CN116898941A - Traditional Chinese medicine composition and application thereof, traditional Chinese medicine preparation and preparation method and application thereof - Google Patents

Traditional Chinese medicine composition and application thereof, traditional Chinese medicine preparation and preparation method and application thereof Download PDF

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CN116898941A
CN116898941A CN202310905407.8A CN202310905407A CN116898941A CN 116898941 A CN116898941 A CN 116898941A CN 202310905407 A CN202310905407 A CN 202310905407A CN 116898941 A CN116898941 A CN 116898941A
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traditional chinese
chinese medicine
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CN116898941B (en
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刘红旭
周明学
邢文龙
尚菊菊
李思耐
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BEIJING INSTITUTE OF TRADITIONAL CHINESE MEDICINE
Beijing Traditional Chinese Medicine Hospital
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BEIJING INSTITUTE OF TRADITIONAL CHINESE MEDICINE
Beijing Traditional Chinese Medicine Hospital
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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)
    • A61K36/23Apiaceae 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
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56Materials from animals other than mammals
    • A61K35/62Leeches; Worms, e.g. cestodes, tapeworms, nematodes, roundworms, earth worms, ascarids, filarias, hookworms, trichinella or taenia
    • 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)
    • A61K36/35Caprifoliaceae (Honeysuckle family)
    • A61K36/355Lonicera (honeysuckle)
    • 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)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/906Zingiberaceae (Ginger family)
    • A61K36/9066Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/02Drugs for disorders of the nervous system for peripheral neuropathies
    • 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

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Abstract

The application relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition and application thereof, a traditional Chinese medicine preparation and a preparation method and application thereof. The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 10-50 parts of wine angelica, 10-50 parts of szechuan lovage rhizome, 10-50 parts of honeysuckle stem, 5-15 parts of curcuma longa and 1-5 parts of leech. The Chinese medicinal composition can be used for treating diabetic peripheral neuropathy, and has blood sugar lowering effect.

Description

Traditional Chinese medicine composition and application thereof, traditional Chinese medicine preparation and preparation method and application thereof
Technical Field
The application relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition and application thereof, a traditional Chinese medicine preparation and a preparation method and application thereof.
Background
Diabetes is a metabolic disease characterized by hyperglycemia. Diabetic peripheral neuritis is the most important chronic complication of diabetes mellitus, and is also known as diabetic peripheral neuropathy in medicine, which is most frequently seen in peripheral symmetrical sensory and motor neuropathy and autonomic neuropathy. Patients with diabetic peripheral neuritis feel more symmetrical limb numbness, pain, burning sensation, hypoesthesia, epigastric distention, constipation, palpitation, localized hyperhidrosis, little sweat, cold hands and feet, etc.
Through better blood sugar control, the metabolic abnormality and even pathological change of nerves can be prevented and reversed, the symptoms can be lightened, and the progress of diabetic neuropathy can be delayed.
Comprehensive treatment of peripheral neuropathy of diabetes by Chinese and Western medicine finds: the western medicine mainly improves nerve microcirculation, antagonizes oxidative stress and neurotrophic treatment, however, clinical adverse reactions are larger, such as anisodamine can only generate medicine effect by using larger dosage, but partial patients can have adverse reactions such as dry mouth, flushed complexion, blurred vision, increased heart rate, difficult urination and the like.
Therefore, the traditional Chinese medicine composition for treating diabetic peripheral neuropathy and assisting in reducing blood sugar has important significance.
In view of this, the present application has been made.
Disclosure of Invention
The first aim of the application is to provide a traditional Chinese medicine composition which can treat diabetic peripheral neuropathy and has the function of reducing blood sugar.
The second aim of the application is to provide an application of a traditional Chinese medicine composition in preparing a medicine for treating peripheral neuritis.
The third aim of the application is to provide an application of a traditional Chinese medicine composition in preparing a hypoglycemic drug.
The fourth object of the application is to provide a traditional Chinese medicine preparation.
The fifth aim of the application is to provide a preparation method of the traditional Chinese medicine preparation, which has the advantages of simple and feasible operation, short process flow, high extraction efficiency and the like.
The sixth aim of the application is to provide an application of a traditional Chinese medicine preparation in preparing a medicine for treating peripheral neuritis.
