Composition of dense extract of conifer needles for capsulation

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention relates to chemical-pharmaceutical industry, namely to creation of composition of dense extract of conifer needles for capsulation. Composition of dense extract of conifer needles contains the following ingredients: dense extract of conifer needles, emulsifier, a-tocopherol (vitamin E), retinol (vitamin A), naphthoquinones (vitamin K), essential fatty acids (vitamin F), vegetable oil. Microelements can be included additionally.

EFFECT: composition improves state of mucous membranes and enhances protective properties of organism.

2 ex

 

The invention relates to the field of pharmacy, pharmaceutical and food industries and relates to the creation of various compounds, which contribute to improving the state of the mucous membranes and skin, improved protective properties of the body, and also improve the technological properties and the stability of the extract of pine needles thick, increase the shelf life of the finished capsule forms.

There are various biologically active compounds containing vitamins and other biologically active components that contribute to the stimulation of protective factors in the gastrointestinal tract [1-6].

The compositions prepared in the form of capsules, offer the following advantages: ease of administration, accurate dosing, no specific taste sensations of various drugs and the stability during storage [7-11].

Known complex drug fitesten (extract of pine needles thick), which is produced from wood green conifers in accordance with the standard of the Republic of Latvia-US-000312820-08-99 or GOST 21769-84 [12]. The drug is produced in the form of a thick pasty mass. The drug is registered in the Register of medicinal products of the Republic of Latvia No. 95-0002.

The complex composition of the extract of pine needles thick (ECG) has high biological activity, since b contains lsoe number of biologically active compounds: carotenoids, polyprenols, chlorophylline acid, Italiana, vitamins C, K, E, di - and triterpenoids, sesquiterpenoid, labdanoids, wax pine, fungicides, fatty acids, stearine, polymeric compounds. The drug has the properties of vitoantonio, antioxidant, biostimulant, hepatoprotector, cell membranoprotector and immunomodulator [13-17]. ECG and its individual components - polyprenols and itaberai is widely used to improve the activity of the gastrointestinal tract, to improve immunity and other

ECG has a dense thick texture, dark green color, odor and taste, which makes the drug and its dosage. To eliminate these deficiencies have developed a composition for encapsulation ECG [18]. This known composition ECG for encapsulation is the prototype of the invention.

For the qualitative improvement of the composition of the ECG for encapsulation and enhance its biological activity, it is desirable to Supplement the composition of the ECG vitamins and trace elements and to determine their proportion in relation to the composition of the ECG.

The aim of the invention is to provide a composition containing the ECG, which has qualitatively improved composition, increasing the biological activity of the components while maintaining the technological properties and the stability of the ECG in capsule the form.

This goal is achieved due to the fact that the ECG for encapsulation further added α-tocopherol (vitamin E), retinol (vitamin a), naftochinona (vitamin K) and essential fatty acids (vitamin F) in the following ratio, wt.%:

The extract of pine needles thick20-70
Emulsifier2-10
α-Tocopherol (vitamin E)5-20
Retinol (vitamin a)0,01-0,5
Naftochinona (vitamin K)0,01-0,6
Essential fatty
acid (vitamin F)2-5
Vegetable oilthe rest of it.

In addition, the composition may additionally contain trace elements (zinc, selenium) in the following ratio, wt.%:

The extract of pine needles thick20-70
Emulsifier2-10
α-Tocopherol (vitamin E)5-20
Retinol (vitamin a)0,01-0,5
Naftochinona (vitamin K)0,01-0,6
Essential fatty
acid (vitamin F)2-5
Trace elements (zinc, selenium)of 0.01-0.1
Vegetable oilthe rest of it.

α-Tocopherol (vitamin E) has antioxidant activity involved in the inactivation of free radicals, thereby prevents damage to the structure of cell membranes. Reducing the number of α-tocopherol leads to reduced activity of the drug and the stability of the active components of the ECG.

