Realgar/Indigo naturalis

Realgar/Indigo naturalis (RIF), also known as Compound Huangdai (复方黄黛), is a medication used to treat acute promyelocytic leukemia.[1] Effectiveness appears similar to arsenic trioxide.[1] It is generally used together with all-trans-retinoic acid (ATRA).[1] It is taken by mouth.[2]

Realgar/Indigo naturalis
Combination of
RealgarArsenic compound
Indigo naturalisTraditional Chinese medicine
Clinical data
Other namesRealgarIndigo naturalis formulation (RIF); Compound Huangdai
Routes of
administration
By mouth
ATC code
Legal status
Legal status
  • US: Not FDA approved

Side effects may include abdominal pain and rash.[1] It is made up of a combination of realgar (tetra-arsenic tetra-sulfide), Indigo naturalis, root of Salvia miltiorrhiza, and root of Pseudostellaria heterophylla.[1] It works by breaking down the cancer protein retinoic acid receptor alpha. The main active ingredients according to NCI are tetraarsenic tetrasulfide (realgar), indirubin (from the indigo) and tanshinone IIA (from the Salvia).[3]

Realgar-Indigo naturalis was developed in the 1980s and approved for medical use in China in 2009.[1][4] It is on the World Health Organization's List of Essential Medicines.[2] It is made in China and was originally a herbal remedy.[1] It is not approved in either the United States or Europe as of 2019.[1]

Composition

WHO data indicates that the medication is provided in units of 270 mg of the mixture, 30 mg of which is tetraarsenic tetrasulfide (As4S4).[5] The 2004 Chinese patent for this medication indicates that it contains 12-18% realgar (90-95% As4S4), 25-42% Indigo naturalis, 36-46% Salvia miltiorrhiza root (separately water-extracted), and 12-18% Pseudostellaria heterophylla root.[6]

References

  1. Howard SC. "Proposal for the inclusion of arsenic therapies in the WHO Model list of ESSENTIAL MEDICINES for the treatment of acute promyelocytic leukemia" (PDF). WHO. Archived from the original (PDF) on 9 March 2022. Retrieved 15 November 2019.
  2. World Health Organization (2019). World Health Organization model list of essential medicines: 21st list 2019. Geneva: World Health Organization. hdl:10665/325771. WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.
  3. "realgar-Indigo naturalis formulation". National Cancer Institute. 2 February 2011. Retrieved 15 November 2019.
  4. Ghosh D, Smarta RB (2016). Pharmaceuticals to Nutraceuticals: A Shift in Disease Prevention. CRC Press. p. PT41. ISBN 9781315354934.
  5. "Realgar-indigo naturalis formulation". eEML - Electronic Essential Medicines List.
  6. "Chinese medicine preparation compound Huangdai tablet for treating leukemia and its jpreparing method". Google Patents. 11 June 2008.

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