Method of manufacturing capsules for determination of gastric juice acidity

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention relates to chemical-pharmaceutical industry and medicine. Method includes: formation of hollow capsules, their hardening and following packing, which differs in the act that as material for manufacturing of capsules applied are substances, able to dissolve in gastric juice with speed, depending on its acidity degree, and manufacturing of capsules is carried out in chamber with increased gas atmosphere pressure. Packing of capsules can also be carried out in chamber with increased pressure, it is necessary to do packing of capsule able to preserve said pressure and provide air-tightness during fixed term of capsule storage.

EFFECT: increased efficiency of method of manufacturing capsules for determination of gastric juice acidity.

3 cl, 1 ex

 

The invention relates to the field of analysis of biological materials, namely the composition of the gastric juice.

There is a method of measuring the acidity of gastric juice by the time of the dissolution of capsules filled with air or gas under high pressure, the point of brittle fracture which is recorded by the patient on the subjective feelings of cotton (Patent RU №2314782). The disadvantage of the above mentioned patent, limiting its applicability, is that it does not offers the possible ways of making capsules.

A known method of making capsules for oral administration based on gelatin (Technology of medicinal forms: a Textbook in 2 volumes. Edited Laipanov. - M.: Medicine, 1991, vol 2, s.226-237). Capsules made of other materials can be obtained, for example, using flour and starch, the methods used in the production of pasta (Hrolenkov V.M. Technological equipment bakeries and pasta factories. - SPb.: GIARD, 2004), as well as the methods used in the manufacture of caramel. Thus, known methods of making caramel filling (Zubchenko AV Technology for confectionery production/Voronezh state technology. Acad. - Voronezh, 1999, s-235), which allows to obtain a solid product, containing inside is filled with whatever content the cavity.

A common feature in the ex the following methods is the initial preparation of the plastic mass, forming the products of desired shape and size and their subsequent curing by drying, use of phase transitions such as crystallization or chemical reactions such as polymerization.

As a prototype of the present invention is to select the first of the following methods - a method of making capsules gelatin-based, as the closest belonging to the technology of medicinal forms. The method involves the following technological operations: preparation of a plastic mass capable of subsequent solidification; forming from her capsules and their cure; subsequent, or simultaneous with the forming, filling capsules with the medication; the packaging of finished products. This method has various implementation options: immersion method, drip method, pressing. Any of these methods are equally suitable for the purposes of the present invention.

Lack of gelatinous capsules from the point of view of applicability to those described in the patent RU No. 2314782 method is the absorption of gelatin and its ability to swell and soften in the environment of gastric juice, which does not allow for brittle fracture of the capsule when it is thinning. In addition, the described method of making capsules does not provide for the possibility of creating both outside gas environment with high blood pressure.

The aim of the invention is to extend the scope of application of the known method of manufacture of capsules for the production of capsules to determine the acidity of gastric juice containing gaseous atmosphere under high pressure.

This goal is achieved by using materials that meet the requirements of the patent RU №2314782 - ability to brittle fracture and dissolution in gastric juice with a speed that depends on the degree of acidity. And the fact that the manufacture of capsules offered to produce in a sealed chamber containing air or other gas under high pressure corresponding to the desired pressure of the gas medium inside the capsules. Then, after removing the finished capsules from the camera, they are containing air or gas under high pressure, as is required in accordance with the patent RU No. 2314782.

The filling of capsules can also be produced in the same chamber, which in some cases will reduce the cycle time, due to the fact that the final curing of the material of the capsule may occur already in the warehouse of finished products, and not in a production environment. In addition, it will allow to exclude possible negative manifestation of the effects of creep in the material of the capsules during prolonged storage. Obviously, the packaging should cover the ü individual storage of each capsule and to ensure the integrity and maintaining the desired pressure throughout the established shelf life capsules. Packaging can be, for example, a small rigid containers, resealable lids on the thread, or sealed bags made of thick and dense plastic that does not allow for gas diffusion.

Known technology is the so-called "clean rooms" by creating indoors excess pressure. However, this method according to the author of a proposal is to be contrasted with the present invention, since the goal of the technology of clean rooms is to maintain a highly clean atmosphere in the areas where it is needed: in operating on the production of ultra-pure materials, etc. used For this air conditioning system, which creates excessive pressure value less than the thousandth part of the atmosphere. The method assumes the location of the slit, through which the air under pressure escapes, his current preventing penetration inside of polluted outdoor air. In the proposed same the invention the purpose of this method is the production of articles containing gas under high pressure, the magnitude of this pressure up to several atmospheres, to create such pressure can only compressor installations, the presence of cracks in the chamber is eliminated. Thus, the proposed method does not have the same technology net premises or goals or methods re the implementation, neither the values of the key parameters, or set of essential attributes.

