CN111467411A - Traditional Chinese medicine composition for preventing and treating diabetic complications and preparation method and application thereof - Google Patents

Traditional Chinese medicine composition for preventing and treating diabetic complications and preparation method and application thereof Download PDF

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CN111467411A
CN111467411A CN202010311492.1A CN202010311492A CN111467411A CN 111467411 A CN111467411 A CN 111467411A CN 202010311492 A CN202010311492 A CN 202010311492A CN 111467411 A CN111467411 A CN 111467411A
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traditional chinese
chinese medicine
root
capsule
radix
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孙成磊
宋毅
赵麟
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Lunan Pharmaceutical Group Corp
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Lunan Pharmaceutical Group Corp
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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
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/32Bones; Osteocytes; Osteoblasts; Tendons; Tenocytes; Teeth; Odontoblasts; Cartilage; Chondrocytes; Synovial membrane
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/55Glands not provided for in groups A61K35/22 - A61K35/545, e.g. thyroids, parathyroids or pineal glands
    • 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
    • A61K36/11Pteridophyta or Filicophyta (ferns)
    • A61K36/12Filicopsida or Pteridopsida
    • A61K36/126Drynaria
    • 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)
    • 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
    • A61K36/232Angelica
    • 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
    • A61K36/236Ligusticum (licorice-root)
    • 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)
    • A61K36/47Euphorbiaceae (Spurge family), e.g. Ricinus (castorbean)
    • 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
    • A61K36/488Pueraria (kudzu)
    • 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)
    • A61K36/65Paeoniaceae (Peony family), e.g. Chinese peony
    • 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)
    • A61K36/70Polygonaceae (Buckwheat family), e.g. spineflower or dock
    • A61K36/704Polygonum, e.g. knotweed
    • 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)
    • A61K36/71Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • AHUMAN NECESSITIES
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    • 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)
    • A61K36/71Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • A61K36/716Clematis (leather flower)
    • 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)
    • A61K36/81Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
    • A61K36/815Lycium (desert-thorn)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4866Organic macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/12Drugs for disorders of the urinary system of the kidneys
    • 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 belongs to the field of traditional Chinese medicines, and particularly relates to application of a angelica-astragalus-containing blood-activating capsule in treating and preventing diabetic complications, which is a new application of a traditional Chinese medicine composition developed on the basis of the invention patent CN 1188161C. The invention relates to a Chinese angelica-astragalus-containing blood-activating capsule which is mainly prepared from astragalus root, Chinese angelica root, root of herbaceous peony, fleece-flower root, wolferry fruit, mistletoe, pilose antler, drynaria rhizome, Clematis chinensis, speranskia herb, musk, kudzu vine root and Ligusticum wallichii. The traditional Chinese medicine composition can effectively reduce the content of microalbumin in 24h urine of a rat; has obvious improvement effect on kidney pathologies such as mesentery thickening, mesentery hyperplasia, renal tubular epithelial edema, renal interstitial hyperplasia and the like in an early diabetic nephropathy model.

Description

Traditional Chinese medicine composition for preventing and treating diabetic complications and preparation method and application thereof
Technical Field
The invention belongs to the field of traditional Chinese medicines, relates to a traditional Chinese medicine composition for treating diabetic complications, and particularly relates to a traditional Chinese medicine composition for preventing and treating diabetic complications as well as a preparation method and application thereof.
Background
Diabetic Nephropathy (DN) is one of the common microvascular complications of diabetes, is commonly seen in diabetic patients with a history of more than 10 years, and can be seen in type 1 diabetes and type 2 diabetes. Diabetic nephropathy is a leading cause of death in type 1 diabetics and also one of the leading causes of death in type 2 diabetics. Diabetic nephropathy is mainly classified into stage 5: 1. stage I is the initial stage of diabetic nephropathy and is primarily characterized by increased glomerular filtration rate. 2. Stage II is intermittent proteinuria, which is mainly manifested by intermittent increase of the ratio of urine trace protein to creatinine. 3. Stage iii is early diabetic nephropathy with persistent microalbuminuria. 4. Stage IV is the clinical diabetic nephropathy, i.e. the massive proteinuria stage. The routine examination of the urine at this stage shows that the urine protein varies from 1 plus sign to 4 plus signs, namely the clinical proteinuria stage. 5. Stage V is the uremia stage, in addition to proteinuria, elevated blood creatinine and blood pressure can occur, i.e., end stage renal disease, which requires dialysis treatment to maintain life.
