RU2468795C1 - Sorption, antimicrobial and deodorising medication for external application - Google Patents

Abstract

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention relates to chemical-pharmaceutical industry, in particular, to production of drugs for external application. As shaping component used is sterile hydrophilic powder of Kimmeridgian (blue) medicinal "Undorovskaya" powder-like, as deodorating -menthol powder, and as solvent and penetrator - dimethylsulphoxide with the following ratio of components (wt %): menthol 1.5-3.5, furacillin 1.0-5.0, dimethylsulphoxide 20.0-24.0, blue clay 74.0-67.0.

EFFECT: invention ensures increase of therapeutic efficiency in wound treatment, possessing adsorption, antimicrobial and deodorating action.

3 tbl, 1 dwg, 1 ex

Description

The invention relates to the pharmaceutical industry, in particular to the production of medicinal powders for external use, intended for application to the skin, mucous membranes and wound surfaces in order to provide sorption, antimicrobial, wound healing, deodorizing effects.

In pharmaceutical technology, the composition of the external drug is known - furacilin tablets [1]. However, this tool does not have a sorption effect and has limited use, which cannot be considered quite sufficient, given the widespread need for practical medicine in such drugs and the convenience of using powders.

Known composition for external use "Furoplast" containing furatsilin. However, this dosage form has limited use [2].

The known composition of the drug with furacilin in the form of a paste [3]. The disadvantage of this dosage form is the low effectiveness of the therapeutic effect.

In medical practice, a solution of furatsilina 0,067% is used [4]. However, it contains ethyl alcohol, which is a pharmacologically non-indifferent component and requiring the observance of special rules when working with it.

For the prototype of the invention, we took the composition of furacilin ointment 0.02% [5], intended for the treatment of purulent wounds, pressure sores, burns of the II-III degree, minor skin lesions (abrasions, scratches, cracks, cuts).

The disadvantage of this tool is that it contains in its composition as form-forming bases - fatty components that violate the perspiration and are able to create a "greenhouse effect" in the wound and on the skin. In addition, this composition does not have a deodorizing and sorption effect, which does not allow it to be used for skin hyperhidrosis.

The aim of the invention is to increase therapeutic efficacy and expand the therapeutic spectrum of the use of powders for external use, having both adsorption, antimicrobial and deodorizing effects.

This goal is achieved by the fact that sterile hydrophilic clay powder of the Kimmeridge (blue) therapeutic “Undorovskaya” powder is used as the forming component, menthol powder is used as deodorizing powder, and dimethyl sulfoxide is used as solvent and penetrator in the following ratio of components, wt.%:

menthol 1,5-3,5 furatsilin 1.0-5.0 dimethyl sulfoxide 20.0-24.0 blue clay 74.0-67.0

Sorption, antimicrobial, deodorizing medicine is made as follows: pre-sterilized Kimeridzhsky clay (blue) therapeutic Undorovskaya powder in a dry heat sterilizer at 180 ° C for 30 minutes and sterile blue clay is mixed under aseptic conditions with the prepared solution of menthol and furacilulfide in dimethyl , thoroughly triturated until complete absorption of the solution and the formation of a powder mass. The prepared mixture is transferred to a sterile glass or polymer container, closed with a perforated lid and hermetically sealed.

A search by the applicant for scientific, technical and patent sources of information and a prototype selected from the list of analogues [5] made it possible to identify distinctive features in the claimed technical solution. Therefore, the claimed composition meets the criterion of "novelty."

The applicant conducted an additional search for technical solutions [6-8] in order to detect signs in them that are similar to the features of the distinctive part of the formula of the claimed production method, showed that these signs are absent, therefore, the claimed technical solution meets the criterion of "inventive step".

The inventive method is illustrated by the following example.

Example

On a VSM-5 balance, 2.0 g of Kimmeridzhsky (blue) therapeutic “Undorovskaya” clay powder (hereinafter referred to as clay) is weighed into a glass Petri dish, distributed evenly over the entire surface, covered with a lid and placed in a dry heat sterilizer for 30 minutes at a temperature of 180 ° FROM. After sterilization, the Petri dish with clay is transferred to an aseptic block. 0.05 g of menthol and 0.15 g of furatsilin are weighed into a sterile porcelain mortar, 0.8 g of dimethyl sulfoxide are added, and menthol with furatsilin is dissolved by grinding. When dispersed, sterile clay powder is added. Stir until a uniformly colored yellow powder is formed. The finished dosage form is applied to the skin with hypehydrosis, with wound and inflammatory processes to provide a prolonged sorption, antimicrobial and wound healing effect.

The rationality of introducing blue clay into the claimed composition as a shaper is physiologically determined and the following experimental results demonstrate that standard methods were used to determine moisture absorption and sorption activity by methylene blue [7, 9] (Appendix 1-4).

Thus, the obtained experimental data form the basis for expanding the assortment of medicines with sorption, antimicrobial, and deodorizing effects for use in surgery, traumatology, and dermatology.

