CN114848748B - Composition with blood sugar reducing effect and preparation method thereof - Google Patents
Composition with blood sugar reducing effect and preparation method thereof Download PDFInfo
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- CN114848748B CN114848748B CN202210642495.2A CN202210642495A CN114848748B CN 114848748 B CN114848748 B CN 114848748B CN 202210642495 A CN202210642495 A CN 202210642495A CN 114848748 B CN114848748 B CN 114848748B
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
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Abstract
The invention relates to a composition with a blood sugar reducing effect and a preparation method thereof, wherein the composition comprises the following components in parts by weight: 3-7 parts of fenugreek, 1-7 parts of cyclocarya paliurus, 1-6 parts of mulberry leaf, 2-8 parts of astragalus, 2-8 parts of dwarf lilyturf tuber, 1-6 parts of puer tea and 1-6 parts of mannitol. The invention fully exerts the advantages of traditional Chinese medicine resources, and under the guidance of traditional Chinese medicine theory, fenugreek, cyclocarya paliurus leaves, mulberry leaves, astragalus roots, dwarf lilyturf tuber and puer tea are selected as raw materials, and the modern and traditional combined hypoglycemic product is prepared by reasonable preparation and modern technology.
Description
Technical Field
The invention relates to the technical field of traditional Chinese medicines, in particular to a composition with a blood sugar reducing effect and a preparation method thereof.
Background
Diabetes is now one of the most common epidemic diseases worldwide, the incidence of which is on an increasing trend year by year, both in developed and developing countries. Statistically, 1.6 million type II diabetics are worldwide, and 2025 is predicted to increase the world to 3 hundred million people.
Diabetes is a common endocrine and metabolic disease with certain genetic tendency, and has the characteristics of more complications, long treatment time and the like. At present, conventional diabetes treatment is mainly oral hypoglycemic western medicines mainly including sulfonylureas, biguanides, a-glycosidase inhibitors, novel insulin sensitizers and the like, and the medicines help diabetes patients to control blood sugar level by different action mechanisms, but the medicines have side effects such as hypoglycemia, gastrointestinal tract reactions and the like, and meanwhile, along with the extension of treatment time, the hypoglycemic effect is in a reduced trend. The theory of traditional Chinese medicine considers that diabetes belongs to the category of diabetes, and the traditional Chinese medicine has the characteristics of mild and durable treatment effect, small side effect, long-term taking and the like, and the action mechanism of the traditional Chinese medicine is often multi-target, multi-effect and multifunctional comprehensive effect, and has the irreplaceable advantage of western medicines, so that the traditional Chinese medicine is selected for more diabetics.
The Chinese patent application No. 201310291634.2 discloses a pure traditional Chinese medicine health food for assisting in reducing blood sugar and a preparation method thereof, and the traditional Chinese medicine compound comprises the following components: 10-15 parts of kudzuvine root, 6-14 parts of cortex lycii radicis, 6-14 parts of mulberry leaf, 4-10 parts of acanthopanax, and 4-10 parts of fenugreek. The invention uses kudzuvine root to strengthen spleen and raise yang, and fenugreek and the like as adjuvant drugs, and has the function of assisting in reducing blood sugar in terms of patent content, but the daily dosage of the patent product is larger, the compliance of consumers is poor, and the cost is higher.
Therefore, there is a need to provide a composition with long-lasting hypoglycemic effect, small toxicity and side effects, convenient administration, easy storage and portability, and a preparation method thereof.
Disclosure of Invention
The invention aims to provide a composition with a blood sugar reducing effect and a preparation method thereof.
In order to solve the problems, the invention adopts the following technical scheme:
the composition with the blood sugar reducing effect comprises the following components in parts by weight: 3-7 parts of fenugreek, 1-7 parts of cyclocarya paliurus, 1-6 parts of mulberry leaf, 2-8 parts of astragalus, 2-8 parts of dwarf lilyturf tuber, 1-6 parts of puer tea and 1-6 parts of mannitol.
As an embodiment of the invention, the composition comprises the following components in parts by weight: 4-6 parts of fenugreek, 2-5 parts of cyclocarya paliurus, 2-5 parts of mulberry leaf, 2-5 parts of astragalus, 2-5 parts of dwarf lilyturf tuber, 1-3 parts of puer tea and 1-4 parts of mannitol.
As one embodiment of the invention, the method comprises:
(1) Weighing: weighing fenugreek, cyclocarya paliurus, mulberry leaf, astragalus mongholicus, radix ophiopogonis, puer tea and mannitol according to the weight parts of the raw materials;
(2) Pretreatment: pretreating Pu 'er tea with the formula amount of 1/3 to obtain Pu' er tea powder; sieving mannitol with 20 mesh sieve;
(3) Extracting: reflux-extracting semen Trigonellae, cyclocarya paliurus, folium Mori, radix astragali, radix Ophiopogonis and 2/3 of Pu' er tea with 12 times of water for 2 times each for 1 hr, filtering the extractive solution, and mixing filtrates to obtain extractive solution;
(4) Concentrating and drying: concentrating the filtrate obtained in the step (3) for the first time, centrifuging, concentrating for the second time, and drying to obtain an extract;
(5) Adding the puer tea powder prepared in the step (2), mannitol and the extract prepared in the step (4) into a mixer for mixing;
(6) The mixed materials are granulated and packaged by a dry method to obtain the composition with the blood sugar reducing effect.
As an implementation mode of the invention, in the step (2), 1/3 of the Pu 'er tea with the formula amount is irradiated and then coarsely crushed to obtain Pu' er tea coarse powder, the Pu 'er tea coarse powder is screened by a 20-mesh screen, and fine powder below 80 meshes is discarded to obtain the Pu' er tea powder with 20-80 meshes.
As an implementation mode of the invention, 60 Co-gamma rays are adopted to irradiate 1/3 formula amount of puer tea, and the radiation dose is 5 KGy.
As one embodiment of the invention, the step (4) includes:
primary concentration: concentrating the combined filtrate obtained in the step (3) to a relative density of 1.05-1.1 measured at 60 ℃ under reduced pressure, and filtering with 300-mesh filter cloth to obtain a first concentrated extract;
and (3) centrifuging: centrifuging the concentrated extract I at 4000rpm/min for 3min;
secondary concentration: concentrating the supernatant under reduced pressure until the relative density is 1.2-1.25 at 60 ℃ to obtain a second concentrated extract;
and (3) drying: drying the second concentrated extract at 50-65deg.C under reduced pressure, and pulverizing to obtain extract.
