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1.
Phytomedicine ; 127: 155481, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38452693

RESUMO

BACKGROUND: Functional dyspepsia (FD) is a prevalent and challenging gastrointestinal disorder. Conventional medicine often faces limitations in providing effective treatment for FD, thus indicating the need to explore alternative approaches. Traditional Chinese medicine (TCM), which is rooted in ancient Chinese traditions and has evolved over thousands of years, offers a holistic approach to well-being. TCM incorporates herbal remedies, acupuncture, and other therapies while shaping the future of complementary and alternative medicine. PURPOSE: To review the existing literature on the current status and future prospects of using TCM to treat FD. METHODS: We extensively searched the PubMed, Google Scholar, Embase, an China National Knowledge Internet databases from inception to May 31, 2023 to identify relevant literature. We also searched the reference lists of the included articles. RESULTS: Clinical evidence-based research has explored the efficacy of TCM in treating FD. Recent research has illuminated the multifaceted mechanisms through which TCM interventions affect FD. TCM is a promising alternative, as it emphasizes a holistic approach and holds potential advantages in addressing the complex nature of FD. CONCLUSIONS: The integration of TCM and Western medicine offers a comprehensive approach to understanding and managing FD by bridging traditional wisdom with modern scientific understanding. This paper highlights the practical implications of this integration, the challenges to be addressed, and the potential for international collaboration to further elucidate the efficacy of TCM. However, continued research and dialog are needed to advance the modern development of TCM and to improve the quality of life of FD patients.


Assuntos
Medicamentos de Ervas Chinesas , Dispepsia , Humanos , Medicamentos de Ervas Chinesas/uso terapêutico , Dispepsia/tratamento farmacológico , Medicina Tradicional Chinesa , Fitoterapia , Qualidade de Vida
2.
Artigo em Inglês | MEDLINE | ID: mdl-38310833

RESUMO

Huanghou antidiarrhea dropping pills (HADP) is an efficient Chinese patent drug that is clinically used to treat diarrhea. However, its functional materials remain unclear due to the characteristics of traditional Chinese medicine, which is a multi-component and multi-target complex system. In this study, we investigated the intrinsic chemical components and combined with in vivo metabolism to reveal the functional material basis of HADP. Spectral behavior (accurate molecular weight and secondary fragmentation) and chromatographic behavior (retention time) were key criterions that throughout the whole research of components identification, prototypes screening, and tissue distribution. Mass defect filter (MDF), characteristic product ion filter (PIF), and neutral loss filter (NLF) were other three criterions for metabolites searching. Consequently, a total of 102 components in HADP, including alkaloids, lignans, lactones, gingerols, and alkaloid complexes were identified or tentatively characterized. About 39 metabolites that related to 37 prototypes were calculated and matched in bio-samples. Among them, 14 prototypes and 18 metabolites were detected distribution in colon, liver, heart, spleen, lung or kidney. This study provides a systematic investigation into the metabolism of HADP and offers effective analytical strategies for the characterization of compounds and metabolites in Chinese patent drugs.


Assuntos
Medicamentos de Ervas Chinesas , Metaboloma , Cromatografia Líquida de Alta Pressão/métodos , Medicina Tradicional Chinesa , Fígado/metabolismo , Medicamentos de Ervas Chinesas/química
3.
Artigo em Chinês | WPRIM (Pacífico Ocidental) | ID: wpr-961697

