Preparation method and application of a broad-spectrum biological drug for efficient treatment of type 2 diabetes

Abstract

The present application provides a kind of broad-spectrum biological medicine of high efficiency treatment 2 type diabetes, is made of the following weight parts of raw materials: 1-8 parts of various proteins of placenta, 1-8 parts of amino acid of black ant, 1-6 parts of earthworm nucleotide, 1-6 parts of leech polypeptide, 1-6 parts of earthworm fatty acid, 1-6 parts of ganoderma triterpenes, 1-6 parts of radix rehmanniae oligosaccharide, 1-6 parts of polygonatum polysaccharide, 1-6 parts of radix astragali triterpene saponin, 1-6 parts of emodin, 1-6 parts of medlar polysaccharide, 1-6 parts of ophiopogon saponin, 1-6 parts of pomegranate peel flavone, 1-6 parts of salvia miltiorrhiza diterpene quinone, 1-4 parts of sea golden sand flavone, 1-4 parts of saussurea saponin;The present application is compatible with animal source active ingredient and plant source active ingredient and trace element and vitamin group by system, by activating islet beta cell function, promoting proinsulin to insulin conversion, regulating zinc metabolism, inhibiting insulin resistance four links synergistically play the role of reducing sugar, different from the existing single target hypoglycemic drug.

Description

Technical Field

[0001] This invention relates to the field of biomedicine, and in particular to a method for preparing and applying a broad-spectrum biological drug for the efficient treatment of type 2 diabetes. Background Technology

[0002] Diabetes mellitus is a common endocrine and metabolic disease, and the third leading chronic non-communicable disease posing a serious threat to human health after cancer and cardiovascular disease. It is characterized by high morbidity, high disability rate, and high medical costs. Type 2 diabetes accounts for more than 90% of all diabetes cases. Its pathological features include insulin resistance combined with progressive decline in pancreatic β-cell function. Clinically, it manifests as persistently elevated fasting and postprandial blood glucose levels and can lead to various complications such as diabetic nephropathy, diabetic retinopathy, diabetic neuropathy, diabetic foot, and macrovascular complications.

[0003] Currently, the main Western medical treatments for type 2 diabetes include oral hypoglycemic agents (biguanides, sulfonylureas, alpha-glucosidase inhibitors, thiazolidinediones, DPP-4 inhibitors, SGLT-2 inhibitors) and injectable insulin. While these medications can control blood sugar in the short term, they generally have the following limitations:

[0004] First, most drugs only treat the symptoms by promoting insulin secretion, increasing insulin sensitivity, or reducing glucose absorption, and fail to fundamentally improve pancreatic β-cell function. As the disease progresses, the efficacy decreases, and patients eventually need to rely on exogenous insulin for maintenance. Second, long-term use of this medication may be accompanied by adverse reactions such as gastrointestinal reactions, hypoglycemia, weight gain, and liver and kidney damage. Third, diabetic patients generally have lower levels of trace elements such as zinc, copper, and manganese, as well as B vitamins, than normal people, and existing blood sugar control programs rarely provide systematic interventions targeting trace element deficiencies and pancreatic β-cell metabolism.

[0005] Traditional Chinese medicine classifies diabetes under the category of "Xiao Ke" (wasting and thirsting syndrome). Traditionally, it is often treated with a combination of herbs such as Astragalus membranaceus, Rehmannia glutinosa, Lycium barbarum, and Polygonatum sibiricum. However, existing Chinese medicine hypoglycemic agents generally have problems such as single components, inconsistent content of effective ingredients, slow onset of action, and limited effect on the repair of pancreatic β-cell function. Therefore, a method for preparing and applying a highly effective broad-spectrum biological drug for the treatment of type 2 diabetes is proposed. Summary of the Invention

[0006] In view of this, embodiments of the present invention provide a method for preparing and applying a highly effective broad-spectrum biological drug for treating type 2 diabetes, in order to solve or alleviate the technical problems existing in the prior art, and at least provide a beneficial option.

[0007] The technical solution of this invention is implemented as follows: A highly effective broad-spectrum biological drug for treating type 2 diabetes is made from the following raw materials in parts by weight: 1-8 parts of placenta protein, 1-8 parts of black ant amino acids, 1-6 parts of earthworm nucleotides, 1-6 parts of leech polypeptide, 1-6 parts of ground beetle fatty acid, 1-6 parts of Ganoderma lucidum triterpenes, 1-6 parts of Rehmannia glutinosa oligosaccharides, 1-6 parts of Polygonatum sibiricum polysaccharides, 1-6 parts of Astragalus membranaceus triterpenoid saponins, 1-6 parts of processed emodin, 1-6 parts of Lycium barbarum polysaccharides, 1-6 parts of Ophiopogon japonicus steroidal saponins, 1-6 parts of pomegranate peel flavonoids, and 1-6 parts of Salvia miltiorrhiza diterpenes. Quinones 1-6 parts, Lygodium japonicum flavonoids 1-4 parts, Achyranthes bidentata saponins 1-4 parts, Citrus reticulata flavonoids 1-4 parts, Coix lacryma-jobi fatty acids 1-4 parts, Scutellaria barbata polysaccharides 1-4 parts, Lophatherum gracile flavonoids 1-4 parts, Amomum villosum volatile oil 1-4 parts, Artemisia capillaris coumarin 1-4 parts, Poria cocos polysaccharides 1-4 parts, Glycyrrhiza uralensis flavonoids 1-4 parts, Dioscorea opposita polysaccharides 1-4 parts, Lilium brownii polysaccharides 1-4 parts, roasted malt amylase 1-4 parts, Safflower flavonoids 1-4 parts, Peppermint volatile oil 1-2 parts, Folic acid 0.4-0.8 parts, Dioscorea opposita 2-8 parts, Vitamins (B1, B2, B6 and B1) 12 The total amount is 0.05-0.08 parts, copper sulfate 2-10 parts, zinc sulfate 10-16 parts, manganese sulfate 5-10 parts, and water 100 parts.

