Rock oleoresin tablets' preparation method

FIELD: pharmaceutical industry.

SUBSTANCE: preparation method comprises heating rock oleoresin to specified temperature, forming tape by passing through rolls, and tableting in laminar air flow using, for example, tubular knife with cutting edge sharpening radius no greater than 0.2 mm.

EFFECT: enabled tableting in absence of inert additives at any temperature and moisture characteristics of atmospheric air and enhanced therapeutical effect of rock oleoresin tablets.

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The invention relates to the pharmaceutical industry, in particular, to methods for producing pharmaceutical preparations in the form of tablets of substances with high viscosity without making inert additives.

A known method of manufacturing tablets mummy (without making inert additives), namely, that the mass of purified Shilajit with moisture content of 1-5% is subjected to granulation in environmental humidity not exceeding 50%, and then tabletirujut at the same humidity environment (see RF patent №2066993, MKI a 61 K 9/20).

However, this method before tabletting contains a number of operations that can impair the healing properties of Shilajit, namely:

granulation of the drug implies drying 1-5% humidity that causes loss of essential oils (30%). The tabletting process is quite complex, with high labor and energy costs, as well as drying is crushing and double sieving through a sieve to ensure uniformity of particle size distribution, and the tabletting process is performed under a pressure of 95 MPa. In addition, tableting Shilajit is only possible if atmospheric moisture within 50%, while the humidity can reach (for example, during rainy weather) up to 80% and above, which causes the termination of the process table the tests in this period. It should also be noted that Shilajit with humidity 1-5% due to the increased hygroscopicity poorly stored.

Known “Method of purification of the mummy”, including the preparation operation mumie to the tabletting process, namely dried to 4% moisture content, heating (melt) extract Shilajit at 55-60° and the pressure of 6.0 MPa, followed by extrusion of the heated mass in a continuous stream through a round hole, the feed rolls to form a continuous ribbon and tabletting (see RF patent №2072850, MKI a 61 K 35/00-prototype). However, tableting mummy with 4% humidity due to the fragility of the tape with a thickness of 2 mm is possible only by pressing. In addition, drying and melt worsen the healing properties of Shilajit. Thus, both well-known method of preparation of Shilajit to manufacture tablets are characterized by the operations that can impair the quality of the preparation (drying, melt) with high labor and energy costs. In addition, due to the high hygroscopicity mumie (causing sticking of the working bodies in the pelletizing) the manufacture of tablets as the way to similar, and the prototype is only possible when environmental humidity (atmospheric air) is not higher than 50%.

An object of the invention is to develop a method of manufacturing tablets mummy, allowing the tabletting process when Shir the kOhm range of temperature and humidity characteristics of the atmospheric air, while improving the quality of tablets and reducing labor and energy costs due to the exclusion of processes of drying and melt mummy.

The method consists in that in the method of manufacturing tablets mummy, including the formation of a short ribbon by passing through the rolls, mummy before formation of the tape is brought to a temperature of 22-28° and tableting is carried out in a laminar air stream with a temperature of not higher than 30° and humidity 55-65%, for example, a tubular knife with radius sharpening of the cutting edge is not more than 0.2 mm

Mumie on THE 9100-001-20888341-98 “Mummy cleaned “Asil-C” is a dark brown (close to black) hygroscopic mass with characteristic resinous smell and bitter-astringent taste, which is intended for tableting. For the manufacture of tablets of the claimed method can be used any Shilajit produced in different regions of the CIS, as its final consistency (after cleaning) usually the same. Therefore, the claimed method is applicable for tabletting mummy from any region (Kyrgyz, Altaic and so on).

Due to the high hygroscopicity mummy degree of plasticity and viscosity depend not only on temperature but also on the humidity of the air. In addition, studies have shown, much of the flexibility, ensuring the maintenance of quality shaping ribbon and tablets as well as the viscosity, which determines the sticky, largely from its own temperature mummy. Thus, blocks mummy weighing 2 kg were subjected to uniform warming up to 17° With subsequent determination of ductility and toughness.

