CN112168861A - Astragalus granules and preparation method thereof - Google Patents

Astragalus granules and preparation method thereof Download PDF

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Publication number
CN112168861A
CN112168861A CN202011023534.8A CN202011023534A CN112168861A CN 112168861 A CN112168861 A CN 112168861A CN 202011023534 A CN202011023534 A CN 202011023534A CN 112168861 A CN112168861 A CN 112168861A
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astragalus
parts
granules
extract
powder
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王志标
张元坤
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Anhui Kangxin Pharmaceutical Co ltd
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Anhui Kangxin Pharmaceutical Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/481Astragalus (milkvetch)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/23Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics

Abstract

The invention discloses astragalus mongholicus particles which are prepared from the following raw materials in parts by weight: 10-30 parts of astragalus extract, 10-15 parts of pumpkin polysaccharide and 2-4 parts of probiotic fermented carrot pulp. Mixing radix astragali extract, pumpkin polysaccharide and probiotic fermented carrot pulp uniformly, drying under reduced pressure, micronizing, and sieving to obtain mixed powder; adding 2 times of starch into the above mixed powder, mixing, making into granule with pill making machine, sterilizing, and packaging. The astragalus extract used in the invention realizes high-value effective utilization of waste; the astragalus extract can remarkably improve the intestinal health of a diabetic patient by improving the intestinal flora; in an in vitro test, the pumpkin polysaccharide has the potential of enhancing the proliferation activity of islet cells; probiotic fermentation can enhance the functional properties of the carrot component; the production process of the astragalus granules is simple and quick, and is suitable for industrial production.

Description

Astragalus granules and preparation method thereof
Technical Field
The invention relates to the technical field of medicines, and particularly relates to astragalus membranaceus particles and a preparation method thereof.
Background
With the change of living standard of human, the incidence of metabolic and endocrine diseases such as diabetes mellitus is increasing year by year. Diabetes is classified into type 1 and type 2, and clinically more than 90% of patients have type 2diabetes mellitus (T2 DM). The prevention and treatment of diabetes and complications thereof are important scientific problems faced by China at present. The main cause of the onset of T2DM is insulin resistance, which not only extends throughout the entire process of T2DM, but is also a major causative factor in many metabolic diseases. Insulin Resistance (IR) refers to a condition in which the target organ on which insulin acts has a reduced responsiveness to insulin, i.e., a condition in which a normal dose of insulin produces less than normal biological effects.
At present, western medicines are mainly used for treating diabetes, and comprise an alpha-glycosidase inhibitor such as bayer glucose, and medicines for promoting glucose absorption such as metformin and the like, although the hypoglycemic effect is quick, the effect is single, the islet burden is increased, side effects such as hypoglycemia and gastrointestinal tract reaction exist, the cognitive dysfunction related to metabolic disorder is a common complication of diabetes, the hypoglycemic effect is in a reduction trend along with the prolonging of the treatment time, and the toxic and side effects of liver and kidney can be caused after long-term administration. Diabetes is a diabetes-related disease in traditional Chinese medicine, and has the clinical manifestations of more than three and one less, namely that more people eat more and more people drink more and more people have less excretion and absorption, which is a recognized chronic disease in the world, is difficult to cure and is a lifelong disease. At present, no good treatment method exists, the disease can be maintained only by medicaments, and according to the medical principle, the disease is mainly endocrine dyscrasia, and causes the symptoms of insufficient or no insulin secretion, increased blood sugar and urine sugar in vivo, low metabolism, limb weakness, visual deterioration and the like.
Astragalus, also known as astragalus membranaceus, perennial herbs with a height of 50-100 cm, thick main roots, wood, frequent branches, grey white, upright stems, multi-branches at the upper part, thin edges and white velvety hair; produced in inner Mongolia, Shanxi, Gansu, Heilongjiang, etc. The medicinal use of astragalus has been in the history of more than 2000 years so far, and has the functions of enhancing the body immunity, protecting the liver, promoting urination, resisting aging, stress and pressure, lowering blood pressure and wider antibacterial action, astragalus has been used in traditional Chinese medicines for thousands of years due to the pharmacological action, and a large number of researches on human and animal models in the past decades show that astragalus has the function of resisting diabetes.