The seventh aim of the application is to provide an application of a traditional Chinese medicine preparation in preparation of hypoglycemic drugs.
In order to achieve the above object of the present application, the following technical solutions are specifically adopted:
the application provides a traditional Chinese medicine composition, which comprises the following raw materials in parts by weight: 10-50 parts of wine angelica, 10-50 parts of szechuan lovage rhizome, 10-50 parts of honeysuckle stem, 5-15 parts of curcuma longa and 1-5 parts of leech.
The application also provides application of the traditional Chinese medicine composition in preparing medicines for treating peripheral neuritis.
Preferably, the peripheral neuritis comprises diabetic peripheral neuritis.
The application also provides application of the traditional Chinese medicine composition in preparation of hypoglycemic drugs.
The application provides a traditional Chinese medicine preparation, which comprises the traditional Chinese medicine composition.
The preparation method of the traditional Chinese medicine preparation provided by the application comprises the following steps: mixing the above materials, and decocting.
The application also provides application of the traditional Chinese medicine preparation in preparing a medicament for treating peripheral neuritis.
The application also provides application of the traditional Chinese medicine preparation in preparation of hypoglycemic drugs.
Compared with the prior art, the application has the beneficial effects that:
(1) The traditional Chinese medicine composition provided by the application not only has a good treatment effect on diabetic peripheral neuropathy, but also has the effect of reducing blood sugar.
(2) The traditional Chinese medicine composition provided by the application has small toxic and side effects and easily available raw materials.
Drawings
In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings that are needed in the description of the embodiments or the prior art will be briefly described, and it is obvious that the drawings in the description below are some embodiments of the present application, and other drawings can be obtained according to the drawings without inventive effort for a person skilled in the art.
FIG. 1 is a comparative bar graph of the glucose levels of zebra fish after treatment with the present application provided normal control, model control, sitagliptin phosphate and the traditional Chinese medicine decoction of example 1;
FIG. 2 is a typical diagram of neutrophils around zebra fish nerves after treatment with the present application provided with a normal control group, a model control group, sitagliptin phosphate and the traditional Chinese medicine decoction of example 1;
fig. 3 is a comparative bar graph of the numbers of neutrophils around zebra fish nerves after treatment with the present application, normal control, model control, sitagliptin phosphate and the traditional Chinese medicine decoction of example 1.
Detailed Description
The technical solution of the present application will be clearly and completely described below with reference to the accompanying drawings and detailed description, but it will be understood by those skilled in the art that the examples described below are some, but not all, examples of the present application, and are intended to be illustrative of the present application only and should not be construed as limiting the scope of the present application. All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application. The specific conditions are not noted in the examples and are carried out according to conventional conditions or conditions recommended by the manufacturer. The reagents or apparatus used were conventional products commercially available without the manufacturer's attention.
In a first aspect, the application provides a traditional Chinese medicine composition, in particular to a traditional Chinese medicine composition for treating diabetic peripheral neuropathy and assisting in reducing blood sugar, which comprises the following raw materials in parts by weight: 10-50 parts of angelica sinensis, including, for example, but not limited to, any one of 15 parts, 20 parts, 25 parts, 30 parts, 35 parts, 40 parts, 45 parts of spot values or range values between any two; 10-50 parts of ligusticum wallichii, for example, including but not limited to 15 parts, 20 parts, 25 parts, 30 parts, 35 parts, 40 parts, 45 parts of any one point value or any range value between the two; 10-50 parts of honeysuckle stem, for example, including but not limited to any one of 15 parts, 20 parts, 25 parts, 30 parts, 35 parts, 40 parts, 45 parts of spot value or range value between any two; 5-15 parts of curcuma longa, for example, including but not limited to any one of 7 parts, 9 parts, 10 parts, 12 parts, 14 parts or a range value between any two, and 1-5 parts of leech, for example, including but not limited to any one of 1.5 parts, 2 parts, 2.5 parts, 3 parts, 3.5 parts, 4 parts, 4.5 parts or a range value between any two.
The wine radix Angelicae sinensis is processed product of dried root of Angelica sinensis Diels of Umbelliferae. The wine Chinese angelica is mainly used for enriching and activating blood, regulating menstruation and relieving pain, and relaxing bowel, and is used for treating blood deficiency and sallow complexion, dizziness and palpitation, irregular menstruation, amenorrhea and dysmenorrhea, deficiency-cold abdominal pain, constipation due to intestinal dryness, rheumatalgia, traumatic injury and carbuncle and ulcer.