As an implementation mode of the invention, the concentration temperature of the primary concentration and the secondary concentration is 40-80 ℃, and the vacuum degree is 0.04-0.09 mpa.
In step (5), the rotation speed of the mixer was 8 rpm, and the mixing time was 30min.
In the step (6), the mixed materials are granulated by a dry method and pass through a 20-mesh screen to obtain granules; and subpackaging the granules into tea bags, wherein each package contains 5g of granules, and packaging the granules by using a composite film outer bag to obtain the composition with the blood sugar reducing effect.
The beneficial effects of adopting above-mentioned technical scheme to produce lie in:
the invention fully exerts the advantages of traditional Chinese medicine resources, and selects fenugreek, cyclocarya paliurus leaves, mulberry leaves, astragalus roots, dwarf lilyturf tuber and puer tea as raw materials under the guidance of traditional Chinese medicine theory, and prepares the modern and traditional combined hypoglycemic product through reasonable preparation and modern technology, thus the product has definite function, controllable quality, safe administration, high long-term administration safety and no dependence, and the preparation technology related to the preparation method is simple, has lower cost and can realize industrial production.
In addition, the raw materials in the formula have the effect of directly or indirectly improving diabetes, fenugreek is used for warming kidney and supporting yang, cold dispelling and pain relieving are used as monarch drugs, cyclocarya paliurus and mulberry leaf are used as ministerial drugs for dispelling wind and heat, clearing lung and moistening dryness and enhancing the function of suppressing liver yang, and astragalus and dwarf lilyturf tuber are used as ministerial drugs for tonifying qi and raising yang, inducing diuresis and relieving swelling, nourishing yin and promoting fluid production. The whole formula has the effects of clearing heat, promoting fluid production, tonifying qi, warming kidney, improving lung dryness and kidney deficiency, mutually promoting, synergistically enhancing the functions of the lung and the kidney, strengthening the body's ability of regulating blood sugar, and achieving the effect of reducing blood sugar. In addition, the composition adopts the preparation mode of the extract and the tea to prepare the tea, has large drug loading rate and less daily taking times (2 bags a day), and solves the problems of more taking times of capsules and tablets sold in the market and poor compliance of consumers.
The results of the animal functional evaluation test and the human body test feeding test show that the invention has good blood sugar reducing function.
The description of the raw materials in the composition of the invention is as follows:
the Trigonella foenum-graecum is dry mature seed of Trigonella foenum-graecum of Leguminosae. Bitter, warm, enter kidney meridian and are well known yang-tonifying traditional Chinese medicines. Fenugreek starts from Jiayou Ben Cao's principal component viscera deficiency cold, from Ben Cao Yan Yi's medicine carried by Ben Cao's medicine carried by He Ji Fang to treat infantile intestinal qi and hernia, from Yang Shi Jia Tibetan Fang to treat all cold-dampness beriberi, leg and knee pain and walking weakness, and from Ben Cao Hui Yan's medicine carried by Ben Cao's medicine to treat spleen and stomach deficiency cold and diarrhea. China mainly produces in Henan, hebei, anhui, sichuan, xinjiang and other places, and cultivated in all places of south and north. Studies show that 4-hydroxyisoleucine, a unique active ingredient of fenugreek seeds, has the effect of promoting glucose uptake by adipocytes and skeletal muscle cells, thereby playing a role in improving insulin resistance. The pharmacological activity of the fenugreek is numerous in modern researches, animal experiments and clinical treatment prove that the fenugreek has good curative effect on diabetes mellitus, and can be used for developing and utilizing medicaments for preventing and treating diabetes mellitus.
Cyclocarya paliurus leaves are leaves of cyclocarya paliurus (Latin name: cyclocyaroya paliurus) belonging to Juglandaceae, are a special medicinal plant in China, and have effects of clearing heat and detoxicating, promoting salivation to quench thirst, relieving summer heat, relieving pain, etc. according to the description of Chinese traditional medicine resource. Modern researches show that cyclocarya paliurus leaves contain a large amount of flavone, triterpene and polysaccharide, and the alcohol extract and the water extract of cyclocarya paliurus leaves have remarkable effects of reducing blood sugar, blood pressure and blood fat.
Sang Shewei dried leaves of Morus alba L. Sweet, bitter and cold in nature. It enters lung and liver meridians. Has effects of dispelling pathogenic wind heat, clearing lung-heat, moistening dryness, removing liver heat, improving eyesight, and can be used for treating wind-heat common cold, lung-heat dry cough, etc. The mulberry leaf mainly contains flavonoid compounds, alkaloid compounds, sterol compounds, volatile oil components, amino acids, vitamins and the like. Modern pharmacological researches have shown that mulberry leaves have the effects of reducing blood sugar, blood pressure and blood lipid, inhibiting fat accumulation and thrombosis, resisting aging, increasing endurance, inhibiting the proliferation of harmful bacteria in intestinal tracts, inhibiting the generation of harmful oxides and the like.
The radix astragali is dried root of Astragalus membranaceus (Fisch.) bge. Var. Mongholicus (bge.) Hsiao or Astragalus membranaceus (Fisch.) bge. Of Leguminosae. Sweet and slightly warm. Enter lung and spleen meridians. Has effects of invigorating qi, invigorating yang, consolidating superficial resistance, relieving sweating, inducing diuresis, relieving edema, promoting salivation, and nourishing blood. Modern phytochemistry and pharmacological tests prove that polysaccharide is one of main active ingredients of astragalus roots and has various important biological activities. Astragalus polysaccharide has been reported to have significant hypoglycaemic effect in diabetic mice.
The radix Ophiopogonis is dried root tuber of Ophiopogon japonicus (L.f) Ker-Gawl. Sweet, slightly bitter and slightly cold. It enters heart, lung and stomach meridians. Has effects of nourishing yin, promoting salivation, moistening lung, and clearing away heart-fire. Can be used for treating cough due to lung dryness, body fluid deficiency, thirst, internal heat, and diabetes. Modern phytochemistry and pharmacological tests prove that the traditional Chinese medicine composition can improve type 2 diabetes from various aspects such as reducing blood sugar, inhibiting formation of glycosylation end products, relieving diabetic complications and the like.