Natural products are developed by modern research means, and health-care food with active ingredients derived from food and medicinal and edible traditional Chinese medicines is developed, so that the medicine dosage can be reduced by assisting chemical medicines, and the toxic and side effects are reduced; the composition is suitable for patients with mild symptoms by taking alone, and can be taken for a long time; has important social value for improving the symptoms of the patients with the metabolic diseases and relieving the pain of the patients.
Disclosure of Invention
In order to partially solve the technical problems, the invention provides astragalus mongholicus particles and a preparation method thereof, and the specific technical scheme is as follows: the astragalus membranaceus particles are prepared from the following raw materials in parts by weight: 10-30 parts of astragalus extract, 10-15 parts of pumpkin polysaccharide and 2-4 parts of probiotic fermented carrot pulp.
Preferably, the astragalus particles are prepared from the following raw materials in parts by weight: 30 parts of astragalus extract, 10 parts of pumpkin polysaccharide and 4 parts of probiotic fermented carrot pulp.
The astragalus extract is obtained by the following method: drying the waste residue extracted from the industrial radix astragali in an oven at 60 ℃ for 4h, sieving and grinding the waste residue into powder, dissolving the powder in double distilled water, and standing the powder at 50 ℃ for 6 h; removing insoluble part, adding anhydrous ethanol to make ethanol final concentration be 80%, mixing thoroughly, standing overnight at 4 deg.C; centrifuging to collect precipitate, washing with anhydrous ethanol, acetone and anhydrous diethyl ether, and drying in vacuum drying chamber to obtain desired radix astragali extract.
The concentration of the above sieved powder in double distilled water was 10 g/L.
The pumpkin polysaccharide is obtained by the following method: (1) peeling fresh fructus Cucurbitae Moschatae, slicing, drying in sunlight until completely dried, and grinding into powder; (2) dissolving pumpkin powder with hot distilled water and ethanol, sequentially purifying the aqueous phase extract with diethyl ether and n-butanol, deproteinizing with sevag reagent, concentrating, filtering, adding 4 times of cold anhydrous ethanol into the filtrate, standing the mixed solution at 4 deg.C overnight, centrifuging, and lyophilizing to obtain pumpkin polysaccharide.
The probiotic fermented carrot pulp is obtained through the following steps: inoculating the sterilized carrot pulp with lactobacillus plantarum, and fermenting at 37 ℃ for 24 hours; then, sterilizing the fermented carrot pulp at 105 ℃ for 20s to obtain the probiotic fermented carrot pulp.
The astragalus granules also comprise pharmaceutically acceptable auxiliary materials, and the pharmaceutically acceptable auxiliary materials comprise starch.
A preparation method of astragalus granules comprises the following steps: mixing radix astragali extract, pumpkin polysaccharide and probiotic fermented carrot pulp uniformly, drying under reduced pressure, micronizing, and sieving to obtain mixed powder; adding 2 times of starch into the above mixed powder, mixing, making into granule with pill making machine, sterilizing, and packaging.
Compared with the prior art, the invention has the following advantages:
1. the astragalus is a raw material for preparing the medicine, namely the ginseng-astragalus strengthening injection, the ginseng-astragalus strengthening injection is prepared from supernatant of an astragalus extract precipitated by ethanol, and part of the ethanol precipitate cannot exert the residual value of the ethanol precipitate; the astragalus extract can remarkably improve the intestinal health of a diabetic patient by improving the intestinal flora;
2. in an in vitro test, the pumpkin polysaccharide has the potential of enhancing the proliferation activity of islet cells; the use of pumpkin polysaccharide restores liver glycogen and insulin to normal levels and significantly lowers blood glucose levels, and it can be used as a functional and nutritional food ingredient; the pumpkin polysaccharide and the astragalus extract are used in a matching way, so that the blood sugar is indirectly reduced by enhancing the proliferation activity of islet cells, and complications related to the diabetes intestinal diseases can be obviously improved through the astragalus extract; the invention can be directly orally taken, so that the taste of the astragalus granules is improved;
3. carrots contain many nutritional ingredients, especially rich in carbohydrates and carotenoids, of which various ingredients are indicated for functional properties related to health, such as antioxidants, anticancer agents, enhancing body immunity and vitamin a supplements, it is indicated in the prior art that probiotic fermentation can enhance the functional properties of its ingredients;
4. the production process of the astragalus granules is simple and quick, and is suitable for industrial production.
