RU2740655C1 - Method of producing vaginal velvet antler suppositories for women - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: present invention relates to a method for producing vaginal velvet antler suppositories for women consisting of a natural hydrophobic base and complementary medicinal substances, with content of components in (g) per 1 suppository with weight of 1.2 g: cacao butter—0.3 or 0.6; lanolin—0.09 or 0.12; dry pantohematogen—0.12 or 0.23; propolis—0.06 or 0.07; vitamin PP—0.03 or 0.04; vitamin E—0.03 or 0.04; fir sap—0.04 or 0.06; Orthilia secunda extract—0.09 or 0.17; red brush extract—0.8 or 0.18, consisting in that at the first step of producing vaginal velvet antler suppositories for females to obtain a natural hydrophobic base of suppositories in a reactor with stirrer at 60 °C the following base components are manually fed—cocoa butter—0.3 g or 0.6 g, lanolin—0.09 g or 0.12 g and stirring for 1 hour until complete dissolution of the base components, further into the obtained natural hydrophobic base, adding complementary drug substances having recommendations for treating cervical erosion—dry pantohematogen—0.12 g or 0.23 g, propolis—0.06 g or 0.07 g, vitamin PP—0.03 g or 0.04 g, vitamin E—0.03 g or 0.04 g, fir sap—0.04 g or 0.06 g and carried out at temperature of 40 °C continuously stirring until complete dissolution of drug components of mixture for 0.5 hour, and at the last step of producing the vaginal velvet antler suppositories for women into the suppository mass at 40 °C and stirring are added with medicinal complementary substances—vegetable extracts, having recommendations for use for treating uterine cervical erosion and menstrual dysfunctions—Orthilia secunda extract—0.09 g or 0.17 g, red bristle extract—0.8 g or 0.18 g.

EFFECT: present invention provides a method of preparing vaginal antler suppositories for women, with improvement of product quality through increase of dry pantohematogen content and addition of complementary (mutually supportive) drug components having affinity for therapeutic action of vaginal velvet antler suppositories in cervical erosion and menstrual dysfunctions elimination.

1 cl, 2 ex, 1 tbl

Description

The invention relates to pharmacology and can be used for the manufacture of vaginal antler suppositories for women, consisting of cocoa butter, lanolin, dry pantogematogen, propolis vitamins, fir resin and plant extracts-boron uterus and a red brush, with their subsequent use as a dosed drug for treatment of female gynecological diseases.

Vaginal antler suppositories for women made according to the method have the following ratios of components in the resulting composition, wt. %: cocoa butter 25-50, pantohematogen 5-10, lanolin 8-10, propolis 3-5, vitamin PP 1.5-3, vitamin E 1.5-3, fir sap 2-4, uterus extract 4- 8, red brush extract 4-7.

The technical result of the invention is to create a dosage form of an antler product in the form of vaginal antler suppositories for women, which can be used in the treatment of female gynecological diseases (cervical erosion, menstrual dysfunction).

The essence of the invention is achieved by creating a method for producing vaginal antler suppositories for women using complementary (complementary) medicinal components of the composition: cocoa butter, lanolin, dry pantogematogen, propolis, vitamins, fir resin and herbal extracts - boron uterus and a red brush. This composition has optimal medicinal action, environmental safety and increased efficiency in the treatment of female gynecological diseases.

Analogues of antler products (with dry pantogematogen) are presented in the form of cosmetics for intimate hygiene of the Endogem series for women. The Endogem cosmetic product for women contains two active components: the Pantogematogen dry substance and the boron uterus extract. In general, the velvet cosmetic intimate product consists of cocoa butter, dry C pantohematogen, and boron uterus extract.

This product is positioned on the market as a cosmetic product for intimate hygiene of women in the form of suppositories. There is a certain contradiction in this interpretation of the antler cosmetic product for intimate hygiene of women, since the cosmetic product for intimate hygiene of the "ENDOGEM" series for women is simultaneously endowed with the medicinal ability of the product in the treatment of female gynecological diseases. This contradicts the main provisions of the technical regulation of the Customs Union TP CU 009/2011 "On the safety of perfumery and cosmetic products."

