Pharmaceutical composition "oflomelid" for external application in pyoinflammatory disease treatment

FIELD: medicine, pharmaceutics.

SUBSTANCE: pharmaceutical composition includes fluoroquinolone antibiotic ofloksacin, tissue reparation stimulator methyluracil and local anesthetic lidocain hydrochloride as active components. Composition base part is polyethyleneoxides with mol weight of 400 and 1500, soluble in water. Also composition includes nipagin and nipasol conservation agents at the ratio of 4:1 and propyleneglycol as plasticiser. Composition is produced as soft sterile formulation. Composition shows aseptic properties in the absence of repeated contamination. Composition has antibacterial, anaesthetic, regeneration and wound healing effect.

EFFECT: obtaining composition with antibacterial, anaesthetic, regeneration and wound healing effect.

2 cl, 3 ex

 

The invention relates to the pharmaceutical industry, namely, pharmacology, particularly to drugs used in medicine as a drug, possess anti-microbial, anti-inflammatory, analgesic, and osmotic dehydrating properties.

Known ointment "LINEIN", containing (wt.%) as the antibiotic is a combination of lincomycin hydrochloride 0,85-1,15 and gentamicin sulfate 0,42-0,6, as a proteolytic enzyme (protease C - 0,2-0,3 and as ointment bases - polyvinylpyrrolidone - 9,5-10,5, glycerin 9,5-10,5, polyethylene oxide with a molecular weight of 1500 23,75-26,25 and 1,2-propylene glycol - the rest is up to 100 (Patent No. 2076697, EN. Publ. 10.04.1997,).

Known ointment with propolis containing polyethylene oxide (mol. m 400 and 1500 and preservatives nipagin and nipazol in the following ratio, wt.%:

propolis - 10,69-11,81; polyethylenoxide mol. m 400-60,57-66,93; nipagin - 0,142-0,158; nipazol - 0,19-0,21; polyethylene oxide (mol. m 1500 - rest (Patent No. 2135159, EN. Publ. 27.08.1999,).

Known composition for local anesthesia in the form of a gel containing the following components, wt.%: hydrochloride lidocaine - 3,5-5,5; menthol - 3-3,1; methylcellulose 1.5 to 2.5; glycerol - 10-11; nipagin 0,15; nipazol - 0.05 and water to 100 (Application No. 2001105304, EN. Publ. 27.07.2003,).

Known ointment with propolis containing drug vexes the in - propolis and base, containing organic matter, comprising methylene group, in which the organic matter basis contains a polyethylene oxide with a molecular mass of 400 and 1500, and optionally preservatives nipagin and nipazol, with the following ratio of components, wt.%: propolis 10,69-11,81, polyethylene oxide with a molecular weight of 400 - 60,57-66,93, nipagin - 0,142-0,158, nipazol - 0,19-0,21, and polyethylene oxide with a molecular weight of 1500 (Application No. 97112208, EN. Publ. 20.07.1999,).

Known anti-inflammatory and wound-healing drug, including drug containing carotene, antimicrobial agent, methyluracil, tween-80, alcohols of synthetic primary higher fatty fraction16-C21, preservative, purified water and refrigerant-12, in which the antimicrobial agent use nitazolom as preservative - 1.2 propylene glycol or a mixture of glycerol and ethanol 95%in the ratio of 1:1 at the next appropriate ratio of components (Application No. 95116621, EN. Publ. 10.10.1997,).

Known means anticongestive conduct constituting the emulsion of the type oil-in-water containing nafazolina nitrate, eucalyptus oil and vaseline oil per 100 g of the emulsion in a certain ratio, in addition, it further comprises a soluble starch, lecithin, acid on eyouuu, the polyethylene oxide - 400, equivalent, PEG-40, hydrogenated castor oil, nipagin, nipazol, water at a certain ratio of components (Patent 2238081, EN. Publ. 20.10.2004,).

Known means of stimulating the healing process of wounds, comprising in wt.%: levomycetin of 0.65-0.75, methyluracil - 0,35-0,45, lavender - 0,5-0,7, gylcerin - 10,0-15,0, anhydrous lanolin - 3,0-4,0, butter fat (stone) - 10,0-20,0, distilled monoglycerides - 1,0-2,0, abbasian (stabilizer) is 0.5 - 0.8, nipagin - 0,11-0,12, napsal - 0,11-0,12 distilled water - the rest (Patent No. 2146924, EN. Publ. 27.03.2000).

Known drug, possessing regenerative and wound healing properties, comprising as active components in wt.%: Pancreatin 5, methyluracil 3, as the basis of a polyethylene oxide 1500 18.4, polyethylene oxide 400 73.5, as well as preservatives nipagin 0.08 and nipazol 0, 02 (Patent No. 2191574, EN. Publ. 27. 10. 2002).

However, the known drug does not have a pronounced antibacterial and analgesic properties and is not intended for the treatment of purulent wounds.