Similar experiments were carried out at temperatures from 18 to 29° C. it Turned out that the optimal value of these parameters, i.e. working condition mummy when pelletizing knife was observed when the temperature uniform heating unit mumie from 22 to 28° C. When the temperature is 17-18° With the tape by passing through the rolls fell apart when 19-21° had cracks, i.e. was fragile. When the temperature warms up more than 28° With symptoms of sticky rolls and knife. The formation of the tape and tableting at each value of the investigated temperatures warm up (from 17 to 29° (C) held with the spectrum of relative humidity from 45 to 90%. Optimal humidity, eliminating the sticking knife, and providing (if necessary) the degree of drying without fragility, was 55-65%. However, since the humidity of the atmospheric air can be up to 85% and above, it was necessary to exclude the influence of atmospheric moisture variations in the manufacturing process of tablets. The latter was achieved by the fact that the manufacture of tablets after the formation of the ribbon spend the laminar jet of air at a speed for example, 7-16 m/s and brought to the temperature at which the humidity of the jet is in the range of 55-65%. The air jet formation is taken from the ambient air. The stream of air is passed over the tape during tabletting, because speed is characterized by an increased pressure compared with the surrounding air, thus eliminating its effect on the humidity of the stream.

The calculation of the required temperature of the jet to ensure that it is optimal for tabletting humidity (55-65%) is quite simple. So, there is a well-defined dependence of the maximum air humidity on the temperature (see the Handbook of physics X. Kuhling, M., Mir, 1982, page 172-173, 486), reported in table 1.

Table 1
IndicatorsThe temperature of the atmospheric air, °, t° )
141516171819202122232425262728
Maximum humidity,

g/m3(f0max)
12,0812,8413,6514,515,3916,2 17,3218,3519,4420,621,8123,0724,425,7927,26

Using this table, taking into account the temperature and humidity of the atmospheric air, as well as the required humidity in the manufacture of tablets, we find the temperature to which it is necessary to bring the stream is sent to the tape, thereby ensuring its optimum moisture content. From equation relative humidity ϕ =fac/fmax· 100 follows that fac=ϕ · fmax/100, where ϕ - relative humidity, fac - absolute humidity, fmax - maximum humidity temperature ϕ . Thus, the relative humidity in the shop tabletting can be expressed by the formula ϕ ° =f° anti-lock brakes/f° max· 100, where f° abs - absolute humidity in the shop, f° max - maximum humidity at the temperature of the air in the shop.

Relative humidity jet - ϕwith=fwithanti-lock brakes/fwithmax· 100, where fcabs - absolute humidity of the air taken from the shop, fwithmax - maximum humidity at a temperature of providing ϕc. Here f° abs=ϕ ° · f° max/100, f° abs=ϕ ° · f° max/100, as well as the air jet formation is taken from the shop, then f° abs=fc abs, and then ϕ ° · f° max=ϕc·fwithmax, and mean maximum humidity jet fcmax ϕ ° · f° max/ϕc. Because ϕ ° , ϕcand f° max values are known, they calculate values of fcmax and table 1, find the temperature that is necessary to bring the stream to provide the required humidity (55-65%).

Example: In the beginning of a shift in the production shop tablets ambient temperature was 21° C and relative humidity 70% (ϕ ° ). To process the humidity of the jet should be in the range of 55-65%, for example, 59% (average value). In table 1 we nd f° max=18,35 g/m3hence fcmax=70/59· 18,35=21.8 g/m3on table 1, find the value of fcmax (21,8), it corresponds to a temperature of 24° C. Therefore, to achieve the required moisture content (59%) a stream of air is enough to warm up on 3° C. For convenience, the claimed method can be used to develop worksheets that reflect the desired temperature of the heating or cooling at a given (selected) the value of relative humidity. For example, table 2 presents the values of the temperatures to which it is necessary to cool or heat the air directed jets to ensure that it is working humidity was 58%. The temperature in the shop is taken from 18 to 22° With as optimal for the working space. The relative humidity in the shop presented within the fluctuations of the atmospheric air from 50 to 88% is the most common.

Table 2
The temperature in the shop,

°
f° max

on

table. 1
Relative humidity, % (ϕ ° )
5052545658606264666870727476788082848688
1815.391616171718181919202121222223232424252525
1916.321717181819192020212122 232324242525252626
2017.321718191920202121222323242425252526262728
2118,351819202021222223232424252526262727272828
2219.4419202121222324242425252626272728282929 

ftmax=ϕ ° /ϕt·f° max, where ϕ ° - relative humidity in the shop

ϕtthe required relative humidity (58%)

f° max - maximum humidity 18, 19, 20, 21, 22°

ftmax - maximum humidity at a temperature of providing ϕ ° .

