EA013243B1 - Process of making herbal composition with masked bitter taste and composition prepared using said process - Google Patents

Abstract

The present invention provides a process for utilizing the bitter tasting herbs in a herbal composition having hepatoprotective properties. The composition comprises one or more of Picrorhiza kurroa, Andrographis paniculata, Phyllanthus niruri, Eclipta alba Solanum nigrum, Tinospora cordifolia, Boerhaavia diffusa, Piper longum, Zingiber officinale, Bacopa monneiri and is suitable even for paediatric use.

Description

The present invention relates to a method for preparing a composition of medicinal herbs useful in the treatment of liver diseases. The invention also relates to a composition of medicinal herbs, including increased concentrations of bioactive compounds, thereby providing a more effective product in a form acceptable even for children.

State of the art

In the past, some herbs, such as Rhysparidae rashea1a1a, Ryugogsh / a kiggoa, P11u11ap11i.15 shgsht, Trzozrog sogyoyoya, EcHp (and a1La, 8o1apit shdgit, were found to be useful for health as having the main hepatoprotective properties, which, however, are. of these herbs, that is, Lpigodgar lyz rhsi1a1a, known as the king of bitterness, P | ogog1iha kiggoa, P11u11ap11i.15 pieces, Trzozrog sogy1Go11a, Esp1a a1ba and 8o1apit shdgit, are characterized by very pronounced bitter taste, which makes them uncommon. Herbal preparations containing the herbs listed above as active ingredients have a bitter taste and are therefore not suitable for use in pediatrics. In addition, to mask the bitter taste, these herbs were used in compositions in amounts below optimal, which cast doubt on them. To satisfy the need for the above compositions, the authors of this application have developed a method in which medicinal herbs with very pronounced bitterness can be combined in the required quantities while masking the bitter taste.

SUMMARY OF THE INVENTION

The main objective of the present invention is to provide a method for preparing a composition of medicinal herbs, including herbs that are bitter in taste, and in which the herbal extracts are present in an effective concentration, higher than in traditional similar preparations, and at the same time mask the bitterness.

The present invention provides a method for preparing a herbal mask with a bitter taste mask to optimize liver function, comprising the following steps:

b

(ίί) adding an antioxidant to the extract and optionally boiling the extract;

(ίίί) filtering the extract and concentrating the residual mass to obtain a concentrate;

(ίν) converting the concentrate to a formulation by adding a pharmaceutically acceptable carrier or excipient to form a herbal composition.

The herbal composition of the present invention, including an increased concentration of biologically active substances, thus provides a more effective product in a form suitable even for children.

For the claimed method, it matters that the antioxidant is added before the extract is filtered and subsequently concentrated to the target product. This stage provides a reduced bitter taste in the final product.

Brief Description of the Figures

FIG. 1 (a) is a histogram that shows, in a bar chart, the results of clinical trials of a composition of series 2 or series C in the treatment of hepatitis and the gradual removal of symptoms of anorexia, digestive disorders and nausea, i.e. the three main symptoms of hepatitis.

FIG. 1 (b) is a histogram that shows, in a bar chart, the results of clinical trials of a composition of series 2 or series C in the treatment of hepatitis and an indicator of 8ORT, LLR.

FIG. 1 (c) is a histogram that shows, in a bar chart, the results of clinical trials of a composition of series 2 or series C in the treatment of hepatitis and a serum bilirubin index.

FIG. 2 (a) is a histogram that shows, in a bar chart, the results of clinical trials of a composition of series 2 or series C in the treatment of hepatitis due to alcoholism (hereinafter referred to as alcoholic hepatitis) and the gradual withdrawal of symptoms of anorexia, digestive disorders and nausea, i.e. .the three main symptoms of hepatitis.

FIG. 2 (b) is a histogram that shows, in a bar chart, the results of clinical trials of a series 2 or series C composition in the treatment of alcoholic hepatitis and a liver function test.

FIG. 2 (c) is a histogram that shows, in a bar chart, the results of clinical trials of a composition of series 2 or series C in the treatment of alcoholic hepatitis and an indicator of total serum bilirubin.

The implementation of the invention

Thus, the present invention provides a method for preparing a herbal mask with a masked bitter taste for optimizing liver functions, comprising

- 1 013243 blowing stages:

(ΐ) obtaining the extract of herbs ΡίοϊΌΐΊιίζα kiggoa, Aptodtary Raschi1a!: a. RyuNapshtshy piece. EcHp1a a1ba, Zo1atstit. Tojoroga sotFGoya. Wow11aaa for FEGYa. P1reg 1 opt. Ζίη ^ ώθτ 1 1 с,,,,, Vasora toppes;

(ίί) adding an antioxidant to the extract and optionally boiling the extract;

(ίίί) filtering the extract and concentrating the residual mass to obtain a concentrate;

(ίν) converting the concentrate to a formulation by adding a pharmaceutically acceptable carrier or excipient to form a herbal composition.

