RU2709011C1 - Method for producing rectal antler suppositories for men - Google Patents

Abstract

FIELD: medicine; pharmaceuticals.

SUBSTANCE: invention refers to pharmaceutical industry, namely to a method for producing rectal antler suppositories. Method for producing rectal antler suppositories for treating male urological and proctologic diseases selected from rectal inflammatory processes, anal fissures, prostatitis and prostate adenoma, consisting of cocoa butter, lanolin, dry pantogematogen, propolis, vitamin PP, vitamin E, humic acids, a red root extract having an anti-inflammatory effect, and a nettle extract having an anti-inflammatory effect, with certain proportions of components, consisting in fact that into reactor with included agitator at 60 °C is fed cocoa oil and lanolin, stirred for 1 hour until complete dissolution of components to obtain a base, the obtained base is added with dry pantogematogen, propolis, vitamin PP, vitamin E, humic acids and continuously mixed at temperature 40 °C for 0.5 hour until complete dissolution of mixture components, red root extract and nettle extract are added to obtained mixture at stirring and temperature at 40 °C, the mixture is poured into the contour cellular package.

EFFECT: suppositories obtained by the method described above are effective for treating male urological and proctologic diseases selected from inflammatory processes in the rectum, anal fissures, prostatitis and prostate adenoma.

1 cl, 1 tbl, 1 ex

Description

The invention relates to pharmacology and can be used for the manufacture of rectal antler suppositories for men, consisting of cocoa butter, lanolin, dry pantohematogen, propolis extract, vitamins PP and E, humic acids of plant extracts from tea roots (red root) and dioica nettle leaves liquid followed by their use as a dosed drug for the treatment of male urological and proctological diseases.

Rectal antler suppositories for men has the following ratio of medicinal components, masses. %: cocoa butter 48, lanolin 14, pantogematogen dry 9.5, propolis 4.7, vitamin PP 2.6, vitamin E 2.6, humic acids 3.6, red root extract 7.5, nettle extract 7.5 .

The technical result of the invention is to create a dosage form of antler products in the form of rectal antler suppositories for men, which can be used in the treatment of male urological and proctological diseases selected from inflammatory processes in the rectum, anal fissures, prostatitis and prostate adenoma.

The essence of the invention is achieved by creating a method for producing rectal antler suppositories for men using complementary medicinal components of the composition: cocoa butter, lanolin, dry pantohematogen, liquid propolis extract, vitamins PP and E, humic acids of plant extracts from the roots of tea penny (red root) and Stinging nettle leaves. This composition has an optimal medicinal effect, environmental safety and increased effectiveness in the treatment of male urological and proctological diseases

Analogs of antler products with pantogematogen dry are presented mainly in the form of cosmetics for intimate hygiene of the Endogem series for men. The composition of the cosmetic product “Endogem” for men includes two active components: the substance “Pantohematogen dry C” and nettle extract. In general, antler cosmetic intimate product consists of cocoa butter, pantogematogen dry C, nettle extract. This product is marketed as a cosmetic for intimate hygiene in the form of suppositories. There is a certain contradiction in this interpretation of the antler cosmetic product for intimate hygiene, as the cosmetic product for intimate hygiene of the ENDOGEM series is simultaneously endowed with the medicinal ability of the product. This contradicts the main provisions of the technical regulation of the Customs Union TP TS 09/2011 "On the safety of perfumes and cosmetics."

The cosmetic product for intimate hygiene of the ENDOGEM series for men is recommended for use in the treatment of inflammatory diseases of the genitourinary system (prostatitis, prostate adenoma) in parallel with antibacterial agents as a final stage. The cosmetic product for intimate hygiene of the ENDOGEM series for men has an anti-inflammatory absorbable effect, helps the body fight against hidden infections that cause prostatitis, and stimulates sexual function.

The analogue in the form of an intimate antler cream for men according to RU patent No. 2625502 (1) has the following composition: cocoa butter, lecithin, beeswax, antler-honey extract, propolis extract, bee subpestion extract, honey, vitamin PP, vitamin E, cedar oil , St. John's wort oil, clover extract, red root extract, nettle extract, tea tree essential oil, juniper essential oil.

This intimate antler cream for men helps to improve blood circulation, restore skin elasticity, increase potency. Adjusting the composition of the antler intimate cream through the introduction of targeted medicinal components provides a basis for expanding the scope of the antler product, but already in the field of pharmacology by creating dosage forms (suppositories) for the treatment of male urological and proctological diseases.

