RU2121358C1 - Medicinal forms for treatment of patients with suppurative wounds and a method of treatment of patients with suppurative wounds - Google Patents

Abstract

FIELD: medicine, pharmacy. SUBSTANCE: invention proposes a new composition of medicinal forms (sprinkling and gel) where microalga spirulina (Spirulina platensis) is added. Method of treatment involves the use of a sprinkling of developed composition at the first stage of treatment and a gel of developed composition at the second stage of treatment. The proposed agent shows the expressed wound-healing properties and provides a wound process recovery for 6-8 days. EFFECT: enhanced effectiveness of treatment. 3 cl, 8 ex

Description

 The invention relates to medicine and pharmacy, in particular to preparations in the form of powders and gels for the treatment of purulent wounds and a method for the treatment of purulent wounds.

 The etiology, pathogenesis and phase of the wound process make it necessary to differentiate the approach to creating dosage forms for local treatment of purulent wounds.

 In practical surgery, the main technique for treating purulent wounds is the technique for treating them under a dressing with various ointments and gels. Known multi-component ointments, polyethylene oxide gels, gels based on pectin, etc. / B. M. Datsenko and others. "Clinical Surgery", 1984, N 1, p. 10-14; B.M. Datsenko, T. I. Tamm "Clinical Surgery", 1981, N 1, p. 43-45; THEM. Peppers and other "Pharmacy", 1990, N 5, p. 73-77 /.

 The composition of multicomponent ointments includes antibacterial drugs / antibiotics, sulfonamides /, tissue process regulator methyluracil and hydrophilic base.

 Gels are widely used to treat purulent wounds. These are gels based on pectin, which contain sulfanilamide as a antibacterial agent / Clinical Surgery, 1984, N 1. p. 10-13 / or gel, where an antibiotic is used as an antibacterial agent, for example, chloramphenicol or gentamicin. As a stimulant of repair, methyluracil or acetamin is used. To form a gel without lumps and clots, an anesthetic aqueous solution is introduced into the composition in a certain weight ratio to pectin / RF Patent N 2033788 /.

 The presence of synthetic and semi-synthetic antibacterial and other ingredients in ointments and gels limits their use due to possible side reactions.

 Currently, in medical practice, herbal medicines with an antimicrobial, anti-inflammatory and wound healing spectrum are gaining popularity. This is due to the fact that, compared with synthetic drugs, they have sufficient breadth and softness of the therapeutic effect, less toxicity and minimal side effects.

 Powdered drugs are also known for topical treatment of purulent, burn wounds. For example, the sorbent SKN-1K, which is a spherical granule of activated carbon, the use of which is based on their hydrophilicity. Exudate with bacteria and decay products is aspirated from the wound. The wound surface is actively cleansed of purulent-necrotic masses. However, the sorbent is quite quickly saturated with wound exudate and loses its suction ability. In addition, the lack of anesthetic leads to pain of the patient / L. D. Taranenko et al. "Clinical Surgery", 1984, N 1, p. 44-46 /.

 For the treatment of extensive burn wounds, "Algipor" / M.I. is used. Kuzmin and others. "Surgery", 1979, N 8, p. 86-88 /. Algipor polymer coating is a yellow porous hygroscopic material based on a mixed sodium-calcium salt of alginic acid. Algipor stimulates wound healing.

 The aim of the present invention is to expand the range of agents for the treatment of purulent wounds and increase the effectiveness of the treatment of purulent wounds with these agents.

 The essence of the invention lies in the fact that as an antibacterial agent, the composition of the developed powder and gel includes the extract of a large celandine, and the microalgae spirulina (Spirulina platensis /) as a stimulator of reparative processes.

1. Dosage form - powder
The inventive powder has the following composition / in wt.% /:
Aerosil / GOST 14922-77 / - 50.0-90.0
Spirulina microalgae dry powder / Spirulina platensis / - 2.0-35.0
Tincture of celandine / GF XI, t. 2, Art. 47 / - 5.0-20.0
Anestezin / GF X, Art. 55 / - 1.0-4.0
The proposed quantitative and qualitative combinations of the ingredients form a powder that is stable during storage and easy to use. The presence of Aerosil as a highly dispersed microionized ingredient enhances the antimicrobial and necrolytic effect, while also serving as the basis for this dosage form.

 Extractives from celandine grass have a wide spectrum of antimicrobial activity and, at the same time, act as a stabilizer, protecting the dosage form from microbial cantamination.

 The introduction of microalgae powder Spirulina platensis in the proposed composition helps to accelerate tissue regeneration and epithelization.

