Pharmaceutical Herbal Products Research Articles

Chemical and Physical Methods to Analyze a Multicomponent Traditional Chinese Herbal Prescription Using LC-MS/MS, Electron Microscope, and Congo Red Staining

This study develops several chemical and physical methods to evaluate the quality of a traditional Chinese formulation, Jia-Wei-Xiao-Yao-San. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) coupled with electrospray ionization was used to measure the herbal biomarkers of saikosaponin A, saikosaponin D, ferulic acid, and paeoniflorin from this herbal formula. A scanning electron microscope (SEM) and light microscopy photographs with Congo red staining were used to identify the cellulose fibers if raw herbal powder had been added to the herbal pharmaceutical product. Moreover, water solubility and crude fiber content examination were used to inspect for potential herbal additives to the herbal pharmaceutical products. The results demonstrate that the contents of the herbal ingredients of saikosaponin A, saikosaponin D, ferulic acid, and paeoniflorin were around 0.351 ± 0.017, 0.136 ± 0.010, 0.140 ± 0.005, and 2.281 ± 0.406 mg/g, respectively, for this herbal pharmaceutical product. The physical examination data demonstrate that the raw herbal powder had rough, irregular, lumpy, filamentous, and elongated shapes, as well as strong Congo red staining. In addition, water solubility and crude fiber content were not consistent in the herbal pharmaceutical products.

Valutazione dei rischi connessi all’utilizzo di prodotti farmaceutici e parafarmaceutici contenenti piante medicinali

[ Evaluation of risks related to the use of pharmaceutical and parapharmaceutical herbal products] The increasing interest in natural and complementary products for the treatment of many different diseases leads to important concern about their safety. Phytotherapy and dietary supplementation with herbal products can be useful in clinical practice, but health care professionals should carefully consider a comprehensive clinical risk assessment. Recognition of adverse events related to the use of medicinal herbs should involve a complete analysis of their main characteristics, together with the assessment of patients’ clinical conditions, concomitant drug intake and history of use. This process is important, not only because it may prevent adverse events, but also to improve pharmacovigilance reports.

Herbal drug leaflets: are they in compliance with standards?

Leaflets inside pharmaceutical packages should include focal points about medicines being used by patients. The current study was designed to assess the compliance of information cited in herbal medicine leaflets with the standards released by the Ministry of Health and Medical Education of Iran (MHMEI). Leaflets of commonly used herbal pharmaceutical products sold in pharmacies of Iran were collected. Standards for herbal drug leaflets were obtained from the MHMEI, Drug Administration Office. These standards are classified into two main groups of criteria: 1. information for health professionals and 2. information for patients. First group is summarized as 14 principles consisting of: official name of plant, therapeutic category, components, pharmacokinetics, pharmacological action (s), indication (s), contraindication (s), side effects, precaution and interactions, usage in pregnancy, usage in lactation, dosage, administration method and finally dosage form. This information should be in English. Information for patients included 3 main benchmarks of dose and administration method, side effects and storage instructions. This information should be in Persian. Data obtained from the leaflets was entered into the Excel spreadsheet and their compliance with the standard criteria was analyzed. 35 leaflets from 10 pharmaceutical companies were analyzed of which 23 (66.7%) had group 1 information in Persian and only 12 (34.3%) of them were in English. None of those written in English had the whole of the itemized standard information. None of them had pharmacokinetics data either. Overall, these 12 leaflets contained 123/168 (73.2%) of the criteria recommended by the MHMEI. Regarding the information for patients, all leaflets included dose and usage method advice. However, both side effects and storage conditions were not quoted in 11/35 (31.4%) of them. 16/35 (45.7%) of the leaflets had all-inclusive information for patients complying with MHMEI standards. Overall, 83/105 (79.1%) of the principles recommended by the MHMEI were followed. Taking standards as points of reference which should be abided by pharmaceutical companies, results of this study discloses that a significant proportion of the herbal product leaflets need to be revised and re-written in accordance with the criteria recommended by the MHMEI. MHMEI should have a higher level of controlling on these products since they are easily available for public sale.

Interactions of Valeriana officinalis L. and Passiflora incarnata L. in a patient treated with lorazepam

There is an increasing interest in the health risks related to the use of herbal remedies. Although most consumers think that phytomedicines are safe and without side effects, interactions between complementary alternative and conventional medicines are being described. The aim of this clinical case report is to highlight the importance of the safe use of herbal remedies by providing a clinical interaction study between pharmaceutical medicines and herbal medicinal products. The case of a patient self-medicated with Valeriana officinalis L. and Passiflora incarnata L. while he was on lorazepam treatment is described. Handshaking, dizziness, throbbing and muscular fatigue were reported within the 32 h before clinical diagnosis. The analysis of family medical history ruled out essential tremor, Parkinson's disease, Wilson's disease and other symptom-related pathologies. His medical history revealed a generalized anxiety disorder and medicinal plant consumption but no neurological disorder. Appropriate physical examination was carried out. An additive or synergistic effect is suspected to have produced these symptoms. The active principles of Valerian and passionflower might increase the inhibitory activity of benzodiazepines binding to the GABA receptors, causing severe secondary effects. Due to the increase in herbal product self-medication, the use of herbal remedies should be registered while taking the personal clinical history. Multidisciplinary teams should be created to raise studies on medicinal plants with impact on medical praxis.

Determination of Sildenafil, Tadalafil, and Vardenafil in Tablets and Adulterated Herbal Products by ESI‐MS‐MS

Abstract An electrospray tandem mass spectrometry (ESI‐MS‐MS) method was developed for the analysis of selected phosphodiesterase type 5 (PDE‐5) inhibitors, namely, sildenafil, tadalafil, and vardenafil in pharmaceutical preparations and adulterated herbal products. The method permits a fast ( 100, 390>268, 489>169, respectively. The concentration of each compound was determined from the calibration curve constructed by the internal standard calibration using phenylalanine (m/z 166>103) as ...

Development and Validation Method for Silica Determination by Spectrophotometry in Some Herbs and Pharmaceutical Formulations

ABSTRACT A spectrophotometric method for determination of silica in herbs and herbal pharmaceutical products has been developed and validated. The method showed excellent accuracy and precision with S.D. 1.67 and RSD 1.72%, 2.75%, respectively. The established linearity range was 0.05–0.5 μg/mL(r2 > 0.99974). The recovery of silica from spiked placebo was > 95% over the linear range. The method has been successfully used in the analysis of silica in raw material and herbal pharmaceutical formulations. This validated method proved to be rapid and less costly.