European Pharmacopoeia Monographs on Herbal Drugs used in Traditional Chinese Medicines - An Update from the European Directorate for the Quality of Medicines

Planta Medica ◽  
2012 ◽  
Vol 78 (05) ◽  
Author(s):  
M Wierer
Planta Medica ◽  
2017 ◽  
Vol 84 (06/07) ◽  
pp. 449-456 ◽  
Author(s):  
Jinjun Hou ◽  
Ruihong Feng ◽  
Yibei Zhang ◽  
Huiqin Pan ◽  
Shuai Yao ◽  
...  

AbstractIt remains a challenge to establish new monographs for herbal drugs derived from multiple botanical sources. Specifically, the difficulty involves discriminating and quantifying these herbs with components whose levels vary markedly among different samples. Using Uncaria stem with hooks as an example, a characteristic chromatogram was proposed to discriminate its five botanical origins and to quantify its characteristic components in the chromatogram. The characteristic chromatogram with respect to the components of Uncaria stem with hooks with the five botanical origins was established using 0.02% diethylamine and acetonitrile as the mobile phase. The total analysis time was 50 min and the detection wavelength was 245 nm. Using the same chromatogram parameters, the single standard to determine multicomponents method was validated to simultaneously quantify nine indole alkaloids, including vincosamide, 3α-dihydrocadambine, isocorynoxeine, corynoxeine, isorhynchophylline, rhynchophylline, hirsuteine, hirsutine, and geissoschizine methyl ether. The results showed that only the Uncaria stem with hooks from Uncaria rhynchophylla, the most widely used in the herbal market, showed the presence of these nine alkaloids. The conversion factors were 1.27, 2.32, 0.98, 1.04, 1.00, 1.02, 1.26, 1.33, and 1.25, respectively. The limits of quantitation were lower than 700 ng/mL. The total contents of 31 batches of Uncaria stem with hooks were in the range of 0.1 – 0.6%, except for Uncaria hirsuta Havil and Uncaria sinensis (Oliv.) Havil. The results also showed that the total content of indole alkaloids tended to decrease with an increase in the hook diameter. This showed that the characteristic chromatogram is practical for controlling the quality of traditional Chinese medicines with multiple botanical origins.


2013 ◽  
Vol 44 ◽  
pp. 39-45 ◽  
Author(s):  
Jing Jing ◽  
Harendra S. Parekh ◽  
Ming Wei ◽  
Wei Chao Ren ◽  
Si Bao Chen

2017 ◽  
Vol 12 (9) ◽  
pp. 1934578X1701200
Author(s):  
Shu-Chao Yan ◽  
Jie Ma ◽  
Qian-Qian Huang ◽  
Ana Mani ◽  
Ya-ling Cai ◽  
...  

Pueraria lobata, Salvia miltiorrhiza and Panax notoginseng are traditional Chinese medicines which have been used for thousands of years either singly or in combination. However, the quality of formulas containing either all or part of the three herbs is, at present, controlled by only one or two easily detectable compounds.. A rapid resolution liquid chromatography (RRLC) method has been developed for the quality control of the three herbs in combination through ten active ingredients originating from the raw herbs. The analysis was achieved in a run of less than 25 minutes. Using the same method, the finger-prints of the three herbs are detectable in the chromatogram, and so the method could be applied for identification of different species in the same genus. Four formula preparations {xinkeshu capsule (XKSC), xinkeshupian (XKSP), fufang-danshenpian (FFDSP), and naodeshengpian (NDSP)} were analyzed by this new RRLC method. Controlling only one or two easily detectable ingredients is far from enough to assure the quality of the formula preparations. However, controlling multiple ingredients originating from the raw herbs and their ratios is an effective and feasible approach to solve this problem.


2020 ◽  
Author(s):  
Nan Yang ◽  
Huihui Zhang ◽  
Taoyi Deng ◽  
Ming Hu

Abstract Background: This study aimed to describe the current situation of the published Pharmacoeconomic researches on Traditional Chinese Medicine and evaluate the quality of the researches to analyze existing problem and make suggestions for improvement.Methods: We developed a search strategy, set inclusion and exclusion criteria and searched the articles of Pharmacoecnomic studies on Traditional Chinese Medicine from CNKI, VIP, Wanfang, Sinomed database and Pubmed from their inception to February 2020. Basic information of the literatures was extracted. Then quality of each article was evaluated by using Guidelines for authors and peer reviewers of economic submissions to the BMJ.Results: 430 articles with 433 pharmacoeconomics studies were included. And the information of time of publication, journal, author, funding, diseases, interventions, research design, evaluation methods, cost identification, health outcomes, uncertainty analysis and so on. The overall quality score of the literatures was 0.62 according to the evaluation standard of BMJ guidelines. The highest mark was 0.85 and the lowest mark was 0.38.Conclusions: Quality of pharmacoeconomic studies on traditional Chinese medicines was generally low.There were some problems in the published pharmacoeconomic articles, such as lack of fund support, short research horizon, unclear perspective and research design, misidentification of cost, poor comparability of health outcome and so on. We suggested to develop guidelines for pharmacoeconomic evaluation on Traditional Chinese Medicine to standardize the research procedure and establish reasonable health outcome indicators of Traditional Chinese Medicine to enhance comparability and generalization of studies.


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