Antibacterial agent in the form of ointments and method thereof

 

(57) Abstract:

The invention relates to the field of medicine. Antibacterial agent in the form of ointment contains the antibiotic erythromycin, stabilizer, emulsifier, medical vaseline. The ratio of the components of wt. %: erythromycin 0,889-1,333, sodium sulfate pyro 0,009-0,011, anhydrous lanolin 36-44, vaseline medical 53,1-64,8. The medicinal substance in the form of a powder erythromycin crushed to particle size of 40-50 microns. Mixed with a stabilizer, which is used as powdered sodium sulfate pyro. It is sifted. Ointment base is prepared by mixing the emulsifier, which used the anhydrous lanolin and vaseline medical. They melt at a temperature of 50-55oC, cooled to a temperature of 30-35oWith, mixed at this temperature with a mixture of powders of the drug substance and a stabilizer. Homogenization is carried out in 2-3 min, the ratio of the components of wt. %: erythromycin 0,889-1,333, sodium sulfate pyro 0,009-0,011, anhydrous lanolin 36-44, vaseline medical 53,1-64,8. The invention improves the stability of the drug. 2 S. p. f-crystals.

The invention relates to medicaments for therapeutic jam and the basics for them, and can find application in the treatment of pustular skin diseases, infected wounds, sores, burns, II and III level, trophic ulcers.

Known ointment containing as an antibiotic combination of lincomycin and gentamicin, as ointment bases polyvinylpyrrolidone, glycerin, polyethylene oxide, propylene glycol (p. Russia 2076697, IPC a 61 K 9/06 from 05.01.93 year).

Known antibacterial composition in the form of tablets containing erythromycin in the form of polymorphic modifications (p. Russia 2045953 And 61 To 31/71 from 29.04.91 year).

Known ointment eritromicina containing erythromycin ointment base the rest is used in the treatment of pustular skin diseases, infected wounds, burns, diseases of the eye (Mashkovsky M. D. Medicines. - M.: New wave, 2000, so 2, S. 259).

Known antibacterial ointment for the treatment of burns, containing chloramphenicol, benzocaine, aloe, lanolin, vaseline, a solution of hydrocortisone, novocaine, vitamins (p. Russia 2128500, IPC a 61 K 9/06 from 17.01.97 year). The disadvantage of this ointment is the complexity and duration of the technological process due to the presence of a large number of components. In addition, as the active drug is installed ratios for ointment bases anhydrous lanolin and vaseline medical does not provide consistency of ointment, possessing good light ability and no preservative does not provide stability during storage.

Known antimicrobial agent for treatment of infected wounds of any etiology (p. Russia 1820505, a 61 K 9/06 from 10.05.90 year).

It contains antibiotics, proteolytic enzyme prosthesis With, preservatives and ointment base. As antibiotics tool contains gentamicin sulfate and erythromycin, as preservative - nipagin and ether propyl n-oksibenzoynoy acid, and as ointment bases paraffin, ceresin and vaseline oil.

The disadvantage of this tool is gentamicin sulfate in combination with erythromycin, which increases the effect of the drug, but may cause an allergic skin reaction. In addition, the presence of two antibiotics increases the cost of the drug.

Use as ointment bases paraffin, ceresin and paraffin oil in predetermined ratios does not provide the stability of the tool during storage, also complicates the manufacture of the tools.

The tool chosen by the applicant as a prototype.

A method of obtaining the specified money. It consists in the preparation of the ointment on the up with vaseline oil and cooled under stirring to a temperature of 40-37oC. Mix gentamicin sulfate with erythromycin, and protease and rubbed with vaseline oil. Concentrate the drug substance is mixed with ointment base.

The disadvantage of this method is the high melting point of ointment bases, which increases energy consumption. The temperature of the refrigerated ointment bases are high, which reduces the activity of medicinal substances when mixed with ointment base. Rubbing the drug substance with vaseline oil without additional grinding of the powders increases the smooth tool.

The method chosen by the applicant as the nearest equivalent.

Tasks offer a comprehensive invention is to provide an antibacterial agent in the form of an ointment containing an antibiotic erythromycin having a high therapeutic effect and storage stability due to the optimum ratio of components and improvement of production technologies.

