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: а) with swelling Gelatin; б) without swelling gelatin.
а) Gelatin in a reactor fill in water (temperature 15 - 18? С) 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.
б) 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? С.
Manufacturing shells of capsules by way of immersing.
а) 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.
б) 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.
а) 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.
б) 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.

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