Diabetic nephropathy is also one of the most important complications of diabetes, and is also the leading cause of end-stage renal failure. The long-term hyperglycemic state due to insulin dysbolism is the most critical cause of diabetic kidney damage. The incidence of diseases in China is also on the rise, and the disease is the second cause of end-stage nephropathy at present, and is only second to various glomerulonephritis. Due to the existence of complex metabolic disorder, the treatment of the kidney disease is more troublesome once the kidney disease reaches the terminal stage than the treatment of other kidney diseases, so the timely prevention and treatment of the kidney disease is significant for delaying the diabetic nephropathy.
Chinese patent CN1188161C discloses a Chinese medicinal composition, which is prepared from radix astragali, radix Angelicae sinensis, radix Paeoniae alba, Polygoni Multiflori radix, fructus Lycii, herba Visci, cornu Cervi Pantotrichum, rhizoma Drynariae, radix Clematidis, herba Speranskiae Tuberculatae, Moschus, radix Puerariae and rhizoma Ligustici Chuanxiong, and has effects of invigorating qi and kidney, promoting blood circulation and dredging collaterals, and can be used for treating cervical syndrome (neck type and nerve root type), liver and kidney deficiency, qi deficiency and blood stasis. The symptoms comprise heavy neck pain, aching pain of shoulders and backs, numbness of arms, weakness and weakness of limbs, vertigo and the like. A product based on the patent technology is marketed and named as 'Guiqi Huoxue capsule', an approved character is a Chinese medicine standard Z20090686 respectively, and is a product produced by Shanghan pharmaceutical company Limited in Shannan province, and is clinically used for treating liver and kidney deficiency, qi deficiency and blood stasis syndrome with symptoms of heavy neck pain, aching pain in shoulders and backs, arm numbness, limb weakness and weakness, dizziness, dark red or pale tongue with ecchymosis, thin and white fur, deep and weak pulse or deep and wiry unsmooth tongue, and the total clinical treatment effective rate is more than 90%.
Disclosure of Invention
The invention relates to a new application of a traditional Chinese medicine composition developed on the basis of Chinese patent CN 1188161C. The product on the market at present comprises the angelica and astragalus blood-activating capsules.
The invention aims to provide a traditional Chinese medicine composition for treating diabetic complications, which is mainly prepared from astragalus, angelica, white paeony root, polygonum multiflorum, medlar, mistletoe, pilose antler and drynaria rhizome.
Preferably, the traditional Chinese medicine composition also comprises clematis root, garden balsam stem, musk and kudzu root.
Further preferably, the Chinese medicinal composition further comprises ligusticum wallichii.
Specifically, the traditional Chinese medicine composition provided by the invention comprises the following components:
Figure BDA0002457787020000021
further preferably, the traditional Chinese medicine composition contains the following components:
Figure BDA0002457787020000022
further preferably, the traditional Chinese medicine composition contains the following components:
Figure BDA0002457787020000023
more preferably, the fleece-flower root is prepared fleece-flower root, and the musk is artificial musk.
The diabetic complication is diabetic microvascular complication.
Preferably, the diabetic microvascular complication is diabetic nephropathy.
Further preferably, the diabetic nephropathy is stage i diabetic nephropathy.
The invention also aims to provide a traditional Chinese medicine preparation prepared from the traditional Chinese medicine composition and pharmaceutically available auxiliary materials, wherein the traditional Chinese medicine preparation is one or more of granules, tablets, pills, capsules or liquid oral preparations.
Preferably, the traditional Chinese medicine preparation is a capsule.
Further preferably, the capsule is a angelica and astragalus blood-activating capsule.
The fourth purpose of the invention is to provide a preparation method of the capsule, which comprises the following steps:
1) pulverizing cornu Cervi Pantotrichum and artificial Moschus into fine powder;
2) extracting mistletoe, radix Puerariae and rhizoma Ligustici Chuanxiong with 70% ethanol twice, each for 2 hr, mixing extractive solutions, filtering, recovering ethanol from filtrate, and concentrating under reduced pressure to obtain soft extract I with relative density of 1.30-1.32 (60 deg.C);
3) decocting the other eight medicinal materials such as astragalus and the like twice by adding water, decocting for 2 hours for the first time and decocting for 1 hour for the second time, combining decoction liquids, filtering, concentrating the filtrate under reduced pressure to obtain a concentrated solution with the relative density of 1.14-1.16 (60 ℃), adding ethanol to ensure that the ethanol content reaches 70%, refrigerating for overnight or 24 hours at (-2 ℃), filtering, recovering ethanol from the filtrate, and concentrating to obtain a thick paste II with the relative density of 1.30-1.35 (60 ℃) for later use;
4) mixing the above soft extracts I and II, adding appropriate amount of starch, mixing, drying, granulating, adding cornu Cervi Pantotrichum and Moschus fine powder, mixing, sieving, and making into capsule.
