Biologically active additive "lactogen"

 

(57) Abstract:

The invention relates to the pharmaceutical industry that produces drugs for the lack of breast milk in lactating women, burdened with the obstetric history and hypogalactia, with malnutrition and anorexia in infants and young children. Food Supplement contains as active substances infusion of fennel seeds, infusion of nettle leaves, infusion of marjoram, carrot juice, ginger, potassium iodide, ascorbic acid, other ingredients: sugar, starch, oats, calcium stearate, the amount of each active component of 0.1-99 wt.%. The invention allows to obtain a product with antioxidant properties.

The invention relates to medicine, in particular to the pharmaceutical industry for the production of drugs therapeutic and prophylactic purposes, and can be used as a drug with a lack of breast milk in lactating women, burdened with the obstetric history and hypogalactia, with malnutrition and anorexia in infants and young children, and chronic digestive disorders of various etiologies, including on the grounds of fetal the food herbal tea "Lackovic" /Pilate T. L. (as amended). Federal register biologically active additives to food. M , Kohelet, 2000, S. 311/ that contain fennel fruit, fruit dill, caraway seeds, nettle leaves and used as an aid in the lack of breast milk in lactating women.

Known drug "Apilak" dry substance native bee Royal jelly /Mashkovsky M. D. Drugs, so 2, Kharkov, Torching, 1997, S. 190/, used for the treatment and prevention of malnutrition and anorexia in infants and young children, adults with the disorder of lactation in the postpartum period.

A significant disadvantage of this drug is that it does not have an antioxidant effect and does not compensate for the deficiency of vitamin C and iodine in the organism of mother and child.

The objective of the invention is to develop a new affordable drug is a biologically active food Supplement "Lactogen" manufactured in tablet form, is easy to use and also stimulate lactation in women and prevent the development of dyspeptic phenomena in infants with antioxidant action and complementary deficiency of vitamin C and iodine.

The invention is directed to rasspro chronic digestive disorders of different etiology, including on the grounds of fetal and birth injuries.

This is achieved by the fact that the proposed biologically active additive to food with a lack of breast milk in lactating women, when hypogalactia, malnutrition and anorexia in infants and young children "Lactogen" as known BAD, contains as an active ingredient Royal jelly.

However, in contrast to the known BAD we Supplement contains an infusion of fennel seeds, infusion of nettle leaves, infusion of marjoram, carrot juice, ginger root, potassium iodide, ascorbic acid and auxiliary substances: sugar, starch, oats, calcium stearate, the amount of each active component of 0.1-99 wt.%.

"Lactogen" - adjuvant lack of breast milk in lactating women, burdened with the obstetric history and hypogalactia feeding previous children with malnutrition and anorexia in infants and young children, and chronic digestive disorders of various etiologies, including on the grounds of fetal and birth injuries, blood loss during childbirth.

Stimulates lactation, prevents the development deceptional appetite. Has beneficial effects on physical and mental development of the child.

Technological form of the BAD can be a tablet, powder, capsule, etc.

The choice of the form of execution is determined by the adopted technology, specific conditions of use, as well as the size of a single dose of the drug.

The formula is based on the biologically active substance with the lactogenic activity (extractive components of oregano, carrots, fennel, ginger, nettle). These components are aimed at regulating the hormonal balance in the postpartum period, the normalization of metabolism and result in increased production of breast milk and its composition. Essential oil of fennel contains containing stimulating lactation in women and increases secretion during digestion.

In addition, Lactogen contains nutrients, limiting the nutritional value of breast milk, protein, vitamin C, b group, folic acid and especially minerals (primarily iron, calcium, zinc and others). These nutrients are beneficial not only for the development of the child's body, but contribute to the restoration of the mother in the postpartum period and support EGEE milk, as a concentrated source of nutrients, including minerals, trace elements and vitamins. Known for the ability of Royal jelly to enhance the production of prolactin. A significant number of proteins of Royal jelly possesses enzymatic activity. They are involved in the metabolism of carbohydrates, lipids and proteins, redox processes. The enzymatic system of Royal jelly intensifies the breakdown and utilization of glucose normalizes the power bodies of the growing organism.

Carrots are often prescribed to women who are breastfeeding to ensure normal growth and development of newborns. Minerals and vitamins contained in carrots, mainly carotenoids, participate in the regulation of trophic processes and increasing the body's resistance to infections, improve the barrier function of the mucous membranes, primarily the respiratory tract, digestive tract and urinary tract, increase the phagocytic activity of leukocytes and other factors of nonspecific resistance of the organism. Carotenoids contribute to the formation and ensure the normal functioning of the organs of vision.

Flavone compounds of oregano, vitamin complex the conversion.

