MD1769Z - Biologically active food additive with hypoglycemic and immunostimulatory effect - Google Patents

Biologically active food additive with hypoglycemic and immunostimulatory effect Download PDF

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Publication number
MD1769Z
MD1769Z MDS20230088A MDS20230088A MD1769Z MD 1769 Z MD1769 Z MD 1769Z MD S20230088 A MDS20230088 A MD S20230088A MD S20230088 A MDS20230088 A MD S20230088A MD 1769 Z MD1769 Z MD 1769Z
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Moldova
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dry extract
extract
dry
hypoglycemic
leaves
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MDS20230088A
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Romanian (ro)
Russian (ru)
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Анастасия БАБИЛЕВА
Ион МЕРЕУЦА
Тудор СТРУТИНСКИЙ
Владимир КАРАУШ
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Анастасия БАБИЛЕВА
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Publication of MD1769Z publication Critical patent/MD1769Z/en

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Abstract

The invention relates to the food industry, sanocreatology and medicine, in particular to a phytotherapeutic biologically active food additive, which has both hypoglycemic and immunostimulating activity and can be used in the treatment of type II diabetes mellitus.The food additive, according to the invention, comprises: dry extract of bay leaf (Laurus nobilisL.), dry extract of Jerusalem artichoke leaves (Helianthus tuberósusL.), dry extract of black mulberry leaves (Morus nigraL.), dry extract of cinnamon (Cinnamomum verumL.), dry extract of turmeric rhizome (Cúrcuma lóngaL.), dry extract of bean pods (Phaseoli pericarpiumL.), dry extract of black caraway seeds (Nige-llasativaL.), dry extract of holy thistle seeds (Silybum marianumL.) and glutathione powder ( L-Glutathione).

Description

Invenţia se referă la industria alimentară, sanocreatologie şi medicină, în special la un supliment alimentar fitoterapeutic, biologic activ, care posedă activitate hipoglicemică şi imunostimulatoare în acelaşi timp şi poate fi utilizat în tratamentul diabetului zaharat de tip II. The invention relates to the food industry, sanocreatology and medicine, in particular to a phytotherapeutic, biologically active food supplement, which possesses hypoglycemic and immunostimulating activity at the same time and can be used in the treatment of type II diabetes mellitus.

Este cunoscut un supliment alimentar biologic activ cu efect hipoglicemic care conţine: extract uscat din coajă de scorţişoară, extract uscat din frunze de dafin, extract uscat din frunze şi rizomi din curcumă, extract uscat din coajă de fasole, extract uscat din rădăcină de cicoare, extract uscat din rădăcină din ghimber şi extract uscat din frunze de armurariu, componentele fiind luate în următorul raport, în % mas.: A biologically active food supplement with a hypoglycemic effect is known which contains: dry extract of cinnamon bark, dry extract of bay leaves, dry extract of turmeric leaves and rhizomes, dry extract of bean bark, dry extract of chicory root, dry extract of ginger root and dry extract of milk thistle leaves, the components being taken in the following ratio, in % by mass:

extract uscat din coajă de scorţişoară 13 dry cinnamon bark extract 13

extract uscat din frunze de dafin 11 dried bay leaf extract 11

extract uscat din frunze şi rizomi din curcuma 12 dried extract of turmeric leaves and rhizomes 12

extract uscat din coajă de fasole 24 dry bean husk extract 24

extract uscat din rădăcină de cicoare 12 dry chicory root extract 12

extract uscat din rădăcină de ghimber 13 dried ginger root extract 13

extract uscat din frunze de armurariu 15 [1]. dry extract of milk thistle leaves 15 [1].

Dezavantajul acestui supliment constă în aceea că are un efect hipoglicemic redus şi nu posedă un efect imunostimulator pronunţat în acelaşi timp. The disadvantage of this supplement is that it has a reduced hypoglycemic effect and does not possess a pronounced immunostimulatory effect at the same time.