RESUMO

ObjectiveTo review the drug information and clinical researches on Chinese patent drug in Pharmacopoeia of the People's Republic of China,National Essential Drugs List and Medicine List for National Basic Medical Insurance,Employment Injury Insurance and Maternity Insurance. MethodSearch Chinese patent medicine,which can reduce blood sugar in the three major catalogues above. CNKI,VIP,Wanfang,Embase and PubMed were searched from their inception dates to August 14th,2021 for the clinical researches on Chinese patent drug. A database was established based on the collected Chinese patent drug for the treatment of diabetes. And then,descriptive analysis was performed to analyze the general condition of clinical researches. ResultFrom the three catalogues above,28 kinds of Chinese patent drugs were retrieved, and Supplementing Qi and Nourishing Yin was the basic effect of 22 kinds of Chinese patent drugs. A total of 1 069 clinical researches published and peaked in 2017 before August 14th,2021 were included. Clinical studies have been carried out and published in all 30 provinces and autonomous regions,and the province with the largest number of published literature was Henan.What's more,16.65% of the projects were supported by government funding. The number of research to Shenqi Jiangtang tablets/granules/capsules was the largest,among the 28 kinds of Chinese patent drugs.Besides,the most frequent type of interventions in the 958 two-arm trials was the load test,accounting for 78.91%.Most types of diabetes,including type 1 diabetes,type 2 diabetes and its complications,gestational diabetes,other types of diabetes and pre-diabetes,were covered in in this study. And the results showed that different drugs with different suitable crowd. ConclusionA summary of the current status of clinical research on Chinese patent drug by means of scoping review can provide direction for the next research.

4.
Zhongguo Zhong Yao Za Zhi ; 45(15): 3497-3504, 2020 Aug.
Artigo em Chinês | MEDLINE | ID: mdl-32893536

RESUMO

To evaluate the economy and applicability of Jinye Baidu Granules in the treatment of acute upper respiratory tract infection, a randomized, double-blind, positive drug parallel control clinical trial was conducted in this study. Stratified block random, double-blind and double simulation test was used. The experimental group took Jinye Baidu Granules, 10 g/time, three times a day, and Compound Shuanghua Granules placebo, 6 g/time, four times a day. The control group took Compound Shuanghua Granules, 6 g/time, 4 times a day, and Jinye Baidu Granules placebo, 10 g/time, 3 times a day. The course of treatment was 5 days. The total cost of this study included direct medical cost and indirect medical cost. The incremental cost-effect analysis method was used for evaluation. Treeage Pro software was used to build a pharmaco-economics model and make statistical analysis. Patients from 10 hospitals were divided into experimental group(304 cases) and control group(302 cases). The baseline values of age, sex ratio, clinical symptoms and signs scores, and important physical examination indexes of the two groups were compared. After 5 days of treatment, the cost per capita of the experimental group was(388.06±94.17) Yuan, and that of the control group was(378.47±95.46) Yuan. The cost of direct medical treatment per capita was(271.24±54.11) Yuan for the experimental group and(264.88±112.71) Yuan for the control group. The average cost of indirect medical treatment was(116.82±82.75) Yuan in the experimental group and(113.59±87.77) Yuan in the control group, with no significant difference in the cost of medical treatment per capita, the cost of direct medical treatment per capita and the cost of indirect medical treatment per capita between both groups. The results of incremental cost-effect analysis based on the total score difference in symptoms and signs after 5 days of treatment showed that ICER=23.39 Yuan/score, which was less than the willingness to pay 100 Yuan/score determined through expert interviews. The experimental group had economic advantages over the experimental group, with the economic probability of 53%. Sensitivity analysis supported the robustness of the results. The results of incremental cost-effect analysis based on the total recovery rate of symptoms and signs showed that compared with the experimental group, the control group had lower cost, better effect and absolute economic advantage, with a corresponding probability of 55%. Based on the above results, it is concluded that there is no significant difference in economic outcome between Jinye Baidu Gra-nules and Compound Shuanghua Granules in the treatment of acute upper respiratory tract infection.