The composition of medicinal herbs according to the invention includes the following ratio of medicinal herbs to each other:

No. p / p Ingredients The amount in the range (wt.%) one ΡίνΓο / Ηίζα kiggoa 10% -50% 2 An 10% -50% 3 Esiru a1a 10% -25% 4 RkuIap Zhiz Tgip 10% -25% 5 8o1apit gp% git 5% -25% 6 Tyuzrog sleep N / O 5% -25% 7 Voehkast SN 2% -10% 8 ΖίηξΛΐΓ about $ hundred 2% -10% nine Vasora Toppet 2% -10% 10 P1reg 1op £ it 1% -5%

Antioxidant. used in the extraction process. is a water soluble antioxidant. such as sodium metabisulfite, sodium sulfite, sodium bisulfite, sodium thiosulfate, ascorbic acid. citric acid and others. Preferably, the antioxidant is metabisulfite. since extraction with this antioxidant showed a significant degree of masking bitterness compared to other antioxidants. An optimized batch (series C or series 2) using sodium metabisulfite as an antioxidant was further used to evaluate effectiveness and analysis. as these lots showed well-masked bitterness in herbal compositions.

In the method, the yield of extractable substance is increased to 54 wt. % compared with the traditional method. and bioactive compounds - up to more than 100 wt.%. due to which the increased bioactivity of the resulting product is ensured.

It should be noted. that the herbal composition of the present invention is synergistic in nature in contrast to the currently available compositions. since many pharmaceutical companies either administer the indicated active ingredients in concentrations below optimal. or use an aqueous distillate of said bitter herbs. which does not contain active ingredients present in herbs. which in these herbs are not volatile. and. Consequently. the bioefficiency of such drugs is usually in doubt. while the herbal composition of the present invention contains bitter herbs. such as P ^ c ^ o ^ ζζa kiggoa. Appraisal rashsi1a!: A. RyuPapShtip. EcHp1a a1ba. Zo1apit shdgat. Tojoroga sogShGONa. Voe ^ yaaν ^ a bShiyya. P1reg 1 opt. Ζίη ^ ί ^ τ oGysshak. Vasora topping. and is significantly enriched with bioactive compounds of these herbs while masking their unpleasant bitter taste. which makes it suitable even for children. Clinical data of a herbal composition. shown in FIG. 1 (a). 1 (b). 1 (s). 2 (a). 2 (b). 2 (c) and in table. 7. 8. 9. 10. 11 and 12. also confirm its higher efficiency and better adherence to treatment by patients. Thus. the composition of the present invention is a synergistic composition. not a simple mixture.

The herbal extract obtained using sodium metabisulfite as an antioxidant tastes from an almost complete absence of bitterness to very moderately bitter and can be easily incorporated into the composition with a pleasant taste. The base may contain pharmaceutically approved excipients. such as sweeteners. for example sucrose. sorbitol in solution. glycerol; preservatives. e.g. methyl paraben. propyl paraben or their more complex salts. sorbic acid or its salts. benzoic acid or its salts; buffering agents. for example citrate. Ascendant. phosphate or other suitable buffer for this purpose. and appropriate colorants and flavors. Composition of medicinal herbs. prepared by the method of the present invention. may be in tablet dosage form. capsules. powder. granules or syrup. Excipients for the composition of medicinal herbs are selected from the group. including diluents. binders. disintegrating agents. lubricants. moving substances. sweeteners. flavoring additives. solvents. suspending agents. preservatives. bactericidal agents. antioxidants. buffers and stabilizers. For the preparation of tablets, a ready-made dry powder extract. obtained by this method. may be mixed with appropriate pharmaceutical approved excipients. such as dilute

- 2013243 bodies, for example, microcrystalline cellulose, lactose, calcium carbonate, dicalcium phosphate, tricalcium phosphate, magnesium carbonate, etc .; disintegrating agents, for example, natural gums, various cellulose derivatives, starch, sodium starch glycolate, sodium lauryl sulfate, etc .; lubricants and lubricants, for example colloidal silicon dioxide, talc, stearic acid and magnesium stearate, etc.

Preferably, the active ingredient in the herbal composition prepared from the filtered and concentrated extract may be present in an amount of up to 70 wt.%.

Below the present invention is described in more detail in the form of examples, but the scope of the present invention should not be limited to these examples. In the examples, part and parts mean respectively wt. part and wt. parts, unless otherwise specified.