Chuan Xiong is pungent and warm in nature. Is mainly used for activating blood circulation to dissipate blood stasis, dispelling wind and relieving pain. For headache, dizziness, hypochondriac pain, abdominal pain, cold arthralgia, spasm of tendons, amenorrhea, dystocia, puerperal stasis, block pain, carbuncle, cellulitis and pyocutaneous disease. Can be used for treating menoxenia, amenorrhea, dysmenorrhea, abdominal pain, chest and hypochondrium pain, traumatic injury, headache, and rheumatalgia.
Caulis Lonicerae is also known as Ficus pumila, caulis seu radix salicylate or caulis Stephaniae Japonicae. Has effects of clearing heat and detoxicating, dispelling pathogenic wind and dredging collaterals. Can be used for treating epidemic febrile disease, skin sore, carbuncle, toxic swelling, dysentery with blood, rheumatic arthralgia, and joint redness, swelling and pain.
The dried rhizome of Curcuma wenyujin Y.H.Chen et C.Ling of Curcuma of Zingiberaceae is mainly used for breaking blood, promoting qi circulation, dredging channels and relieving pain. Can be used for treating amenorrhea due to blood stagnation, abdominal pain during menstruation, thoracocentesis, rheumatalgia, shoulder and arm pain, and traumatic injury.
Leech is neutral in nature, salty and bitter in taste, and enters liver meridian. Has effects of removing blood stasis, dredging channels, and eliminating symptoms. Can be used for treating amenorrhea due to blood stasis, abdominal mass, traumatic injury, and pain in heart and abdomen.
Among the above prescriptions, wine angelica is sweet and warm in nature, has the effects of replenishing blood, regulating menstruation, activating blood and relieving pain, and is used for treating arthralgia syndrome due to blood deficiency and blood stasis; ligusticum wallichii has the effects of promoting blood circulation, activating qi-flowing, dispelling wind and relieving pain; the honeysuckle stem has the effects of clearing heat and detoxicating, and activating meridians to stop pain; the three medicines are reused as monarch medicines, and have the effects of nourishing blood, activating blood, detoxifying and relieving pain, thus embodying the large method of nourishing blood, activating blood and relieving pain.
Wenyujin is a theory of "the traditional Chinese medicine is used for promoting qi circulation and blood circulation", and is a ministerial drug in the recipe.
Leech has the effects of removing blood stasis and eliminating mass, and is slightly used as an adjuvant drug because of its strong blood-breaking power. The five herbs are divided into different types and are indispensable.
The traditional Chinese medicine considers that the diabetic peripheral neuropathy belongs to the category of arthralgia, and the root of the diabetic peripheral neuropathy is blood stasis and obstruction of collaterals. The traditional Chinese medicine composition provided by the application has a good treatment effect on diabetic peripheral neuropathy and can also assist in reducing blood sugar by scientifically proportioning the traditional Chinese medicine raw materials to enable the traditional Chinese medicine raw materials to be matched with each other.
In addition, the traditional Chinese medicine composition provided by the application has the advantages of small toxic and side effects, simple and easily available raw materials and the like.
In order to obtain the traditional Chinese medicine composition with better treatment effect, the dosage of each raw material is optimized, and specifically, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 20-40 parts of wine angelica, 20-40 parts of szechuan lovage rhizome, 20-40 parts of honeysuckle stem, 7-13 parts of curcuma longa and 2-4 parts of leech.
In a preferred embodiment, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 30 parts of wine angelica, 30 parts of ligusticum wallichii, 30 parts of honeysuckle stem, 9 parts of curcuma longa and 3 parts of leech.
In a second aspect, the application provides application of the traditional Chinese medicine composition in preparation of a medicine for treating peripheral neuritis.
In a preferred embodiment, the peripheral neuritis comprises diabetic peripheral neuritis, i.e. diabetic peripheral neuropathy.
In a third aspect, the application provides application of the traditional Chinese medicine composition in preparation of hypoglycemic drugs.
It is understood that the above-mentioned drugs for treating peripheral neuritis also have the effect of reducing blood sugar. And/or, the hypoglycemic agent also has the effect of treating peripheral neuritis.