According to the manufacturer's recommendation, the ENDOGEM series cosmetic product for intimate hygiene for women helps to increase local immunity, reduces the risk of developing infectious and inflammatory diseases of the female reproductive system, improves blood circulation in the pelvic organs, indicates anti-inflammatory, bactericidal, antitumor, antispasmodic and analgesic effects. The pronounced bactericidal and anti-inflammatory property of "Endohem" for women is due to the presence of vitamin C, arbutin, flavonoids, chlorophyll, tannins, organic acids in the extract of the boron uterus, and is also largely associated with vitamins A and E contained in "Endohem" and some macro- and microelements (including calcium, manganese, magnesium, silicon, zinc, copper, selenium, sulfur, cobalt).

Cosmetic "Endogema" for women also activates the processes of granulation and epithelization of damaged mucous membranes of female genital organs, promotes the speedy healing of the mucous membranes of the female genital organs affected by the erosive-ulcerative process, which is facilitated by the tannins present in "Endogem", vitamins A, E and C, chlorophyll, amino acids lysine, leucine, valine, histidine.

When using the "Endogem" cosmetic product for women, hormonal homeostasis is normalized, the normal menstrual-ovarian cycle is restored and the optimal balance of the vaginal microflora is restored. Recommendations for the use of Endogem are the following gynecological diseases: uterine fibroids, endometriosis, endometritis, vaginitis, endocervicitis, vulvitis, vulvovaginitis, colpitis, ovarian cyst, polycystic ovaries, salpingoophoritis, adnexitis, female infertility, venereal diseases inflammatory diseases of the internal female genital organs at the stages of fading exacerbation or remission, characterized by frequent relapses or cicatricial adhesions in the small pelvis (including uterine obstruction, dysmenorrhea (menstruation accompanied by severe pain syndrome)., painful sensations in women during menopause, associated with age-related estrogen deficiency (dry, burning or itching in the vagina, pain during intercourse).

An analogue in the form of an intimate antler cream for women according to patent RU No. 2625738 (1) has the following composition: cocoa butter, beeswax, lecithin, beeswax extract, propolis extract, honey, St. John's wort oil, cedar oil, vitamin PP, vitamin E, essential tea tree oil, juniper essential oil and a complex of biologically active antler - plant raw materials, including extract from Altai maral antlers, borax uterus extract, clover extract, yarrow extract and chaga extract. Intimate antler cream (for women) helps to moisturize the skin, strengthen the skin tone, restore hormonal levels, improve the microflora of the mucous membranes of the female genital organs, fill the epidermis cells with a balanced set of nutrients.

Correction of the composition of the antler intimate cream for women by introducing targeted medicinal components gives grounds for expanding the scope of the antler product, but already with the use in the field of pharmacology through the creation of medicinal dosage forms (suppositories) for the treatment of female gynecological diseases.

The analogue of the RF patent No. 2200564, the dosage form of pantogematogen on a gel basis, indicates that the patented composition can be used in the treatment of gynecological diseases in women. In this case, the gel with pantogematogen is injected directly vaginally with routine procedures (2).

The medicinal properties of dry pantogematogen are well known (3). The medicinal component of antler products - dry pantogematogen is defibrinated blood of the Altai maral dried under vacuum at 49-50 ° C and containing the whole range of useful active substances. Pantogematogen dry has recommendations for use in the treatment of gynecological diseases in women, in particular for the treatment of cervical erosion and menstrual dysfunctions.

The closest in technical results is the patent of the Russian Federation No. 2288727 "Dosage form of pantogematogen on a gel basis and a method for its production" (4). The invention relates to medicine, namely to the production technology of medicines, and can be used in pharmacology for the preparation of preparations based on the dry blood of antler deer - pantogematogen "dry" for external use. The preferred area of application of the new dosage form is the treatment of diseases where alcohol-containing forms are contraindicated - for burns of varying degrees, the presence of minor skin lesions, etc., and the treatment of persons with intolerance to alcohol-containing drugs.

A dosage form based on pantogematogen for external use, including pantogematogen, water and a polymer gel-forming composition, characterized in that pantohematogen "dry" is introduced in the form of an aqueous solution with a weight ratio of pantogematogen / water: 1 / 50-1 / 200 with the following ratio of components , wt. %:

Pantohematogen "dry" 0.01-6% Polymer gelling composition 0.1-20% Water Rest

Medicinal polymer gelling composition has a composition, wt. %:

Polymer gelling agent - lightly crosslinked

acrylic acid polymer

and / or polyvinylpyrrolidone 1-6 Carbomer 2.1-7.5 Glycerin and / or propylene glycol 2-60 Preservatives nipagin and nipazole 0.05-0.4 Triethanolamine Up to pH 6-8 Water Rest,

It should be noted that the presence in the polymer gel-forming composition of the medicinal 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 application and situations when polyvinylpyrrolidone comes into contact with mucous membranes.