Example 1. The formulation of a herbal composition containing the herbs listed below was weighed, coarsely ground, and extracted with or without an antioxidant, ie sodium metabisulfite (Table 1 or Table 2), with an 8-fold volume of demineralized water by boiling contents over the burner flame for 5 min. The corresponding samples were filtered through two-layer cheesecloth, the filtrate volume was brought to 200 ml with demineralized water, 0.2 wt.% Sodium methylparaben and 0.02 wt.% Sodium propylparaben, calculated on its weight, were added and the liquid was left alone overnight. The next day, a decanted clear liquid and a sample were used to calculate the content of extractable substance from herbs, determine bitterness, and analyze by the HPLC method (Н1дй RegГотапсе Тииауу Сигоша1одгарю) (high performance thin layer chromatography).

The calculation of the extractable substance was measured in 10 ml of clear liquid from each sample and transferred to Petri dishes, which were dried to constant weight over a boiling water bath, and the residue was weighed.

Table 1. Demonstrates a hepatoprotective composition from medicinal herbs containing various amounts of sodium metabisulfite as an antioxidant during the extraction process.

No. p / p Component Series A, qty Series B, qty in g Series C, qty Series Ώ, qty one Rkogogka kiggoa 4 4 4 4 2 ApAgo ^ Garryz Ratsikaa 4 4 4 4 3 Esir) a1ba 4 4 4 4 4 RkuNapAiz shgip 4 4 4 4 5 8o1apit t% git 3 3 3 3 6 Ttozrog sog <I / oIa 3 3 3 3 7 Voegkaachga Squeeze one one one g 8 ΖΐηχίύβΓϋΐϊΐνΐηαίβ I one one one nine Vasora Toppet one one one one 10 P1reg 1op £ it 0.5 0.5 0.5 0.5 eleven Sodium metabisulfite 0 0.1 0.2 0.4 12 Demineralized water 200 ml 200 ml 200 ml 200 ml

Example 2. The formulation of a herbal composition containing the above herbs was weighed, coarsely ground, and subjected to extraction with or without an antioxidant, ie sodium metabisulfite (Table 2), with an 8-fold volume of demineralized water by boiling the contents over the burner flame in within 5 minutes The corresponding samples were filtered through two-layer cheesecloth, the filtrate volume was brought to 200 ml with demineralized water, 0.2 wt.% Sodium methylparaben and 0.02 wt.% Sodium propylparaben, calculated on its weight, were added and the liquid was left alone overnight. The next day, the decanted clear liquid and the sample were used to calculate the content of extractable substance from herbs, to determine bitterness, and to be analyzed by the HPTLC method.

Calculation of extractable substance: 10 ml of clear liquid was measured from each sample and transferred to Petri dishes, which were dried to constant weight over a boiling water bath and the residue was weighed.

Example 3. The formulation of a herbal composition containing the above herbs was weighed, coarsely ground and extracted with or without an antioxidant, ie sodium thiosulfate (Table 2), with an 8-fold volume of demineralized water by boiling the contents over the burner flame in within 5 minutes. The corresponding samples were filtered through two-layer cheesecloth, the filtrate volume was brought to 200 ml with demineralized water, 0.2 wt.% Sodium methylparaben and 0.02 wt.% Sodium propylparaben, calculated on its weight, were added and the liquid was left alone overnight. The next day, the decanted clear liquid and the sample were used to calculate the content of extractable substance from herbs, to determine bitterness, and to be analyzed by the HPTLC method.

Calculation of extractable substance: 10 ml of clear liquid was measured from each sample and

- 3 013243 was transferred to Petri dishes, which were dried to constant weight over a boiling water bath, and the residue was weighed.

Example 4. A formulation of a herbal composition containing the above herbs was weighed, coarsely ground, and extracted with or without an antioxidant, i.e. sodium sulfite (table. 2), 8-fold volume of demineralized water by boiling the contents over the burner flame for 5 minutes The corresponding samples were filtered through two-layer cheesecloth, the filtrate volume was brought to 200 ml with demineralized water, 0.2 wt.% Sodium methylparaben and 0.02 wt.% Sodium propylparaben, calculated on its weight, were added and the liquid was left alone overnight. The next day, the decanted clear liquid and the sample were used to calculate the content of extractable substance from herbs, to determine bitterness, and to be analyzed by the HPTLC method.

Calculation of extractable substance: 10 ml of clear liquid was measured from each sample and transferred to Petri dishes, which were dried to constant weight over a boiling water bath and the residue was weighed.

