Quality Control Tests on &lt;i&gt;Andrographis paniculata Nees&lt;/i&gt; (Family: Acanthaceae) – an Indian ‘Wonder’ Plant Grown in Nigeria

Ameh, Sunday J.; Obodozie, Obiageri O.; Inyang, Uford S.; Abubakar, M.S.; Garba, M.

doi:10.4314/tjpr.v9i4.58937

Cited by 15 publications

(15 citation statements)

References 9 publications

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“…Basic morphological studies were carried out as per WHO (1998). Appropriate phytochemical tests were also conducted by official methods as described elsewhere (Ameh et al, 2010c;2010d).…”

Section: Methodsmentioning

confidence: 99%

Herbal Drug Regulation Illustrated with Niprifan® Antifungal Phytomedicine

Ameh¹,

Obodozie²,

Abubakar³

et al. 2011

Modern Approaches to Quality Control

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“…Basic morphological studies were carried out as per WHO (1998). Appropriate phytochemical tests were also conducted by official methods as described elsewhere (Ameh et al, 2010c;2010d).…”

Section: Methodsmentioning

confidence: 99%

Herbal Drug Regulation Illustrated with Niprifan® Antifungal Phytomedicine

Ameh¹,

Obodozie²,

Abubakar³

et al. 2011

Modern Approaches to Quality Control

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“…Tests for secondary metabolites (phytochemicals) may be performed according to standard procedures as described elsewhere. Such tests, as described and applied elsewhere [10][11][12][13][14][15]…”

Section: Examination Of Fresh or Air-dried Materialsmentioning

confidence: 99%

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2012

IJPSR

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Background: Following the Alma-Ata Declaration of 1978, the World Health Organization (WHO) began the issuance of guidelines for developing standardized herbal preparations from Traditional Medicine (TM). Similarly in 1987, the International Organization for Standardization (ISO) launched the most anticipated industrial standard (ISO 9001) in world history. The seventh (7 th ) clause of ISO 9001's eight clauses is devoted to "Product Realization"-a quality management system (QMS) procedure that includes: planning of product realization; appreciation of customer-related processes; design and development processes; purchasing; production and service provision; and control of measuring and monitoring equipment. Purpose: The article takes a hard look at the QMS processes involved in product realization and the critical stages of the WHO model of herbal drug development from TM, with a view to devising a framework that can be used to promote the production of quality herbal products, commencing from the stage of ethnobotanical survey, through the laboratory, to the clinic. Methodology: Both the WHO model of herbal drug development and the 7 th clause of ISO 9001:2008 were critically reviewed and combined to yield a framework that is discussed within the context of guiding herbal drug development from TM. Results and Discussion: The resulting WHO-ISO framework of herbal product realization is discussed in terms of its relevance to practical problems of GMP-production using herbal starting materials, given their innate variability in composition, potency and appearance. Conclusion: The provisions of ISO 9001's seventh clause can, to a large extent, be applied to the production of quality herbal products developed in accordance with WHO.

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“…The plant is domesticated at the National Institute for Pharmaceutical Research and Development (NIPRD), Abuja Nigeria with a seed obtained from India in the 1990s. Its use was popular among HIV patients under the name Conavir before anti-HIV drugs became readily available (Ameh et al, 2010). The aqueous freeze-dried leaves extract of Andrographis paniculata (NIPRD-AH1) is being developed at NIPRD as immune-stimulant for Human Immune Virus (HIV) infected patients.…”

Section: Introductionmentioning

confidence: 99%

<i>In vitro</i> screening of NIPRD-AH1 on CYP3A4 activity for plausible herb-drug interaction

Adzu¹,

Mustapha²,

Thelingwani³

et al. 2015

Int. J. Bio. Chem. Sci

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NIPRD-AH1 is being developed from freeze-dried aqueous extract of Andrographis paniculata at the National Institute for Pharmaceutical Research and Development (NIPRD), Abuja Nigeria as immunestimulant for HIV infected patients. The aim of this study was to evaluate the effect of NIPRD-AH1 on human cytochrome P450 3A4 (CYP3A4) drug metabolising enzyme in order to generate clinically significant data for its safe and efficacious use. Activity on CYP3A4 was measured with and without the addition of NIPRD-AH1 in a reaction medium with testosterone (70 µM) as CYP3A4 substrate, and ketoconazole (2.5 µM) as positive inhibitor. The metabolites formed after the enzymatic reactions were quantified by validated HPLC techniques. Results showed NIPRD-AH1 exhibiting low IC 50 value of 0.03 mg/ml, indicating that its metabolic processes are likely to inhibit CYP3A4. This suggests possibility of herb-drug interaction, with potential implication on concomitant administration of NIPRD-AH1 with CYP3A4 substrates. We therefore suggested that this effect be examined in vivo in order to draw a definitive conclusion.

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Quality Control Tests on <i>Andrographis paniculata Nees</i> (Family: Acanthaceae) – an Indian ‘Wonder’ Plant Grown in Nigeria

Cited by 15 publications

References 9 publications

Herbal Drug Regulation Illustrated with Niprifan® Antifungal Phytomedicine

Herbal Drug Regulation Illustrated with Niprifan® Antifungal Phytomedicine

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<i>In vitro</i> screening of NIPRD-AH1 on CYP3A4 activity for plausible herb-drug interaction

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