Method of introduction protective medium into biologically active material

FIELD: medicine.

SUBSTANCE: invention relates to method of introduction of protective medium into liquid phase during dispersion of biologically active material. Biologically active material contains liquid phase with active substances in microdrop state, which is stabilised by highly-disperse hydrophobic disconnector with nanosized particles.

EFFECT: increase of dispersity of biologically active materials, containing active substances in liquid phase.

6 tbl, 3 ex

 

The invention relates to medicine, biotechnology and pharmaceutical industry and relates to a method of introducing a protective environment in drip powders containing biologically active ingredients in the liquid phase.

Due to the large number of experimental studies by scientists from different countries of the world have demonstrated the possibility of preserving the viability of many microorganisms after dehydration and storage in the dry state.

Significant achievements in this area were associated not so much with the improvement of methods of dehydration, but with the use of effective protective environments.

However, methods for the introduction of protective environments in dried material was not characterized by diversity.

A method of obtaining dry probiotic preparation, according to which the culture of bifidobacteria or Streptococcus grown in submerged cultivation, with protective environment mix (patent RU №2067114 C1, C12N 1/20, 1/04, AK 35/74, 27.09.1996).

Known sharethelove environment califorina buffer to the lyophilized vaccine strain Ersysipielothrix rhusiopthicae suis BP-2, which is grown and concentrated strain Ersysipielothrix rhusiopthicae suis BP-2 plant (patent RU №1589448 WITH, AC 39/00, 15.11.1994).

Known dry probiotic preparation and method thereof, whereby liquid biomass from the exploring the culture of lactic acid bacteria (strain Lb. plantarum) is obtained by mixing the dissolution of the carbohydrate-protein complex (patent RU 2268926 C2, C12N 1/20, AS 9/12, F26B 5/16, 10.03.2005).

The main disadvantage of this method is the inability to provide a high dispersion of the biologically active materials containing active substances in the liquid phase.

The basis of the claimed invention is the task of improving the dispersion of the biologically active materials containing active substances in the liquid phase.

The problem is solved by the fact that the protective medium is introduced into the liquid phase in the dispersion of the biologically active material.

As a result of our research shows for the first time while getting drip powder materials with the liquid phase in finely dispersed micro-drip condition, stable finely dispersed inert hydrophobic disconnector with nano particles - the introduction of a protective environment in the preparations before drying is possible not only at the stage of preparation of the object dehydration (before receiving drip powder), but drip directly into the finished powder. This requires a protective environment to enter into the liquid phase of the drug in the dispersion, the dispersion will be introduced protective environment. Drops of the liquid phase of the drug, losing dispersion the Institute stabilizing layer of fine disconnector, combined with drops of protective environment, again dispersed, decreasing in size, and again covered with a stabilizing layer of highly dispersed hydrophobic disconnector. As a result, the dispersibility of the obtained materials is increasing, and because the duration of the process of introducing a protective environment is a few seconds, it does not affect the activity of active substances. In addition, the inventive method does not depend on the type of active substance, which is the basis of biologically active material.

According to the invention increase the dispersion of the biologically active materials containing active substances in the liquid phase, provided that the protective medium is introduced into the liquid phase in the dispersion of the biologically active material.

The inventive method of introducing a protective environment in biologically active material is new and is not described in literature.

The technical result of the claimed invention is to improve the dispersion of the biologically active materials containing active substances in the liquid phase.

The invention is illustrated in the following examples, showing the increase in the dispersion of the biologically active materials containing active substances in the liquid phase, when using the proposed method.

The content in the preparation is tah viable aerobic microorganisms Serratia marcescens, Entherococcus faecium were identified by means of Pasteur-Koch on solid nutrient media. Biological activity of antibodies preparations characterized anticolonialism activity (in the credits RIGA) [FS 42-3347-97]. The dispersion of the preparations was measured by a laser analyzer of grain Malvern Instruments)) S by the method developer.

