Composition and method for preparing ophthalmic hydrocortisone ointment

FIELD: chemical-pharmaceutical industry, pharmacy.

SUBSTANCE: invention relates to a method for preparing ophthalmic hydrocortisone ointment. Method involves mixing hydrocortisone acetate and a base prepared by melting Vaseline of sort "for ophthalmic ointments" and anhydrous lanolin at temperature 60-80°C at stirring, filtration through caprone fabric on funnel for hot filtration into thermostable capacity, sterilization in drying chamber at temperature 180-200°C for 1.5-2 h or in hermetic reactor by steam under pressure at temperature 120°C for 40-60 min, and preserving agents are added to the sterile melt at stirring. Ophthalmic ointment prepared by such method shows the improved adhesion properties and doesn't irritate the eye mucosa.

EFFECT: improved preparing method.

3 ex

 

The invention relates to the field of pharmaceutical industry, in particular the production of drugs used for the local treatment of inflammatory diseases of allergic origin [1].

Known drugs hydrocortisone and its salts, used in the form of ointments, and methods for their preparation.

Known anti-inflammatory and antimicrobial agent for topical application (patent RU 2137469, a 61 K 9/06 from 16.04.98)containing (in %) hydrocortisone acetate 0.25 to about 1.75, nitazol from 0.50 to 3.50, medical vaseline oil 5,0-35,0, tween-80) of 0.60 and 1.80, synthetic primary higher saturated alcohols fraction C16-C20or cetosteatil alcohol 4,00-7,60, propylene glycol 5,00-40,00, purified water to 100%. Possible additive medicine halon-12 of about 15-17%. The drug provides a comprehensive effect on the damaged tissues of the skin, mucous membranes of the genitals and the rectum in the form of multiple therapeutic actions.

A disadvantage of the known dosage forms in the form of ointment or foam aerosol, representing the type of the dispersed system emulsion oil-in-water", is the inability of the application to the conjunctiva of the eye, due to the composition and type of dispersed systems. Antimicrobial drug nitazolom not approved for use in ophthalmic practice, causes dryness of the mucous and ustwo burning [1, 2]. Application glycolamide environments, in particular, propylene glycol, in ocular dosage forms is not recommended because of their dehydrating properties, causing a sharp drop in osmotic pressure. The emulsion of the type oil-in-water" heavily clouded vision [3].

A method of obtaining corticosteroid ointments for the treatment of skin diseases (patent RU 2097063, a 61 K 38/22 from 15.11.95 prototype on the way), including a preliminary preparation of the concentrate by grinding a mixture of hydrocortisone acetate, chloramphenicol and melted vaseline and mix it with a Foundation containing petrolatum, liquid paraffin, lanolin, sorbifolia and stearic acid, followed by emulsification with water. The disadvantage of this method is the presence of a stage of emulsification with water, which leads to the formation of emulsion system is not stable when stored in physico-chemical (striping) and microbiological (microbial growth in the aqueous medium). In addition, as shown in patent method for producing a corticosteroid ointments for the treatment of skin diseases, there is no stage sterilization that does not allow sterile ointment complying with the requirements of the State Pharmacopoeia 11 editions to eye ointments [6].

Closest to the claimed composition is repeat ointment hydrocortisone 0.5% eye on ND 42-9349-98 "Alfa JSC (Poland) (prototype). 1 g eye ointment on the basis of white vaseline contains hydrocortisone acetate 5.0 mg, methoxybenzoate (nipagina) 2 mg [2, 4].

The disadvantage of the prototype is the poor distribution of the ointment on the mucous membrane of the conjunctiva of the eyes and nesmachivaemost ointment lacrimal fluid surrounding the cornea, due to the hydrophobic properties of vaseline [5].

The aim of the invention is to provide a composition and method of producing ophthalmic ointment hydrocortisone for treatment of inflammatory diseases of allergic origin.

The essence of the invention is that of hydrocortisone acetate is produced in a way which excludes emulsification, eye ointment sterile-based alloy petrolatum and anhydrous lanolin, which improves the wettability ointment lacrimal fluid and contributes to the fixation of the ointment on the mucous membrane of the eye.

The technical result of the proposed invention is expressed in the composition of the ointment hydrocortisone ophthalmic, containing hydrocortisone acetate as active ingredient, a preservative, for example, nipagin, and petrolatum and lanolin - based ointment, in the following ratio, wt.%:

hydrocortisone acetate0.1 to 2
preservative (for example, nipagin)0,05-1
Lano is in anhydrous 1-50
vaseline varieties for eye ointments"100

The use of hydrocortisone acetate in a quantity below the lower limit does not provide a therapeutic effect of eye ointments. The use of hydrocortisone acetate in a quantity above the upper limit leads to the irritating action of the ointment.

The introduction of the ointment preservative in an amount below the lower limit does not provide preservative properties. The use of preservative in the amount above the upper limit leads to the irritating action of the ointment.