The task is achieved by the fact that the antibacterial agent in the form of an ointment containing an antibiotic erythromycin, stabilizer, emulsifier, medical vaseline, according to the invention in quality is the ratio of the components, wt.%: erythromycin 0,889-1,333, sodium sulfate pyro 0,009-0,011, anhydrous lanolin 36-44, vaseline medical 53,1-64,8.

In a method of producing an antibacterial agent in the form of an ointment containing an antibiotic erythromycin, comprising preparing a pharmaceutical substance in powder form erythromycin, the introduction of the stabilizer, the preparation of ointment bases, mixing the drug substance with the ointment base, the homogenization of the mixed components, according to the invention of the medicinal substance in the form of a powder erythromycin crushed to particle size of 40-50 microns, is mixed with a stabilizer, which is used as the sodium sulfate Piro, also pre-crushed to a particle size of 40-50 microns, sift, ointment base is prepared by mixing the emulsifier, which is used as the anhydrous lanolin and vaseline medical, melted at a temperature of 50-55oC, cooled to a temperature of 30-35oWith, mixed at this temperature with a mixture of powders of the drug substance and a stabilizer, and homogenization is carried out in 2-3 min, the ratio of the components is, wt.%: erythromycin 0,889-1,333, sodium sulfate pyro 0,009-0,011, anhydrous lanolin 36-44, medical vaseline 53,CSOs effect of the drug without side effects, for example allergic reactions on the skin.

The stated ratio of anhydrous lanolin and vaseline medical help to get ointment with good light ability, preserving the activity of erythromycin for 3 years. The ointment is well Packed in tubes.

Use as a stabilizer sodium sulfate Piro provides stability ointment in storage during shelf life (3 years).

Grinding powder erythromycin powder and stabilizer until the particle size of 40-50 microns and sifting provide a fine mixture of powders, which is widely distributed in the ointment base. In addition, the reduced process energy is saved.

Mixing anhydrous lanolin and vaseline medical melt to a temperature of 50-55oC and cooling to a temperature of 30-35oTo reduce energy costs and reduce the time of the process. In addition, this temperature does not reduce activity of the drug substance by mixing it with the ointment base.

The homogenization of the mixture for 2-3 minutes reduces the time process, saves energy.

The stated ratio of the components is shelf life (3 years).

Selected in the present limits as a stabilizer sodium sulfate Piro provides stability ointment when stored.

Anhydrous lanolin is an excellent emulsifier and the claimed ratios allow to obtain stable ointment base, which is well dosed and does not drain during storage of the tubes.

The invention differ from the prototypes and do not follow explicitly studied the prior art, i.e., meet the criterion of "novelty", can find application in the production of an antibacterial agent in the form of ointments, i.e., "industrially applicable".

The essence of the invention consists in the following.

Antibacterial agent in the form of an ointment containing an antibiotic erythromycin, stabilizer, as it contains sodium sulfate Piro, emulsifier, in which it contains anhydrous lanolin, vaseline medical, the ratio of the components is, wt.%: erythromycin 0,889-1,333, sodium sulfate pyro 0,009-0,011, anhydrous lanolin 36-44, vaseline medical 53,1-64,8. The components of the ointment and the specified ratios allow to get active during the term, stable during storage antibacterial in the following ratio, wt. %: erythromycin 0,889, sodium sulfate pyro 0,009, anhydrous lanolin 36, vaseline medical 53,1. With this ratio of components is insufficient therapeutic effect of erythromycin, in addition, the consistency of the liquid, which does not ensure the stability of the tool during storage.

Example 2.

In example 1 the ratio of the components is, wt.%: erythromycin 1,1, sodium sulfate pyro 0,01, anhydrous lanolin 40, vaseline medical 58,95.

At this rate the components of the inventive tool has a high therapeutic activity, stable during storage, has a consistency suitable for dosage and usage.

Example 3.

In example 1 the ratio of the components is, wt.%: erythromycin 1,333, sodium sulfate pyro to 0.011, anhydrous lanolin 44, vaseline medical 64,8.

At this rate the components of the inventive tool has a high therapeutic activity that can cause side effects while using the medicine, in addition, the consistency will be thick, which makes packing tool and its use.

Thus, antibacterial with the claimed ratios, and policosanol, stability during storage.

Antibacterial agent in the form of an ointment containing an antibiotic erythromycin, obtained as follows.