Example 5. A formulation of a herbal composition containing the above herbs was weighed, coarsely ground, and extracted with or without an antioxidant, i.e. ascorbic acid (table. 2), 8-fold volume of demineralized water by boiling the contents over the burner flame for 5 minutes. The corresponding samples were filtered through two-layer cheesecloth, the filtrate volume was brought to 200 ml with demineralized water, 0.2 wt.% Sodium methylparaben and 0.02 wt.% Sodium propylparaben, calculated on its weight, were added and the liquid was left alone overnight. The next day, the decanted clear liquid and the sample were used to calculate the content of extractable substance from herbs, to determine bitterness, and to be analyzed by the HPLC method.

Calculation of extractable substance: 10 ml of clear liquid was measured from each sample and transferred to Petri dishes, which were dried to constant weight over a boiling water bath and the residue was weighed.

Example 6. The formulation of a herbal composition containing the above herbs was weighed, coarsely ground, and extracted with or without an antioxidant, i.e. citric acid (Table 2), with an 8-fold volume of demineralized water by boiling the contents over the burner flame in within 5 minutes The corresponding samples were filtered through two-layer cheesecloth, the filtrate volume was brought to 200 ml with demineralized water, 0.2 wt.% Sodium methylparaben and 0.02 wt.% Sodium propylparaben, calculated on its weight, were added and the liquid was left alone overnight. The next day, the decanted clear liquid and the sample were used to calculate the content of extractable substance from herbs, to determine bitterness, and to be analyzed by the HPTLC method.

Calculation of extractable substance: 10 ml of clear liquid was measured from each sample and transferred to Petri dishes, which were dried to constant weight over a boiling water bath, and the residue was weighed.

Table 2. Demonstrates a hepatoprotective composition from medicinal herbs containing various antioxidants during the extraction process.

No. p / p Components Series one, count in g Series 2, count in g Series 3, count in g Series 4, count in g Series 5, count in g Series 6, count in g Series 7, count in g one R & GIGA KIGGOA 4 4 4 4 4 4 4 2 Αηώ ^ βταρΗϊχ ratsi1a1a 4 4 4 4 4 4 4 3 Ес1цМа а1Ъа 4 4 4 4 4 4 4 4 Rku11ap (ki8 p1gip 4 4 4 4 4 4 4 5 8o1apit w% git 3 3 3 3 3 3 3 6 Ttozrog sogsI / oNa 3 3 3 3 3 3 3 7 Voegkast one one one one I one one 8 Ζίηχίύβν о $ 1с1ра1е one one one one one one one nine Vasora Tottegg one one one one one one one 10 P1reg 1op & it 0.5 0.5 0.5 0.5 0.5 0.5 0.5 eleven Sodium metabisulfite 0 0.2 - - - - - 12 Sodium sulfite - - 0.20 - - - - thirteen Sodium thiosulfate - - - 0.20 - .. 14 Sodium bisulfite - - - - 0.20 - - fifteen Vitamin C - - - - - 0.20 - sixteen Lemon acid - - - - - 0.20 17 Demineralized 200 200 200 200 200 200 200 water ml ml ml ml ml ml ml

- 4 013243

Example 7. The concentrate obtained in examples 1-6 was converted into a pleasant syrup by adding a base containing sucrose, sorbitol solution, glycerin, a preservative such as methylparaben and propylparaben, together with appropriate buffering agents such as citrate, ascorbate, phosphate or other suitable buffer, and colorants and flavoring agents suitable for this purpose.

Example 8. For the manufacture of tablets, the concentrate obtained in examples 1-6 was transferred to a dry powder extract using a vacuum dryer. The prepared dry powder extract was mixed with appropriate pharmaceutical approved excipients, such as diluents, for example microcrystalline cellulose, lactose, calcium carbonate, dicalcium phosphate, tricalcium phosphate, magnesium carbonate, etc .; disintegrating agents, for example, natural gums, various cellulose derivatives, starch, sodium starch glycolate, sodium lauryl sulfate, etc .; lubricants and lubricants, for example colloidal silicon dioxide, talc, stearic acid, magnesium stearate, etc.

Example 9. For the manufacture of capsules, the concentrate obtained in examples 1-6 was transferred to a dry powder extract using a vacuum dryer. The prepared dry powder extract was mixed with appropriate pharmaceutical approved excipients, such as diluents, for example, bentonite, lactose, calcium carbonate, dicalcium phosphate, tricalcium phosphate, magnesium carbonate, mannitol, etc. lubricants and lubricants, for example, colloidal silicon dioxide, talc, stearic acid, magnesium stearate, etc. After homogeneous mixing of the powder components by any suitable method for this purpose, the obtained powder mixture was filled into capsules of the required size, for example capsules from 0 to 5, which can hold from 0.6 g to 0.12 g

Example 10

Percentage (wt.%) Of extractable substance = mass of Petri dish containing residue. - mass of an empty Petri dish x 100 x 200

10x25.5

The results are presented in table. 3 using sodium metabisulfite as the preferred antioxidant in the extraction process.

