Study on the quality standard of Tudihailingjian Granules.
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Background: Organic acids (malic, citric, tartaric, oxalic, acetic, formic, isovaleric, ascorbic acids) make up a large group of biologically active substances and play an important role in plant and human metabolism. They are found in large quantities in the fruits of Rosaceae family medicinal plants that included in State Pharmacopoeia of the Russian Federation. Standardization of crude herbal drugs containing organic acids by modern physicochemical methods is a high-priority task. Materials and Methods: The determination of total organic acids amount was carried out in aqueous extracts from different fruits of Rosaceae family plants by galvanostatic coulometry and potentiometry methods. Galvanostatic coulometry was performed with the help of the “Expert-006” coulometer with a current of 5 mA (integrated pH meter). Iodine as an electrogenerated titrant was used for ascorbic acid determination; electro generation of hydroxide ions was carried out for determination of total organic acids amount. A potentiometer “Aquilon pH-410” with attached glass and silver chloride electrodes was used for potentiometric determination of total organic acids amount. Individual organic acids have been determined by reverse-phase high-performance liquid chromatography with ultra-violet detection (RP-HPLCUV) method. The following conditions were established: Gilson HPLC system, Alltech OA- 1000 Organic Acids (6.5×300 mm, 9 μm) chromatography column, a gradient elution mode, component A of the mobile phase is 98% (0.1% phosphoric acid, 10 mM KH2PO4, solution in water) with 2% acetonitrile, component B is acetonitrile, the eluent feed rate is 1 ml/min. Results: Modern physicochemical methods for the analysis of biologically active substances, organic acids, for quality control of crude herbal drugs and medicinal herbal preparations, are developed and discussed. The optimal conditions for the qualitative and quantitative organic acid analysis are selected and described taking into account modern pharmacopoeial requirements. Conclusion: Galvanostatic coulometry and potentiometry methods, as well as RP-HPLC-UV, can be successfully used in the quality control of crude herbal drugs and medicinal herbal preparations, specifically fruits of Rosaceae family plants. Development and validation of analytical methods for monitoring the content of this BAS group is an important research area in the pharmacopoeial standardization of crude herbal drugs.
Coulometry
Daminozide
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Pill
Quality standard
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Content determination
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Quality standard
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Background and Objective: Taohongsiwu decoction, a traditional Chinese medicine formula has been widely developed to treat thrombotic diseases for hundreds of years.It contains variations of multi-components, which pose a serious challenge to its quality control.This study aimed to develop a simple and reliable ultra high performance liquid chromatography coupled with diode array detector method to separate and detect the constituents of the decoction.Materials and Methods: A total of 15 compounds was detected and 6 compounds (including ferulic acid, hydroxysafflor yellow a, ligustilide, amygdalin, 5-hydroxymethyl furfuraldehyde and paeoniflorin) were tentatively identified, using high performance liquid chromatography coupled with diode array detector method.Results: The four components (Ferulic acid, hydroxysafflor yellow a, ligustilide, amygdalin) showed good regression (R>0.9996)within test ranges and the recovery method ranged from 101.73-106.44%.Ten batches of taohongsiwu decoction were analyzed.The similarity scores of common peaks from these samples ranged from 0.957-1.000,which indicating that samples were highly correlated.Conclusion: It is concluded that this extraction method was found to be sensitive and simple, so it was feasible for comprehensive quality control of THSWD.
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