Разработка и регистрация лекарственных средств (Sep 2023)

Development of the Composition and Technology of Tablets Based on <i>Astragalus membranaceus</i> (Fisch.) Bunge Dry Extract

  • M. V. Aroyan,
  • D. E. Lohmatova,
  • D. D. Vantorina,
  • E. K. Novikova,
  • I. E. Kaukhova,
  • M. V. Nechaev

DOI
https://doi.org/10.33380/2305-2066-2023-12-3-73-79
Journal volume & issue
Vol. 12, no. 3
pp. 73 – 79

Abstract

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Introduction. Human performance depends on external and internal factors. Of a number of external factors, the environmental aspect is one of the leading ones. Internal factors are interrelated with external ones. The latter include the general condition of the human body, as well as the normal functioning of individual systems and organs. It must be noted that the use of herbal drugs in order to prevent the development of pathologies caused by internal factors is rational. A number of plants contain substances that can improve performance by strengthening the cardiovascular system, normalizing the liver, adjusting daily rhythms, reducing stress. In this regard, the development of the composition and technology of drugs based on substances of plant origin does not lose relevance.Aim. Development of the composition of solid oral dosage form based on dry extract of Astragalus membranaceus (Fisch.) Bunge containing saponins.Materials and methods. As an object of research, a substance was used – dry extract of Astragalus membranaceus (Fisch.) Bunge, standardized in accordance with the requirements of SP XIV ed. Lactose monohydrate, calcium stearate, methylcellulose, corn starch, talc were used as excipients in the tablet technology. Under laboratory conditions, granulation was carried out by the wet mass extrusion method. A 3 % methylcellulose solution was used as the wetting reagent. Quality parameters of the final dosage form, tablets, were determined according to the methods described in SP XIV ed.Results and discussion. As a result of the conducted research, the composition of a solid oral dosage form based on a dry extract of Astragalus membranaceus (Fisch.) Bunge was proposed. The main quality indicators of the obtained dosage form are determined. A design quality specification has been developed for a drug.Conclusion. The present study proposed technology dry extract for Astragalus membranaceus (Fisch.) Bunge herb. Quality index of the obtained plant substance are determined. The composition and technology of tablets based on the dry extract of Astragalus membranaceus (Fisch.) Bunge herb have been developed. The main quality indicators of tablets based on the dry extract of Astragalus membranaceus (Fisch.) Bunge herb were determined. A draft quality specification of the resulting dosage form has been developed.

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