Mai este cunoscut remediul fitoterapeutic pentru tratamentul diabetului zaharat cu efect imunostimulator, care include: extract uscat din seminţe de amarant (AmaranthusL.), extract uscat din frunze de pelin (Artemisia absinthiumL.), extract uscat de dihidroquercetină (Larix sibiricaL.), extract uscat din coajă de nucă (Juglans regiaL.), extract uscat din flori de cuişoare (DianthusL.), extract uscat de fructe noni (Morinda citrifoliaL.), extract uscat de astaxantină (Astaxanthin), extract uscat din rădăcină de păpădie (Taraxacum officinaleL.), componentele fiind luate în următorul raport, în % mas: There is also a known phytotherapeutic remedy for the treatment of diabetes with an immunostimulating effect, which includes: dry extract of amaranth seeds (AmaranthusL.), dry extract of wormwood leaves (Artemisia absinthiumL.), dry extract of dihydroquercetin (Larix sibiricaL.), dry extract of walnut shell (Juglans regiaL.), dry extract of clove flowers (DianthusL.), dry extract of noni fruits (Morinda citrifoliaL.), dry extract of astaxanthin (Astaxanthin), dry extract of dandelion root (Taraxacum officinaleL.), the components being taken in the following ratio, in % mass:

extract uscat din seminţe de amarant 12 dry extract from amaranth seeds 12

extract uscat din frunze de pelin 13 dry extract of wormwood leaves 13

extract uscat de dihidroquercetină 10 dry extract of dihydroquercetin 10

extract uscat din coajă de nucă 13 dry walnut shell extract 13

extract uscat din flori de cuişoare 13 dry extract of clove flowers 13

extract uscat din fructe noni 18 noni fruit dry extract 18

extract uscat de astaxantină 11 dry astaxanthin extract 11

extract uscat din rădăcină de păpădie 10 [2]. dry extract of dandelion root 10 [2].

Dezavantajul acestui supliment constă în aceea că are un efect hipoglicemic şi imunostimulator redus. The disadvantage of this supplement is that it has a reduced hypoglycemic and immunostimulatory effect.

Problema invenţiei constă în lărgirea gamei de suplimente alimentare, care posedă un efect hipoglicemic şi imunostimulator pronunţat în acelaşi timp. The problem of the invention consists in expanding the range of food supplements, which possess a pronounced hypoglycemic and immunostimulatory effect at the same time.

Invenţia soluţionează problema prin aceea că se propune un supliment alimentar biologic activ cu efect hipoglicemic şi imunostimulator, care conţine: extract uscat din frunze de dafin (Laurus nobilisL.), extract uscat din frunze de topinambur (Heliánthus tuberósusL.), extract uscat din frunze de dud negru (Morus nigraL.), extract uscat din scorţişoară (Cinnamomum verumL.), extract uscat din rizomi de curcumă (Cúrcuma lóngaL.), extract uscat din păstăi de fasole (Phaseoli pericarpiumL.), extract uscat din seminţe de chimen negru (Nige-llasatīvaL.), extract uscat din seminţe de ciulin de lapte (Silybum marianumL.), pulbere de glutation (L-Glutathione), componentele fiind luate în următorul raport, în % mas.: The invention solves the problem by proposing a biologically active food supplement with hypoglycemic and immunostimulating effect, which contains: dry extract of bay leaves (Laurus nobilisL.), dry extract of Jerusalem artichoke leaves (Heliánthus tuberósusL.), dry extract of black mulberry leaves (Morus nigraL.), dry extract of cinnamon (Cinnamomum verumL.), dry extract of turmeric rhizomes (Cúrcuma lóngaL.), dry extract of bean pods (Phaseoli pericarpiumL.), dry extract of black cumin seeds (Nige-llasatīvaL.), dry extract of milk thistle seeds (Silybum marianumL.), glutathione powder (L-Glutathione), the components being taken in the following ratio, in % by mass:

extract uscat din frunze de dafin 2 dried bay leaf extract 2

extract uscat din frunze de topinambur 20 dried Jerusalem artichoke leaf extract 20

extract uscat din frunze de dud 10 dry mulberry leaf extract 10

extract uscat din scorţişoară 10 dry cinnamon extract 10

extract uscat din rizomi de curcumă 10 dried extract of turmeric rhizomes 10

extract uscat din păstăi de fasole 18 dry bean pod extract 18

extract uscat din seminţe de chimen 7 dry extract of cumin seeds 7

extract uscat din seminţe de ciulin de lapte 18 dry extract of milk thistle seeds 18

pulbere de glutation 5. glutathione powder 5.

Rezultatul invenţiei constă în lărgirea gamei de suplimente alimentare fitoterapeutice, biologic active, care posedă activitate hipoglicemică pronunţată şi imunostimulatoare în acelaşi timp, datorită selectării reuşite a componentelor cantitative şi calitative şi care manifestă un sinergism. The result of the invention consists in expanding the range of phytotherapeutic, biologically active food supplements, which possess pronounced hypoglycemic and immunostimulating activity at the same time, due to the successful selection of quantitative and qualitative components and which manifest a synergism.