[0008] In some embodiments, the product is made from the following raw materials in parts by weight: 4 parts of placenta protein, 4 parts of black ant amino acids, 3 parts of earthworm nucleotides, 3 parts of leech polypeptides, 3 parts of ground beetle fatty acids, 3 parts of Ganoderma lucidum triterpenes, 3 parts of Rehmannia glutinosa oligosaccharides, 3 parts of Polygonatum sibiricum polysaccharides, 3 parts of Astragalus membranaceus triterpenoid saponins, 3 parts of processed emodin, 3 parts of Lycium barbarum polysaccharides, 3 parts of Ophiopogon japonicus steroidal saponins, 3 parts of pomegranate peel flavonoids, 3 parts of Tanshinone diterpenoid quinones, 2 parts of Lygodium japonicum flavonoids, 2 parts of Achyranthes bidentata saponins, and tangerine peel. Flavonoids 2 parts, Coix seed fatty acids 2 parts, Scutellaria barbata polysaccharides 2 parts, Lophatherum gracile flavonoids 2 parts, Amomum villosum volatile oil 2 parts, Artemisia capillaris coumarin 2 parts, Poria cocos polysaccharides 2 parts, Glycyrrhiza uralensis flavonoids 2 parts, Dioscorea opposita polysaccharides 2 parts, Lilium brownii polysaccharides 2 parts, roasted malt amylase 2 parts, Safflower flavonoids 2 parts, Peppermint volatile oil 1.5 parts, Folic acid 0.6 parts, Dioscorea opposita 5 parts, Vitamin B1 0.016 parts, Vitamin B2 0.016 parts, Vitamin B6 0.016 parts, Vitamin B... 12 0.017 parts, copper sulfate 6 parts, zinc sulfate 13 parts, manganese sulfate 7.5 parts and water 100 parts.

[0009] The preparation method of the above-mentioned highly effective broad-spectrum biological drug for treating type 2 diabetes includes the following steps: S1. Placenta protein, black ant amino acids, earthworm nucleotides, leech polypeptides, ground beetle fatty acids, Ganoderma triterpenes, Rehmannia glutinosa oligosaccharides, Polygonatum polysaccharides, Astragalus triterpenoid saponins, processed emodin, Lycium barbarum polysaccharides, Ophiopogon japonicus steroidal saponins, pomegranate peel flavonoids, Tanshinone diterpenoid quinones, Lygodium japonicum flavonoids, Achyranthes bidentata saponins, Citrus reticulata flavonoids, Coix lacryma-jobi fatty acids, Scutellaria barbata polysaccharides, Lophatherum gracile flavonoids, Amomum villosum volatile oil, Artemisia capillaris coumarin, Poria cocos polysaccharides, Glycyrrhiza uralensis flavonoids, Dioscorea opposita polysaccharides, Lilium brownii polysaccharides, roasted malt amylase, and Carthamus tinctorius flavonoids are dried at low temperature of 40-60℃ until the moisture content is less than 8%, and then passed through an 80-mesh sieve to obtain fine powder of each raw material; S2. First, heat the water to 50-60℃, then add the fine powders of each raw material obtained in S1 in sequence, and stir at 200-300 rpm for 30-60 minutes to form a uniform suspension. S3. Heat the suspension obtained in S2 to 70-80℃, keep it warm for 1.5-3 hours, cool it to below 40℃, filter it through a 200-mesh filter cloth, and collect the filtrate. S4. The filtrate obtained in S3 is concentrated under reduced pressure at a vacuum of -0.06 to -0.08 MPa and a temperature of 55 to 65°C to a concentrate with a relative density of 1.05 to 1.15 (measured at 50°C). S5. Add folic acid, digestive enzymes, vitamin B1, vitamin B2, vitamin B6, and vitamin B6 to the concentrated solution obtained in S4. 12 Copper sulfate, zinc sulfate, and manganese sulfate are stirred and dissolved for 30 minutes. S6. Sterilize the liquid obtained in S5 with flowing steam at 100°C for 30 minutes. After cooling, fill, seal and package in a clean environment to obtain an oral liquid preparation.

[0010] In some embodiments, the heating temperature of the water in S2 is 55°C, the heat preservation extraction temperature in S3 is 75°C and the time is 2 hours, and the relative density of the concentrate in S4 is 1.10.

[0011] In some embodiments, the dosage form of the drug is an oral liquid, granules, capsules, or tablets.

[0012] In some embodiments, the drug is taken orally, twice daily, 50-100 ml each time, for 8-10 months as one course of treatment.

[0013] The above-mentioned highly effective broad-spectrum biological drugs for treating type 2 diabetes are used in the preparation of drugs for treating type 2 diabetes.