The invention has the following beneficial effects:
the traditional Chinese medicine composition can effectively reduce the amount of microalbumin in 24h urine of rats and reduce blood sugar; has obvious improvement effect on kidney pathology such as glomerular capillary basement membrane thickening, mesangial hyperplasia, renal tubular epithelial edema, renal interstitial hyperplasia and the like in an early diabetic nephropathy model.
DETAILED DESCRIPTION OF EMBODIMENT (S) OF INVENTION
The technical solution of the present invention will be clearly and completely described below with reference to specific embodiments, but the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments obtained by a person skilled in the art without making any inventive step are within the scope of protection of the present invention.
EXAMPLE 1 Capsule preparation
The formula is as follows:
Figure BDA0002457787020000031
the preparation method comprises the following steps:
1) pulverizing cornu Cervi Pantotrichum and artificial Moschus into fine powder;
2) extracting mistletoe, radix Puerariae and rhizoma Ligustici Chuanxiong with 70% ethanol twice, each for 2 hr, mixing extractive solutions, filtering, recovering ethanol from filtrate, and concentrating under reduced pressure to obtain soft extract I with relative density of 1.30-1.32 (60 deg.C);
3) decocting the other eight medicinal materials such as astragalus and the like twice by adding water, decocting for 2 hours for the first time and decocting for 1 hour for the second time, combining decoction liquids, filtering, concentrating the filtrate under reduced pressure to obtain a concentrated solution with the relative density of 1.14-1.16 (60 ℃), adding ethanol to ensure that the ethanol content reaches 70 percent, refrigerating overnight at (-2 ℃) or 24 hours, filtering, recovering the ethanol from the filtrate, and concentrating to obtain a thick paste II with the relative density of 1.30-1.35 (60 ℃) for later use;
4) mixing the above soft extracts I and II, adding appropriate amount of starch, mixing, drying, granulating, adding cornu Cervi Pantotrichum and Moschus fine powder, mixing, sieving, and making into capsule 1000.
EXAMPLE 2 Capsule preparation
The formula is as follows:
Figure BDA0002457787020000041
the preparation method comprises the following steps: the same as in example 1.
EXAMPLE 3 tablet preparation
The formula is as follows:
Figure BDA0002457787020000042
the preparation method comprises the following steps:
1) pulverizing cornu Cervi Pantotrichum and Moschus into fine powder;
2) extracting mistletoe, radix Puerariae and rhizoma Ligustici Chuanxiong with 70% ethanol twice, each for 2 hr, mixing extractive solutions, filtering, recovering ethanol from filtrate, and concentrating under reduced pressure to obtain soft extract I with relative density of 1.30-1.32 (60 deg.C);
3) decocting the other eight medicinal materials such as astragalus and the like twice by adding water, decocting for 2 hours for the first time and decocting for 1 hour for the second time, combining decoction liquids, filtering, concentrating the filtrate under reduced pressure to obtain a concentrated solution with the relative density of 1.14-1.16 (60 ℃), adding ethanol to ensure that the ethanol content reaches 70 percent, refrigerating overnight at (-2 ℃) or 24 hours, filtering, recovering the ethanol from the filtrate, and concentrating to obtain a thick paste II with the relative density of 1.30-1.35 (60 ℃) for later use;
4) mixing the above soft extracts I and II, adding appropriate amount of starch, mixing, drying, granulating, adding cornu Cervi Pantotrichum and artificial Moschus fine powder, mixing, and sieving to obtain Chinese medicinal composition;
the traditional Chinese medicine composition is prepared into tablets according to a conventional process.
Example 4 preparation of granules
Figure BDA0002457787020000051
The preparation method of the traditional Chinese medicine composition comprises the following steps: the same as in example 3;
the Chinese medicinal composition is prepared into granules according to a conventional process.
EXAMPLE 5 pellet preparation
The formula is as follows:
Figure BDA0002457787020000052
the preparation method of the traditional Chinese medicine composition comprises the following steps: the same as in example 3;
the Chinese medicinal composition is prepared into pills according to the conventional process.
