Formes galéniques

Artemisia afra Jacq.

Cet article regroupe les publications consacrées aux formes pharmaceutiques d’Artemisia afra Jaq.

Formes galéniques

Artemisia afra Jacq.

2016

A. Dube
The Design, Preparation and Evaluation of Artemisia Afra and Placebos in Tea Bag Dosage Form Suitable for Use in Clinical Trials
A thesis submitted in partial fulfilment of the requirements for the degree of Magister Pharmaceuticiae in the School of Pharmacy, University of the Western Cape, Bellville, South Africa. June 2006

Abstract:

Artemisia afra, a popular South African traditional herbal medicine is commonly administered as a tea infusion of the leaves. However, clinical trials proving its safety and efficacy are lacking mainly due to the absence of good quality dosage forms and credible placebos for the plant.

The objectives of this study were to prepare a standardized preparation of the plant leaves and freeze-dried aqueous extract powder of the leaves, in a tea bag dosage form and to design and prepare credible placebos for these plant materials. It was hypothesised that the intra-batch variation in the plant flavonoid constituents would be lower in the standardized A. afra leaves and freeze-dried aqueous extract powders compared to the traditionally used non-standardized leaves, that the tea bag would be a pharmaceutically suitable dosage form for the traditionally used plant leaves, that the infusion profiles of luteolin (the flavonoid marker), from the tea bag would be similar to that of the loose leaves traditional form and that credible placebos for the plant materials devoid of pharmacological activity could be prepared.

To realise the objectives, different batches of plant materials were blended and an aqueous decoction and freeze-drying method used to prepare the standardized leaves and freeze-dried aqueous extract powder of the plant leaves, respectively. These plant materials were packed in 36cm2 tea bags which were pharmaceutically evaluated using the European Pharmacopoeia criteria, subjected to stability testing and their infusion profiles determined using the British Pharmacopoeia dissolution apparatus I (basket) and a modification of the BP apparatus II (paddle) incorporating a holding cell, for the loose leaves and the tea bag preparations, respectively, and the infusion profiles compared using the f1 and f2 mathematical method. The A. afra leaves were exhaustively solvent extracted and inert in-organic salts blended to prepare the placebos for the leaves and freeze-dried aqueous extract powder, respectively. Finally, the placebos were evaluated for lack of pharmacological activity using the isolated guinea pig tracheal muscle preparation.
The A. afra standardized dried leaves and freeze-dried aqueous extract powder, contained a total luteolin content of 2.065 ± 0.2347 and 13.870 ± 1.2460μg/mg, respectively, with an intra-batch variation (% R.S.D) of 11.36% and 6.70%, respectively, reduced from an initial %R.S.D of 21.24%, 30.00% and 16.77%, for the three separately collected plant batches used. The tea bag of the A. afra standardized dried leaves was stable under room temperature and humidity conditions for 6 months, while the freeze-dried aqueous extract tea bag was not and both tea bag preparations were unstable at conditions of 40°C/ 75% RH. The f1 and f2 values for the infusion of luteolin from the leaves in tea bag compared to the loose leaves were 73.52% and 13.85%, respectively, indicating that the profiles were not similar. Finally, the placebo materials prepared closely resembled the respective plant materials and the placebo of the A. afra leaves possessed only slight muscle relaxant activity while the placebo for the extract powder was pharmacologically inert.

In summary, the results showed that the tea bag was a suitable dosage form for the A. afra standardized dried leaves, but not the freeze-dried aqueous extract powder and that the tea bag preparation did not have similar infusion profiles to the loose leaves, but could still be used in clinical trials provided that adjustments in the dose preparation and administration methods are made. Finally, credible placebos for the plant materials suitable for use in clinical trials were prepared.

The Design, Preparation and Evaluation of Artemisia Afra and Placebos in Tea Bag Dosage Form {{Suitable for Use in Clinical Trials
Published online by La vie re-belle
 25/05/2020
 http://lavierebelle.org/formes-galeniques

 Documents

 The Design, Preparation and Evaluation of Artemisia Afra and Placebos in Tea Bag Dosage Form {{Suitable for Use in Clinical Trials
PDF 
 A. Dube

Pharmacologie

Revue des études sur la composition, les mécanismes d’action, les formes galéniques, la toxicologie et l’épidémiologie d’Artemisia afra

Articles 3

2005James Tshikosa Mukinda Acute and chronic toxicity of the flavonoid- containing plant, Artemisia afra in rodents A thesis submitted in partial (...)
IMG: Artemisia afra Pharmacokinetic 2004Raymond Muganga Luteolin Levels in Selected Folkloric Preparations and the Bioavailability of Luteolin from Artemisia afra Aqueous Extract in the (...)
IMG: Artemisia afra Jacq. Composition and Mechanisms This article presents and provides access to scientific publications on the phytochemical composition of Artemisia annua and the mechanisms of action of (...)
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