Therapeutic-cosmetic agent for external use

FIELD: medicine.

SUBSTANCE: therapeutic-cosmetic agent for the external use contains pantohematogen, water, polymeric gel-forming component, as well as dimethyl sulfoxide and water. The components are taken in particular quantitative ratio.

EFFECT: agent shows stable efficiency in treatment of osteoarthrosis and spinal osteochondrosis.

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The invention relates to medicine, including medical, cosmetic, and is intended for prophylactic and therapeutic applications in home, outpatient and clinical conditions.

In the late 90-ies developed a new domestic drug "Pantogematogen dry" (registration certificate of Ministry of health of Russia NP N00051/01-200 from 12.10.2000 year, the Fund 42-0148-0391-00), which is a concentrate obtained from natural raw materials - blood Altai maral (Cervus elaphus sibiricus), taken from the major vessels of the head during cutting antlers. Due to the production of the drug with the use of modern technologies in sterile conditions at low-temperature vacuum dehydration it is characterized by high safety of biologically active substances and according to some clinical trials excels in its activity pantocrine and such well-known herbal adaptogens like ginseng extract, extracts of Siberian ginseng, and Rhodiola rosea. This drug is used for the preparation of capsules, solutions for oral administration, therapeutic baths and microenemas. Recently developed drugs for local application using pantogematogen.

Famous CREAM FOR MASSAGE (EN 2197942). containing pantogematogen and biologically active components of plant origin in the following ratio of components, the AC.%: wax propolis 14,0-16,0, sunflower oil 20,0-22,0 oil viburnum 4,0-6,0, oil fir 16,0-18,0, peppermint oil 7,0-9,0, purified water 8,0-10,0, mummy or pantogematogen 0.5 to 2.0, lanolin - rest.

Known dosage form based pantogematogen for external use, including pantogematogen in the form of a 3%aqueous-alcohol solution with a content of 8-14% ethanol 5-35, polymeric gel-forming composition based Recoletos polymer of acrylic acid and/or polyvinylpyrrolidone 0.5 to 15, and water the rest (EN 2200564).

The disadvantage of this dosage form is inadequate therapeutic efficacy, which limits its use preventive medicine.

The purpose of the invention to provide therapeutic and cosmetic products with high therapeutic efficacy, intended for the treatment and prevention of diseases of the musculoskeletal system and health of the skin.

Improving the efficiency and stability of treatment, and getting cosmetic effect is achieved by selection of the components of medical-cosmetic products in an optimal way to achieve maximum and stable result.

Medical-cosmetic product for external use on a gel base comprising pantogematogen, water, polymer gel-forming composition, characterized in that the inof the composition is dimethyl sulfoxide in the following ratio of components, wt.%:

Polymer gelling component is 0.5-20%;

- Pantogematogen 0.5-20%;

- Sulfoxide 1-50%;

- Water - the rest.

The technical result of the invention is to create a highly effective therapeutic and cosmetic products on a gel base.

To determine the optimum ratio of ingredients was conducted placebo-controlled study of the proposed tools in comparison with the gel containing dimethyl sulfoxide (DMSO), and the gel containing pantogematogen (next PG)conducted a double-blind GU NIIKI WITH the RAMS.

The study included patients with osteoarthritis and dorsopathy mixed Genesis, as well as women with cosmetic defects of the skin (early withering of the skin, and others). Each group consisted of 80 ambulatory patients received monotherapy gel preparations PG, DMSO or a placebo. In patients with osteoarthritis and dorsopathy during the study were excluded the use of drugs or non-drug methods of treatment, which could affect the course of the disease. For ethical reasons, patients had the opportunity to take as a subsidiary of the analgesic paracetamol up to 3 times per day in doses of up to 1000 mg; thus, the placebo group optionally not remained without treatment.