Detailed Description
The technical solutions of the present invention will be described clearly and completely with reference to the following embodiments of the present invention, and it should be understood that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
The astragalus root extracts used in the following examples were obtained by the following method: drying the waste residue extracted from the industrial radix astragali in an oven at 60 ℃ for 4h, sieving and grinding the waste residue into powder, dissolving the powder in double distilled water, and standing the powder at 50 ℃ for 6h, wherein the concentration of the sieved powder in the double distilled water is 10 g/L; removing insoluble part, adding anhydrous ethanol to make ethanol final concentration be 80%, mixing thoroughly, standing overnight at 4 deg.C; centrifuging to collect precipitate, washing with anhydrous ethanol, acetone and anhydrous diethyl ether, and drying in vacuum drying chamber to obtain desired radix astragali extract.
The pumpkin polysaccharide used in the following examples is obtained by the following method: (1) peeling fresh fructus Cucurbitae Moschatae, slicing, drying in sunlight until completely dried, and grinding into powder; (2) dissolving pumpkin powder with hot distilled water and ethanol, sequentially purifying the aqueous phase extract with diethyl ether and n-butanol, deproteinizing with sevag reagent, concentrating, filtering, adding 4 times of cold anhydrous ethanol into the filtrate, standing the mixed solution at 4 deg.C overnight, centrifuging, and lyophilizing to obtain pumpkin polysaccharide.
The probiotic fermented carrot pulp used in the following examples was obtained by the following steps: inoculating the sterilized carrot pulp with lactobacillus plantarum, and fermenting at 37 ℃ for 24 hours; then, sterilizing the fermented carrot pulp at 105 ℃ for 20s to obtain the probiotic fermented carrot pulp.
Example 1:
a preparation method of radix astragali granules comprises the following steps:
(1) uniformly mixing 10 parts of astragalus extract, 10 parts of pumpkin polysaccharide and 2 parts of probiotic fermented carrot pulp, drying under reduced pressure, carrying out superfine grinding treatment, and sieving to obtain mixed powder; adding 44 parts of starch into the mixed powder, uniformly mixing again, making into small granular medicine granules by using a pill making machine, sterilizing and packaging.
Example 2:
a preparation method of radix astragali granules comprises the following steps:
(1) uniformly mixing 10 parts of astragalus extract, 15 parts of pumpkin polysaccharide and 2 parts of probiotic fermented carrot pulp, drying under reduced pressure, carrying out superfine grinding treatment, and sieving to obtain mixed powder; adding 54 parts of starch into the mixed powder, uniformly mixing again, making into small granular medicine granules by using a pill making machine, sterilizing and packaging.
Example 3:
a preparation method of radix astragali granules comprises the following steps:
(1) uniformly mixing 30 parts of astragalus extract, 10 parts of pumpkin polysaccharide and 4 parts of probiotic fermented carrot pulp, drying under reduced pressure, carrying out superfine grinding treatment and sieving to obtain mixed powder; adding 88 parts of starch into the mixed powder, uniformly mixing again, making into small granular medicine granules by using a pill making machine, sterilizing and packaging.
Example 4:
a preparation method of radix astragali granules comprises the following steps:
(1) uniformly mixing 20 parts of astragalus extract and 4 parts of probiotic fermented carrot pulp, drying under reduced pressure, carrying out superfine grinding treatment, and sieving to obtain mixed powder; adding 48 parts of starch into the mixed powder, uniformly mixing again, making into small granular medicine granules by using a pill making machine, sterilizing and packaging.
Example 5:
a preparation method of radix astragali granules comprises the following steps:
(1) uniformly mixing 30 parts of astragalus extract, 10 parts of pumpkin polysaccharide and 4 parts of unfermented carrot pulp, drying under reduced pressure, carrying out superfine grinding treatment, and sieving to obtain mixed powder; adding 88 parts of starch into the mixed powder, uniformly mixing again, making into small granular medicine granules by using a pill making machine, sterilizing and packaging.