The proposed method can be implemented in various ways. As mentioned above, for the manufacture of capsules can be used drip method, immersion method, extrusion. So, in the drip method, replacing the drug with air or other gas, the hollow capsule can be obtained from solid droplets of viscous material "blowing", just as it occurs in the glass case. In a method of immersing the slices capsules are manufactured separately and then assembled and sealed the finished capsules. To obtain hollow capsules in this case, it is sufficient merely to exclude the procedure of filling her drug. In the method of pressing capsules get their connection halves obtained, for example, a rotary-matrix machines. In this case also, by eliminating the step of filling, you can get a hollow capsule. In addition, it is possible to use methods used in the above-mentioned processes, related in nature to the analyzed. For example, a method of forming caramel harness with an inner canal filled with stuffing, with subsequent separation of the harness on a separate closed fragments. If we exclude from this procedure using the filling and the shaping of the caramel mass harness with the internal channel, i.e. the receiver, then dividing it by squeezing in short fragments, it is possible to obtain a hollow, hermetically closed volumes.

In most of the reviewed methods of sealing the capsule occurs simultaneously with the molding, but, for example, a method of immersing the molding and curing of the fragments occurs earlier, and sealing is performed during Assembly of the capsule of the finished pieces. For example, this difference can be seen that there is no need at all stages in the preparation of capsules to be executed in the high-pressure chamber. From the point of view of the principle of the present invention is the presence of capsules under high pressure stage sealing that provides ingress into its cavity and preserving the necessary quantity of air or gas.

If desired, it is easy to provide a partial filling of the internal cavity of the hollow capsules heavy ballast weight, for example of barium sulfate, to give a capsule negative buoyancy.

Strictly speaking, not necessary that the entire capsule was made of material that meets the requirements of the patent RU №2314782, because any of the above and some other well-known ways you can get thin hollow capsule from unstable or extremely short-lived material. Such a capsule in the future can the be used as a germ for the coating of material required by the patent RU No. 2314782 properties (or from layers of the necessary materials) for example, the method drazhirovanija. In this case, the strength and fracture behavior of capsules to be defined not by the embryonic capsule, the role of which is extremely technological and mechanical characteristics of the coating, which essentially forms the enclosure.

To improve the stability characteristics of the capsules when used, it seems advisable to perform on the capsule surface, girding her ring grooves, which should serve as a hub stresses and to determine the direction of crack initiation in brittle fracture. This will avoid the possibility of inadvertent development of cracks that would have made it less predictable nature of the fracture and the time before him.

An example implementation of the method.

Sugar-candy was heated to the melting temperature and stirred it with antacid agent in an amount up to 5 wt.% (in the first experiments used the baking soda, and later - to avoid partial decomposition during cooling, the sodium carbonate with the formation of micro bubbles, carbon dioxide, reducing the strength of the resulting material is milled drug "Rennie", containing 680 mg of calcium carbonate and 80 mg of magnesium carbonate in 1 tablet). Next, the resulting composition was poured into a hemispherical form with a diameter of 10 mm and in the process his sate is Devane squeezed in the Central part of the formed blanks hemispherical pits with a diameter of 5 mm, thus obtaining the original shells. Then one shell was installed inside a disposable syringe with pre-melted conical tip, positioning it so that the rounded part of the shell was converted to the tip. Next, the edge of the second shells were fused and was quickly introduced its plunger into the syringe until it touches the edge of the first shell, after which the piston was fixed in this position by means of a clamp and additionally gerotziafas fast-curing adhesive based on ethylcyanoacrylate. After complete solidification and cooling of the obtained capsules piston is released and the finished capsule, containing within itself the air under high pressure, were extracted for use in subsequent experiments.

This laboratory experience proves the applicability of the proposed method, and it is obvious that the application of known industrial technologies inside the chambers of the appropriate size it can be implemented on an industrial scale in the framework of a continuous production process.

When carrying out the invention may be obtained from the technical result consists in the adaptation of existing methods to the task of making a new product designed to simplify and facilitate the procedure of determining the parameters of gastric juice.

. A method of making capsules to determine the acidity of gastric juice, comprising preparing a plastic capable of subsequent solidification, mass, forming from her hollow, or partially filled ballast weight, capsules, sealing, hardening and subsequent filling, characterized in that at least the stage of manufacturing that is associated with the sealing of the capsules produced in the chamber with a high pressure gas atmosphere, and as the material of the capsules use substances that can dissolve in gastric juice with a speed that depends on the degree of acidity or soft cover technological capsule such substances.

2. The method according to claim 1, characterized in that the filling of capsules produced in the chamber with higher pressure, and packaging of capsules do are able to maintain this pressure and to ensure the integrity within the prescribed shelf life capsules.

3. The method according to claim 1 or 2, characterized in that each capsule perform around its annular groove.



 

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