Drawings
Fig. 1 is a process flow diagram of a preparation method of a composition with hypoglycemic effect according to an embodiment of the invention.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention will be clearly and completely described in connection with the following specific embodiments.
Example 1
A composition with the function of reducing blood sugar is prepared from the following components in parts by weight: 3 parts of fenugreek, 1 part of cyclocarya paliurus, 1 part of mulberry leaf, 2 parts of astragalus mongholicus, 2 parts of radix ophiopogonis, 1 part of puer tea and 1 part of mannitol.
The preparation method comprises the following steps:
(1) Weighing: weighing fenugreek, cyclocarya paliurus, mulberry leaf, astragalus mongholicus, radix ophiopogonis, puer tea and mannitol according to the weight parts of the raw materials;
(2) Pretreatment of
(1) Irradiating and crushing: 1/3 of formula amount of puer tea is irradiated (60 Co,5 kGy) and coarsely crushed to obtain puer tea coarse powder for later use.
(2) Sieving: sieving Pu 'er tea coarse powder with 20 mesh sieve, discarding fine powder below 80 mesh to obtain Pu' er tea powder (20-80 mesh); taking mannitol and sieving with a 20-mesh sieve for standby.
(3) Extraction of
Adding 12 times of water into the fenugreek, cyclocarya paliurus, mulberry leaf, astragalus mongholicus, radix ophiopogonis and 2/3 of Pu' er tea, reflux-extracting for 2 times, extracting for 1 hour each time, filtering the extracting solution, and mixing the filtrates to obtain an extracting solution for later use.
(4) Primary concentration
Concentrating the extractive solution under reduced pressure (concentration temperature 40-80deg.C, vacuum degree 0.04-0.09 Mpa) to relative density 1.05-1.1 (measured at 60deg.C), and filtering with 300 mesh filter cloth to obtain concentrated extract I.
(5) Centrifuging
Centrifuging the concentrated extract, setting the parameters of the centrifuge at 4000rpm/min, and centrifuging for 3min.
(6) Secondary concentration
Concentrating the supernatant under reduced pressure (concentration temperature is 40-80 ℃ and vacuum degree is 0.04-0.09 mpa) until relative density is 1.2-1.25 (measured at 60 ℃), and obtaining a second concentrated extract for later use.
(7) Vacuum drying
Drying the concentrated extract II under reduced pressure at 50-65deg.C, and pulverizing to obtain extract.
(8) Mixing
Adding puer tea powder (20-80 mesh), mannitol, and extract into a mixer, and mixing at rotation speed of 8 rpm for 30min.
(9) Dry granulation
And granulating the mixed materials by a dry method, and sieving the granules with a 20-mesh sieve to obtain the granules.
(10) Packaging arrangement
And (3) inner packaging: and subpackaging the particles into tea bags, wherein each package is 5g, and packaging the tea bags by using a composite film outer bag to obtain the product.
Example 2
A composition with the function of reducing blood sugar is prepared from the following components in parts by weight: 7 parts of fenugreek, 7 parts of cyclocarya paliurus, 6 parts of mulberry leaf, 8 parts of astragalus mongholicus, 8 parts of radix ophiopogonis, 6 parts of puer tea and 6 parts of mannitol.
The preparation method comprises the following steps:
(1) Weighing: weighing fenugreek, cyclocarya paliurus, mulberry leaf, astragalus mongholicus, radix ophiopogonis, puer tea and mannitol according to the weight parts of the raw materials;
(2) Pretreatment of
(1) Irradiating and crushing: 1/3 of formula amount of puer tea is irradiated (60 Co,5 kGy) and coarsely crushed to obtain puer tea coarse powder for later use.
(2) Sieving: sieving Pu 'er tea coarse powder with 20 mesh sieve, discarding fine powder below 80 mesh to obtain Pu' er tea powder (20-80 mesh); taking mannitol and sieving with a 20-mesh sieve for standby.
(3) Extraction of
Adding 12 times of water into the fenugreek, cyclocarya paliurus, mulberry leaf, astragalus mongholicus, radix ophiopogonis and 2/3 of Pu' er tea, reflux-extracting for 2 times, extracting for 1 hour each time, filtering the extracting solution, and mixing the filtrates to obtain an extracting solution for later use.
(4) Primary concentration
Concentrating the extractive solution under reduced pressure (concentration temperature 40-80deg.C, vacuum degree 0.04-0.09 Mpa) to relative density 1.05-1.1 (measured at 60deg.C), and filtering with 300 mesh filter cloth to obtain concentrated extract I.
(5) Centrifuging
Centrifuging the concentrated extract, setting the parameters of the centrifuge at 4000rpm/min, and centrifuging for 3min.
(6) Secondary concentration
Concentrating the supernatant under reduced pressure (concentration temperature is 40-80 ℃ and vacuum degree is 0.04-0.09 mpa) until relative density is 1.2-1.25 (measured at 60 ℃), and obtaining a second concentrated extract for later use.
(7) Vacuum drying
Drying the concentrated extract II under reduced pressure at 50-65deg.C, and pulverizing to obtain extract.
(8) Mixing
Adding puer tea powder (20-80 mesh), mannitol and extract into a mixer, and mixing at rotation speed of 8 rpm for 30min.
(9) Dry granulation
And granulating the mixed materials by a dry method, and sieving the granules with a 20-mesh sieve to obtain the granules.
(10) Packaging arrangement
And (3) inner packaging: and subpackaging the particles into tea bags, wherein each package is 5g, and packaging the tea bags by using a composite film outer bag to obtain the product.
Example 3
A composition with the function of reducing blood sugar is prepared from the following components in parts by weight: 4 parts of fenugreek, 3 parts of cyclocarya paliurus, 3 parts of mulberry leaf, 4 parts of astragalus mongholicus, 4 parts of radix ophiopogonis, 2 parts of puer tea and 2 parts of mannitol.