[0014] In some embodiments, a highly effective broad-spectrum biological drug for treating type 2 diabetes, its preparation method, and its application are described. The present invention uses multiple proteins from placenta and amino acids from black ants as principal drugs, and earthworm nucleotides, leech polypeptides, ground beetle fatty acids, Ganoderma lucidum triterpenes, Rehmannia glutinosa oligosaccharides, Polygonatum sibiricum polysaccharides, Astragalus triterpenoid saponins, processed emodin, Lycium barbarum polysaccharides, Ophiopogon japonicus steroidal saponins, pomegranate peel flavonoids, and Tanshinone diterpenoid quinones as adjuvant drugs, with Lygodium japonicum flavonoids... The formula uses achyranthes bidentata saponins, tangerine peel flavonoids, coix seed fatty acids, Scutellaria barbata polysaccharides, Lophatherum gracile flavonoids, Amomum villosum volatile oil, Artemisia capillaris coumarin, Poria cocos polysaccharides, Glycyrrhiza uralensis flavonoids, Dioscorea opposita polysaccharides, Lilium brownii polysaccharides, roasted malt amylase, and safflower flavonoids as adjuvants, and peppermint volatile oil, folic acid, glutenin, B vitamins, copper sulfate, zinc sulfate, and manganese sulfate as guiding ingredients. The whole formula works to warm the kidneys and replenish essence, invigorate qi and nourish blood, promote blood circulation and unblock collaterals, strengthen the spleen and resolve dampness, and clear heat and generate fluids.

[0015] The pharmacological mechanism of this invention is as follows: When the various proteins, polysaccharides, and amino acids of placenta are combined with the amino acids and acetic acid of black ants, they contain abundant vitamins, amino acids, and various trace elements. Their synergistic effect can regulate the human endocrine system, enhance human metabolism, activate pancreatic β-cell function, promote insulin secretion, increase insulin activity, and inhibit the production of insulin resistance, thereby reducing blood sugar levels.

[0016] The above components work synergistically to provide zinc, an essential trace element for the human body. Zinc is involved in the composition of more than 200 enzymes in the human body or is essential for the activity of enzymes. Zinc is present in all six major classes of enzymes in the human body.

[0017] Zinc can directly participate in the metabolism of proteins, nucleic acids, carbohydrates and blood lipids, and plays an antioxidant and cell membrane protection role in the human body, and participates in the regulation of gene expression in the human body; Zinc plays a role in stabilizing the structure of insulin. Zinc is required to activate the breakdown of proinsulin into insulin. Zinc deficiency reduces the body's ability to convert proinsulin into insulin, and the zinc content in diabetic patients is generally lower than that in normal people.

[0018] Therefore, the composition of the present invention lowers blood sugar and improves symptoms by increasing zinc intake, activating and increasing the conversion of proinsulin into insulin.

[0019] In addition, the various proteins, polysaccharides, and amino acids in placenta, when mixed with the amino acids and acetic acid of black ants, have a synergistic effect on the human immune system. This can inhibit the production of harmful antibodies, increase the activity of serum superoxide dismutase and glutathione peroxidase, protect cell membranes, scavenge oxygen free radicals, and enhance enzyme activity, thereby exerting anti-aging and blood sugar-lowering effects.

[0020] The placenta extract of this invention contains multiple proteins, polysaccharides, and amino acids, and has the effects of warming the kidneys, replenishing essence, and nourishing qi and blood. The black ant amino acid is an extract of the dried body of the black stinging ant (Formica fusca Linnaeus), a formic insect. It consists of two main pharmacologically active components: black ant amino acids and acetic acid. It has the effects of dispelling cold, reducing edema, nourishing the heart and brain, and strengthening yang. The earthworm nucleotides are dried body extracts of the following species: Pheretima aspergillum (E. Perier), Pheretima vulgaris chen, Pheretima guillelmi (Michaelsen), or Pheretima pectinifera Michaelsen. The former is commonly known as "Guangdong earthworm," and the latter three are commonly known as "Shanghai earthworm." They are composed of two main pharmacologically active components: nucleotides and esters, and have the effects of clearing heat and calming the nerves, promoting blood circulation, relieving asthma, and promoting diuresis. The leech polypeptide is a dried whole extract of the leech Whitmania pigra Whitman, leech Hirudonipponica Whitman, or willow leaf leech Whitmania acranulata. It contains the main pharmacologically active polypeptide components and has the effects of breaking up blood stasis, promoting menstruation, removing blood stasis and eliminating masses. The fatty acid from the ground beetle is an extract of the dried body of the female ground beetle Eupolyphaga sinensis Walker or Steleophaga plancyi (Boleny), which is composed of fatty acids as the main component and volatile oil, alkaloids and amino acids as auxiliary components. It has the effects of breaking up blood stasis and promoting tendon and bone healing. The Ganoderma triterpenes mentioned are extracts of the dried fruiting bodies of Ganoderma lucidum (Leyss. ex Fr.) Karst. or Ganoderma sinense Zhao, Xu et Zhang, belonging to the Polyporaceae family. They are mainly composed of Ganoderma triterpenes and polysaccharides, and have the effects of tonifying qi, calming the mind, relieving cough and asthma. The prepared Rehmannia oligosaccharide is an extract made from the fresh or dried tuberous roots of Rehmannia glutinosa Libosch., a plant of the Scrophulariaceae family, after processing. It is composed of three main pharmacologically active components: prepared Rehmannia oligosaccharide, polysaccharide, and catalpol. It has the effects of nourishing blood and yin and replenishing essence and marrow. The Polygonatum polysaccharide mentioned is an extract of the dried rhizome of Polygonatum kingianum Coll. et Hemsl., Polygonatum sibiricum Red., or Polygonatum cyrtonema Hua, belonging to the Liliaceae family. It contains the main pharmacologically active component of Polygonatum polysaccharide and has the effects of tonifying qi and nourishing yin, strengthening the spleen, moistening the lungs, and benefiting the kidneys. The astragalus triterpenoid saponins mentioned are the dried root extracts of Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao or Astragalus membranaceus (Fisch.) Bge. of the Fabaceae family. They contain the main components of astragalus, triterpenoid saponins, flavonoids, and polysaccharides, and have the effects of tonifying qi and raising yang, consolidating the exterior and stopping sweating, promoting diuresis and reducing swelling, generating fluids and nourishing blood, promoting blood circulation and relieving pain, promoting detoxification and draining pus, and promoting wound healing and tissue regeneration. The prepared rhein is an extract of the dried root and rhizome of Rheum palmatum L., Rheum tanguticum Maxim. ex Balf., or Rheum officinale Baill., belonging to the Polygonaceae family. It contains prepared rhein and has the effects of purgation, promoting pancreatic juice secretion, promoting bile secretion, anti-liver damage, antifungal and antiviral, anti-inflammatory, hemostatic, lipid-lowering, diuretic, anti-tumor, and reducing blood urea nitrogen and serum creatinine. The wolfberry polysaccharide is an extract of the dried, mature fruit of Lycium barbarum L., a plant of the Solanaceae family. It contains wolfberry polysaccharide and has the effects of nourishing the liver and kidneys and improving eyesight. The steroidal saponins mentioned are the dried tuberous root extracts of Ophiopogon japonicus (Lf) Ker Gawl., a plant of the Liliaceae family. They are composed of two main components of Ophiopogon japonicus: steroidal saponins and polysaccharides. They have the effects of nourishing yin and promoting body fluid production, as well as moistening the lungs and clearing the heart. The pomegranate peel flavonoids mentioned are extracts of the dried pericarp of Punica granatum L., a plant of the Punicaceae family. They are composed of three components: pomegranate peel flavonoids, tannins, and organic acids. They have the effects of lowering blood sugar, astringing the intestines and stopping diarrhea, stopping bleeding, and expelling parasites. The tanshinone diterpenoids mentioned are extracts from the dried roots and rhizomes of Salvia miltiorrhiza Bge., a plant of the Lamiaceae family. They contain two main pharmacologically active components: tanshinone diterpenoids and phenolic acids. They have the effects of lowering blood pressure, lowering blood lipids, promoting blood circulation and removing blood stasis, regulating menstruation and relieving pain, clearing the mind and relieving irritability, and cooling blood and reducing swelling.

