RU2342955C1 - Method of antiseptic film obtaining - Google Patents

Abstract

FIELD: medicine; pharmacology.

SUBSTANCE: invention can be used at treatment of pyoinflammatory diseases and trophic ulcers, and also in gynecology - at a cervical pathology. After secondary crushing pectin is dissolved in water in the ratio accordingly 0.09÷0.1:1.0; then the colloidal solution in thickness of 2.0÷2.5 mm is applied on a fluoroplastic surface, dried and the pectinaceous film obtained for the medical purposes in tight packing is sterilised a method of ultra-violet radiation within not less than 15 minutes.

EFFECT: reduction of terms of healing wounds at the expense of their reliable isolation from an environment, reduction of terms of mediko-social rehabilitation of patients at the expense of creation of favorable conditions for tissue regeneration.

5 dwg, 2 tbl, 2 ex

Description

The invention relates to medicine and pharmacology and can be used in the treatment of purulent-inflammatory diseases and trophic ulcers, as well as in gynecology for cervical pathology.

Pectin is a multifunctional biologically active substance. According to studies of domestic and foreign scientists, pectins can be widely used in the complex treatment of socially significant diseases such as drug addiction, alcoholism, malignant neoplasms, coronary heart disease, diabetes mellitus, tuberculosis, etc. They are able to enhance the effect of various drugs - antimicrobials (antibiotics), cardiovascular, etc. Along with the enterosorption properties, pectins also have other equally important pharmacological actions that represent pain interest in medicine and dietetics (for example, see French Patent B-2495473).

A known method of producing absorbent occlusive dressings (in particular, hydrocolloid) for wound healing (US patent A-3339546), comprising mainly carboxylmethyl cellulose, pectin and gelatin. Due to its composition, the tight-fitting mass of such dressings is transformed into a soft and moist gel in contact with the wound, creating a macroenvironment favorable for cell multiplication, for collagen synthesis, for fibrinolysis, for angiogenesis and for the good course of the bacteriocycle in the wound.

Disadvantages:

1) Granulation is not sufficiently protected.

2) Healing studies with this type of dressing remain insufficiently substantiated and reliable.

3) The positive effect of the treatment of wounds when using this dressing is provided only by 30-40%.

For the closest analogue, a method has been adopted for the production of pectin, which can be used in medicine and pharmacology (RF Patent No. 2144848 of 01.20.99. Bull. No. 2). The raw materials are washed, hydrolysis-extraction is carried out. The hydrolysis mixture is separated to isolate the pectin extract, which is treated with a cation exchange resin, then with an anion exchange resin at a ratio of specific consumption of anion exchange resin to cation exchange resin 1.3: 1.4 cm ³ / cm ^{3 of} extract. Next, dry pectin is treated with ethanol, dried and ground.

Disadvantages:

1) It is difficult to control the uniformity of the thickness of the layer of pectin powder applied to the wound.

2) Non-sterility of pectin powder.

Tasks:

1) Develop a form of pectin that reliably isolates the wound from the external environment.

2) To achieve the sterility of the proposed pectin film.

3) Provide a reliable positive outcome for the treatment of wounds.

The essence of the invention is that after secondary grinding, pectin is dissolved in water in a ratio of 0.09 ÷ 0.1: 1.0, respectively; then a colloidal solution with a thickness of 2.0 ÷ 2.5 mm is applied to the fluoroplastic surface, dried, and the pectin film obtained for medical purposes in a sealed package is sterilized by ultraviolet radiation for at least 15 minutes.

The technical result of the invention is to reduce the healing time of wounds due to their reliable isolation from the external environment, reducing the time of medical and social rehabilitation of patients by creating favorable conditions for tissue regeneration (antiseptic, enterosorption properties of pectin, prolonging effect).

The method is as follows.

Dry beet pulp is subjected to washing-swelling with water at a temperature of 30-60 ° C for 20-30 minutes. During washing, water-soluble substances (sugars, starch, coloring substances, etc.) are extracted from raw materials, and such mineral impurities are removed. Prepared raw materials are subjected to hydrolysis-extraction at a temperature of 74-75 ° C for 2 hours at a ratio of raw materials and a solution of hydrochloric acid with a concentration of 1.3-1.5%, respectively 1:15.

At the end of the hydrolysis-extraction, the hydrolysis mixture is separated by one of the known methods: pressing, centrifuging, on a stacker, etc., with the isolation of pectin extract. The extract is purified from raw material particles by known methods: filtration, separation, settling, etc. Pectin extract with a pH of 0.7-0.8 and a temperature of 40-50 ° C is treated with a KU-2-8chS cation exchange resin in an H ⁺ form at a rate of 6 -8 cm ³ / min. The specific consumption of cation exchanger is 0.05-0.06 cm ³ / cm ^{3 of} extract. The H ⁺ cationic pectin extract is treated with an EDE-10P anion exchange resin in an OH ^- form. The specific consumption of anion exchange resin is 0.09-0.1 cm ³ / cm ^{3 of} extract. Pectin isolated from extracts treated with ion exchange resins has a purity of 70-72%. The most effective is the treatment of the pectin extract with ion-exchange resins with a ratio of the specific consumption of anion exchange resin to cation exchange resin 1.3-1.4 cm ³ / cm ³ extract. With a lower ratio of specific consumption of anion exchange resin to cation exchange resin, the purity of the resulting pectin is below 70%. An increase in the ratio of the specific consumption of anion exchange resin to cation exchange resin above the optimum is not economically feasible, since purity of pectin remains almost at the same level. To ensure the possibility of use in medicine, alcohol purification of dry pectin powder is performed, which allows to obtain pectin with a purity of 75-77% and a complexing ability of 500-600 mg Pb ²⁺ / g.