Retinol (vitamin a) improves visual function, has a positive system-wide effects, normalize the differentiation of epithelial tissue, regulates metabolism.

Naftochinona (vitamin K): deficiency affects the blood clotting process, naftochinona involved in the processes of energy metabolism, they serve an important continuu function, involved in the synthesis of easily renewable proteins (eksperimentov organs of the digestive the ia) and other enzymes.

Essential fatty acids (vitamin F) used in violation of the growth and development of the body, dysfunction and dryness of the skin, recurrent eczema, hair loss, fragility and the bundle of nails, increased susceptibility to bacterial infections of the gastrointestinal tract, pulmonary infections, reduction of visual acuity, impaired renal function, etc.

Zinc (Zn) neutralizes free radicals, reduces the inflammatory response, promotes healing, and stabilizes the immune system of the skin.

Selenium (Se) is a biologically active trace mineral that is part of a number of hormones and enzymes and is associated with activity of all organs, tissues and systems. Selenium along with vitamin E supports the vital functions of the cells and prevents them from dying. Thus, selenium supports the youth of the body and affects the duration of a person's life. Selenium is quite a powerful antioxidant, it stimulates the formation of antibodies and this increases protection against colds and infectious diseases. The lack of selenium - reduces the body's immunity to colds and cancer.

In the method of obtaining ECG heated to 45-50°C, add a solution of the emulsifier and α-tocopherol (vitamin E) oil with constant stirring until a homogeneous mass. In listadopeliculas enter retinol (vitamin a), naftochinona (vitamin C), essential fatty acids (vitamin F) and trace elements (zinc, selenium).

The composition containing the ECG, emulsifier, vegetable oil and additional biologically active components obtained according to the technology described in the invention was successfully used for the preparation of dosage forms in the form of soft gelatin capsules containing 0.3 to 1.0,

For the preparation of capsules you must have the appropriate equipment for pressing capsules rotary-matrix method.

Example 1

For the preparation of the weigh ECG in the amount of 20-70 g in a beaker, heated on a water bath to 45-50°C. Separately weighed emulsifier (for example, glycerol monooleate) in an amount of 2-10 g of α-tocopherol (vitamin E) in an amount of 5-20 g, enter retinol (vitamin a) in an amount of 0.01-0.5 g, naftochinona (vitamin K) in an amount of 0.01-0.6 g, essential fatty acids (vitamin F) in an amount of 2-5 g and add vegetable oil in quantity of rest, heat the mixture on a water bath to 45-50°C and added to the ECG.

Example 2

For the preparation of the weigh ECG in the amount of 20-70 g in a beaker, heated on a water bath to 45-50°C. Separately weighed emulsifier (for example, glycerol monooleate) in an amount of 2-10 g of α-tocopherol (vitamin E) in an amount of 5-20 g, enter R Tina (vitamin a) in an amount of 0.01-0.5 g, naftochinona (vitamin K) in an amount of 0.01-0.6 g, essential fatty acids (vitamin F) in an amount of 2-5 g, trace elements (zinc, selenium) in an amount of 0.01-0.1 g and add vegetable oil in quantity of rest, heat the mixture on a water bath to 45-50°C and add to the ECG.

Each of the components in the composition, has its own specific useful properties, and their joint application allows you to obtain a synergistic effect, in which it was possible to obtain the composition containing the ECG suitable for encapsulation and keep their bioactive properties.

Reducing the number of ECG less than 20 g leads to reduced activity of the drug, increasing the number of ECG more than 70 g leads to the complexity of the process and storage of the drug.

The emulsifier reduces the surface tension at the phase boundary of a disperse system, promotes mixing of hydrophilic (extract of pine needles thick) and lipophilic (vegetable oil, α-tocopherol, retinol and other) components. As the emulsifier used glycerol monooleate. Can be used are glycerol esters of high molecular fatty acids, esters sorbitan and polyoxyethylenesorbitan and higher fatty acids, distilled monoglycerides, natural phospholipids, as well as their combination is tion. The decrease in the amount of emulsifier is less than 2 g or increasing its amount is more than 10 g accompanied by complication of the process technology and the difficulty of obtaining a homogeneous mixture.