Assuntos
Infecções Respiratórias , Análise Custo-Benefício , Método Duplo-Cego , Humanos , Marketing
5.
Zhongguo Zhong Yao Za Zhi ; 45(14): 3336-3339, 2020 Jul.
Artigo em Chinês | MEDLINE | ID: mdl-32726048

RESUMO

Shujin Jianyao Pills is a kind of concentrated honey pills made of 13 Chinese herbal medicines, such as Cibotii Rhizoma, Rosae Laevigatae Fructus, and Spatholobi Caulis. It has the effects in tonifying liver and kidney, strengthening muscles and bones, removing wind and dampness, activating collaterals and relieving pain. Under the leadership of the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences and Wangjing Hospital of China Academy of Chinese Medical Sciences, the Expert consensus on clinical application of Shujin Jianyao Pills was developed by 22 universities, scientific research institutes and hospitals. This consensus formed 1 recommendation and 9 consensus suggestions, which were based on evidence and oriented to clinical practice. The expert consensus had a new understanding of the indications of Shujin Jianyao Pills, especially the applicable Western medicine diseases, the advantages and characteristics of treatment, the time of intervention, the applicable syndromes, the precautions and contraindications of medication. The indications were detailed and expressed as the combination of disease, symptom and syndrome. And it filled in the gaps of package inserts in applicable syndrome and special population medication in the process of drug use. The expert consensus showed the optimization of precautions and contraindications, and more detailed description of drug safety. Therefore, it provides guidance and reference for clinicians to use Shujin Jianyao Pills rationally.


Assuntos
Medicamentos de Ervas Chinesas , Medicina Tradicional Chinesa , China , Consenso
6.
Artigo em Chinês | WPRIM (Pacífico Ocidental) | ID: wpr-828439

RESUMO

Shujin Jianyao Pills is a kind of concentrated honey pills made of 13 Chinese herbal medicines, such as Cibotii Rhizoma, Rosae Laevigatae Fructus, and Spatholobi Caulis. It has the effects in tonifying liver and kidney, strengthening muscles and bones, removing wind and dampness, activating collaterals and relieving pain. Under the leadership of the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences and Wangjing Hospital of China Academy of Chinese Medical Sciences, the Expert consensus on clinical application of Shujin Jianyao Pills was developed by 22 universities, scientific research institutes and hospitals. This consensus formed 1 recommendation and 9 consensus suggestions, which were based on evidence and oriented to clinical practice. The expert consensus had a new understanding of the indications of Shujin Jianyao Pills, especially the applicable Western medicine diseases, the advantages and characteristics of treatment, the time of intervention, the applicable syndromes, the precautions and contraindications of medication. The indications were detailed and expressed as the combination of disease, symptom and syndrome. And it filled in the gaps of package inserts in applicable syndrome and special population medication in the process of drug use. The expert consensus showed the optimization of precautions and contraindications, and more detailed description of drug safety. Therefore, it provides guidance and reference for clinicians to use Shujin Jianyao Pills rationally.


Assuntos
China , Consenso , Medicamentos de Ervas Chinesas , Medicina Tradicional Chinesa
7.
Artigo em Chinês | WPRIM (Pacífico Ocidental) | ID: wpr-828420

RESUMO

To evaluate the economy and applicability of Jinye Baidu Granules in the treatment of acute upper respiratory tract infection, a randomized, double-blind, positive drug parallel control clinical trial was conducted in this study. Stratified block random, double-blind and double simulation test was used. The experimental group took Jinye Baidu Granules, 10 g/time, three times a day, and Compound Shuanghua Granules placebo, 6 g/time, four times a day. The control group took Compound Shuanghua Granules, 6 g/time, 4 times a day, and Jinye Baidu Granules placebo, 10 g/time, 3 times a day. The course of treatment was 5 days. The total cost of this study included direct medical cost and indirect medical cost. The incremental cost-effect analysis method was used for evaluation. Treeage Pro software was used to build a pharmaco-economics model and make statistical analysis. Patients from 10 hospitals were divided into experimental group(304 cases) and control group(302 cases). The baseline values of age, sex ratio, clinical symptoms and signs scores, and important physical examination indexes of the two groups were compared. After 5 days of treatment, the cost per capita of the experimental group was(388.06±94.17) Yuan, and that of the control group was(378.47±95.46) Yuan. The cost of direct medical treatment per capita was(271.24±54.11) Yuan for the experimental group and(264.88±112.71) Yuan for the control group. The average cost of indirect medical treatment was(116.82±82.75) Yuan in the experimental group and(113.59±87.77) Yuan in the control group, with no significant difference in the cost of medical treatment per capita, the cost of direct medical treatment per capita and the cost of indirect medical treatment per capita between both groups. The results of incremental cost-effect analysis based on the total score difference in symptoms and signs after 5 days of treatment showed that ICER=23.39 Yuan/score, which was less than the willingness to pay 100 Yuan/score determined through expert interviews. The experimental group had economic advantages over the experimental group, with the economic probability of 53%. Sensitivity analysis supported the robustness of the results. The results of incremental cost-effect analysis based on the total recovery rate of symptoms and signs showed that compared with the experimental group, the control group had lower cost, better effect and absolute economic advantage, with a corresponding probability of 55%. Based on the above results, it is concluded that there is no significant difference in economic outcome between Jinye Baidu Gra-nules and Compound Shuanghua Granules in the treatment of acute upper respiratory tract infection.


