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Indigo naturalis: Qingdai, a TCM monograph proposed for the European Pharmacopoeia (Ph. Eur.)

van der Sluis, W ; Toren, J ; van Alphen, C ; de Kaste, D

Planta Medica, 2007, Vol.73 (9) [Periódico revisado por pares]

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  • Título:
    Indigo naturalis: Qingdai, a TCM monograph proposed for the European Pharmacopoeia (Ph. Eur.)
  • Autor: van der Sluis, W ; Toren, J ; van Alphen, C ; de Kaste, D
  • É parte de: Planta Medica, 2007, Vol.73 (9)
  • Descrição: Indigo naturalis is one of the TCM monographs from the Chinese Pharmacopoeia proposed by the European Pharmacopoeia Commission to include in the Ph. Eur. [1]. It is prepared from the leaves or stems of Baphicacanthus cusia (Nees) Bremek., Persicaria tinctoria (Aiton) Spach., Isatis tinctoria L. or Indigofera tinctoria L. after fermenting. Content : minimum 2.0 per cent of indigo (C 16 H 10 N 2 O 2 ; M r 262.3) and minimum 0.13 per cent of indirubin (C 16 H 10 N 2 O 2 ; M r 262.3) (dried drug). Several indigo samples, including very old samples from Java (Indonesia) have been analysed by means of TLC and HPTLC and most proved to fulfil the requirements. Proposed TLC : Test solution : To 0,5g of the powdered drug (355) add 25ml chloroform R. Sonicate during 30min and filter. Reference solution : Dissolve 1mg of indigo R and 1mg of indirubin R in 5ml of chloroform R. Plate : TLC silica gel plate R (5–40µm [or TLC silica gel plate R 2–10µm]. Mobile phase : acetone R, chloroform R, light petroleum R (5:15: 30 V/V/V). Application : 20µl as bands of 10mm [or 10µl as bands of 7mm]. Development : over a path of 6cm [or 3cm]. Detection : immediately after development in daylight because of the instability of blue indigo colour. HPLC : Test solution . To 25.00mg of the powdered drug add 25ml chloroform R and sonicate for about 10min and add methanol R to 50.00ml and filter. Reference solution : Dissolve 1.000mg indigo CRS in 50.00ml chloroform R and sonicate for about 10min and add methanol R to 100.00ml and filter. The same for indirubin CRS. Prepare the solutions immediately before use. Column : – size : l =0.125m, Ø=4mm, – stationary phase : octadecylsilyl silica gel for chromatography R (5µm ) . Mobile phase . water R, methanol R (34:66 V/V ). Flow rate: 1.0ml/min. Detection : spectrophotometer at 290 nm. Injection : 10µl. Acknowledgements: Dr Riepl, TU München for the indirubin sample. References: [1] Pharmeuropa 19.3 (2007)
  • Idioma: Alemão;Inglês

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