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
Highlights
Social danger of the central nervous system diseases determines the relevance of the search and development of new psychotropic drugs [1]
We have offered to develop two dosage forms containing medicinal plant material and a dry extract of the Scutellaria baicalensis – tablets and capsules
On a chromatogram of test solution, a spot of brown color should be detected on the value of Rf corresponding to the spot on the chromatogram of baicalin PRS
Summary
Social danger of the central nervous system diseases determines the relevance of the search and development of new psychotropic drugs [1]. To create solid medicinal preparations on the basis of plant material, it was necessary to investigate the qualitative composition of the active substance, conduct a series of physico-chemical and pharmaco-technological studies in order to justify the choice of auxiliary substances and the method of obtaining. We have offered to develop two dosage forms containing medicinal plant material and a dry extract of the Scutellaria baicalensis – tablets and capsules. Determination of the kinetics of moisture absorption of plant material substances, both dry extracts and native raw material, is an important criterion for further choice of auxiliary substances and technology for the manufacture of solid dosage forms. The general methodological approach to the development of medicinal products with nootropic action on the basis of plant material is shown in Fig. . Results of stability study of tablets under the conditional name "Scutex" during storage
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