The polymer gel-forming composition is taken in excess (0.1-20%) with respect to the main medicinal component of the product, dry pantohematogen, which significantly reduces the therapeutic effect of the medicinal gel.

The presence of nipagin (methyl paraben) and nipazole (propyl paraben) as preservatives for the medicinal gel form of pantogematogen may provoke the onset of cancer. Parabens tend to accumulate in the body. 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 resulting in itching, redness and other manifestations, carcinogenic or allergenic effects.

Triethanolamine in the pantogematogen gel formulation can cause dry skin and hair, redness and eye irritation. Triethanolamine penetrates the skin and can accumulate in it, and over time, show its toxic properties.

Medicinal substances in the gel are represented by pantogematogen in the form of a 0.01-6% aqueous solution in a gel with preservatives parabens (napagin, nipazol). Dry pantogematogen itself is characterized by low stability in aqueous solution at room temperature and requires special storage conditions.

The above examples show that the use of chemical components in excess in relation to the main medicinal component - pantohematogen dry can significantly impair the capabilities of the dosage form of pantohematogen for the treatment of gynecological diseases, and the use of chemical preservation by methylparaben (nipagin) and propylparaben (nipazole) in amounts of 0.05 -0.4 wt. %. for the purpose of stabilizing the medicinal component, dry pantogematogen, can significantly affect the medicinal activity of pantogematogen-containing gel with its further use in the composition of drugs for use in pharmacology and practical medicine.

The aim of the present invention is to develop a method for producing vaginal antler suppositories for women and concerns the optimization of the recipe composition of a medicinal antler product, by improving its natural and environmental characteristics with the use of medicinal substances in the composition that have a complementary (complementary) effect for the treatment of gynecological diseases in women.

This goal is achieved by creating a method for the preparation of vaginal antler suppositories for women with the ability to treat female gynecological diseases (erosion of the cervix, menstrual dysfunction) with a concomitant improvement in product quality due to an increase in the content of dry pantohematogen and the addition of complementary (complementary) medicinal components that have an affinity for therapeutic action for diseases of cervical erosion and menstrual dysfunction in women.

The method of manufacturing vaginal antler suppositories for women provides for obtaining, at the first stage, a natural suppository hydrophobic base based on cocoa butter and lanolin.

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

The production of a natural suppository hydrophobic base of vaginal antler suppositories for women should ultimately provide the necessary consistency of the medicinal antler product and preservative properties for the medicinal component, dry pantohematogen, and ensure optimal administration of complementary (complementary) medicinal components of the composition: propolis, vitamins, plant extracts, fir resin.

Hydrophobic suppository base for vaginal antler suppositories for women consists of the following components in (wt%):

cocoa butter - 25-50,

lanolin 8-10.

The components of the hydrophobic suppository base for vaginal antler suppositories for women have the following medicinal properties:

Cocoa butter - has a softening, nourishing effect on mucous membranes and skin. It is used as a hydrophobic base for the preparation of rectal suppositories.

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

At the second stage of obtaining vaginal antler suppositories for women, complementary medicinal components are introduced into the prepared natural hydrophobic suppository base - pantohematogen dry, propolis, vitamin PP, vitamin E, fir resin in a percentage (wt.%):

pantohematogen 5-10

propolis 3-5

vitamin PP 1.5-3

vitamin E 1.5-3

fir sap 2-4

These complementary medicinal components of the vaginal antler suppository composition have the following medicinal properties:

Dry pantogematogen eliminates disorders of the central, peripheral and microcirculatory blood circulation, helps to eliminate skin diseases (eczema, psoriasis, furunculosis, dermatitis, trophic ulcers, etc.), is used for the complex therapeutic therapy of female gynecological diseases.

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

Vitamin PP - improves blood circulation, promotes tissue cell renewal.

Vitamin E - contributes to the restoration of damaged areas in a shorter time, promotes wound healing.

Fir sap promotes the healing of ulcers and long non-healing wounds, burns, boils and abscesses, is indispensable in the treatment of female diseases - cervical erosion, thrush.