The medicinal properties of dry pantohematogen are well known (2). The medicinal component of antler products — pantohematogen dry — is the defibrinated blood of Altai maral, dried under vacuum at 49-50 ° C and containing the whole complex of useful active ingredients. Pantohematogen dry is recommended for use in the treatment of urological and proctologic diseases in men, in particular inflammatory processes in the rectum, prostatitis, prostate adenoma, and anal fissures.

The closest in technical results is the patent of the Russian Federation No. 2200564 "Dosage form pantogematogen on a helium basis" (3). The technical result of the invention is achieved in that the dosage form of pantogematogen for external use includes pantogematogen dry and aqueous medium. The aqueous medium contains a polymer gelling composition, and dry pantohematogen is introduced in the form of a water-alcohol solution containing 8-14% ethyl alcohol, in the following ratio, wt. %: pantohematogen dry in the form of a 3% aqueous-alcoholic solution - 5-35; Polymer gelling composition - 0.5-15; Water - The rest.

The dosage form can be characterized in that the polymer gelling composition contains, by weight. %: Polymer gelling agent - a rare cross-linked polymer of acrylic acid or polyvinylpyrrolidone - 1.2-5.4; Carbomer - 2.4-7.2; Glycerin and / or propylene glycol - 3.0-60.0; Preservatives nipagin and nipazole - 0.06-0.36 Driethanolamine - Up to pH 6-8. The dosage form may also be characterized in that it contains an aromatherapy component in an amount of 0.2-2 wt. %, as well as the fact that the aromatherapy component is at least one essential oil of natural origin.

The inventors recommend the use of a patentable composition for the treatment of diseases of the gynecological and urological profile. In this case, the gel is administered directly rectally or vaginally with routine procedures.

It should be noted that the presence in the polymer gel-forming composition of the drug profile of ingredients of a chemical nature, in particular polyvinylpyrrolidone, can contribute to the manifestation of allergic reactions to polyvinylpyrrolidone, especially with regard to its subcutaneous use and situations where polyvinylpyrrolidone comes into contact with mucous membranes.

The use of nipagin (methyl paraben) and nipazole (propyl paraben) as preservatives for the medicinal helium form of pantohematogen can provoke the oncological disease. In recent years, the occurrence of breast cancer has been associated with a class of paraben preservatives. Studies conducted by the FDA (US Food and Drug Administration) have shown that parabens are safe to use in minimal concentrations.

However, parabens tend to accumulate in the body. With breast cancer, a high content of methyl parabens was observed in the samples of the upper outer square of the affected organ. Along with this, methyl paraben (nipagin) is able to enhance the negative effect of ultraviolet radiation, which accelerates the aging process, causes pigmentation and is even able to change the structure of the DNA of the surface epithelium, which in turn leads to mutations on the part of the skin. In people with hypersensitivity to methyl paraben, it can cause an allergic reaction, expressed in itching, redness and other manifestations, a carcinogenic or allergenic effect. Triethanolamine, which is part of the medicinal gel form with pantogematogen, can cause dry skin and hair, redness and irritation of the eyes. Triethanolamine penetrates the skin and can accumulate in it, and eventually manifest its toxic properties.

Medicinal substances in the gel are represented by pantohematogen in the form of a 3% aqueous-alcoholic solution in the gel with preservatives parabens (napagin, nipazole). Pantohematogen dry itself is characterized by low stability in an aqueous solution at room temperature and requires special storage conditions.

The above examples show that the use of chemical components of the medicinal pantogematogen-containing gel significantly impairs the ability of the pantogematogen dosage form to treat diseases of the urological and gynecological profile, while the use of chemical preservation with methylparaben (nipagin) and propyl paraben (nipazole) in an amount of 0.06-0.36 wt. . % for the purpose of stabilization of the drug component - dry pantohematogen, they can significantly affect the medicinal activity of the pantohematogen-containing gel with its further use as part of drugs for use in pharmacology and practical medicine.

The aim of the invention is to develop a method for producing rectal antler suppositories for men and for optimizing the prescription composition of the antler drug product by improving its natural and environmental characteristics using in the composition of medicinal substances having a complementary effect for the treatment of urological and proctological diseases in men.

This goal is achieved by creating a method for preparing rectal antler suppositories for men with the ability to treat male urological and proctological diseases with a concomitant improvement in product quality by increasing the content of dry pantohematogen and adding complementary drug components with an affinity for therapeutic effect in eliminating inflammatory processes in the mucous membranes of the rectum, treatment of prostatitis, prostate adenoma and healing of tr even the anus.

