CN116474023A - Traditional Chinese medicine composition and application thereof in preparation of medicines with function of treating/preventing chronic obstructive pulmonary disease - Google Patents
Traditional Chinese medicine composition and application thereof in preparation of medicines with function of treating/preventing chronic obstructive pulmonary disease Download PDFInfo
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
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- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/62—Leeches; Worms, e.g. cestodes, tapeworms, nematodes, roundworms, earth worms, ascarids, filarias, hookworms, trichinella or taenia
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
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- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
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Abstract
The invention relates to the technical field of traditional Chinese medicines, and in particular discloses a traditional Chinese medicine composition and application thereof in preparation of medicines with the effect of treating/preventing chronic obstructive pulmonary diseases. The traditional Chinese medicine composition comprises the following raw material components: cortex Mori, herba Taraxaci, radix Scutellariae, radix seu radix Kadsurae Longipedunculatae, and pericarpium Citri Reticulatae. Further, the traditional Chinese medicine composition also comprises peucedanum root and earthworm. The traditional Chinese medicine composition prepared from the traditional Chinese medicine raw material components has the effect of treating/preventing bronchitis; further clinical studies have shown that it also has a therapeutic and/or prophylactic effect on chronic obstructive pulmonary disease. In addition, the prescription has the advantages of fine prescription, no valuable or toxic drugs, safety, reliability, low technical risk, wide market demand and obvious economic and social benefits.
Description
Technical Field
The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition and application thereof in preparing medicines with the function of treating/preventing chronic obstructive pulmonary diseases.
Background
Chronic obstructive pulmonary disease is a chronic bronchitis and/or emphysema characterized by airflow obstruction; and can further develop into common chronic diseases of pulmonary heart disease and respiratory failure; it is associated with abnormal inflammatory reactions of harmful gases and harmful particles, and generally, its disability rate and death rate are high. Therefore, it is of great clinical significance to provide a medicament which can treat or prevent chronic bronchitis and further chronic obstructive pulmonary disease.
The Chinese patent 201310693698.5 discloses a traditional Chinese medicine for treating chronic obstructive pulmonary disease, which is characterized by comprising the following raw materials in percentage by weight: 10-14% of rhizoma acori graminei, 8-12% of schizonepeta, 6-10% of cynanchum atratum, 2-6% of coltsfoot flower, 5-7% of semen lepidii, 2-6% of semen brassicae, 2-6% of coix seed, 5-7% of myrobalan, 6-10% of kaempferia galanga, 5-7% of fructus trichosanthis, 2-6% of pubescent holly root, 6-10% of semen cuscutae, 2-5% of caulis tinosporae, 2-6% of paris, 2-6% of radix stephaniae tetrandrae and 6-10% of blackberry lily, soaking the raw materials in water, decocting and removing residues to obtain filtered juice. The invention has low cost, no toxic or side effect and high curative effect on chronic obstructive pulmonary disease.
Chinese patent 201310693698.5 discloses a Chinese medicine for treating chronic obstructive pulmonary disease; however, the formula is complex, and multiple medicines are needed to be compounded. Therefore, if a medicine with simple formula capable of treating or preventing chronic bronchitis and further capable of treating or preventing chronic obstructive pulmonary disease is provided, the medicine has important clinical significance.
Disclosure of Invention
In order to overcome at least one technical problem existing in the prior art, the invention provides a traditional Chinese medicine composition.
The technical problems to be solved by the invention are realized by the following technical scheme:
a Chinese medicinal composition comprises the following raw material components: cortex Mori, herba Taraxaci, radix Scutellariae, radix seu radix Kadsurae Longipedunculatae, and pericarpium Citri Reticulatae.
The inventor discovers in the research that the traditional Chinese medicine composition prepared by taking the white mulberry root-bark, dandelion, baikal skullcap root, radix cynanchi wilfordii and dried orange peel as raw materials has the effect of treating and/or preventing bronchitis.
Preferably, the traditional Chinese medicine composition comprises the following raw material components in parts by weight:
15-20 parts of white mulberry root-bark; 15-20 parts of dandelion; 12-18 parts of radix scutellariae; 25-35 parts of a golden lock; 8-10 parts of dried orange peel;
most preferably, the traditional Chinese medicine composition comprises the following raw material components in parts by weight:
18 parts of white mulberry root-bark; 18 parts of dandelion; 15 parts of radix scutellariae; unlocking 30 parts of a gold lock; 9 parts of dried orange peel.