In a specific embodiment, the traditional Chinese medicine composition is decocted to obtain a liquid medicine, and the liquid medicine is divided into 200 milliliters per bag, and the usage is 1 bag per time, 2 times per day and is orally taken.
In a fourth aspect, the application provides a traditional Chinese medicine preparation, which comprises the traditional Chinese medicine composition.
The traditional Chinese medicine preparation provided by the application has the function of reducing blood sugar while treating diabetic peripheral neuropathy, and can improve diabetes symptoms.
In a preferred embodiment, the Chinese medicinal preparation further comprises pharmaceutically acceptable auxiliary materials. Among them, the auxiliary materials include, for example, disintegrants, lubricants, binders, and the like, but are not limited thereto.
In a preferred embodiment, the dosage form of the Chinese medicinal preparation comprises a pharmaceutically acceptable dosage form, such as decoction, pill, lozenge, granule, powder, paste, capsule, etc., but is not limited thereto.
In a fifth aspect, the present application provides a preparation method of the above-mentioned Chinese medicinal preparation, in particular to a preparation method of decoction (i.e. decoction), which specifically comprises the following steps: mixing the above materials, and decocting.
The preparation method has the advantages of simple and easy operation, short process flow, high extraction efficiency and the like.
It will be appreciated that adjuvants, such as water, are also added during the decoction process.
The temperature and time of the decoction, the water adding amount and other parameters can be any and conventional parameters, and the application is not limited to the above.
In a preferred embodiment, the preparation method of the traditional Chinese medicine preparation of the decoction comprises the following steps: decocting the Chinese medicinal composition with water, concentrating, and filtering to obtain Chinese medicinal preparation. More preferably, the method further comprises the step of soaking the Chinese medicinal composition before the decoction. More preferably, when in decoction, the mass ratio of the traditional Chinese medicine composition to water is 1:6 to 9.
In a specific embodiment, the preparation method of the traditional Chinese medicine preparation of the decoction specifically comprises the following steps: weighing the traditional Chinese medicine composition according to the parts by weight, and soaking the traditional Chinese medicine composition in 1600ml of purified water for 0.5h; then decocting the Chinese medicinal composition with the soaking solution, boiling with strong fire, boiling with slow fire for 1h, and filtering with 100 mesh sieve to obtain about 400ml oral liquid.
It is understood that the preparation method of the traditional Chinese medicine preparation is not limited to the preparation method of the decoction, and any preparation method of other dosage forms such as powder, paste, pill, lozenge, granule and the like which are conventional in the prior art can be adopted.
In a preferred embodiment, the preparation method of the traditional Chinese medicine preparation of the powder comprises the following steps: drying and sterilizing the traditional Chinese medicine composition, crushing and sieving the traditional Chinese medicine composition with a 20-60-mesh sieve, extracting active ingredients in the obtained undersize product by a supercritical low-temperature extraction method, and drying the undersize product to obtain a powdery traditional Chinese medicine preparation. More preferably, the drying before pulverization and the drying after extraction of the active ingredient have a temperature of 50 ℃ or less. More preferably, the method further comprises the step of passing the obtained powdery drug through a 200-300 mesh sieve after extracting the active ingredient and drying.
In a specific embodiment, the preparation method of the traditional Chinese medicine preparation of the powder specifically comprises the following steps: drying the above Chinese medicinal composition at 30deg.C, sterilizing in a double leaf sterilizing cabinet, pulverizing into particles with 20 mesh sieve, extracting active ingredients of the pulverized particles by supercritical low temperature extraction method, drying at 40deg.C, pulverizing the dried medicinal materials, and sieving with 200 mesh sieve to obtain powdered Chinese medicinal preparation.
In a sixth aspect, the application provides an application of the traditional Chinese medicine preparation in preparing a medicine for treating peripheral neuritis.
In a preferred embodiment, the peripheral neuritis comprises diabetic peripheral neuritis.
In a seventh aspect, the application provides application of the traditional Chinese medicine preparation in preparation of hypoglycemic drugs.
In a preferred embodiment, in the above-mentioned Chinese medicinal preparation, the medicament for treating peripheral neuritis also has the effect of reducing blood sugar, and/or the medicament for reducing blood sugar also has the effect of treating peripheral neuritis.
