Pharmaceutical technologies | THE CHAPTER 24

Chapter 24 Solvents and ekstragents.  Ethyl spirit. WATER.
Water distilled (Aqua destillata). Water demineralizovannaja. Cleared and apirogennaja water.
Solvents and ekstragenty.
Manufacturing medical products is connected to application The various liquids necessary for dissolution or extraction farmakologicheski active substances. Depending on purpose These liquid substances can be solvents or ekstragentami.
Under solvents subdivide individual chemical Connections or the mixes, capable to dissolve various substances, I.e. forming homogeneous systems - the solutions consisting from 2 and more numbers of components. To solvents concern The substances possessing properties: 1) possessing active Solubility; 2) are nonaggressive to rastvorjaemomu to substance and To the equipment;
Distinguished by the minimal toxicity and inflammability;
Are accessible and cheap.
Under ekstragentami subdivide the solvents used at ekstraktsii a vegetative or biological material or at ekstraktsii from liquids of those or other valuable substances.
To the solvents, used in quality ekstragentov, Additional requirements are showed:
Selective (selective) solubility;
High diffuzionnye the abilities providing good His penetration cherz time chastichek a vegetative material and Walls of cells;
Ability to interfere with development in an extract of microflora;
letuchest, whenever possible low temperature of boiling, easy regeneriruemost.
All solvents and ekstragenty are subdivided on inorganic And organic. From a class of inorganic connections the greatest Water has value. The circuit of reception and water treating for Pharmaceutical manufactures it is considered below. Now We shall familiarize with the most widespread solvents and ekstragentami.
Etilovyj spirit - in a farmaceutical industry is applied The spirit received in the way sbrazhivanija krahmalsoderzhashchego of raw material - in The basic of a potato.
Sbrozhennoe the mash - brazhka - contains 8 - 10 % of spirit.
By distillation from it it turns out spirtovoj syrets, containing up to 88 % of spirit. Spirit - syrtse always contains impurity - 0,3- 0,4 % which worsen flavouring qualities of spirit, give to him A unpleasant smell and which very harmful to health of the person. To It flying organic acids (vinegary, dairy concern, Oil); fusel oils (the maximum spirits - has spent on drink, izobutil); Ethers (uksusno-etilovyj, oil - etilovyj) and aldehydes (vinegary , etc.).
In this connection spirit - syrets is exposed repeated distillation Named rectification, as a result of which maintenance Impurity decreases in 300 times. Thus in addition There is a strengthening spirit up to 95 - 96 %. In rektifikatsionnoj To a column head, i.e. easily boiling impurity all over again leave (acids, ethers and aldehydes). During rectification a part kond-ti from deflegmatora (phlegm) is allocated back in the device, That, being in contact to pairs spirit, promote it To strengthening. Vysokokipjashchie fusel oils remain in "tail" Impurity.

The circuit rektifikatsionnoj installations.




Properties of spirit as solvent and ekstragenta:
Is good solvent alkaloidov, glikozidov, radio Oils, pitches, etc. substances which in water are dissolved badly.
2. much more difficultly, than water, will penetrate through walls of cells (taking away water and fibers, spirit transforms them into deposits, zakuporivavshih time of cells and thus diffusion) worsens The below concentration of spirit, the more easy he will penetrate inside Cells.
3. The more strong spirit, the is less possible gidrometich. Process. Spirit inaktiviruet enzymes.
Is the bactericidal environment. In the solutions containing ≥ 20 % Spirit, do not develop neither microorganisms, nor a mould.
Spirit farmakologicheski neindifferenten. He renders as Local, and the general action that it is necessary to take into account at Manufacture of extraction.
Spirit is enough letuch and spirtovoe extraction is easily condensed up to Dense liquids and poroshkoobraznyh substances. Evaporation and drying - under vacuum.
Spirit is inflammable.
Spirit is a limiting product.
The fortress of spirit is expressed weight or volumetric percent. Under By a fortress are understood % of the maintenance b/v (absolute) spirit in Has given. A solution. The volume spirtovodnogo a solution changes in Dependences on temperature, his fortress in volumetric percent Carry to t=20? C.
Translation of volumetric % in weight:
Д100
R = q---
Дq