Test example 1: rat diabetes model establishment
1.1: moulding group
Selecting a plurality of SPF (specific pathogen free) rats, injecting 40mg/kg of streptozotocin solution into the abdominal cavity (prepared by citric acid buffer solution with pH of 4.2) after fasting for 12 hours, taking 10 of the rats as a blank control group, and injecting the citric acid buffer solution with the same volume into the blank control group; and (5) after 72h, sampling blood from the retroorbital venous plexus to determine fasting blood glucose. Taking a diabetic rat with blood sugar of more than or equal to 11mmol/L, adding 35mg/kg of streptozotocin to the diabetic rat with blood sugar of less than 11mmol/L every other day, and randomly measuring the blood sugar of more than or equal to 11mmol/L after 1 week to obtain a diabetic model rat with obvious symptoms of polydipsia, polyphagia and polyuria; 70 rats which are successfully molded are taken and randomly divided into 7 groups again, namely a model control group, a metformin group, an embodiment 1 group, an embodiment 2 group, an embodiment 3 group, an embodiment 4 group and an embodiment 5 group; the male rat and the female rat in each group are half respectively; except for a blank control group and a model control group, rats in each group are administered with the drug by intragastric administration once a day for 28 days in total; wherein the blank control group and the model control group are given with 20ml/kg physiological saline, the other groups are prepared into suspension solution with the total concentration of the active ingredients of the medicine of 10mg/L by the corresponding medicine and distilled water, and the suspension solution is perfused into the stomach according to 20 ml/kg; during the experiment, rats had standard diet and free drinking water; fasting was 18 hours on day 27, and fasting blood glucose (FBC) was measured 2 hours after the last dose on day 28.
1.2: detecting the index
1.2.1: general state observation: regular observations include mental status, body mass, urine volume, etc. of the animals.
1.2.2: determination of fasting blood glucose: after 72h of model building and 4 weeks of treatment, 1mL of blood is collected from orbital sinus of each group of rats at 3000r/min, centrifuged for 15min, and serum is separated and determined according to the instruction of a glucose liquid kit.
1.2.3: and (3) determination of biochemical indexes: each group of rats is subjected to neck breaking and blood taking, 3000r/min, centrifugation for 15min, serum and hemoglobin separation, and storage at the temperature of-20 ℃ is carried out, and the operation and the determination are carried out according to the instructions of an insulin kit and a glycosylated hemoglobin determination kit.
1.3: results of the experiment
1.3.1: the results of comparison of the quality of the treated forebody and hindbody of each group of rats are shown in table 1, and table 1 shows the influence of the embodiment of the invention on the quality of the treated forebody and hindbody of each group of rats.
TABLE 1 Effect on treatment of forebody and hindbody quality in groups of rats
Figure BDA0002701437050000051
Figure BDA0002701437050000052
Figure BDA0002701437050000061
The experimental result data of the blank control group, the model control group and the examples 1 to 5 in the table 1 show that the astragalus particles provided by the invention can obviously reduce the decrease of the body mass of diabetes mice caused by streptozotocin.
1.3.2: the comparison of fasting plasma glucose before and after treatment of each group of rats is shown in table 2, and table 2 is the comparison result of fasting plasma glucose before and after treatment of each group of rats according to the embodiment of the present invention.
TABLE 2 fasting plasma glucose effect before and after treatment in rats of each group: (
Figure BDA0002701437050000062
n=10)
Grouping Before treatment (mmol/L) After four weeks of treatment (mmol/L)
Blank control group 6.21±0.68 6.94±3.78
Model control group 15.64±3.14 21.36±5.68
Metformin hydrochloride 15.28±6.21 9.27±7.31
Example 1 16.05±2.49 10.39±4.69
Example 2 15.99±3.75 9.67±5.39
Example 3 16.94±6.12 9.89±6.14
Example 4 15.38±4.32 16.18±4.61
Example 5 16.73±6.25 10.46±6.58
As can be seen from table 2, the blood glucose levels of the blank control group before and after treatment changed, and after 4 weeks of administration, the blood glucose of the model control group showed an upward trend, which was significantly different from that of the blank control group, and the blood glucose of the metformin group and the groups of examples 1 to 5 showed a downward trend.
