Baby dosage forms, stimulating hematopoiesis

 

(57) Abstract:

The invention relates to children's dosage forms of the drug intended for the prevention and treatment of hypochromic anemias of various etiologies as a means of stimulating hematopoiesis, on the basis of salts of iron and copper. The composition of the carbohydrate base (butterscotch) for the preparation of the drug is additionally introduced salts of iron and copper. Iron salts make up for its deficiency in the body, and salts of copper stimulate hematopoiesis. As a protein Supplement in obtaining the drug add proteins of animal or vegetable origin. The technical result is to increase the efficiency and safety of application of therapeutic feeding means for the prevention and treatment of hypochromic anemias of various etiologii as a means of stimulating hematopoiesis. No additional reductant (vitamin C) prevents activation of lipid peroxidation milk. 4 C.p. f-crystals.

The invention relates to medicine, to child dosage forms of the drug with therapeutic and nutritional properties, intended for the prevention and treatment of hypochromic anaemia different etiole is known drugs, containing iron powder iron ferrous lactate" pills "photoferroelectric" capsules "iron ferrous sulfate" pills "Berrocal", jelly veraplex" capsules "conferon" pills "ferro-gradumet", dragee "tardyferon" pills "café-Reid" drops "gamier and others [1, 2].

From 1970 to 1997 in clinical practice were used drug Hematogen (Registration certificate 70/367/13). However, due to low and not controlled in the drug content of iron (food dry blood) he was removed from the State register of the Russian Federation and translated into the category of food. At the same time, this dietary Supplement is a convenient form for introduction into its component substances of biologically active compounds and trace elements designed for children.

In 1998 the Ministry of health of Russia registered three drugs: the drug "Hematogen C", "Hematogen new" and "ferrohematogen". However, these dosage forms to maintain iron in the divalent state (the biologically active form), introduced additional reducing agent is vitamin C, which is destroyed during storage of the drug. This leads to a reduction in real shelf life up to 3-4 months. In addition, the presence Budennogo milk, that results in burning of fats and accumulation of toxic products of lipid peroxidation. The factors listed above affect the digestive processes of the child and can lead to the development of pathological processes in his body.

The prototype drug ion composition may be drug tablets "Hemocyanin containing iron ferrous lactate 0,246 g (65.8%) and copper sulfate 0.005 g (1.33 per cent), with the addition of blood dry food 0,123 g (32.9 per cent). Lack of preparation is the need of flood tablets hydrochloric acid and side effects, expressed in nausea and the development of diarrhea. Iron ferrous lactate in free form may cause nausea, vomiting, flushing of the skin, headache, dizziness, lethargy, constipation, and prolonged use - rickets in children, due to the impact on the assimilation of phosphorus. A very dangerous drug overdose (accidental reception children inadvertently parents), which is accompanied by vomiting with blood, gastralgia, intestinal colic, and may even lead to the development of collapse and coma.

To eliminate the disadvantages of the prototype can be used as the basis for paediatric dosage forms, with whom to whole condensed, the starch syrup, sugar and vanilla). In cooked toffee mass is added ferrous ions and copper, as well as proteins of animal or vegetable origin. Using this approach we developed and tested five dosage forms containing the active beginning of ions of bivalent iron and copper (on the basis of toffee mass, toffee mass with addition of animal albumin, toffee mass with the addition of milk powder, toffee mass with addition of soy protein, toffee mass with the addition of Flaxseed meal).

The technical result, which directed this invention is to improve the efficiency and safety of application of children's medicines for the prevention and treatment of hypochromic anemias of various etiologies, as a means of stimulating hematopoiesis. The application forms on the basis of toffee mass reduces the irritant effect of iron salts on the mucous membrane of the gastrointestinal tract and eliminates a drug overdose. Toffee base contributes to the conservation of iron ions in the divalent biologically active form.