Suplimentul alimentar are următoarele avantaje: The dietary supplement has the following advantages:

- este simplu în tehnologia de preparare; - it is simple in preparation technology;

- nu necesită a fi prescris prin reţetă, deoarece nu reprezintă un medicament; - does not require a prescription, as it is not a medicine;

- diminuează glicemia în mediu 3,5 ori faţă de datele iniţiale; - reduces blood sugar levels by an average of 3.5 times compared to the initial data;

- suplimentul revendicat, pe lângă efectul hipoglicemiant, posedă în acelaşi timp şi un efect imunostimulator mai pronunţat. - the claimed supplement, in addition to the hypoglycemic effect, also possesses a more pronounced immunostimulatory effect.

Modul de preparare al suplimentului revendicat: Method of preparation of the claimed supplement:

Componentele suplimentului sunt procurate de la întreprinderea Compania EPO (Estratti Piante Officinali) L.t.d, Italia şi reprezinta extracte vegetale uscate din materie vegetala pentru industria farmaceutica, standardizate 1:10, iar pulberea de glutation, se procură de la întreprinderea JOYWIN, situate pe adresa - 66# Wutong Rd., Baisha Industrial Parc, Jiangjin District, Chongqing, China. Extractele uscate din frunze de dafin, topinambur şi dud negru, din scorţişoară, din rizomi de curcumă, din păstăi de fasole, din seminţe de chimen negru, din seminţe de ciulin de lapte şi pulberea de glutation, se amestecă în următorul raport al componentelor, în % mas.: 2, 20, 10, 10, 10, 18, 7, 18 şi 5, se amestecă bine timp de 3 min, până se obţine o masă omogenă. Masa omogenă obţinută reprezintă extracte uscate de culoare galbenă până la verzuie cu miros şi gust amărui, specific de plante utilizate, ulterior ea se încapsulează în capsule gelatinoase tari de mărimea Nr. 1 sau 0 a câte 10 capsule în folie PVC sudată cu folie de alumin (blister). Capsulele operculate sunt de formă cilindrică, cu capete emisferice, cu suprafaţa netedă, lucioasă (vegetale). După care 3, 6, 9 sau 10 blistere împreună cu prospectul pentru utilizator se plasează într-o cutie individuală de carton. The components of the supplement are purchased from the company EPO (Estratti Piante Officinali) L.t.d, Italy and represent dried plant extracts from plant material for the pharmaceutical industry, standardized 1:10, and the glutathione powder is purchased from the company JOYWIN, located at the address - 66# Wutong Rd., Baisha Industrial Parc, Jiangjin District, Chongqing, China. The dried extracts of bay leaves, Jerusalem artichoke and black mulberry, cinnamon, turmeric rhizomes, bean pods, black cumin seeds, milk thistle seeds and glutathione powder are mixed in the following ratio of components, in % mass: 2, 20, 10, 10, 10, 18, 7, 18 and 5, mix well for 3 min, until a homogeneous mass is obtained. The homogeneous mass obtained represents dry extracts of yellow to greenish color with a bitter odor and taste, specific to the plants used, then it is encapsulated in hard gelatin capsules of size No. 1 or 0 of 10 capsules in PVC foil welded with aluminum foil (blister). The capped capsules are cylindrical in shape, with hemispherical ends, with a smooth, glossy surface (vegetable). After which 3, 6, 9 or 10 blisters together with the user leaflet are placed in an individual cardboard box.

Valoarea energetică şi nutritivă a capsulelor: Energy and nutritional value of the capsules:

Pentru capsula de mărimea Nr.1 For capsule size No.1

Valoarea energetică: 0,28 kcal/caps. Energy value: 0.28 kcal/capsule.

Glucide: 0,04 g/caps. Carbohydrates: 0.04 g/capsule.

Proteine: 0,1 g/caps. Protein: 0.1 g/capsule.

Fibre: 0,04 g/caps. Fiber: 0.04 g/capsule.

Pentru capsula de mărimea Nr.0 For capsule size No.0

Valoarea energetică: 0,42 kcal/caps. Energy value: 0.42 kcal/capsule.

Glucide: 0,06 g/caps. Carbohydrates: 0.06 g/capsule.

Proteine: 0,015 g/caps. Protein: 0.015 g/capsule.

Fibre: 0,007 g/caps. Fiber: 0.007 g/capsule.