Assuntos
Humanos , Análise Custo-Benefício , Método Duplo-Cego , Marketing , Infecções Respiratórias
8.
Zhongguo Zhong Yao Za Zhi ; 44(14): 2943-2946, 2019 Jul.
Artigo em Chinês | MEDLINE | ID: mdl-31602837

RESUMO

Hugan Tablets is a Chinese patent medicine,it has the function of anti-inflammation and reducing transaminase. Based on questionnaire investigation of doctors and a systematic review of research literature on Hugan Tablets,using international clinical practice guidelines' developing methods,with the best available evidence and fully combining expert experience,and following the principle of " evidence-based,consensus-based and experience-based",Expert consensus statement on Hugan Tablets in clinical practice was developed by more than 30 multidisciplinary experts from the nationwide,aimed at guiding and standardizing the rational use of Hugan Tablets by clinicians and to improve clinical efficacy and safety. The expert consensus adopts internationally recognized recommendation criteria for classification of evidence: GRADE. The formation of expert consensus adopts the nominal group technique. Six main considerations are quality of evidence,curative effect,safety,economical efficiency,patient acceptability and other factors. If there is sufficient evidence,a " recommendation" is formed,using GRADE grid voting rule. If there isn' t sufficient evidence,a " consensus opinion" is formed,using majority counting rule. Focus on the indication,usage and dosage,drug use in special population and safety of Hugan Tablets,two recommendations and eight consensus opinions were put forward. Through expert meetings and correspondence,a nationwide consultation and peer review was conducted. This consensus applies to clinicians in hospitals and grass-roots health services,to provide guidance and reference for the rational use of Hugan Tablets.


Assuntos
Medicamentos de Ervas Chinesas/uso terapêutico , Inflamação/tratamento farmacológico , Consenso , Humanos , Medicamentos sem Prescrição , Comprimidos
9.
Phytomedicine ; 54: 159-168, 2019 Feb 15.
Artigo em Inglês | MEDLINE | ID: mdl-30668365

RESUMO

BACKGROUND: Xueshuan-Xinmai-Ning Tablet (XXNT), a commercially available patent drug, has been extensively used in the treatment of coronary heart disease (CHD) with a satisfying therapeutic efficacy. The aim of this study was to explore the underlying pharmacological mechanisms of XXNT acting on CHD. STUDY DESIGN: An integrative pharmacology-based investigation was performed. METHOD: Putative targets of composite compounds contained in XXNT were predicted using the Drug Target Prediction Tool in the Computation Platform for Integrative Pharmacology of Traditional Chinese Medicine (TCMIP, www.tcmip.cn) and MedChem Studio. Then, an interaction network of XXNT putative targets-known CHD-related genes was constructed, and candidate XXNT targets related to its therapeutic effects on CHD were identified by calculating three major network topological features. Functional enrichment analysis was performed to investigate the specific functions and pathways involved by the candidate XXNT targets acting on CHD, which were further validated by in vitro experiments. RESULTS: A total of 742 putative targets hit 126 chemical components contained in XXNT were predicted. Following the construction of XXNT putative target-known CHD-related gene network, and the network topological feature calculation, we identified 51 candidate XXNT targets related to its therapeutic effects on CHD. Functionally, these candidate XXNT targets were significantly associated with various cardiovascular system-related pathways, sedation-related pathways, inflammatory and immune-related pathways and endocrine/metabolic system-related pathways. More importantly, the in vitro experiment validation confirmed the regulatory effects of XXNT in SRC, VEGF and VEGFR-1, which play roles in VEGF signaling pathway, based on the endothelial injury cell model. CONCLUSION: Our findings reveal that XXNT may attenuate the major pathological changes of CHD through regulating its candidate targets, which might be involved into the signal transductions in nervous-endocrine-immune-cardiovascular-metabolic system.