Preferably, the Chinese medicinal composition further comprises peucedanum root and/or earthworm.
Most preferably, the Chinese medicinal composition further comprises radix Peucedani and Lumbricus.
The inventor surprisingly found in the study that the traditional Chinese medicine composition prepared by adding radix peucedani and earthworm into white mulberry root-bark, dandelion, radix scutellariae, radix cynanchi bungei and dried orange peel and taking white mulberry root-bark, dandelion, radix scutellariae, radix cynanchi bungei and earthworm as raw materials has a significantly higher effect on treating and/or preventing bronchitis than the traditional Chinese medicine composition prepared by taking white mulberry root-bark, dandelion, radix scutellariae, radix cynanchi bungei and dried orange peel as raw materials.
The inventor finds that the addition of the peucedanum root and the earthworm is very critical in the research; the traditional Chinese medicine composition prepared by only adding the peucedanum root or the earthworm into the traditional Chinese medicine raw materials of the white mulberry root-bark, the dandelion, the baikal skullcap root, the radix cynanchi wilfordii and the dried orange peel can not be obviously improved compared with the traditional Chinese medicine composition prepared by taking the white mulberry root-bark, the dandelion, the baikal skullcap root, the radix cynanchi wilfordii and the dried orange peel as raw materials; in the traditional Chinese medicine raw materials of the white mulberry root-bark, the dandelion, the baikal skullcap root, the radix cynanchi wilfordii and the dried orange peel, only the traditional Chinese medicine composition prepared by adding the peucedanum root and the earthworm simultaneously has the effect of treating bronchitis, compared with the traditional Chinese medicine composition prepared by taking the white mulberry root-bark, the dandelion, the baikal skullcap root, the radix cynanchi wilfordii and the dried orange peel as raw materials.
Meanwhile, the inventor further discovers in clinical experiments that the traditional Chinese medicine composition prepared by taking the white mulberry root-bark, dandelion, radix scutellariae, radix cynanchi wilfordii, dried orange peel, radix peucedani and earthworm as raw materials has the effect of treating and/or preventing chronic obstructive pulmonary diseases.
Preferably, the feed comprises the following raw material components in parts by weight:
15-20 parts of white mulberry root-bark; 15-20 parts of dandelion; 12-18 parts of radix scutellariae; 25-35 parts of a golden lock; 8-10 parts of dried orange peel; 8-10 parts of radix peucedani; 8-10 parts of earthworm.
Most preferably, the traditional Chinese medicine composition comprises the following raw material components in parts by weight:
18 parts of white mulberry root-bark; 18 parts of dandelion; 15 parts of radix scutellariae; unlocking 30 parts of a gold lock; 9 parts of dried orange peel; 9 parts of radix peucedani; 9 parts of earthworm.
The invention also provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps:
mixing the Chinese medicinal materials, heating and refluxing the extract with solvent, concentrating and drying the extract after extraction, and obtaining the Chinese medicinal composition.
Preferably, the solvent is water or an organic solvent.
Further preferably, the organic solvent is an aqueous ethanol solution;
preferably, the ethanol aqueous solution refers to ethanol aqueous solution with the volume fraction of 50-95%.
Most preferably, the aqueous ethanol solution refers to an aqueous ethanol solution with a volume fraction of 80%.
Preferably, the weight of the solvent is 8-15 times of the total weight of the mixed traditional Chinese medicine raw materials.
Most preferably, the weight of the solvent is 12 times of the total weight of the mixed traditional Chinese medicine raw materials.
Further, the traditional Chinese medicine extract is put on a silica gel column, and then eluting and impurity removing are carried out by adopting a mixed solvent consisting of n-heptane and diethyl ether; eluting with mixed solvent composed of n-heptane and absolute ethanol, collecting eluate eluted with mixed solvent composed of n-heptane and absolute ethanol, concentrating, and drying to obtain the final product.
Preferably, the volume ratio of the n-heptane to the diethyl ether in the mixed solvent consisting of the n-heptane and the diethyl ether is 100:15-20.
Most preferably, the volume ratio of n-heptane to diethyl ether in the mixed solvent consisting of n-heptane and diethyl ether is 100:18.
Preferably, the volume ratio of the n-heptane to the absolute ethyl alcohol in the mixed solvent consisting of the n-heptane and the absolute ethyl alcohol is 100:20-25.