The present invention is to develop drugs with pronounced antibacterial, analgesic, regenerative and wound healing action that increases the effectiveness of treatment and the quality of the ointment C is by giving it the aseptic properties and prevention of re-contamination.

The problem is solved in that the pharmaceutical composition for external use with purulent-inflammatory diseases containing organic matter, in the form of oxides, the active ingredient, preservatives - nipagin and nipazol, as the basis contains a water-soluble oxides mol. m 400 and 1500, as active components in it applied ftorhinolony antibiotic ofloxacin and stimulator repair tissue - methyluracil, and additionally contains a local anesthetic agent is lidocaine hydrochloride and entered the plasticizer is propylene glycol, the following ratio of components, wt.%:

The polyethylene oxide mol. m 15001-40
The polyethylene oxide mol. m 40010-95
Ofloxacin0,1-5,0
Methyluracil0,5 -7,0
Lidocaine hydrochloride0,5-6,0
Nipagin0,01-1,0
Nipazolof 0.005 to 1.0
Propylene glycol1,0-20

while preservatives nipagin and nipazol ispolzovat in the ratio of 4:1.

Convenient application of the pharmaceutical composition is achieved by making it as soft sterile dosage forms, R is Spasovka in tubes for use with small burn injuries and in banks orange glass 30, 50, 100, 1000, 2000 grams for use in large areas burn the body in the treatment in the hospital.

The present invention is explained detailed description, examples of execution.

The pharmaceutical composition for external use "Flamelet" when purulent-inflammatory diseases was obtained as follows.

To obtain ointment bases are mixed with 90 kg of polyethylene oxide 1500 and 247,22 kg of polyethylene oxide 400 when heated to a temperature of 60-65°C.

30 kg of polyethylene oxide 400 suspended 4,527 kg ftorhinolony antibiotic and 18,135 kg stimulator repair tissue. As ftorhinolonov antibiotic use ofloxacin. As a stimulant repair fabric used methyluracil.

To obtain preservative in 45 kg of propylene glycol at a temperature of 65-70°dissolve 14,72 kg local anesthetic, which is used as lidocaine hydrochloride, 0,36 kg nipagina and 0.09 kg nipazola.

The resulting solution of lidocaine hydrochloride and preservative are mixed with a suspension of ofloxacin and methyluracil and injected under stirring ointment base.

Sterile pharmaceutical composition by heating, soaking it in a hot state.

In the manufacture of pharmaceutical compositions for the compliance of its quality and pharmacological properties, use ut canoe ratio, namely, one part of the antimicrobial agent - ftorhinolony antibiotic ofloxacin, four pieces of anti - inflammatory drugs-methyluracil and three parts of local anesthetic means of lidocaine hydrochloride.

The plasticity and elasticity of the pharmaceutical composition in the form of soft medicinal forms get using to prepare the polyethylene oxide mol. m 1500, polyethylene oxide mol. m 400 and the plasticizer is propylene glycol.

Study of the efficacy of the pharmaceutical composition for external use "Flamelet" when purulent-inflammatory diseases was carried out on models of the infected wounds of various localization and origin of the wound healing process, including: amputation stump extremities, ulcers, sores, infected burns II-IV degree, post-operative and post-traumatic wounds and fistulas, abscesses, phlegmon, and others also studied the impact of the proposed pharmaceutical composition for broken bones, deep wounds, purulent-inflammatory diseases of the skin.

Examples of implementation and use of pharmaceutical compositions.

Example 1.

Ointment base receive, mixing 90 kg of polyethylene oxide 1500 and 247,22 kg of polyethylene oxide 400 when heated to a temperature of 60-65°C.

30 kg of polyethylene oxide 400 suspended 4,527 kg ofloxacin and 18,135 kg methyluracil. 45 the g of propylene glycol at a temperature of 65-70° With dissolved 14,72 kg of lidocaine hydrochloride, 0,36 kg nipagina and 0.09 kg nipazola.

The resulting solution of lidocaine hydrochloride and preservatives mixed with suspension ofloxacin and methyluracil and injected under stirring ointment base.

Sterile pharmaceutical composition by heating to a temperature of 120°C and maintained at this temperature for 40 minutes.

The obtained pharmaceutical composition has the following ratio of components, wt.%:

The polyethylene oxide mol. m 1500- 20
The polyethylene oxide mol. m 400- 61,9
Ofloxacin- 1,0
Methyluracil- 4,0
Lidocaine hydrochloride- 3,0
Nipagin- 0,08
Nipazol- 0,02
Propylene glycol- 10,0

while preservatives nipagin and nipazol used in the ratio of 4:1.

Example 2.

Ointment base receive, mixing 95,1 kg of polyethylene oxide 1500 and 294,3 kg of polyethylene oxide 400 when heated to a temperature of 60-65°C.