Bibliographic list

1. FSP 42-0260-4472-03 Furacilin tablets

2. FS 42-2134-92 Furaplast (with Perchlorovinyl)

3. FS 42-2302-93 Furacilin paste

4. FS 42-2087-83 Furatsilina alcohol solution 1: 500

5. FS 42-94-72 Furacilin ointment 0.02%

6. Alekseeva I.V. Development of dosage forms for the treatment of wounds // Pharmacy. 2003. - No. 2. - S. 43-45.

7. GOST 3594.11 - 93. Interstate standard. Method for determination of moisture of powdered clays. Effective Date October 1, 1998

8. The state register of medicines.-M., 2004. - T. 1. - 1404 p.

9. Almeida, C.A. Removal of methylene blue from colored effluents by adsorption on montmorillonite clay. / C.A. Almeida, N. A. Debacher, A. J. Downs, L. Cottet, C. A. Mello. //. Colloid Interface Sci. - 2009, Apr 1; No. 323 (1). - S. 46-53.

10. Reference Vidal. - M .: AstraFarmService, 2010 .-- 1404 p.

12. State Pharmacopoeia X ed. - M.: Medicine, 1968 .-- 1037 p.

13. The State Pharmacopoeia of the Russian Federation. part 1. - M .: Scientific Center for Expertise of Medical Devices, 2008. - 697 p.

Annex 1

Comparative moisture absorption (from its vapor state) for various samples of excipients that are part of the powders was determined by the gravimetric method from the average mass difference of 3 samples before the experiment and at the end using an analytical balance METILER TOLEDO x5204 with max. M 220 g. To create high humidity in a desiccator, a saturated solution of potassium sulfate was used. The results obtained are presented in Table 1, from which it is clear that starch is more moisture absorbing than all the studied samples and its presence in such dosage forms as powders is justified. At the same time, this indicator is the lowest for talc and its use in powders for sorption of moisture is controversial. However, the use of starch in drugs for vulnerosorption in order to clean the wound from wound exudate is not acceptable, since it leads to clogging of the pores of the skin and is a good nutrient medium for microorganisms. In this aspect, it is more rational to use blue clay, since it is much higher in terms of moisture absorption than hydrophobic talc.

Table 1 Moisture absorption indicators of excipients No. p / p Name of the investigated sample Moisture absorbed g % one Blue clay 0.1003 ± 0.0069 4.86 2 Talc 0.0167 ± 0.0050 0.58 3 Starch 0.2443 ± 0.0163 14.31

Appendix 2

When studying the sorption ability of the same auxiliary substances, the average value was calculated from 3 determinations of the maximum absorbed amount of methylene blue from its 0.15% solution by each sample studied [12]. The optical density of the filtrate was determined on an Alpha Analyst (Canberra) spectrophotometer in cuvettes with a layer thickness of 10 mm at a wavelength (λ) of 400 nm. According to the calibration graph, the concentration of methylene blue in the filtrate was calculated. The results are presented in table.2.

table 2 The results of the sorption activity of excipients No. p / p Name of the investigated sample The concentration of methylene blue in the filtrate,% one Blue clay 0.005 ± 0.001 2 Talc 0.087 ± 0.004 3 Starch 0,092 ± 0,006

The results presented in Table 2 indicate a high sorption ability of blue clay in comparison with such components of powders as starch and talc. So, in the filtrate after exposure with blue clay, the concentration of methylene blue is the smallest (17.4 times lower than in the filtrate after exposure with talc, and 18.4 lower than in the filtrate after exposure with starch).

Appendix 3

When studying the sorption activity of blue clay, its sorption activity was also found for Staphylococcus aureus.

During the experiment, 50.0 g of clay, dried for 1 hour in an oven at a temperature of 180 ± 0.5 ° C, was mixed with 60 ml of meat-peptone broth, a culture of Staphylococcus aureus was added and subjected to vigorous stirring in a laboratory setting for 8 hours. Every 2 hours, sowing was performed on a nutrient medium (agar-agar). The results showed that clay actively adsorbs microorganisms. The growth and development of culture in the presence of blue clay is not observed (Fig. 1).

Appendix 4

The antimicrobial activity of the claimed composition in various concentrations was studied [13]. Its activity against Escherichia coli, Staphylococcus aureus, Bacillus cereus has been proven. The results presented in Table 3 indicate a high antimicrobial activity of the developed powder in relation to the main pathological microorganisms of the wound process, which allows it to be recommended for cleaning and treating wounds with a high content of exudate.

Claims (1)

Sorption, antimicrobial and deodorizing medicinal product for external use containing furatsilin, characterized in that the sterile hydrophilic clay of the Kimeridzhsky (blue) therapeutic “Undorovskaya” powder is used as the shaping component, menthol powder is used as deodorizing clay, and menthol powder is used as deodorizing clay. dimethyl sulfoxide in the following ratio, wt.%:
methanol 1,5-3,5 furatsilin 1.0-5.0 dimethyl sulfoxide 20.0-24.0 blue clay 74.0-67.0

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