The preparation method comprises the following steps:
(1) Weighing: weighing fenugreek, cyclocarya paliurus, mulberry leaf, astragalus mongholicus, radix ophiopogonis, puer tea and mannitol according to the weight parts of the raw materials;
(2) Pretreatment of
(1) Irradiating and crushing: 1/3 of formula amount of puer tea is irradiated (60 Co,5 kGy) and coarsely crushed to obtain puer tea coarse powder for later use.
(2) Sieving: sieving Pu 'er tea coarse powder with 20 mesh sieve, discarding fine powder below 80 mesh to obtain Pu' er tea powder (20-80 mesh); taking mannitol and sieving with a 20-mesh sieve for standby.
(3) Extraction of
Adding 12 times of water into the fenugreek, cyclocarya paliurus, mulberry leaf, astragalus mongholicus, radix ophiopogonis and 2/3 of Pu' er tea, reflux-extracting for 2 times, extracting for 1 hour each time, filtering the extracting solution, and mixing the filtrates to obtain an extracting solution for later use.
(4) Primary concentration
Concentrating the extractive solution under reduced pressure (concentration temperature 40-80deg.C, vacuum degree 0.04-0.09 Mpa) to relative density 1.05-1.1 (measured at 60deg.C), and filtering with 300 mesh filter cloth to obtain concentrated extract I.
(5) Centrifuging
Centrifuging the concentrated extract, setting the parameters of the centrifuge at 4000rpm/min, and centrifuging for 3min.
(6) Secondary concentration
Concentrating the supernatant under reduced pressure (concentration temperature is 40-80 ℃ and vacuum degree is 0.04-0.09 mpa) until relative density is 1.2-1.25 (measured at 60 ℃), and obtaining a second concentrated extract for later use.
(7) Vacuum drying
Drying the concentrated extract II under reduced pressure at 50-65deg.C, and pulverizing to obtain extract.
(8) Mixing
Adding puer tea powder (20-80 mesh), mannitol, and extract into a mixer, and mixing at rotation speed of 8 rpm for 30min.
(9) Dry granulation
And granulating the mixed materials by a dry method, and sieving the granules with a 20-mesh sieve to obtain the granules.
(10) Packaging arrangement
And (3) inner packaging: and subpackaging the particles into tea bags, wherein each package is 5g, and packaging the tea bags by using a composite film outer bag to obtain the product.
Example 4
A composition with the function of reducing blood sugar is prepared from the following components in parts by weight: 3 parts of fenugreek, 4 parts of cyclocarya paliurus, 4 parts of mulberry leaf, 3 parts of astragalus mongholicus, 3 parts of radix ophiopogonis, 2 parts of puer tea and 3 parts of mannitol.
The preparation method comprises the following steps:
(1) Weighing: weighing fenugreek, cyclocarya paliurus, mulberry leaf, astragalus mongholicus, radix ophiopogonis, puer tea and mannitol according to the weight parts of the raw materials;
(2) Pretreatment of
(1) Irradiating and crushing: 1/3 of formula amount of puer tea is irradiated (60 Co,5 kGy) and coarsely crushed to obtain puer tea coarse powder for later use.
(2) Sieving: sieving Pu 'er tea coarse powder with 20 mesh sieve, discarding fine powder below 80 mesh to obtain Pu' er tea powder (20-80 mesh); taking mannitol and sieving with a 20-mesh sieve for standby.
(3) Extraction of
Adding 12 times of water into the fenugreek, cyclocarya paliurus, mulberry leaf, astragalus mongholicus, radix ophiopogonis and 2/3 of Pu' er tea, reflux-extracting for 2 times, extracting for 1 hour each time, filtering the extracting solution, and mixing the filtrates to obtain an extracting solution for later use.
(4) Primary concentration
Concentrating the extractive solution under reduced pressure (concentration temperature 40-80deg.C, vacuum degree 0.04-0.09 Mpa) to relative density 1.05-1.1 (measured at 60deg.C), and filtering with 300 mesh filter cloth to obtain concentrated extract I.
(5) Centrifuging
Centrifuging the concentrated extract, setting the parameters of the centrifuge at 4000rpm/min, and centrifuging for 3min.
(6) Secondary concentration
Concentrating the supernatant under reduced pressure (concentration temperature is 40-80 ℃ and vacuum degree is 0.04-0.09 mpa) until relative density is 1.2-1.25 (measured at 60 ℃), and obtaining a second concentrated extract for later use.
(7) Vacuum drying
Drying the concentrated extract II under reduced pressure at 50-65deg.C, and pulverizing to obtain extract.
(8) Mixing
Adding puer tea powder (20-80 mesh), mannitol, and extract into a mixer, and mixing at rotation speed of 8 rpm for 30min.
(9) Dry granulation
And granulating the mixed materials by a dry method, and sieving the granules with a 20-mesh sieve to obtain the granules.
(10) Packaging arrangement
And (3) inner packaging: and subpackaging the particles into tea bags, wherein each package is 5g, and packaging the tea bags by using a composite film outer bag to obtain the product.
Example 5
A composition with the function of reducing blood sugar is prepared from the following components in parts by weight: 5 parts of fenugreek, 4 parts of cyclocarya paliurus, 4 parts of mulberry leaf, 4 parts of astragalus mongholicus, 4 parts of radix ophiopogonis, 2 parts of puer tea and 3 parts of mannitol.
The preparation method comprises the following steps:
(1) Weighing: weighing fenugreek, cyclocarya paliurus, mulberry leaf, astragalus mongholicus, radix ophiopogonis, puer tea and mannitol according to the weight parts of the raw materials;
(2) Pretreatment of
(1) Irradiating and crushing: 1/3 of formula amount of puer tea is irradiated (60 Co,5 kGy) and coarsely crushed to obtain puer tea coarse powder for later use.
(2) Sieving: sieving Pu 'er tea coarse powder with 20 mesh sieve, discarding fine powder below 80 mesh to obtain Pu' er tea powder (20-80 mesh); taking mannitol and sieving with a 20-mesh sieve for standby.
(3) Extraction of
Adding 12 times of water into the fenugreek, cyclocarya paliurus, mulberry leaf, astragalus mongholicus, radix ophiopogonis and 2/3 of Pu' er tea, reflux-extracting for 2 times, extracting for 1 hour each time, filtering the extracting solution, and mixing the filtrates to obtain an extracting solution for later use.