Embodiments of the present application will be described in detail below with reference to examples, but it will be understood by those skilled in the art that the following examples are only for illustrating the present application and should not be construed as limiting the scope of the present application. The specific conditions are not noted in the examples and are carried out according to conventional conditions or conditions recommended by the manufacturer. The reagents or apparatus used were conventional products commercially available without the manufacturer's attention.
Example 1
The traditional Chinese medicine composition provided by the embodiment comprises the following raw materials in parts by mass: 30 parts of wine angelica, 30 parts of ligusticum wallichii, 30 parts of honeysuckle stem, 9 parts of curcuma longa and 3 parts of leech.
The method for preparing the traditional Chinese medicine preparation by adopting the traditional Chinese medicine composition comprises the following steps: mixing the above materials, adding 7 times of water into the mixture, soaking for 0.5 hr, decocting, boiling with strong fire, decocting with slow fire for 1 hr, and filtering with 100 mesh sieve to obtain Chinese medicinal preparation (i.e. Chinese medicinal decoction).
Example 2
The traditional Chinese medicine composition provided by the embodiment comprises the following raw materials in parts by mass: 20 parts of wine angelica, 20 parts of ligusticum wallichii, 20 parts of honeysuckle stem, 7 parts of curcuma longa and 2 parts of leech.
The method for preparing the traditional Chinese medicine preparation by adopting the traditional Chinese medicine composition is the same as that of the embodiment 1.
Example 3
The traditional Chinese medicine composition provided by the embodiment comprises the following raw materials in parts by mass: 40 parts of wine angelica, 40 parts of szechuan lovage rhizome, 40 parts of honeysuckle stem, 13 parts of curcuma longa and 4 parts of leech.
The method for preparing the traditional Chinese medicine preparation by adopting the traditional Chinese medicine composition is the same as that of the embodiment 1.
Example 4
The traditional Chinese medicine composition provided by the embodiment comprises the following raw materials in parts by mass: 10 parts of wine angelica, 10 parts of ligusticum wallichii, 10 parts of honeysuckle stem, 5 parts of curcuma longa and 1 part of leech.
The method for preparing the traditional Chinese medicine preparation by adopting the traditional Chinese medicine composition is the same as that of the embodiment 1.
Example 5
The traditional Chinese medicine composition provided by the embodiment comprises the following raw materials in parts by mass: 50 parts of wine angelica, 50 parts of ligusticum wallichii, 50 parts of honeysuckle stem, 15 parts of curcuma longa and 5 parts of leech.
The method for preparing the traditional Chinese medicine preparation by adopting the traditional Chinese medicine composition is the same as that of the embodiment 1.
Example 6
The traditional Chinese medicine composition provided by the embodiment comprises the following raw materials in parts by mass: 35 parts of wine angelica, 30 parts of ligusticum wallichii, 25 parts of honeysuckle stem, 10 parts of curcuma longa and 4 parts of leech.
The method for preparing the traditional Chinese medicine preparation by adopting the traditional Chinese medicine composition is the same as that of the embodiment 1.
Comparative example 1
The traditional Chinese medicine composition provided by the comparative example comprises the following raw materials in parts by mass: 42.5 parts of ligusticum wallichii, 42.5 parts of honeysuckle stem, 12.8 parts of curcuma longa and 4.2 parts of leech.
The method for preparing the traditional Chinese medicine preparation by adopting the traditional Chinese medicine composition is the same as that of the embodiment 1.
Comparative example 2
The traditional Chinese medicine composition provided by the comparative example comprises the following raw materials in parts by mass: 42.5 parts of wine angelica, 42.5 parts of honeysuckle stem, 12.8 parts of curcuma longa and 4.2 parts of leech.
The method for preparing the traditional Chinese medicine preparation by adopting the traditional Chinese medicine composition is the same as that of the embodiment 1.
Comparative example 3
The traditional Chinese medicine composition provided by the comparative example comprises the following raw materials in parts by mass: 42.5 parts of wine angelica, 42.5 parts of ligusticum wallichii, 12.8 parts of curcuma longa and 4.2 parts of leech.
The method for preparing the traditional Chinese medicine preparation by adopting the traditional Chinese medicine composition is the same as that of the embodiment 1.
Comparative example 4
The traditional Chinese medicine composition provided by the comparative example comprises the following raw materials in parts by mass: 32.9 parts of wine angelica, 32.9 parts of szechuan lovage rhizome, 32.9 parts of honeysuckle stem and 3.3 parts of leech.