A method of manufacturing rectal antler suppositories for men involves the preparation of a suppository base at the first stage using cocoa butter and lanolin.

In the manufacture of the suppository base, it was taken into account the fact that the carriers of the medicinal properties can be both cocoa butter and lanolin, which provides optimal mechanical forms of products in the manufacture of rectal antler suppositories for men.

The manufacture of the suppository base of rectal antler suppositories for men should ultimately provide the necessary consistency of the antler drug product, preserving properties for the medicinal component - dry pantohematogen and ensure the optimal introduction of complementary medicinal components of the composition: propolis extract, vitamins, plant extracts and humic acids.

The suppository base of rectal antler suppositories for men consists of the following components (in mass%):

cocoa butter 48;

lanolin 14.

The components of the suppository base of rectal antler suppositories have the following medicinal properties:

Cocoa Butter - has a softening, nourishing effect on the mucous membranes and skin. Used as the basis for the preparation of rectal suppositories.

Lanolin is used as an emulsifier, which is added in minimal quantities to eliminate the formation of a mass of greasy-like consistency of suppositories and increase their mechanical strength. This substance also contributes to the rapid healing of wounds and cracks and restore the integrity of the skin.

At the second stage of obtaining rectal antler suppositories for men, the complementary medicinal components of the composition are introduced into the prepared suppository base - dry pantohematogen, liquid propolis extract, vitamin PP, vitamin E, humic acids in a percentage mass ratio. %:

Pantohematogen dry 9.5;

Propolis liquid extract 4.7;

vitamin PP 2.6;

vitamin E 2.6;

humic acids 3.6.

These complementary medicinal components of the composition of rectal antler suppositories have the following therapeutic properties:

Pantohematogen dry eliminates central, peripheral and microcirculatory circulatory disorders, helps to eliminate skin diseases (eczema, psoriasis, furunculosis, dermatitis, trophic ulcers, etc.), and is used for complex treatment of inflammatory diseases of the genitourinary system (prostatitis, prostate adenoma).

Propolis - has anti-inflammatory, antibacterial, antiseptic effect.

Humic acids have anti-inflammatory effects. They accelerate the healing of wounds and peptic ulcer due to increased fibroblast proliferation processes, contribute to the activation of water, protein and fat metabolism. The inhibitory effect of humic acids on proteolytic enzymes that damage blood vessel walls and skin has been established.

Vitamin PP - improves blood circulation, promotes the renewal of tissue cells.

Vitamin E - helps to restore damaged areas in a shorter time, promotes wound healing.

At the third stage, in the suppository mass, liquid plant extracts are added from the roots of tea apricot (red root) and dioecious nettle leaves in a percentage ratio (wt.%):

Extract from the roots of the tea penny (red root), liquid 7.5;

Nettle leaf extract, dioecious liquid 7.5.

Plant extracts provide the following medicinal properties:

The extract from the roots of tea penny (red root) is characterized by the presence of an anti-inflammatory effect in diseases of the genitourinary system — prostatitis, which improves blood circulation and eliminates congestion in the prostate gland.

The extract from the leaves of the nettle dioica has an anti-inflammatory effect, helps accelerate tissue regeneration, has the possibility of symptomatic treatment with an enlarged prostate gland.

In general, the manufacture of the composition of rectal antler suppositories for men with the use of complementary medicinal components increases the possibility of achieving optimal therapeutic effects that contribute to the treatment of male urological and proctological diseases. When using a patentable composition in the form of rectal antler suppositories for men, the elimination of inflammatory processes in the rectum, the treatment of prostatitis, the reduction of the size of the prostate gland, and the healing of anal fissures are predicted. To solve these problems, antler suppositories for men should be introduced by the abdominal rectal method into the rectum with an article weight of 1.2 to 3 grams. The described procedure using rectal antler suppositories has a regenerative, anti-inflammatory, anti-prostatitis, healing effect in the treatment of male urological and proctological diseases. Rectal antler suppositories for men do not have an irritating and allergenic effect.

The applicant plans to carry out work in conjunction with the Federal State Budgetary Institution Scientific Research Institute of Pharmacology and Regenerative Medicine named after E.D. Goldberg »Tomsk NIMC RAS on the study of the specific properties of harmlessness, in the development of the dosage form and NTD on candles (suppositories) antlers for men with anti-inflammatory effect.

The following examples illustrate the essence of the sentence in more detail.