Most preferably, the volume ratio of the n-heptane to the absolute ethanol in the mixed solvent consisting of the n-heptane and the absolute ethanol is 100:23.
The inventor has surprisingly found in further research that by the silica gel column elution condition, a great amount of active ingredients for treating and/or preventing bronchitis can be further enriched; the prepared traditional Chinese medicine composition has the effect of treating and/or preventing bronchitis, which is further greatly higher than that of a traditional Chinese medicine extract without the enrichment of active ingredients by a silica gel column.
Here, the inventors have required that the composition of the mixed solvent is critical in the above conditions of elution of the silica gel column; eluting with a mixed solvent consisting of n-heptane and diethyl ether with a volume ratio of 100:15-20, and eluting with a mixed solvent consisting of n-heptane and absolute ethyl alcohol with a volume ratio of 100:20-25 to obtain a Chinese medicinal composition, wherein a large amount of active ingredients for treating and/or preventing bronchitis can be enriched, so that the effect of treating and/or preventing bronchitis of the prepared Chinese medicinal composition can be further greatly improved. However, the traditional Chinese medicine composition prepared by eluting with other silica gel column elution conditions cannot be enriched in a large amount of active ingredients for treating and/or preventing bronchitis, and the effect of treating and/or preventing bronchitis of the prepared traditional Chinese medicine composition cannot be further improved or greatly improved.
The invention also provides application of the traditional Chinese medicine composition in preparing medicines with the effect of treating and/or preventing bronchitis.
Preferably, the application of the traditional Chinese medicine composition in preparing medicines with the function of treating and/or preventing chronic obstructive pulmonary diseases.
Preferably, the chronic obstructive pulmonary disease is a syndrome of phlegm-heat depressed lung in the differentiation of Chinese medicine.
Preferably, the medicament is in the form of granules, pills, powder, oral liquid, tablets or capsules.
The beneficial effects are that: the invention provides a Chinese medicinal composition with brand new composition; the traditional Chinese medicine composition prepared from the traditional Chinese medicine raw material components has the effect of treating/preventing bronchitis; further clinical studies have shown that it also has a therapeutic and/or prophylactic effect on chronic obstructive pulmonary disease. Therefore, the composition provided by the invention has important application value when being used as an active ingredient for preparing a medicament with the effect of treating and/or preventing bronchitis and/or preparing a medicament with the effect of treating and/or preventing chronic obstructive pulmonary diseases.
In addition, the prescription has the advantages of fine prescription, no valuable or toxic drugs, safety, reliability, low technical risk, wide market demand and obvious economic and social benefits.
Detailed Description
The present invention is further explained below with reference to examples, which are not intended to limit the present invention in any way.
EXAMPLE 1 preparation of a Chinese medicinal composition
The traditional Chinese medicine comprises the following raw materials in parts by weight: 18 parts of white mulberry root-bark; 18 parts of dandelion; 15 parts of radix scutellariae; unlocking 30 parts of a gold lock; 9 parts of dried orange peel;
the preparation method comprises the following steps: mixing the above Chinese medicinal materials, heating to boiling state with ethanol water solution with volume fraction of 80% of total weight of the Chinese medicinal materials after 12 times, reflux extracting for 1.5 hr, concentrating and drying the extractive solution after extraction, and obtaining the Chinese medicinal composition.
EXAMPLE 2 preparation of a Chinese medicinal composition
The traditional Chinese medicine comprises the following raw materials in parts by weight: 18 parts of white mulberry root-bark; 18 parts of dandelion; 15 parts of radix scutellariae; unlocking 30 parts of a gold lock; 9 parts of dried orange peel; 9 parts of radix peucedani; 9 parts of earthworm;
the preparation method comprises the following steps: mixing the above Chinese medicinal materials, heating to boiling state with ethanol water solution with volume fraction of 80% of total weight of the Chinese medicinal materials after 12 times, reflux extracting for 1.5 hr, concentrating and drying the extractive solution after extraction, and obtaining the Chinese medicinal composition.
