Determination of the composition of a combination of active pharmaceutical ingredients of the herbal medicinal product with the hepatoprotective action
DOI:
https://doi.org/10.24959/nphj.25.192Keywords:
technology; technological process; combination; medicinal product; polyphenols; active pharmaceutical ingredient; herbal substance, extract.Abstract
Aim. To study the recommended doses and calculate the component composition of a combination of the amorphous solid dispersion of silymarin, the dry artichoke leaf extract and the dry peppermint leaf extract for its further use as part of medicinal products for the treatment of diseases of the hepatobiliary system.
Materials and methods. The study object was the combination of the amorphous solid dispersion of silymarin, the artichoke leaf dry extract and the peppermint leaf dry extract. To determine the recommended doses of individual components of the combination, the bibliosemantic method was used. To calculate the component composition of the combination, data from monographs of the European Medicines Agency and the Commission E were used.
Results. Based on the pharmacological properties and recommended doses of the individual components, the composition of the combination of active pharmaceutical ingredients of plant origin was developed. The content of the solid dispersion of silymarin in one dosage of the combined product was set at the equivalent of 35 mg of silymarin calculated with reference to silibinin corresponding to 162.2-191.7 mg of the substance. The content of the artichoke leaf dry extract in one dosage of the combined product was 100 mg. The content of the dry peppermint leaf extract in one dosage of the combined product was set at 125 mg. The total content of active pharmaceutical ingredients in one dosage unit of the medicinal product was within 387.2-416.7 mg. The daily dose was set within 6 single doses. Considering the pharmaco-technological properties of the components of the combination, as well as taking into account the properties of Syloid® XDP 3150 as a carrier of the solid dispersion of silymarin, the optimal dosage form for the combination developed is hard gelatin capsules. The composition of the combination of active pharmaceutical ingredients determined in this study will provide a wide range of the pharmacological activity of the herbal medicinal product, namely: hepatoprotective, hepatoregenerative, anticholestatic, lipid-lowering and antispasmodic effects.
Conclusions. It has been determined that the active ingredients of the API combination of the hepatoprotective herbal medicinal product are the amorphous solid dispersion of silymarin, the artichoke leaf dry extract and the peppermint leaf dry extract. It has been calculated that the component composition of the individual ingredients of the combination in one dosage unit of the medicinal product should be: the equivalent of 35 mg of silymarin in the form of an amorphous solid dispersion, 100 mg of the artichoke leaf dry extract and 125 mg of the peppermint leaf dry extract. It has been found that, considering the pharmaco-technological properties of the components of the combination, the optimal dosage form for the combination developed is hard gelatin capsules.
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