Before cured what I all patients were informed about the purpose of the study and gave consent to participate. In the group of osteoarthritis included women aged 45-65 years without severe comorbidities with osteoarthritis of the knee and/or ankle joint I-III x-ray stage, complicated periarthritis and/or synovitis. The diagnosis was confirmed by physical data, chest x-ray, clinical, and biochemical analyses. Group dorsopathy included men and women 45-65 years without severe comorbidities with osteochondrosis of the lumbar spine, complicated reflex and/or compression-radicular syndrome. Exclusion criteria were destructive, traumatic and primary inflammatory lesions of the spine. In addition, on the basis of ethical norms and considering that monotherapy with outer means is ineffective when significant compressive lesions, excluded from the study were patients with acute radiculopathy, spinal and radicular-spinal syndromes. The diagnosis is verified by physical examination and x-ray. Laboratory studies were performed according to indications.

Treatment: Medications PG was used as a cutaneous applications 2-3 ml of gel, which was applied on the affected area daily, 3 times a day for 2 weeks. Placebo similarly used metabolically neutral the AUX gel Alcogel (Geltech). Immediately prior to his appointment course to avoid a severe allergic reaction patients were asked to assess possible changes in their health in response to the smell of the drug; then with the same purpose smear of drug was applied to the skin of the inner surface of the forearm. In the absence of unpleasant sensations of smell, as well as redness, swelling, burning and other skin preparations were prescribed for use.

The survey was carried out before, middle and after treatment. The efficacy was assessed quantitatively by analyzing subjective data, results of physical examination and results of laboratory tests.

In the group of osteoarthritis took into account the severity of pain syndrome, the symptoms of frozen shoulder, periarticular edema, synovitis and limit the amount of movements in the group of osteochondrosis - pain syndrome, reflex and compression-root symptoms, neurodystrophic and autonomic disorders.

In the group of osteoarthritis pain was evaluated according to the visual analogue scale; periarthritis - on a 4-point scale (0 - absent; 1 - slight soreness one to two intesion palpation; 2 - moderate pain 1-3 intesion palpation; 3 - severe pain 2 or more intesion palpation and walking); periarticular swelling - index is repuchase (0 - absent; 1 - doubtful or weak; 2 - explicit; 3-strong); synovitis according to the degree of exudation (0 - absent; 1 - KS smoothness peripatellar loops, GSS - smoothness of the contours of the medial malleolus; 2 - KS weakly or moderately expressed the running of the patella, in GSS - exudation in the anterior surface of the joint is determined by palpation; 3 - in the constitutional court pronounced fluctuation of the patella, often fluid in nagpasalamat synovial bag, GSS - exudation in the anterior surface of the joint is determined visually). Limitation of range of motion in patients with osteoarthritis were evaluated goniometric on a 4-point scale (0 - no; 1 - KS bending 110-130°in GSS bending 10-20°, extension 20-30°; 2 - KS bending 90-110°in GSS flexion less than 10°, extension 10-20°; 3 - KS flexion less than 90°in GSS - no bending, extension less than 10°).

In the group of osteochondrosis pain was assessed on a 5-point scale (0 - no pain; 1 - slight pain, endangered alone; 2 - moderate pain at rest, increasing when moving; 3 - constant pain with periodic amplification and selectoptions shade; 4 - sharp constant pain with forced body position of the patient). Reflex syndromes accounted for mythicism, neurovascular and narediti the ical syndromes. Mythicise syndrome was assessed on a 4-point scale (0 - Muscle tone is not changed, the muscle is soft, finger easily immersed in water column; 2 - moderate muscle density, to dive into the seal requires moderate effort; 3 - muscle stony density, it is impossible to deform). Neurovascular syndrome was assessed by 2-point scale (absence-presence of vasomotor disorders associated with cooling or hot weather or sugase-pricking pain, trophic disorders of the skin). Neurodystrophic syndrome was assessed by 3-point scale (0 - absent, 1 - moderately painful to palpation foci osteomyelofibrosis in 1-2 anatomical areas, 2 - very painful lesions in 2 or more areas).

Compressive radicular syndromes (radiculopathy segments L5 (L4-L5 and S1 L5-S1) were included in the study when they are of lesser severity. For their characteristics commonly used for sensitive, reflex and motor disorders 4-point scale (0 - absent, 1 - weak in the area of innervation of a single spine, 2 - moderate in zone 1-2 roots, 3 - strong in zone 1-2 or more roots).