The use of anhydrous lanolin in an amount below the lower limit does not provide a satisfactory adhesion of the ointment on the eye mucosa. The use of anhydrous lanolin in an amount above the upper limit leads to the irritating action of the ointment.

The use of non-sterile anhydrous lanolin and vaseline does not provide microbiological purity ointments.

The compositions and methods of obtaining ointment hydrocortisone ophthalmic described below by examples, but not limited to.

Example 1.

Industrial regulations JSC ğtatkhimpharmpreparatyğ PR 00480750-124-03 "Ointment hydrocortisone ophthalmic 0.5 percent"

In a sealed reactor with a vacuum pump serves 464,72 kg vaseline varieties for eye ointments and to 51.64 kg anhydrous lanolin, will precede the flax melted in containers in the melting bath at 60-70° C. Sterilization alloy petrolatum and anhydrous lanolin is carried out in a reactor at a temperature of 120±2°C for 40-60 minutes. Sterilized ointment base is served in a sealed mixer with steam jacket. Download the 1.04 kg nipagina, 2.6 kg of hydrocortisone and mix. Ointment from the mixer is passed by means of pump packing.

Received hydrocortisone ointment 0.5% is a sterile and stable during storage for 4 years.

At research Institute of eye diseases of the Russian Academy of medical Sciences comparative morphological study of the eyes of rabbits after 30 days laying in the conjunctival SAC is designed to 0.5% hydrocortisone ointment on lanoline-the basis of vaseline and drug hydrocortisone ointment 0.5% eye production Alfa JSC (Poland) on the basis of vaseline. It is noted that lanoline-vaseline base are designed ointment is more hydrophilic and less prevents water gas exchange of the cornea compared to petroleum-based ointment hydrocortisone 0.5% eye production Alfa JSC (Poland).

Example 2. Get hydrocortisone ointment 0.3% of the eye

Composition (per 100 g of ointment):hydrocortisone acetate0.3 g
nipazola0.07 g
the vase is in grade "for eye ointments" 79,63 g
anhydrous lanolin20,0 g

Ointment base (200 g anhydrous lanolin, 796,3 g vaseline varieties for eye ointments") is melted in a porcelain Cup at a temperature of 60-70°S, hot filtered through a nylon cloth over the hot filtration in a heat resistant container. Sterilized at 180°in a drying Cabinet for 2 hours and transferred to the laboratory ointment boiler. Add to the basis of chopped 3 g of hydrocortisone acetate, 0.7 g nipazola and stirred using a stirrer with inclined blades within 1 hour when the stirrer speed of 100 rpm and a temperature of 38°C. within 15 min mix ointment manually using a spatula-spoon. Ready ointment Packed.

Example 3. Get hydrocortisone ointment 1% ophthalmic

Composition (per 100 g of ointment):hydrocortisone acetate1.0 g
nipagina0.2 g
nipazola0.2 g
vaseline varieties for eye ointments"of 80.6 g
anhydrous lanolin18.0 g

Ointment base (180 g of anhydrous lanolin, 806 g of vaseline grade "for glass the x ointments") is melted in the vessel at a temperature of 70-80° With, hot filtered in a heat resistant container. Sterilized at 200°C in an oven for 1.5 hours and transferred to the laboratory ointment mixer. Add to the basis of 10 g of hydrocortisone acetate, 2 g of nipagin, 2 g nipazola and mixed using a disperser. Ready ointment Packed.

The proposed composition and method thereof allow sterile stable hydrocortisone cream for topical use on mucous membrane of the conjunctiva of the eyes and the mucous membranes of the genitals, rectum and skin.

LITERATURE

1. Mashkovsky PPM Drugs, ed 14-E. M.: New Wave, 2000. - Vol.2. - P.28, s.

2. Encyclopedia of drugs. - 8th ed., 2001. -Publishing house "Register of medicinal products of Russia". - S, 221.

3. Ants I.A. Technology of drugs. T.II. - M.: Medicine, 1980. - S.

4. ND 42-9349-98 "Alfa JSC, hydrocortisone Ointment 0.5% eye.

5. Technology of medicinal forms. T.I / edited Tscaingredient. - M.: Medicine, 1991. - S.

6. State Pharmacopoeia of the USSR: 2). - 11th ed., extra - M.: Medicine, 1989. - S.

The method of obtaining ophthalmic ointment for topical treatment of inflammatory diseases of allergic origin comprising a mixture of hydrocortisone acetate and fundamentals, characterized by the presence of additional stages of the sterilization fundamentals, prepared splavlyayutsya varieties for eye ointments and anhydrous lanolin at a temperature of 60-80° With stirring, filtered through a nylon cloth over to hot filtration in a heat resistant container, sterilized in an oven at 180-200°C for 1.5-2 hours or in a sealed reactor steam under pressure at 120°C for 40-60 min and added to sterile alloy preservatives under stirring.



 

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