,提取中药名称、药味、药性、归经等信息,借助Microsoft Excel 2016、SPSS Modeler 18.0、Cytoscape 3.9.1、中医传承计算平台V3.5软件,对中药进行用药频次、性味归经、关联规则分析,并筛选出核心药物。在数据挖掘基础上,借助中药系统药理数据库与分析平台(TCMSP)获取核心药物的活性成分并预测其作用靶点;通过DisGeNET、GeneCards数据库收集抑郁症靶点,并利用EVenn在线平台获得核心药物治疗抑郁症的潜在靶点;通过STRING 11.5数据库分析蛋白-蛋白相互作用(PPI)及关键靶点网络;借助Cytoscape 3.9.1软件构建核心药物-成分-潜在靶点-通路网络;利用R软件包org.Hs.eg.db(version 3.1.0)和ClusterProfiler(version 3.14.3)对潜在靶点进行基因本体(GO)和京都基因与基因组百科全书(KEGG)富集分析。结果①本研究共收集303首中药复方、涉及中药663味,其中使用频次≥30次的中药有26味,共出现1469次,占总频次的39.93%。②本研究涉及的663味中药的药性以温、寒、平为主,药味以甘、苦、辛为主,归经以肝、心、脾、肺、肾、胃为主。③关联规则显示,中药复方治疗抑郁症常用药物组合有15组,涉及中药有当归、柴胡、甘草、郁金、白芍、茯苓等。④网络药理学分析结果显示,中药复方核心药物当归、柴胡、甘草、郁金、酸枣仁、白芍、茯苓的主要活性成分可能是植物甾醇、茯苓酸D、胡萝卜苷、芍药吉酮和当药黄素,这些成分可能作用于非受体酪氨酸蛋白激酶(SRC)、V-Rel网状内皮增生病毒癌基因同源物A(RELA)、蛋白激酶B(AKT)1等关键靶点,并通过调控白介素-17(IL^(-1)7)、C型凝集素受体(CLRs)、肿瘤坏死因子(TNF)、磷脂酰肌醇3激酶(PI3K)/AKT等多条信号通路发挥作用。结论治疗抑郁症的中药复方专利主要涉及疏肝药、理气药、补血药,核心药物有当归、柴胡、甘草、郁金、酸枣仁、白芍、茯苓;其作用机制可能主要与免疫系统信号通路以及神经炎症相关。

中成药相关肝损伤研究进展

药物性肝损伤是指由化学药品、生物制品、中草药及其制剂等所导致的肝损伤,是临床常见的药物不良反应之一。近年来,含何首乌、补骨脂、淫羊藿的中成药导致肝损伤的临床报道逐渐增多,其导致肝损伤的原因及机制受到广泛关注,并取得一定进展。本文主要对含此类组分的中成药及其肝损伤的原因、发病机制等进行综述。

基于数据挖掘分析国家专利口服中药复方治疗冠心病的用药规律

目的:基于数据挖掘方法,对国家专利口服复方治疗冠心病的组方用药规律进行分析,以期为冠心病的中医临床调治及新药新方研发提供参考依据。方法:检索并录入国家知识产权局从2018年1月—2022年12月治疗冠心病的口服专利复方数据,并录入到Excel表格中作为数据源。基于此数据源按要求进行筛选,建立符合要求的数据库。运用IBM SPSS Modeler、IBM SPSS Statistics、Cytoscape等软件对中药的使用频次、药物功效、性味归经、关联规则等进行分析,并对关联强度较高的中药进行聚类分析。结果:共纳入184首口服治疗冠心病的专利复方,总计含有中药322味,其中出现频次≥20次的中药共有30味,排名前3位的药物为丹参、川芎、黄芪,中药功效多为益气、滋阴、活血化瘀、祛痰、清热等,四气以温、寒、平常见,五味以甘、苦、辛居多,归经多属肝、心、脾经。高频药物进行关联规则分析后得出24组药物组合,聚类分析获得3组有效聚类方。结论:虚、热、瘀、痰是冠心病发病关键,病位在心、肝、脾,治疗应注重益气养阴、活血化瘀,辅以清热、化痰等。临证时应注重辨证论治,把握关键治法。

104例儿童中药注射剂不良反应分析

目的:分析儿童中药注射剂不良反应(ADR)发生情况,为临床合理用药提供参考。方法:从国家药品ADR监测系统中收集2006-2021年中成药不良反应案例1356例,筛选出中药注射剂在儿童中发生的ADR共104例。从患儿因素、药物因素及临床因素3个角度对ADR的特点及原因进行分析。结果:男65例(62.50%),女39例(37.50%);≤5岁59例(56.73%);复方制剂63例(60.58%),单一组分制剂41例(39.42%);用药后30 min内发生ADR 86例(82.69%)。结论:儿童尚处于生长发育阶段,需要重视中药注射剂在儿童中的应用,谨慎用药,加强监测,以减少或避免ADR的发生。