Ãëàâà 18 Gelatine
Capsules. Firm capsules. Soft capsules. Reception of gelatine. Reception of soft gelatinous capsules.
Preparation of a gelatinous solution (weight). Manufacturing
Shells of capsules in the way of immersing. Filling of capsules. Others
Ways of reception of gelatinous shells.
Gelatinous capsules.
As the term of "capsule" understand two kinds of production factory
Manufactures:
Special receptacles from gelatinous weight for a premise in them
Different dozes of medicinal substances;
Ready dosed out LF - gelatinous capsules and microcapsules,
Filled poroshkoobraznymi, granulated, pastelike and
Liquid medicinal substances.
More often they are intended for intake, less often for rektalnogo,
vaginalnogo, etc. ways of introduction. Their basic purpose at
Intake - masking of unpleasant taste and a smell of a medicine.
For the first time gelatinous capsules have been offered in 30th years
The last century in France. In the beginning they have received
Distribution only in chemist's practice. However gradually and
Especially for last years this LF became very perspective
Thanking:
High accuracy of batching placed in them medicinal
Substances;
Medicinal substances are protected from influence of light, air,
A moisture;
Unpleasant taste and a smell of medicinal substances is excluded;
Capsules have good, appearance and is easily swallowed;
Quickly nabuhajut, are dissolved and soaked up in gastroenteric
A path, pharmacological action medicinal substances
It is shown through 4 - 5 minutes;
Are characterized by high biological availability.
In gelatinous capsules all substances, not can be released
Entering interaction with glycerin and gelatin and not
rastvorjajushchie gelatin.
Lack of gelatinous capsules is their high
Sensitivity a moisture. It demands observance certain
Conditions of their storage. Other lack of gelatinous capsules-
The perfect environment for duplication of microorganisms-
It is prevented by addition in weight of preservatives: nipagina
(0,4 %) nipazola (0,4 %), sorbinovoj acids (0,1 - 0,2 %), etc.
Distinguish 2 types of capsules: 1) firm with kryshechkami and 2) soft, with
The integral shell.
The consistence of capsules depends on a parity of three basic
Components: gelatin, glycerin and water. Glycerin in part can
To be replaced with other softeners - sorbite, sugar
A syrup.
Firm capsules are intended for batching loose
poroshkoobraznyh and the granulated substances. They have the form
The cylinder with the hemispherical ends will consist of two parts:
Cases and kryshechki; both parts dolzhnysvobodno one enters in
Another, not forming backlashes.
Soft capsules - for liquid and pastelike medicinal
Substances. Have the form spherical, jajtsevidnuju, oblong or
Cylindrical the hemispherical ends.
Quality of capsules in many respects is defined plenkoobrazovateljami,
Which now it is totaled from above 50: gelatin, fats,
Paraffin, MTS, ETS, polythene, nylon, PVC, etc. The Basic raw material
For reception of capsules gelatin is.
Reception of gelatin.
Use of gelatin at manufacturing capsules is based on
Abilities of his water solutions at cooling to form
A firm gel. It receive from various kollagensoderzhashchego
Raw material - bones, cartilages, sinews of large horned livestock and a leather
Pigs, applying 2 ways: acid and alkaline. A product,
Received at sour processing, it is known as gelatin such as "C",
At alkaline - such as "u". In our country apply gelatin of type
"u", though gelatin such as "C" is most perspective (it turns out
A solution with higher durability and viscosity).
Gelatin - Naval Forces of the albuminous nature - a product of partial hydrolysis
Collagen, in a basis of his albuminous molecule lays polipeptidnaja
The circuit formed by 19 amino acids, the main thing from which are
glitsin, prolin, arginin, lizin, etc.
Manufacturing soft gelatinous capsules by three ways:
Immersing, pressing and in the drop way.
Manufacturing firm gelatinous capsules by immersing and
Pressing. In our country of them receive on the first method.
Reception of soft gelatinous capsules.
1 way - a way of immersing (Gorkovsky HFZ).
Will consist of the following operations:
Preparation of a gelatinous solution;
Manufacturing shells of capsules;
Filling capsules;
zapajka capsules;
The control of capsules;
Drying capsules;
Polishing capsules;
Washing capsules;
Regeneration of the rejected capsules.
Preparation of a gelatinous solution (weight).
