WO2005076750A2 - Formulation a base d'herbes medicinales synergique destinee a la guerison des diabetes - Google Patents
Formulation a base d'herbes medicinales synergique destinee a la guerison des diabetes Download PDFInfo
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- WO2005076750A2 WO2005076750A2 PCT/IN2005/000049 IN2005000049W WO2005076750A2 WO 2005076750 A2 WO2005076750 A2 WO 2005076750A2 IN 2005000049 W IN2005000049 W IN 2005000049W WO 2005076750 A2 WO2005076750 A2 WO 2005076750A2
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/47—Euphorbiaceae (Spurge family), e.g. Ricinus (castorbean)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/27—Asclepiadaceae (Milkweed family), e.g. hoya
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/32—Burseraceae (Frankincense family)
- A61K36/328—Commiphora, e.g. mecca myrrh or balm of Gilead
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/38—Clusiaceae, Hypericaceae or Guttiferae (Hypericum or Mangosteen family), e.g. common St. Johnswort
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/42—Cucurbitaceae (Cucumber family)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/58—Meliaceae (Chinaberry or Mahogany family), e.g. Azadirachta (neem)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/906—Zingiberaceae (Ginger family)
- A61K36/9066—Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
Definitions
- the invention relates to a novel synergistic herbal formulation and a process for preparation of synergistic herbal formulation for treatment and cure of diabetes type I and type II especially diabetes mellitus Type-ll, using specific Indian herbs.
- the formulation is a hypoglycemic agent that maintains blood sugar level at normal even after withdrawal of the herbal formulation.
- Diabetes mellitus is a common, grave disease characterized by hyperglycemia.
- IDDM insulin-dependent diabetes mellitus
- NIDDM non-insulin-dependent diabetes mellitus
- IDDM results from insulin deficiency caused by cell-mediated autoimmune destruction of pancreatic beta cells, and generally develops in the young age. IDDM affects the beta cells of pancreas and as a result insufficient insulin is secreted. IDDM accounts for approximately 10-15% of the diabetic population worldwide. The Type II diabetes occurs in the early age group in Indian population as compared to population in western world. NIDDM results from a variable combination of insulin resistance and insulin deficiency, and generally develops in adults. Currently NIDDM accounts for over 85% of the diabetic population worldwide.
- NIDDM is a complex disease that is currently opined influenced by more than a single gene or environmental factor.
- environmental factors includes obesity, lack of physical activity and diet also play a strong role in the development of the type-ll diabetes mellitus.
- the hypoglycemic properties of Momordica charantia have been widely reported.
- the ether extract residue of the alcoholic concentrate from the leaves of Momordica charantia is reported to reveal hypoglycemic activity.
- Momordica Charantia increases the healthy regeneration of beta cells in the pancreas hence increasing the secretion of insulin from the pancreas.
- the various herbal anti-diabetic formulations that are available in market place comprise of one or more of the herbs mentioned above. Almost all of these formulations presented above helps in reducing the blood sugar level, but either with some side effects or to the extent of producing hypoglycemia. Research on the complexities of diabetes mellitus has led to the realization that no single molecule/active agent would be enough to combat the multiple disorder of the disease.
- the limitations of the currently available anti-diabetic drugs or compositions in terms of efficacy and safety coupled with the emergence of the disease into a global epidemic has instigated the need for a formulation that would effectively address the diabetic condition in a more efficient way with less side effects and could holistically address the disease.
- the reason behind this is that from time immemorial the human system is accustomed to absorb and assimilate only natural organic substance.
- the current practice is to use any non- natural solvent during the extraction of any alkaloids, glycosides, active ingredients or any chemicals from herbs for any herbal formulation. This non-natural external solvent will leave the trace of toxicity in the substances extracted which may either result in the losing of the active ingredient in original form or may lead to some other side effect.