(4) Primary concentration
Concentrating the extractive solution under reduced pressure (concentration temperature 40-80deg.C, vacuum degree 0.04-0.09 Mpa) to relative density 1.05-1.1 (measured at 60deg.C), and filtering with 300 mesh filter cloth to obtain concentrated extract I.
(5) Centrifuging
Centrifuging the concentrated extract, setting the parameters of the centrifuge at 4000rpm/min, and centrifuging for 3min.
(6) Secondary concentration
Concentrating the supernatant under reduced pressure (concentration temperature is 40-80 ℃ and vacuum degree is 0.04-0.09 mpa) until relative density is 1.2-1.25 (measured at 60 ℃), and obtaining a second concentrated extract for later use.
(7) Vacuum drying
Drying the concentrated extract II under reduced pressure at 50-65deg.C, and pulverizing to obtain extract.
(8) Mixing
Adding puer tea powder (20-80 mesh), mannitol, and extract into a mixer, and mixing at rotation speed of 8 rpm for 30min.
(9) Dry granulation
And granulating the mixed materials by a dry method, and sieving the granules with a 20-mesh sieve to obtain the granules.
(10) Packaging arrangement
And (3) inner packaging: and subpackaging the particles into tea bags, wherein each package is 5g, and packaging the tea bags by using a composite film outer bag to obtain the product.
Comparative example 1:
the composition comprises the following components in parts by weight: 4 parts of fenugreek, 3 parts of cyclocarya paliurus, 3 parts of mulberry leaf, 4 parts of astragalus mongholicus, 4 parts of radix ophiopogonis and 2 parts of mannitol.
The preparation method comprises the following steps:
(1) Weighing: weighing fenugreek, cyclocarya paliurus, mulberry leaf, astragalus membranaceus, dwarf lilyturf tuber and mannitol according to the weight parts of the raw materials;
(2) Pretreatment of
Sieving: taking mannitol and sieving with a 20-mesh sieve for standby.
(3) Extraction of
Reflux-extracting semen Trigonellae, cyclocarya paliurus, folium Mori, radix astragali, and radix Ophiopogonis with 12 times of water for 2 times each for 1 hr, filtering the extractive solution, and mixing filtrates to obtain extractive solution.
(4) Primary concentration
Concentrating the extractive solution under reduced pressure (concentration temperature 40-80deg.C, vacuum degree 0.04-0.09 Mpa) to relative density 1.05-1.1 (measured at 60deg.C), and filtering with 300 mesh filter cloth to obtain concentrated extract I.
(5) Centrifuging
Centrifuging the concentrated extract, setting the parameters of the centrifuge at 4000rpm/min, and centrifuging for 3min.
(6) Secondary concentration
Concentrating the supernatant under reduced pressure (concentration temperature is 40-80 ℃ and vacuum degree is 0.04-0.09 mpa) until relative density is 1.2-1.25 (measured at 60 ℃), and obtaining a second concentrated extract for later use.
(7) Vacuum drying
Drying the concentrated extract II under reduced pressure at 50-65deg.C, and pulverizing to obtain extract.
(8) Mixing
Adding mannitol and the extract into a mixer, and mixing at 8 rpm for 30min.
(9) Dry granulation
And granulating the mixed materials by a dry method, and sieving the granules with a 20-mesh sieve to obtain the granules.
(10) Packaging arrangement
And (3) inner packaging: and subpackaging the particles into tea bags, wherein each package is 5g, and packaging the tea bags by using a composite film outer bag to obtain the product.
Comparative example 2
The composition comprises the following components in parts by weight: 4 parts of fenugreek, 3 parts of cyclocarya paliurus, 3 parts of mulberry leaf, 4 parts of astragalus mongholicus, 2 parts of puer tea and 2 parts of mannitol.
The preparation method comprises the following steps:
(1) Weighing: weighing fenugreek, cyclocarya paliurus, mulberry leaf, astragalus membranaceus, puer tea and mannitol according to the weight parts of the raw materials;
(2) Pretreatment of
(1) Irradiating and crushing: 1/3 of formula amount of puer tea is irradiated (60 Co,5 kGy) and coarsely crushed to obtain puer tea coarse powder for later use.
(2) Sieving: sieving Pu 'er tea coarse powder with 20 mesh sieve, discarding fine powder below 80 mesh to obtain Pu' er tea powder (20-80 mesh); taking mannitol and sieving with a 20-mesh sieve for standby.
(3) Extraction of
Adding 12 times of water into fenugreek, cyclocarya paliurus, mulberry leaf, astragalus and 2/3 of Pu' er tea, reflux-extracting for 2 times, extracting for 1 hour each time, filtering the extracting solution, and mixing the filtrates to obtain extracting solution for later use.
(4) Primary concentration
Concentrating the extractive solution under reduced pressure (concentration temperature 40-80deg.C, vacuum degree 0.04-0.09 Mpa) to relative density 1.05-1.1 (measured at 60deg.C), and filtering with 300 mesh filter cloth to obtain concentrated extract I.
(5) Centrifuging
Centrifuging the concentrated extract, setting the parameters of the centrifuge at 4000rpm/min, and centrifuging for 3min.
(6) Secondary concentration
Concentrating the supernatant under reduced pressure (concentration temperature is 40-80 ℃ and vacuum degree is 0.04-0.09 mpa) until relative density is 1.2-1.25 (measured at 60 ℃), and obtaining a second concentrated extract for later use.
(7) Vacuum drying
Drying the concentrated extract II under reduced pressure at 50-65deg.C, and pulverizing to obtain extract.
(8) Mixing
Adding puer tea powder (20-80 mesh), mannitol, and extract into a mixer, and mixing at rotation speed of 8 rpm for 30min.
(9) Dry granulation
And granulating the mixed materials by a dry method, and sieving the granules with a 20-mesh sieve to obtain the granules.
(10) Packaging arrangement
And (3) inner packaging: and subpackaging the particles into tea bags, wherein each package is 5g, and packaging the tea bags by using a composite film outer bag to obtain the product.
Comparative example 3
The composition comprises the following components in parts by weight: 4 parts of fenugreek, 3 parts of cyclocarya paliurus, 3 parts of mulberry leaf, 4 parts of astragalus mongholicus, 4 parts of radix ophiopogonis, 0.5 part of puer tea and 2 parts of mannitol.
