CN114732876B - Traditional Chinese medicine composition for treating type II diabetes - Google Patents

Traditional Chinese medicine composition for treating type II diabetes Download PDF

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CN114732876B
CN114732876B CN202210306365.1A CN202210306365A CN114732876B CN 114732876 B CN114732876 B CN 114732876B CN 202210306365 A CN202210306365 A CN 202210306365A CN 114732876 B CN114732876 B CN 114732876B
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chinese medicine
radix
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CN114732876A (en
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孟杰
葛一蒙
梁楚力
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Anhui Jiuzhou Fangyuan Pharmaceutical Co ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/36—Caryophyllaceae (Pink family), e.g. babysbreath or soapwort
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/482—Cassia, e.g. golden shower tree
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/488—Pueraria (kudzu)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • A61K36/718—Coptis (goldthread)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/80—Scrophulariaceae (Figwort family)
    • A61K36/804—Rehmannia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8968—Ophiopogon (Lilyturf)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating type II diabetes mellitus, which comprises the following components: the radix pseudostellariae, the rehmannia root, the dwarf lilyturf tuber, the kudzuvine root, the cassia seed, the corn silk and the coptis root have the advantages of obvious curative effect on treating type II diabetes, simple formula and preparation process and no side effect.

Description

Traditional Chinese medicine composition for treating type II diabetes
Technical Field
The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating type II diabetes.
Background
Diabetes is a common metabolic disease, and the incidence is related to genetic factors, life style, dietary structure, age and other factors. Diabetes mellitus can be divided into two categories according to the pathological characteristics that patients show: type I diabetes and type II diabetes, also known as non-insulin dependent diabetes. Type ii diabetes is mainly characterized by: insulin secretion from pancreatic beta cells decreases and insulin action decreases, i.e., insulin resistance.
Type ii diabetics are characterized by hyperglycemia, relative lack of insulin, insulin resistance, and the like. Common symptoms are Polydipsia, frequent urination, weight loss of unknown origin, and may also include overeating, tiredness or soreness. Long-term complications from hyperglycemia include heart disease, stroke, diabetic retinopathy, which can lead to blindness, renal failure, and even poor blood flow to the extremities, requiring amputation, rarely with diabetic ketoacidosis.
The clinical medicines for treating type II diabetes are chemical medicines except insulin, and can be widely applied and roughly divided into sulfonylureas, biguanides, other hypoglycemic medicines and auxiliary medicines. Sulfonylureas hypoglycemic agents are the most prominent therapeutic agents for diabetes. Can increase liver glycogen synthesis, and increase insulin sensitivity of surrounding tissues and glucose uptake by cell receptor or receptor postaction, thereby reducing blood sugar. But is more prone to cause adverse reactions such as hypoglycemia, granulocytopenia, cardiovascular diseases and the like. The biguanide hypoglycemic agent can cause digestive tract reaction in large dose, and is easy to cause lactic acidosis in patients with pathological changes of lung, liver and kidney. The potential safety hazard is brought to the administration of patients, and in order to change the situation, the treatment by using plant Chinese herbal medicines is tried clinically for a long time.
For example, the ginseng and astragalus blood sugar reducing granule comprises the following components: ginsenoside (stem and leaf), fructus Schisandrae, radix astragali, rhizoma Dioscoreae, rehmanniae radix, rubi fructus, radix Ophiopogonis, poria, radix Trichosanthis, alismatis rhizoma, and fructus Lycii. The main functions are as follows: replenishing qi, nourishing yin, nourishing spleen and tonifying kidney. It is used for treating diabetes and type II diabetes.
Jiangtangning capsule, the prescription of the medicine is: 30g of ginseng, 120g of dwarf lilyturf tuber, 60g of dogwood, 120g of Chinese yam, 300g of gypsum, 100g of rhizoma anemarrhenae, 120g of astragalus mongholicus, 150g of radix trichosanthis, 120g of poria cocos, 120g of dwarf lilyturf tuber, 150g of radix rehmanniae, 150g of cortex lycii radicis, 150g of corn silk and 60g of liquorice. The main functions are as follows: replenishing qi, nourishing yin, and promoting salivation. It is used for treating diabetes due to deficiency of both qi and yin.