- the technical problem as identified above consists in finding a effective hypoglycemic agent without causing hypoglycemia for diabetes mellitus type I and type II, preferably Type II, which will have the following characteristics due to its natural inherent potency: 1 ) Non use of any external solvent during extraction process 2) Use of natural organic solvent produced in the course of process itself 3) No harmful side effects even in case of large daily doses as it is a pure natural extract 3) Capacity to tone the islets of Langerhans. 4) Stimulating the secretion of insulin by regenerating ⁇ -beta cells of pancreas or the sensitivity of cells to insulin 5) effectiveness is non-dependent on a strict or regulated diet.
- the main objective of is to provide a novel synergistic herbal formulation to provide hypoglycemic effect without causing hypoglycemia.
- the second objective is to provide a novel synergistic herbal formulation for diabetes cure without causing hyperglycemia even after withdrawal of the herbal formulation.
- Third objective of the invention is to provide a synergistic herbal formulation for diabetics cure without causing any side effects.
- Fourth objective of the invention is to manufacture an herbal synergistic formulation having functional properties and Therapeutic compounds using indigenous, Eco- friendly manufacturing process.
- Fifth objective of the present invention is to provide a process such that degradation of active sensitive compounds is prevented and the phytochemicals and therapeutic value of the herbal extract is retained.
- Sixth objective of the invention is to provide a process of preparing herbal synergistic formulation from plurality of diverse herbs without using any external solvent (organic or inorganic).
- the seventh and last objective of the present invention is to provide a process so as to reduce the extractability of hydrophobic impurities (micro-organisms or toxic wastes present in the water) and flammability issue (due to use of alcohol etc.),
- the present invention involves a novel synergistic herbal formulation and a process for preparation of synergistic formulation using Indian medicinal herbs.
- the formulation is a combination of natural active principles with hypoglycemic active agents of Indian medicinal plants such as Azadirachta Indica, Curcuma Longa, Trigonelle Foenu- Graecum, Momordica Charantia, Emblica officinalis, Commiphore Mukul, Gymnema Sylvestres, Ocimum Sanctum, Garcinia Camboga.
- Some plant extracts act by increasing the release of insulin and require a minimum of ⁇ cells to exert their action; while other plant extracts used modifies glucose metabolism and corrects the complications of diabetes and some other work on the fat metabolism and reduces lipid level in blood.
- the synergistic formulation results in effective hypoglycemic effect without causing hypoglycemia, even after withdrawal of the formulation.
- the synergistic formulation revitalizes pancreatic ⁇ cells (Histopathological observation revealed that herbal formulation regenerated ⁇ cells of the pancreas in alloxan induced wistar rats), prevents insulin resistance, increases the discharge of insulin and prevents the damage caused to lipids, kidney and vascular tissues.
- Fig 1 Shows the detailed diagram of the wistar rats -
- Fig 2 Shows the detailed diagram of the wistar rats - Histopathology of Pancreas) ( Alloxan + Drug 500 mg/kg b.w)
- Fig 3 Shows the detailed diagram of the wistar rats -
- Fig 4 Shows the detailed diagram of the wistar rats - Histopathology of Pancreas) ( Alloxan + drug 1000 mg/kg b.w)
- Fig 5 Shows the detailed diagram of the wistar rats - Histopathology of Pancreas) ( Drug 1500 mg/kg b.w)
- Fig 6 Shows, the detailed diagram of the wistar rats - Histopathology of Pancreas) (Control)
- the present invention deals with a synergistic formulation that can be administered to a person suffering from type I diabetes, type II diabetes preferably type II diabetes, which results in the lowering of the blood glucose level of the patient without causing any side effects.
- the formulation comprises of Azadirachta Indica, Momordica Charantia, Emblica Officinalis, Gymnema Sylvestres, Trigonella Foenum- gracum, Curcuma Longa, Garcinia Camboga, Commiphor Mukul, Ocimum Sanctum extracted from herbs with active ingredients and mixed in specific ratio without using any solvents such as water, alcohol, etc.