Table 3. Shows the amount of extractable substance from different samples of the hepatoprotective composition of medicinal herbs using various antioxidants in the extraction process.

Series No. The amount of extractable substance (wt./mass.%) The increase in mass. % in relation to control Episode 1 9.53 0.00 Series 2 14.67 53.93 Series 3 13.32 39.77 Series 4 13.63 43.02 Series 5 14.22 49.21 Series b 13.76 44.38 Episode 7 14.25 49.53

Example 11. Bitterness.

Bitterness was evaluated by 5 volunteers by actually tasting all the samples; their taste sensations were classified as weakly expressed bitterness, moderate bitterness and strongly expressed bitterness. The results are given in table. 4 and table 5.

Table 4. Shows the assessment of bitterness in various samples of the hepatoprotective composition from medicinal herbs with sodium metabisulfite as an antioxidant in the extraction process.

Series No. Bitterness - mild Bitterness Bitterness - Strong Serie A V Series B V Series C Series O

The results of the evaluation of bitterness show that compositions of series A and series B had very pronounced bitterness, while composition of series C was optimal and had very weak bitterness, while compositions of series Ό were characterized by moderate bitterness. Therefore, series C, treated with 0.2 wt.% Sodium metabisulphite as an antioxidant, was selected to evaluate effectiveness and analysis, since this batch showed well-masked bitterness compared to other herbal compositions.

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Table 5. Shows the assessment of bitterness in various samples of the hepatoprotective composition from medicinal herbs using various antioxidants.

Series No. Bitterness mild Moderate bitterness Bitterness - Strong Episode 1  V Series 2 Series 3 V Series 4 V Series 5 Series 6 V Episode 7

The results of the bitterness assessment show that the composition of series 1 had very pronounced bitterness, while the composition of series 2 was optimal and had very weak bitterness, and the compositions of series 3, 4, 5, 6, and 7 were characterized by moderate bitterness. Therefore, a series of 2, processed 0.2 wt. % sodium metabisulfite as an antioxidant was selected for evaluation and analysis because this batch showed a well-masked bitterness compared to other herbal compositions.

Example 12. HPMC analysis.

To perform an HPTLC analysis, 10 ml of the extract of each sample was accurately measured and transferred to Petri dishes, the liquid was evaporated over a boiling water bath, and 10 ml of methanol was added to the residue. The contents were slightly heated and filtered through a No. 1 paper filter, and 5 ml of each sample was applied to silica gel 60 E254 coated with a TBC film. The film was developed in the system ethyl acetate: formic acid: acetic acid: water = 100: 11: 11: 27 under conditions of chamber saturation up to 80 mm. The film was removed from the chamber and left alone for some time to evaporate the solvent. The film was scanned using a TLC scanner (M / 8 SAMLS) at a wavelength of 254 nm in the spectral absorbance mode. The area of the main spots corresponding to Kutkin (Kutkozida), andrographolides, as well as the total area was calculated using a computer; details are given in table. 6.

Table 6. Shows the results of HPLC analysis of different samples of the hepatoprotective composition from medicinal herbs using various antioxidants in the extraction process.

Samples The area of spots corresponding to cutcoids The increase in mass. % relative to control The area of the spots corresponding to andrographolides total area The increase in mass,% relative to the control Episode 1 8355.7 0.00 Not detected 21059.7 0.00 Series 2 9932.1 18.87 2149.7 29056.4 37.97 Series 3 8619.3 • 3.15 Not detected 24,432.1 16.01 Series 4 8464.2 1.30 Not detected 24620.8 16.91 Series 5 9871.0 18.13 2191.9 28055,3 33.22 Series 6 8723.6 4.40 1778.0 28860.3 37.04 Episode 7 9805.4 17.34 2016.7 26,067.9 23.78

Example 13. The manufacture of tablets by direct compression of the finished concentrate of the composition prepared in the above manner.

To the resulting filtered mass was added precisely weighed microcrystalline cellulose, dry starch, talc, sodium lauryl sulfate, sodium crosscarmellose, sodium starch glycolate and magnesium stearate, and the mass was thoroughly mixed. This mass was passed through a sieve No. 16, and then through a sieve (mesh) No. 20 to obtain granules of the desired size. Compression compression was carried out in a universal tabletting machine with elongated capsule-shaped (15 mm) punches to obtain tablets weighing 550 mg.

