Protective activity of Ruta chalepensis methanolic extract against nephrotoxicity and testicular damage induced by Carbon tetrachloride on albino male mice

Herbal medicinal products can contain whole or partially prepared plant components from plant leaves, bark, stems, flowers and seeds.They are administered orally, inhaled or directly applied in the skin. Ruta chalepensis is a wild herb of the Mediterranean region used by many countries in herbal medicine. The existence of bioactive molecules responsible for their pharmacological properties has been shown by phytochemical screening. Results of kidney protective activity of plant. Showed that: for total cholesterol, the effect was dose dependant (50 and 100 mg\kg) in which the plant decreased it in compared to positive and negative groups (162.1±1.83 and 154.6±1.11 mg\dl) compared to (202.1±1.13 and 167.5±2.96 mg\dl) respectively. For total protein, creatinin and albumin the plant also had the ability to keep it near control groups compared to CCL4group.While the results of interaction groups indicated the ability of plant to provide protection against CCL4 damage. the plant possessed the ability to keep testosterone, progesterone and estrogen hormones level near normal in compared to CCL4 treated group (2.96±0.03, 1.93±0.01 and 3.63±0.04 ng\dl); (11.51±4.12, 9.85±2.18 and 11.78±3.42 ng\ml); (29.07±7.21, 30.11±9.11 and 30.67±8.98 ng\ml) for 50,100 mg\kg and negative control respectively. While for interaction group the results showed the ability of plant to counteract the damaged caused by CCL4 (1.67±0.01, 2.54±0.02); (10.42±2.21, 13.65±4.37); (39.74±10.13, 35.45±9.91) for testosterone, progesterone and estrogen hormones in Ruta chalepensis +CCL4 at dose (50 +0.02%) and (100+0.02%) respectively. All results of histo-architecture for kidney and testis showed the ability of plant to counteract any necrosis and abnormality caused by CCL4.

Stability of Rosmarinic Acid and Flavonoid Glycosides in Liquid Forms of Herbal Medicinal Products—A Preliminary Study

Peppermint leaf, sage leaf, thyme herb, and their preparations are common components of herbal medicinal products (HMPs). According to the European Pharmacopoeia guidelines, the above-mentioned plant substances are standardized for the content of essential oils, omitting polyphenols, which also have a significant impact on their activities. The aim of this study was to evaluate the stability of the predominant polyphenols—rosmarinic acid, luteolin-7-O-β-glucuronide, and eriocitrin—in selected commercial liquid HMPs containing thyme, sage, and peppermint under long-term, intermediate, and accelerated testing conditions. Qualitative and quantitative analyses of these polyphenols were performed by the previously optimized and validated HPLC-DAD method. Rosmarinic acid stability was better in hydroethanolic than in an aqueous solution. The effect of the solvent on the stability of luteolin-7-O-β-glucuronide and eriocitrin could not be determined and requires further investigation. The present study is the first to analyze the stability of these compounds in commercial herbal medicinal products. The expiration dates proposed by the manufacturers of the tested HMPs did not guarantee stable levels of all analyzed polyphenols throughout the stated period. However, this study is preliminary and requires continuation on a larger number of medicinal products.

Herbal Medicines use in Pregnancy in Northern Cyprus

Objective: To identify the herbal medicinal products used in pregnancy in community pharmacies, the approach of pharmacists in Northern Cyprus and to compare the availability of the most commonly mentioned medicinal plants in accessible databases, in Northern Cyprus. Design: Questionnaire was designed and administered to 263 community pharmacists in Northern Cyprus and gathered the data on herbal medicinal products they had and recommended to pregnant women. Databases such as ScienceDirect, PubMed, OpenAcces Journals were searched through the Near East University Grand Library’s Online Resources for keywords relating to the ‘herbal medicine’, ‘pregnancy’ ‘pregnant women’, ‘herbal products’. Descriptive statistics was used with IBM® Statistical product and service solutions software platform. Location/Setting: Northern Cyprus Outcome Measures: Herbal medicinal products used and recommended in pregnancy by community pharmacists in Northern Cyprus were identified. It has also been determined which of the most used plants in the world are grown in Northern Cyprus. Results: The most recommended herbal pharmaceutical forms were herbal lozenges (n = 76, 31%), then herbal form of teas (n = 60, 24%), herbal oils (n = 57, 23%), herbal capsules (n = 36, 14%), other pharmaceutical forms (n=20, 8%). Within the limitation of our literature search, totally 650 medicinal plants (single or formula) used in pregnancy were determined. Out of these 74 were mostly used worldwide, and it was discovered that 56 species out of these plants are grown or cultivated; 18 of the compiled species were imported species some of the genera have species growing naturally growing in Cyprus. Conclusion: Pregnant women in Cyprus also follow their counterparts in other countries in developing interest in herbal medicines. The number of herbal medicines in the pharmacies owned by Turkish Cypriots is small. Interestingly, the result of this study showed that the pharmacists that were mainly Turkish Cypriots were found not to be selling herbal medicinal products to pregnant women without doctor’s prescriptions. This study recommends that the herbal medicines use in pregnancy should be the ones that have undergone in-depth evidence-based scientific researches with clinically proven efficacy that are known not only to the healthcare professionals such as medical doctors, midwives but also the pharmacists and the general public.

