Assessment of two herbal galactagogue products and a new suggested formula

Abstract

Two galactagogue herbal pharmaceutical products were evaluated for their quality, purity, safety and efficacy. Product (I) contains foenugreek, caraway and fennel oils, while product (II) contains foenugreek, caraway, fennel and dill powders. The assessment included the determination of pharmacopoeial constants, microscopical examination and detection of the microbial contaminants, pesticide residues, aflatoxins and heavy metals. Additionally, the main components of foenugreek (diosgenin and trigonelline) were qualitatively and quantitatively evaluated using HTPLC, HPLC, HPLC/MS and UV. Volatile oils of caraway, dill and fennel as well as the fixed oil of foenugreek were analyzed by GC and compared to the home prepared standard mixture. The efficacy of the products was evaluated by the measurement of prolactin, estradiol and progesterone in adult female rat model receiving the marketed products and their corresponding home prepared mixtures. The results showed that product (II) was more effective than product (I). A new suggested formula was formulated to resemble product (II) with addition of cumin powder proved to increase the effectiveness of the marketed preparation. Cumin powder in the new formula was identified microscopically and examined throughout the determination of the reported pharmacopoeial constants as well as the GLC analysis of its volatile constituents. This work serves as a model for setting up criteria for justifying the quality of herbal products intended for increasing milk secretion in lactating women. The biological and analytical methods used in this research would be suitable for the future enhancement of the quality control assessment of the galactagogue preparations in producing companies.