 In powder, anestezin is used to relieve pain in patients. Instead, you can enter any other pain medication that meets the requirements of an analgesic for external dosage forms.

 The proposed dosage form is characterized in that the specified combination of ingredients in their quantitative ratio provides antimicrobial and regenerative effects, as well as effective cleansing of the wound from purulent-necrotic masses.

Powder preparation technology:
Aerosil is pretreated in an oven at a temperature of 250-300 ^o C for 1-2 hours. The microalga Spirulina platensis, grown according to the technology of NPP Poisk, Samara, is dried, crushed in a ball mill. Tincture of large celandine grass is prepared by maceration with 70% ethanol in the ratio of raw material - extractant 1:10. Anestezin is pre-crushed.

 After preparing the ingredients, they are mixed in a mortar or in other mixers, depending on the amount of powder. Powder is prepared according to the general rules for the preparation of powders, taking into account the fact that Aerosil is a dusty component.

 The ratio of the components of the powder / in wt.% / Are given in the examples.

 Example 1

Aerosil - 50.0
Dry microalgae powder Spirulina platensis - 2.0
Celandine tincture - 5.0
Anestezin - 1.0
Example 2

Aerosil - 70.0
Dry microalgae powder Spirulina platensis - 20.0
Celandine tincture - 15.0
Anestezin - 2.0
Example 3

Aerosil - 90.0
Spirulina platensis dry microalgae powder - 35.0
Celandine tincture - 20.0
Anestezin 4.0
The shelf life of the powder exceeds 2 years, which allows us to recommend it for industrial production.

II. Dosage form - gel
The claimed gel has the following composition / in wt.% /:
Aerosil / GOST 14922-77 / - 5-30
Glycerin (GF IX, Article 227) - 20-80
Dry microalgae powder Spirulina platensis - 2-35
Tincture of celandine / GF XI, t. 2, Art. 47 / - 5-20
Anestezin / GF X, Art. 55 / - 1-4
Purified water / FS 42-2619-89 / - 4-15
Gel preparation technology:
Preliminary preparation of the ingredients is carried out as described above in the preparation of powders / p. 1/. In a separate mortar, anestezin is injected into glycerin. Then the prepared mixture is mixed with Aerosil, get a gel. Separate powder Spirulina plat. mixed with purified water, at the end add tincture of celandine. A mixture of celandine and Spirulina plat. injected into the previously prepared gel and mix thoroughly.

 The ratio of the components of the gel / in wt.% / Are given in the examples.

 Example 1

Aerosil - 5.0
Glycerin - 20.0
Dry microalgae powder Spirulina platensis - 2.0
Celandine tincture - 5.0
Anestezin - 1.0
Purified Water - 4.0
Example 2

Aerosil - 20.0
Glycerin - 50.0
Dry microalgae powder Spirulina platensis - 20.0
Celandine tincture - 15.0
Anestizin - 3.0
Purified water - 10.0
Example 3

Aerosil - 30.0
Glycerin - 80.0
Spirulina platensis dry microalgae powder - 35.0
Celandine tincture - 20.0
Anestezin 4.0
Purified water - 15.0
The shelf life of the gel exceeds 2 years, which allows us to recommend it for industrial production.

III. A method of treating purulent wounds
Known methods of treating purulent wounds by applying dressings with ointments, gels or by dusting with various sorbents / B. M. Udod and others. "Health of Kazakhstan", 1979, N 2, p. 58-59; L.D. Taranenko et al. "Clinical Surgery", 1979, N 8, p. 86-88 /.

 However, these treatment methods are not widely used due to the inaccessibility of a number of ingredients and the unidirectionality of their action.

 The essence of the proposed method lies in the fact that the treatment is carried out taking into account the etiology, pathogenesis and phase development of the wound process in two stages.

 At the first stage, when it is necessary to cleanse the wound from purulent contents, decay products use a powder with spirulina microalgae / Spirulina platensis /. At the second stage, when the wound is cleansed and signs of granulation appear at the edges and at the bottom of the wound, a gel with spirulina microalgae / Spirulina platensis / is used until the wound process is completely resolved.

The method is as follows:
The edges of the wound and the wound itself are treated with methods generally accepted in surgery, after which a powder with Spirulina platensis is applied and an aseptic dressing is applied. The dressing is changed 1 time per day, and so 2-4 days until the wound is cleaned and active granulation appears on the edges of the wound. Powder without dressing can be used depending on the size and location of the wound. After that, a gel with microalgae Spirulina / Spirulina platensis / is used, which is applied to the wound once a day until the wound is completely healed.

