Medicinal agent for treatment of asiderotic anemia

FIELD: medicine, pharmacy.

SUBSTANCE: invention relates to a medicinal agent used in prophylaxis and treatment of asiderotic anemia. The preparation comprises components in their following ratio: ferbitol, 80-99%, and gelatin, 1-20%. Invention provides reducing toxicity of the prepared preparation, improvement of its biological activity that results to enhancing therapeutic effectiveness.

EFFECT: enhanced and valuable medicinal properties of agent.

6 ex

 

The invention relates to medicine and veterinary medicine, namely to pharmacology and therapy, and can be used for the prevention and treatment celesteville anemia.

Iron deficiency anemia was defined as a disease characterized by low content of hemoglobin iron with a subsequent decrease in hemoglobin in the erythrocytes due to iron deficiency due to the mismatch between the intake of iron in the body and its expenditure [1].

For the prevention and treatment of iron deficiency anemia are used medicines containing iron [2].

In medical and veterinary practice iron-containing drugs are used inside and parenteral (mainly intramuscularly or intravenously) [1-3].

The preparations for internal use is represented by ferrous sulfate (activeren, sorbifer durules, conferon, tardyferon, veraplex), chloride (remover, aloe syrup with iron), iron gluconate (poweragent), fumarate iron (ferrata), as well as the preparation of ferric - mellifera [1]. Treatment with oral iron preparations, often salt and divalent effective, simple, cheap, but limited side effects, poor absorbability salt of iron preparations [4].

Preparations for parenteral use presents a comprehensive joint is mi - dextran, dextrin, saharat, gluconate and sorbitol [1, 4, 5]. There is evidence that repeated introduction of iron dextran in the same area of the muscle may contribute to carcinogenesis. In addition, the ion injecting ferrorreporter cause quite serious side effects: pain at the injection site, the taste of iron in his mouth, decreased appetite, fever, urticaria, arthralgia, asthma, nausea and disorders of blood circulation [6]. Gluconate for intravenous iron is so toxic that can only be used in low doses. Iron dextran has a low but significant risk of anaphylaxis [4].

Taking into account the drawbacks of errorreport the search for new drugs for the prevention and treatment of iron deficiency anemia remains relevant.

In General, ferrorreporter for the treatment of iron deficiency anemia presents inorganic salts (sulphates and chlorides), organic compounds (saharat, gluconate, fumarate) and macromolecular complexes - dextran, dextrin. Ferrorreporter made in the form of compounds with lipids and proteins in medical practice are not applied. Proteins can significantly reduce the toxicity of metals, so as to form metalloproteinase complexes, compatible with the tissues of the host and having a substantially m is Nisha annoying activity.

The objective of the invention is to provide iron product for the prevention and treatment of iron deficiency anemia, which combines high biological activity, therapeutic efficacy, low toxicity and good tolerability in comparison with used in medicine and veterinary medicine.

Developed product is an aqueous solution zhelezorudnogo complex and gelatin in the following ratio of components: farbital 80-99%, gelatin 1-20%.

The composition allows to achieve the desired therapeutic and prophylactic effect of parenteral or internal medication.

Farbital is a complex compound of iron with setiathome alcohol sorbitol and is intended for parenteral use in clinical practice [7]. In the developed drug gelatin is introduced into herbicola advanced to increase the biological activity and lower toxicity.

Gelatin is a natural product of animal origin. Compatible with animal tissue and human [8]. In developed medicine gelatin significantly reduces the toxicity of the drug increases its biological activity, such as enhancement of the efficiency of prevention and treatment of iron deficiency anemia.

The elaborately the th drug contains 50 mg of trivalent iron in 1 ml of solution.

The drug is a composition, produced as follows:

Example 1. A portion of gelatin weight of 10 g was placed in the flask, add 100 ml of water, soak for about 30 minutes at room temperature, heated to dissolve under stirring, cooled and mixed with 1000 ml of herbicola. The concentration of iron in the product set by evaporation on a water bath until the desired amount of active substance, i.e. up to 1000 ml of thus Obtained product contains 50 mg of trivalent iron in 1 ml.

Example 2. A portion of gelatin with a weight of 100 g is placed in a flask, add 1000 ml of water, soak for about 30 minutes at room temperature, heated to dissolve under stirring, cooled and mixed with 1000 ml of herbicola. The concentration of iron in the product set by evaporation on a water bath until the desired amount of active substance, i.e. up to 1000 ml of thus Obtained product contains 50 mg of trivalent iron in 1 ml.

Example 3. A portion of gelatin mass of 200 g is placed in a flask, add 1000 ml of water, soak for about 30 minutes at room temperature, heated to dissolve under stirring, cooled and mixed with 1000 ml of herbicola. The concentration of iron in the product ustanavli the Ute by evaporation on a water bath until the desired amount of active substance, that is up to 1000 ml of thus Obtained product contains 50 mg of trivalent iron in 1 ml.

Toxicological studies demonstrate the safety of the drug. When a single subcutaneous, intramuscular and oral administration of the drug to determine LD50(sredneseriynoe dose) is not possible, because the maximum input doses of 25-30 ml/kg of body weight of laboratory animals (which is more than 1875 mg trivalent iron per kg weight of laboratory animals - white mice and rats) the drug did not cause a lethal effect. This greatly exceeds the rate LD50iron sorbitol in its parenteral administration of 50 mg/kg for white mouse [4], and twice LD50for iron dextran in its oral administration of 1000 mg/kg of the white mouse [9].

