Substantiation of the composition and development of technology of granules based on the Alchemilla subcrenata Bus. herbal extract
Keywords:granules; herbal extract; Alchemilla herb; development; technological parameters
Aim. To develop the optimal composition and technology, determine the quality indicators of granules based on a dry extract of Alchemilla subcrenata Bus. herb.
Materials and methods. A dry extract of Alchemilla subcrenata Bus. herb, excipients and granules based on the extract studied were chosen as the study objects. For the analysis of recent research and publications, methods of scientific analysis were used; they contributed to the comparison, analysis, generalization and systematization of literature data. To achieve the aim, the generally accepted physical, physico-chemical and pharmaco-technological methods were used; they contributed to the objective assessment of the quality of the drug obtained.
Results. According to the results of the studies conducted, the composition of granules based on the dry extract of Alchemilla subcrenata Bus. herb (the extractant – 70 % ethanol) was substantiated, and the technology of their production was developed. During the experimental studies, the optimal excipients for the production of granules, namely saccharin, sorbitol, ascorbic acid and 1 % methylcellulose solution, were selected. The granules developed meet the requirements of the State Pharmacopoeia of Ukraine 2.0 by their organoleptic indicators and technological parameters, and are stable during storage.
Conclusions. The optimal composition of such dosage form as granules under the conditional name “Alchemin” has been substantiated, and the technology of their production has been developed. According to the results of pharmaco-technological and physico-chemical studies, the compliance of the granules developed with the requirements of the State Pharmacopoeia of Ukraine 2.0 has been proven.
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