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Series No. Components number one ΡίοτοΜζα kiggoa 4 g 4 g 4g 4g 3g Sg 1 g 1 g 1 g 0.5 g 0.4 g Ζ ApscortarkE ραηίαιίαΐα 4 5 6 Ί 8 nine EsNrSa aLa RkuIagikiz tgip 8o1apit tggit Tyuzroga sonyroNa Voegkaaucha <And // and $ a 2t <pbeg οβκϊηαΐβ 10 Vasora stomps 11 1? Rreg 1op% IT Sodium metabisulfite thirteen Demineralized water H · ⁵ - 1.5 g Microcrystalline cellulose 14 Dry Starch Talc 0.60 g fifteen sixteen Magnesium stearate 0.075 g 0 05 g 17 Sodium Starch Glycolate 0D5 g 0.05 g 0.025 g eighteen nineteen Crosscarmelose Sodium Sodium Lauryl Sulfate

Example 14. The manufacture of capsules from a finished concentrate prepared as described above.

To the resulting filtered mass was added precisely weighed dicalcium phosphate with talc and magnesium stearate and the mass was thoroughly mixed. This mass was passed through a sieve No. 16, and then through a sieve (mesh) No. 20 to obtain granules of the desired size. Hard gelatin capsules weighing 500 mg were filled with this finished mass.

Series No. Components number one Rgsgoggg kiggoa 4 g 2 Apskoruary from ραηϊσαΐαΐα 4 g 3 ΕοΙίρία a1Ъа 4 g 4 RKUIAPVShz TGIP 4 g 5 8o1apit tggit 3 g 6 Ttozrog sog / I / oIa 3 g 7 Voegkaama (Idiza 1 g 8 7lp§1Leg οββοίηαΐβ 1 g nine Vasora stomps 1 g 10 ΡϊρβΓ 1op§it 0.5 g eleven Sodium metabisulfite 0.4 g 12 Dicalcium phosphate 1.10 g thirteen Talc 0.5 g 14 Magnesium stearate 0.05 g

Example 15. The manufacture of granules or powder from a finished concentrate prepared in the manner described above.

The resulting filtered mass was thoroughly mixed to obtain a powder form. Next, this mass was passed through a sieve No. 16, and then through a sieve (mesh) No. 20 to obtain granules of the desired size.

Series No. Components number one Rsgogyga kiggoa 4 g 2 Apskorgarks Ratsi! A1a 4 g 3 ΕοΙϊρία a! Ba 4 g 4 Rku11ap1kiya tgip 4 g 5 8o1apit tggit 3 g 6 Ttozrog sopV / oNa 3 g 7 Voegkaa \ '1a άί / βιεα 1 g 8 ΖίηξίΒβν οβϊοίηαΐβ 1 g nine Vasora stomps 1 g 10 Rreg 1op $ it 0.5 g eleven Sodium metabisulfite 0.4 g 12 Demineralized water _

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Example 16. The manufacture of syrup from a finished concentrate prepared as described above.

The powdered extract was converted into a pleasant syrup by adding a base containing sucrose, glycerin, a preservative such as sodium methyl paraben and sodium propyl paraben, with the addition of an appropriate buffering agent, for example citrate buffer, caramel color as a coloring agent and peppermint as a flavoring additive.

Series No. Components number one RgsgogMga kiggoa 4 g 2 Αηώ'ΟβΓαρΗίζ rashsi1a1a 4 g 3 Esp7a a1ba 4g 4 RkuIapUkiz tgip 4 g 5 8o1apit turit 3 g 6 Ttozrog SogsI / οίία 3 g 7 Voegxita SI / RIAA 1 g 8 Et ^ r ^ ο / βΰίηαΐν 1 g nine Vasora toppet. 1 g 10 P1reg 1opurnp 0.5 g eleven Sodium metabisulfite 0.4 g 12 Demineralized water _B .z. thirteen Sucrose 80 g 14 Citrate buffer f8. fifteen Caramel color ¢ .3. sixteen Mint ΛΣ

17 Methylparaben Sodium 0.2% eighteen Propyl Paraben Sodium 0.02% nineteen Sorbitol solution 60 g

Table 7. Demonstrates the results of clinical trials of compositions of series 2 or series C in the treatment of hepatitis with a gradual weakening of the symptoms of anorexia, digestive disorders and nausea, i.e. three main symptoms of hepatitis

Symptomatic observation of patients (100%) Anorexia Digestive upset Nausea On day 0 one hundred% one hundred%  one hundred% On day 7 33% . twenty% twenty% On day 15 13.5% 0% 0%

The results show the number of patients (%) who showed a gradual decrease in the symptoms of anorexia, digestive upset, and nausea, i.e. the three main symptoms of hepatitis, as of 0, 7th and 15th day of taking the composition of medicinal herbs. Starting from the 7th day, there was a gradual reduction in cases of anorexia, digestive disorders and nausea from 33, 20 and 20%, respectively, to 13.5, 0 and 0%. It was found that cases of anorexia decreased sharply from 100 to 13.5% on the 15th day of observation, while digestive upset and nausea were completely absent in patients on the 15th day of observation. This is also reflected in FIG. 1 (a), in which the gray column of the chart shows 0 day, dark gray - the 7th day, and white - the 15th day.

