Scientific basis of the development and standardization of herbal medicines

The present paper conceptually considers scientific approaches to standardization of starting materials of herbal origin and herbal medicinal products. It was proved that chemical classification of the starting materials of herbal origin is of fundamental importance for Pharmacognosy and Pharmaceutical science in general. It was shown that the chemical nature of biologically active compounds has to be considered as a methodological basis when developing new approaches to standardization of starting materials of herbal origin and herbal medicinal products. The article also discusses the dependence of physical, physical and chemical, spectral, and pharmacological properties on the chemical nature of biologically active compounds, used as identity and quality criteria for raw materials and phytopreparations. The paper describes current trends in Pharmacognosy, as reflected in the State Pharmacopoeia of the Russian Federation XIII edition

Current requirements for standardization of homeopathic raw materials and substances

The article considers modern requirements for standardization of homoeopathic raw material and substances. The study included the analysis of a range of raw materials of plant, animal, mineral and chemical origin, which are used for the production of homeopathic substances. The article describes basic ways of processing raw material for producing homeopathic substances and basic principles of the quality control of raw materials in different countries. It was revealed that there was a difference in the composition of substances used under the same name, as well as in methods of preparation of homeopathic substances. The authors formulated the main approaches to standardization of homoeopathic raw material that were used in the elaboration of monographs on homeopathic products for the State Pharmacopoeia of the Russian Federation

IMPROVEMENT OF QUALITY REQUIREMENTS FOR CRUDE HERBAL DRUGS OF FRUCTUS CARVI, FRUCTUS FOENICULI AND FRUCTUS ANISI VULGARIS

Improvement of the quality requirements for the herbal pharmaceutical substances is the basis for the safety and efficacy of drugs produced from it. Modern diagnostic methods made it possible to clarify and to elaborate the regulatory requirements for Fructus Carvi, Fructus Foeniculi and Fructus Anisi vulgaris and to create innovated pharmacopoeial articles

OPTIMIZATION OF HPLC METHODS FOR QUANTITATIVE DETERMINATION OF GLYCYRRHIZIC ACID IN LICORICE ROOTS

Comparative evaluation of glycyrrhizic acid content in licorice roots by methods of UV-spectrophotometry (GF RF XIII) and high-performance liquid chromatography (HPLC) was carried out. Sample preparation for HPLC method of quantitative determination of glycyrrhizic acid in samples of domestic production is developed. Small selectivity of UV-spectrophotometry at determination of glycyrrhizic acid is experimentally established and perspective of HPLC method for standardization of licorice raw materials is shown

Evaluation of Glycyrrhizic Acid Content in Licorice Roots and Products of its Processing by HPLC-UV Method

Introduction. The actual form of packaging licorice roots for water extraction are filter paper sachets. New forms of licorice root processing provide the proper technological properties of raw materials for filter paper sachets.Aim. A comparative assessment of the of glycyrrhizic acid (GA) content in licorice roots (LR), produced in the Russian Federation and in licorice raw materials of various processing methods by HPLC-UV.Materials and methods. The objects of research were crushed LR, packaged in packs of industrial production and laboratory-industrial samples of coarse powder (CP), cut-pressed granules (CPG) and compositions proposed for packaging in filter paper sachets. The determination of GA content was carried out on an Agilent 1200 high performance liquid chromatography system equipped with a photodiode array detector (Agilent Technologies, USA). The stationary phase is column Phenomenex Luna® C18(2) 250×4.6 mm. The composition of the mobile phase – 5% orthophosphoric acid water solution: acetonitrile (60:40). A flow rate – 1.0 ml/min, isocratic elution mode. The temperature of the column – 30 °C. The sample injected volume – 10 µl. Detection was performed at a wavelength of 254 nm; run time – 15 minutes.Results and discussion. The GA content in CP, CPG and the composition of CP and CPG –was determined in the ratio of 80:20 (composition). It was established that the GA content varies in the LR in the range – 7.08–9.17%, CP – 3.87–3.90%, CPG – 6.88–7.08%, and the composition – 4.44–4.88%.Conclusion. The use of HPLC-UV method for the standardization of licorice roots of domestic production and the roots of various forms of processing is very promising. The technique can be recommended for inclusion in the State Pharmacopoeia of the Russian Federation of a subsequent edition, which will allow harmonizing the quality requirements of domestic licorice raw materials with the requirements of foreign pharmacopoeias

Научные основы разработки и стандартизации лекарственных растительных средств

The present paper conceptually considers scientific approaches to standardization of starting materials of herbal origin and herbal medicinal products. It was proved that chemical classification of the starting materials of herbal origin is of fundamental importance for Pharmacognosy and Pharmaceutical science in general. It was shown that the chemical nature of biologically active compounds has to be considered as a methodological basis when developing new approaches to standardization of starting materials of herbal origin and herbal medicinal products. The article also discusses the dependence of physical, physical and chemical, spectral, and pharmacological properties on the chemical nature of biologically active compounds, used as identity and quality criteria for raw materials and phytopreparations. The paper describes current trends in Pharmacognosy, as reflected in the State Pharmacopoeia of the Russian Federation XIII edition.В настоящей работе в концептуальном плане рассматриваются научные подходы к стандартизации лекарственного растительного сырья и лекарственных растительных препаратов. Обосновано, что химическая классификация лекарственного растительного сырья имеет фундаментальное значение для фармакогнозии и фармации в целом. Показано, что химическая природа биологически активных соединений должна рассматриваться как методологическая основа в плане разработки новых подходов к стандартизации лекарственного растительного сырья и лекарственных растительных препаратов. В работе обсуждаются также зависимости физических, физико-химических, спектральных и фармакологических свойств от химической природы биологически активных соединений, используемых в качестве критерия подлинности и качества сырья и фитопрепаратов. В работе обсуждаются современные тенденции развития фармакогнозии, нашедшие отражение в Государственной фармакопее Российской Федерации XIII издания

Современные требования к стандартизации гомеопатического сырья и субстанций

The article considers modern requirements for standardization of homoeopathic raw material and substances. The study included the analysis of a range of raw materials of plant, animal, mineral and chemical origin, which are used for the production of homeopathic substances. The article describes basic ways of processing raw material for producing homeopathic substances and basic principles of the quality control of raw materials in different countries. It was revealed that there was a difference in the composition of substances used under the same name, as well as in methods of preparation of homeopathic substances. The authors formulated the main approaches to standardization of homoeopathic raw material that were used in the elaboration of monographs on homeopathic products for the State Pharmacopoeia of the Russian Federation.Рассмотрены современные требования к стандартизации гомеопатического сырья и субстанций. Приведен анализ номенклатуры сырья растительного, животного, минерального и химического происхождения, которое используется для получения гомеопатических субстанций. Показаны основные методы обработки сырья для получения гомеопатических субстанций и основные принципы контроля качества сырья в разных странах. Показано наличие разночтений в составе субстанций, использующихся под одинаковыми названиями, а также в методах приготовления гомеопатических субстанций. Сформулированы основные подходы к стандартизации гомеопатического сырья, использованные при подготовке проектов фармакопейных статей на гомеопатические лекарственные средства для Государственной фармакопеи Российской Федерации