Development of the regulatory documentation for herb Astragalus dasyanthus Раll

Relevance. Astragalus dasyanthus is widely used in folk and official medicine as a remedy for the treatment and prevention of various diseases. Requirements for the quality of this medicinal plant material are contained in SP 42-533-72. However, the specified regulatory documentation has lost its relevance, it lacks all the necessary data for the standardization of raw materials in accordance with modern requirements. Therefore, the purpose of our work is to determine the quality indicators for the standardization of the herb Astragalus dasyanthus and to prepare a new pharmacopoeial monograph that meets the requirements of the modern regulatory framework.

Materials and methods. The object of the study was Astragalus dasyanthus Pall., collected in the phase of mass flowering and dried grass of a perennial wild herbaceous plant Astragalus dasyanthus Pall., of the legume family Fabaceae.

Macro- and microscopic analysis of raw materials was carried out according to the methods of SP 14. The development of numerical indicators of the quality of Astragalus woolly-flowered grass was carried out on the basis of SP 42-533-72. Determination of indicators "Moisture", "Total ash", "Ash insoluble in hydrochloric acid", "Determination of the content of extractive substances extracted by water" was carried out for whole, crushed raw materials and powder according to the methods of the relevant general pharmacopoeial articles (GPA) of the State Pharmacopoeia 14 editions. Also, in accordance with the requirements of SP 14, grinding standards were established for whole, crushed and powdered raw materials, and the content of impurities for whole and crushed raw materials. To quantify the content of the sum of flavonoids in the herb Astragalus dasyanthus, the method of direct spectrophotometry was used.

Results. The result of the scientific research carried out is the development of a pharmacopoeial article «Astragalus dasyanthus», which contains the data given in PA 42-533-72, as well as new standard indicators established taking into account the requirements of the State Pharmacopoeia 14th edition. The macro- and microdiagnostic signs of the herb Astragalus dasyanthus were revealed, allowing to carry out the diagnostics of raw materials. The norms for the content of moisture, total ash, ash insoluble in hydrochloric acid, impurities, extractive substances extracted by water, flavonoids in terms of hyperoside, as well as the limits of the degree of grinding of raw materials in the raw materials were determined.

Conclusion. The results obtained make it possible to standardize whole, crushed and powdered raw materials in accordance with the requirements of current regulatory documentation for medicinal raw materials of plant origin.