Drug preparation for treating cataract and method for preparing it (versions)

FIELD: medicine, pharmaceutics.

SUBSTANCE: group of inventions refers to medicine, namely ophthalmology, and aims at treating cataract. A drug preparation for treating cataract based on the active substance sodium dihydroazapentacene polysulphonate (azapentacene) is presented in the form of ophthalmic drops. Stabilising is ensured by using a borate buffer and potassium chloride, a borate buffer and sodium chloride, a phosphate buffer, a quaternary ammonium derivative, Nipaging and a preserving agent of mercury derivatives. The ingredients are used in the declared amounts.

EFFECT: using the group of inventions provides the enhanced antimicrobial properties and the reduced toxicity of the ophthalmic drops, thereby increasing the clinical effectiveness in cataract.

6 cl, 1 ex

 

The invention relates to the pharmaceutical industry, namely the production of medicines.

The invention is a medicinal product for the treatment of cataract based on the active substance dihydroanthracene polysulphate sodium (isopentane), made in the form of eye drops.

Cataract is one of the most common causes of vision loss, the number of patients with age, complicated and traumatic cataract is increasing every year. Currently, the treatment of dominant cataract surgical method [1].

Currently there is no cure, the effect of which could be compared with the operation. Therefore, the search for drugs that can provide an acceptable therapeutic effect.

For conservative treatment of cataract drops are used "Oftan Katahrom, active substances which are cytochrome C, adenosine and nicotinamide content 0,675 mg, 2 mg, 20 mg, respectively. The drug has an antioxidant effect, improves metabolism and trophic tissues of the eye. According to some studies, the drug has no high anticatarrhal action, and effective for tissue located in front of the lens [8].

The closest technical solution eye drops are "Quinn is with an active substance dehydroacetate polysulfone sodium (isopentane) with a concentration of 0.015% of the mass.

Isopentane inhibits the action of substances quinoid structure, resulting from the metabolism of aromatic acids, protecting sulfhydryl group of soluble proteins of the lens from oxidation and further degradation; activates proteolytic enzymes contained in the aqueous fluid of the anterior chamber.

This drug is used to treat many different types of cataracts: senile, traumatic, congenital, secondary.

According to the instructions on the application part of the eye drops "Twinax" the following:

active substance: dehydroacetate polysulfone sodium 0,15 mg

Excipients:

boric acid 6,30 mg;

sodium borate 0.30 mg;

potassium chloride 7,15 mg;

methyl parahydroxybenzoate 0,065 mg;

sodium propyl parahydroxybenzoate 0.035 mg;

thiomersal 0,002 mg;

sodium hydroxide and/or concentrated hydrochloric acid to bring pH;

purified water to 1.0 ml.

Buffer solution (combination of boric acid and sodium borate) plays the role of a stabilizer solution, potassium chloride is isotherwise agent, two ether parabens - methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate, and a derivative of mercury (thiomersal is a preservative, and sodium hydroxide and/or hydrochloric acid concentrated use is conducted as agents, regulating the pH of the solution.

The aim of the invention is to develop a modified medicines in the form of eye drops with active ingredient - isopentane.

The technical result of the invention is the expansion of technological capabilities for the production of medicines in the form of eye drops with current substance isopentane due to:

- use of the active substance (isopentane concentration 0,0050-0,0300 masses. % inclusive;

- the use of cheaper and convenient auxiliary substances;

- enhancement of antibacterial properties, reduce the toxicity of eye drops due to the use of more effective and less toxic combinations of preservatives;

- increase the effectiveness of treatment due to the inclusion of part of the eye drops prolongator.

1. To achieve a technical result of eye drops dosage isopentane taken in an amount 0,0050-0,0300 wt.% inclusive.

2. Instead of borate buffer (combination of boric acid and sodium borate) as an alternative it is proposed to use phosphate buffer (sodium phosphate one-deputizing with a concentration of 0.01 to 1.3% of the mass. inclusive and sodium phosphate disubstituted with a concentration of 0.01 to 1.5 wt%. inclusive).

An example of the masses. %:

dehydroacetate polysulfone sodium0,02
sodium phosphate one-deputizing0,75
sodium phosphate disubstituted0,35
potassium chloride0,75
methyl parahydroxybenzoate0,10
hydrochloric acid to bring pH
purified waterto 100 ml

3. To achieve a technical result in the part of the eye drops as isotherwise agent instead of potassium chloride is proposed to use sodium chloride with a concentration of 0.01 to 0.9 wt%. inclusive. Sodium chloride is a cheaper agent and more widely used in pharmaceutical production.

An example of the masses. %:

dehydroacetate polysulfone sodium0,015
boric acid0,63
sodium borate0,03
sodium chloride 0,55
methyl parahydroxybenzoate0,075
sodium propyl parahydroxybenzoate0,025
thiomersalis 0.0002
sodium hydroxide to bring pH
purified waterto 100 ml

4. As preservatives in the composition of eye drops you can use:

any paraben ester (methylparahydroxybenzoate) with a concentration of 0.001 to 0.2 mass. % inclusive, preferably 0.1 mass. % and the derived mercury - thiomersal concentration 0,00005-0,0065 masses. % inclusive, preferably 0.0002 mass. %;

any paraben ester (methylparahydroxybenzoate) with a concentration of 0.001 to 0.2 mass. % inclusive;

any derived Quaternary ammonium (benzalconi chloride, camillejimene bromide, cetylpyridium chloride, benneton chloride and so on) with a dosage of 0.0001-of 0.015 wt. % inclusive.