This technical result achievement of ispolnjajut its deficiency in the body, and salts of copper stimulate hematopoiesis. No additional reductant (ascorbic acid - vitamin C) prevents activation of lipid peroxidation milk. As a protein Supplement when a drug is added to proteins of animal or vegetable origin.

Example 1. After receiving toffee base and its cooling to +40oWith it further added with stirring iron ferrous lactate and copper sulfate. The final product should contain per 100 g basis - iron ferrous lactate 0.2 g (or 0.04% in terms of the content of iron ions and copper sulfate 0,012 g (or 0.003% in terms of the content of copper ions).

Example 2. After receiving toffee base and its cooling to +40oWith it further added with stirring iron ferrous lactate and copper sulfate. The final product should contain per 100 g basis - iron ferrous lactate 0.5 g (or 0.1% in terms of the content of iron ions and copper sulfate 0,006 grams (or 0,0015% in terms of the content of copper ions).

Example 3. After receiving a mixture of ingredients to obtain the gladden fields the basics and cooling to +40oWith it further added with stirring milk powder, iChat 0.2 g (or 0.04% in terms of the content of iron ions) and copper sulfate (0,006 grams or 0,0015% in terms of the content of copper ions).

Example 4. After receiving a mixture of ingredients to obtain the gladden fields the basics and cooling to +40oWith it further added with stirring protein soybean meal, ferrous iron lactate. The final product should contain per 100 g basis - iron ferrous lactate 0.5 g (or 0.1% in terms of the content of iron ions).

Example 5. After receiving a mixture of ingredients to obtain the gladden fields the basics and cooling to +40oWith it further added with stirring protein meal flax, iron, ferrous lactate and copper sulfate. The final product should contain per 100 g basis - iron ferrous lactate 0.2 g (or 0.04% in terms of the content of iron ions and copper sulfate 0,006 grams (or 0,0015% in terms of the content of copper ions).

Example 6. After receiving a mixture of ingredients to obtain the gladden fields the basics and cooling to +40oWith it further added with stirring iron ferrous sulfate and copper sulfate. The final product should contain per 100 g basis - iron ferrous sulfate 0.11 g (or 0.04% in terms of the content of iron ions and copper sulfate 0,012 g (or 0.003% in terms of the content of copper ions).

Example 7. After receiving a mixture of ingredients to produce Il is t and copper sulfate. The final product should contain per 100 g basis - iron ferrous sulfate 0,54 g (or 0.1% in terms of the content of iron ions and copper sulfate 0,012 g (or 0.003% in terms of the content of copper ions).

Example 8. After receiving a mixture of ingredients to obtain the gladden fields the basics and cooling to +40oWith it further added with stirring food albumin, iron, ferrous lactate. The final product should contain per 100 g basis - iron ferrous lactate 0.2 g (or 0.4% in terms of the content of iron ions and copper sulfate 0,012 g (or 0.003% in terms of the content of copper ions).

Example 9. After receiving a mixture of ingredients to obtain the gladden fields the basics and cooling to +40oWith it further added with stirring food albumin, iron ferrous sulfate and copper sulfate. The final product should contain per 100 g basis - iron ferrous sulfate 0,54 g (or 0.1% in terms of the content of iron ions and copper sulfate 0,006 grams (or 0,0015% in terms of copper ions).

Example 10. After receiving a mixture of ingredients to obtain the gladden fields the basics and cooling to +40oWith it further added with stirring milk powder, iron ferrous sulfate and copper sultanganj iron ions and copper sulfate 0,006 grams (or 0,0015% in terms of the content of copper ion).

A drug called "Hematogen M", developed according to example 9, is recommended for use in medical practice, hypochromic anemia of various etiologies as a means of stimulating hematopoiesis. The drug has been pilot-tested (preclinical and clinical expertise in the Pharmacological Committee of the health Ministry and recommended for clinical use R 000136/01-2000 on 04.12.2000. On the drug in the State Pharmacopoeia Committee approved Pharmacopeia enterprise Fund 42-0076-0171-00.