The method for preparing the traditional Chinese medicine preparation by adopting the traditional Chinese medicine composition is the same as that of the embodiment 1.
Comparative example 5
The traditional Chinese medicine composition provided by the comparative example comprises the following raw materials in parts by mass: 30.9 parts of wine angelica, 30.9 parts of szechuan lovage rhizome, 30.9 parts of honeysuckle stem and 9.3 parts of curcuma longa.
The method for preparing the traditional Chinese medicine preparation by adopting the traditional Chinese medicine composition is the same as that of the embodiment 1.
Comparative example 6
The traditional Chinese medicine composition provided by the comparative example comprises the following raw materials in parts by mass: 30 parts of wine angelica, 30 parts of ligusticum wallichii, 30 parts of honeysuckle stem, 20 parts of curcuma longa and 10 parts of leech.
The method for preparing the traditional Chinese medicine preparation by adopting the traditional Chinese medicine composition is the same as that of the embodiment 1.
Test examples
Pharmacodynamic experiments
1. Detection material
1.1. Sample formulation information
Traditional Chinese medicine decoction: the traditional Chinese medicine preparations prepared in the above examples and comparative examples are directly used as stock solutions.
Positive control: the sitagliptin phosphate tablet, abbreviated as sitagliptin phosphate, orange-yellow tablet, lot number T027963, merck Sharp & Dohme Italia SPA, was stored in the shade. 3.50mg/mL mother liquor was prepared with ultrapure water, sonicated and stored at 4 ℃.
1.2. Experimental animal
Zebra fish are all cultivated in water for fish cultivation at 28 deg.C (water quality: 200mg instant sea salt is added into 1L reverse osmosis water, conductivity is 450-550 mu S/cm, pH is 6.5-8.5, hardness is 50-100 mg/LCaCO) 3 ) By nourishingThe fish center breeds and provides that experimental animals use license number as follows: SYXK (Zhe) 2022-0004. The feeding management meets the requirements of international AAALAC authentication (authentication number: 001458).
Wild type AB strain zebra fish is bred in a natural pairing mating breeding mode. Zebra fish aged 5 days after fertilization (5 dpf) is used for auxiliary blood sugar reduction efficacy maximum detection concentration (MTC) of traditional Chinese medicine decoction and efficacy evaluation thereof.
The transgenic neutrophil fluorescent zebra fish Tg (mpx: EGFP) strain is hybridized with the peripheral motor nerve green fluorescent zebra fish Tg (NBT: MAPT-GFP) strain, and the natural pairing mating propagation mode is adopted. Zebra fish with the age of 5dpf is used for detecting the effect of eliminating peripheral nerve inflammation of the traditional Chinese medicine decoction.
1.3. Instrument, consumable and reagent
Dissecting microscope (SZX 7, OLYMPUS, japan); CCD camera (VertA 1, shanghai Tusen Vision technologies Co., ltd.); electrokinetically focused continuously variable magnification fluorescence microscope (AZ 100, nikon, japan); precision electronic balances (CP 214, OHAUS, USA); glucometer (ACCU-CHEK Performa, roche diagnostics (Shanghai), inc.; high-speed centrifuges (TG 16G, shanghai ihe biotechnology limited, china); ultrasonic cleaning machine (JP-010T, shenzhen clean Equipment Co., ltd., china); full-automatic sample rapid grinding apparatus (JXFSPRP-24L, shanghai Jijing laboratory equipment science and technology, china).
Pure egg yolk powder (lot 20200809, argin biotechnology, inc., china, zhejiang); glucose (lot number F2209126, china, gladine biochemical technologies inc.); absolute ethanol (lot 20210107, national pharmaceutical systems chemical company, china); blood glucose meter test paper (lot 478829, roche diagnostics products (Shanghai), china).