Extract of nettle increases the percentage of hemoglobin and the number of erythrocytes in maternal blood and contributes to the formation of the hematopoietic system of the child.

Essential oil of oregano, containing thymol, carvacrol, geraniaceae and other substances, as well as components of carrot juice, getting into breast milk and affect the baby and the mother. Fixes an atony of the intestines, improves digestion, removes dyspepsia, has a calming effect on the Central nervous system of the child and the mother. The biologically active components of fennel and ginger eliminate bloating and dyspepsia in children.

BAD "Lactogen contains biologically active components with hemostatic properties that increase the contractility of the smooth muscles of the uterus, providing anti-inflammatory effect, improves the regeneration of the mucous membranes, stimulates granulation and epithelization of the affected tissues. Thus, contributing to postpartum involution of the uterus, preventing the development of obstetric complications, reduces the time of bleeding. In particular, nettle has pronounced hemostatic properties, which is associated with nastyware blood - prothrombin. The experimental data contained in large quantities in the nettle chlorophyll enhances metabolism, increases contractility of the smooth muscles of the uterus, anti-inflammatory effect, improves the regeneration of the mucous membranes, stimulating granulation and epithelization of the affected tissues.

Ascorbic acid, along with carotenoids, has a stimulating effect on the oxidative processes in the body, helps protect the developing tissues from damage by free radicals, stimulates the immune system.

Biologically active food Supplement "Lactogen", for example, in the form of tablets obtained as follows (using excipients: starch, oats, sugar and calcium stearate).

1. Sugar, in the amount of 80.4 kg, weighed in the bag on the scale, visually check for the presence of mineral and organic impurities, and then, in the absence of impurities, crushed in the mill.

Powdered sugar through the bottom fitting of the mill gathering into a polyethylene bag, the ends of which are pre-fixed to the fitting. The bag is placed in the receiver.

The output of the powdered sugar is the presence of mineral and organic impurities, then, in the absence of impurities, crushed in the mill.

Crushed flakes oat through the bottom fitting of the mill gathering into a polyethylene bag, the ends of which are pre-fixed to the fitting. The bag is placed in the receiver.

The output of crushed flakes oat - 10,2 kg

3. The roots of the ginger, the amount of 0.96 kg, weighed in bags on the scales, visually check for the presence of mineral and organic impurities, and then, in the absence of impurities, crushed in the mill.

Chopped ginger roots through the bottom fitting of the mill gathering into a polyethylene bag, the ends of which are pre-fixed to the fitting. The bag is placed in the receiver.

The output of crushed flakes oat - 0,93 kg

4. The roots of carrots, in the amount of 4.0 kg, weighed in bags on the scales, visually check for the presence of mineral and organic impurities. Then washed in running water, clean peel and squeeze the juice extractor.

The output of finished juice - 1,85 kg

5. Fennel seeds, in the amount of 0.37 kg, weighed, visually check for the presence of mineral and organic impurities. Placed in an enamel pan, with a capacity of 15 litres, whereas 9 is 5 minutes

Pre-crushed nettle leaves, number 0,185 kg, and marjoram, the number 0,185 kg, weighed, visually check for the presence of mineral and organic impurities. Placed in an enamel pan, with a capacity of 15 liters, containing the infusion of fennel seeds, and insist on a boiling water bath for another 15 minutes

Cool at room temperature for 45 min, after which the infusion is filtered, pressing plant material. If necessary, add purified water to the desired volume. Then filtered through four layers of gauze.

The output of infusion - 7,4 kg

6. 1,85 kg carrot juice is weighed in an enamel pot, capacity 3.0 l, on balance, lead up to 95oWith in a boiling water bath, add 0,37 kg of Royal jelly, stirred and maintained at a temperature of 95oWith 5 minutes Cool to 30-40oC.

Output - 2,22 kg

7. Potassium iodide in the amount 0,19 kg, weighed, poured in a glass flask, add 0.4 kg infusion of herbs, mix until dissolved.

Output - 0,59 kg

8. Ascorbic acid, in the amount of 0.93 kg, weighed on the scales. Starch, in the amount of 10.2 kg (in terms of 100% of the drug), the ot is OPIE oat, ginger root, ascorbic acid, starch is sifted on the shaker through a sieve with the hole diameter of 1 mm calcium stearate is sifted through a sieve with the hole diameter of 0.5 mm

Juice carrots with Royal jelly filtered through four layers of gauze. The solution of calcium iodide is filtered through four layers of gauze.

9. In an enamel saucepan, with a capacity of 10 l, weighed 6.0 kg of the finished infusion of herbs, bring to a boil. Separately starch, in the amount of 0.5 kg (in terms of 100% of the drug), weighed, placed in an enamel pan with a capacity of 3 l, add 1.0 kg infusion of herbs. Prepared suspension of starch contribute to the boiling flask with constant stirring, bring to a boil.