[0021] The flavonoids from Lygodium japonicum (Thunb.) Sw. are dried, mature spores of the Lygodium japonicum plant (Thunb.) Sw., and consist of three components: flavonoids, volatile oil, and triterpenes. They have the effects of clearing heat and dampness and relieving pain. The achyranthes saponins are the dried root extracts of Achyranthes bidentata Bl., a plant of the Amaranthaceae family. They contain two main active ingredients: achyranthes saponins and polysaccharides. They have the effects of removing blood stasis and promoting menstruation, tonifying the liver and kidneys, strengthening tendons and bones, promoting diuresis and relieving strangury, and guiding blood downward. The tangerine peel flavonoids mentioned are extracts of the dried mature peel of Citrus reticulata Blanco and its cultivated varieties, which contain tangerine peel flavonoids and have the effects of regulating qi and strengthening the spleen, as well as drying dampness and resolving phlegm. The coix seed fatty acid is an extract of the dried mature seed kernel of the grass Coix lacryma-jobi L. var. mayuen (Roman) stapf, containing three active ingredients: coix seed fatty acid, sterol, and polysaccharide. It has the effects of lowering blood sugar, promoting diuresis and dampness removal, strengthening the spleen and stopping diarrhea, relieving numbness, draining pus, and detoxifying and dispersing nodules. The Scutellaria barbata polysaccharide is an extract of the dried whole herb of Scutellaria barbata D. Don, a plant of the Lamiaceae family. It contains two active ingredients: Scutellaria barbata polysaccharide and flavonoids, and has the effects of clearing heat and detoxifying, removing blood stasis and promoting diuresis. The Lophatherum gracile Brongn. flavonoids are extracts of the dried stems and leaves of the grass Lophatherum gracile Brongn., containing active Lophatherum gracile flavonoids, which have the effects of clearing heat and purging fire, relieving irritability and quenching thirst, and promoting diuresis and relieving strangury. The cardamom volatile oil is an extract of the dried, nearly mature seeds of Alpinia katsumadai Hayata, a plant of the ginger family. It contains active ingredients of cardamom volatile oil and has the effects of drying dampness, promoting qi circulation, and warming the middle jiao to stop vomiting. The coumarin is an extract of the dried aerial parts of Artemisia scoparia Waldst. et Kit. or Artemisia capillaris Thunb., belonging to the Asteraceae family. It contains two active ingredients: coumarin and flavonoids, and has the effects of clearing heat and dampness and promoting bile secretion and relieving jaundice. The poria polysaccharide is an extract of the dried sclerotium of the fungus Poria cocos (Schw.) Wolf, which contains two active ingredients: poria polysaccharide and triterpenes. It has the effects of promoting diuresis and removing dampness, strengthening the spleen and calming the mind. The licorice flavonoids mentioned are extracts from the dried roots and rhizomes of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat., or Glycyrrhiza glabra L., which contain two active ingredients: licorice flavonoids and triterpenoid saponins. They have the effects of tonifying the spleen and replenishing qi, clearing heat and detoxifying, resolving phlegm and relieving cough, relieving pain and pain, and harmonizing other drugs. The yam polysaccharide is an extract of the dried rhizome of Dioscorea opposita Thunb., a plant of the Dioscoreaceae family. It contains the main pharmacologically active components of yam polysaccharide and has the effects of tonifying the spleen and stomach, promoting body fluid production and benefiting the lungs, and tonifying the kidneys and astringing essence. The lily polysaccharide is an extract of the dried fleshy scales of Lilium lancifolium Thunb., Lilium brownii FEBrown var.viridulum Baker, or Lilium pumilum DC., which contain two active ingredients: lily polysaccharide and alkaloids. It has the effects of nourishing yin and moistening the lungs, and calming the mind and soothing the nerves. The roasted malt amylase is an extract of the mature fruit of barley (Hordeum vulgare) that has been germinated and dried. It contains the main pharmacologically active ingredient of roasted malt amylase and has the effects of promoting digestion, strengthening the spleen and stomach, and reducing lactation and bloating. The safflower flavonoids mentioned are the dried flower extracts of the safflower plant Carthamus tinctorius L., which contains the main active ingredient of safflower flavonoids and has the effects of promoting blood circulation, regulating menstruation, and relieving pain.

