Physicochemical variables and real time stability of the herbal substance of Niprd-AM1®- an antimalarial developed from the root of Nauclea latifolia S.M. (Rubiaceae).

Authors

  • Sunday Ameh Department of Medicinal Chemistry and Quality Control, National Institute for Pharmaceutical Research and Development (NIPRD), PMB 21, Garki, Idu Industrial Area, Abuja, Nigeria.
  • Obiageri Obodozie Department of Medicinal Chemistry and Quality Control, National Institute for Pharmaceutical Research and Development (NIPRD), PMB 21, Garki, Idu Industrial Area, Abuja, Nigeria.
  • Shingu Gamaniel Department of Medicinal Chemistry and Quality Control, National Institute for Pharmaceutical Research and Development (NIPRD), PMB 21, Garki, Idu Industrial Area, Abuja, Nigeria.
  • Mujitaba Abubakar Department of Pharmacognosy and Drug Development, Ahmadu Bello University, Zaria.
  • Magaji Garba epartment of Pharmaceutical and Medicinal Chemistry, Ahmadu Bello University, Zaria.

Keywords:

Niprd-AM1, Nauclea latifolia, Antimalarial, Physicochemical, Stability, Good pharmaceutical practice (GXP)

Abstract

The evidence for using the root of Nauclea latifolia S.M. (Rubiaceae) in treating malaria in Africa; and the development of Niprd AM1, as an antimalarial phytomedicine from it, are reviewed. This study aimed at paving the way for the registration and controlled production of Niprd-AM1, which was developed by National Institute for Pharmaceutical Research and development (NIPRD), Abuja, Nigeria. The study applied official procedures to authenticate and evaluate the changes that occur during normal storage in the physicochemical variables of the herb and extract. The herb contained alkaloids, saponins, terpenoids, but cardiac and cyanogenic glycosides and anthraquinones were not detected. Heavy metal presence was well below the limits allowed. Most of the quality variables evaluated, including TLCs, remained largely unchanged up to the 39 month of storage, but a few began to decline as from the 21st month. The results are consistent with NIPRD’s intention to regularize the production and use of Niprd-AM1 according to good pharmaceutical practice (GXP), and suggest that the dried herb and extract are stable under tropical room conditions for over a year in sealed glass containers.

References

Snow RW, Guerra CA, Noor AM, Myint HY,

Hay SI. The global distribution of clinical

episodes of Plasmodium falciparum malaria.

Nature 2005, 434 (7030): 214–7.

Ransome-Kuti O. Address by the Honorable

Minister of Health and human Services. In:

Rational use of antimalarial drugs. Ed. Obi,

C. C., as: Proceedings of the National

workshop organized by the Federal Ministry

of Health and Human Services and May and

Baker Nigeria Plc, at Banquet Hall, Lagos

Airport Hotel, Ikeja, on May 21, 1992.

Lamidi M, Ollivier E, Faure R. Debrauwer L,

Nze-Ekekang L, Balansard G. Quinovic acid

glycosides from Nauclea diderichii. Planta

Med. 1995, 61:280–281.

Benoit-Vical F, Valentin A, Cournac V,

Pélissier Y, Mallié M, Bastide J. In vitro

antiplasmodial activity of stem and root

extracts of Nauclea latifolia S.M.

(Rubiaceae). J. Ethnopharmacol. 1998, 61 (3):

-178.

Onyeyili PA, Nwosu CO, Amin JD, Jibike

JI. Anthelmintic activity of crude aqueous

extract of Nauclea latifolia stem bark against

ovine nematodes. Fitoterapia 2001, 72(1):

-21.

Abreu P, Pereira A. New indole alkaloids

from Sarcocephalus latifolius. Natural

Product Letters 2001, 15 (1):43-48.

Gamaniel K. A comparative randomized

clinical trial of NIPRD AM1 against a

chloroquine and sulphadoxine/pyrimethamine

combination in symptomatic but

uncomplicated malaria. African Journal of

Traditional, Complementary and Alternative

medicines (AJTCAM), Abstracts of the World

Congress on Medicinal and Aromatic Plants,

Cape Town, November 2008.

WHO. Quality Control Methods for

Medicinal Plant Materials. WHO, Geneva;

128 p.

Harborne JB. Phytochemical Methods. 2nd

Edition. Chapman and Hall, London and New

York. ISBN 0-412-25550-2. 1984. 288 p

Onwukaeme DN, Ikuegbvweha TB, Asonye CC.

Evaluation of Phytochemical Constituents,

Antibacterial Activities and Effect of Exudate of

Pycanthus Angolensis Weld Warb

(Myristicaceae) on Corneal Ulcers in Rabbits.

Trop. J. Pharm. Res. 2007, 6 (2): 725-730.

Obodozie OO, Ameh SJ, Afolabi E. K., Oyedele

EO, Ache TA, Onanuga CE, Ibe MC, Inyang US.

Standardization of the components of Niprisan: a

phytomedicine for treating sickle cell disease. J.

Med. Plants Res. 2009, 3(4): 284-289.

Downloads

Published

30-09-2010

How to Cite

1.
Sunday Ameh, Obiageri Obodozie, Shingu Gamaniel, Mujitaba Abubakar, Magaji Garba. Physicochemical variables and real time stability of the herbal substance of Niprd-AM1®- an antimalarial developed from the root of Nauclea latifolia S.M. (Rubiaceae). ijp [Internet]. 2010 Sep. 30 [cited 2024 Dec. 23];2(3):332-40. Available from: https://ijp.arjournals.org/index.php/ijp/article/view/54

Issue

Section

Original Research Articles