Comparative example 1 preparation of capsules
The formula is as follows:
Figure BDA0002457787020000053
the preparation method comprises the following steps:
1) pulverizing cornu Cervi Pantotrichum and artificial Moschus into fine powder;
2) extracting radix puerariae and ligusticum wallichii twice with 70% ethanol for 2 hours each time, mixing the extracting solutions, filtering, recovering ethanol from the filtrate, and concentrating under reduced pressure to obtain thick paste I with the relative density of 1.30-1.32 (60 ℃) for later use;
3) taking the rest 6 medicinal materials such as astragalus and the like, adding water for decocting twice, decocting for 2 hours for the first time and decocting for 1 hour for the second time, combining decoction liquids, filtering, concentrating the filtrate under reduced pressure to obtain a concentrated solution with the relative density of 1.14-1.16 (60 ℃), adding ethanol to ensure that the ethanol content reaches 70 percent, refrigerating overnight at (-2 ℃) or 24 hours, filtering, recovering ethanol from the filtrate, and concentrating to obtain a thick paste II with the relative density of 1.30-1.35 (60 ℃) for later use;
4) mixing the above soft extracts I and II, adding appropriate amount of starch, mixing, drying, granulating, adding cornu Cervi Pantotrichum and Moschus fine powder, mixing, sieving, and making into capsule 1000.
Comparative example 2 preparation of capsules
The formula is as follows:
Figure BDA0002457787020000061
the preparation method comprises the following steps:
1) pulverizing cornu Cervi Pantotrichum and artificial Moschus into fine powder;
2) extracting radix dipsaci, radix puerariae and ligusticum wallichii with 70% ethanol twice for 2 hours each time, combining the extracting solutions, filtering, recovering ethanol from the filtrate, and concentrating under reduced pressure to obtain thick paste I with the relative density of 1.30-1.32 (60 ℃) for later use;
3) decocting the other eight medicinal materials such as astragalus and the like twice by adding water, decocting for 2 hours for the first time and decocting for 1 hour for the second time, combining decoction liquids, filtering, concentrating the filtrate under reduced pressure to obtain a concentrated solution with the relative density of 1.14-1.16 (60 ℃), adding ethanol to ensure that the ethanol content reaches 70 percent, refrigerating overnight at (-2 ℃) or 24 hours, filtering, recovering the ethanol from the filtrate, and concentrating to obtain a thick paste II with the relative density of 1.30-1.35 (60 ℃) for later use;
4) mixing the above soft extracts I and II, adding appropriate amount of starch, mixing, drying, granulating, adding cornu Cervi Pantotrichum and Moschus fine powder, mixing, sieving, and making into capsule 1000.
Comparative example 3 preparation of capsules
The formula is as follows:
Figure BDA0002457787020000062
the preparation method comprises the following steps:
1) pulverizing cornu Cervi Pantotrichum and artificial Moschus into fine powder;
2) extracting radix dipsaci, radix puerariae and ligusticum wallichii with 70% ethanol twice for 2 hours each time, combining the extracting solutions, filtering, recovering ethanol from the filtrate, and concentrating under reduced pressure to obtain thick paste I with the relative density of 1.30-1.32 (60 ℃) for later use;
3) decocting the other eight medicinal materials such as astragalus and the like twice by adding water, decocting for 2 hours for the first time and decocting for 1 hour for the second time, combining decoction liquids, filtering, concentrating the filtrate under reduced pressure to obtain a concentrated solution with the relative density of 1.14-1.16 (60 ℃), adding ethanol to ensure that the ethanol content reaches 70 percent, refrigerating overnight at (-2 ℃) or 24 hours, filtering, recovering the ethanol from the filtrate, and concentrating to obtain a thick paste II with the relative density of 1.30-1.35 (60 ℃) for later use;
4) mixing the above soft extracts I and II, adding appropriate amount of starch, mixing, drying, granulating, adding cornu Cervi Pantotrichum and Moschus fine powder, mixing, sieving, and making into capsule 1000.
Pharmacodynamic experiment
In order to verify the efficacy of the traditional Chinese medicine composition for treating diabetic complications, the inventor carries out experimental research, and the following takes an early diabetic nephropathy mouse model as an example for description, but the inventor intends to say that the inventor also carries out pharmacological experimental research on other diabetic complications described in the specification, and the composition of the invention can achieve the same or similar effects, and the effect is not described any more.
(I) the traditional Chinese medicine composition has the treatment effect on early diabetic nephropathy of mice
1 Material
1.1 animals:
SD rat, body mass 200 + -20 g, laboratory animal license number: SYXK (Shandong) 20180008, available from Lunan pharmaceutical group, Inc., was acclimatized for one week prior to the experiment.
