Suppositories bacterial preparations and method of production thereof

 

(57) Abstract:

The invention relates to the field of pharmacology and medicine. The method of producing suppositories for correction of dysbacteriosis includes mixing a bacterial component in the form of a dry lyophilized biomass basis, molding the mixture, before the introduction of the basis of the bacterial mass is mixed with the filler in a ratio of 1:1-1:10, enter the basis, stirred for 3-10 minutes at a temperature of 35-41P, as the basis, take the mixture of Witepsol” H-15+++and W-35 in the ratio of 1:1-1:3 or tallow brand And, as a bacterial component - microbial mass of Bifidobacterium bifidum 45 PMBC As-1621, or Bifidobacterium bifidum No.1, or Lactobacillus plantarum 8P-A3, or a mixture of these strains in the ratio(1:100): (1:100): (1:100) when the total number of bacteria at least 1107SOME of the suppository. The filler used the song as the stimulant bioenergetic reactions of bacterial cells, in a ratio of components in the suppository, wt.%: the source of carbon and energy - 0,9-2,2, donor-electron acceptor of 0.07 to 0.5, the carrier electrons 0,0005 is 0.0015, as a source of carbon and energy use lactose, or galactose, or glucose or lactulose, or fructo is a rate of 1:1, as a carrier of electrons used-amino-3 carboxyl-4 naphthoquinone or vitamin K3. Suppositories containing live bacteria, filler, base in the form of a mixture of “Witepsol” H-15+++and W-35 in the ratio of 1:1-1:3 or tallow brand And, as live bacteria contain microbial mass of Bifidobacterium bifidum 45 PMBC Ac-1621, or Bifidobacterium bifidum No.1, or Lactobacillus plantarum 8P-A3, or a mixture of these strains in the ratio(1:100):(1:100):(1:100) when the total number of bacteria at least 1107SOME of the suppository in a ratio of components in the suppository, mg: dry lyophilized microbial mass of bacteria-eubiotics - 10,0-100,0, filler - 21,0-111,0, the basis (Witepsol H-15+++Witepsol W-35) to 2200. The invention provides a high therapeutic effect and does not cause side effects. 2 S. and 4 C.p. f-crystals.

The invention relates to medicine, in particular to drugs, and can be used in the manufacture (rectal and vaginal) suppositories for the prevention and treatment of dysbacteriosis and for treatment of related diseases of other organs and systems.

Known drug - suppository for prevention and treatment of urogenital infections, including germ No. 791, or the two-3, or a mixture of strains on a single therapeutic dose (EN, Pat. No. 2073520, class a 61 K 35/74, 96 g).

However, the range of use of the above drug is narrow, as it is only used for the prevention and treatment of urogenital infections.

Closest to the invention to the technical essence and the achieved therapeutic effect is a method of obtaining suppositories for rectal and intravaginal use, including mixing a bacterial component in the form of a dry lyophilized biomass basis, molding the resulting mixture. The suppository contains microbial mass of bifidobacteria or lactobacilli, or PEP (see EN, Pat. No. 1587701, class a 61 K 9/02, 1988).

However, these suppositories have complicated the technology, the range of application of the above medicinal product to be very close, as is applicable only for adults, in addition, these drugs only contain lactobacilli or bifidobacteria, which limits the degree of their therapeutic effects.

Object of the invention is the development of a new pharmaceutical composition and method of producing suppositories that have antimicrobial, antiviral docno-intestinal tract, do not cause side effects on the human body and having a high therapeutic effect.

This task is solved in that suppositories, possessing inhibitory activity against pathogenic bacteria include live bacteria, filler, candle base, which contains a mixture of “Witepsol” H-15+++and W-35 in the ratio of 1:1-1:3 or tallow grade, or the basis of similar composition, as well as live bacteria using microbial mass of Bifidobacterium bifidum 45 PMBC Ac-1621, or Bifidobacterium bifidum No.1, or Lactobacillus plantarum 8P-A3, or a mixture of these strains in the ratio(1:100):(1:100):(1:100) when the total number of bacteria at least 1107SOME of the suppository in the following ratio of components in the suppository, mg:

Dry lyophilized

microbial mass

bacteria-eubiotics 10,0-100,0

Filler 21,0-111,0

The basis To 2200

(Witepsol H-15+++

Witepsol W-35)