(1) Weighing: weighing fenugreek, cyclocarya paliurus, mulberry leaf, astragalus mongholicus, radix ophiopogonis, puer tea and mannitol according to the weight parts of the raw materials;
(2) Pretreatment of
(1) Irradiating and crushing: 1/3 of formula amount of puer tea is irradiated (60 Co,5 kGy) and coarsely crushed to obtain puer tea coarse powder for later use.
(2) Sieving: sieving Pu 'er tea coarse powder with 20 mesh sieve, discarding fine powder below 80 mesh to obtain Pu' er tea powder (20-80 mesh); taking mannitol and sieving with a 20-mesh sieve for standby.
(3) Extraction of
Adding 12 times of water into the fenugreek, cyclocarya paliurus, mulberry leaf, astragalus mongholicus, radix ophiopogonis and 2/3 of Pu' er tea, reflux-extracting for 2 times, extracting for 1 hour each time, filtering the extracting solution, and mixing the filtrates to obtain an extracting solution for later use.
(4) Primary concentration
Concentrating the extractive solution under reduced pressure (concentration temperature 40-80deg.C, vacuum degree 0.04-0.09 Mpa) to relative density 1.05-1.1 (measured at 60deg.C), and filtering with 300 mesh filter cloth to obtain concentrated extract I.
(5) Centrifuging
Centrifuging the concentrated extract, setting the parameters of the centrifuge at 4000rpm/min, and centrifuging for 3min.
(6) Secondary concentration
Concentrating the supernatant under reduced pressure (concentration temperature is 40-80 ℃ and vacuum degree is 0.04-0.09 mpa) until relative density is 1.2-1.25 (measured at 60 ℃), and obtaining a second concentrated extract for later use.
(7) Vacuum drying
Drying the concentrated extract II under reduced pressure at 50-65deg.C, and pulverizing to obtain extract.
(8) Mixing
Adding puer tea powder (20-80 mesh), mannitol, and extract into a mixer, and mixing at rotation speed of 8 rpm for 30min.
(9) Dry granulation
And granulating the mixed materials by a dry method, and sieving the granules with a 20-mesh sieve to obtain the granules.
(10) Packaging arrangement
And (3) inner packaging: and subpackaging the particles into tea bags, wherein each package is 5g, and packaging the tea bags by using a composite film outer bag to obtain the product.
Comparative example 4
The composition comprises the following components in parts by weight: 2 parts of fenugreek, 3 parts of cyclocarya paliurus, 3 parts of mulberry leaf, 4 parts of astragalus mongholicus, 4 parts of radix ophiopogonis, 7 parts of puer tea and 2.5 parts of mannitol.
(1) Weighing: weighing fenugreek, cyclocarya paliurus, mulberry leaf, astragalus mongholicus, radix ophiopogonis, puer tea and mannitol according to the weight parts of the raw materials;
(2) Pretreatment of
(1) Irradiating and crushing: 1/3 of formula amount of puer tea is irradiated (60 Co,5 kGy) and coarsely crushed to obtain puer tea coarse powder for later use.
(2) Sieving: sieving Pu 'er tea coarse powder with 20 mesh sieve, discarding fine powder below 80 mesh to obtain Pu' er tea powder (20-80 mesh); taking mannitol and sieving with a 20-mesh sieve for standby.
(3) Extraction of
Adding 12 times of water into the fenugreek, cyclocarya paliurus, mulberry leaf, astragalus mongholicus, radix ophiopogonis and 2/3 of Pu' er tea, reflux-extracting for 2 times, extracting for 1 hour each time, filtering the extracting solution, and mixing the filtrates to obtain an extracting solution for later use.
(4) Primary concentration
Concentrating the extractive solution under reduced pressure (concentration temperature 40-80deg.C, vacuum degree 0.04-0.09 Mpa) to relative density 1.05-1.1 (measured at 60deg.C), and filtering with 300 mesh filter cloth to obtain concentrated extract I.
(5) Centrifuging
Centrifuging the concentrated extract, setting the parameters of the centrifuge at 4000rpm/min, and centrifuging for 3min.
(6) Secondary concentration
Concentrating the supernatant under reduced pressure (concentration temperature is 40-80 ℃ and vacuum degree is 0.04-0.09 mpa) until relative density is 1.2-1.25 (measured at 60 ℃), and obtaining a second concentrated extract for later use.
(7) Vacuum drying
Drying the concentrated extract II under reduced pressure at 50-65deg.C, and pulverizing to obtain extract.
(8) Mixing
Adding puer tea powder (20-80 mesh), mannitol, and extract into a mixer, and mixing at rotation speed of 8 rpm for 30min.
(9) Dry granulation
And granulating the mixed materials by a dry method, and sieving the granules with a 20-mesh sieve to obtain the granules.
(10) Packaging arrangement
And (3) inner packaging: and subpackaging the particles into tea bags, wherein each package is 5g, and packaging the tea bags by using a composite film outer bag to obtain the product.
Effect example 1: animal functional test
(1) Test examples
The hypoglycemic compositions prepared in examples 1 to 5 and the compositions prepared in comparative examples 1 to 4 were subjected to animal function tests to investigate the hypoglycemic function of the present invention.
(2) Experimental animal
100 male Kunming rats are selected, and the weight of the male Kunming rats is 160-200 g. And constructing a pancreatic islet injury hyperglycemia model by adopting tetraoxypyrimidine. The method comprises the following steps: after the rats are adapted for 3-5 days, 10 animals are fasted for 3-5 hours at random, and fasting blood glucose is measured as the basal blood glucose value of the batch of animals. The animals were then fasted for 24 hours (free drinking water), model was made by injecting 60mg/kg BW.iv of tetraoxypyrimidine (freshly prepared before use) into rats, and fasted for 3-5 hours after 6 days of dosing, blood glucose was measured, and blood glucose levels of 10-25mmol/L were the successful animals for the hyperglycemic model.
Model rats were randomly divided into 10 groups for experiments. 10 rats in each group, 9 rats in each group were subjected to gavage with the solution of the composition prepared in the above test example, and 1 group of mice was subjected to gavage with sterile water as a model control.