2. Detection method and detection result
Mtc assay
The 5dpf wild type AB strain zebra fish were randomly selected in beakers, and 30 zebra fish were treated per beaker (each experimental group). The Chinese medicinal decoction prepared in example 1 was diluted with water to a concentration of 6.25. Mu.L/mL, 12.5. Mu.L/mL, 25. Mu.L/mL, 50. Mu.L/mL and 100. Mu.L/mL, respectively, while setting a normal control group and a model control group, each beaker having a capacity of 25mL. Except for a normal control group, each experimental group Bai Tianshui was given a 0.15% egg yolk powder solution and a 3% glucose solution at night to establish a zebra fish hyperglycemia model. During sample treatment, the number of dead zebra fish per experimental group was counted daily and dead zebra fish were removed in time. After treatment at 28℃for 4 days, the MTC of the traditional Chinese medicine decoction to the model zebra fish was measured, and the results are shown in Table 1.
TABLE 1 MTC test results of traditional Chinese medicine decoction on model Zebra fish
As can be seen from Table 1, under the experimental conditions, the MTC of the traditional Chinese medicine decoction to the model zebra fish was 12.5 mu L/mL.
2.2. Auxiliary blood sugar reducing effect
The 5dpf wild type AB strain zebra fish were randomly selected in beakers, and 30 zebra fish were treated per beaker (experimental group). The Chinese medicinal decoction prepared in example 1 was diluted with water to a concentration of 3.125. Mu.L/mL, 6.25. Mu.L/mL and 12.5. Mu.L/mL, respectively, and examples 2-6 and comparative examples 2-6 were diluted with water to a concentration of 6.25. Mu.L/mL, respectively, and the positive control sitagliptin phosphate concentration was 350. Mu.g/mL, while setting the normal control group and the model control group, with a beaker capacity of 25mL. Except for a normal control group, each experimental group Bai Tianshui was given a 0.15% egg yolk powder solution and a 3% glucose solution at night to establish a zebra fish hyperglycemia model. After 2d treatment at 28 ℃, zebra fish is washed 3 times by water for fish culture, data are collected by a glucometer, the glucose level of the zebra fish is analyzed and counted, and the effect of the traditional Chinese medicine decoction for assisting in reducing blood sugar is evaluated according to the statistical analysis result of the index. Statistical treatment results are expressed in mean+ -SE. Statistical analysis was performed with SPSS26.0 software, p <0.05 indicated that the differences were statistically significant. The test results of the hypoglycemic test are shown in table 2.
TABLE 2 evaluation of hypoglycemic efficacy test results
P <0.05, p <0.01, p <0.001 compared to model control.
As shown in Table 2, the Chinese medicinal decoction prepared by the embodiments of the application has good blood sugar reducing effect. In each comparative example, the blood sugar lowering effect was reduced due to the lack of components or improper proportions.
In addition, a comparative bar graph of zebra fish glucose levels after treatment with the normal control, model control, sitagliptin phosphate and the traditional Chinese medicine decoction of example 1 (decoction at concentrations of 3.125. Mu.L/mL, 6.25. Mu.L/mL and 12.5. Mu.L/mL, respectively) is shown in FIG. 1.
2.3. Evaluation of peripheral nerve inflammation resolution efficacy
The 5dpf transgenic neutrophil fluorescence and peripheral motor nerve green fluorescence hybrid strain zebra fish is randomly selected in beakers, and 30 zebra fish are treated in each beaker (experimental group). The Chinese medicinal decoction prepared in example 1 was diluted with water to a concentration of 3.125. Mu.L/mL, 6.25. Mu.L/mL and 12.5. Mu.L/mL, respectively, and examples 2-6 and comparative examples 2-6 were diluted with water to a concentration of 6.25. Mu.L/mL, respectively, and the positive control sitagliptin phosphate concentration was 350. Mu.g/mL, while setting the normal control group and the model control group, with a beaker capacity of 25mL. Except for a normal control group, each experimental group Bai Tianshui was given a 0.15% egg yolk powder solution and a 3% glucose solution at night to establish a zebra fish hyperglycemia model. After treatment for 4D at 28 ℃, 10 zebra fish are randomly selected from each group, photographed under a fluorescence microscope, and the pictures are saved, analyzed and data are collected by NIS-Elements D3.20 advanced image processing software, the number of neutrophils around the zebra fish nerves is analyzed and counted, and the effect of eliminating the inflammation of the nerves around the traditional Chinese medicine decoction is evaluated according to the statistical analysis result of the index. Statistical treatment results are expressed in mean+ -SE. Statistical analysis was performed with SPSS26.0 software, p <0.05 indicated that the differences were statistically significant. The peripheral nerve inflammation regression test results are shown in table 3.