Drug substance powder erythromycin crushed in the mill until the particle size of 40-50 microns, mixed with shredded to a particle size of 40-50 microns stabilizer, sift, getting a fine mixture.

Prepare ointment base, mixing anhydrous lanolin with vaseline medical. The mixture is melted at a temperature of 50-55oC, then cooled to a temperature of 30-35oC. At this temperature the wax base is mixed with a mixture of powders of the drug substance and a stabilizer and placed in a homogenizer. Spend homogenization within 2-3 minutes.

Conduct laboratory analysis ointments and Packed in tubes.

The ratio of the components of the resulting ointment is, wt.%: erythromycin 0,889-1,333, sodium sulfate pyro 0,009-0,011, anhydrous lanolin 36-44, vaseline medical 53,1-64,8.

Received antibacterial agent in the form of ointments has a high therapeutic activity, is stable during storage. Additionally, the time process is reduced, thus saving energy costs.

Received with predetermined ratios of components and temperature regimes ointment does not have sufficient therapeutic activity, as well as insufficiently active drug component, unstable when stored, poorly Packed in tubes, as the ointment will be liquid.

Example 5.

In the process of obtaining an antibacterial agent in the form of ointment take erythromycin powder of 1.1% relative to the weight, ground in the mill until the particle size of 45 μm, is mixed with 0.01% sodium sulfate Piro, pre-crushed to a particle size of 45 μm, sifted, prepared ointment base, mixing 40% anhydrous lanolin and 58,95% medical vaseline. Ointment base is melted at a temperature of 52,SKOV the drug substance and a stabilizer and homogenized in 2.5 minutes.

Received with predetermined ratios of components and temperature regimes ointment has sufficient therapeutic activity, good light ability, stable during storage, well Packed in tubes.

Example 6.

In the process of obtaining an antibacterial agent in the form of ointment take erythromycin powder 1,333% relative to the weight, ground in a mill to a particle size of 50 μm, is mixed with 0,011% sodium sulfate Piro, pre-crushed to a particle size of 50 μm, sifted, prepared ointment base, mixing 44% anhydrous lanolin and 64.8% medical vaseline. Ointment base is melted at a temperature of 55oC, cooled to a temperature of 30oC. At this temperature the wax base is mixed with a mixture of powders of the drug substance and a stabilizer and homogenize for 3 minutes.

Received with predetermined ratios of components and temperature regimes, the ointment has a high therapeutic activity, which may cause allergic reactions on the skin. Such a particle size enables the production of fine powder, but will need additional fine-meshed sieve to prosea, which is uneconomical. Ointment h the th temperature and as a consequence, poorly Packed into tubes. The technological process is delayed, which is uneconomical. The ointment is not stable during storage.

Thus, the antibacterial agent in the form of ointments, obtained by the claimed method and ratios of components, has therapeutic activity in the period (3 years), stable in storage, well Packed in tubes. The method of obtaining ointment cheap.

1. Antibacterial agent in the form of an ointment containing an antibiotic erythromycin, stabilizer, emulsifier, medical vaseline, characterized in that the stabilizer it contains sodium sulfate pyro, as emulsifier - anhydrous lanolin in the following ratio, wt. %:

Erythromycin 0,889-1,333

Sodium sulfate pyro 0,009-0,011

Lanolin anhydrous 36-44

Vaseline medical 53,1-64,8

2. The method of obtaining an antibacterial agent in the form of an ointment containing an antibiotic erythromycin, comprising preparing a pharmaceutical substance in powder form erythromycin, the introduction of the stabilizer, the preparation of ointment bases, mixing the drug substance with the ointment base, the homogenization of the mixed Kosmacheva with a stabilizer, which is used as the sodium sulfate Piro, also pre-crushed to a particle size of 40-50 microns, sift, ointment base is prepared by mixing the emulsifier, which is used as anhydrous lanolin, vaseline medical, melted at a temperature of 50-55C, cooled to a temperature of 30-35C, mixed at this temperature with a mixture of powders of the drug substance and a stabilizer, and homogenization is carried out in 2-3 min, the ratio of the components is, wt.%:

Erythromycin 0,889-1,333

Sodium sulfate pyro 0,009-0,011

Lanolin anhydrous 36-44

Vaseline medical 53,1-64,8

 

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< / BR>
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