 Clinical and laboratory tests on animals and sick volunteers showed that the proposed gel and powder do not have an allergenic and sensitizing effect.

Example 1
Patient D., born in 1948, was admitted to the clinic of propaedeutic surgery 01/17/96

 Diagnosis: on the rear of the right foot, the wound is 1x2 cm, granularly sluggish, with scanty serous-purulent discharge and cicatricial edges. Sick for 1 month. The previous treatment of the wound on an outpatient basis and in the hospital by rinsing with a solution of hydrogen peroxide, a hypertonic solution of sodium chloride, and Iruxol ointment did not lead to its healing.

 In the clinic, the wound edges and the wound itself were treated with a solution of hydrogen peroxide, after which the entire area of the wound was abundantly sprinkled with spirulina / Spirulina platensis / and added an aseptic dressing, which was changed once a day for 3 days. Starting from 2 days, the wound surface was actively cleaned of purulent-necrotic masses, the edges and bottom of the wound turned pink, the cavity decreased, the infiltration and pain disappeared.

Starting from the 4th day from the start of treatment, a gel with spirulina microalgae / Spirulina platensis / was used, which was applied to the wound 0.5 cm ³ once a day until the process was completely resolved. On day 5, bright, juicy granulations appeared at the bottom of the wound. A marginal wound biopsy revealed a large number of cellular elements and collagen fibers. During bacteriological examination of the wound during treatment, there was a sharp decrease in the seeding of their microbial flora. The stage of scarring and epithelization occurred on the 6-8th day.

 After 1 month, the patient was examined - there was no relapse.

 Example 2

 Patient M., born in 1953. Was admitted to the clinic of propaedeutic surgery 02/12/96

Diagnosis: purulent wound of the right tibia 1.5x3.0 cm ² , granular sluggishly, with necrotic plaque, scarred edges and bottom, scanty serous-purulent discharge.

 For 3 weeks, treatment was carried out by washing with solutions of furatsillina, hydrogen peroxide, the use of Solcoseryl ointment. The treatment did not give an effect.

 Appointed 2-stage treatment of the proposed powder and gel with microalgae Spirulina / Spirulina platensis / analogously to example 1. Surgical tissue excision was not performed. After two days of treatment, detachable and necrotic plaque disappeared, the pain stopped, revitalization and growth of granulations was noted. 8 days after the start of treatment, the wound completely closed.

 After 1 month, the patient was examined - there was no relapse.

 The effectiveness of treatment is judged by the dynamics of the wound process / bacteriological, cytological and morphological control /, as well as according to laboratory studies and the general condition of the patient.

 The results of the studies showed that the powder with spirulina microalgae / Spirulina platensis / has pronounced necrolytic properties and is recommended for the treatment of the first phase of the wound healing process, and the gel has pronounced wound healing properties and allows the wound healing process to resolve within 6-8 days.

Claims (1)

1. A dosage form for the treatment of purulent wounds, made in the form of a powder, containing a base, an antibacterial substance, an analgesic, characterized in that Aerosil is taken as a base, anesthesin is used as an analgesic, celandine tincture is used as an antibacterial agent, and as a stimulant reparative processes - dry powder of microalgae spirulina (Spirulina platensis) in the following quantitative proportions, wt.%:
Aerosil - 50 - 90
Spirulina microalgae dry powder (Spirulina platensis) - 2 - 35
Celandine tincture - 5 - 20
Anestezin - 1 - 4
2. A dosage form for the treatment of purulent wounds, made in the form of a gel, containing a base, an antibacterial substance, an analgesic, characterized in that Aerosil is taken as a base, anesthesin is used as an analgesic, celandine tincture is used as an antibacterial agent, and as a stimulant reparative processes - dry powder of microalgae spirulina (Spirulina platensis) in the following quantitative proportions, wt.%:
Aerosil - 5 - 30
Glycerin - 20 - 80
Spirulina microalgae dry powder (Spirulina platensis) - 2 - 35
Celandine tincture - 5 - 20
Anestezin - 1 - 4
Purified water - 4 - 15
3. A method of treating purulent wounds by topical application of dosage forms, characterized in that the treatment is carried out in 2 stages: the first uses a powder (according to claim 1), which is applied to the wound 1 time per day for 3-4 days before the wound is cleaned and the appearance of active granulation along the edges of the wound; at the second stage, a gel is used (according to claim 2), which is applied 1 time per day for 6 to 8 days until the wound process is completely resolved.