EXAMPLE 3 preparation of a Chinese medicinal composition
The traditional Chinese medicine comprises the following raw materials in parts by weight: 18 parts of white mulberry root-bark; 18 parts of dandelion; 15 parts of radix scutellariae; unlocking 30 parts of a gold lock; 9 parts of dried orange peel; 9 parts of radix peucedani; 9 parts of earthworm;
the preparation method comprises the following steps:
(1) Mixing the above Chinese medicinal materials, heating to boiling state with ethanol water solution with volume fraction of 80% of total weight of the mixed Chinese medicinal materials of 12 times, reflux extracting for 1.5 hr, concentrating and drying the extractive solution after extraction is completed to obtain Chinese medicinal extract;
(2) Loading the Chinese medicinal extract onto a silica gel column (silica gel column is filled with 200-300 mesh silica gel with 30 times of the weight of the Chinese medicinal extract), and eluting with mixed solvent composed of n-heptane and diethyl ether with volume ratio of 5 times of column volume of 100:18 to remove impurities; then eluting with a mixed solvent of n-heptane and absolute ethyl alcohol with the volume ratio of 100:23 by adopting 8 times of the column volume, collecting eluent eluted by the mixed solvent of n-heptane and absolute ethyl alcohol with the volume ratio of 100:23 after eluting, concentrating and drying to obtain the traditional Chinese medicine composition.
EXAMPLE 4 preparation of a Chinese medicinal composition
The traditional Chinese medicine comprises the following raw materials in parts by weight: 18 parts of white mulberry root-bark; 18 parts of dandelion; 15 parts of radix scutellariae; unlocking 30 parts of a gold lock; 9 parts of dried orange peel; 9 parts of radix peucedani;
the preparation method comprises the following steps: mixing the above Chinese medicinal materials, heating to boiling state with ethanol water solution with volume fraction of 80% of total weight of the Chinese medicinal materials after 12 times, reflux extracting for 1.5 hr, concentrating and drying the extractive solution after extraction, and obtaining the Chinese medicinal composition.
Example 4 differs from example 2 in that example 4 only peucedanum root is added in white mulberry root-bark, dandelion, baikal skullcap root, radix cynanchi wilfordii and dried orange peel; the traditional Chinese medicine composition is prepared from the raw materials of white mulberry root-bark, dandelion, radix scutellariae, radix cynanchi wilfordii, dried orange peel and radix peucedani; in the embodiment 2, radix peucedani and earthworm are added into the white mulberry root-bark, dandelion, baikal skullcap root, radix cynanchi wilfordii and dried orange peel, and the white mulberry root-bark, dandelion, baikal skullcap root, radix cynanchi wilfordii, dried orange peel and earthworm are used as raw materials to prepare the traditional Chinese medicine composition.
EXAMPLE 5 preparation of a Chinese medicinal composition
The traditional Chinese medicine comprises the following raw materials in parts by weight: 18 parts of white mulberry root-bark; 18 parts of dandelion; 15 parts of radix scutellariae; unlocking 30 parts of a gold lock; 9 parts of dried orange peel; 9 parts of earthworm;
the preparation method comprises the following steps: mixing the above Chinese medicinal materials, heating to boiling state with ethanol water solution with volume fraction of 80% of total weight of the Chinese medicinal materials after 12 times, reflux extracting for 1.5 hr, concentrating and drying the extractive solution after extraction, and obtaining the Chinese medicinal composition.
Example 5 differs from example 2 in that example 5 only adds earthworm in the white mulberry root-bark, dandelion, baikal skullcap root, radix cynanchi wilfordii and dried orange peel; the traditional Chinese medicine composition is prepared from cortex mori, dandelion, radix scutellariae, radix cynanchi wilfordii, dried orange peel and earthworm as raw materials; in the embodiment 2, the radix peucedani and the earthworm are added into the white mulberry root-bark, the dandelion, the baikal skullcap root, the radix cynanchi wilfordii and the dried orange peel, and the white mulberry root-bark, the dandelion, the baikal skullcap root, the radix cynanchi wilfordii, the dried orange peel, the radix peucedani and the earthworm are used as raw materials to prepare the traditional Chinese medicine composition.