(3) Gastric lavage method and dosage
The recommended dose for the sample is 6g of extract per day for an adult (60 kg body weight), corresponding to 0.1 g/day/kg body weight. The experiment sets 5 times of the recommended amount of human body, namely, 0.5g/kg BW stomach irrigation is carried out every day. Test article treatment method: the solution with the concentration of 0.5g/10mL is prepared by aseptic water for standby. Oral administration is carried out once daily, gastric lavage is carried out continuously for 4 weeks, fasting blood glucose values are measured, and blood glucose values of animals in each group are compared. The lavage volume of the rat was 1.0mL/100g of the rat weight.
The model control group was (0 g/kg BW), and water (sterilized) was used instead of the test substance, and the daily gastric lavage volume was the same as that of each test substance group.
(4) Detection instrument:
strong life One Touch Horizon is a convenient blood glucose meter and matched test paper.
(5) Data processing
Generally, variance analysis is adopted, but the variance homogeneity is checked according to the procedure of variance analysis, and the variance homogeneity is calculatedFThe value of the sum of the values,Fvalue of<F 0.05 Conclusion: the difference between the average numbers of the groups is not significant;Fthe value is not less thanF 0.05 ，PCounting by a comparison method of average values between a plurality of experimental groups and a control group; proper variable conversion is carried out on the data with non-normal or variance, and statistics is carried out on the converted data after the normal or variance alignment requirement is met; if the normal or variance alignment purpose is not achieved after the variable conversion, the rank sum test is used for statistics.
(6) The test results obtained are shown in Table 1.
As can be seen from the experimental results in Table 2, compared with the model control group, rats filled with the hypoglycemic composition provided in examples 1-5 have significantly reduced fasting blood glucose values after the test, and exhibit good hypoglycemic effects.
In comparison with example 3, comparative examples 1-2 lack puer tea and dwarf lilyturf tuber components, respectively, and neither the ratio between comparative example 3 puer tea nor comparative example 4 fenugreek is within the scope of the present invention, resulting in that the blood glucose values of rats that were intragastrically administered with comparative examples 1-4 components are consistent with those of the model control, i.e., did not exhibit efficacy in lowering blood glucose. Therefore, the formula of the invention has the effect of synergistically enhancing the hypoglycemic effect, and when partial components or the proportion of the components in the formula are out of the range defined by the invention, the synergistic effect can be influenced, so that the hypoglycemic effect is reduced.
Effect example 2: human body test food test function test
The testers respectively consumed the teas obtained by soaking the teabags obtained in example 3 and comparative example 1, and conducted a human test feeding test function test.
(1) Subject
(1) The illness state is stable after dietary control or oral hypoglycemic treatment, the drug variety and dosage are not needed to be changed, and only the adult type II diabetes mellitus subject (DM) with the maintenance amount is taken, namely, the fasting blood glucose is more than or equal to 7mmol/L (126 mg/dl) or the blood glucose is more than or equal to 11.lmmol/L (200 mg/dl) after 2 hours of meal.
(2) Impaired Glucose Regulation (IGR) in fasting blood glucose 5.6-7mmol/L (100-126 mg/dl) or 2 hours postprandial blood glucose 7.8-11.lmmol/L (140-200 mg/dl).
(2) Test design and grouping
Two control designs, self and inter-group, were used. Grouping is performed according to the requirements of the random blind method. The blood sugar levels of the subjects are randomly divided into a test feeding group and a control group, and main factors affecting the results, such as the course of disease, the type of medicine taking and the like, are considered as far as possible, so that the equality test is carried out to ensure the comparability among the groups. 60 subjects per group. The test group took the tea obtained by soaking the tea bag obtained in example 3, and the control group took the tea obtained by soaking the tea bag obtained in comparative example 1.
(3) Edible dosage and method
Is taken by soaking in hot water for 45 days 2 times daily with 1 bag each time.
(4) Observation index
(1) Symptomatic observation: the medical history is queried in detail, the eating condition, the medication condition, the activity of the patient are known, the main clinical symptoms such as thirst, polydipsia, polyphagia, hunger, fatigue, diuresis and the like are observed, the integral is carried out according to the light and heavy symptoms, the integral value is counted before and after the test, the main symptoms are improved (improvement is effective in 1 scale), and the improvement rate of the clinical symptoms is observed.
TABLE 2 integration of clinical symptoms
(2) Fasting blood glucose: the test was conducted for the blood glucose level, percentage decrease in blood glucose level, and the effective rate of blood glucose level.
(3) Postprandial 2h blood glucose: the effective rate of the blood sugar level, the percent of the blood sugar reduction after 2h after meal and the blood sugar reduction after 2h after meal after taking 100g of fine powder dumpling head before and after the test is observed.
(4) Side effects and taste acceptance: and observing whether two groups of subjects have feedback of side effects in the process of trial feeding, and simultaneously researching the taste acceptance of the product.
(5) Efficacy determination validation criteria:
the method is effective: a. restoring the fasting blood glucose to be normal (less than or equal to 5.6 mmol/L) after the test, or reducing the fasting blood glucose by more than or equal to 10 percent;
b. the blood sugar returns to normal after 2 hours after the test (less than or equal to 7.8 mmol/L), or the blood sugar reduction amplitude after 2 hours after the test is more than or equal to 10 percent.
Invalidation: the effective standard is not reached.
(5) Data processing and statistical analysis
The self-comparison data can adopt paired t test, the two groups of average comparison adopts grouped t test, the latter needs to carry out variance alignment test, proper luer conversion is carried out on data with non-normal distribution or uneven variance, and t test is carried out by using converted data after normal variance is satisfied. The effective rate adopts x 2 And (5) checking.
(6) Results
The test diet test is carried into 120 subjects, 60 subjects are respectively tested in a test diet group and a control group, 3 subjects are separated from the test diet group after the test is finished, 5 subjects are separated from the control group, and the effective number of the test diet group and the control group is 57 subjects and 55 subjects respectively.
(1) General data comparison prior to testing: inquiring and checking the subjects before the test, comparing the general data of the test feeding group and the control group, wherein the difference has no statistical significanceP>0.05 The two sets of base data are comparable.