- the said herbs are present to each other in the extract in the relative ratio of: about 5% by weight to about 15% by weight of Azadirachta Indica, about 15% by weight to about 25% by weight of Momordica Charantia , about 15% by weight to about 25% by weight of Emblica Officinalis, about 15% by weight to about 25% by weight of Gymnem Sylvestres, about 5% by weight to about 15% by weight Trigonella Foenum-gracum, about 5% by weight to about 15% by weight of Curcuma Longa, about 3% by weight to about 10% by weight of Garcinia Camboga, and about 1% by weight to about 10% by weight of Commiphor Mukul, and about 2% by weight to about 10% by weight of Ocimum Sanctum.
- the ratio is maintained is Azadirachta Indica 6% - 10%, Momordica Charantia 18% - 22%, Emblica Officinalis 18% - 22%, Gymnema Sylvestres 18% - 22%, Curcuma Longa 8% -12 %, Trigonella Foenum-gracum 8% - 12%, Commiphor Mukul 1 % -5%, Ocimum Sanctum 3% - 6%.
- the active ingredients extracted from the herbs Azadirachta Indica, Momordica Charantia, Emblica Officinalis, Gymnema Sylvestres, Trigonella Foenum-Gracum, Curcuma Longa, Garcinia Camboga, Commiphor Mukul, Ocimum Sanctum, without using any solvents is in the range of 0.1% -1.2%.
- the seeds of Trigonella Foenum-Graecum, Curcuma Longa, Garcina Cambogia and resins of Commiphor Mukul, Ocimum Sanctum are air dried at room temperature and fine powdered using a mixer or machine.
- the fine powdered mixture thus obtained is soaked in the liquid obtained, which acts as a natural organic solvent and normal dried without any heating process in the room temperature. This process can be repeated continuously for 20 - 22 times to obtain a fine spray dried powder form.
- the extract is used in spray dried powder form but not restricted to liquid form. But it is understood that mere extraction and combination of all of these herbs without set combination of the herbs in proportion along with active ingredients in given ratio may not produce the desired effect of reducing blood glucose levels without causing hypoglycemia.
- the major advantage of this invention the synergistic formulation is that it provides hypoglycemic effect i.e it maintains the blood sugar level at normal without causing hypoglycemia even after withdrawal of the synergistic formulation.
- Another advantage of the invention is that during the extraction of herbs heating process and solvents are not used as a result pure extract with rich active ingredients is obtained i.e. degradation of active sensitive compounds is prevented and the phytochemicals and therapeutic value of the herbal extract is retained.
- the extraction of the formulation is performed using indigenous, eco- friendly manufacturing process and also reduces the extractability of hydrophobic impurities.
- the invention provides an alternative approach for curing of diabetes Type and Type II preferably Type II also can be used as dietary supplement.
- a method of treating diabetes consists of administration of the novel synergistic herbal formulation comprising extracts from herbs Azadirachta Indica, Momordica Charantia, Emblica Officinalis, Gymnema Sylvestres, Trigonella Foenum-Gracum, Curcuma Longa, Garcinia Camboga, Commiphor Mukul and Ocimum Sanctum.
- the extract from herbs with active ingredients are mixed in proportion without using any solvents to provide hypoglycemic effect without causing hypoglycemia.
- the method increases insulin secretion from pancreatic ⁇ cells.
- the weight gain was not significant in animals that received the synergistic formulation and the weight gain in animals was due to normal biological process and the formulation did not lead to obesity.
- the rats were randomly distributed into four groups. Groups 1 and 2 were given alloxan at 122 mg/kg. b.w. by intraperitoneal injection ( day 0). On day 3, blood was collected from individual rat of these groups for glucose estimation. The animals showed elevation of glucose level thus confirming induction of diabetes. Then, Group 2 was treated with 1000 mg/Kg.b.w. with the synergistic formulation of this invention suspended in distilled water. Group 3 was given 1000 mg/kg b.w of the synergistic formulation of this invention. Group 4 was administered orally with distilled water alone. The synergistic formulation was given to group 2 and 3 by oral incubation for 18 days without interruption.
