GPM.1.4.1.0020.15 Species

MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

GENERAL MONOGRAPH

Species GPM.1.4.1.0020.15

Supersedes the XI Monograph of the State Pharmacopoeia

Medicinal herbal species is a mixture of two or more types of herbal substance processed by various methods, possibly with the addition of substances of mineral, synthetic, herbal and animal origin.

Species can be metered-dose and not metered-dose and available both in multi-dose and unit-dose containers.

Species are meant for both external and internal administration. They are used for aqueous extracts, less often in pure form, as powders for insufflation or oral administration, etc.

TECHNOLOGY CHARACTERISTICS

Medicinal herbal raw material and substances used for species should comply with the requirements of the relevant monograph or regulatory documentation.

Medicinal herbal medicinal raw materials, which are included in species, are ground separately. The fineness of herbal medicinal raw materials included in species used for infusions and decoctions should comply with the requirements of the GM «Infusions and decoctions» and the corresponding monographs or regulatory documentation for medicinal herbal medicinal raw materials. In all cases, after grinding medicinal herbal substance, fine particles in the form of dust are screened through a sieve with an opening size of 0.18 mm.

When producing a species, raw materials included in its composition are mixed until a homogeneous mixture is obtained. In cases where the composition of a species includes water-soluble substances, a saturated aqueous solution is produced from them and sprayed onto the species while stirring, after which it is dried at a temperature of no higher than 60 °C. Hygroscopic and easily damaged when moistened raw materials should be added to species after the procedure of spraying and drying, followed by stirring.

Essential oils and other alcohol-soluble substances are introduced into a species in the form of a solution (1:10) in 96% alcohol by spraying while stirring.

In case of producing a metered-dose species, it is thoroughly mixed to avoid stratification.

Medicinal herbal raw materials and substances belonging to the category of poisonous or potent substances should not be added into the composition of not metered-dose species.

TESTING

Sampling for analysis of species is carried out in accordance with the requirements of the GM “Sampling of medicinal herbal medicinal raw materials and herbal medicines”.

External characteristics. Ground species. An analytical sample weighing 10.0 g is taken from an average sample of ground species, placed on a clean smooth surface, visual inspection is carried out, fixing the color, odor of the species and, if necessary, the flavor of the aqueous extract of the species according to the requirements of a monograph or regulatory documentation. Further, the components of the species are determined in the sample by appearance viewed with the naked eye, as well as with a magnifying glass (10 x) and a stereo microscope (8 *, 16 *, 24 *, etc.). It is necessary to confirm the morphological features of certain types of medicinal herbal substance included in the species, specifying the type of raw material.

Species-powders. An analytical sample weighing 10.0 g is taken from an average sample of species-powders, placed on a clean smooth surface, visual inspection is carried out, fixing the color, odor of the species and flavor of the aqueous extract of the species according to the requirements of monographs or regulatory documentation.

In case of producing species from raw materials processed by other methods (cut-pressed, etc.), the analysis of external characteristics is described in the monograph or regulatory documentation.

Microscopic characteristics. Species are microscopically analyzed in accordance with the GM «Technique of microscopic and microchemical study of medicinal herbal substance and herbal medicines».

Ground species. From an analytical sample, 25 to 30 uniformly shaped particles of each component of the species are selected and several preparations are prepared from several pieces, which are then examined under a microscope to determine the type of raw material.

When studying by the main features, all components of the species should be diagnosed, photomicrographs of the main anatomical and diagnostic features of the components should be given in the monograph or regulatory documentation.

Species-powders. Some part of an analytical sample is placed on a clean smooth surface and, according to external features the components of the species are marked out, viewing them with the naked eye and using a magnifying glass (10 x) or a stereo microscope (8 *, 16 *, 24 *, etc.). For each component, a sufficient number (but not less than 5) of uniformly shaped pieces is chosen and several microscopic preparations are prepared from the several selected pieces according to the procedure for preparing microslides from ground medicinal herbal substance. They note the presence of diagnostic features, characteristic of individual components of species. Microphotographs of the main anatomical and diagnostic features of components should be given in the monograph or regulatory documentation.