Vegetable oil is necessary for optimal consistency ECG to be filled in soft gelatin capsules.

α-Tocopherol (vitamin E) has antioxidant activity. Reducing the number of α-tocopherol, less than 5 g leads to reduced activity of the drug and the stability of the active components of the ECG, the increase in the number of α-tocopherol more than 20 grams is not recommended.

Retinol (vitamin a) has a positive system-wide effects, normalize the differentiation of epithelial tissue. The decrease in the amount of retinol less than 0.01 g leads to decreased activity of the preparation and stability of active ingredients, increasing the amount of retinol than 0.5 grams is not recommended.

Experimental and clinical studies have shown that ECG is a stimulant protective factors of gastric mucosa and duodenum, it has antioxidant properties, bactericidal effect on various flora and immunomodulatory activity, positive action for inflammation of the mucous membrane of the stomach and duodenum.

The use of a complex of vitamins and microsemi the tov significantly increases the biological and nutritional value, as well as the stability of a capsulated form ECG.

The composition containing the ECG, emulsifier, vegetable oil and additional biologically active ingredients, obtained according to the technology described in the invention was successfully used for the preparation of dosage forms in the form of soft gelatin capsules containing 0.3 to 1.0,

If necessary, the number of members may be increased up to 10-100 kg subject as ratios of components and the production technology described in the invention.

Sources of information

1. Pat. EP 96/02773, 1996, A61K 45/00.

2. Pat. WO 97/01636, 1997, A61K 45/00.

3. Pat. DE 4221836, 1994, A61K 45/00.

4. Pat. WO 00/02554, 2000, A61K 45/00.

5. Pat. EN 2004103013, A, 2005, A61K 45/00.

6. Pat. EN 2000124390, A, 2002, A61K 35/78.

7. Pat. EN 2240768, C2, 2004, A61K 9/48.

8. Pat. GB 01/01126, 2001, A61K 9/48.

9. Pat. WO 01/68032, 2001, A61K 9/48.

10. Pat. US 03/16732, 2003, A61K 9/48.

11. Pat. EP 02/09770, 2002, A61K 9/48.

12. GOST 21769-84. The green wood. TU, M., 1984.

13. Pat. LV of 10,915, B, 1996, A61K 31/045.

14. Pat. LV 10925, B, 1996, A61K 35/78.

15. Pat. LV 10926, B, 1996, A61K 35/78.

16. Pat. LV 11276, B, 1997, A61K 35/78.

17. Pat. LV 11277, B, 1997, A61K 3 5/78.

18. Pat. LV 13 566, B, 2007, A61K 36/00.

1. The composition of the extract of pine needles thick for encapsulation containing the emulsifier and vegetable oil, characterized in that it further comprises α-tocopherol (vitamin E), retinol (vitamin a), naftochinona (vitamin K) and essential fatty acids (vitamin F) when CL is blowing ratio of components wt.%:

the extract of pine needles thick20-70
emulsifier2-10
α-tocopherol (vitamin E)5-20
retinol (vitamin a)0,01-0,5
naftochinona (vitamin K)0,01-0,6
essential fatty acids (vitamin F)2-5
vegetable oilrest

2. The composition according to claim 1, characterized in that it additionally contains trace elements such as zinc, selenium, in the following ratio, wt.%:

the extract of pine needles thick20-70
emulsifier2-10
α-tocopherol (vitamin E)5-20
retinol (vitamin a)0,01-0,5
naftochinona (vitamin K)0,01-0,6
essential fatty acids (VI is Amin F) 2-5
trace elements (zinc, selenium)of 0.01-0.1
vegetable oilrest



 

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