DOI: https://doi.org/10.15587/2519-4852.2019.158007

Methodological approaches to the design of solid dosage forms of nootropic action on the basis of plant raw materials

Galina Slipchenko, Olena Ruban, Sergiy Kutsenko

Abstract


The general methodology of design of solid dosage forms from plant raw materials on the example of dry extract and shredded roots with rhizomes of the Scutellaria baicalensis and their stability in the process of storage has been substantiated.

Aim. To find out general methodological approaches for the development of solid dosage forms with plant material of Scutellaria baicalensis.

Materials and Methods. We have offered to develop two dosage forms containing medicinal plant material and a dry extract of the Scutellaria baicalensis - tablets and capsules. The stability of the developed formulations was studied by the method of prolonged storage at a temperature (25±2) °С, and relative humidity of air 60±5 %. Quality indices were monitored during (0, 3, 6, 9, 12, 18, 22, 24, 27 months).

Results. In accordance with the proposed methodological approach, the first stage of the research was the study of the current state of phytopreparations with nootropic and sedative effects creation.

Factors which can affect both the substance itself and the quality of the finished dosage form have been established. Natural sources of mineral complexes (macro- and microelements (ME)) have been investigated. Moisture absorption and its impact on physical and chemical stability and technological behavior during preparation of the medicinal product were studied. A group of biorelevant media that allow simulating the behavior, dissolution and adsorption of drugs in the gastrointestinal tract of the patient was applied.

Conclusions. The methodological approach to the preparation of drugs on the basis of native vegetable raw material and dry extract (Scutellaria baicalensis) has been developed. The shelf life of tablets and capsules has been studied and it was determined that tablets and capsules are stable for 2 years of storage at a storage temperature of 15-25 °C; optimal packaging materials - polyvinyl chloride film and aluminum foil printed lacquered


Keywords


Scutellaria baicalensis; methodological; approaches; plants; biorelevant; nootropic; technology; pharmaco-technological; tablets; capsules

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References


Filippenko, T. A., Gribova, N. Yu. (2012). Antioksidantnoe deystvie ekstraktov lekarstvennykh rasteniy i fraktsiy ikh fenol'nykh soedineniy. Khimiya rastitel'nogo syr'ya, 1, 77–81.

Yatziuk, V. Y., Chaly, G. A., Soshnikova, O. V. (2006). Biologically active substances of the herb of urtica dioica. I.P.Pavlov Russian Medical Biological Herald, 14 (1), 25–29. doi: http://doi.org/10.17816/pavlovj2017130-41

Margolina, A. A., Ernandes, E. I. (2015). Novaya kosmetologiya. Kosmeticheskie sredstva: ingredienty, retseptury, primenenie. Moscow, 580.

Olenikov, D. N, Chirikova, N. K., Tanhaeva, L. M. (2010). Khimicheskiy sostav Shlemnika Baykal'skogo (Scutellaria Baicalensis Georgi). Khimiya rastitel'nogo syr'ya, 2, 77–84.

Yarnikh, T. G., Rukhmakova, O. A. (2013). Methodological aspects of development medicines for children. News of Pharmacy, 4, 52–56. Available at: http://nbuv.gov.ua/UJRN/VPhC_2013_4_14

Kovalevska, I., Ruban, O. (2018). Development of the methodological approach of obtaining preparations based on solid dispersions. ScienceRise: Pharmaceutical Science, 4 (14), 4–8. doi: http://doi.org/10.15587/2519-4852.2018.140756

Gaire, B. P., Moon, S.-K., Kim, H. (2014). Scutellaria baicalensis in stroke management: Nature’s blessing in traditional Eastern medicine. Chinese Journal of Integrative Medicine, 20 (9), 712–720. doi: http://doi.org/10.1007/s11655-014-1347-9

Slipchenko, G. D., Ruban, E. A. (2016). Investigation of kinetics of drying for tablet mass «skutex». News of Pharmacy, 2 (72), 30–35.

Slipchenko, G. D., Hrudko, V. O., Ruban, O. A., Kutsenko, S. A. (2017). Study of bioavailability of capsules with Scutellaria baicalensis roots and rhizomes powder. The Pharma Innovation Journal, 6 (12), 294–296.

Slipchenko, G. D., Piven, O. P. (2018). The conjuncture analysis of the range of nootropic drugs registered in Ukraine. Social Pharmacy in Health Care, 4 (2), 9–18. doi: http://doi.org/10.24959/sphhcj.18.117


GOST Style Citations


Filippenko T. A., Gribova N. Yu. Antioksidantnoe deystvie ekstraktov lekarstvennykh rasteniy i fraktsiy ikh fenol'nykh soedineniy // Khimiya rastitel'nogo syr'ya. 2012. Issue 1. P. 77–81.

Yatziuk V. Y., Chaly G. A., Soshnikova O. V. Biologically active substances of the herb of urtica dioica // I.P.Pavlov Russian Medical Biological Herald. 2006. Vol. 14, Issue 1. P. 25–29. doi: http://doi.org/10.17816/pavlovj2017130-41 

Margolina A. A., Ernandes E. I. Novaya kosmetologiya. Kosmeticheskie sredstva: ingredienty, retseptury, primenenie. Moscow, 2015. 580 p.

Olenikov D. N., Chirikova N. K., Tanhaeva L. M. Khimicheskiy sostav Shlemnika Baykal'skogo (Scutellaria Baicalensis Georgi) // Khimiya rastitel'nogo syr'ya. 2010. Issue 2. P. 77–84.

Yarnikh T. G., Rukhmakova O. A. Methodological aspects of development medicines for children // News of Pharmacy. 2013. Issue 4. P. 52–56. URL: http://nbuv.gov.ua/UJRN/VPhC_2013_4_14

Kovalevska I., Ruban O. Development of the methodological approach of obtaining preparations based on solid dispersions // ScienceRise: Pharmaceutical Science. 2018. Vol. 4, Issue 14. P. 4–8. doi: http://doi.org/10.15587/2519-4852.2018.140756 

Gaire B. P., Moon S.-K., Kim H. Scutellaria baicalensis in stroke management: Nature’s blessing in traditional Eastern medicine // Chinese Journal of Integrative Medicine. 2014. Vol. 20, Issue 9. P. 712–720. doi: http://doi.org/10.1007/s11655-014-1347-9 

Slipchenko G. D., Ruban E. A. Investigation of kinetics of drying for tablet mass «skutex» // News of Pharmacy. 2016. Issue 2 (72). P. 30–35.

Study of bioavailability of capsules with Scutellaria baicalensis roots and rhizomes powder / Slipchenko G. D. et. al. // The Pharma Innovation Journal. 2017. Issue 6 (12). P. 294–296.

Slipchenko G. D., Piven O. P. The conjuncture analysis of the range of nootropic drugs registered in Ukraine // Social Pharmacy in Health Care. 2018. Vol. 4, Issue 2. P. 9–18. doi: http://doi.org/10.24959/sphhcj.18.117 







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ISSN 2519-4852 (Online), ISSN 2519-4844 (Print)