Assuntos
Doença das Coronárias/tratamento farmacológico , Doença das Coronárias/genética , Avaliação Pré-Clínica de Medicamentos/métodos , Medicamentos de Ervas Chinesas/química , Medicamentos de Ervas Chinesas/farmacologia , Redes Reguladoras de Genes/efeitos dos fármacos , Endotélio Vascular/efeitos dos fármacos , Células Endoteliais da Veia Umbilical Humana , Humanos , Peróxido de Hidrogênio/farmacologia , Medicina Tradicional Chinesa , Transdução de Sinais/efeitos dos fármacos , Comprimidos , Fator A de Crescimento do Endotélio Vascular/metabolismo , Receptor 1 de Fatores de Crescimento do Endotélio Vascular/genética , Receptor 1 de Fatores de Crescimento do Endotélio Vascular/metabolismo
10.
Chin J Integr Med ; 25(11): 861-866, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-28840586

RESUMO

OBJECTIVE: To analyze the composition rules of oral prescriptions in the treatment of headache, stomachache and dysmenorrhea recorded in National Standard for Chinese Patent Drugs (NSCPD) enacted by Ministry of Public Health of China and then make comparison between them to better understand pain treatment in different regions of human body. METHODS: Constructed NSCPD database had been constructed in 2014. Prescriptions treating the three pain-related diseases were searched and screened from the database. Then data mining method such as association rules analysis and complex system entropy method integrated in the data mining software Traditional Chinese Medicine Inheritance Support System (TCMISS) were applied to process the data. RESULTS: Top 25 drugs with high frequency in the treatment of each disease were selected, and 51, 33 and 22 core combinations treating headache, stomachache and dysmenorrhea respectively were mined out as well. CONCLUSIONS: The composition rules of the oral prescriptions for treating headache, stomachache and dysmenorrhea recorded in NSCPD has been summarized. Although there were similarities between them, formula varied according to different locations of pain. It can serve as an evidence and reference for clinical treatment and new drug development.


Assuntos
Analgésicos , Mineração de Dados/métodos , Desenvolvimento de Medicamentos/estatística & dados numéricos , Medicamentos de Ervas Chinesas , Medicina Tradicional Chinesa , Dor/tratamento farmacológico , Software , Administração Oral , Analgésicos/administração & dosagem , Analgésicos/classificação , Analgésicos/provisão & distribuição , China , Análise de Dados , Bases de Dados de Produtos Farmacêuticos , Aprovação de Drogas/legislação & jurisprudência , Desenvolvimento de Medicamentos/legislação & jurisprudência , Medicamentos de Ervas Chinesas/administração & dosagem , Medicamentos de Ervas Chinesas/classificação , Medicamentos de Ervas Chinesas/provisão & distribuição , Humanos , Medicina Tradicional Chinesa/estatística & dados numéricos , Manejo da Dor , Patentes como Assunto , Projetos de Pesquisa
11.
Chinese Pharmaceutical Journal ; (24): 1374-1379, 2019.
Artigo em Chinês | WPRIM (Pacífico Ocidental) | ID: wpr-857918