[0022] The peppermint volatile oil is an extract of the dried aerial parts of the plant Mentha haplocalyx Briq. of the Lamiaceae family. It contains the main pharmacologically active components of peppermint volatile oil and has the effects of dispelling wind-heat, clearing the head and eyes, relieving sore throat, promoting rash eruption, and soothing the liver and regulating qi. The folic acid, digestive enzymes, vitamin B1, vitamin B2, vitamin B6, and vitamin B1 are mentioned. 12 As a coenzyme, it participates in the formation of various coenzymes in the process of glucose metabolism; the copper sulfate, zinc sulfate and manganese sulfate are trace element supplements, among which zinc participates in the storage, release and conversion of proinsulin to insulin.

[0023] The embodiments of the present invention have the following advantages due to the adoption of the above technical solutions: I. This invention systematically combines animal-derived active ingredients (various proteins from placenta, amino acids from black ants, nucleotides from earthworms, polypeptides from leeches, and fatty acids from ground beetles) with plant-derived active ingredients (Ganoderma lucidum triterpenes, astragalus triterpenoid saponins, polysaccharides from Polygonatum sibiricum, etc.), as well as trace elements (zinc, copper, manganese) and vitamins. It exerts a hypoglycemic effect through four synergistic mechanisms: activating pancreatic β-cell function, promoting the conversion of proinsulin to insulin, regulating zinc metabolism, and inhibiting insulin resistance. This is different from existing single-target hypoglycemic drugs.

[0024] II. After oral administration for 8-10 months, this invention enables the patient's body to automatically produce, store, and release insulin to regulate blood sugar, resulting in a significant decrease in fasting and postprandial blood sugar, a significant reduction in glycated hemoglobin levels, an increase in serum superoxide dismutase and glutathione peroxidase activity, protection of cell membranes, scavenging of oxygen free radicals, inhibition of the production of harmful antibodies, and delay in the occurrence of complications. The production process generates no wastewater, waste gas, or waste residue, making it very environmentally friendly. All raw materials used in the formula are pharmacopoeia-listed varieties or conventional edible / medicinal ingredients, and no significant adverse reactions were observed during clinical observation.

[0025] The above overview is for illustrative purposes only and is not intended to be limiting in any way. Detailed Implementation

[0026] In the following description, only certain exemplary embodiments are briefly described. As those skilled in the art will recognize, the described embodiments can be modified in various ways without departing from the spirit or scope of the invention.

[0027] It is important to note that terms such as "first," "second," "symmetric," "array," "set in," and "set with" are used only to distinguish between descriptive and positional descriptions and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Therefore, features specified with terms such as "first" or "symmetric" may explicitly or implicitly include one or more of that feature; similarly, when the quantity of certain features is not limited by words such as "two" or "three," it should be noted that such features also explicitly or implicitly include one or more features.

[0028] In this invention, unless otherwise explicitly specified and limited, terms such as “installation,” “connection,” and “fixation” should be interpreted broadly; for example, they can be fixed connections, detachable connections, or integral moldings; they can be mechanical connections, direct connections, welding, or indirect connections through an intermediate medium; they can be internal connections between two components or the interaction between two components.

[0029] Example 1 Preparation of the oral liquid medicine of the present invention (preferred formulation) Weigh out 4 parts of various proteins from placenta, 4 parts of amino acids from black ants, 3 parts of nucleotides from earthworms, 3 parts of polypeptides from leeches, 3 parts of fatty acids from ground beetles, 3 parts of triterpenes from Ganoderma lucidum, 3 parts of oligosaccharides from Rehmannia glutinosa, 3 parts of polysaccharides from Polygonatum sibiricum, 3 parts of triterpenoid saponins from Astragalus membranaceus, 3 parts of emodin from processed rheum palmatum, 3 parts of polysaccharides from Lycium barbarum, 3 parts of steroidal saponins from Ophiopogon japonicus, 3 parts of flavonoids from pomegranate peel, 3 parts of diterpenoid quinones from Salvia miltiorrhiza, 2 parts of flavonoids from Lygodium japonicum, 2 parts of saponins from Achyranthes bidentata, 2 parts of flavonoids from Citrus reticulata peel, 2 parts of fatty acids from Coix lacryma-jobi, 2 parts of polysaccharides from Scutellaria barbata, 2 parts of flavonoids from Lophatherum gracile, 2 parts of volatile oil from Amomum villosum, 2 parts of coumarin from Artemisia capillaris, 2 parts of polysaccharides from Poria cocos, 2 parts of flavonoids from Glycyrrhiza uralensis, 2 parts of polysaccharides from Dioscorea opposita, 2 parts of polysaccharides from Lilium brownii, 2 parts of amylase from roasted malt, and 2 parts of flavonoids from Carthamus tinctorius. Dry them separately at 50℃ until the moisture content is less than 8%, and pass them through an 80-mesh sieve. Heat 100 parts of water to 55°C, add the fine powders of the above raw materials in sequence, and stir at 250 rpm for 45 minutes to form a uniform suspension. Heat to 75℃ and keep warm for 2 hours for extraction, then cool to below 40℃ and filter through a 200-mesh filter cloth; The filtrate was concentrated under reduced pressure at a vacuum of -0.07 MPa and 60°C to a relative density of 1.10 (measured at 50°C). Add 0.6 parts folic acid, 5 parts digestive enzymes, 0.016 parts vitamin B1, 0.016 parts vitamin B2, 0.016 parts vitamin B6, and vitamin B2. 12 0.017 parts, copper sulfate 6 parts, zinc sulfate 13 parts, manganese sulfate 7.5 parts, stir and dissolve for 30 minutes; Sterilize with flowing steam at 100℃ for 30 minutes, cool, fill and seal to obtain 100 ml oral liquid per vial.