Diabetes treating pill, the medicine composition formula: radix Puerariae, rehmanniae radix, radix astragali, radix Trichosanthis, stigma Maydis, fructus Schisandrae Sphenantherae, rhizoma Dioscoreae, and glibenclamide. The main functions are as follows: nourish kidney and yin, benefit qi and promote the production of body fluid. Can be used for treating diabetes due to deficiency of both qi and yin, with symptoms of polydipsia, diuresis, polyphagia, emaciation, tiredness, debilitation, poor sleep, and lumbago; type 2 diabetes mellitus is the condition.
The Chinese patent application CN109157617A discloses a traditional Chinese medicine composition for treating diabetes, which is prepared from the following raw materials, by weight, 20-25 parts of rhizoma polygonati, 22-24 parts of Chinese yam, 20-23 parts of schisandra chinensis, 21-24 parts of radix rehmanniae, 23-25 parts of radix asparagi, 20-24 parts of dark plum, 22-25 parts of mulberry, 21-23 parts of sappan wood, 20-25 parts of horsetail, 20-23 parts of red sage root, 23-25 parts of suberect spatholobus stem, 10-12 parts of campsis grandiflora, 10-13 parts of pipewort, 11-14 parts of reed rhizome, 11-15 parts of stiff silkworm, 10-13 parts of kudzuvine root and 10-14 parts of luffa.
The Chinese patent application CN106177622A discloses a traditional Chinese medicine composition for treating diabetes, which is prepared from the following raw materials, by weight, 3-10 parts of rhizoma atractylodis, 9-30 parts of semen coicis, 3-6 parts of fructus amomi, 3-15 parts of fingered citron, 9-15 parts of radix puerariae, 3-15 parts of cortex lycii radicis, 5-15 parts of folium mori, 6-15 parts of glossy privet fruit, 5-15 parts of perilla fruit, 5-15 parts of stiff silkworm, 3-15 parts of citron, 3-10 parts of dried orange peel, 6-15 parts of lily, 10-15 parts of hawthorn, 1-5 parts of cinnamon, 9-15 parts of poria cocos, 3-6 parts of fennel, 6-15 parts of dwarf lilyturf tuber, 9-15 parts of gorgon fruit, 6-15 parts of Chinese date, 10-15 parts of malt, 6-15 parts of fragrant solomonseal rhizome and 6-10 parts of ootheca mantidis.
However, the traditional Chinese medicine composition has more raw medicines, a complex formula and certain side effects, and the curative effect of the traditional Chinese medicine composition is still to be further improved.
Therefore, it is very necessary to develop a Chinese medicinal composition for treating type II diabetes which can solve the above technical problems.
Disclosure of Invention
The invention aims to overcome the defects of the prior art and provide the traditional Chinese medicine composition for treating the type II diabetes mellitus, which has the advantages of obvious curative effect, simple formula and preparation process and no side effect.
The invention is realized by the following technical scheme:
a Chinese medicinal composition for treating type II diabetes comprises the following components: radix Pseudostellariae, rehmanniae radix, radix Ophiopogonis, radix Puerariae, semen Cassiae, stigma Maydis and Coptidis rhizoma.
The medicinal materials or decoction pieces used in the invention all meet the first requirement of the 2020 edition of Chinese pharmacopoeia or the processing specification of Chinese medicinal decoction pieces of Anhui province (2019 edition).
Radix Pseudostellariae is dried root tuber of radix Pseudostellariae Pseudostellaria heterophylla (Miq.) Pax ex Pax et Hoffm of Caryophyllaceae.
Rehmannia root is fresh or dried root tuber of rehmannia Rehmannia glutinosa Libosch of Scrophulariaceae.
Radix Ophiopogonis is dry root tuber of Ker-GawL of liliaceae plant Ophiopogon japonicus (L.f).
Radix Puerariae is dry root of Pueraria lobata (Willd.) Ohwi of Leguminosae. It is known as Pueraria lobata.
Semen Cassiae is dry mature seed of Cassia obtusifolia Cassia obtusifolia L or Cassia parvifolia tora L.