In case of producing species from raw materials processed by other methods, the analysis of microscopic characteristics should be described in the monograph or regulatory documentation.

Qualitative microchemical and histochemical reactions. They are carried out in microslides of species components in accordance with the requirements of the GM «Technique of microscopic and microchemical study of medicinal herbal substance and herbal medicines».

An analytical sample weighing 10 g is taken from an average sample to carry out qualitative reactions, tests using chromatographic and spectral studies.

Qualitative reactions. Qualitative reactions are carried out directly on the components of species and/or with the extraction from the species indicating the name of the group(s) of biologically active substances or detectable individual compounds according to the methods specified in monographs or regulatory documentation for medicinal herbal substance. The reactions used must be specific for the biologically active substances of the species components. When bringing into species of various substances of natural, mineral and synthetic origin, they are identified using appropriate qualitative reactions.

Chromatography. Chromatographic analysis is carried out with the help of various chromatographic techniques (TLC, HPLC, etc.), allowing to identify the biologically active substances of the species components, using the appropriate standard samples (individual biologically active compounds). For testing, aqueous or hydroalcoholic extracts from the species are used as well as extracts obtained with other suitable solvents, as specified in the monograph or regulatory documentation.

Spectrum (UV-spectrum). The test is carried out with extracts from species, if specified in the monograph or regulatory documentation. Reference to the section «Assay» is allowed. There is given a description of the conditions for recording the spectrum with the wavelength indication at which the maximum(s) and minimum(s) of absorption should be observed.

For species from medicinal herbal substance processed by various methods the following should be determined:

  • the content of biologically active substances that determine the pharmacological effect of extraction from species, which methods for determination are specified in the relevant monographs or regulative documentation for medicinal herbal substance;
  • humidity in accordance with the requirements of the GM “Humidity determination of medicinal herbal substance and herbal medicines”.
  • the content of total ash and ash insoluble in hydrochloric acid in accordance with the requirements of the GM «Total ash» and the GM «Ash insoluble in hydrochloric acid»;
  • fineness and the amount of impurities in accordance with the requirements of the GM «Determination of identification, fineness and content of impurities in herbal medicinal raw materials and herbal medicinal products».

Uniformity of weight for metered-dose and not metered-dose species.

It is determined in accordance with the requirements of the GM «Sampling of medicinal herbal substance and herbal medicines».

Pest Infestation. The determination is carried out in accordance with the requirements of the GM «Determination of the degree of pest infestation of medicinal herbal substance and herbal medicines».

Radionuclides. The determination is carried out in accordance with the requirements of the GM «Determination of radionuclide content in medicinal herbal substance and herbal medicines».

Heavy metals. The determination is carried out in accordance with the requirements of the GM «Determination of heavy metals and arsenic content in medicinal herbal substance and herbal medicines».

Pesticide residues. The determination is carried out in accordance with the requirements of the GM «Determination of pesticide residue content in medicinal herbal substance and herbal medicines» at the manufacturing process stage.

Microbiological purity. In accordance with the requirements of the GM «Microbiological purity».

Assay of biologically active substances (individual compounds or the total of substances in terms of individual compounds), which determine the pharmacological effect of water extraction from species, is carried out by various chemical, physical, as well as physical and chemical, and other validated methods. Methods of determination (one or some) should be specified in the monograph or regulatory documentation.

Packaging. In accordance with the requirements of the GM «Packaging, labelling and transportation of medicinal herbal substance and herbal medicines».

Labelling. In accordance with the requirements of the GM «Packaging, labelling and transportation of medicinal herbal substance and herbal medicines». Labelling of secondary packaging should include a note «The product has passed the radiation control».

Transportation. In accordance with the requirements of the GM «Packaging, labelling and transportation of medicinal herbal substance and herbal medicines».

Storage conditions. In accordance with the requirements of the GM «Storage of medicinal herbal substance and herbal medicines». In a dry, protected from light place.

Shelf life should be justified by the actual data of stability determination for all quality attributes of medicinal herbal substance stored in each package type.