Example 1

To obtain rectal antler suppositories for men at the first stage of manufacture, components for the manufacture of a natural hydrophobic suppository base of suppositories — cocoa butter — 4.8 kg, lanolin — 1.4 kg — are manually fed into the reactor with the mixer turned on at 60 C and stirring for 1 hour until complete dissolution of the components of the base. Next, the temperature in the reactor is reduced to 40 ° C and when the stirrer is switched on, at the second stage of preparation of rectal antler suppositories for men, drug complementary components of the composition are added, which have indications for the treatment of inflammatory processes in the rectum and stimulation of wound and crack healing - dry hematogen - 0.97 kg propolis - 0.47 kg. vitamin PP - 0.26 kg; vitamin E - 0.26 kg; humic acids - 0.36 kg and mix until the components of the mixture are completely dissolved within 0.5 hours. At the third stage of preparation of rectal antler suppositories for men at 40 ° C and constant stirring in a suppository mass, plant extracts are added that have recommendations for the treatment of prostatitis, prostate adenoma, an extract from the roots of tea penny (red root) 0.75 kg, extract of dioica nettle leaves - 0.75 kg. The total mass yield is 10.06 kg. The number of rectal antler suppositories for men, packaged in 1.2 g in blisters, is 8383 pieces.

The obtained rectal antler suppositories for pouring into a blister strip packaging have a solid consistency of suppositories (candles), dark brown.

The applicant does not have information about the use of rectal antler suppositories for men of this composition, including the complex of complementary medicinal substances of this composition for the treatment of male urological and proctological diseases.

The use of the proposed rectal antler suppositories for men involves cavity (rectal) use for the treatment of male urological and proctological diseases.

In this regard, the applicant believes that the compositions of complementary medicinal substances in the form of rectal antler suppositories for men are original and have not been used to achieve the same goal, which suggests that the proposed meets the requirements of the invention.

Below is table 1 with the parameters and indicators of the known and proposed method for producing rectal antler suppositories for men.

LITERATURE:

1. Kazazayev E.A. METHOD FOR PRODUCING AN INTIMATE PANT PURPLE CREAM FOR MEN. (22) Application: 2016114110, 04/12/2016 (24) Date of commencement of the validity of the patent: 04/12/2016 Priority (s): (22) Date of filing: 12/04/2016 (45) Published: 07/14/2017 Bul. No.20 (72) Author (s): Kazazayev Evgeny Aleksandrovich (RU) (73) Patentee (s): Karym Limited Liability Company (Karym LLC) (RU).

2. V.G. Lunitsyn, N.A. Frolov. Products of antler reindeer husbandry (canning methods, processing use) / Russian Academy of Agricultural Sciences / All-Russian Scientific Research Institute of Antler Reindeer Herding /, Barnaul /, 2006 /, p. 139.

3 (54) GEL-BASED PANTOGEMATOGEN DOSAGE FORM (21) Application registration number: 2002103730/14 (22) Application filing date: 2002.02.15 (24) Published: 2003.03.20 (71) Applicant name: Marina Gerasimenko; Dementienko Valery Vasilievich (72) Name of the inventor: Gerasimenko M.Yu .; Dementienko V.V .; Goncharenko N.L .; Kudryashova V.A .; Lazarenko N.N .; Filatova E.V. (73) Name of patent holder: Gerasimenko Marina Yuryevna; Dementienko Valery Vasilyevich Kudryashova V.A .; Lazarenko N.N .; Filatova E.V.

Claims (3)

A method of obtaining rectal antler suppositories for men for the treatment of male urological and proctological diseases selected from inflammatory processes in the rectum, anal fissures, prostatitis and prostate adenoma, consisting of cocoa butter, lanolin, dry pantohematogen, propolis, vitamin PP, vitamin E , humic acids, red root extract, which has an anti-inflammatory effect, and nettle extract, which has an anti-inflammatory effect, in the following proportions, in mass%: cacao butter 48 lanolin 14 pantohematogen dry 9.5 propolis 4.7 vitamin PP 2.6 vitamin e 2.6 humic acids 3.6 red root extract 7.5 nettle extract 7.5, consisting in the fact that cocoa butter and lanolin are fed into the reactor with the stirrer turned on at 60 ° C, stirred for 1 hour until the components are completely dissolved to obtain a base, dry pantogematogen, propolis, vitamin PP, vitamin E, humic acids are added to the resulting base and constantly stirred at a temperature of 40 ° C for 0.5 hours until the components of the mixture are completely dissolved, red root extract and nettle extract are added to the resulting mixture with stirring and temperature at 40 ° C, the mixture is poured into a blister pack taste.