- Alloxan treated groups (Group 1 and 2) showed dullness during the first week of the treatment. one of the animals of the other groups showed any clinical sign. A transient decrease in body weight gain was noted in alloxan alone treated group. On day 21 , body weight of both males and females off this group was less that that of their respective day 0 body weight. Alloxan + the synergistic formulation treated group also showed a transient decrease in body weight gain upto day 7, thereafter the body weight gain of these animals markedly improved. On 21 , body weight of both males and females of this group was more than that of the respective day 0 body weight. Rats treated with synergistic formulation alone and those of control group showed similar increasing trend in the body weight gain. Compared to that of control, no major change was seen in feed consumption in any group. Haematological parameters such as RBC WBC, hemoglobin, haematocrit and differential counts estimated on day 22 in groups of animals were statistically similar.
- the test result thus proves that histologic changes were seen in Alloxan induced diabetic rats, especially in pancreas.
- the pancreatic changes revealed depletion of islets of Langerhans with accompanying reactions as periductular cuffing and necrotic foci. All these were conspicuously absent in controls, synergistic formulation treated and others.
- the decrease in BUN and alkaline phosphatase observed in alloxan- induced diabetic animals following the treatment with synergistic formulation of this invention the treatment indicates curative aspect of the drug in nephro and hepato-toxicity. Histopathological observation revealed that the formulation f this invention regenerated ⁇ cells of the pancreas.
- mice 4 (control) was administered orally with distilled water alone.
- Groups 2 and 3 consisted of 10 males and 10 females each and groups 1 and 4 consisted of 20 males and 20 females each.
- Animals were given Synergistic herbal formulation in distilled water by oral intubation, daily, for 90 consecutive days. Rats belonging to control were administered orally with distilled water alone. Daily observations were made on clinical signs of each rat. Body weight of individual animal and group wise feed consumption of the animals were also recorded weekly.
- haematology W.B.C, R.B.C, haemoglobin, PCV (haematocrit), differential count of W.B.C., thrombocyte count and coagulation time
- biochemical investigations calcium, phosphorous, potassium, chloride, sodium, glucose, alanine, aminotransferase (ALT), aspar
- NOEL of Synergistic herbal formulation -Anti- Diabetic Herbal Drug/Diet Supplement for Wistar rats can be arrived at 1500 mg/kg b.w. under the experimental conditions described in the present 90 days subacute oral investigation.
- the test results reveal that the synergistic herbal formulation given to Wistar rats even at high dose employed (1000 mg/kg b.w. 1500 mg/kg b.w.) as in the present investigation is proved to be safe by oral route.
- the above test result can be summarized in the following manner: 1. Decrease in BUN and alkaline phosphates observed in alloxan induced diabetic animals indicating curative aspect of the drug in nephro and hepato-toxicity. Histopathological evidence suggested the regeneration of beta cells of pancreas. 2. Possess glucose lowering ability in alloxan induced diabetic rats 3. LD 50 for Wistar rats was considered as greater than 5000 mg/kg. bw 4. Effective in reversing the blood sugar to normalcy in alloxan induced diabetic Wistar rats 5. Safe by oral route to Wistar rat even at the high dose employed in the investigation
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Abstract
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IN122CH2004 | 2004-02-18 | ||
IN122/CHE/2004 | 2004-02-18 |
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WO2005076750A2 true WO2005076750A2 (fr) | 2005-08-25 |