Comparative example 1 preparation of Chinese medicinal composition
The traditional Chinese medicine comprises the following raw materials in parts by weight: 18 parts of white mulberry root-bark; 18 parts of dandelion; 15 parts of radix scutellariae; unlocking 30 parts of a gold lock; 9 parts of dried orange peel; 9 parts of radix peucedani; 9 parts of earthworm;
the preparation method comprises the following steps:
(1) Mixing the above Chinese medicinal materials, heating to boiling state with ethanol water solution with volume fraction of 80% of total weight of the mixed Chinese medicinal materials of 12 times, reflux extracting for 1.5 hr, concentrating and drying the extractive solution after extraction is completed to obtain Chinese medicinal extract;
(2) Loading the Chinese medicinal extract onto a silica gel column (silica gel column is filled with 200-300 mesh silica gel with 30 times of the weight of the Chinese medicinal extract), and eluting with mixed solvent composed of n-heptane and diethyl ether with volume ratio of 5 times of column volume of 100:8 to remove impurities; then eluting with a mixed solvent of n-heptane and absolute ethyl alcohol with the volume ratio of 100:13 by adopting 8 times of the column volume, collecting eluent eluted by the mixed solvent of n-heptane and absolute ethyl alcohol with the volume ratio of 100:13 after eluting, concentrating and drying to obtain the traditional Chinese medicine composition.
Comparative example 1 differs from example 3 in that comparative example 1 was eluted with a mixed solvent consisting of n-heptane and diethyl ether in a volume ratio of 100:8 to remove impurities, and then eluted with a mixed solvent consisting of n-heptane and absolute ethanol in a volume ratio of 100:13 to obtain a Chinese medicinal composition; in example 2, eluting with a mixed solvent of n-heptane and diethyl ether at a volume ratio of 100:18 to remove impurities, and eluting with a mixed solvent of n-heptane and absolute ethanol at a volume ratio of 100:23 to obtain the traditional Chinese medicine composition.
Comparative example 2 preparation of Chinese medicinal composition
The traditional Chinese medicine comprises the following raw materials in parts by weight: 18 parts of white mulberry root-bark; 18 parts of dandelion; 15 parts of radix scutellariae; unlocking 30 parts of a gold lock; 9 parts of dried orange peel; 9 parts of radix peucedani; 9 parts of earthworm;
the preparation method comprises the following steps:
(1) Mixing the above Chinese medicinal materials, heating to boiling state with ethanol water solution with volume fraction of 80% of total weight of the mixed Chinese medicinal materials of 12 times, reflux extracting for 1.5 hr, concentrating and drying the extractive solution after extraction is completed to obtain Chinese medicinal extract;
(2) Loading the Chinese medicinal extract onto a silica gel column (silica gel column is filled with 200-300 mesh silica gel with 30 times of the weight of the Chinese medicinal extract), and eluting with a mixed solvent composed of n-heptane and absolute ethyl alcohol with a volume ratio of 5 times of column volume of 100:25 to remove impurities; then eluting with a mixed solvent of n-heptane and absolute ethyl alcohol with the volume ratio of 100:40 by adopting 8 times of the column volume, collecting eluent eluted by the mixed solvent of n-heptane and absolute ethyl alcohol with the volume ratio of 100:40 after eluting, concentrating and drying to obtain the traditional Chinese medicine composition.
Comparative example 2 differs from example 3 in that comparative example 2 was first eluted with a mixed solvent of n-heptane and absolute ethanol in a volume ratio of 100:25 to remove impurities, and then eluted with a mixed solvent of n-heptane and absolute ethanol in a volume ratio of 100:40 to obtain a Chinese medicinal composition; in example 2, eluting with a mixed solvent of n-heptane and diethyl ether at a volume ratio of 100:18 to remove impurities, and eluting with a mixed solvent of n-heptane and absolute ethanol at a volume ratio of 100:23 to obtain the traditional Chinese medicine composition.
Experimental example 1 experiment for treating and/or preventing bronchitis
The method for establishing the chronic bronchitis model mice comprises the following steps: selecting KM mice with weight of 20+ -2 g, and injecting lipopolysaccharide into respiratory tract of the mice on day 1 and day 15; the mice were smoked starting on day 2, continuously smoked for 30d, smoked for 30min each day, and after smoking was completed, chronic bronchitis model mice were established.
160 mice of the chronic bronchitis model are selected and randomly divided into 8 groups, and each group comprises 20 mice, and male and female halves; the method is divided into experimental groups 1-7 and model control groups; experimental groups 1 to 7 were each day at a rate of 100 mg.kg -1 ·d -1 The administration doses of the Chinese medicinal compositions prepared in examples 1 to 5 and comparative examples 1 to 2 were lavaged; the model control group is filled with the same amount of distilled water every day; after 14 days of continuous gastric lavage, the mice were tested for the concentration of TNF- α and IL-8 in bronchoalveolar lavage fluid; the test results are shown in Table 1.