RESUMO

Calculus Bovis is the dry gall-stone of Bos taurus domesticus Gmelin, which is the most precious traditional Chinese medicine for its incomparable therapeutic effects. In vitro cultured Calculus Bovis,cultured Calculus Bovis and artificial Calculus Bovis are developed as the substitutes of Calculus Bovis. The Chinese Pharmacopoeia 2015 edition includes 89 Chinese patent drugs containing cow-bezoar and its substitutes. In this paper, the standards of Calculus Bovis and its substitutes in 89 Chinese patent drugs were reviewed to provide suggestions and reference for improving the relative standards. The qualities of Calculus Bovis and its substitutes of several Chinese patent drugs were summarized and analyzed based on the quality research of these drugs in recent years to offer suggestions for the revision of quality standards of relevant drugs and regulatory policy.

12.
Artigo em Inglês | WPRIM (Pacífico Ocidental) | ID: wpr-771441

RESUMO

OBJECTIVE@#To analyze the composition rules of oral prescriptions in the treatment of headache, stomachache and dysmenorrhea recorded in National Standard for Chinese Patent Drugs (NSCPD) enacted by Ministry of Public Health of China and then make comparison between them to better understand pain treatment in different regions of human body.@*METHODS@#Constructed NSCPD database had been constructed in 2014. Prescriptions treating the three pain-related diseases were searched and screened from the database. Then data mining method such as association rules analysis and complex system entropy method integrated in the data mining software Traditional Chinese Medicine Inheritance Support System (TCMISS) were applied to process the data.@*RESULTS@#Top 25 drugs with high frequency in the treatment of each disease were selected, and 51, 33 and 22 core combinations treating headache, stomachache and dysmenorrhea respectively were mined out as well.@*CONCLUSIONS@#The composition rules of the oral prescriptions for treating headache, stomachache and dysmenorrhea recorded in NSCPD has been summarized. Although there were similarities between them, formula varied according to different locations of pain. It can serve as an evidence and reference for clinical treatment and new drug development.

13.
Artigo em Chinês | WPRIM (Pacífico Ocidental) | ID: wpr-773206

RESUMO

Hugan Tablets is a Chinese patent medicine,it has the function of anti-inflammation and reducing transaminase. Based on questionnaire investigation of doctors and a systematic review of research literature on Hugan Tablets,using international clinical practice guidelines' developing methods,with the best available evidence and fully combining expert experience,and following the principle of " evidence-based,consensus-based and experience-based",Expert consensus statement on Hugan Tablets in clinical practice was developed by more than 30 multidisciplinary experts from the nationwide,aimed at guiding and standardizing the rational use of Hugan Tablets by clinicians and to improve clinical efficacy and safety. The expert consensus adopts internationally recognized recommendation criteria for classification of evidence: GRADE. The formation of expert consensus adopts the nominal group technique. Six main considerations are quality of evidence,curative effect,safety,economical efficiency,patient acceptability and other factors. If there is sufficient evidence,a " recommendation" is formed,using GRADE grid voting rule. If there isn' t sufficient evidence,a " consensus opinion" is formed,using majority counting rule. Focus on the indication,usage and dosage,drug use in special population and safety of Hugan Tablets,two recommendations and eight consensus opinions were put forward. Through expert meetings and correspondence,a nationwide consultation and peer review was conducted. This consensus applies to clinicians in hospitals and grass-roots health services,to provide guidance and reference for the rational use of Hugan Tablets.


