The way to obtain microencapsulated forms of lactobacilli

 

(57) Abstract:

The invention relates to medicine, namely to technology drugs with bacterial preparations, method for obtaining microencapsulated forms of microorganisms using a copolymer of acrylic and methacrylic acids in aqueous suspension. As the external phase are paraffins, mineral and vegetable oils. The technical result is to increase environmental purity, and reduced fire hazard method of producing microencapsulated forms of lactobacilli.

The invention relates to medicine, namely to the technology of medicinal forms with bacterial drugs.

For the correction of dysbiotic conditions in medical practice widely used a variety of drugs, created on the basis of live strains of microorganisms that are part of the normal flora.

It is known that lactobacilli group L. acidophillus (L. fermentum, L. plantarum, L. bulgaricum, L. rhamnosus, L. casei, L. thermophilus different strains) are important representatives of the normal flora of man and can be used in pharmaceuticals, oral, intravaginal or cutaneous injection for treatment according to acetelyne advantages over using democracyplayer their forms. First, micro-encapsulated form, obtained using acidresistant polymers that are resistant to the action of hydrochloric acid of gastric juice. It is important for oral microencapsulated bacteria, which should reach the lower parts of the small intestine, where the destruction of the shells of the microcapsules with subsequent colonization of bacteria in the mucosa of the large intestine. Secondly, micro-encapsulated form allows disseminirovanne colonization of mucous membranes of the intestines or vagina. Thirdly, micro-encapsulated form when introduced into the body dissolves gradually and provides a continuous flow of bacteria in the environment. Competition for the substrate is reduced at the point of exit of bacteria and provides better colonization of the mucous membranes. Fourthly, in the case of use of lactobacilli as a therapeutic agent for the treatment of pseudomembranous colitis or other types of antibiotic-associated diarrhea, microencapsulation allows you to protect the patient from traces of sugars, such as lactose or lactulose remaining on freeze-dried microorganisms after washing the culture from the nutrient medium. Imennoi of intolerance to lactose. Therefore, even small amounts of sugars can worsen the condition of the patient. Fifthly, microencapsulation increases the survival of lactic acid bacteria during storage of the drug. Sixth, the use of microencapsulated forms of bacteria in the composition of the combined dosage forms can further be input in the composition of the active drug substances, for example antibiotics.

Recently, various researchers pay much attention to the use of microencapsulated forms of bacterial preparations.

Known coating methods microorganisms artificial polymers for medical purposes has one important disadvantage of the use in the process of organic solvents, toxic for microorganisms.

Closest to the proposed and it is the prototype of a patent (US Patent 5614209, 519963, 1997), which describes how to obtain microencapsulated drugs lactobacilli method of removing volatile solvent from a solution of copolymers of acrylic and methacrylic acids. In this method, it is proposed to introduce a mixture of microorganisms and protective substances - hydroxypropylcellulose in aqueous suspension is stirred until complete evaporation of the solvents, accompanied by the formation of microcapsules.

However, the use of organic solvents used in the process, significantly reduces the survival of bacteria and makes this method of producing microcapsules environmentally and pozharoopasny.

The objective of the invention was to improve environmental cleanliness and reducing fire hazard method of producing microencapsulated forms of lactobacilli.

The essence of the invention:

Method for obtaining microencapsulated forms of living organisms using a copolymer of acrylic and methacrylic acids, namely, that the freeze-dried culture of microorganisms dispersed in aqueous suspension of a copolymer, the obtained suspension is injected in the liquid light paraffin, mineral oils, light oils containing 0.1 to 0.5% aluminum stearate and 3 - 7% PEG 400, homogenized before formation of the emulsion particles of the desired size and leave at constant heating and stirring 100 - 300 rpm before the formation of the microcapsules.

As lactic acid bacteria are Lactobacillus strains L. fermentum 90-TS-4 or VKM B-7573.

PRA is not less than 103living cells on a single microcapsule.

These bacteria was dispersed for 10 min in 10 ml of 30% aqueous suspension of a copolymer of acrylic and methacrylic acids at room temperature. The resulting suspension is quickly injected into the pre-warmed to 55oC liquid light paraffin (C12-C15) (200 ml) containing 7% (V/o) PEG-400 and 0.5% (V/V) of aluminum stearate. The resulting mixture was rapidly homogenized using a turbine mixer at 8000 rpm for 1 min Then the mixture is transferred into a 500-ml chemical glass and leave in a water bath for 24 h under stirring using a propeller stirrer at a speed of 250 rpm

The obtained microcapsules washed three times with excess amount of 1% solution of TWEEN 80 in water and dried under vacuum.

Example 2

For the manufacture of microcapsules taken lyophilized Lactobacillus strains L. fermentum VKM B-7573 rate of not less than 103living cells on a single microcapsule.

These bacteria was dispersed for 10 min in 10 ml of 40% aqueous suspension of a copolymer of acrylic and methacrylic acids at room temperature. The resulting suspension is quickly injected into the pre-heated sunflower oil (200 ml) containing 3% (V/o) PE who/min for 1 min Next, the mixture is transferred into a 500-ml chemical glass and leave in a water bath at a constant heated for 24 h under stirring using a propeller stirrer at a speed of 250 rpm

The obtained microcapsules washed three times with excess amount of 1% solution of TWEEN 80 in water and dried under vacuum.

Example 3

For the manufacture of microcapsules taken lyophilized Lactobacillus strains L. fermentum VKM B-7573 rate of not less than 103living cells on a single microcapsule.

These bacteria was dispersed for 10 min in 10 ml of 30% aqueous suspension of a copolymer of acrylic and methacrylic acids at room temperature. The resulting suspension is quickly injected into the pre-heated vaseline oil (200 ml) containing 7% (V/o) PEG-400 and 0.5% (V/V) of aluminum stearate. The resulting mixture was rapidly homogenized using a turbine mixer at 8000 rpm for 1 min Then the mixture is transferred into a 500-ml chemical glass and leave in a water bath at a constant heated for 24 h under stirring using a propeller stirrer speed of 400 rpm

The obtained microcapsules washed three times with excess amount of 1% solution of TWEEN 80 in water and dried under vacuum.

The way to obtain microencapsulated forms of living organisms using a copolymer of acrylic and methacrylic acids, wherein the freeze-dried culture of microorganisms dispersed in aqueous suspension of a copolymer, the obtained suspension is injected in the liquid light paraffin or mineral oil or light vegetable oil containing 0.1 - 0.5% aluminum stearate and 3 - 7% PEG, homogenized before formation of the emulsion particles of the desired size, and leave at constant heating and stirring 100 - 300 rpm before the formation of the microcapsules.

 

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