TABLE 1 Experimental results for the treatment and/or prevention of bronchitis
As can be seen from the experimental data in Table 1, the concentrations of TNF- α and IL-8 were reduced in experimental group 1 relative to the model group; this illustrates: the traditional Chinese medicine composition is prepared from the raw materials of white mulberry root-bark, dandelion, radix scutellariae, radix cynanchi wilfordii and dried orange peel, and has the effect of treating and/or preventing bronchitis.
As can be seen from the experimental data in table 1, the concentrations of TNF- α and IL-8 in experimental group 2 (tested for the traditional Chinese medicine composition prepared in example 2) were further significantly reduced relative to that in experimental group 1 (tested for the traditional Chinese medicine composition prepared in example 1); this illustrates: the Chinese medicinal composition prepared from the raw materials of the white mulberry root-bark, the dandelion, the scutellaria baicalensis, the radix cynanchi wilfordii and the dried orange peel is remarkably higher in the effect of treating and/or preventing bronchitis than the Chinese medicinal composition prepared from the raw materials of the white mulberry root-bark, the dandelion, the scutellaria baicalensis, the radix cynanchi wilfordii and the dried orange peel.
However, the decrease in the concentrations of TNF-. Alpha.and IL-8 was not significant in experimental group 4 (the Chinese medicinal composition prepared in example 4 was tested) and in experimental group 5 (the Chinese medicinal composition prepared in example 5 was tested), and the decrease in the concentrations of TNF-. Alpha.and IL-8 was significantly smaller in both experimental groups 2, relative to experimental group 1 (the Chinese medicinal composition prepared in example 1 was tested). This illustrates: the addition of the peucedanum root and the earthworm is very critical; the traditional Chinese medicine composition prepared by only adding the peucedanum root or the earthworm into the traditional Chinese medicine raw materials of the white mulberry root-bark, the dandelion, the baikal skullcap root, the radix cynanchi wilfordii and the dried orange peel can not be obviously improved compared with the traditional Chinese medicine composition prepared by taking the white mulberry root-bark, the dandelion, the baikal skullcap root, the radix cynanchi wilfordii and the dried orange peel as raw materials in the treatment and/or the prevention of bronchitis; in the traditional Chinese medicine raw materials of the white mulberry root-bark, the dandelion, the baikal skullcap root, the radix cynanchi wilfordii and the dried orange peel, only the traditional Chinese medicine composition prepared by adding the peucedanum root and the earthworm simultaneously has the effect of treating and/or preventing bronchitis, compared with the traditional Chinese medicine composition prepared by taking the white mulberry root-bark, the dandelion, the baikal skullcap root, the radix cynanchi wilfordii and the dried orange peel as raw materials. Adding radix Peucedani and Lumbricus into cortex Mori, herba Taraxaci, scutellariae radix, radix seu herba Achillea Wilsonianae and pericarpium Citri Tangerinae; can synergistically improve the effects of treating and/or preventing bronchitis of the traditional Chinese medicine composition prepared by taking the white mulberry root-bark, dandelion, baical skullcap root, radix cynanchi wilfordii and tangerine peel as raw materials.
As can be seen from the experimental data in table 1, the concentrations of TNF- α and IL-8 in experimental group 3 (the traditional Chinese medicine composition prepared in example 3 was tested) were further significantly reduced relative to that in experimental group 2 (the traditional Chinese medicine composition prepared in example 2 was tested); this illustrates: the traditional Chinese medicine composition prepared by further using the silica gel column elution condition disclosed by the invention has the effect of treating and/or preventing bronchitis, which is further greatly higher than that of the traditional Chinese medicine extract without enriching active ingredients by a silica gel column.
However, the TNF-. Alpha.and IL-8 concentrations were not significantly reduced or decreased in experimental group 6 (tested for the Chinese medicinal composition prepared in comparative example 1) and experimental group 7 (tested for the Chinese medicinal composition prepared in comparative example 2) relative to experimental group 2 (tested for the Chinese medicinal composition prepared in example 2); this specification: in the silica gel column elution condition, eluting with a mixed solvent consisting of n-heptane and diethyl ether with the volume ratio of 100:15-20 to remove impurities, and eluting with a mixed solvent consisting of n-heptane and absolute ethyl alcohol with the volume ratio of 100:20-25 to obtain the traditional Chinese medicine composition, so that the treatment and/or bronchitis prevention effects of the prepared traditional Chinese medicine composition can be further greatly improved. However, the traditional Chinese medicine composition prepared by eluting with other silica gel column elution conditions cannot further improve or greatly improve the effect of treating and/or preventing bronchitis of the prepared traditional Chinese medicine composition.