[0030] Example 2 Preparation of the drug granules of the present invention After preparing the concentrated solution according to the same proportions and methods as in Example 1, 15% dextrin and 10% sucrose powder by weight of the concentrated solution were added, mixed evenly, vacuum-dried, pulverized and passed through a 60-mesh sieve, and then made into a soft mass with 75% ethanol. This soft mass was then granulated through a 14-mesh sieve, dried at 60°C, sized, and packaged to obtain granules. Example 3 Preparation of the drug capsule of the present invention After preparing the concentrated solution according to the same proportions and methods as in Example 1, it was spray-dried (inlet air temperature 180℃, outlet air temperature 85℃) to obtain dry extract powder. 5% by weight of micronized silica gel was added to the dry extract powder, mixed well, and then filled into No. 0 empty capsules, with each capsule containing 0.45 grams, thus obtaining the capsule formulation.

[0031] In this embodiment, specifically, Experiment Example 1: Pharmacodynamic Experiment (Streptozotocin-induced Type 2 Diabetic Rats) Experimental animals: 70 SPF-grade male SD rats, weighing 180-220 grams.

[0032] Model establishment: After 7 days of adaptive feeding, rats were fed a high-sugar, high-fat diet for 4 weeks. After fasting for 12 hours, streptozotocin (STZ, dissolved in 0.1 mol / L citrate buffer, pH 4.4) was injected intraperitoneally at a dose of 35 mg / kg. Rats with a fasting blood glucose level ≥11.1 mmol / L after 72 hours were considered to have successfully established the model. A total of 60 rats were successfully modeled.

[0033] Grouping and administration: The model rats were randomly divided into 6 groups, with 10 rats in each group; The model control group (gavage with equal volume of physiological saline), metformin group (150 mg / kg), low-dose group of the present invention (2.5 g crude drug / kg), medium-dose group of the present invention (5 g crude drug / kg), and high-dose group of the present invention (10 g crude drug / kg).

[0034] A separate normal control group of 10 animals was set up. Each group was given gavage once a day for 8 consecutive weeks.

[0035] Detection indicators: After 8 weeks of drug administration, fasting blood glucose (FBG), 2-hour post-oral glucose tolerance test (OGTT-2h), glycated hemoglobin (HbA1c), fasting insulin (FINS), insulin resistance index (HOMA-IR), serum zinc (Zn) level, serum superoxide dismutase (SOD) and glutathione peroxidase (GSH-Px) activities were measured in each group. The results are shown in the table below (mean ± standard deviation): Histopathological observation of pancreatic tissue: In the model control group, the pancreatic islets were atrophied, the number of β cells was significantly reduced, and the cytoplasm was vacuolated; In the high-dose group of this invention, the pancreatic islet structure was basically intact, the number of β cells was significantly increased compared with the model control group, and the positive expression of insulin immunohistochemistry was significantly enhanced.

[0036] Experimental conclusions: The drug of this invention can significantly reduce fasting blood glucose, postprandial blood glucose and glycated hemoglobin levels in type 2 diabetic rats, increase fasting insulin levels and improve insulin resistance. Its mechanism of action is closely related to increasing serum zinc levels, activating the conversion of proinsulin to insulin and increasing the activity of antioxidant enzymes in the body. The overall efficacy is better than that of metformin positive control.

[0037] Experimental Example 2: Clinical Observation General Information: 120 patients with type 2 diabetes who visited XX Hospital from January 2023 to December 2025 were selected. Among them, 68 were male and 52 were female, aged 30-58 years, with a mean age of 45.6 years. All patients met the WHO 1999 diagnostic criteria for type 2 diabetes. Patients with type 1 diabetes, gestational diabetes, or severe liver or kidney dysfunction were excluded. All patients signed informed consent forms.

[0038] Treatment plan: All patients discontinued their original hypoglycemic Western medicines and only took the oral liquid obtained in Example 1 of this invention, 100 ml twice a day, for 8-10 months. During the medication period, dietary control and appropriate exercise were also maintained.

[0039] Criteria for evaluating therapeutic efficacy: Significant effect: Fasting blood glucose ≤6.1mmol / L, 2-hour postprandial blood glucose ≤7.8mmol / L, symptoms basically disappear; Effective: Fasting blood glucose decreased by ≥30% compared to before treatment, 2-hour postprandial blood glucose decreased by ≥30% compared to before treatment, and symptoms were significantly improved; Invalid: Blood glucose levels did not meet the above criteria.

[0040] Treatment results: Among 120 patients, 86 cases (71.7%) showed significant improvement, 29 cases (24.2%) showed improvement, and 5 cases (4.1%) showed no improvement, with a total effective rate of 95.8%. The changes in blood glucose levels before and after treatment are shown in the table below (mean ± standard deviation): Follow-up results: After discontinuation of medication, patients with significant and effective results were followed up for 6-12 months. Blood glucose levels remained normal and stable, with no complications or recurrence.

