A film-coated tablet preparation for the treatment of colitis and irritable bowel syndrome, and the process for manufacturing this preparation.

Abstract

This useful solution refers to a film-coated tablet formulation used to support the treatment of colitis and irritable bowel syndrome, and the manufacturing process of this formulation. The preparation is a solution containing herbal extracts obtained from the following medicinal plants: White peony (Radix Paeoniae lactiflorae), White atractylodes (Rhizoma Atractylodis macrocephalae), Chinese yam (Tuber Dioscoreae persimilis), Saussurea lappae (Radix Saussureae lappae), and Scutellaria baicalensis (Radix Scutellariae), in which the medicinal plants are used in appropriate amounts to create synergistic effects supporting anti-inflammation, reducing spasms, and regulating digestive function. It protects the colonic mucosa and helps improve symptoms of colitis and irritable bowel syndrome. The preparation also includes a film-coating system containing film-forming polymers, plasticizers, and colorants, along with tablet-forming excipients such as preservatives, fillers, stabilizers, anti-caking agents, and pH regulators in appropriate proportions to create highly stable film-coated tablets. The solution-based formulation has the advantage of preserving the active ingredients from medicinal herbs, enhancing the stability of the formulation, facilitating storage and use, and helping to alleviate symptoms such as abdominal pain, bowel disorders, diarrhea, and damage to the colonic mucosa. Evaluation results in a rat model of colitis induced by acetic acid showed that the preparation reduced disease activity index (DAI) levels according to dose, with the effect at a dose of 500 mg / kg / day being nearly equivalent to the control group treated with mesalazine. Furthermore, the product is derived from medicinal herbs that have been used for centuries in traditional medicine, contains no corticosteroids or antibiotics, and the extraction and purification process helps reduce unwanted components, contributing to enhanced safety for long-term use.