Example 6 preparation of granules
Taking the traditional Chinese medicine composition prepared in the example 2 as an effective component, and preparing into medicine granules by adopting a conventional method; wherein the mass fraction of the traditional Chinese medicine composition prepared in the embodiment 2 in the granule is 10%.
Example 7 preparation of granules
Taking the traditional Chinese medicine composition prepared in the example 3 as an effective component, and preparing into medicine granules by adopting a conventional method; wherein the mass fraction of the traditional Chinese medicine composition prepared in the embodiment 3 in the granule is 10%.
Example 8 preparation of pills
Taking the traditional Chinese medicine composition prepared in the example 2 as an effective ingredient, and preparing into a medicinal pill by adopting a conventional method; wherein the mass fraction of the traditional Chinese medicine composition prepared in the example 2 in the pill is 10%.
Example 9 preparation of capsules
Taking the traditional Chinese medicine composition prepared in the example 3 as an effective component, and preparing into a medicine capsule by adopting a conventional method; wherein the mass fraction of the traditional Chinese medicine composition prepared in the embodiment 3 in the capsule is 10%.
Example 10 preparation of tablets
Taking the traditional Chinese medicine composition prepared in the example 3 as an effective ingredient, and preparing a medicine tablet by adopting a conventional method; wherein the mass fraction of the traditional Chinese medicine composition prepared in the embodiment 3 in the tablet is 10%.
Experimental example 2 clinical experiments
The experimental object: clinically, it is a chronic obstructive pulmonary disease, and the syndrome differentiation of traditional Chinese medicine pertains to phlegm-heat stagnation in the lung.
Grouping: the treatment group and the control group are divided; of these, 55 treatment groups and 53 control groups. The treatment group took the traditional Chinese medicine composition granules prepared in example 6 every day; the medicine is taken with boiled water 2 times a day, 30g each time, and continuously taken for 10 days. The medicines taken by the control group are as follows: lung-heat clearing granule simulator; the medicine is taken with boiled water 2 times a day, 30g each time, and 14 days continuously.
Clinical test results and data are shown in tables 2-10; from the clinical test results and data in tables 2 to 10, the traditional Chinese medicine composition disclosed by the invention has the advantage of treating chronic obstructive pulmonary disease (phlegm-heat lung stagnating syndrome).
1. Total integral comparison of syndrome of Chinese medicine
As shown in table 2, the total integral of the traditional Chinese medicine symptoms of the patient after treatment is divided into a treatment group (45.00±52.38) and a control group (76.71± 86.60), the two groups of data are normally distributed, and p=0.011 < 0.05 after t test.
TABLE 2 comparison of total integral of the symptoms of TCM before and after treatment (unit: minute)
2. Main symptom integral comparison
As shown in table 3, the two groups were compared in groups before and after treatment, p < 0.05, by Mann-Whitney U rank sum test; comparison between the two groups after treatment, P < 0.05.
TABLE 3 integral comparison (Unit: minute) of main symptoms before and after treatment
3. Secondary symptom score comparison
Table 4 shows that, by Mann-Whitney U rank sum test, the two groups of treatment were compared in groups before and after treatment, and p < 0.05; comparison between the two groups after treatment, > P > 0.05.
TABLE 4 integral comparison (unit: minutes) of the symptoms before and after treatment
4. Lung sound-producing efficacy comparison
As shown in table 5, the effective rate of the treatment group was 83.64% and the effective rate of the control group was 66.04%; the lung sound-burning curative effect of the two groups is tested by the chi-square, and p=0.035 < 0.05.
Table 5 comparison of lung sound effects
5. Traditional Chinese medicine syndrome curative effect comparison
As shown in table 6, the curative effect of the traditional Chinese medicine symptoms of the treatment group is 90.91%, and the curative effect of the traditional Chinese medicine symptoms of the control group is 73.58%; the efficacy of the two groups of Chinese medical syndromes is compared, and the difference has statistical significance (p=0.018 < 0.05).
Comparative curative effects of the symptoms of the traditional Chinese medical science of Table 6
6. Comparison of mMRC scores before and after treatment
Table 7 shows that, by Mann-Whitney U rank sum test, the two groups of treatment were compared in groups before and after treatment, p < 0.05; comparison between groups after the end of treatment of the two groups p < 0.05.