Translation of weight % in volumetric:
Dr
q = p ――
Д100
Where r - weight percent;
q - volumetric percent;
Дq - density of a hydroalcoholic solution, which fortress q About. %;
Дp - density of a hydroalcoholic solution, which fortress r Weight. %;
Д100 - density b/v spirit (0,78927.)
At mixing spirit with water it is allocated warmly and temperature Mixes raises. The greatest heat - at reception of 30 weight. % Spirit.
Besides at mixing water and spirit it is observed the phenomenon The counteractions, consisting in reduction of volume of a mix against The arithmetic sum of initial substances: 50 l spirit + 50 l waters = 96,4 l mixes (that it has turned out 100 l 54 % about. Spirit it is necessary to take 54 l spirit and 49,679 l waters). Therefore tables are developed for Cultivations of spirit (the application to GF X).
Other solvents and ekstragenty:
Methyl or wood (СН3ОН). It turns out sinteticheski. On To a smell reminds etilovyj. A strong poison: a doze 15 - 20 ml It is fatal. Mix with water.
Izopropilovyj spirit (СН3 SN (HE) СН3). It is poisonous. A forming mix with Water, contains 12,3 % of water.
Glycerin (СН2ОН SNON СН2ОН). Mix with water and spirit, not We shall dissolve on air and fat oils. Is part taken Mixes, independently it is not used.
Acetone (СН3СОСН3). Mixs up with water and organic Solutions.
Vinegary acid (СН3СООН) .Ispolzuetsja b/v and water solutions. B/v at temperature <16,6?C stiffens in the crystals similar on Ice. Mixs up with water, spirit, an ether and others Solvents.
Etilovyj ether (С2Н5ОС2Н5). It is dissolved in 12 parts of water. Mixs up with spirit, chloroform, petrolejnym an ether, etc.
Gasolines (a mix of hydrocarbons). The important property - is fast Disappear, are very inflammable.
Chloroform (СНСI3). Mixs up with spirit, an ether, gasoline. It is difficultly dissolved in water (1:200.)
Dihloretan (СН2СI СН2СI). Mixs up with spirit, an ether. At Inhalation parov - a poisoning. Maloogneopasen.
Four-chloride carbon (ССI4). Neogneopasen.
Oils vegetative - peach, almond, sunflower. Mix up with an ether, chloroform, gasoline, do not mix up with Spirit and water. Property - progorkajut, raises acid Number.

WATER.
Water distilled (Aqua destillata)
Till now you dealed with water distilled at carrying out Laboratory researches. Quality of her is regulated GF XI. She There should be colorless, transparent, without a smell and taste, a value rN within the limits of 5,0 - 6,8, the dry rest should not exceed 0,001 % (i.e. 1 mg in 100 ml), in her should be absent nitrates, Nitrites, chlorides, sulfates, calcium, heavy metals, carbon dioksid, traces of ammonia (0,00002 %) are supposed. The general principle Receptions of water distilled consists in the following. Potable water or the water past v/p, place in distilljator, Consisting of 3 basic sites: the evaporator, the condenser and The collection. The evaporator with water heat up to boiling. Pairs water Act in the condenser, where they szhizhajutsja and as distillate Act in the collection. All nonvolatile impurity which are taking place in To initial water, remain in distilljatore. On ability of heating distilljatory share on electric and steam. Are known distilljatory electric continuous action of stamp ДЭ-1 and ДЭ-25. One of them Q = 4 l/ch works in one of laboratories.

Water demineralizovannaja (Aqua deminevalisata).
Recently pay attention to use of water demineralizovannoj instead of distilled. It is connected to that, What is distilljatory often fail. High The maintenance of salts in initial water results in education of a scum On walls of the evaporator that worsens a condition of distillation and Reduces quality of water. For obessolivanija waters it is applied Various installations. The principle of their action is based that Water is released from salts at propuskanii her through Ionic - exchange pitches. The basic part of such installations are The columns filled kationitami and anionitami. Activity kationitov it is defined by presence karboksilnoj or sulfonovoj The groups, possessing ability to exchange ions N + on ions Alkaline and shchelochnozemelnyh metals. Anionity - more often Products polim-i aminov with formaldehyde, exchange the gidroksilnye groups HE on aniony. Installations also have capacities For solutions of an acid, alkali and water distilled for Regenerations of pitches.

Cleared and apirogennaja water.
However today in a farmaceutical industry it is used Only water cleared (ФС42-2619-89) and water for injections. (ФС42-2620-89.)
By the example of the device and job of installation « Dzherelo - 500 » We shall familiarize with the typical circuit of water treating.
The principle of job of installation is based on a method of the opposite osmosa, I.e. kills of a liquid with small concentration dissolved Substances through polupronitsaemye membranes rolled o-o elements (ERO) under influence of superfluous pressure of a liquid. Thus From permeata 98 % of the dissolved salts are removed. The rest salt It is removed with the help i-o filters.
Installation will consist from o-o the block and the block of operational development of water (it is possible Inclusion in the circuit of the block v/p). The description of the circuit: Initial water for The bill of pressure in a network moves on an input of filter F1 (detained Ability 20 microns) and further in filter F2 (detained Ability 5 microns). From filter F2 acts on the pump high Pressure for submission in consistently connected o-o devices (ERO). The cleared water (permiat) is selected from o-o devices and Acts in the block of operational development of water where consistently passes Through to-о filter F3, a-o filter F4 and filters finishing clearing Ф5 and Ф6 with detained ability 5 microns and 0,22 microns Accordingly. e-КУ-2-8 (N +); C-АВ-17-8 (he).
During clearing from water leave:
- Fe; (the filter of rough clearing)
Salts; return osmos, i-o
Microorganisms;
pirogeny. (membranes 5 microns and 0,22 microns)
Collections for chemical clearing ERO, regeneration Ф3 иФ4.
Kirishi - UOV and UVV.
УВВ-500.
The block of prepreparation - the filter with a limit of detention 5 microns.
Zn - 80 %; Мn - from 50 up to 96 %; Fe from 60 up to 95 %; caesium and strontium- 99 %% phenol - 65 %; hlororganika - 85 %; ammonia - 35 %; nitrites- 58 %; nitrates - 80 %; bacteria - 95 %; dioxine - 99 %.
O-o installation
Salts 90 - 95 %; full removal on item 1.
The block of finishing clearing
Superpure water leaves.

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