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Cited By (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1974737A1 (fr) * | 2007-03-23 | 2008-10-01 | Phyto Health Pharma B.V. | Composition pour le traitement du diabète sucré et du syndrome métabolique |
EP1974736A1 (fr) * | 2007-03-23 | 2008-10-01 | Phyto Health Pharma B.V. | Composition pour le traitement du diabète sucré |
US8071844B1 (en) | 2007-09-13 | 2011-12-06 | Nutritional Health Institute Laboratories, Llc | Cultivated momordica species and extract thereof |
WO2013065015A2 (fr) | 2011-11-03 | 2013-05-10 | Promed Research Centre | Composition synergique à base d'herbe pour la prévention et le traitement de la rétinopathie diabétique et de la cataracte |
US20150352172A1 (en) * | 2013-01-03 | 2015-12-10 | Laila Nutraceuticals | Synergistic dietary supplement compositions for enhancing physical performance and energy levels |
CN108936662A (zh) * | 2018-08-07 | 2018-12-07 | 广州汝丽多食品科技有限公司 | 一种辅助降血糖的苦瓜保健食品的制备方法 |
US10542989B2 (en) | 2015-07-06 | 2020-01-28 | Laila Nutraceuticals | Synergistic dietary supplement compositions for enhancing physical performance and energy levels |
CN114190459A (zh) * | 2021-12-21 | 2022-03-18 | 昆明理工大学 | 一种辅助性降血糖茶包及其制备方法 |
Families Citing this family (1)
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RU2625737C2 (ru) * | 2015-07-13 | 2017-07-18 | Федеральное государственное бюджетное образовательное учреждение высшего образования "Ставропольский государственный медицинский университет" Министерства здравоохранения Российской Федерации (ФГБОУ ВО СтГМУ Минздрава России) | Шипучий фитоминеральный комплекс с антидиабетическим действием |
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DE4221818A1 (de) * | 1992-06-03 | 1994-06-30 | Khalil Ahmad | Haarwuchsmittel und Haarwasser gegen Haarausfall |
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Non-Patent Citations (1)
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DATABASE EPAB [Online] 30 June 1994 KHALIL A.: 'Lotion or shampoo promoting hair growth and reducing hair loss' Retrieved from STN & DE 004 221 818 A1 * |
Cited By (13)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1974737A1 (fr) * | 2007-03-23 | 2008-10-01 | Phyto Health Pharma B.V. | Composition pour le traitement du diabète sucré et du syndrome métabolique |
EP1974736A1 (fr) * | 2007-03-23 | 2008-10-01 | Phyto Health Pharma B.V. | Composition pour le traitement du diabète sucré |
WO2008118010A1 (fr) * | 2007-03-23 | 2008-10-02 | Phyto Health Pharma B V | Composition servant au traitement du diabète sucré et du syndrome métabolique |
WO2008118011A1 (fr) * | 2007-03-23 | 2008-10-02 | Phyto Health Pharma B.V. | Composition servant au traitement du diabète sucré |
US20100173022A1 (en) * | 2007-03-23 | 2010-07-08 | Devindra Ramautarsing | Composition for the treatment of diabetes mellitus and metabolic syndrome |
US8071844B1 (en) | 2007-09-13 | 2011-12-06 | Nutritional Health Institute Laboratories, Llc | Cultivated momordica species and extract thereof |
WO2013065015A2 (fr) | 2011-11-03 | 2013-05-10 | Promed Research Centre | Composition synergique à base d'herbe pour la prévention et le traitement de la rétinopathie diabétique et de la cataracte |
US20150352172A1 (en) * | 2013-01-03 | 2015-12-10 | Laila Nutraceuticals | Synergistic dietary supplement compositions for enhancing physical performance and energy levels |
US9907825B2 (en) * | 2013-01-03 | 2018-03-06 | Laila Nutraceuticals | Synergistic dietary supplement compositions for enhancing physical performance and energy levels |
US10542989B2 (en) | 2015-07-06 | 2020-01-28 | Laila Nutraceuticals | Synergistic dietary supplement compositions for enhancing physical performance and energy levels |
CN108936662A (zh) * | 2018-08-07 | 2018-12-07 | 广州汝丽多食品科技有限公司 | 一种辅助降血糖的苦瓜保健食品的制备方法 |
CN108936662B (zh) * | 2018-08-07 | 2022-06-14 | 广州汝丽多食品科技有限公司 | 一种辅助降血糖的苦瓜保健食品的制备方法 |
CN114190459A (zh) * | 2021-12-21 | 2022-03-18 | 昆明理工大学 | 一种辅助性降血糖茶包及其制备方法 |
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