Example 1. Introduction lactose protective environment in the liquid phase drip powder on the basis of S.marcescens pieces VKM-851 carried out when the dispersion in the electromagnetic apparatus. The protective medium of the following composition: lactose - 20,0, thiourea - 6,6, poliglyukin - 1,5, ascorbic acid - 3,6 distilled water - 68,3, they dosaged in dispersible material in 15 seconds in such quantity, to ensure that its ratio to the liquid phase powder as 1:2.

As control was used drip powder obtained by dispersing in the same apparatus a mixture of a suspension of S. marcescens stuck-851 with lactase protective environment at a ratio of 2:1.

The results are presented in tables.

3
The method of introducing a protective environmentSurvival (%) of bacteria in the experienceAverage
124567
Control100of 99.110010095,998,110099,0
Declareto 97.110097,910010096,596,398,4

The dispersion parameterThe method of introducing a protective environmentThe parameter value in the experienceAverage
123
The average median diameter, μmcontrol30,631,531,0 31,0
declare22,820,524,422,6
Content (%) drops fractions 1-10 micronscontrol9,28,68,98,9
declare16,520,415,417,4
Content (%) drops fraction of 1-25 micronscontrol36,435,035,835,7
declare52,158,048,352,8

Example 2. Introduction saharso gelatin protective environment in the liquid phase drip powder based .faecium carried out when the dispersion in the electromagnetic apparatus. The protective medium of the following composition: sucrose - 10, gelatin - 1 distilled water - 89, they dosaged in dispersible material in 15 seconds in such quantity that provided the ü its ratio to the liquid phase powder as 1:2.

As control was used drip powder obtained by dispersing in the same apparatus the mixture of the suspension .faecium with saharso gelatin protective environment at a ratio of 2:1.

The results are presented in tables.

The method of introducing a protective environmentSurvival (%) of bacteria in the experienceAverage
1234567
Control10010098,810099,410097,699,4
Declare99,610010098,410010010099,7

The dispersion parameterThe method of introducing a protective environmentThe parameter value in the experienceAverage
123
The average median diameter, μmcontrol35,130,938,034,7
declareto 25.3of 21.227,424,6
Content (%) drops fractions 1-10 micronscontrolthe 10.19,811,310,4
declare17,421,716,618,5
Content (%) drops fraction of 1-25 micronscontrol31,733,132,432,4
declare50,254,049,751,3

Example 3. Introduction glycine protective environment in the liquid phase drip powder on the basis of immunoglobulins IgG, IgA, IgM was carried out when the dispersion in the disk apparatus. The protective medium of the following composition: glycine - 1, glucose - 2, distilled water - 97, were dosed out in the dispersible material within 10 to this number to ensure that its ratio to the liquid phase powder as 1:2.

As control was used drip powder obtained by dispersing in the same apparatus a mixture solution of immunoglobulins IgG, IgA, IgM with glycine protective environment at a ratio of 2:1.

The results are presented in tables.

The method of introducing a protective environmentSave anticolonialism activity (%) experienceAverage
1234567
Control100 100100100100100100100
Declare100100100100100100100100

The dispersion parameterThe method of introducing a protective environmentThe parameter value in the experienceAverage
123
The average median diameter, μmcontrol14,315,114,114,5
declare11,010,611,911,2
Content (%) drops fractions 1-10 microns control41,340,441,641,1
declare56,157,056,556,5
Content (%) drops fraction of 1-25 micronscontrol67,765,966,466,6
declare79,478,177,6to 78.3

As follows from the analysis of the submitted materials, the inventive method of introducing protective environments does not depend on the type of active substances, which form the basis of the drug, nor on the composition of the protective environment and increases the dispersion of the drug by introducing a protective gas into the liquid phase in the dispersion of the biologically active material.

The method of introducing a protective environment in biologically active material containing liquid phase with active substances in drip condition, stable finely dispersed hydrophobic disconnector with nano particles, characterized in that the protections of the second medium is introduced into the liquid phase in the dispersion of the biologically active material.



 

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3 tbl, 15 ex, 1 dwg

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3 ex

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11 dwg, 3 ex

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41 cl, 19 ex, 10 dwg

FIELD: medicine, pharmaceutics.

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5 cl, 5 dwg, 4 ex

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