1.2 drugs
The capsules obtained in examples 1 and 2 of the present invention;
comparative examples capsules obtained in comparative examples 1, 2, 3;
a blood sugar lowering capsule.
1.3 dosage for mice
Example 1 capsules: 0.858g/kg (high dose), 0.429g/kg (medium dose), 0.214g/kg (low dose);
example 2 capsules: 0.429 g/kg;
comparative example 1 capsules: 0.429 g/kg;
comparative example 2 capsules: 0.429 g/kg;
comparative example 3 capsules: 0.429 g/kg;
hypoglycemic Shu capsule: 0.486 g/kg.
1.4 reagent: streptozotocin, a rat urinary albumin radioimmunoassay kit and a glucose kit.
2. Test method
2.1 Molding method
60mg/kg of streptozotocin is injected into the abdominal cavity of a rat at one time, blood is collected from the tail vein after 72 hours to measure the blood sugar value, and the standard that the blood sugar concentration is more than or equal to 16.7 mmol/L is used as the successful model building standard of diabetes.
2.2 grouping
Taking 90 mice with successful diabetes modeling, randomly dividing the mice into 9 groups, and 10 mice in each group, wherein the mice are respectively a model group, a positive medicine group, an example 1 (high, medium and low dose group), an example 2 group and a comparative example 1, 2 and 3 group;
another 10 normal mice were selected as a blank group.
2.3 administration of drugs
24h after the molding is successful, the positive medicine group, the example 1 (high, medium and low dose group), the 2 groups and the comparative examples 1, 2 and 3 groups are respectively administered with corresponding doses of liquid medicines by intragastric administration; air and the model group were given an equal amount of physiological saline.
The administration is carried out 1 time daily, with fixed time, and continuously for 8 weeks.
2.4 detection
Blood glucose levels were observed in each group of animals after the 2, 4, and 8 weeks of administration. After the administration of the medicine in the 2 nd and 4 th weeks, cutting the tail and taking blood to measure the blood sugar value, after the administration in the 8 th week, taking blood from the eyeball vein, centrifuging, taking serum and measuring the blood sugar value;
collecting urine volume 24h after administration of drug at 8 weeks of rats, centrifuging fresh urine sample, and detecting urine microalbumin amount after removing residues;
the two kidneys were taken after the administration of the drug in the rat at 8 weeks, the mass of the kidneys was measured, the kidney capsule was removed, the right kidney was fixed with 4% formaldehyde solution, and the morphological changes of the kidneys were observed after the conventional procedure.
3. Results and conclusions
3.1 rat urinary microalbumin levels
Compared with the model group, after 8 weeks of administration, the urinary albumin amount of rats in each group except the group of comparative example 1 was significantly reduced, and the difference was statistically significant (P < 0.01).
Compared with the positive medicine group, the white protein amount of rats in the high and medium dose groups in the embodiment 1 is obviously reduced, and the difference has statistical significance (P is less than 0.05); the amount of albumin in rats in the dose groups of comparative examples 1, 2 and 3 is not obviously reduced, and the difference has statistical significance (P < 0.05).
TABLE 1 urinary microalbumin amounts in rats of each group after administration at week 8
Figure BDA0002457787020000081
Figure BDA0002457787020000082
Figure BDA0002457787020000091
Note: in contrast to the blank group,@P<0.05,*P<0.01;
in contrast to the model set,P<0.05,#P<0.01;
compared with the positive medicine group,&P<0.05,P<0.01。
3.2 rat blood glucose levels
Compared with the model group, the blood sugar levels of rats in the high, medium and low dose groups of example 1, the group of example 2 and the positive drug group are obviously reduced on average.
Compared with the positive drug, the blood sugar reduction level of rats in the comparative examples 1, 2 and 3 is small, and the difference has statistical significance (P is less than 0.05, and P is less than 0.01); example 1 the high dose group showed a significant drop in blood glucose levels at week 8, with the difference being statistically significant (P < 0.05).