For his preparation use gelatin, glycerin and water. For
Soft capsules spend 20 - 25 % of glycerin, for firm - 0,3 %.
Besides take softeners: sorbite, polietilensorbit with
oksietilenom; dyes: the titan dvuoksid (white), amorant
Sour, eritrozin (red), tartrazin (yellow), indigotin
(Dark blue). For antimicrobic stability of shells in structure
A solution enter preservatives: nipagin and nipazol, an acid
benzojnuju, sodium benzoat, etc.
For gelatinous weight prepare in the enameled reactor with steam
A shirt, supplied with an anchor mixer (25 - 30 rev/min). In
Avoidance infitsirovanija the equipment and industrial
Premises subject disinfection 2 times month, devices-
Sharp the ferry.
There are 2 methods of reception of gelatinous weight: à) with swelling
Gelatin; á) without swelling gelatin.
à) Gelatin in a reactor fill in water (temperature 15 - 18? Ñ) on
1,5 - 2 hours, then rasplavljajut it at t=45 - 75? C at
Hashing within 1 hour add preservatives, etc.
Auxiliary substances, continuing hashing of 30 more minutes
Then disconnect heating and a mixer, leave weight in a reactor on
1,5 - 2 hours with connection of vacuum for removal from weight
puzyrkov air. The prepared weight pass in termostat and
Maintain at t = 50 (60)? With for stabilization 2,5 - 3 hours.
This technology is used for reception of capsules by a method
Pressing with high concentration of gelatin.
á) in the water which has been heated up in a reactor up to 70-75? With, dissolve
Preservatives and softeners also load gelatin at switched off
To a mixer. The prepared weight maintain in termostate for
Stabilization 2,5 - 3 hours at t = 45 - 50? Ñ.
Manufacturing shells of capsules by way of immersing.
à) Soft capsules.
Gelatinous shells are produced with the help makalnyh frameworks-
Forms. Forms represent duralumin pegs oval
Forms (height 21 mm, diameter 10 mm), ukreplennye on a framework in
Quantity of 28 pieces on distance of 50 mm from each other. Before
makaniem a framework with forms place in a refrigerator and maintain 5
- 6 minutes at temperature 3 - 8? C. A cooled framework,
Preliminary greased with a thin layer of peach oil, smoothly
Lower in makalnuju the bath filled in the heated up weight, then
Smoothly take out, give to flow down to surplus of weight and, having turned
Pegs upwards, again put in a refrigerator for zhelatinizatsii on
10 - 15 minutes (thus frameworks move on the conveyor). From
Temperatures makanija, coolings and zhelatinizatsii depend thickness
And weight of the shell. The weight of the shell should be within the limits of 0,85-
0,9
The cooled framework take out from a refrigerator, remove manually
Shells also establish them on the aluminium board having 12
Jacks. Ready shells act on filling, defective-
Regenerations are subject.
á) firm capsules.
Cylindrical forms - pins on the frame - holder smoothly
Are immersed by means of the automatic device in gelatinous
Weight and, rotating about the axis, rise and pass
Some stages of drying, all over again at t? Air = 26 - 27? With and
Relative humidity 45 - 50 %, then at t = 18? With and
Relative humidity 70 - 75 %. From drying installation of a frame
In pairs (one with donyshkom, another with kryshechkami) move in
The automatic site, where shells of a capsule podrezajutsja
A rotational knife, are removed by mechanical paws and move in
The connecting block where there is an acquisition of capsules.
Forms - pins are cleared, greased vegetative or
Mineral oils, the cycle repeats, his duration
Makes 45 - 47 minutes. The received empty capsules with kryshechkami
Are filled with medicinal substances on special automatic devices
Or act in drugstores empty, and there are filled necessary
Substances.
Filling capsules.
à) Soft capsules.
It is applied electronic dozator (Gorkovsky HFZ). Dozator
Represents the piston pump with a regulator of volume of the worker
The cylinder and an electronic regulator of a pause. The basic working site
dozatora - a medical syringe in capacity of 20 sm?, which is supplied
System of valves (soaking up and forcing) and system
Adjustments otsechki.
At a soaking up course the piston dozatora the liquid gets in a syringe.
At reverse motion she is pushed out in a rubber tube, which
Comes to an end a pipette which the packer enters in empty
Shells. After filling gelatinous capsules immediately act
On zapajku.
Zapajka capsules (for soft capsules).