At the third stage, complementary plant extracts were added to the suppository mass of vaginal antler suppositories for the treatment of cervical erosion and menstrual dysfunctions - borax uterus extract and red brush extract in percentage (wt%):

boron uterus extract 4-8

red brush extract 4-7.

Herbal extracts provide the following medicinal properties:

Boron uterus extract is recommended for problems with the menstrual cycle and pronounced manifestations of PMS, hormonal imbalances, infertility and adhesions, various inflammations of the female genital area, endometriosis, myoma and uterine fibroids.

Red brush extract is prescribed for endometriosis, cervical erosion, to restore and normalize the menstrual cycle, eliminates inflammation caused by infections of different etymologies: fungi, viruses, bacteria.

In general, in the manufacture of a complementary composition for vaginal antler suppositories for women, the possibility of achieving optimal therapeutic effects contributing to the treatment of female gynecological diseases increases.

When using the patented composition in the form of vaginal antler suppositories for women, the possibility of eliminating cervical erosion and menstrual dysfunctions is predicted. To solve these problems, suppositories for women should be introduced by the cavity vaginal method with a product weight of 1.2 to 3 grams. The described procedure with the use of vaginal antler suppositories for women has regenerating, anti-erosion, healing effects in the treatment of female gynecological diseases, contributes to the normalization of the menstrual cycle. Vaginal antler suppositories for women have no irritating or allergenic effect.

The applicant plans to carry out work jointly with the Federal State Budgetary Institution "Research Institute of Pharmacology and Regenerative Medicine named after E. D. Goldberg ”of the Tomsk Scientific Research Center of the Russian Academy of Sciences on the study of the specific properties of harmlessness, in the development of the dosage form and NTD for candles (suppositories) antler for women for the treatment of cervical erosion and menstrual dysfunctions.

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

Example 1.

To obtain vaginal antler suppositories for women at the first stage of manufacturing, components for making a natural hydrophobic suppository base are manually fed into a reactor with a stirrer at 60 ° C - cocoa butter-5 kg, lanolin-1 kg and stirring is carried out for 1 hour until complete dissolution base components. Further, the temperature in the reactor is reduced to 40 ° C and, with the stirrer on, at the second stage of preparation of vaginal antler suppositories for women, complementary medicinal components of the composition are added, which have indications for the treatment of cervical erosion pantogematogen dry-1 kg, propolis-0.5 kg, vitamin PP -0.3 kg vitamin E-0.3 kg, fir gum-0.4 kg and stirring is carried out until the components of the mixture are completely dissolved within 5 hours. At the third stage of preparation of vaginal antler suppositories for women at 40 ° C and constant stirring, complementary plant extracts are added to the suppository mass, which have recommendations for the treatment of cervical erosion and menstrual dysfunctions - boron uterus extract-0.8 kg, red brush extract-0 , 7 kg. The total weight yield is 10 kg. The number of vaginal antler suppositories for women packaged in 1.2 g in blisters is 8333 pieces.

Example 2

To obtain vaginal antler suppositories for women at the first stage of manufacturing, components for making a natural hydrophobic suppository base are manually fed into the reactor with a stirrer turned on at 60 ° C - cocoa butter-2.5 kg, lanolin-0.8 kg and stirring is carried out for 1 hours until the base components are completely dissolved. Further, the temperature in the reactor is reduced to 40 ° C, and with the stirrer turned on, at the second stage of obtaining vaginal antler suppositories for women, complementary medicinal components of the composition are added with recommendations for the treatment of cervical erosion - pantohematogen dry -1.95 kg, propolis-0, b kg, vitamin PP-0.35 kg, vitamin E-0.35 kg, fir resin-0.52 kg and stirring is carried out until the components of the mixture are completely dissolved for 0.5 hour. At the third stage of obtaining vaginal antler suppositories for women at 40 ° C and constant stirring, complementary plant extracts are added to the obtained suppository mass, which have recommendations for the treatment of cervical erosion and menstrual dysfunctions - boron uterus extract -1.5 kg, red brush extract - 1.5 kg. The total weight yield is 10.07 kg. The number of vaginal antler suppositories for women packed in 1.2 g in blisters is 8391 pieces.

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

The applicant has no information on the use of vaginal antler suppositories for women of this composition (including a complex of complementary medicinal substances of the specified composition) for the treatment of female gynecological diseases.