[0041] Typical medical case: Case 1: Ms. Jiang, 45 years old, from Beijing, was diagnosed with type 2 diabetes in February 2000 and relied on medication and insulin injections to maintain her life. In August of the same year, she chose to take the broad-spectrum biological drug of this invention orally for 10 months. After several comprehensive physical examinations at the hospital, the results showed that her fasting blood glucose was 5.0-5.6 mmol / L, her postprandial blood glucose was 6.6-7.8 mmol / L, and all other physical indicators were normal.

[0042] After discontinuing the medication, as of February 2026, Ms. Jiang's blood sugar levels remained stable and within the normal range, with no complications or recurrence.

[0043] Case 2: Mr. Chen, 30 years old, from Tianjin, was diagnosed with type 2 diabetes in May 2000. In June of the same year, he directly chose to take the broad-spectrum biological drug oral liquid of this invention for 8 months. After multiple comprehensive physical examinations at the hospital, the results showed that his fasting blood glucose was 5.5-6.0 mmol / L, his postprandial blood glucose was 6.6-7.0 mmol / L, and all other physical indicators were normal.

[0044] After discontinuing the medication, Mr. Chen's blood sugar levels have remained normal and stable as of March 2026, with no complications or recurrence.

[0045] Case 3: Ms. Duan, 50 years old, from Hebei Province, was diagnosed with type 2 diabetes in April 2001 and relied on daily medication and insulin injections to maintain her life. At the end of August of the same year, she chose to take the broad-spectrum biological drug of this invention orally for 10 months. After several comprehensive physical examinations at the hospital, the results showed that her fasting blood glucose was 5.6 mmol / L, her postprandial blood glucose was 7.0 mmol / L, and all other physical indicators were normal.

[0046] After discontinuing the medication, Ms. Duan's blood sugar levels have remained normal and stable as of March 2026, with no complications and no recurrence.

[0047] Case 4: Mr. Gao, 48 years old, from Shanghai, was diagnosed with type 2 diabetes in April 2001. In June of the same year, he directly chose to take the broad-spectrum biological drug of this invention orally for 10 months. After multiple comprehensive physical examinations at the hospital, the results showed that his fasting blood glucose was 6.0 mmol / L, his postprandial blood glucose was 6.7-7.0 mmol / L, and all other physical indicators were normal.

[0048] After discontinuing the medication, Mr. Gao's blood sugar levels have remained normal and stable as of April 2026, with no complications or recurrence.

[0049] Case 5: Ms. Zhang, 50 years old, from Liaoning Province, was diagnosed with type 2 diabetes in July 2000 and relied on daily medication and insulin injections to maintain her life. At the end of September of the same year, she directly chose to take the broad-spectrum biological drug of this invention orally for 10 months. After several comprehensive physical examinations at the hospital, the results showed: fasting blood glucose was 5.0-5.8 mmol / L, 2-hour postprandial blood glucose was 7.0-7.8 mmol / L, and all other physical indicators were normal.

[0050] After discontinuing the medication, Ms. Zhang's blood sugar levels have remained normal and stable as of May 2026, with no complications or recurrence.

[0051] Case 6: Mr. Guo, 55 years old, from Guangdong, was diagnosed with type 2 diabetes in February 2000. He relied on oral hypoglycemic drugs and insulin injections to maintain his life. At the end of March of the same year, Mr. Guo directly chose to take the broad-spectrum biological drug of this invention orally for 10 months. After several follow-up physical examinations at a tertiary hospital, the results showed that his fasting blood glucose was 5.5-6.0 mmol / L, his postprandial blood glucose was 7.0-7.6 mmol / L, and all other physical indicators were normal.

[0052] After discontinuing the medication, Mr. Guo's blood sugar levels have remained normal and stable as of June 2026, with no complications or recurrence.

[0053] The above-mentioned animal experiments and clinical observations jointly demonstrate that the drug of the present invention can effectively treat type 2 diabetes through the synergistic effects of activating pancreatic β-cell function, promoting the conversion of proinsulin to insulin, regulating zinc metabolism, and inhibiting insulin resistance. The efficacy is definite and stable after drug withdrawal, and it has significant novelty, inventiveness and practicality.

[0054] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any person skilled in the art can easily conceive of various variations or substitutions within the technical scope disclosed in the present invention, and these should all be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A highly effective broad-spectrum biological drug for treating type 2 diabetes, characterized in that, Made from the following ingredients in parts by weight: 1-8 parts placenta protein, 1-8 parts black ant amino acids, 1-6 parts earthworm nucleotides, 1-6 parts leech polypeptides, 1-6 parts ground beetle fatty acids, 1-6 parts Ganoderma lucidum triterpenes, 1-6 parts prepared Rehmannia glutinosa oligosaccharides, 1-6 parts Polygonatum sibiricum polysaccharides, 1-6 parts Astragalus triterpenoid saponins, 1-6 parts prepared emodin, 1-6 parts Lycium barbarum polysaccharides, 1-6 parts Ophiopogon japonicus steroidal saponins, 1-6 parts pomegranate peel flavonoids, 1-6 parts Tanshinone diterpenoid quinones, 1-4 parts Lygodium japonicum flavonoids, bovine... Knee saponins 1-4 parts, tangerine peel flavonoids 1-4 parts, coix seed fatty acids 1-4 parts, Scutellaria barbata polysaccharides 1-4 parts, Lophatherum gracile flavonoids 1-4 parts, cardamom volatile oil 1-4 parts, Artemisia capillaris coumarin 1-4 parts, Poria cocos polysaccharides 1-4 parts, licorice flavonoids 1-4 parts, yam polysaccharides 1-4 parts, lily polysaccharides 1-4 parts, roasted malt amylase 1-4 parts, safflower flavonoids 1-4 parts, peppermint volatile oil 1-2 parts, folic acid 0.4-0.8 parts, digestive enzymes 2-8 parts, vitamins (B1, B2, B6 and B1) 12 The total amount is 0.05-0.08 parts, copper sulfate 2-10 parts, zinc sulfate 10-16 parts, manganese sulfate 5-10 parts, and water 100 parts.