(2) Efficacy index affects one: effects on abdominal blood glucose and postprandial 2 hours blood glucose
The test feeding group has the advantages that the fasting blood sugar, the blood sugar after 2 hours after meal and the reduction rate before and after test are compared with the control group, and the difference has statistical significanceP<0.05 A) is provided; the fasting blood sugar before and after the test of the test feeding group and the blood sugar after 2 hours after the meal are compared, and the difference has statistical significanceP<0.05 Compared with the control group, the difference has no statistical significanceP>0.05 The results are shown in Table 3).
TABLE 3 fasting blood glucose before and after test meal and 2 hours postprandial blood glucose changes
(3) Efficacy index impact two: effective rate comparison of various efficacy indexes
The effective rates of fasting blood sugar and postprandial blood sugar of the test group are respectively 43.90 percent and 40.4 percent, and compared with the control group, the difference has statistical significanceP<0.05 The blood sugar lowering effect of the test group is obviously better than that of the control group, and the table 4 shows.
TABLE 4 Table 4
(4) Efficacy index impact three: total integral change of clinical symptoms
The total integral of clinical symptoms of the test feeding group after the test and the reduction rate before and after the test are compared with the comparison group, and the difference has statistical significanceP<0.05 A) is provided; the total integral of clinical symptoms before and after the test feeding group test is compared with the total integral, and the difference has statistical significanceP<0.05 A) is provided; and is opposite toThe comparison difference of the group is not statistically significantP>0.05 See table 5 for details).
Table 5 total integral comparison of clinical symptoms before and after the trial
(5) Efficacy index impact four: side effects and taste acceptance
The incidence rate of side effects of the test feeding group is 7.0 percent, which is obviously lower than that of the control group, and the difference has statistical significanceP<0.05 A) is provided; the acceptance rate of the test feeding group to the products is 89.5%, which is obviously higher than that of the control group, and the difference has statistical significanceP<0.05 The results are shown in Table 6 and Table 7.
Table 6 side effects comparison
Table 7 comparison of taste acceptability of the products
Claims (6)
1. The composition with the blood sugar reducing effect is characterized by comprising the following components in parts by weight: 3-7 parts of fenugreek, 1-7 parts of cyclocarya paliurus, 1-6 parts of mulberry leaf, 2-8 parts of astragalus mongholicus, 2-8 parts of radix ophiopogonis, 1-6 parts of puer tea and 1-6 parts of mannitol;
the preparation method of the composition with the blood sugar reducing effect comprises the following steps:
(1) Weighing: weighing fenugreek, cyclocarya paliurus, mulberry leaf, astragalus mongholicus, radix ophiopogonis, puer tea and mannitol according to the weight parts of the raw materials;
(2) Pretreatment: pretreating Pu 'er tea with the formula amount of 1/3 to obtain Pu' er tea powder; sieving mannitol with 20 mesh sieve; the pretreatment comprises the following steps: 1/3 of the formula amount of puer tea is irradiated and then coarsely crushed to obtain puer tea coarse powder, the puer tea coarse powder is screened by a 20-mesh screen, fine powder below 80 meshes is removed, and 20-80-mesh puer tea powder is obtained, wherein 60 Co-gamma rays are adopted to irradiate 1/3 of the formula amount of puer tea, and the radiation dose is 5 KGy;
(3) Extracting: reflux-extracting semen Trigonellae, cyclocarya paliurus, folium Mori, radix astragali, radix Ophiopogonis and 2/3 of Pu' er tea with 12 times of water for 2 times each for 1 hr, filtering the extractive solution, and mixing filtrates to obtain extractive solution;
(4) Concentrating and drying: concentrating the filtrate obtained in the step (3) for the first time, centrifuging, concentrating for the second time, and drying to obtain an extract;
(5) Adding the puer tea powder prepared in the step (2), mannitol and the extract prepared in the step (4) into a mixer for mixing;
(6) The mixed materials are granulated and packaged by a dry method to obtain the composition with the blood sugar reducing effect.
2. The composition with the hypoglycemic effect according to claim 1, wherein the composition is prepared from the following components in parts by weight: 4-6 parts of fenugreek, 2-5 parts of cyclocarya paliurus, 2-5 parts of mulberry leaf, 2-5 parts of astragalus, 2-5 parts of dwarf lilyturf tuber, 1-3 parts of puer tea and 1-4 parts of mannitol.
3. The hypoglycemic composition according to claim 1, wherein the step (4) comprises:
primary concentration: concentrating the combined filtrate obtained in the step (3) to a relative density of 1.05-1.1 measured at 60 ℃ under reduced pressure, and filtering with 300-mesh filter cloth to obtain a first concentrated extract;
and (3) centrifuging: centrifuging the concentrated extract I at 4000rpm/min for 3min;
secondary concentration: concentrating the supernatant under reduced pressure until the relative density is 1.2-1.25 at 60 ℃ to obtain a second concentrated extract;
and (3) drying: drying the second concentrated extract at 50-65deg.C under reduced pressure, and pulverizing to obtain extract.
4. The composition with hypoglycemic effect according to claim 3, wherein the concentration temperature of the primary concentration and the concentration temperature of the secondary concentration are both 40-80 ℃ and the vacuum degree is 0.04-0.09 mpa.
5. The composition for reducing blood glucose according to claim 1, wherein in the step (5), the rotation speed of the mixer is 8 rpm and the mixing time is 30min.
6. The composition with hypoglycemic effect as claimed in claim 1, wherein in the step (6), the mixed material is dry granulated through a 20 mesh sieve to obtain granules; and subpackaging the granules into tea bags, wherein each package contains 5g of granules, and packaging the granules by using a composite film outer bag to obtain the composition with the blood sugar reducing effect.
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| CN107319553A (en) * | 2017-07-10 | 2017-11-07 | 溧阳市天目湖保健品有限公司 | A kind of health products of auxiliary hyperglycemic strengthen immunity and preparation method thereof |
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| CN113826731A (en) * | 2021-09-22 | 2021-12-24 | 贺新义 | Preparation method of green mulberry and citrus Pu' er tea |
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Denomination of invention: A composition with hypoglycemic effect and its preparation method Granted publication date: 20230428 Pledgee: Pudong Development Bank of Shanghai Limited by Share Ltd. Shijiazhuang branch Pledgor: HEBEI YUZHILIN BIOTECHNOLOGY Co.,Ltd. Registration number: Y2024980013359 |