The Level of Cadmium Impurities in Traditional Herbal Medicinal Products with Plantago lanceolata L., folium (Ribwort Plantain Leaves) Available in Polish Pharmacies — Comprehensive Toxicological Risk Assessment Including Regulatory Point of View and ICH Q3D Elemental Impurities Guideline

Plantago lanceolata L., folium (ribwort plantain) is an active pharmaceutical ingredient in traditional herbal medicinal products (THMP) available in pharmacies as a demulcent for the symptomatic treatment of oral or pharyngeal irritations and associated dry cough. This kind of THMP is widely applied among the European population; however, recently, voices have been heard in the public about alleged cadmium impurities. The idea of our study was a comprehensive risk assessment of the Cd impurity exposure and its effect on human health. Our assessment strategy was based on regulatory aspects (raw results versus limits set by FAO/WHO for herbal medicines) and toxicological risk assessment approach based on ICH Q3D guideline for elemental impurities in final pharmaceutical products. The cadmium was determined by electrothermal atomization atomic absorption spectrometry based on our previously described methodology. Obtained results show that all analysed THMP with P. lanceolata L., folium available in the Polish pharmacies contain cadmium impurities, but at a very low level (ranged 0.73 – 20.6 μg/L). The content of Cd in a single dose (ng/single dose) is also very low and is not a threat to patients. The estimated maximum daily exposure (ng/day) of Cd based on the ‘worst-case scenario’ (maximum concentrations by oral administration) meets the standards of ICH Q3D guideline (all results were below oral permitted daily exposure; PDE for Cd, i.e. < 5.0 µg/day). It can be concluded that all analysed samples of THMP with P. lanceolata L., folium should not represent any health hazard to the patients due to cadmium levels. To the best of our knowledge, this is the first study about Cd impurity level in THMP with P. lanceolata L., folium (ribwort plantain leaves) available in European pharmacies.

The Health Risk Assessment of Essential Elemental Impurities (Cu, Mn and Zn) Through the Dermal Exposure of Herbal Ointment Extracted from Marjoram Herb (Majoranae herbae extractum)

Essential elements like Cu, Mn and Zn are extremely important for herbs’ growth and physiological functions; however, from a toxicological point of view, the exposure of these elements (as essential elemental impurities) can exhibit potential harmful effects for patients. In Europe, very popular are ointments with Marjoram herb extract (Majoranae herbae extractum) as herbal medicinal products for adjunctively in rhinitis (runny nose). Based on posology of ointments with Marjoram herb extract, the exposure to these elemental impurities may be high during long-term use. Hence, the aim of this article is the health risk assessment of essential elemental impurities (Cu, Mn and Zn) through the dermal exposure of ointments with Marjoram herb extract (Majoranae herbae extractum) as herbal medicinal products applied adjunctively in rhinitis available in Polish pharmacies. The investigated essential elements were determined by well-validated methodology (R > 0.997, recoveries, LOD and LOQ values were acceptable) based on flame atomic absorption spectrometry (FAAS). Our results indicated that all analysed herbal medicinal products with Marjoram herb extract available in Polish pharmacies contain relatively low levels of essential element impurities, i.e. Cu (0.14–0.49 mg/kg), Mn (0.31–2.57 mg/kg) and Zn (0.73–3.19 mg/kg). The estimated exposure of the investigated elemental impurities confirms the safety of all products. To the best of our knowledge, the study about Cu, Mn and Zn contents in HMPs with Majoranae herbae extractum is described for the first time. The applied methodology and results are extremely important from regulatory toxicology point of view due to ICH Q3D elemental impurity guideline for pharmaceuticals.