Method for producing bacterial preparation

FIELD: biotechnology.

SUBSTANCE: method includes pouring the preparation into a vessel, its freezing, sublimation and finish drying on the shelves of sublimation plant. Freezing of the preparation is performed at inclined position of vessel axis relatively to vertical line for angle of 45÷75 degrees, and sublimation process is conducted during heating of shelves at the speed of 10÷15°C per hour up to temperature of 30÷35°C.

EFFECT: claimed method makes it possible to accelerate the process of drying with simultaneous reduction of energy flow.

2 dwg, 3 ex

 

The invention relates to biotechnology and can be used for the production of bacterial preparations, such as Lactobacterin, bifidumbakterin, bificol, bifilosa, colibacterin and other

The closest in technical essence of the present invention is a method for dosed bacterial preparation in the form of dry biomass in the packaging of cylindrical shape (ampoules, vials) with a capacity of 5-20 ml, including the filling of the drug in the container, its freezing vertical position of the container, sublimation and final drying in a freeze-installation chamber type (AIT, Africart and other Theoretical and practical bases of technology of freeze-drying of biological products". Publisher Kursk state agricultural Academy, Kursk, 2002, p.87-137.).

The downside of it is the difficulty of evaporation of moisture from the deeper layers of biomaterial on the bottom of the vials (bottles) when filling more than one third of its volume and, therefore, unsustainable use of volume containers, high energy consumption during long duration of the drying process, due to the small area of the open surface of the frozen product.

The invention solves the problem of the acceleration of the drying process, use a volume of containers, the reduction of energy consumption.

To achieve the technical data of the method of obtaining a bacterial probiotic preparation in the container of cylindrical shape includes the filling of the drug in the container, its freezing, sublimation and final drying on the shelves of the freeze installation, with the freezing of the drug is carried out at an angle to the axis of the container relative to the vertical at an angle of 45÷75 degrees, and the process of sublimation is carried out at the heated shelves with a speed of 10÷15°C/hour to a temperature of 30÷35°while after the drug specified temperature carry out its final drying, which provides a residual moisture content in the product at the level of 1-3%.

The features that distinguish the proposed method for bacterial probiotic preparation in the container has a cylindrical shape from the prototype, characterized by the fact that the freezing of the drug is carried out at an angle to the axis of the container relative to the vertical at an angle of 45÷75° degrees and the process of sublimation is carried out at the heated shelves with a speed of 10÷15°C/hour to a temperature of 30÷35°C.

The proposed method is illustrated in the drawings, in which figure 1 shows a bottle of medication in an inclined position, as in figure 2 - vial.

Probiotic preparation is poured into a container of cylindrical shape, for example into the vial 1 and vial 2. The maximum amount spilled in the packaging of the drug 3 is not less than 50% of its capacity. Freezing of the drug is carried out at a temperature not less than minus 45°when the tilting state is the axis of the container AA relative to the vertical at an angle α =45÷75 degrees. The process of sublimation is carried out at the intensive heating of the shelves at a rate of 10÷15°C/hour to a temperature of 30÷35°C. Sublimation occurs first on the open surface, and then spread further afield ice on the deeper layers of the frozen mass. This forms a dry porous mass of dehydrated product. All stages of the drying process accelerated significantly increased since the surface of the frozen mass. This creates more favorable conditions venting that allows to heat the shelves sublimator without damage to the structure and macrobid dried drug. After the preparation of the final temperature of the shelves carry out its final drying for at least 8 hours, which provides a residual moisture of the product at the level of 1-3%. While retaining a high level of viability of microorganisms and provides the necessary structure of the dry drug.

Example 1.

Suspension of Lactobacterin poured into 2.5 ml vials PHI-5 (capacity 5 ml). Tapes vials placed in a freezer with an inclination of 45 degrees and frozen at minus 50°C for 16 hours. Next, the drug is placed on the shelves of the freeze camera apparatus of the type TG-50. Shelves sublimator will prefix is Ino cooled to a temperature not higher than minus 25° C. After sealing apparatus creates a vacuum around 16.6 PA, which is achieved through 30 minutes after the start of evacuation. Throughout the drying process, the vacuum in sublimator should not exceed 16.6 PA, and the temperature of the condenser should not be higher than minus 60°C. within 1 hour after loading of the drug produce heating of the shelves of sublimator with a speed of 15°C/hour to a temperature of 35°C. the shelves Temperature reaches this level for 4 hours and maintained until the end of drying. After the preparation of the specified temperature its final drying is 12 hours.

The drug meets the requirements of the monograph on appearance, physical and microbiological parameters (FS 42-0054-00 "Lactobacterin dry").

Example 2.

Suspension of Bifidumbacterin poured into 5 ml vials FD-10 (capacity 10 ml). Tapes vials placed in a freezer tilted 60 degrees and frozen at minus 45°C for 24 hours. Next, the drug is placed on the shelves of the freeze camera apparatus of the type TG-50. Shelves sublimator pre-cooled to a temperature of minus 20°C. After sealing apparatus creates a vacuum around 16.6 PA, which is achieved through 30 minutes after the start of evacuation. Throughout the process the temperature of the condenser is not up to what Gina to be higher than minus 60° C. After 1 hour after loading of the drug produce heating of the shelves of sublimator with a speed of 10°C/hour to a temperature of 30°C. the shelves Temperature reaches this level for 5 hours and maintained until the end of drying. After the preparation of the specified temperature, the time it dried up to 12 hours. The drug meets the requirements of the monograph on appearance, physical and microbiological parameters (FS 42-3947-00 "Bifidumbacterin dry").

Example 3.

Suspension of bificol poured into 3 ml ampoule silk-5 (capacity 5 ml). Tapes vials placed in a freezer tilted 75 degrees and frozen at minus 48°C for 20 hours. Next, the drug is placed on the shelves of the freeze camera apparatus of the type TG-50. Shelves sublimator pre-cooled to a temperature of minus 20°C. After sealing apparatus creates a vacuum around 16.6 PA, which is achieved through 30 minutes after the start of evacuation. Throughout the process the temperature of the condenser should not be higher than minus 60°C. within 1 hour after loading of the drug produce heating of the shelves of sublimator at a rate of 12°C/hour to a temperature of 32°C. the shelves Temperature reaches a given level for 5.5 hours and maintained until the end of drying. After the preparation of the decree is Noah temperature time it is dried 16 hours.

The drug meets the requirements of the monograph on appearance, physical and microbiological parameters (FS 42-3268-96 "Bificol dry").

A method of obtaining a bacterial preparation in a container of cylindrical shape, including the filling of the drug in the container, its freezing, sublimation and final drying on the shelves of the freeze installation, characterized in that the freezing of the drug is carried out at an angle to the axis of the container relative to the vertical at an angle of 45÷75°and the process of sublimation is carried out at the heated shelves sublimation setup with a speed of 10÷15°C/h to a temperature of 30÷35°when the vacuum is not above 16,6 PA and the temperature of the condenser is not above minus 60°C.



 

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