Table 8. Demonstrates the results of clinical trials of compositions of series 2 or series C in the treatment of hepatitis and indicators 8CRT. Lr

Serum bilirubin index, mg / ml Total serum bilirubin Direct (bound) bilirubin Indirect (free) bilirubin 1st visit to the doctor 5.94 mg / ml 4.65 mg / ml 1.36 mg / ml 2nd visit 6.15 mg / ml 4.87 mg / ml 1.46 mg / ml 3rd visit 3.14 mg / ml 2.52 mg / ml 1.08 mg / ml

The results show an improvement in total serum bilirubin in mg / ml at the 1st, 2nd and 3rd doctor's visits. Serum bilirubin was found to be 5.94, 6.15 and 3.14 mg / ml, respectively, after the 1st, 2nd and 3rd visits, while direct bilirubin was 4.65, 4 , 87 and 2.52 mg / ml, respectively, after the 1st, 2nd and 3rd visits, and indirect bilirubin - 1.36, 1.46 and 1.08 mg / ml, respectively, after the 1st, 2nd 3rd and 3rd visit. Found that total bilirubin in

- 8 013243 serum decreased significantly from 5.94 to 3.14 mg / ml at the 3rd visit, while direct bilirubin decreased significantly from 4.65 to 2.52 mg / ml at the 3rd visit, and indirect bilirubin decreased significantly from 1.36 to 1.08 mg / ml by the 3rd visit. This is also reflected in FIG. 1 (b), on which the gray column corresponds to the 1st visit to the doctor, dark gray - to the 2nd, and white - to the 3rd.

Table 9. Demonstrates the results of clinical trials of compositions of series 2 or series C in the treatment of hepatitis and serum bilirubin index.

Indicator 8ORT & ALP, go / b * 8ORT ALP 1st visit to the doctor 375.9 GO / b 373.9 GO / b 2nd visit 211.9 GO / b 947.7 GO / b 3rd visit 97.33 GO / b 289.67 GO / b

* ΐυ / b = international units / liter.

The results show the value of 8 CPT and LLL (GO / L) at the 1st, 2nd and 3rd visits to the doctor. The 8СРТ indicator was found to be 375.9 GO / L, 211.9 GO / L and 97.33 ΐυ / L, respectively, at the 1st, 2nd and 3rd visits, while the LLR indicator is 373.9 GO / b, 347.7 ΐυ / b and 280.67 ΐυ / b, respectively, at the 1st, 2nd and 3rd visits to the doctor. 8СРТ decreased significantly from 375.9 ΐυ / до to 97.33 ΐυ / к by the 3rd visit, while ЛРР decreased significantly from 373.9 ΐυ / до to 289.67 ΐυ / к by the 3rd visit. This is also reflected in FIG. 1 (e), on which the gray column corresponds to the 1st visit to the doctor, dark gray - to the 2nd, and white - to the 3rd.

Table 10. Shows the results of clinical trials of compositions of series 2 or series C in the treatment of alcoholic hepatitis with a gradual weakening of the symptoms of anorexia, digestive disorders and nausea, i.e. three main symptoms of hepatitis

Symptomatic observation, moderate FATIGUE WEAKNESS ANOREXIA 0 weeks later 4.3 4.36 4.25 2 weeks later 3.53 3.64 3.98 4 weeks later 2.88 2.94 2.78 8 weeks later 2.44 2,33 2.2 After 12 weeks 1.86 1.73 1.78

The results show an average degree of symptom severity in patients, which confirms the gradual weakening of the symptoms of anorexia, digestive disorders and nausea, which are the three main symptoms of hepatitis, after 0, 2, 4, 8, and 12 weeks of taking the composition from herbs. It was found that the degree of fatigue averaged 4.3, 3.53, 2.88, 2.44 and 1.86, respectively, after 0, 2, 4, 8 and 12 weeks, while the degree of weakness averaged, respectively 4.36, 3.64, 2.94, 2.33 and 1.73 after 0, 2, 4, 8 and 12 weeks, and the degree of anorexia averaged 4.25, 3.98, 2.78, respectively. 2.2 and 1.78 after 0, 2, 4, 8 and 12 weeks. The average degree of fatigue decreased significantly from 4.3 to 1.86 after 12 weeks, while the average degree of weakness decreased significantly from 4.36 to 1.73 after 12 weeks, and the average degree of anorexia decreased significantly from 4.25 to 1 78 after 12 weeks. This is also reflected in FIG. 2 (a), in which a gray column shows values after 0 weeks, dark gray after 2 weeks, white after 4 weeks, yellow after 8 weeks and a black column shows values after 12 weeks.