Table 7 comparison of mrrc scores for two groups of patients before and after treatment
7. CAT score comparison before and after treatment
As shown in table 8, the two groups were compared in groups before and after treatment, p < 0.05, by Mann-Whitney U rank sum test; comparison between groups after the end of treatment of the two groups p < 0.05.
Table 8 comparison of CAT scores for two groups of patients before and after treatment
8. Serum IL-6, IL-8, TNF-alpha levels comparison before and after treatment
Table 9 shows that, by Mann-Whitney U rank sum test, the two groups of treatment were compared in groups before and after treatment, p < 0.05; comparison between groups after the end of treatment of the two groups p < 0.05.
TABLE 9 comparison of serum IL-6, IL-8, TNF- α levels for two groups of patients before and after treatment (unit: pg/ml)
10. Comparison of peripheral blood TLR2 and TLR4 levels before and after treatment
As shown in table 10, the two groups of treatments were compared in groups before and after the Mann-Whitney U rank sum test, and p was less than 0.05; comparison between groups after the end of treatment by t-test, p < 0.05.
Table 10 comparison of peripheral blood TLR2 and TLR4 levels (Unit: pg/ml) for two groups of patients before and after treatment
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Claims (10)
1. A Chinese medicinal composition is characterized by comprising the following raw material components: cortex Mori, herba Taraxaci, radix Scutellariae, radix seu radix Kadsurae Longipedunculatae, and pericarpium Citri Reticulatae.
2. The traditional Chinese medicine composition according to claim 1, which is characterized by comprising the following raw material components in parts by weight:
15-20 parts of white mulberry root-bark; 15-20 parts of dandelion; 12-18 parts of radix scutellariae; 25-35 parts of a golden lock; 8-10 parts of dried orange peel;
most preferably, the traditional Chinese medicine composition comprises the following raw material components in parts by weight:
18 parts of white mulberry root-bark; 18 parts of dandelion; 15 parts of radix scutellariae; unlocking 30 parts of a gold lock; 9 parts of dried orange peel.
3. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition further comprises peucedanum root and/or earthworm.
4. The traditional Chinese medicine composition according to claim 3, which is characterized by comprising the following raw material components in parts by weight:
15-20 parts of white mulberry root-bark; 15-20 parts of dandelion; 12-18 parts of radix scutellariae; 25-35 parts of a golden lock; 8-10 parts of dried orange peel; 8-10 parts of radix peucedani; 8-10 parts of earthworm;
most preferably, the traditional Chinese medicine composition comprises the following raw material components in parts by weight:
18 parts of white mulberry root-bark; 18 parts of dandelion; 15 parts of radix scutellariae; unlocking 30 parts of a gold lock; 9 parts of dried orange peel; 9 parts of radix peucedani; 9 parts of earthworm.
5. The method for preparing a Chinese medicinal composition according to any one of claims 1 to 4, comprising the steps of:
mixing the Chinese medicinal materials, heating and refluxing the extract with solvent, concentrating and drying the extract after extraction, and obtaining the Chinese medicinal composition.
6. The method for preparing a pharmaceutical composition according to claim 5, wherein the solvent is water or an organic solvent.
7. The method for preparing a pharmaceutical composition according to claim 6, wherein the organic solvent is an aqueous ethanol solution.
8. The use of the Chinese medicinal composition according to any one of claims 1 to 4 in the preparation of a medicament for treating and/or preventing bronchitis.
9. The use of the Chinese medicinal composition according to any one of claims 1 to 4 in the preparation of a medicament for treating and/or preventing chronic obstructive pulmonary disease.
10. The use according to claim 8 or 9, wherein the medicament is in the form of granules, pills, powders, oral liquids, tablets or capsules.
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Non-Patent Citations (2)
| Title |
|---|
| 徐树华;折哲;熊必丹;石克华;: "清肺颗粒治疗慢性支气管炎痰热郁肺证的临床研究", 辽宁中医杂志, no. 04, 18 April 2016 (2016-04-18), pages 747 - 749 * |
| 折哲等: "清肺颗粒干预TLR4/NF⁃κB信号通路调控COPD大鼠气道损伤的机制研究", 上海中医药杂志, vol. 56, no. 3, 31 March 2022 (2022-03-31), pages 64 - 73 * |
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