Corn silk is the dried flower and column head of Zea mays L.
Coptis chinensis Franch of Ranunculaceae is the dried rhizome of Coptis chinensis deltasnap C.Y. Cheng et Hsiao or Coptis teeta wall.
Preferably, the traditional Chinese medicine composition comprises the following components in parts by weight: 65-85 parts of radix pseudostellariae, 210-250 parts of rehmannia, 210-250 parts of dwarf lilyturf tuber, 210-250 parts of kudzuvine root, 210-250 parts of cassia seed, 210-250 parts of corn silk and 200-240 parts of coptis chinensis.
Preferably, the traditional Chinese medicine composition comprises the following components in parts by weight: 70-80 parts of radix pseudostellariae, 220-240 parts of rehmannia, 220-240 parts of dwarf lilyturf tuber, 210-240 parts of kudzuvine root, 210-240 parts of cassia seed, 210-240 parts of corn silk and 210-240 parts of coptis chinensis.
Preferably, the traditional Chinese medicine composition comprises the following components in parts by weight: 77.1 parts of radix pseudostellariae, 231.2 parts of rehmannia, 231.2 parts of dwarf lilyturf tuber, 231.2 parts of kudzuvine root, 231.2 parts of cassia seed, 231.2 parts of corn silk and 230 parts of coptis chinensis.
The invention also relates to a preparation process of the traditional Chinese medicine composition, which comprises the following steps: decocting 7 raw materials with water for 1-2 times (6-10 times of water for 1-2 hr each time), filtering, mixing filtrates, concentrating, and drying.
Preferably, 7 raw materials are decocted with water twice, the first time is decocted with 10 times of water for 1 hour, the second time is decocted with 8 times of water for 1 hour, the filtrate is filtered, and the filtrate is combined, concentrated and dried to obtain the traditional Chinese medicine.
The invention also relates to a preparation comprising the traditional Chinese medicine composition or the traditional Chinese medicine composition prepared by the preparation process.
Preferably, the formulation is in the form of granules.
The invention also relates to a preparation process of the preparation, which comprises the following steps: decocting 7 raw materials with water for 1-2 times (6-10 times of water for 1-2 hr each time), filtering, mixing filtrates, concentrating, adding dextrin, drying, adding dextrin, mixing, and granulating.
Preferably, the preparation process of the preparation comprises the following steps: decocting 7 raw materials with water twice, decocting for 1 hour with 10 times of water for 1 hour, decocting for 1 hour with 8 times of water for the second time, filtering, mixing filtrates, concentrating under reduced pressure to obtain fluid extract with relative density of 1.05-1.10 (60 ℃) and dextrin accounting for 15% -25% of the weight of the 7 raw materials, mixing, spray drying, adding dextrin accounting for 20% -30% of the weight of the 7 raw materials, mixing, and granulating.
More preferably, the preparation process of the preparation comprises the following steps: decocting 7 raw materials with water twice, decocting with 10 times of water for 1 hour for the first time, decocting with 8 times of water for 1 hour for the second time, filtering, mixing filtrates, concentrating under reduced pressure to obtain fluid extract with relative density of 1.05-1.10 (60 ℃) and dextrin accounting for 20% of the weight of 7 raw materials, mixing, spray drying, adding dextrin accounting for 26% of the weight of 7 raw materials, mixing, and granulating.
The invention also relates to the application of the traditional Chinese medicine composition or the traditional Chinese medicine composition prepared by the preparation process or the preparation prepared by the preparation process in preparing medicines for treating type II diabetes.
The beneficial effects of the invention are as follows:
the traditional Chinese medicine composition disclosed by the invention has obvious synergistic effect of all components, can tonify qi and nourish yin, clear heat and quench thirst, and is used for treating type II diabetes with deficiency of both qi and yin, and the curative effect is obvious.