The use of the proposed vaginal antler suppositories for women assumes cavity (vaginal) use for the treatment of female gynecological diseases.

In this regard, the applicant believes that the compositions of medicinal substances of complementary action in the composition of vaginal antler suppositories for women are original and have not previously been used to achieve the same goal, which gives reason to believe that the proposed meets the requirements for the invention.

Below is table 1 with the parameters and indicators of the known and proposed method of obtaining vaginal antler suppositories for women.

LITERATURE:

1. METHOD FOR OBTAINING INTIMATE PANT CREAM FOR WOMEN. Application: 2016114795, April 15, 2016 (24) Starting date of the patent validity period: April 15, 2016 Priority (s): (22) Application filing date: April 15, 2016 (45) Published: July 18, 2017 Byull. No.20 (72) Author (s): Kazazaev Evgeniy Aleksandrovich (RU) (73) Patentee (s): Limited Liability Company "Karym" (LLC "Karym") (RU).

2. V.G. Lunitsyn, N.A. Frolov. Products of antler reindeer breeding (methods of canning, processing, use) / Russian Academy of Agricultural Sciences / All-Russian Scientific Research Institute of Antler Reindeer Breeding /, Barnaul /, 2006 /, p. 199.

3 (54) GEL-BASED PANTOHEMATOGEN DOSAGE FORM (21) Application registration number: 2002103730/14 (22) Application filing date: 2002.02.15 (24) Published: 2003.03.20 (71) Applicant's name: Marina Yuryevna 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) The name of the patentee: Gerasimenko Marina Yurievna; Dementienko Valeriy Vasilievich Kudryashova V.A .; Lazarenko N.N .; Filatova E.V.

4. (72) 54) DOSAGE FORM OF PANTOHEMATOGEN ON A GEL-BASED AND METHOD FOR ITS PREPARATION Author (s): Matyukhin Boris Pavlovich (RU), Sidorov Dmitry Vladimirovich (RU), Tregubov Alexander Alexandrovich (RU), Shebalin Alexander Ivanovich (RU) 21 ) (22) Application: 2005114924 / 15.17.05.2005 (24) Starting date of the patent validity period: 17.05.2005 (45) Published: 10.12.2006 Byull. No. 34 (56) List of documents cited in the search report: RU 2200564 C1, 20.03.2003. RU 2197942 C1, 10.02.2003. RU 2130314 C1, 20.05.1999. Correspondence address: 105064, Moscow, Gorokhovsky per., 8, apt. 6, G.G. Valeev (73) Patentee (s): Closed Joint Stock Company Medical Anti-Doping Center (RU).

Claims (3)

A method of producing vaginal antler suppositories for women, consisting of a natural hydrophobic base and complementary medicinal substances, with a content of components in (g) per 1 suppository weighing 1.2 g: cacao butter 0.3 or 0.6 lanolin 0.09 or 0.12 pantohematogen dry 0.12 or 0.23 propolis 0.06 or 0.07 vitamin PP 0.03 or 0.04 vitamin E 0.03 or 0.04 fir resin 0.04 or 0.06 boron uterus extract 0.09 or 0.17 red brush extract 0.8 or 0.18, consisting in the fact that at the first stage of obtaining vaginal antler suppositories for women to obtain a natural hydrophobic suppository base, the following base components are manually fed into a reactor with a stirrer at 60 ° C - cocoa butter 0.3 g or 0.6 g, lanolin 0, 09 g or 0.12 g and stirring is carried out for 1 hour until the components of the base are completely dissolved, then complementary medicinal substances are added to the resulting natural hydrophobic base, which have recommendations for the treatment of cervical erosion - pantohematogen dry 0.12 g or 0.23 g, propolis 0.06 g or 0.07 g, vitamin PP 0.03 g or 0.04 g, vitamin E 0.03 g or 0.04 g, fir resin 0.04 g or 0.06 g and carry out at a temperature of 40 ° C, constant stirring until the complete dissolution of the medicinal components of the mixture for 0.5 hour, and at the last stage of obtaining vaginal antler suppositories for women, medicinal synergies are added to the suppository mass at 40 ° C and stirring decongestants - plant extracts with recommendations for use for the treatment of cervical erosion and menstrual dysfunctions, - boron uterus extract 0.09 g or 0.17 g, red brush extract 0.8 g or 0.18 g.