The obtained beet pectin, highly purified and finely ground, is dissolved in distilled water at a temperature of 20-30 ° C and mixed until smooth for 20-30 minutes. The resulting pectin solution with a thickness of 2.0-2.5 mm is applied to the fluoroplastic surface and dried at a temperature of 20-50 ° C for 24-48 hours, then separated from the substrate, transferred to a sealed package and sterilized by ultraviolet radiation for at least 15 minutes.

The use of the proposed film was tested in a clinical setting for 24 patients. We provide a comparative analysis of the treatment results of the proposed method (table 1).

Table 1 Comparative results of treatment of patients with purulent wounds and trophic ulcers by the traditional and proposed methods Nosology Number of patients The term for the elimination of pain, days Duration of treatment in the traditional way, days Duration of treatment with pectin films, days Purulent wounds in the first phase of the wound process eleven four 5 - 5* one - four Purulent wounds in the second phase of the wound process 32 5 fifteen - 8* one - 5 Trophic ulcers of the leg against varicose veins of the VI century by CEAP 35 6 thirty 7 * four - 26 Trophic ulcers of the leg on eleven 5 thirty - arterial insufficiency 5* four - 28 * Groups of patients treated with pectin film

The use of pectin film showed that its use is most effective in the treatment of purulent wounds in the second phase of the wound process, where the treatment time is reduced by 2.5-3 times, which either ends with epithelialization of the wounds or plastic skin graft is performed earlier. In the treatment of trophic ulcers of the legs against the background of venous insufficiency, the use of the film has reduced the treatment time by 25-30%. Rapid wound cleansing and granulation are noted. The effect of treating trophic ulcers of the legs against arterial insufficiency is less pronounced, which is expressed in a small reduction in the treatment time for patients, but a pronounced analgesic effect of the use of membranous coating is also noted.

Clinical example. Patient 3., born in 1939, source bol. No. 7841, was hospitalized in the surgical department of the Krasnodar hospital for war veterans from 09/13/07 to 10/20/07 with a diagnosis of Purulent wound of the left forearm in the granulation phase after surgical treatment of anaerobic non-clostridial phlegmon. To protect the granulating wounds of the forearm (figure 1) used pectin film (figure 2). Figure 3 shows a view of a granulating wound after film removal after 48 hours. The wound was cleaned, filled with granulations, the size of the pockets decreased significantly. Sowing the wound on the microflora gave a negative result. The study of smears of exudate (figure 4), obtained from the surface of the wounds at the time of the start of observation and stained according to May-Grunwald, showed that a moderate number of cells of both hematogenous and histiogenic origin were found in the smears. The latter are mainly represented by polynuclear cells. It should be noted that eosinophils, fibroblast-like cells, histiocytes and plasma cells are practically absent in exudate smears.

When repeated microscopic examination (figure 5) 48 hours after application of the pectin film, the visual cytological picture in smears of the wound discharge was characterized by poverty of cell forms. The observed cells are characterized by strong degenerative changes regarding their morphological structure. Many cells have a violation of the integrity of the outer shell, the nuclei of many of them are highly fragmented, and the cytoplasm is vacuolated. Basically, exudate contains cells of hematogenous origin - poly- and mononuclear cells. It should be noted that morphological identification of cells is very difficult due to their degenerative changes. The total number of cells detected in smears is negligible.

The use of the film allowed to reduce the time for performing plastic surgery with a free skin flap by 20-25%.

An example of obtaining a film. Beet pulp was subjected to acid hydrolysis, the obtained pectin extract was treated with ion-exchange resins with a ratio of specific consumption of anion exchange resin to cation exchange resin 1.3-1.4 cm ³ / cm ^{3 of} extract. Pectin was precipitated with ethyl alcohol, filtered, pressed, dried, crushed, again purified with alcohol, dried and crushed. A weighed portion of beet pectin finely ground in an amount of 0.1 g was dissolved in 1 ml of distilled water at a temperature of 20-30 ° C and stirred until smooth for 30 minutes. The obtained colloidal pectin solution was transferred to a fluoroplastic surface with a thickness of 2.0-2.5 mm and dried at a temperature of 20 ° C for 48 hours. The film thus obtained was packaged in a kraft bag and sterilized by ultraviolet radiation for at least 15 minutes.

Table 2 provides information on the results of bacteriological studies of the pectin film depending on the exposure in the UV field.

table 2 The results of bacteriological sterility testing of the material Object name The results of bacteriological culture. Sterilization time with UV rays, min 0 10 fifteen thirty 45 60 Pectin film Floor. Floor. Neg. Neg. Neg. Neg.

Claims (1)

A method of producing an antiseptic film, including acid hydrolysis of beet pulp, purification of pectin extract by ion exchange resins, precipitation with ethanol, filtration, pressing, drying, grinding, secondary purification of pectin with alcohol, drying and grinding, characterized in that pectin is dissolved in water after secondary grinding the ratio, respectively, 0.09 ÷ 0.1: 1.0; then a colloidal solution with a thickness of 2.0 ÷ 2.5 mm is applied to the fluoroplastic surface, dried, and the pectin film obtained for medical purposes in a sealed package is sterilized by ultraviolet radiation for at least 15 minutes.

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