Pathomorphological study by the end of the experiment revealed no irregularities in the structural organization of the internal organs. The drug toxicity refers to hazard class IV - low hazardous substances (GOST 12.1.007-76). This demonstrates the significant improvement in the safety performance among iron preparations for parenteral use.

Intraperitoneal injection sredneseriynoe dose for rats LDDS ratswas 17,67 ml/kg - that is, 1325 mg Fe/kg LDDS micethe beat is and of 15.5 ml/kg 1163 mg Fe/kg For geisterstreiber complex LDDS rats980 mg/kg (0,98 ml/kg) or 98 mg Fe/kg of body weight [10]. LDDS miceintraperitoneally at a similar zhelezorudnogo drug is 25 mg(Fe)/kg [11], and to declare zhelezorudnogo complex with gelatin - 1163 mg(Fe)/kg, that is, this indicator improved in 46 times.

Examples of use of the product

Example 4. In studies on laboratory animals (white rats), medicines containing 90% zhelezorudnogo complex and 10% gelatin, found that a single subcutaneous (at a dose of 75 mg Fe/kg weight of the animal) the introduction of the drug leads to an increase in the hemoglobin content of 16.9% (148 g/l before administration of the drug to 173 g/l on day 14 after injection). The increase in Hb was 1.78 g/liter in 1 day, it is 75% more in comparison with the increase in Hb with the introduction of the nearest similar product farbital, which amounted to 1,025 g/liter in 1 day [4].

Example 5. After a single intramuscular administration of a medicinal product containing 99% zhelezorudnogo complex and 1% gelatin, in terms of animal farm, the pigs at 3 days of age at a dose of 75-112,5 mg Fe/kg (1,5-2,25 ml per animal), it was found that the drug prevents iron deficiency anemia during the first month of life of the piglets. At approximately adnych data average weight of the pigs head at 60 days of age and the rate of increase in live weight, the application of the proposed drug, than those used for similar purposes by the drug horseferry [12], reduced the incidence of piglets at 65% and improved the safety of 9.7% (reaching safety 100%).

Example 6. For domestic use medicines containing 80% zhelezorudnogo complex and 20% gelatin, pigs ten days of age, patients with iron deficiency anemia, within 10 days at a dose of 5 mg Fe/kg weight of the animal is established that the drug is effective in the treatment of iron deficiency anemia. Baseline hemoglobin level of 12 piglets was 62,00±2.83 g/l and 30 th day of life of the piglets (20-th day of the experiment) he was 120,40±3,29 g/l, color index, respectively 0,84±0.06 and 1,20±0,24. These data are significantly higher than those of the negative control, namely 69,00±1,41 and 92,67±to 6.43, 0,88±0.14 and 0,77±0,04. Thus, the increase in hemoglobin was in the experience of 2.92 g/l and in control of 1.18 g/l, i.e. the indicator is improved by 2.5 times.

The clinical status of the experimental animals in the experiment did not differ from physiological parameters inherent in healthy animals.

The product is stable when stored in a temperature range from 18 to 100°C. Is a homogeneous red-brown liquid, odourless, with low specific taste. The product does not contain free the x iron ions.

Drug containing farbital 80-99%, gelatin 1-20% demonstrates significantly better performance as security - data LD50significantly higher than those of similar - both prophylactic and therapeutic efficacy. The drug can be used parenterally and orally.

Sources of information

1. Sparrows P.A. Anemic syndrome in clinical practice. - M.: Novamed, 2001. - 168 C.

2. Butler LI Iron deficiency anemia. - M.: Novamed, 1998. - 40 S.

3. Karelin A.I. Anemia piglets. - M.: Rosselchozizdat, 1983. - 166 C.

4. The use of intramuscular iron preparations in clinical practice. Chernov V.M. and other Hematology and Transfusiology, 2004, v.49, No.3.

5. Medical and stimulants in non-contagious diseases of animals. Collection of scientific papers. - M., Ed. Uncelebrated, 1981. - S-19.

6. Iron deficiency in children: problems and solutions T.V. Kazakova and other Consilium-Medicum application, 2002, V. 4, No. 3.

7. PPM Mashkovsky. Medicinal product. Ed. 13-E., t.ii. - M.: "Intel Media, 1997. - P.160.

8. State Pharmacopoeia X, St. - M.: Medicine, 1968. - S-334.

9. British Journal of Pharmacology and Chemotherapy. London. UK. v.24, p.352, 1965.

10. American Journal of the Medical Sciences. Slack Inc., Thorofare, NJ, v.241, p.296, 1961.

11. NNAPBA Naunyn-Schmiedebergs Archiv fuer Pharmakologie. (Berlin, Ger.) Volume 270, page R50, 1971.

12. Handbook on import veterina the major drugs. - M.: Kolos, 1998. - 272 S.

Drug for the treatment of iron-deficiency anemia, containing farbital, characterized in that it further contains gelatin in the following ratio, wt.%: farbital 80-99, gelatin 1-20.



 

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