Manufacturing of maximal purified substances Biogenic stimulants Neogalenical

Manufacturing of maximal purified substances. Biogenic stimulants.

• Neogalenical drugs (maximally purified drugs) - group of phytodrugs containing complexes of natural medicinal substances, separated from concomitants. • Neogalenical drugs differ essentially from Galenical ones in almost full absence of concomitant substances. This fact provides their high pharmacological activity, decreasing of side effect reactions, increasing in stability and permits to use it for injections.

General stages of technological process of Neogalenical drugs production: 1. Extraction of herbal raw material. 2. Purification of extract. 3. Evaporation of the extragent. 4. Drying the condensed extract. 5. Standardization the purified extract. 6. Neogalenical drugs production.

Methods of extracts obtaining at neogalenical prepapartion production: 1. Percolation 2. Repercolation (various types) 3. Bismaceration 4. Counter current extraction 5. Maceration 6. Hot continuous extraction

Repercolation is the process the successive application of the same percolating menstruum to fresh portions of the PRM. The principal object of repercolation is to effect the saving of menstruum by accomplishing the saturation of the menstruum, as nearly as possible, by passing the unsaturated or weaker percolate from one portion of the PRM through another portion, and again passing the unsaturated or weaker percolate from this second portion through a third portion.

Repercolation. Extragent is load in the first percolator, passes successively through all the battery of percolators and is unload from the last percolator becoming in the saturated extract. In each percolator significant difference concentrations is supported.

The methods of repercolation 1. Methods repercolation about Chulkov 2. Methods repercolation with dividing PRM and uncompleted cycle 3. Methods repercolation with dividing PRM and completed cycle 4. Methods repercolation about Bosyn 5. Methods repercolation with dividing PRM on the unequal parts (by pharmacopoeia USA and Germany) 6. Fractional maceration by CRSPL

Methods of repercolation about Chulkov Starting time (for 4 days): loading of percolators Working time (from 5 day) obtaining of final product

Methods repercolation with dividing PRM and uncompleted cycle 1. Selection (extract) from the 1 st percolator is divided into: the finished product (80%). 2. The similar from the second percolator extract is divided into: the finished product (100%). 3. Selection (extract) from the 1 st percolator is divided into: the finished product (100%).

Methods repercolation with dividing PRM and completed cycle 1. Selection (extract) from the 1 st percolator is divided into: the finished product (80%). 2. The similar from the second percolator extract is divided into: the finished product (100%). 3. Selection (extract) from the 1 st percolator is divided into: the finished product (100%) and three weak selections is condensed to obtain 20 % of final product.

Methods repercolation about Bosyn Fresh menstruum is loaded only in first percolator, formed extract is passed through all devices and final product is obtained from last apparatus.

Methods repercolation with dividing PRM on the unequal parts (by pharmacopoeia USA and Germany) Total mass of PRM is divided on 3 parts: 5 : 3 : 2. Selection (extract) from the 1 st percolator is divided into: the finished product (20%) and weak selections is used for extraction in the second percolator. Extract from second – finished product 30 %, and 50 % - from third percolator.

Dissolution of soft and dry extracts is carry out in the Reactor

• • Methods of extracts purification of extracts at Neogalenical drugs production Denaturation Salting-out clarificatio, Dialysis, electrodialysis Alcohol clarification Liquid-liquid extraction Changeover of a solvent Sorption (adsorption, absorption and chemisorptions )

Denaturation. • In this process, a precipitation of ballast substances is carried out under the influence of heating, UV-radiation and ultrasonic waves on proteins.

Salting-out clarification. • In this process, high molecular natural compounds (proteins, gums, pectins) are precipitated from extracts under the influence of strong electrolytes. • It becomes possible due to hydration ability of electrolyte ions.

Clarification with alcohol • The mechanism of alcohol clarification is analogue with mechanism of salting - out clarification. • Alcohol is very hydrophilic substance and in solutions of biopolymers alcohol takes away a protective hydrated layer from their molecules and is hydrated itself.

Dialysis and electrodialysis. • The dialysis is based on properties of biopolymer's molecules to pass selectively through semipermeable membranes. • Films made of gelatin, cellophane, collodium, nitrocellulose are used for dialysis.

Electrodialysis • The substances disintegrating on ions are subjected basically by influence of electricity. During this process, separation of substances from dialysate is carried out continuously or periodically.

Sorption is process of sorption of gases, vapours or dissolved solids by solid or fluid sorbents. Adsorption - it is sorption of substance on a surface of sorbent. Adsorption is a selective process, which allows to adsorb fixed substances from a solution.

Absorption • it is sorption of substance by all volume of solid or liquid sorbent. For example, absorption is used at obtaining of volatile oils by anfleurage of flowers: volatile oils are absorbed from raw material by all volume of fat in the closed vessel.

Equipment for purification

Hemosorption • it is sorption of substances due to creation of chemical combinations between sorbent and BAS. • The ion exchange is attributed to chemisorptions.

Liquid-liquid extraction • is widely used for purification of NGD and obtaining of individual substances from herbal and animals raw material. Liquid-liquid extraction is a diffusive process during which one or more dissolved substances are extracted from extract by another solvent immiscible or sparingly soluble in it. For efficient realization of liquid-liquid extraction, it is necessary to make in contact non-miscible liquids, and then to separate them.

Liquid-liquid extraction

Biogenic stimulants • It is complex of medicines substances which supposed that isolated tissues of vegetative or animal origin after their acclimatization to severe surrounding conditions are subjected to biochemical reorganization in metabolic systems forming substances capable to render stimulating influence and to accelerate vital processes when administered by an organism.

In 1942 V. P. Filatov had formulated the doctrine were the author emphasized two positions: a) formation of biogenic stimulants should be considered as the way of body adaptation to environment produced by evolution; b) biogenic stimulants are formed within tissues separated from an organism until these tissues are alive and are placed under extreme conditions.

The main factors causing formation of biostimulants include: 1. low temperature (2 -4 C); 2. storage in dark place (parts of plants); 3. hard work of muscles; 4. x-ray irradiation.

Properties: 1. Biogenic stimulators being entered into a "large" organism (by transplantations of tinned tissues or by injections of their extracts) will activate vital processes there. 2. Strengthening metabolism, they enhance physiological functions of a body; 3. In the case of body disease raise its resistibility and regenerative properties, promote recovery.

The main objective of biostimulant manufacture is to obtain the whole complex of biologically active substances from plant or animal tissues in native (unchanged) state.

General stages of technological process of Biogenic stimulants production: 1. Preparing herbal raw material (washing, cutting). 2. Biostimulation HRM. 3. Milling HRM. 4. Extraction of herbal raw material. 5. Purification of extract. 6. Evaporation of the extragent. 5. Standardization the purified extract. 6. Neogalenical drugs production.

Biogenic preparations of vegetable, animal and mineral origin Biossedum, Fluid aloe extract for injections and as oral solution, Peloidinum, Peloidodistillate for injections, Fi. BS for injections, Gumisolum, Placenta extract, Corpus vitreum, etc

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