The product is standardized according to the following parameters:

1. Description - tiles brown or dark brown, divided by plates, sweet taste, fragrant smell.

2. The authenticity of the drug is determined in accordance with section "quantification" in the preparation of nitrogen, iron, copper sulfate, beet sugar and invert sugar.

3. The loss in weight on drying is determined in accordance with the global Fund XI, vol. 1, S. 176. At a temperature of 100-105oBy drying to constant weight 3 g of the drug. The loss in weight should not exceed 8%.

4. Microbiological purity in accordance with the global Fund XI, vol.2, S. 193 and changes to 1, the category is t - is determined according to the method of Kjeldal 0.5 g of the drug according to the method described in the global Fund XI, vol.1, S. 180. The nitrogen content in the product should be from 0.9 to 1.3%.

6. Determination of sugars. Total sugar from 65 to 74%. About 3.0 g (accurately weighed) of powdered drug after sample preparation titrate with 0.1 N. sodium thiosulfate until the discoloration of the solution (indicator - starch). The content found on the calibration curve.

7. Determination of the mass fraction invertase sugar is conducted according to the same methodology, but the product is not treated with concentrated hydrochloric acid.

8. The definition of beet sugar. Calculated by the difference between total and invertase sugar should be from 55 to 61%.

9. Iron ferrous sulfate. Determined after combustion of the sample preparation in concentrated hydrochloric acid at fotoelektrokalorimetry at 490 nm or spectrophotometer at 510 nm by a color reaction with a solution orthophenanthroline. The iron content of ferrous sulfate 7-water (FeSO47H2O) should be from 0.15 g to 0.22 g tile weighing 50 g, which corresponds to a content of iron ions (Fe+2) from 0.035 to 0.045 g; from 0.09 g to 0.13 g tile weighing 30 g, which corresponds to the content of the om ammonia post-combustion sample preparation in concentrated sulfuric acid. The concentration of copper sulfate in the tile of drug weighing 50 g must be from 0,0024 to 0,0026 g, tile preparation, weighing 30 - from 0,0014 to 0,0016,

11. The weight of the tiles. In the case of the release of the drug in the form of a 50-gram tiles weight of one tile from 48 to 52 g, and with the release of a 30-gram tiles from 29 to 31,

12. Packaging. Tile 50 or 30 grams divided by 10 or 6 plates, respectively, wrapped in the material combined paper-based on THE 10 RF 754-90 without Podgorski or in a two-layer film material on THE other 8064 -0043800 - 04 - 92. Tiles are Packed in a shipping container in accordance with GOST 17768-90.

13. The marking. On the label indicate the manufacturer and the trademark name of the drug in Latin and Russian languages, a lot of tiles, dose, number of doses per day, storage conditions, registration number, batch number, expiry date, bar code. Marking a shipping container in accordance with GOST 14192-77.

14. The storage. In dry, the dark place at a temperature of from 15 to 21oC.

15. The transportation. In accordance with GOST 177-68-60.

16. Shelf life 6 months.

17. Pharmacological group. Stimulator of hematopoiesis.

Sources of information

1. GOS. RH">

3. GOST 6478 - 89 "iris". General technical conditions.

1. The means of stimulating hematopoiesis, intended for the prevention and treatment of hypochromic anemias of various etiologies containing ferrous iron ions and copper ions, characterized in that for the preparation of pediatric dosage forms it is prepared on the basis of the gladden fields of mass in the following ratios, wt.%:

Ferrous iron ions - 0,04-0,1%

Copper ions is Not more than 0,003%

Toffee mass - Rest

2. The drug under item 1, characterized in that it further contains food albumin at a concentration of 1-20%.

3. The drug under item 1, characterized in that it further comprises soy protein meal in a concentration of 1-20%.

4. The drug under item 1, characterized in that it further contains flax protein meal in a concentration of 1-20%.

5. The drug under item 1, characterized in that additionally contains milk powder at a concentration of 1-20%.

 

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