10 kg of polyethylene oxide 400 suspended 0,452 kg ofloxacin and 2,27 kg methyluracil. 45 kg of propylene glycol at a temperature of 65-70°dissolve 2,45 kg of lidocaine hydrochl the reed, 0,36 kg nipagina and 0.09 kg nipazola.

The resulting solution of lidocaine hydrochloride and preservatives mixed with suspension ofloxacin and methyluracil and injected under stirring ointment base.

Then sterilize pharmaceutical composition by heating to a temperature of 120°and kept in a heated state at a temperature of 40 minutes.

The obtained pharmaceutical composition has the following ratio of components, wt.%:

The polyethylene oxide mol. m 1500- 20,93
The polyethylene oxide mol. m 400- 67,87
Ofloxacin- a 0.1
Methyluracil- 0,5
Lidocaine hydrochloride- 0,5
Nipagin- 0,08
Nipazol- 0,02
Propylene glycol- 10,0

while preservatives nipagin and nipazol used in the ratio of 4:1.

Example 3.

Ointment base receive, mixing 76,2 kg of polyethylene oxide 1500 and 164,5 kg of polyethylene oxide 400 when heated to a temperature of 60-65°C.

80 kg of polyethylene oxide 400 suspended 22,635 kg ofloxacin and 31,736 kg methyluracil. 45 kg of propylene glycol at a temperature of 65-70°dissolve 29,44 kg lidocaine hydroch oride, 0,36 kg nipagina and 0.09 kg nipazola.

The resulting solution of lidocaine hydrochloride and preservatives mixed with suspension ofloxacin and methyluracil and injected under stirring ointment base.

Sterile pharmaceutical composition by heating to a temperature of 120°and aged at this temperature for 40 minutes.

The obtained pharmaceutical composition has the following ratio of components, wt.%:

The polyethylene oxide mol. m 1500- 54,78
The polyethylene oxide mol. m 400- 17,12
Ofloxacin- 5,0
Methyluracil- 7,0
Lidocaine hydrochloride- 6,0
Nipagin- 0,08
Nipazol- 0,02
Propylene glycol- 10

while preservatives nipagin and nipazol used in the ratio of 4:1.

In clinical practice applied pharmaceutical composition for external use "Flamelet" when purulent-inflammatory processes in the following way.

After the standard treatment of wounds and burns pharmaceutical composition in the form of soft sterile dosage forms (the ointment) was applied directly on the wound surface in a thin layer. the ATEM put a sterile gauze bandage. In addition, if necessary, used gauze bandage with subsequent application to the lesion.

When purulent wounds tampons, which are impregnated with ointment loosely filled purulent cavity after surgical treatment. Gauze pads with ointment was introduced in fistulous passages in their treatment.

In the treatment of purulent wounds ointment applied once a day. In the treatment of burns daily. The maximum daily dose when applying the ointment does not exceed 100 grams.

The duration of treatment using the pharmaceutical composition for external application "Flamelet" in the treatment of purulent-inflammatory diseases depended on the dynamics of the cleansing of wounds from purulent exudate and terms of inflammation.

Topically applied ointment once a day for 1-2 weeks at a set time.

The proposed pharmaceutical composition for external application "Flamelet" in the treatment of purulent-inflammatory diseases allows to treat infected wounds of various localization and origin of the wound process, namely: amputation stump extremities, ulcers, sores, infected burns II-IV degree, post-operative and post-traumatic wounds and fistulas, abscesses, cellulitis and other

Moreover, its application in the treatment of open fractures of bones, deep wounds, GN is Ino inflammatory skin diseases.

The proposed pharmaceutical composition has a higher quality and efficiency. It has no interactions with other drugs, which would decrease the efficiency and safety of its use. When it found no side effects. The use of this ointment helps to prevent the development of inflammatory process.

The proposed pharmaceutical composition for external application "Flamelet" developed and produced by LLC "Sintez".

1. The pharmaceutical composition for external use with purulent-inflammatory diseases containing organic matter in the form of oxides, the active ingredient, preservatives - nipagin and nipazol, characterized in that as the Foundation it contains the water-soluble oxides mol. m 400 and 1500, as active ingredients applied ftorhinolony antibiotic ofloxacin and stimulator repair tissue - methyluracil, and additionally contains a local anesthetic agent is lidocaine hydrochloride and entered the plasticizer is propylene glycol in the following ratio, wt.%:

The polyethylene oxide mol. m 15001-40
The polyethylene oxide mol. m 40010-95
Ofloxacin0,1-5,0
Methyluracil0,5-7,0
Lidocaine hydrochloride0,5-6,0
Nipagin0,01-1,0
Nipazolof 0.005 to 1.0
Propylene glycol1,0-20,

while preservatives nipagin and nipazol used in the ratio of 4:1.

2. The pharmaceutical composition according to claim 1, characterized in that it is made in the form of a soft sterile dosage forms.



 

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