The output of starch paste - 7,4 kg

10. In the mixer when the cover is open loads of 79.6 kg powdered sugar; 10.2 kg of oats; 9.7 kg of starch (in recalculation on 100% of the drug); 0.93 kg of ground ginger stirred for 5 min, then add 2,22 kg of carrot juice with Royal jelly, stirred for 3 minutes, add a solution of potassium iodide, in the amount of 0.59 kg), stirred for 3 min, add starch paste, in the amount of 7.4 kg, stirred for 10 min.

Yield - 110,64 kg

Include hot air distribution device of the drying Cabinet. When should light the bulb "network". Set the drying temperature 40-45oWith the increase of which the flow of hot air is automatically disabled.

The drying process is carried out in a period of 8-10 h to a constant weight, with occasional stirring (not less than 3 times).

The control end of the drying conduct in the laboratory by weighing samples of the product from the trays to a constant weight. The humidity of the product - not more than 2%. Dry tablet weight is directed to a dry granulation.

The output of the dry tablet weight - 102,26 kg

12. The dried mixture in an amount of 102,26 kg load scoop portions in the device for producing granules from dry tablespace. Include a screw device, in which the mixture is forced through the mesh holes with a diameter of 1.5 mm, the Dry granulate is collected in the receiver. From the receiver the dry granulate download scoop when the cover is open in the mixer.

The yield of dry granulate - 101,25 kg

13. To the dry granulated pellet mixture in a mixer add the sifted acid is eshivot within 10 minutes The finished granulate is passed on tableting.

The output of the finished granulate - 103,20 kg

14. From the mixer, the dry granulate is directed to tableting in the hopper tablet press machine. Include the main drive (the network), the clutch, the feeder motor. Pre-set engine speed in accordance with a bulk weight of the pressing zone and the height of the tablet. When you start the machine turn on a vacuum cleaner.

The diameter of the tablet - 12,00,2 mm;

the height of the tablet 3,80,2 mm;

the average weight of a tablet is 0.55 g,02, it includes about carrot juice - 0.01 grams of Royal jelly - 0.002 g, infusion of oregano - 0.001 g, ascorbic acid 0.005 g, infusion of nettle leaves - 0.001 g, infusion of fennel seeds - 0,002 g of potassium iodide - 0.001 g, ginger root -0,005 g starch - 0.55 g, oats - by 0.055 g, sugar - 0,4294 g, calcium stearate - 0,0055,

During tabletting watching the machine work and quality tablets. Every 30 min check raspadaemost, the strength and the average weight of the tablets. Tablets that do not meet the requirements, rejected and sent for recycling. At the end of the process the machine off in the reverse order. Tablets are collected in the receiver and sent to the dust.

The output product on the scales at 8 lbs and load in a clean dry plastic bucket.

Samples of finished tablets passed into the analytical laboratory for analysis.

In accordance tablets norms technical documentation, prepared tablets passed the stage of packing.

The output of finished tablets - 100 kg.

As has been shown in clinical trials "Lactogen effectively stimulates lactation and improves the quality of breast milk. In this connection helps to eliminate dyspepsia have a kid, bloating, normalization of stool and improve appetite. "Lactogen" has beneficial effects on physical and mental development of the child, increases the immune status.

The most effective purpose of Lactogen" women with complicated obstetric history or a history of hypogalactia feeding previous children immediately after birth. During clinical observations were noted staying breast milk for 2-3 days. The kids watched a good sucking activity, rapid normalization of stool. Physiological loss of weight newborns were restored to 5-6 a day.

"Lactogen helps women with hypogalactia, feeding infants up to 6 months, when the introduction of mixed wsca 10 days of application Lactogen" the women said, that milk was enough to refuse the lure. Women who have completed treatment "Lactogen", continued feeding only breast milk for 5-7 months and then on the background of the lure. Most of them expressed a desire to continue breastfeeding for 2-3 years.

Increase lactation functions mothers had a positive effect on the development of children. Research conducted one month after receiving the "Lactogen", showed that weight in children are normal. The kids were active, emotional. They noted good muscle tone.

Children breastfed mothers who received "Lactogen", observed the normalization of functional activity and microbiocenosis indicators of the digestive tract, which resulted in relief of dyspeptic symptoms and normalization of stool and improving the immunological status of the organisms.

Biologically active additive to food with a lack of breast milk in lactating women, when cipolatti, malnutrition and anorexia in infants and young children, comprising as an active ingredient Royal jelly, characterized in that it further comprises the infusion slotw in the amount of each active component of 0.1-99 wt. %.

 

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