BackgroundThe presence of poor quality medicines in the market is a global threat on public health, especially in developing countries. Therefore, we assessed the quality of two commonly used anthelminthic drugs [mebendazole (MEB) and albendazole (ALB)] and one antiprotozoal drug [tinidazole (TNZ)] in Ethiopia.Methods/Principal FindingsA multilevel stratified random sampling, with as strata the different levels of supply chain system in Ethiopia, geographic areas and government/privately owned medicines outlets, was used to collect the drug samples using mystery shoppers. The three drugs (106 samples) were collected from 38 drug outlets (government/privately owned) in 7 major cities in Ethiopia between January and March 2012. All samples underwent visual and physical inspection for labeling and packaging before physico-chemical quality testing and evaluated based on individual monographs in Pharmacopoeias for identification, assay/content, dosage uniformity, dissolution, disintegration and friability. In addition, quality risk was analyzed using failure mode effect analysis (FMEA) and a risk priority number (RPN) was assigned to each quality attribute. A clinically rationalized desirability function was applied in quantification of the overall quality of each medicine. Overall, 45.3% (48/106) of the tested samples were substandard, i.e. not meeting the pharmacopoeial quality specifications claimed by their manufacturers. Assay was the quality attribute most often out-of-specification, with 29.2% (31/106) failure of the total samples. The highest failure was observed for MEB (19/42, 45.2%), followed by TNZ (10/39, 25.6%) and ALB (2/25, 8.0%). The risk analysis showed that assay (RPN = 512) is the most critical quality attribute, followed by dissolution (RPN = 336). Based on Derringer's desirability function, samples were classified into excellent (14/106,13%), good (24/106, 23%), acceptable (38/106, 36%%), low (29/106, 27%) and bad (1/106,1%) quality.Conclusions/SignificanceThis study evidenced that there is a relatively high prevalence of poor quality MEB, ALB and TNZ in Ethiopia: up to 45% if pharmacopoeial acceptance criteria are used in the traditional, dichotomous approach, and 28% if the new risk-based desirability approach was applied. The study identified assay as the most critical quality attributes. The country of origin was the most significant factor determining poor quality status of the investigated medicines in Ethiopia.

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The leaves extracts of two indigenous plants of Ethiopia: Clematis longicauda steud ex A. Rich. and Clematis burgensis Engl. are used in Southwestern Ethiopia to treat otorrhoea and eczema. Antimicrobial activity and MIC of crude extracts were determined by disk diffusion and broth dilution. Phytochemical screening was performed on the extracts. The methanol and petroleum ether extracts of both plants showed antibacterial and antifungal activity. Sensitivity of reference strains was concentration dependent. Methanol and petroleum ether extracts of C. burgensis leaves exerted greater inhibitory effects than C. longicauda extracts whereas aqueous extracts of both plants were inactive. The MIC study revealed a concentration of 0.78 mg/ml on bacteria and 3.125 mg/ml on fungi for methanol extract and 1.56 mg/ml on both fungi and bacteria for petroleum ether extract. Phytochemical screening results indicated the presence of proteins, fixed oils, carbohydrates, tannins, saponins, flavonoids, and steroids. Preliminary chromatographic investigation showed fluorescing spots with Rf values that ranged from 0.05 to 0.96 for phenolic compounds and saponins. As the study is one of the first reports on the two indigenous species of Clematis; isolation, purification and characterization of the different primary and secondary metabolites may further yield alternative options to the microbial chemotherapy.

Objective: To investigate the vulnerary activity of the methanol extracts of Clematis longicauda steud ex A. Rich, and Clematis burgensis Engl leaves. Materials and Methods: In vivo wound healing activity of methanol extracts of C. longicauda and C. burgensis were studied using excision wound model, re-sutured incision wound model, histopathological analysis and anti-inflammatory activity test. The variables studied were percentage of wound contraction and epithelialisation period in excision wound model; tensile strength in incision wound model; and percentage of acetic-acid-induced capillary permeability inhibition in the anti-inflammatory activity test. The histopathological study qualitatively assessed presence of inflammatory cells, fibroblast proliferation, collagen formation and angiogenesis. Differences between experimental groups were compared by one-way analysis of variance, followed by Dunnett's test. P < 0.0001 was considered statistically significant. Results: C. longicauda and C. burgensis extracts treated animals showed significant reduction in wound area and faster rate of epithelialisation, P < 0.0001. Extracts of these plants also demonstrated statistically significant wound breaking strength and inhibition of vascular permeability induced by acetic acid. Histological studies on granulation tissue sections showed formation of collagen bundles in the C. longicauda and C. burgensis extracts treated and standard drug-treated groups while inflammatory cells were present in control. Conclusion: Methanol extracts of C. longicauda and C. burgensis had comparable wound healing activity to Madecassol, containing 1% of Centalla asiatica extracts.