1.3.3: the results of the biochemical indexes are shown in Table 3, and Table 3 shows the influence of the example of the present invention on the biochemical indexes of the rats in each group.
TABLE 3 Effect on Biochemical indicators of various groups of rats: (
Figure BDA0002701437050000063
n=10)
Figure BDA0002701437050000064
Figure BDA0002701437050000071
The results in table 3 show that both the metformin group and the groups in examples 1 to 5 can reduce glycated hemoglobin and increase serum insulin secretion, but the effect of the present invention is significantly superior to that of the metformin group.
The results show that the astragalus mongholicus particles disclosed by the invention can obviously regulate the fasting blood glucose of normal mice, reduce the fasting blood glucose of diabetic rats caused by streptozotocin and have ideal regulating action on glycosylated hemoglobin and serum insulin, and the astragalus mongholicus particles have the effects of improving the blood glucose and obviously assisting in reducing the blood glucose and also show obvious advantageous action compared with the existing metformin.
Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that changes, modifications, substitutions and alterations can be made in these embodiments without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.

Claims (8)

1. An astragalus granule is characterized in that: the feed is prepared from the following raw materials in parts by weight: 10-30 parts of astragalus extract, 10-15 parts of pumpkin polysaccharide and 2-4 parts of probiotic fermented carrot pulp.
2. The astragalus granules of claim 1, wherein: the astragalus particles are prepared from the following raw materials in parts by weight: 30 parts of astragalus extract, 10 parts of pumpkin polysaccharide and 4 parts of probiotic fermented carrot pulp.
3. The astragalus granules of claim 2, wherein: the astragalus extract is obtained by the following method: drying the waste residue extracted from the industrial radix astragali in an oven at 60 ℃ for 4h, sieving and grinding the waste residue into powder, dissolving the powder in double distilled water, and standing the powder at 50 ℃ for 6 h; removing insoluble part, adding anhydrous ethanol to make ethanol final concentration be 80%, mixing thoroughly, standing overnight at 4 deg.C; centrifuging to collect precipitate, washing with anhydrous ethanol, acetone and anhydrous diethyl ether, and drying in vacuum drying chamber to obtain desired radix astragali extract.
4. The astragalus granules of claim 3, wherein: the concentration of the sieved powder in double distilled water was 10 g/L.
5. The astragalus granules of claim 1, wherein: the pumpkin polysaccharide is obtained by the following method: (1) peeling fresh fructus Cucurbitae Moschatae, slicing, drying in sunlight until completely dried, and grinding into powder; (2) dissolving pumpkin powder with hot distilled water and ethanol, sequentially purifying the aqueous phase extract with diethyl ether and n-butanol, deproteinizing with sevag reagent, concentrating, filtering, adding 4 times of cold anhydrous ethanol into the filtrate, standing the mixed solution at 4 deg.C overnight, centrifuging, and lyophilizing to obtain pumpkin polysaccharide.
6. The astragalus granules of claim 1, wherein: the probiotic fermented carrot pulp is obtained through the following steps: inoculating the sterilized carrot pulp with lactobacillus plantarum, and fermenting at 37 ℃ for 24 hours; then, sterilizing the fermented carrot pulp at 105 ℃ for 20s to obtain the probiotic fermented carrot pulp.
7. The astragalus granules of claim 1, wherein: the radix astragali granules also comprise pharmaceutically acceptable auxiliary materials, and the pharmaceutically acceptable auxiliary materials comprise starch.
8. The method for preparing astragalus membranaceus particles according to any one of claims 1 to 7, which is characterized by comprising the following steps: mixing radix astragali extract, pumpkin polysaccharide and probiotic fermented carrot pulp uniformly, drying under reduced pressure, micronizing, and sieving to obtain mixed powder; adding 2 times of starch into the mixed powder, uniformly mixing again, making into small granular medicine granules by a pill making machine, sterilizing and packaging.
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