The radix pseudostellariae in the prescription has the effects of tonifying qi and nourishing yin and can be used as a monarch; the rehmannia root has the effects of clearing heat, cooling blood and nourishing yin, the dwarf lilyturf tuber has the effects of promoting the production of body fluid and nourishing yin, and the two medicines assist the monarch and minister; corn silk has the effects of inducing diuresis to alleviate edema, cassia seed has the effects of clearing heat and relaxing bowel, and is used together, so that the pathogenic heat is eliminated from the urine and the root of kudzu vine can raise yang and relieve muscle, and the three medicines are combined together as an adjuvant. Huang Lian is used to clear heat and dry dampness. The medicines are combined together to play the roles of tonifying qi and yin, clearing heat and quenching thirst.
Detailed Description
The invention will be further described with reference to specific embodiments, and advantages and features of the invention will become apparent from the description. These examples are merely exemplary and do not limit the scope of the invention in any way. It will be understood by those skilled in the art that various changes and substitutions of details and forms of the technical solution of the present invention may be made without departing from the spirit and scope of the present invention, but these changes and substitutions fall within the scope of the present invention.
Example 1
A traditional Chinese medicine composition for treating type II diabetes comprises the following components in parts by weight: 65 parts of radix pseudostellariae, 250 parts of rehmannia, 250 parts of dwarf lilyturf tuber, 210 parts of kudzuvine root, 250 parts of cassia seed, 210 parts of corn silk and 240 parts of coptis chinensis.
Example 2
A traditional Chinese medicine composition for treating type II diabetes comprises the following components in parts by weight: 85 parts of radix pseudostellariae, 210 parts of rehmannia, 210 parts of dwarf lilyturf tuber, 250 parts of kudzuvine root, 210 parts of cassia seed, 250 parts of corn silk and 200 parts of coptis chinensis.
Example 3
A traditional Chinese medicine composition for treating type II diabetes comprises the following components in parts by weight: 77.1 parts of radix pseudostellariae, 231.2 parts of rehmannia, 231.2 parts of dwarf lilyturf tuber, 231.2 parts of kudzuvine root, 231.2 parts of cassia seed, 231.2 parts of corn silk and 230 parts of coptis chinensis.
Comparative example 1
The difference from example 3 is only that the cassia seed is replaced with rheum officinale of equal quality, and the other conditions are the same.
Comparative example 2
The difference from example 3 is that the cassia seed is replaced by kudzuvine root and corn silk, and the other conditions are the same, and the specific conditions are as follows:
a traditional Chinese medicine composition for treating type II diabetes comprises the following components in parts by weight: 77.1 parts of radix pseudostellariae, 231.2 parts of rehmannia, 231.2 parts of dwarf lilyturf tuber, 346.8 parts of kudzuvine root, 346.8 parts of corn silk and 230 parts of coptis chinensis.
Comparative example 3
The difference from example 3 is that the kudzu root and corn silk are replaced by cassia seed, and the other conditions are the same, specifically as follows:
a traditional Chinese medicine composition for treating type II diabetes comprises the following components in parts by weight: 77.1 parts of radix pseudostellariae, 231.2 parts of rehmannia, 231.2 parts of dwarf lilyturf tuber, 693.6 parts of cassia seed and 230 parts of coptis chinensis.
Comparative example 4
The difference from example 3 is only that the dosage proportions of the components are different, and the other conditions are the same, and the specific conditions are as follows:
a traditional Chinese medicine composition for treating type II diabetes comprises the following components in parts by weight: 110 parts of radix pseudostellariae, 180 parts of rehmannia, 260 parts of dwarf lilyturf tuber, 231.2 parts of kudzuvine root, 231.2 parts of cassia seed, 231.2 parts of corn silk and 190 parts of coptis chinensis.
Preparation example
The preparation process of the traditional Chinese medicine composition comprises the following steps: decocting 7 raw materials (in any formulation of examples 1-3 or comparative examples 1-4) with water for 2 times, decocting with 10 times of water for 1 hr for the first time, decocting with 8 times of water for 1 hr for the second time, filtering, mixing filtrates, concentrating, and drying.
The preparation process of the granule comprises the following steps: decocting 7 raw materials (in any formulation of examples 1-3 or comparative examples 1-4) with water for 2 times, decocting with 10 times of water for 1 hr for the first time, decocting with 8 times of water for 1 hr for the second time, filtering, mixing filtrates, concentrating under reduced pressure to obtain fluid extract with relative density of 1.10 (60deg.C), adding dextrin 20% of the raw materials, mixing, spray drying, adding dextrin 26% of the raw materials, mixing, and granulating.