TABLE 3 evaluation of peripheral nerve inflammation resolution efficacy test results
P <0.01 and p <0.001 compared to model control.
As shown in Table 3, the Chinese medicinal decoction prepared by the embodiments of the application has good effect of eliminating peripheral nerve inflammation. In each comparative example, the decrease in the efficacy of the regression of peripheral nerve inflammation was caused by the lack of components or improper proportions.
Further, typical diagrams of the perinerve neutrophils of zebra fish after treatment of the normal control group, the model control group, the sitagliptin phosphate and the traditional Chinese medicine decoction of example 1 (decoction with the concentration of 3.125. Mu.L/mL, 6.25. Mu.L/mL and 12.5. Mu.L/mL after dilution) are shown in FIG. 2. Specifically, the dashed line box in fig. 2 is the zebra fish analysis site, fig. 2 (a) corresponds to the normal control group, fig. 2 (b) corresponds to the model control group, fig. 2 (c) corresponds to sitagliptin phosphate (concentration is 350 μg/mL), fig. 2 (d) corresponds to the traditional Chinese medicine decoction of example 1 diluted to a concentration of 3.125 μl/mL, fig. 2 (e) corresponds to the traditional Chinese medicine decoction of example 1 diluted to a concentration of 6.25 μl/mL, and fig. 2 (f) corresponds to the traditional Chinese medicine decoction of example 1 diluted to a concentration of 12.5 μl/mL.
In addition, a comparison bar graph of the numbers of neutrophils around zebra fish nerves after treatment of the normal control group, the model control group, sitagliptin phosphate and the traditional Chinese medicine decoction of example 1 (decoction with the concentration of 3.125. Mu.L/mL, 6.25. Mu.L/mL and 12.5. Mu.L/mL after dilution respectively) is shown in FIG. 3.
According to the test results of the blood sugar reducing effect and the peripheral nerve inflammation fading effect, the traditional Chinese medicine composition provided by the application not only can treat diabetic peripheral neuropathy, but also has the blood sugar reducing effect, and can be used for preparing medicines for treating peripheral neuritis and blood sugar reducing medicines.
While the application has been illustrated and described with reference to specific embodiments, it is to be understood that the above embodiments are merely illustrative of the technical aspects of the application and not restrictive thereof; those of ordinary skill in the art will appreciate that: modifications may be made to the technical solutions described in the foregoing embodiments, or equivalents may be substituted for some or all of the technical features thereof, without departing from the spirit and scope of the present application; such modifications and substitutions do not depart from the spirit of the corresponding technical solutions; it is therefore intended to cover in the appended claims all such alternatives and modifications as fall within the scope of the application.

Claims (10)

1. The traditional Chinese medicine composition is characterized by comprising the following raw materials in parts by weight: 10-50 parts of wine angelica, 10-50 parts of szechuan lovage rhizome, 10-50 parts of honeysuckle stem, 5-15 parts of curcuma longa and 1-5 parts of leech.
2. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition comprises the following raw materials in parts by mass: 20-40 parts of wine angelica, 20-40 parts of szechuan lovage rhizome, 20-40 parts of honeysuckle stem, 7-13 parts of curcuma longa and 2-4 parts of leech.
3. The use of a Chinese medicinal composition according to claim 1 or 2 in the preparation of a medicament for the treatment of peripheral neuritis;
preferably, the peripheral neuritis comprises diabetic peripheral neuritis.
4. Use of a Chinese medicinal composition according to claim 1 or 2 in the preparation of a hypoglycemic agent.
5. A Chinese medicinal preparation, comprising the Chinese medicinal composition according to claim 1 or 2.
6. The traditional Chinese medicine preparation according to claim 5, further comprising pharmaceutically acceptable auxiliary materials.
7. The traditional Chinese medicine preparation according to claim 5, wherein the dosage form of the traditional Chinese medicine preparation comprises at least one of decoction, pill, lozenge, granule, powder, ointment and capsule.
8. The method for preparing a Chinese medicinal preparation according to any one of claims 5 to 7, comprising the steps of: mixing the above materials, and decocting.
9. The use of a Chinese medicinal preparation according to any one of claims 5 to 7 in the manufacture of a medicament for the treatment of peripheral neuritis.
10. The use of a Chinese medicinal preparation according to any one of claims 5 to 7 in the preparation of a hypoglycemic agent.
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