In addition, in the method of producing suppositories comprising a mixture of a bacterial component in the form of a dry lyophilized biomass with the candlestick base, molding the mixture, before the introduction of the basis of the bacterial mass is mixed with napolniteley use a mixture of “Witepsol” H-15+++and W-35 in the ratio of 1:1-1:3 or tallow brand And and as bacterial component using microbial mass of Bifidobacterium bifidum 45 PMBC Ac-1621, or Bifidobacterium bifidum No.1, or Lactobacillus plantarum 8P-A3, or a mixture of these strains in the ratio(1:100):(1:100):(1:100) when the total number of bacteria at least 1107SOME of the suppository.

At the same time as filler for dry lyophilized biomass of bacteria probiotics use composition, which is a stimulant bioenergetic reactions of bacterial cells, in the following ratio of components in the suppository, wt.%:

The source of carbon and energy 0,9-2,2

Donor-electron acceptor of 0.07 to 0.5

Carrier electrons 0,0005-0,0015

As a source of carbon and energy use lactose, or galactose, or glucose or lactulose, or fructose, or a mixture, and as a donor-acceptor use ascorbic acid or a mixture of cystine and cysteine in the ratio of 1:1, and as a carrier of electrons used-amino-3 carboxyl-4 naphthoquinone or vitamin K3.

The method is as follows.

The estimated amount of the dry microbial biomass, seasoned with komnatnaya grinding biomass and milled for 30 to 60 seconds to obtain a homogeneous mass with a particle size of not more than 0.2 mm

In the capacity load suppozitornyj basis, the mixture of Witepsol” H-15+++and W-35 in the ratio of 1:1-1:3 in the amount needed for one production cycle. The best foundations turned out to be a mixture of “Witepsol” H-15+++and W-35 or tallow type A. the Basis sterilized at a temperature of (112±2)C for 30 minutes

Further, in capacity-mixer place the calculated amount of sterile candle (suppozitornyj) basis, cooled to a temperature of 38-41P. Include the stirrer. Set the rotation speed of 50-60 rpm At a temperature of suppozitornoj bases 35-41P portions contribute crushed biomass with filler. Continue to mix for 5-10 minutes

After mixing suppozitornyj mass is poured into pre-assembled, sterilized, cooled form. The filled form is cooled in the refrigerator for 10-15 minutes at a temperature of minus (2-4)C. the forms are Then removed from the fridge. Frozen suppositories released from the molds and wrap in waxed paper or placed in blister packaging PVC. Packed and screened in the laboratory, suppositories are placed in cardboard boxes.

All operations conducted with supp the Prepared suppositories are white with a yellowish tinge, torpedo-shaped form with a diameter up to 11 mm Slice homogeneous. Average weight suppositories- (1,5±0,03)-(2,2±0,03) ,

Suppositories are stored for 1 year without loss of clinical effect at a temperature of 2-10C.

Example 1.

10 g of dry microbial biomass of bifidobacteria (Bifidobacterium bifidum No.1) mixed with chopped filling:

Lactose 9.0 g

A mixture of cystine and cysteine (1:1) 0,997 g

Vitamin K30.003 g

In the capacity of the mixer contribute sterilized suppozitornyj basis (calculated on 1000 suppositories): a mixture of “Witepsol” H-15+++and W-35 in the ratio 1:1.5. When the temperature 38C and under stirring to make a dry microbial mass with filler. Stirred for 10 minutes Then suppozitornyj mass is poured into molds, pre-cooled to minus (2-4)C. the Filled form is cooled in the refrigerator for 15 minutes to a temperature of minus (2-4)C. Frozen suppositories are removed from the refrigerator, free form, wrapped in waxed paper and placed in cardboard boxes. All operations is carried out in aseptic conditions.

The candle has a weight of 1.5 g (for children) on the cut homogeneous and contains not less than 1107CFU Bifidobacterium clients per 1000 suppositories:

Dry lyophilized microbial

lots of Lactobacillus plantarum 8P A3 10 g

Filler:

Lactulose 4.5 g

Glucose 4.5 g

Ascorbic acid 0,997 g

-amino-3 carboxyl-4 naphthoquinone 0.003 g

Received suppositories have weight 2.2 grams and contain 1109SOME lactobacilli.