Assuntos
Humanos , Consenso , Medicamentos de Ervas Chinesas , Usos Terapêuticos , Inflamação , Tratamento Farmacológico , Medicamentos sem Prescrição , Comprimidos
14.
Zhongguo Zhong Yao Za Zhi ; 41(15): 2932-2937, 2016 Aug.
Artigo em Chinês | MEDLINE | ID: mdl-28914040

RESUMO

To analyze the prescription rules of preparations containing Crataegi Fructus in the drug standards of the People's Republic of China Ministry of Public Health-Chinese Patent Drug(hereinafter referred to as Chinese patent drug), and provide some references for clinical application and the research and development of new medicines. Based on TCMISS(V2.5), the prescriptions containing Crataegi Fructus in Chinese patent drug were collected to build the database; association rules, frequency statistics and other data mining methods were used to analyze the disease syndrome, common drug compatibility and prescription rules. There were a total of 308 prescriptions containing Crataegi Fructus, involving 499 kinds of Chinese medicines, 34 commonly used drug combinations, and mainly for 18 kinds of diseases. Drug combination analysis was done with "Crataegi Fructus-Citri Reticulatae Pericarpium" and "Crataegi Fructus-Poria" as the high-frequency herb pairs and with "stagnation" and "diarrhea" as the high-frequency diseases. The results indicated that the Crataegi Fructus in different herb pairs had a roughly same function, and its therapy effect was different in different diseases. The prescriptions containing Crataegi Fructus in Chinese patent drug had the effect of digestion, and they were widely used in clinical application, often used together with spleen-strengthening medicines to achieve different treatment effects; the prescription rules reflected the prescription characteristics of Crataegi Fructus for different diseases, providing a basis for its clinically scientific application and the research and development of new medicines.


Assuntos
Crataegus/química , Medicamentos de Ervas Chinesas/normas , Asteraceae , China , Combinação de Medicamentos , Prescrições de Medicamentos , Humanos , Medicina Tradicional Chinesa
15.
Artigo em Chinês | WPRIM (Pacífico Ocidental) | ID: wpr-853113

RESUMO

It is of great importance to bring proprietary Chinese medicines to EU as its herbal medicinal product is world-leading, yet the current status for registrations from China is full of challenges. The routes for registration of herbal medicinal products are introduced at first and then the current registration status on the overall assessment of the products, the characteristics of combinations, the utilization of EU monograph and main indications are analyzed. Suggestions on registering proprietary Chinese medicines are made in the end.

16.
Artigo em Chinês | WPRIM (Pacífico Ocidental) | ID: wpr-258439

RESUMO

To analyze the prescription rules of preparations containing Crataegi Fructus in the drug standards of the People's Republic of China Ministry of Public Health-Chinese Patent Drug(hereinafter referred to as Chinese patent drug), and provide some references for clinical application and the research and development of new medicines. Based on TCMISS(V2.5), the prescriptions containing Crataegi Fructus in Chinese patent drug were collected to build the database; association rules, frequency statistics and other data mining methods were used to analyze the disease syndrome, common drug compatibility and prescription rules. There were a total of 308 prescriptions containing Crataegi Fructus, involving 499 kinds of Chinese medicines, 34 commonly used drug combinations, and mainly for 18 kinds of diseases. Drug combination analysis was done with "Crataegi Fructus-Citri Reticulatae Pericarpium" and "Crataegi Fructus-Poria" as the high-frequency herb pairs and with "stagnation" and "diarrhea" as the high-frequency diseases. The results indicated that the Crataegi Fructus in different herb pairs had a roughly same function, and its therapy effect was different in different diseases. The prescriptions containing Crataegi Fructus in Chinese patent drug had the effect of digestion, and they were widely used in clinical application, often used together with spleen-strengthening medicines to achieve different treatment effects; the prescription rules reflected the prescription characteristics of Crataegi Fructus for different diseases, providing a basis for its clinically scientific application and the research and development of new medicines.