Test example 1
The traditional Chinese medicine compositions of examples 1-3 and comparative examples 1-4 were tested after being prepared by the preparation process of the preparation example.
1% STZ (streptozotocin) solution preparation process: fresh preparation was carried out in an ice bath at 4℃with a buffer containing streptozotocin at a concentration of 0.1mol/L and having a pH of 4.4 citric acid-sodium citrate.
90 male SD rats were adaptively fed for 1 week and randomly divided into blank groups (10) and model groups (80) according to body weight. The blank group was fed with basal feed, and the modeling group was fed with high-fat high-sugar feed (10% lard, 20% sucrose, 2.5% cholesterol, 1% cholate, 5% yolk powder, 61.5% normal feed), and after 4 weeks of continuous feeding, rats were fasted without water withdrawal. The molding module was intraperitoneally injected with 35mg/kg of 1% STZ (streptozotocin) solution; the blank was given an injection of the same volume of standard-converted 0.1mol/L citric acid-sodium citrate buffer solution (pH 4.4). After 72h of injection, blood is taken from the tail vein to measure blood sugar, and if the random blood sugar is higher than 16.7mmol/L, the diabetes modeling is considered to be successful, and if the standard value is not reached, 30mg/kg of 1% STZ solution is injected again the next day. After blood glucose stabilization, the model groups were randomly divided into 8 groups according to body weight, wherein 10 groups were each model group, example 1-3 groups, and comparative example 1-4 groups. The respective drugs were administered 1.5g crude drug/kg in the examples and comparative examples at a volume of 10mL/kg (the prepared composition was dissolved in physiological saline in advance and then filled with stomach). The blank group and the model group were administered with a 0.9% NaCl solution in a volume of 10mL/kg. The administration was continued for 4 weeks. After the completion of administration, the patients were fasted for 4 hours, blood was collected from the tail vein, and the blood glucose level was measured by a blood glucose meter, and the results are shown in Table 1. Rats were anesthetized with chloral hydrate, blood was collected from the abdominal aorta, centrifuged, and the Total Cholesterol (TC) and Triglyceride (TG) contents in serum were measured by a kit method, and the results are shown in table 2.
TABLE 1 rat blood glucose determination results [ (]
Figure BDA0003565554110000051
n＝10)/>
Figure BDA0003565554110000052
Figure BDA0003565554110000061
Note that: p <0.05 compared to the blank; comparison with model group △ P is less than 0.05; in comparison with example 3, the #P is < 0.05.
As can be seen from the results of the study in table 1, the blood glucose was increased after the rat modeling compared with the blank group, the blood glucose level was significantly reduced in the example group compared with the model group, and there was no significant difference in the comparative example group compared with the model group.
TABLE 2 determination of TG, TC in rat serum
Figure BDA0003565554110000062
n＝10)
Grouping TG(mmol/L) TC(mmol/L)
Blank spaceGroup of 1.89±0.46 0.60±0.41
Model group 2.90±0.37* 2.21±0.32*
Example 1 2.25±0.36 △ 1.24±0.35 △
Example 2 2.23±0.42 △ 1.21±0.30 △
Example 3 2.14±0.33 △ 1.16±0.27 △
Comparative example 1 2.73±0.31 1.91±0.29
Comparative example 2 2.77±0.41 1.93±0.33
Comparative example 3 2.79±0.38 1.89±0.42
Comparative example 4 2.70±0.43 1.86±0.43
Note that: p <0.05 compared to the blank; comparison with model group △ P＜0.05。
As can be seen from the results of the study in table 2, the TC and TG were significantly increased after the rat molding compared to the blank group, the TC and TG values were significantly decreased in the example group compared to the model group, and there was no significant difference in the comparative group compared to the model group.
Test example 2
100 outpatients are collected, and all meet the diagnosis standard of diabetes mellitus complicated with hyperlipidemia in Western medicine and the diagnosis standard of deficiency of both qi and yin in traditional Chinese medicine. The treatment group and the control group were randomized to 50 cases each, and the gender, age and course of disease of the two groups of patients were statistically analyzed without significant differences (P > 0.05).