Using the derived Quaternary ammonium compounds are preferable as the paraben esters are poorly soluble in water, and derivatives of mercury are toxic substances.

5. To increase the effectiveness of treatment of eye drops with active ingredient - isopentane, perhaps the adding part prolongator.

Prolongator use for more long-term presence of eye drops on the surface of the cornea and in konyunktivalny cavity of the eye due to the enveloping action. As prolongation can be used polyvinyl alcohol, polyvinylpyrrolidone, derivatives of polyacrylic acid, methylcellulose, hydroxypropylcellulose, hydroxyethylcellulose, carboxymethyl cellulose, hypromellose. The concentration of the prolongator is 0.01-2.0 wt.% inclusive, and the list of prolongation not limited to the above substances.

An example of the masses. %:

dehydroacetate polysulfone sodium0,01
the hypromellose0,1
boric acid0,60
sodium borate0,03
sodium chloride0,58
benzalkonium chloride0,01
sodium hydroxide to bring pH
purified waterto 100 ml

As agents for regulating the pH of the solution, part of the eye drops used sodium hydroxide and/or hydrochloric acid.

The method of obtaining eye drops includes the preparation of a solution of preservatives, introduction to the solution of the active ingredient, preparation of buffer solution, the introduction of isotherwise agent in the buffer, a mixture of the obtained solutions, sterile filtration, aseptic filling.

The method of obtaining prolonged eye drops includes the preparation of a solution prolongator, sterilization solution prolongator, separate preparation of buffer solution, the introduction of buffer preservative, dissolution, introduction isotherwise agent, the introduction of the active component, sterilizing filtration, mixing the resulting solution with a solution of prolongator, aseptic filling.

Bibliography

1. Eye diseases. Ed. Century, Capeway. - M.: Medicine, 2002, s 249.

2. Bagirov N. A. Modern problems of cataractogenesis. / N.A. Bagirov. // Oftalmol. zhurn., 2000. - 6. - S. 98-102.

3. Boldyrev, A. A. Carnosine: endogenous physiological corrector activity of the antioxidant system of the body [Text]. / A. A. Boldyrev, S. L. Stvolinsky, T. N. Fedorov. // USP. Fiziol. Sciences. - 2007. - 38 (3). - S. 57-71.

4. Boldyrev, A. A. Carnosine. - M.: Publishing house of Moscow state University. M. C. University. - 1998.

5. Iscove.T., Stepanova E. F., Novikov M. Y. Harmonization requirements of eye drops in the light of the modern development of pharmaceutical production. // Materials of international scientific-practical conference "Biologically active compounds of natural origin: herbal medicine, pharmaceutical marketing, pharmaceutical technology, pharmacology, botany". Belgorod, 2008. S. 62-66.

6. Mashkovsky M. D. Drugs: 2 so, So 2. - M.: OOO "Publishing house New Wave", 2004. - S. 126.

7. Morozov, C. I., Yakovlev A. A. Pharmacotherapy of eye diseases: a Handbook. M.: Medicine, 1989, S. 240.

8. On The Main Page. Drugs in Russia: a Handbook. Ed. 9-E. M.: Attraversare, 2003.

9. Technology and standardization of drugs. Collection of scientific papers. - T. 2. - Kharkov: IG REREG". - 2000, S. 292-293.

10. Technology of medicinal forms: a Textbook in 2 volumes. T. 1 / Ed. by L. A. Ivanova. - M.: Medicine, 1991. - S. 228.

1. Drug for the treatment of cataract based on the active substance dihydroanthracene polysulphate sodium (isopentane), made in the form of eye drops, characterized in that in order to stabilize and isatoribine used borate buffer and potassium chloride with the following ratios, wt. %:

boric acid0,1-,0
sodium tetraborateof 0.01 to 3.0
potassium chloride0,01-1,2

2. Drug for the treatment of cataract based on the active substance dihydroanthracene polysulphate sodium (isopentane), made in the form of eye drops, characterized in that in order to stabilize and isatoribine used borate buffer and sodium chloride with the following ratios, wt. %:

boric acid0,1-2,0
sodium tetraborateof 0.01 to 3.0
sodium chlorideof 0.01 to 0.9

3. Drug for the treatment of cataract based on the active substance dihydroanthracene polysulphate sodium (isopentane), made in the form of eye drops, characterized in that the stabilization is used phosphate buffer under the following ratios, wt. %:

sodium phosphate one-deputizing0,01-1,3
sodium phosphate disubstituted0,01-1,5

4. Lekarstvo the E. means for cataract treatment on the basis of substance dihydroanthracene polysulphate sodium (isopentane), made in the form of eye drops, characterized in that the preservative used is derived Quaternary ammonium with a dosage of 0.0001-.0015 masses. %.

5. Drug for the treatment of cataract based on the active substance dihydroanthracene polysulphate sodium (isopentane), made in the form of eye drops, characterized in that as preservatives are methyl parahydroxybenzoate (nipagin) and the preservative from the group of derivatives of mercury, mass. %:

methyl parahydroxybenzoate (nipagin)of 0.001 to 0.2
the preservative from the group of derivatives of mercury0,00005-0,0065

6. Drug under item 5, characterized in that it eliminates the preservative from the group of derivatives of mercury.



 

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