This operation make with the help of an electrosoldering iron. Heated up up to
55 - 65? About a soldering iron manually rotate on a circle of an aperture shejki
Capsules that results in local fusion of gelatinous weight
At the moment of contact with a soldering iron. Podplavlennaja weight
Hermetically closes shejku capsules.
The control of capsules (for soft capsules).
Check quality zapajki. Reject the capsules giving a leak (at
Easy compression by fingers).
Drying capsules (for soft capsules).
Drying make in a case with compulsory air circulation
At t = 23 - 26? With within 20 hours. Capsules mix at
To drying.
Polishing capsules (for soft capsules).
Do with the purpose of removal of oils, etc. pollution from a surface
Capsules. For this purpose capsules place in capacity, fill in
trihloretilenom or izopropilovym spirit, maintaining at
Constant hashing 5 - 10 minutes. Then capsules unload in
A grid, give to flow down, peresypaju on a grid covered by parchment, and
Dry in a case. The second drying - for removal of solvent - in
Current of 4 hours by air at t = 23 - 26? S.Posle etogo again
Capsules fill in trihloretilenom or izopropilovym spirit and 2-
3 mines mix. Then capsules pour out on lattices,
Covered by pure parchment also dry at t = 20 - 22? With air
Within 1,5 hours for finishing humidity of shells up to 8 - 10 %.
The dried up capsules pack up in jars.
Regeneration of the rejected capsules.
Defective capsules razrezajut also separate shells from a solution
A preparation with the help of a centrifuge. Shells recycle and let
In manufacture of capsules separately.
á) firm capsules.
Process of filling of firm capsules by medicinal substances
For filling firm demountable gelatinous capsules use
Automatic devices of various firms (Q = 20 - 150 thousand / ch) and accuracy
Batchings 2 - 5 %. Depending on mechanical properties
Medicinal substance automatic devices with shnekovymi are used,
tarelochnymi, piston, vacuum or vibrating
dozatorami. The closed capsules act in the bunker, from him in the block
Orientations. Focused capsules (donyshko downwards, kryshechka
Upwards) are passed in the block napolnitelja, where they with the help of vacuum
Open, filled poroshkoobraznymi or granulated
Medicinal substances, are closed kryshechkami and are stuck
(podplavlennoj a tape of gelatin or polyvinyl spirit). Further
There is a rejection of empty capsules (are easily sucked away as having
Smaller weight).
Other ways of reception of gelatinous shells.
II way - drop.
Masloobraznyj the preparation from the tank acts in dosing out
The device, whence is pushed out simultaneously with fused
In gelatinous weight from the tank in zhihlernyj the site, where
There is a formation of drops. The help of a pulsator of a drop
Come off and act in a cooler representing
Circulating system for formation of capsules, which in
A ready kind act in the vessel filled cooled up to +4? With
Oil olive or paraffin. Submission of the cooled oil to
To a pulsator and a cooler - with the help of pumps. Capsules wash out and
Dry. The drop method is based on simultaneous education
The gelatinous shell and filling with its doze medicinal
Substances. A method are characterized by high efficiency (28
- 100 thousand / ch), accuracy batching of medicinal substance,
Durability of issued capsules, their good appearance.
Lack of a method - is applicable for kapsulirovanija only liquid
Substances - vitamins And, D, E, To, a solution of nitroglycerine, etc. On
Capsules on this method there is no seam.
III way - pressing (shtampovanija).
Consists in reception of a gelatinous tape (foil), from which
Stamp capsules. ZHelatino - glyceric weight as
The gelatinous tape, hardened and dried up, place on bottom
A part of a matrix inside of which acts pairs or hot water.
The tape slightly rasplavljaetsja also fills in deepenings of a matrix, in
Which medical product (oils, oil is filled in
Solutions, suspensions, etc.). From above impose the second
A gelatinous tape also cover with the top matrix. Both matrixes
Connect and place under press where cut out capsules with a seam on
To perimeter. The machines working by such principle-
Are unproductive.
Instead of horizontal kapsulnogo press on Gorkovskom HFZ
The automatic transfer line (England) is applied Lajnerovskaja. These are two
A drum which rotate and are supplied with numbers screw-cutting
Matrixes on which gelatinous tapes are imposed.
Such line can serve and for filling capsules
poroshkoobraznymi substances. Productivity of her 20 thousand / hour.
