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Comparison of Granules for Prescription and Classical Decoctions by High-performance Thin-layer Chromatography-fingerprint Analysis

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World Journal of Traditional Chinese Medicine 2018年第1期4卷 1-7页

作者： Katharina Schiller Jorg Heilmann Detlef Manns Gerhard Franz Department of Pharmaceutical Biology Institute of PharmacyUniversity of Regensburg Federal Institute for Drugs and Medicinal Devices(BfArM)

Objective: The so?called granules for prescription have been developed about 20 years ago as a new form of modernizing and simplification of the classical decoction common in Traditional Chinese Medicine (TCM) practice. Due to actual problems in Germany/Europe, which are caused by the lack of quality monographs and judicial classification of granules for prescription, the aim of the study was a comparison of the chemical composition of commercial granules versus decoctions. Taking an example, decoctions, commercial granules, and organic extracts of two well?established TCM herbal drugs, Scrophulariae Radix and Xanthii Fructus, were examined in their specific composition. Methods: Using high?performance thin?layer chromatography (HPTLC) for fingerprint analysis of different batches of herbal drugs and samples from various suppliers of Xanthii Fructus and Scrophulariae Radix were critically examined. The decoctions were prepared according to traditional rules, while the granules were dissolved in water in accordance with actual regulations. Furthermore, organic extracts of the plant material were examined and compared with aqueous extracts. Results: It could be demonstrated, that in some cases, there are remarkable differences in the specific composition between granules from different suppliers, the classical aqueous decoction and the organic extract used for the HPTLC fingerprinting. On the other hand, few examples exist for good comparability of decoctions and commercial granules. Conclusion: After critical evaluation of the above results, it can be questioned, if there is a so?called phytoequivalence between decoctions and commercial granules for prescription used in TCM practice.

关键词： Granules for prescription phytoequivalence quality control quality monographs Scrophulariae Radix Xanthii Fructus

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Efficacy and tolerability of hydrogen carbonate-rich waterfor heartburn

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World Journal of Gastrointestinal Pathophysiology 2016年第1期7卷 171-180页

作者： andré-michael beer ralf uebelhack ute pohl Klinik Blankenstein Ruhr-Universität Bochum45527 HattingenGermany Analyze and Realize GmbH 13456 BerlinGermany

AIM To investigate the efficacy and safety of mineralwater with a high content of hydrogen carbonate inpatients with ***： This open, single-center, single-armclinical pilot study enrolled 50 patients, 18-64 yearsold, who had been suffering from heartburn at leasttwice a week for at least 3 mo before entering thestudy. Pharmacological treatment of heartburn was notpermitted, and patients with severe organic diseaseswere excluded. After a run-in period of one week, theparticipants received 1.5 L of the test water for thefollowing 6 wk; 300 mL with meals t.i.d., the remainderto be drunk throughout the day. During the trial, therewere five visits at the study center （screening, baseline,two interim visits and the final visit）. The efficacyendpoints included incidence and duration of heartburnepisodes per week by patient＇s self-assessment （heartburndiary） as well as changes in symptom severity asper symptom specific questionnaires [Reflux Disease Questionnaire （RDQ）; Quality of Life in Reflux andDyspepsia （QOLRAD）; Gastrointestinal Quality of LifeIndex] and overall health-related quality of life per SF-12（12-question short form） at each visit. At the end of thestudy, patients and investigators independently ratedthe overall efficacy of the test water on a 4-point Likertscale. Safety was assessed by evaluation of adverseevents （AEs）, vital signs （heart rate, blood pressure）and laboratory parameters. Changes from initial to finalexaminations were assessed by the non-parametricWilcoxon test; categorical variables were comparedusing the χ 2 test, and for more than 5 categories, by ***： Twenty-eight participants were men, 22women. The mean age of the patients in the fullanalysis set/intention-to treat population （FAS/ITT） was40.6 years. Forty-two participants completed the studyaccording to the study protocol and formed the perprotocolset （PP population）; 48 participants drank thewater at least once as requested and were analyzedas ITT population.

关键词： Heartburn Hydrogen carbonate-rich mineralwater Open clinical pilot study Patients Regurgitation Gastroesophageal reflux disease symptoms Dyspepsia Blood pressure Tolerability Quality of life

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