Capsulele se administreazăper oralcu o cantitate suficientă de lichid (aproximativ 150-200 ml de apă) cu 15 min înainte de masa de 3 ori pe zi. The capsules are administered orally with a sufficient amount of liquid (approximately 150-200 ml of water) 15 minutes before meals 3 times a day.

Dinamica glicemiei la pacienţii trataţi cu suplimentul biologic activ revendicat pe un lot de 200 de pacienţi, dintre care 100 (grupul de studiu) şi 100 (grupul de control). Blood glucose dynamics in patients treated with the claimed biologically active supplement in a group of 200 patients, of which 100 (study group) and 100 (control group).

La pacienţii din grupul de studiu, care au urmat suplimentul alimentar revendicat, glicemia s-a diminuat în mediu de 3,5 ori, faţă de lotul de control care au utilizat suplimentul conform celei mai apropiate soluţii, unde glicemia s-a diminuat de 2,5 ori. In patients in the study group who took the claimed dietary supplement, blood sugar levels decreased on average by 3.5 times, compared to the control group who used the supplement according to the closest solution, where blood sugar levels decreased by 2.5 times.

Rezultatele obţinute demonstrează convingător activitatea hipoglicemică sporită a suplimentului biologic activ elaborat. The results obtained convincingly demonstrate the enhanced hypoglycemic activity of the developed biologically active supplement.

Exemplu de realizare a invenţiei. Example of embodiment of the invention.

Bolnavul P., 52 ani, monitorizat la instituţia medicală IMSP, Spitalul Clinic Republican cu diagnosticul: diabet zaharat de tip II, cu o glucozemie de 17,0 mmol/l. Cu consimţământul informat al pacientului şi în baza Avizului Comitetului de Etică, bolnavului i s-a administrat suplimentul alimentar revendicat. Au fost studiaţi indicii glucozemiei la începutul administrării SABA (supliment alimentar biologic activ) şi la sfârşitul tratamentului, dar şi indicii imunităţii celulare (vezi tabelul). Patient P., 52 years old, monitored at the IMSP medical institution, Republican Clinical Hospital with the diagnosis: type II diabetes mellitus, with a blood glucose level of 17.0 mmol/l. With the informed consent of the patient and based on the Opinion of the Ethics Committee, the patient was administered the claimed dietary supplement. Glucose indices were studied at the beginning of SABA administration (biologically active dietary supplement) and at the end of treatment, as well as cellular immunity indices (see table).

Tabel Table

Analiza sângelui bolnavului P. până şi după administrarea SABA revendicat Blood analysis of patient P. before and after administration of the claimed SABA

Rezultate Analiza sângelui bolnavului P. Analiza sângelui bolnavului C. (din cea mai apropiată soluţie) Indicii glucozemiei şi imunităţii Până la administrare la a 21-a zi de administrare la a 21-a zi de administrare Glucoza bazală, mmol/l 17 4,8 6,7 Hemoglobină glicată, mmol/l 16,4 5,4 7,1 Profilul glicemic, mmol/l 16,36 5,8 7,6 Leucocite x 109, cel/l 5,34 6,8 6,72 Limfocite x 109, cel/l 1,96 2,51 2,16 CD 4+x 109 ,cel/l 0,94 1,20 0,92 CD 4+, % 42,1 56,5 49,3 CD 8+x 109cel/l 0,81 0,48 0,56 CD 8+, % 44,7 36,4 38,1 CD 19+x 109cel/l 0,48 0,40 0,46 CD 19+, % 16,9 18,2 17,8 CD 16+, % 11,9 13,7 13,2 IgG g/l 21,3 17,4 18,1 IgA g/l 2,33 1,27 1,94 IgM g/l 1,25 1,02 1,13Results Patient's blood analysis P. Patient's blood analysis C. (from the closest solution) Glucose and immunity indices Until administration on the 21st day of administration on the 21st day of administration Basal glucose, mmol/l 17 4.8 6.7 Glycated hemoglobin, mmol/l 16.4 5.4 7.1 Glycemic profile, mmol/l 16.36 5.8 7.6 Leukocytes x 109, cells/l 5.34 6.8 6.72 Lymphocytes x 109, cells/l 1.96 2.51 2.16 CD 4+x 109 , cells/l 0.94 1.20 0.92 CD 4+, % 42.1 56.5 49.3 CD 8+x 109cells/l 0.81 0.48 0.56 CD 8+, % 44.7 36.4 38.1 CD 19+x 109cel/l 0.48 0.40 0.46 CD 19+, % 16.9 18.2 17.8 CD 16+, % 11.9 13.7 13.2 IgG g/l 21.3 17.4 18.1 IgA g/l 2.33 1.27 1.94 IgM g/l 1.25 1.02 1.13

