RU2146922C1 - Preparation for treatment of patient with trophic ulcers - Google Patents

Abstract

FIELD: medicine, pharmacy. SUBSTANCE: invention relates to development of drugs for treatment of patients with trophic ulcers. Preparation has kalanchoe juice, novocaine, glycerol, eubasidan, distilled monoglyceride, lanolin, kernel oil, nipagin, nipazol and distilled water. Preparation shows the high therapeutic effect in treatment of patients with sluggish wounds, decreases time of reparative, regenerative and epithelization processes in their significantly. EFFECT: enhanced effectiveness of treatment. 3 tbl

Description

 The invention relates to medicine, can be used in the manufacture of medicines and relates to a drug for the treatment of trophic ulcers, long non-healing wounds, bedsores.

 It is known to use Kalanchoe juice as an anti-inflammatory agent for cleansing wounds from necrotic tissues, in the treatment of trophic ulcers, long-term non-healing wounds, burns, bedsores, etc. [1,2].

 However, the use of Kalanchoe juice in the form of wet dressings and irrigation is irrational and does not provide high therapeutic activity, in addition, such use of Kalanchoe juice leads to drying of the skin. Kalanchoe ointment, prepared on anhydrous lanolin, is poorly distributed on the surface of the wound, is not absorbed by the skin, clogs up the follicular funnels and causes folliculitis and allergic reactions [4].

 The aim of the invention is to develop a drug for the treatment of trophic ulcers with a high therapeutic effect.

The goal is achieved by introducing Kalanchoe juice in an emulsion base stabilized with a bacterial polysaccharide - aubazidan, in the following ratio, wt.%:
Kalanchoe juice - 2.0 - 3.0
Novocaine - 1.0 - 2.0
Glycerin - 4.0 - 5.0
Aubazidan - 0.8 - 1.0
Distilled monoglycerides (MHD) - 2.0 - 3.0
Anhydrous lanolin - 2.0 - 3.0
Stone Oil - 10.0 - 20.0
Nipagin - 0.10 - 0.11
Nipazole - 0.10 - 0.11
Distilled water - up to 100.0
The proposed technical solution allows to obtain an effective, low-toxic, stable drug. The emulsion base (polysaccharide) of the oil-water type, containing stone seed oil and which is the carrier of the active substance (Kalanchoe juice), provides high bioavailability of the drug, while softening and nourishing the skin. To prevent burning in the wound, novocaine is introduced in an amount of 1.0 - 2.0 (wt.%). Polysaccharide - aubazidan, which in this case is an emulsifier, increases the protective function of the skin, the resistance of the macroorganism and provides a prolonged effect of drugs.

The inventive tool is prepared as follows: aubazidan solution is mixed with nipagin, novocaine, Kalanchoe juice and glycerin previously dissolved in water. The temperature of the resulting mixture was brought to 65-70 ^o C and, with the stirrer working, the fat fraction was added: an alloy of distilled monoglycerides, anhydrous lanolin, almond oil, in which nipazole was dissolved. The emulsification process is carried out at a stirrer speed of 1400-1500 rpm for 20-25 minutes.

 The resulting primary emulsion is passed through a colloidal mill, from where the finished emulsion is transported in the apparatus, where it is cooled at a low speed of rotation of the mixer (60-100 rpm) to ambient temperature.

 The invention is illustrated by the following examples.

Example 1. In accordance with the composition of the recipe 2 (table 1) prepare a solution of aubazidan. To do this, 0.8 aubazidane is added to the measured amount of distilled water and left to swell for 40 minutes. Then 0.1 nipagin, 4.0 glycerol and novocaine and Kalanchoe juice previously dissolved in water are placed here and the mixer is simultaneously heated, i.e. supply of hot water to the jacket, and to the mixer (1400-1500 rpm). The temperature of the mixture was brought to 65-70 ^o C and stirring was continued until complete dissolution of aubazidan and nipagin. At the same time, when the stirrer is working, an oil solution of nipazole (0.1 g) in MHD alloy (2.0 g), almond oil (10.0) and anhydrous lanolin (2.0) is preheated to 70 ^° C. The emulsification process in the emulsifier is carried out at a stirrer speed of 1400-1500 rpm, for 20-25 minutes The resulting emulsion is passed through a colloidal mill, from where the finished emulsion is transferred to the apparatus, where it is cooled at a low speed of rotation of the mixer (60-100 rpm) to ambient temperature.

 Examples 2, 3, 4 are carried out analogously to example 1.