TABLE 2 blood glucose Change in rats of each group: (
Figure BDA0002457787020000092
n=10,mmol/L)
Figure BDA0002457787020000093
Note: in contrast to the blank group,@P<0.05,*P<0.01;
in contrast to the model set,P<0.05,#P<0.01;
compared with the positive medicine group,&P<0.05,P<0.01。
3.3 rat Kidney morphology
The boundary of the kidney skin and medulla of the blank group of rats is clear, the structure of glomerulus is normal, the mesangial cells and mesangial matrixes are not proliferated, and the capillary vessels are not extruded;
the renal cortex and medulla of the model group are not clear, the glomerulus is enlarged diffusely, the glomerulus capillary is congested, and the renal capsule is narrowed. The basement membrane of glomerular capillaries is thickened, the mesangium is widened, mesangial cells are proliferated, and podocytes are obviously swelled; epithelial edema appears in part of the renal tubules and the lumen narrows. The kidney interstitium is hyperplastic, and some edema is manifested as interstitial fibrosis.
Compared with the model group, the renal pathology of the high, medium and low dose groups, the 2 group and the positive drug group in the embodiment is obviously improved.
TABLE 3 pathological histological changes of kidney of rats in each group
Figure BDA0002457787020000101

Claims (8)

1. A Chinese medicinal composition for treating diabetic complication is prepared from radix astragali, radix Angelicae sinensis, radix Paeoniae alba, Polygoni Multiflori radix, fructus Lycii, herba Visci, cornu Cervi Pantotrichum, rhizoma Drynariae, radix Clematidis, caulis et folium Gaultheriae Yunnanensis, Moschus, radix Puerariae, and rhizoma Ligustici Chuanxiong.
2. The use of claim 3, wherein the Chinese medicinal composition comprises the following components:
Figure FDA0002457787010000011
3. the use of claim 1, wherein said polygonum multiflorum is prepared polygonum multiflorum and said musk is an artificial musk.
4. The use according to claim 1, wherein the diabetic complication is a diabetic microvascular complication.
5. The use according to claim 1, wherein the diabetic microvascular complication is diabetic nephropathy; preferably, the diabetic nephropathy is stage i diabetic nephropathy.
6. A traditional Chinese medicine preparation prepared from the traditional Chinese medicine composition in the use of any one of claims 1 to 5 and pharmaceutically-usable auxiliary materials, wherein the traditional Chinese medicine preparation is a capsule.
7. The use of claim 1, wherein the capsule is a GUIQIHUOXUE Capsule.
8. The angelica and astragalus blood-activating capsule according to claim 7, wherein the preparation method comprises the following steps:
1) pulverizing cornu Cervi Pantotrichum and artificial Moschus into fine powder;
2) extracting herba Visci, radix Puerariae and rhizoma Ligustici Chuanxiong with 70% ethanol for 2 times, each for 2 hr, mixing extractive solutions, filtering, recovering ethanol from filtrate, and concentrating under reduced pressure to obtain soft extract I with relative density of 1.30-1.32 at 60 deg.C;
3) decocting the rest eight medicinal materials of astragalus, angelica, white paeony root, tuber fleeceflower root, medlar, rhizoma drynariae, clematis root and garden balsam stem for 2 times by adding water, decocting for 2 hours for the first time and decocting for 1 hour for the second time, merging decoction, filtering, concentrating filtrate under reduced pressure to a concentrated solution with the relative density of 1.14-1.16 at 60 ℃, adding ethanol to ensure that the alcohol content reaches 70%, refrigerating for overnight preservation at (-2 ℃) or 24 hours, filtering, recovering ethanol from the filtrate, and concentrating to a thick paste II with the relative density of 1.30-1.35 at 60 ℃ for later use;
4) mixing the above soft extracts I and II, adding appropriate amount of starch, mixing, drying, granulating, adding cornu Cervi Pantotrichum and Moschus fine powder, mixing, sieving, and making into capsule.
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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1424097A (en) * 2002-12-31 2003-06-18 鲁南制药股份有限公司 Medicines for treating cervical vertebra illness
CN103251867A (en) * 2013-06-03 2013-08-21 滕信涛 Chinese herbal compound medicine for treating diabetes mellitus and preparation method thereof

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Publication number Priority date Publication date Assignee Title
CN1424097A (en) * 2002-12-31 2003-06-18 鲁南制药股份有限公司 Medicines for treating cervical vertebra illness
CN103251867A (en) * 2013-06-03 2013-08-21 滕信涛 Chinese herbal compound medicine for treating diabetes mellitus and preparation method thereof

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* Cited by examiner, † Cited by third party
Title
孔畅;等: "芪归药对治疗糖尿病肾病的理论探讨", 辽宁中医杂志, vol. 45, no. 02, pages 4 *
戚传福;等: "前列地尔联合芪参肾康散治疗糖尿病肾病疗效观察", 中国中医急症, vol. 20, no. 09, pages 1482 - 1483 *

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