SABA revendicat are proprietăţi hipoglicemice, care au fost demonstrate de scăderea glicemiei de la 17,0 mmol/l până la 4,8 mmol/l. Acţiunea hipoglicemică este argumentată şi prin scăderea hemoglobinei glicate de la 16,4 mmol/l până la 5,4 mmol/l şi a profilului glicemic de la 16,36 mmol/l la 5,8 mmol/l. The claimed SABA has hypoglycemic properties, which were demonstrated by the decrease in blood glucose from 17.0 mmol/l to 4.8 mmol/l. The hypoglycemic action is also supported by the decrease in glycated hemoglobin from 16.4 mmol/l to 5.4 mmol/l and the glycemic profile from 16.36 mmol/l to 5.8 mmol/l.

Suplimentul are şi o acţiune imunostimulatoare, deoarece după administrare se atestă o creştere a leucocitelor, limfocitelor, a T-helperilor (CD 4+) de la 42,1 la 56,5, a kilerilor naturali (CD 16+) de la 11,9 la 13,7 şi a B-limfocitelor (CD 19+). Are loc şi normalizarea imunoglobulinelor IgA, IgG, IgM ce denotă scăderea imunoinflamaţiei cronice sistemice la bolnavii cu hiperglucozemie. The supplement also has an immunostimulating effect, because after administration there is an increase in leukocytes, lymphocytes, T-helpers (CD 4+) from 42.1 to 56.5, natural killers (CD 16+) from 11.9 to 13.7 and B-lymphocytes (CD 19+). There is also a normalization of immunoglobulins IgA, IgG, IgM, which denotes a decrease in chronic systemic immunoinflammation in patients with hyperglycemia.

1. MD 1654 Y 2022.12.31 1. MD 1654 Y 2022.12.31

2. MD 1613 Y 2022.04.30 2. MD 1613 Y 2022.04.30

Claims (1)

Supliment alimentar biologic activ cu efect hipoglicemic şi imunostimulator, care conţine: extract uscat din frunze de dafin (Laurus nobilisL.), extract uscat din frunze de topinambur (Heliánthus tuberósusL.), extract uscat din frunze de dud negru (Morus nigraL.), extract uscat din scorţişoară (Cinnamomum verumL.), extract uscat din rizomi de curcumă (Cúrcuma lóngaL.), extract uscat din păstăi de fasole (Phaseoli pericarpiumL.), extract uscat din seminţe de chimen negru (Nige-llasatīvaL.), extract uscat din seminţe de ciulin de lapte (Silybum marianumL.), pulbere de glutation (L-Glutathione), componentele fiind luate în următorul raport, în % mas.:Biologically active food supplement with hypoglycemic and immunostimulating effect, containing: dry extract of bay leaves (Laurus nobilisL.), dry extract of Jerusalem artichoke leaves (Heliánthus tuberósusL.), dry extract of black mulberry leaves (Morus nigraL.), dry extract of cinnamon (Cinnamomum verumL.), dry extract of turmeric rhizomes (Cúrcuma lóngaL.), dry extract of bean pods (Phaseoli pericarpiumL.), dry extract of black cumin seeds (Nige-llasatīvaL.), dry extract of milk thistle seeds (Silybum marianumL.), glutathione powder (L-Glutathione), the components being taken in the following ratio, in % by mass: extract uscat din frunze de dafin 2dried bay leaf extract 2 extract uscat din frunze de topinambur 20dried Jerusalem artichoke leaf extract 20 extract uscat din frunze de dud 10dry mulberry leaf extract 10 extract uscat din scorţişoară 10dry cinnamon extract 10 extract uscat din rizomi de curcumă 10dried extract of turmeric rhizomes 10 extract uscat din păstăi de fasole 18dry bean pod extract 18 extract uscat din seminţe de chimen 7dry extract of cumin seeds 7 extract uscat din seminţe de ciulin de lapte 18dry extract of milk thistle seeds 18 pulbere de glutation 5.glutathione powder 5.
MDS20230088A 2023-11-03 2023-11-03 Biologically active food additive with hypoglycemic and immunostimulatory effect MD1769Z (en)

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