 The composition of the ointments is presented in table 1.

 The developed product is an oil-water emulsion system of soft, delicate texture and characterized by high stability (observation period 24 months). Studies of the main physical and chemical parameters of the system allow us to conclude that the proposed product is highly stable (Table 2).

 For an experimental study of the effectiveness of the claimed drug, a model of a purulent wound against the background of diabetes mellitus was chosen, since such a wound is infected (which is typical for most trophic ulcers), has a long cleaning time, in it the processes of growth and maturation of granulation tissue, epithelization are slowed down.

 The study was performed on 90 white outbred male rats weighing 16 - 200 g. Diabetes was caused by intraperitoneal administration of alloxan at a dose of 200 mg / kg body weight, a model of a purulent wound on the back was created using the modified granuloma sac technique (5).

All animals were divided into three groups of 30 animals each. Animals of the first group did not receive additional effects on the wound (control). Animals of the 2nd group were applied to the wound surface with Kalanchoe ointment based on anhydrous lanolin at a dose of 0.5 g / cm ² daily until the wound was completely healed. Animals of the 3rd group were applied to the wound of the claimed drug in a dose of 0.5 g / cm ² daily until complete healing.

 For morphological control, animals were slaughtered by intraperitoneal administration of short-acting muscle relaxants in accordance with Order No. 755 of the Ministry of Health of the USSR dated 08.08.77 (6) on the 3rd, 5th, 7th, 9th, 12th, 15th, 21st, 30th and 40th days. Histological sections were stained with hematoxylin and eosin, microfuchsin and methylene blue, studied under a light microscope. Daily measurements were made of the area of the wound, the terms of its cleansing, reduction and disappearance of near-wound infiltrate, the appearance of granulation and epithelization until its complete healing were noted.

 Comparative macro- and microscopic characteristics of wound healing in laboratory animals, depending on the method of exposure, are presented in table 3.

 An analysis of the results of an experimental study showed that the use of anhydrous lanolin-based Kalanchoe ointment (group of animals T 2) significantly (p <0.05) accelerates the healing of purulent wounds in rats with allaxan diabetes mellitus (from 34.4 + 1.2 to 29, 3 + 2.1 days) mainly due to the earlier appearance of granulation (on 6.6 + 0.8 days, p <0.05), however, the time for wound cleansing and resorption of near-wound infiltrate remains the same (see table 3) . In animals of the 3rd group receiving applications on the wound of the claimed drug, a significant acceleration of wound healing was observed compared with the control and the 2nd group (p 2.3 <0.05; p 1.3 <0.01), but also due to earlier wound cleansing and resorption of near-wound infiltrate (p 2,3 = p 1,3 <0,05).

 Thus, the claimed tool has a high therapeutic effect in the treatment of long non-healing wounds, significantly reduces the time of reparative and regenerative processes in them, not only by stimulating the formation and maturation of granulation tissue and epithelization, but also by accelerating the cleansing of wounds and the manifestation of local anti-inflammatory effects.

Sources of information
1. Medicines used in medical practice in the USSR. Handbook edited by M.A. Klyuyev. - M., Medicine, 1989.

 2. Mashkovsky M.D. Medicines -M., Medicine, 1984.

 3. The use of drugs in dermatology. Under the general editorship of A. Znaevskaya - Lviv, 1981.

 4. Gretsky V. M., Tsagareishvili G.V. Carriers of medicinal substances in ointments. Tbilisi, 1979.

 5. Vereev M. I. Gausman B.Ya., Denisov I.N., Chumachenko P.A. // Application of lasers in medicine. -M., 1985, issue 1 (220). - p.21-22.

 6. Order of the Ministry of Health of the USSR N 755 of 08/12/07 "On the humane treatment of experimental animals."

Claims (1)

A drug for the treatment of trophic ulcers containing Kalanchoe juice, characterized in that it additionally contains aubazidan, novocaine, glycerin, bone oil, distilled monoglycerides, anhydrous lanolin, nipagin, nipazole and distilled water in the following ratio of components, wt.%:
Kalanchoe juice - 2.0 - 3.0
Novocaine - 1.0 - 2.0
Glycerin - 4.0 - 5.0
Aubazidan - 0.8 - 1.0
Distilled monoglycerides - 2.0 - 3.0
Anhydrous lanolin - 2.0 - 3.0
Stone Oil - 10.0 - 20.0
Nipagin - 0.10 - 0.11
Nipazole - 0.10 - 0.11
Distilled water - Up to 100

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