17.
J Pharm Biomed Anal ; 102: 1-8, 2015 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-25222137

RESUMO

Shuang-Huang-Lian oral liquid (SHL) is a well-known Chinese patent drug containing three herbal medicines: Radix Scutellariae, Flos Lonicerae Japonicae and Fructus Forsythiae. It is usually used to treat acute upper respiratory tract infection caused by virus or bacteria. Although the licensing of botanical drug Veregen approved by FDA has indicated the importance of quantitative analysis in quality control of herbal medicines, quantitative evaluation of a Chinese patent drug like SHL remains a challenge due to the complex chemical profile. In this study, 15 small molecular components of SHL (four flavonoids, six quinic acid derivatives, three saponins and two phenylethanoid glycosides) were simultaneously determined using ultra-high performance liquid chromatography coupled with quadrupole-time-of-flight mass spectrometry (UHPLC-Q-TOF-MS). The contents of the three major saccharides, namely fructose, glucose and sucrose were quantified using high performance liquid chromatography-evaporative light scattering detector on an amino column (HPLC-ELSD). The macromolecules were quantified by precipitating in 80% ethanol, drying the precipitate, and then weighing. The established methods were validated in terms of linearity, sensitivity, precision, accuracy and stability and then successfully applied to analyze 12 batches of commercial products of SHL produced by four different manufacturers. The results indicated that 57.52-78.11% (w/w) of SHL could be quantitatively determined (non-saccharide small molecules: 1.77-3.75%, monosaccharides: 0.93-20.93%, macromolecules: 2.63-5.76% and sucrose: 49.20-65.94%). This study may provide a useful way to comprehensively evaluate the quality of SHL.


Assuntos
Medicamentos de Ervas Chinesas/análise , Medicamentos de Ervas Chinesas/química , Flavonoides/análise , Glicosídeos/análise , Ácido Quínico/análise , Saponinas/análise , Cromatografia Líquida de Alta Pressão , Forsythia/química , Lonicera/química , Espectrometria de Massas , Estrutura Molecular , Ácido Quínico/análogos & derivados , Scutellaria baicalensis/química
18.
Artigo em Chinês | WPRIM (Pacífico Ocidental) | ID: wpr-462053

RESUMO

Objective To put forward suggestions for improving the writing standards of package inserts of Chinese patent drug in China. Methods Totally 84 package inserts of Chinese patent drug were chosen randomly. The labeled items in them would be investigated and analyzed according to legal documents in China. Results The rate of complete labeled items was 0%. Meanwhile, many problems existed in the items which affected medication safety seriously. In addition, there were defects in expression of the content, revision of package inserts of Chinese patent drug and so on. Conclusion It is urgent to improve the writing standards and the completeness of the labeled items as well as the scientificalness on the expressions of package inserts of Chinese patent drug.

19.
Artigo em Chinês | WPRIM (Pacífico Ocidental) | ID: wpr-854710

RESUMO

To analyze the problems in the essential medicine of Chinese materia medica (CMM) in China and make the corresponding suggestions to provide a reference for the improvement of our characterized essential medicine list of CMM. By reviewing literatures, we learnt from foreign experience and analyzed the current situation of the essential medicine of CMM, stated the five primary problems existing in the part of the national essential medicine list of CMM, and proposed the suggestions. The problems are as follows: selection of the list in CMM is more based on the expertise with subjective factors; The proportion of the list in Chinese patent drug (CPD) is not clear; The access to the essential medicines of CMM is poor; There are many security risks with the quality of CMM injections and the prominent phenomenon of irrational use in CMM. The suggestions are as follows: to strengthen the evidence-based decision-making, improve the scientificity of the evidence in selecting the essential medicine of CMM, definite the proportion of the CPD in the list as soon as possible, strengthen the equipment and use of essential medicines of CMM, strengthen the ADR's monitoring and reevaluation of CMM injections, strengthen the guidance and advocacy of CMM, and reduce irrational drug use as well.

20.
China Pharmacy ; (12)2007.
Artigo em Chinês | WPRIM (Pacífico Ocidental) | ID: wpr-529848

RESUMO

OBJECTIVE:To offer references for clinical rational use of Chinese patent drugs. METHODS:The basic theory of Chinese medicine was applied to analyze the current common problems encountered by western medicine physicians in the use of Chinese patent drugs. RESULTS & CONCLUSION:In the clinical use of Chinese patent drugs, the western medicine physicians should give consideration of the specific condition and get a detailed knowledge of drug constituents and the related clinical data as well as strictly follow the specification of drug package inserts.

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