2. The highly effective broad-spectrum biological drug for treating type 2 diabetes according to claim 1, characterized in that, Made from the following ingredients in parts by weight: 4 parts placenta protein, 4 parts black ant amino acids, 3 parts earthworm nucleotides, 3 parts leech polypeptides, 3 parts ground beetle fatty acids, 3 parts Ganoderma lucidum triterpenes, 3 parts Rehmannia glutinosa oligosaccharides, 3 parts Polygonatum sibiricum polysaccharides, 3 parts Astragalus membranaceus triterpenoid saponins, 3 parts processed emodin, 3 parts Lycium barbarum polysaccharides, 3 parts Ophiopogon japonicus steroidal saponins, 3 parts pomegranate peel flavonoids, 3 parts Tanshinone diterpenoid quinones, 2 parts Lygodium japonicum flavonoids, 2 parts Achyranthes bidentata saponins, and 2 parts Citrus reticulata peel flavonoids. 2 parts of coix seed fatty acids, 2 parts of Scutellaria barbata polysaccharide, 2 parts of Lophatherum gracile flavonoids, 2 parts of Amomum villosum volatile oil, 2 parts of Artemisia capillaris coumarin, 2 parts of Poria cocos polysaccharide, 2 parts of Glycyrrhiza uralensis flavonoids, 2 parts of Dioscorea opposita polysaccharide, 2 parts of Lilium brownii polysaccharide, 2 parts of roasted malt amylase, 2 parts of Safflower flavonoids, 1.5 parts of peppermint volatile oil, 0.6 parts of folic acid, 5 parts of digestive enzymes, 0.016 parts of vitamin B1, 0.016 parts of vitamin B2, 0.016 parts of vitamin B6, and 0.016 parts of vitamin B2. 12 0.017 parts, copper sulfate 6 parts, zinc sulfate 13 parts, manganese sulfate 7.5 parts and water 100 parts.

3. The method for preparing a highly effective broad-spectrum biological drug for treating type 2 diabetes according to claim 1 or 2, characterized in that, Includes the following steps: S1. Placenta protein, black ant amino acids, earthworm nucleotides, leech polypeptides, ground beetle fatty acids, Ganoderma triterpenes, Rehmannia glutinosa oligosaccharides, Polygonatum polysaccharides, Astragalus triterpenoid saponins, processed emodin, Lycium barbarum polysaccharides, Ophiopogon japonicus steroidal saponins, pomegranate peel flavonoids, Tanshinone diterpenoid quinones, Lygodium japonicum flavonoids, Achyranthes bidentata saponins, Citrus reticulata flavonoids, Coix lacryma-jobi fatty acids, Scutellaria barbata polysaccharides, Lophatherum gracile flavonoids, Amomum villosum volatile oil, Artemisia capillaris coumarin, Poria cocos polysaccharides, Glycyrrhiza uralensis flavonoids, Dioscorea opposita polysaccharides, Lilium brownii polysaccharides, roasted malt amylase, and Carthamus tinctorius flavonoids are dried at low temperature of 40-60℃ until the moisture content is less than 8%, and then passed through an 80-mesh sieve to obtain fine powder of each raw material; S2. First, heat the water to 50-60℃, then add the fine powders of each raw material obtained in S1 in sequence, and stir at 200-300 rpm for 30-60 minutes to form a uniform suspension. S3. Heat the suspension obtained in S2 to 70-80℃, keep it warm for 1.5-3 hours, cool it to below 40℃, filter it through a 200-mesh filter cloth, and collect the filtrate. S4. The filtrate obtained in S3 is concentrated under reduced pressure at a vacuum of -0.06 to -0.08 MPa and a temperature of 55 to 65°C to a concentrate with a relative density of 1.05 to 1.15 (measured at 50°C). S5. Add folic acid, digestive enzymes, vitamin B1, vitamin B2, vitamin B6, and vitamin B6 to the concentrated solution obtained in S4. 12 Copper sulfate, zinc sulfate, and manganese sulfate are stirred and dissolved for 30 minutes. S6. Sterilize the liquid obtained in S5 with flowing steam at 100°C for 30 minutes. After cooling, fill, seal and package in a clean environment to obtain an oral liquid preparation.

4. The method for preparing a highly effective broad-spectrum biological drug for treating type 2 diabetes according to claim 3, characterized in that, The heating temperature of the water in S2 is 55℃, the heat preservation extraction temperature in S3 is 75℃ and the time is 2 hours, and the relative density of the concentrate in S4 is 1.

10.

5. The highly effective broad-spectrum biological drug for treating type 2 diabetes according to claim 1 or 2, characterized in that, The dosage form of the drug is oral liquid, granules, capsules or tablets.

6. The highly effective broad-spectrum biological drug for treating type 2 diabetes according to claim 1 or 2, characterized in that, The medication is to be taken orally, twice a day, 50-100 ml each time, for 8-10 months as one course of treatment.

7. The use of the highly effective broad-spectrum biological drug for treating type 2 diabetes as described in claim 1 or 2 in the preparation of drugs for treating type 2 diabetes.

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