Both groups were given regular treatment of diabetes, enhanced dietary control, proper exercise, and instruction for diabetes education. The control group was given metformin hydrochloride tablets 0.25g,3 times/day; rosuvastatin 10mg, 1 time daily. The treatment group was added with 0.44g of granules prepared from the traditional Chinese medicine composition of example 3 on the basis of the control group, 3 times/day, and the metformin hydrochloride tablet was reduced by one time/day. I.e. the treatment group was given metformin hydrochloride tablets 0.25g,2 times/day; rosuvastatin 10mg, 1 time daily; example 3 Chinese medicinal composition prepared granule 0.44g,3 times/day. After 1 month of administration, the results of the two groups of clinical treatment were evaluated and are shown in table 3. The two groups were treated with significantly lower fasting glucose (FBG), 2h postprandial glucose (2 hPG), and blood lipid levels than the control group (P < 0.05).
TABLE 3 improvement of blood sugar and blood lipid in two groups
Group of Number of examples FBG(mmol/L) 2hPG(mmol/L) Blood lipid ((mmol/L)
Control group 50 7.15±1.33 10.33±2.15 7.56±1.88
Treatment group 50 6.23±1.16* 8.26±1.52* 6.54±1.73*
Note that: p <0.05 compared to the control group.
The foregoing detailed description is directed to one of the possible embodiments of the present invention, which is not intended to limit the scope of the invention, but is to be accorded the full scope of all such equivalents and modifications so as not to depart from the scope of the invention.

Claims (9)

1. A traditional Chinese medicine composition for treating type II diabetes is characterized by being prepared from the following components: 65-85 parts of radix pseudostellariae, 210-250 parts of radix rehmanniae, 210-250 parts of radix ophiopogonis, 210-250 parts of radix puerariae, 210-250 parts of semen cassiae, 210-250 parts of corn silk and 200-240 parts of coptis chinensis.
2. The traditional Chinese medicine composition according to claim 1, which is characterized by comprising the following components in parts by weight: 70-80 parts of radix pseudostellariae, 220-240 parts of radix rehmanniae, 220-240 parts of radix ophiopogonis, 210-240 parts of radix puerariae, 210-240 parts of semen cassiae, 210-240 parts of corn silk and 210-240 parts of coptis chinensis.
3. The traditional Chinese medicine composition according to claim 2, which is characterized by comprising the following components in parts by weight: 77.1 parts of radix pseudostellariae, 231.2 parts of radix rehmanniae, 231.2 parts of radix ophiopogonis, 231.2 parts of radix puerariae, 231.2 parts of semen cassiae, 231.2 parts of corn silk and 230 parts of coptis chinensis.
4. A process for preparing a Chinese medicinal composition according to any one of claims 1 to 3, comprising the steps of: decocting 7 raw materials with water for 1-2 times (6-10 times of water for 1-2 hr each time), filtering, mixing filtrates, concentrating, and drying.
5. The preparation process according to claim 4, characterized by comprising the following steps: decocting 7 raw materials with water twice, the first time with 10 times of water for 1 hr, the second time with 8 times of water for 1 hr, filtering, mixing filtrates, concentrating, and drying.
6. A formulation comprising the Chinese medicinal composition of any one of claims 1-3.
7. The formulation of claim 6, wherein the formulation is in the form of a granule.
8. A process for preparing the formulation of claim 7, comprising the steps of: decocting 7 raw materials with water for 1-2 times, each time with 6-10 times of water for 1-2 hours, filtering, mixing filtrates, concentrating under reduced pressure to obtain fluid extract with relative density of 1.05-1.10 at 60deg.C, adding dextrin 15-25% of the raw materials, mixing, spray drying, adding dextrin 20-30% of the raw materials, mixing, and granulating.
9. The use of a traditional Chinese medicine composition according to any one of claims 1-3 or a traditional Chinese medicine composition prepared by a preparation process according to any one of claims 4-5 or a preparation according to any one of claims 6-7 or a preparation prepared by a preparation process according to claim 8 in the preparation of a medicament for treating type II diabetes.
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