In groups of osteoarthritis and dorsopathy each patient before treatment, mid-treatment and after treatment were calculated severity index (it) and the coefficient of clinical effectiveness the spine (e). It was calculated according to symptomatology as the sum of all points taken into account symptoms, and e is the quotient of the difference (when it arrives - it at the time of accounting for it upon receipt.

Statistical processing of data was performed by methods of variation statistics, the significance of differences was assessed using t-student criterion when the accepted confidence level of P<0.05.

The results of the study.

Just groups of ostearthritis and dorsopathy were surveyed 160 patients, 80 patients each. Between subgroups treated with different preparations of GHGs and placebo, no significant differences in disease severity, age distribution, sex, body mass index.

Therapeutic efficacy means based on the change severity index in patients after the treatment (figures 1 and 2, for clarity, are presented as changes of indexes of gravity.

From the drawings it is seen that gel products containing DMSO or PG, possess a significantly less pronounced efficiency than the product containing the composition of the PG+DMSO. Obviously, the combination of PG and DMSO leads to a synergistic effect due to changes in the mechanism of action of the drug. A synergistic effect is related to the fact that:

1. The most effective GHG components do not dissolve in spirtovodnogo, used in the preparation of drugs-prototypes containing PG, but is easily dissolved in a mixture of DMSO with water in the preparation of the proposed tools.

2. DMSO is present in the composition tools, enhances transdermal transport of soluble therapeutic component of GHGs.

3. DMSO has its own anti-inflammatory action.

4. In turn, PG, obviously, has the ability to enhance the anti-inflammatory action of DMSO, since PG has the ability to stimulate local blood circulation at the capillary level and increase lymphatic drainage of tissues, thereby further increasing the bioavailability DMSO.

Cosmetic efficacy of the drug was investigated in a separate study, women 25-45 years of age during the application of the same medications as in the main study, and were evaluated on a 10-point scale. Evaluation was performed on the subjective experiences of women about the condition of the skin using a 10-point scale of effectiveness. It has been shown that preparations containing the proposed composition, have the most pronounced cosmetic effect compared with other investigational drugs.

Conclusions:

1. Gel preparations PG for external use are well tolerated and have no local or systemic side effects.

2. Therapeutic effective is here appliqués drugs studied is located in the ascending order as follows: Placebo, DMSO, PG, PG + DMSO.

3. Gel DMSO-containing medicines PG for external use as monotherapy osteoarthritis, osteochondrosis of the spine and as cosmetic products have a pronounced therapeutic and cosmetic efficiency.

The General conclusion of the conducted research: pharmaceutical composition corresponding proposed in the invention therapeutic and cosmetic treatment has a high stable efficiency in the treatment of osteoarthritis and osteochondrosis of the spine, can be applied in clinical pharmacology and has a cosmetic effect.

1. Medical-cosmetic product for external use, containing pantogematogen, water, polymeric gelling component, characterized in that it further comprises dimethyl sulfoxide in the following ratio, wt.%:

polymeric gelling componentof 0.5 to 20.0
pantogematogenof 0.5 to 20.0
the sulfoxidefrom 1.0 to 50.0
waterrest

2. Cosmetic tool according to claim 1, characterized in that it further comprises an anticoagulant in an amount of 0.2-2.0 wt.%.

3. Cosmetic tool according to claim 2, featuring the be fact, what an anticoagulant selected drug from a number of: heparin, citrate, EDTA, hirudin in a pharmaceutically acceptable concentrations.

4. Cosmetic tool according to claim 1, characterized in that it further contains aromatherapy component in amount of 0.2-2.0 wt.%.

5. Cosmetic tool according to claim 4, characterized in that the aromatherapy component represents at least one essential oil of natural origin.

6. Cosmetic tool according to claim 1. characterized in that it further contains feedbacki in amount of 0.2-10.0 wt.%.

7. Cosmetic tool according to claim 1, characterized in that it further comprises ethanol in an amount of 0.2-5.0 wt.%.



 

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