From table 2 the calculated ftmax find the temperature, providing 58% humidity.

Example 1. Two kilograms mummy in the shape of a bar with 13% humidity (stored at a temperature of 0° (C) kept in a thermostat at a temperature of 26° C for 2 hours to achieve 24° in the centre of the bar. After that softened mumie was passed through rolls to form a tape thickness of 2 mm, the Temperature and humidity in the shop at the time of formation of the tapes were 18° and 80%, respectively.

According to the working table 2 required 58% relative humidity will be provided by heating the flow of atmospheric air up to 24° With (intersection of lines 18° and column 80%), in which ftmax=21,81 g/m3(table 1). Heating of the jet and its direction was carried out by the heater, and tableting tubular knife.

Example 2. Preparation and formation of the tape of example 1. Temperature and humidity in the shop at the time of formation of the tape 21° and 50%, respectively. According to table 2 required 58% humidity will be provided at the cooling flow of atmospheric air up to 18° (fmax=15,39 g/m3).

Example 3. Training, formation of the tape and the mode is tabletting mummy in example 1. Next to 3 cesam day the air in the shop was characterized by 20° and 76% humidity. The air flow according to the work table 2 is necessary to warm up to 25° (fmax=23,07 g/m3).

Range of the optimum process for tableting humidity from 55 to 65% can affect the excess moisture mummy coming to tableting. So, when humidity mumie 14% of the required drying in the tabletting process up to 12% (the moisture content of the finished tablets according to the technical conditions). Therefore, as the optimum moisture content of the laminar jet of air is passed over the plate, you should choose more dry air, for example, 58% humidity, and at 12% moisture mummy set of 64% relative humidity spray. Drying at the moment tabletting can be done by increasing the speed of the jet of air directed to the tape.

Physico-chemical characteristics of tablets mummy, made the claimed method are illustrated in table 3.

Table 3
No.IndicesThe value of the index
1Appearance, smell and tasteTablet black with a smooth shiny surface, characteristic resinous smell and bitter - astringent taste
2The average weight of the tablets, g0,2 +/- 0,02
3pH of 1% aqueous solution7,0-9,0
4Solubility, min, not more than10
5Mass fraction of moisture, %, maxto 12.0
6Mass fraction of total ash, %, max35,0
7Mass fraction of ash insoluble in 10% hydrochloric acid,%, not more than1,6
8AuthenticityChemical reactions positive
9Mass fraction of humic acid, %, not less than4,0
10Mass fraction of glycine, % not less than1,0

The content of toxic elements, radionuclides, and microbiological indicators tablets mummy, made the claimed method, comply with the requirements of SanPiN 2.3.2. 1078-01 and THE 9377-001-01898825-2002 developed by the applicant and applicable to tablets mummy “Altai”, used as a biologically active food additives.

An example of using tablets mummy, received claimed: tablets Mummy cleaned “Altai”, it is recommended to use as biological and active additives to food tonic action adults : 1 tablet 1-2 times a day during meals with food. The duration of intake 25 days, 10 days, repeat the course (registration certificate №R..08.2002 issued by the Ministry of health of the Russian Federation).

Thus, the technical effect of the claimed method is that the process of manufacturing tablets, Shilajit can be conducted at any ambient air humidity in the shop tabletting, in contrast to known methods, where the process of manufacturing tablets mummy impossible with 51% humidity. In addition, the processes of drying and melt Shilajit increases its therapeutic properties and reduces labor and energy costs in the manufacture of tablets mummy, that is ultimately increases the intensification of the process of tabletting and productivity.

1. A method of manufacturing tablets mummy, comprising heating the mummy, the formation of the tape by passing through the rolls, followed by pelletizing, characterized in that prior to formation of the ribbon temperature mummy is brought to 22-28°and tableting lead to laminar jet of air at a temperature of not higher than 30°and humidity 55-65%, for example, a tubular knife.

2. The method according to claim 1, characterized in that the radius sharpening the cutting edge of the knife is not more than 0.2 mm



 

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