Therapeutic effect of medicinal substance-probiotic depends on a number of factors (pharmaceutical, pharmacological, physiological) used medicinal substances, therapeutic dose, the correct choice of filler (nature and concentration), the nature of the technological process, storage conditions, body condition and route of administration Leksredstva in the body.

Clinical example 3.

Child, I. P., age 5, case history No. 1024, 2000, was hospitalized on day 3 of illness in the state of moderate severity: body temperature was 37.4, chair 3 times a day, liquid, watery, with mucus and undigested lumps, sour smell, loss of appetite, weakness. Clinical diagnosis: intestinal dysbiosis of the II degree. From the first day of hospitalization the child assigned probiotic suppositories 1 pc. 3 times a day after rectal definately, normalized body temperature and appetite, improved the character of the chair. The child was discharged on the 10th day in a satisfactory condition with complete clinical recovery.

Clinical example 4.

Patient S. K., 24, case history No. 3785, 2001 admitted to the gynecological Department on the 5th day of illness with complaints whitish vaginal discharge with strong odor, burning and itching in the genital area.

Clinical diagnosis of bacterial vaginosis.

From the first day after admission to hospital the patient was administered probiotic suppositories 1 candle 3 times a day in the vagina for 3 days. The next day the patient's condition improved significantly decreased leucorrhoea, burning and itching of the genitals, the less pronounced was the smell of the discharge. The patient was discharged on the 4th day in a satisfactory condition with the recommendation to continue treatment probiotic suppositories in the outpatient setting within 10 days.

Thus, the proposed method and the new-origin pharmaceutical composition provide increased therapeutic effect, a simple technology in the manufacture of suppositories.

Suppositories with probiotics izgotavlivaem, as well as improving, compared with others, persistence biological active component (bifidobacteria lactobacilli) and, as a consequence, the enhancement of therapeutic effect of this medicinal product.

Aseptic management of manufacturing processes and packaging in combination with the use of sterilized candlestick basics allows the provision of multi-purpose suppositories: for vaginal, children, rectal.

Implemented in this technology, the monitoring process at all stages ensures compliance stated in the technical documentation of the quality parameters of suppositories.

1. The method of producing suppositories bacterial preparations for correction of dysbacteriosis, comprising mixing a bacterial component in the form of a dry lyophilized biomass with the candlestick base, molding the resulting mixture, characterized in that before the introduction of the basis of the bacterial mass is mixed with the filler in a ratio of 1:1-1:10, enter the basis, stirred for 3-10 minutes at a temperature of 35-41P, and as the basis of a mixture of “Witepsol” H-15+++and W-35 in the ratio of 1:1-1:3 or tallow grade, and as bacteriolog 8P-A3, or a mixture of these strains in the ratio(1:100):(1:100):(1:100) when the total number of bacteria at least 1107SOME of the suppository.

2. The method according to p. 1, characterized in that as filler for dry lyophilized biomass of bacteria probiotics use composition, which is a stimulant bioenergetic reactions of bacterial cells, in the following ratio of components in the suppository, wt.%:

The source of carbon and energy 0,9-2,2

Donor-electron acceptor of 0.07 to 0.5

Carrier electrons 0,0005-0,0015

3. The method according to PP.1 and 2, characterized in that as a source of carbon and energy use lactose, or galactose, or glucose or lactulose, or fructose, or a mixture.

4. The method according to PP.1 to 3, characterized in that as a donor-acceptor use ascorbic acid or a mixture of cystine and cysteine in the ratio of 1:1.

5. The method according to PP.1 to 4, characterized in that as a carrier of electrons used-amino-3-carboxyl-4-naphthoquinone or vitamin K3.

6. Suppositories with inhibitory activity against pathogenic bacteria that contain live bacteria, filler, candle base, otlichayas the p grade a, and as live bacteria contain microbial mass of Bifidobacterium bifidum 45 PMBC Ac-1621, or Bifidobacterium bifidum No.1, or Lactobacillus plantarum 8P-A3, or a mixture of these strains in the ratio(1:100):(1:100):(1:100) when the total number of bacteria at least 1107SOME of the suppository in the following ratio of components in the suppository, mg:

Dry lyophilized microbial mass of bacteria-eubiotics 10,0-100,0

Filler 21,0-111,0

Basis (Witepsol H-15+++Witepsol W-35) To 2200

 

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