Table 11. Demonstrates the results of clinical trials of a composition of series 2 or series C in the treatment of alcoholic hepatitis and liver function test.

Test for liver function, GO / b Ab A8T ALP 0 weeks later 148.66 GO / b 162.78 GO / b 181.38 GO / b 4 weeks later 73.22 GO / b 82.25 GO / b 166.47 GO / b 8 weeks later 52.75 GO / b 62.38 GO / b 146.26 GO / b After 12 weeks 48.53 GO / b 48 GO 121.47 GO / b

The results show a liver function test (in печениυ /)) after 0, 4, 8 and 12 weeks of taking the composition of medicinal herbs. It was found that the ATT was 148.66 ΐυ / b, 73.22 ΐυ / b, 52.75 ΐυ / b and 48.53 ΐυ / b, respectively, after 0, 4, 8 and 12 weeks, respectively, while the AZT, respectively 162.78 ΐυ / b, 82.25 ΐυ / b, 62.38 ΐυ / b and 48.00 ΐυ / b after 0, 4, 8 and 12 weeks, and ABP - 181.38 ΐυ / b, 166, respectively 47 ΐυ / b, 146.26 ΐυ / b and 121.47 ΐυ / b after 0, 4, 8 and 12 weeks. ATT decreased significantly

- 9 013243 after 12 weeks - from 148.66 to 48.53 mg / ml, while the A8T indicator decreased significantly after 12 weeks - from 181.38 to 121.47, and the ALP indicator decreased significantly after 12 weeks - from 181.38 to 121.47. This is also reflected in FIG. 12 (b), in which the gray column shows indicators after 0 weeks, dark gray after 4 weeks, white - after 8 weeks and yellow shows indicators after 12 weeks.

Table 12. Demonstrates the results of clinical trials of a composition of series 2 or series C in the treatment of alcoholic hepatitis and an indicator of total serum bilirubin

Serum total bilirubin  mg / dl Total serum bilirubin 0 weeks later 2.98 mg / dl 2 weeks later 1.6 mg / dl 3 weeks later 1.34 mg / dl 4 weeks later 1.1 mg / dl

The results show the total serum bilirubin in mg / ml after 0, 2, 3 and 4 weeks of taking the composition of medicinal herbs. The total serum bilirubin was found to be 2.98, 1.6, 1.34 and 1.1 mg / ml, respectively, after 0, 2, 3 and 4 weeks. The total serum bilirubin index decreased significantly after 4 weeks - from 2.98 mg / ml to 1.1 mg / ml. This is also reflected in FIG. 2 (c), in which the gray column indicates the indicator after 0 weeks, dark gray after 2 weeks, white - after 3 weeks, and yellow indicates the indicator after 4 weeks.

Claims (8)

CLAIM 1. A method of preparing a composition of medicinal herbs with a masked bitter taste to optimize liver function, comprising the following stages: (ί) obtaining the extract of the herbs of Argonacea kiggoa, Ai'godgarz raschisa, Rku11ai1yi8 πίιυτί, Esir1a a1aa, 8o1aiit shdgit, Tshokrog sogFGoIa. Voegyashza FGGiza. Р1reg 1пдит, 2шщЬе о £ Гюша1е, Vasora тоиееш; (ίί) adding an antioxidant to the extract and optionally boiling the extract; (ίίί) filtering the extract and concentrating the residual mass to obtain a concentrate; (ίν) converting the concentrate to a formulation by adding a pharmaceutically acceptable carrier or excipient to form a herbal composition. 2. The method according to claim 1, wherein the antioxidant is selected from sodium metabisulfite, sodium sulfite, sodium bisulfite, sodium thiosulfate, ascorbic acid and citric acid. 3. The method according to claim 2, in which the antioxidant is sodium metabisulfite. 4. The method according to claim 1, in which the amount of antioxidant is 0.01-0.4 wt.% By weight of the entire composition. 5. The method according to claim 4, in which the amount of antioxidant is preferably 0.1-0.2 wt.% By weight of the total composition. 6. The method according to claim 1, wherein the pharmaceutically acceptable carrier is selected from the group consisting of diluents, binders, disintegrating agents, lubricants, lubricants, sweeteners, flavoring agents, solvents, suspending agents, preservatives, bactericidal agents, antioxidants, buffers and stabilizer. 7. A composition of medicinal herbs with a masked bitter taste to optimize liver function, made in accordance with the method according to any one of claims 1 to 6. 8. The composition according to claim 7, in which the percentage by weight between the herbs in the concentrate is as follows: