CN116966222A - Traditional Chinese medicine composition for treating liver fibrosis as well as preparation and application thereof - Google Patents
Traditional Chinese medicine composition for treating liver fibrosis as well as preparation and application thereof Download PDFInfo
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- CN116966222A CN116966222A CN202310829009.2A CN202310829009A CN116966222A CN 116966222 A CN116966222 A CN 116966222A CN 202310829009 A CN202310829009 A CN 202310829009A CN 116966222 A CN116966222 A CN 116966222A
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- liver fibrosis
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Abstract
The application belongs to the technical field of traditional Chinese medicines, and provides a traditional Chinese medicine composition for treating hepatic fibrosis, a preparation and application thereof; the traditional Chinese medicine composition comprises the following raw materials: peach kernel, cordyceps sinensis, polygonum multiflorum, gynostemma pentaphylla, schisandra chinensis, red sage root, safflower and medlar; through the compounding of the active components of the raw materials, the Chinese medicinal composition has the effects of strengthening body resistance and eliminating evil, and compared with the prior art, the Chinese medicinal composition has the advantages of good effect of treating the hepatic fibrosis, wide raw material sources and more concise formula.
Description
Technical Field
The application belongs to the technical field of traditional Chinese medicines, and in particular relates to a traditional Chinese medicine composition for treating hepatic fibrosis, a preparation and application thereof.
Background
Liver fibrosis (HF) is a pathological change occurring in most chronic liver disease processes, and is mainly represented by the hyper-proliferation and deposition of extracellular matrix (extracellular matrix, ECM) in liver tissue, which is essentially a reversible gate of liver tissue injury over-repair reaction. Liver fibrosis, if not treated and controlled in time, may progress to cirrhosis, liver cancer or liver failure, reversing liver fibrosis is an important means to prevent the progression of chronic liver disease. Currently, there is no recognized chemical and biological agent that is specifically effective for treating liver fibrosis. In recent years, research on anti-liver fibrosis of traditional Chinese medicine has become a focus and a hotspot of attention in the medical community. Several studies have shown that traditional Chinese medicine plays an important role in the treatment of anti-hepatic fibrosis.
CN115475200a discloses a traditional Chinese medicine compound preparation for treating hepatic fibrosis, which is prepared from the following raw materials in parts by weight: 20-30 parts of radix scutellariae, 10-20 parts of tiger thorn, 10-12 parts of fructus piperis, and 3-7 parts of herba fraxini. The preparation method comprises the following steps: respectively preprocessing the raw materials, adding 10 times of 50% ethanol, and extracting under reflux for 3 times each for 1 hr; mixing the filtrates, recovering ethanol under reduced pressure, and vacuum drying at 60deg.C; adding appropriate amount of adjuvants corresponding to different dosage forms, and making into tablet, capsule, granule, oral liquid or honeyed pill by conventional method. The pharmacodynamic test shows that the Chinese herbal compound preparation has good treatment effect on hepatic fibrosis, and has good market popularization value and potential.
CN1069542C discloses a medicament for treating chronic liver diseases and a preparation method thereof. The related medicine is prepared from peach kernel, red sage root, gynostemma pentaphylla, fermented cordyceps fungus powder, pine pollen, schisandra fruit and a proper amount of starch as raw materials. Has the advantages of improving clinical symptoms of chronic hepatitis B patients, inhibiting and reversing liver fibrosis progress, playing a good role in comprehensive treatment of liver cirrhosis after hepatitis, and having important significance and application value in preventing and reversing the progress of chronic liver fibrosis, inhibiting or delaying the formation of liver cirrhosis and treating liver cirrhosis.
However, the traditional Chinese medicines for treating the diseases at home and abroad have a plurality of types, but most of the medicines have no specially recognized curative effect, and the diseases are easy to repeat after the treatment and have high price. Therefore, the traditional Chinese medicine composition which has low cost for treating liver fibrosis and is more effective is provided, and has great significance for improving the health degree and the life quality of patients.
Disclosure of Invention
Terminology and statement of the application:
1. as used herein, the articles "a," "an," and "the": unless explicitly limited to one object(s) in other ways, plural objects are included.
2. As used herein, the numerical range: unless explicitly stated otherwise, all ranges or ratios disclosed herein are to be understood to include any and all subranges or subranges subsumed therein. For example, a stated range or ratio of 1 to 30 should be considered to be inclusive between the minimum value of 1 and the maximum value of 30, and any subrange or subrange, integer, fraction, or subrange composed of integer or fraction, inclusive.
3. As used herein, the terms "comprising," "including," "having," "can," "containing," and variations thereof are meant to be open-ended terms or terms that do not exclude the possibility of additional compositions or structures.
In order to solve the technical problems, the application provides a traditional Chinese medicine composition for treating liver fibrosis, a preparation and application thereof, and the traditional Chinese medicine composition has the effects of strengthening body resistance and eliminating evil through the synergistic effect of peach kernels, cordyceps sinensis, polygonum multiflorum, gynostemma pentaphylla and schisandra chinensis, and has good liver fibrosis treatment effect.
In order to achieve the above purpose, the technical scheme adopted by the application is as follows:
a Chinese medicinal composition for treating liver fibrosis comprises semen Persicae, cordyceps, polygoni Multiflori radix, herba Gynostemmatis and fructus Schisandrae.
The peach kernels include, but are not limited to, wei peach kernels, raw peach kernels and fried peach kernels.
The polygonum multiflorum comprises, but is not limited to, black bean-made polygonum multiflorum, wine-made polygonum multiflorum and black bean-yellow wine-made polygonum multiflorum.
The gynostemma pentaphylla includes, but is not limited to, gynostemma pentaphylla.
Fructus Schisandrae chinensis includes, but is not limited to, parched fructus Schisandrae chinensis, steamed fructus Schisandrae chinensis, wine fructus Schisandrae chinensis, vinegar fructus Schisandrae chinensis, and honey fructus Schisandrae chinensis.
The Cordyceps powder is obtained by drying Cordyceps and pulverizing; such drying includes, but is not limited to, sun drying, anion drying, and drying.
Preferably, the traditional Chinese medicine composition comprises the following components in parts by weight:
6-18 parts of peach kernel, 1-9 parts of cordyceps sinensis, 8-19 parts of polygonum multiflorum, 8-19 parts of gynostemma pentaphylla and 8-19 parts of schisandra chinensis.
Further preferably, the traditional Chinese medicine composition comprises the following components in parts by weight:
6-15 parts of peach kernel, 1-7 parts of cordyceps sinensis, 10-18 parts of polygonum multiflorum, 10-18 parts of gynostemma pentaphylla and 10-18 parts of schisandra chinensis.
Still more preferably, the traditional Chinese medicine composition comprises the following components in parts by weight:
6-12 parts of peach kernel, 1-5 parts of cordyceps sinensis, 11-16 parts of polygonum multiflorum, 11-16 parts of gynostemma pentaphylla and 11-16 parts of schisandra chinensis.
Most preferably, the traditional Chinese medicine composition comprises the following components in parts by weight:
12 parts of peach kernel, 5 parts of cordyceps sinensis, 13 parts of polygonum multiflorum, 13 parts of gynostemma pentaphylla and 13 parts of schisandra chinensis.
Preferably, the Chinese medicinal composition further comprises radix Salviae Miltiorrhizae, flos Carthami, and fructus Lycii.
The radix Salviae Miltiorrhizae includes, but is not limited to, radix Salviae Miltiorrhizae preparata, radix Salviae Miltiorrhizae with wine, radix Salviae Miltiorrhizae with vinegar, and radix Salviae Miltiorrhiae with rice.
The safflower includes but is not limited to stir-fried safflower and vinegar safflower.
The wolfberry fruit includes but is not limited to fried wolfberry fruit and salted wolfberry fruit.
Further preferably, the traditional Chinese medicine composition further comprises the following components in parts by weight:
10-20 parts of red sage root, 6-18 parts of safflower and 5-12 parts of medlar.
Still more preferably, the traditional Chinese medicine composition further comprises the following components in parts by weight:
12-18 parts of red sage root, 6-15 parts of safflower and 6-12 parts of medlar.
Still further preferably, the traditional Chinese medicine composition further comprises the following components in parts by weight:
13-17 parts of red sage root, 6-12 parts of safflower and 8-12 parts of medlar.
Most preferably, the traditional Chinese medicine composition further comprises the following components in parts by weight:
15 parts of red sage root, 12 parts of safflower and 8 parts of medlar.
The application also provides application of the traditional Chinese medicine composition for treating liver fibrosis in preparation of a preparation for treating liver fibrosis.
Preferably, the preparation is in the form of granule, tablet, capsule, pill or oral liquid.
The application also provides a granule for treating liver fibrosis, which comprises the traditional Chinese medicine composition.
Preferably, the particles for treating liver fibrosis further comprise a pharmaceutically acceptable adjuvant.
The application also provides a preparation method of the granule for treating liver fibrosis, which comprises the following steps:
s1, decocting peach kernels, polygonum multiflorum, gynostemma pentaphylla, schisandra chinensis, red sage roots, safflower and medlar in water to obtain decoction;
s2, filtering and concentrating the decoction obtained in the step S1 to obtain a concentrated solution;
s3, adding dextrin into the concentrated solution obtained in the step S2, and drying to obtain dry powder;
s4, adding the cordyceps sinensis powder and dextrin with the formula amount into the dry powder obtained in the step S3, and uniformly mixing to obtain the granules.
Preferably, the water in the step S1 is added in an amount of 8-12 times of the total weight of the peach kernel, the polygonum multiflorum, the gynostemma pentaphylla, the schisandra chinensis, the red sage root, the safflower and the medlar; more preferably 10 times.
Preferably, the concentration in step S2 is performed to a relative density of 1.05-1.10.
Further preferably, the relative density is a relative density at a temperature of 60 ℃.
Preferably, the dextrin in step S3 is used in an amount of 5% of the total weight of the peach kernel, polygonum multiflorum, gynostemma pentaphylla, schisandra chinensis, red sage root, safflower and wolfberry fruit in step S1.
Preferably, the dextrin is used in an amount of 18-20% of the total weight of the granule to be made in step S4.
The medicinal efficacy of the Chinese herbal medicines used in the application:
peach kernel: has effects of promoting blood circulation, removing blood stasis, loosening bowel to relieve constipation, relieving cough and asthma; can be used for treating amenorrhea dysmenorrhea, abdominal mass, pulmonary abscess, intestinal abscess, traumatic injury, constipation due to intestinal dryness, cough and asthma.
Cordyceps sinensis: has effects of invigorating kidney, nourishing lung, stopping bleeding, and eliminating phlegm. It is used for treating sexual impotence, spermatorrhea, soreness of waist and knees, cough, asthma, and phlegm.
Polygonum multiflorum Thunb: liver and kidney tonifying, essence and blood replenishing, beard and hair blackening, tendons and bones strengthening, turbidity eliminating and lipid lowering; can be used for treating blood deficiency, sallow complexion, dizziness, tinnitus, premature gray hair, soreness of waist and knees, numbness of limbs, metrorrhagia, leukorrhagia, and hyperlipidemia.
Gynostemma pentaphylla: has effects of clearing heat and detoxicating, relieving cough and eliminating phlegm, tranquilizing, improving sleep, and reducing blood lipid. Can be used for treating chronic bronchitis, hepatitis, gastric ulcer, duodenal ulcer, arteriosclerosis, leukotrichia, migraine, and tumor.
Chinese magnoliavine fruit: astringe and astringe, replenish qi and promote the production of body fluid, tonify kidney and calm heart. Can be used for treating chronic cough, deficiency asthma, nocturnal emission, enuresis, frequent urination, chronic diarrhea, spontaneous perspiration, night sweat, body fluid deficiency, thirst, short qi and pulse deficiency, internal heat, diabetes, palpitation, and insomnia.
Root of red-rooted salvia: has effects of promoting blood circulation, regulating menstruation, removing blood stasis, relieving pain, cooling blood, resolving carbuncle, relieving restlessness and tranquilizing. Is used for treating menoxenia, amenorrhea, dysmenorrhea, puerperal stagnant abdominal pain, blood stasis and heart pain, abdominal mass, traumatic injury, rheumatalgia, sore, carbuncle, toxic swelling, fever, dysphoria, unconsciousness, palpitation and insomnia.
Safflower: has effects of promoting blood circulation, dredging channels, removing blood stasis, and relieving pain. Is used for treating amenorrhea due to blood stagnation, dysmenorrhea, puerperal abdominal pain due to blood stasis, abdominal mass, chest pain due to obstruction of qi in the heart, blood stasis abdominal pain, hypochondriac pain, traumatic injury, swelling and pain due to blood stasis, and macula due to blood stasis.
Wolfberry fruit: has effects of nourishing liver and kidney, and replenishing vital essence. Can be used for treating asthenia, essence deficiency, soreness of waist and knees, dizziness, tinnitus, impotence, spermatorrhea, internal heat, diabetes, blood deficiency, sallow complexion, and blurred vision.
The beneficial effects of the application are as follows:
(1) The traditional Chinese medicine composition provided by the application has the advantages of simple formula, wide component sources and simple preparation method;
(2) Products for treating liver fibrosis in the market are mainly treated by syndrome differentiation, or detoxify, or remove dampness, or strengthen body resistance, and are used for single disease type; the traditional Chinese medicine composition provided by the application has good effects of strengthening body resistance and eliminating evil through the synergistic effect of medicines among peach kernel, cordyceps sinensis, polygonum multiflorum, gynostemma pentaphylla and schisandra chinensis.
Detailed Description
Other advantages and effects of the present application will become apparent to those skilled in the art from the following disclosure, which describes the embodiments of the present application with reference to specific examples. The application may be practiced or carried out in other embodiments that depart from the specific details, and the details of the present description may be modified or varied from the spirit and scope of the present application.
Before the embodiments of the application are explained in further detail, it is to be understood that the application is not limited in its scope to the particular embodiments described below; it is also to be understood that the terminology used in the examples of the application is for the purpose of describing particular embodiments only, and is not intended to limit the scope of the application.
Where numerical ranges are provided in the examples, it is understood that unless otherwise stated herein, both endpoints of each numerical range and any number between the two endpoints are significant both in the numerical range. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs.
The application does not limit the sources of the adopted raw materials, and if no special description exists, the adopted raw materials are all common commercial products in the technical field; the gynostemma pentaphylla in the traditional Chinese medicine composition for treating liver fibrosis accords with 2005 edition requirements of Zhejiang province traditional Chinese medicine processing standards, and the rest decoction pieces accord with 2020 edition one requirement of Chinese pharmacopoeia.
Basic embodiment
A traditional Chinese medicine composition for treating liver fibrosis comprises the following components in parts by weight: 6-18 parts of peach kernel, 1-9 parts of cordyceps sinensis, 8-19 parts of polygonum multiflorum, 8-19 parts of gynostemma pentaphylla, 8-19 parts of schisandra chinensis, 10-20 parts of radix salviae miltiorrhizae, 6-18 parts of safflower and 5-12 parts of medlar.
The application also provides application of the traditional Chinese medicine composition in preparation of a preparation for treating liver fibrosis.
Preferably, the preparation is in the form of a tablet, a pill, a granule, a capsule or an oral liquid.
The application also provides a granule for treating liver fibrosis, which comprises the traditional Chinese medicine composition.
Preferably, the particles for treating liver fibrosis further comprise a pharmaceutically acceptable adjuvant.
The application also provides a preparation method of the granule for treating liver fibrosis, which comprises the following steps:
s1, decocting peach kernels, polygonum multiflorum, gynostemma pentaphylla, schisandra chinensis, red sage roots, safflower and medlar in water to obtain decoction;
s2, filtering and concentrating the decoction obtained in the step S1 to obtain a concentrated solution;
s3, adding dextrin into the concentrated solution obtained in the step S2, and drying to obtain dry powder;
s4, adding the cordyceps sinensis and dextrin into the dry powder obtained in the step S3, uniformly mixing, and preparing the particles.
Examples 1-3A Chinese medicinal composition for treating liver fibrosis
The raw materials and the amounts of the traditional Chinese medicine composition for treating liver fibrosis described in examples 1 to 3 are shown in Table 1, and each part is by weight.
Examples 4-6A Chinese medicinal composition for treating hepatic fibrosis
Examples 4-6 differ from examples 1-3 in that: radix Salviae Miltiorrhizae, flos Carthami, and fructus Lycii can be added to semen Persicae, cordyceps, radix Polygoni Multiflori, gynostemma pentaphyllum, and fructus Schisandrae chinensis; the raw materials and the dosage of the traditional Chinese medicine composition for treating liver fibrosis are shown in table 1.
Comparative example 1A Chinese medicinal composition for treating hepatic fibrosis
This comparative example differs from example 1 in that: the amounts of peach kernel, cordyceps, polygonum multiflorum, gynostemma Pentaphyllum and Schisandra chinensis were varied, and specifically, shown in Table 1.
Comparative example 2A Chinese medicinal composition for treating hepatic fibrosis
This comparative example differs from example 1 in that: the amounts of peach kernel, cordyceps, polygonum multiflorum, gynostemma Pentaphyllum and Schisandra chinensis were varied, and specifically, shown in Table 1.
Comparative example 3A Chinese medicinal composition for treating hepatic fibrosis
This comparative example differs from example 1 in that: the rhodiola rosea is used for replacing gynostemma pentaphylla in the traditional Chinese medicine composition.
Comparative example 4A Chinese medicinal composition for treating hepatic fibrosis
This comparative example differs from example 4 in that: the amounts of red sage root, safflower and wolfberry fruit vary, and are shown in table 1.
Comparative example 5
The traditional Chinese medicine composition disclosed by CN1243743A is prepared according to the preparation method of the granules provided by the application, and is used for treating chronic liver diseases and dry medicinal powder for rat experiments; specifically, the raw materials (g) are weighed according to the following proportion:
140 parts of peach kernel, 550 parts of red sage root, 450 parts of gynostemma pentaphylla, 230 parts of fermented cordyceps sinensis powder, 150 parts of pollen pini and 150 parts of shizandra berry.
The particles for treating chronic liver disease are prepared according to the following method:
s1, adding water which is 10 times the total weight of peach kernel, gynostemma pentaphylla, schisandra chinensis, red sage root and pollen pini into the formula amount of peach kernel, gynostemma pentaphylla, schisandra chinensis, red sage root and pollen pini, and decocting twice to obtain decoction;
s2, merging the decoctions obtained in the step S1, filtering and concentrating to a relative density of 1.05-1.10 (60 ℃), thus obtaining a concentrated solution;
s3, adding dextrin accounting for 5% of the total weight of the peach kernel, the gynostemma pentaphylla, the schisandra chinensis, the red sage root and the pine pollen in the step S1 into the concentrated solution obtained in the step S2, and performing spray drying to obtain spray-dried powder;
s4, adding 230 g of fermented cordyceps fungus powder and dextrin accounting for 18% of the total weight of the granules to be prepared into the spray-dried powder obtained in the step S3, and uniformly mixing to prepare the granules.
The dry powder for rat test was prepared as follows:
s1, adding water which is 10 times the total weight of peach kernel, gynostemma pentaphylla, schisandra chinensis, red sage root and pollen pini into the formula amount of peach kernel, gynostemma pentaphylla, schisandra chinensis, red sage root and pollen pini, and decocting twice to obtain decoction;
s2, merging the decoctions obtained in the step S1, filtering and concentrating to a relative density of 1.05-1.10 (60 ℃), thus obtaining a concentrated solution;
s3, adding dextrin accounting for 5% of the total weight of the peach kernel, the gynostemma pentaphylla, the schisandra chinensis, the red sage root and the pine pollen in the step S1 into the concentrated solution obtained in the step S2, and performing spray drying to obtain spray-dried powder;
and S4, adding 230 g of fermented cordyceps sinensis powder into the spray-dried powder obtained in the step S3, and uniformly mixing to obtain dry medicinal powder for rat experiments.
TABLE 1 raw materials and dosage Table
The "-" mark in the table indicates that the corresponding raw materials are not added to the formula; the "×" mark in the table indicates that the raw material used was replaced by gynostemma pentaphylla with rhodiola rosea.
In order to further embody the efficacy of the traditional Chinese medicine composition of the present application in detail, the traditional Chinese medicine compositions of the above examples 1-6 and comparative examples 1-4 are prepared into granules for treating liver fibrosis and dry medicinal powder for rat experiments.
The preparation method of the granule for treating liver fibrosis comprises the following steps:
s1, adding water with the formula amount of peach kernel, polygonum multiflorum, gynostemma pentaphylla, schisandra chinensis, red sage root, safflower and medlar to be 10 times of the total weight of the peach kernel, the polygonum multiflorum, the gynostemma pentaphylla, the schisandra chinensis, the red sage root, the safflower and the medlar into water for two times to obtain decoction;
s2, merging the decoctions obtained in the step S1, filtering and concentrating to a relative density of 1.05-1.10 (60 ℃), thus obtaining a concentrated solution;
s3, adding dextrin accounting for 5% of the total weight of the peach kernel, the polygonum multiflorum, the gynostemma pentaphylla, the schisandra chinensis, the red sage root, the safflower and the medlar in the step S1 into the concentrated solution obtained in the step S2, and performing spray drying to obtain spray-dried powder;
s4, adding the cordyceps sinensis powder with the formula amount and the dextrin accounting for 18% of the total weight of the granules to be prepared into the spray-dried powder obtained in the step S3, and uniformly mixing to prepare the granules.
The preparation method of the dry medicinal powder for rat experiments is as follows:
s1, adding water with the formula amount of peach kernel, polygonum multiflorum, gynostemma pentaphylla, schisandra chinensis, red sage root, safflower and medlar to be 10 times of the total weight of the peach kernel, the polygonum multiflorum, the gynostemma pentaphylla, the schisandra chinensis, the red sage root, the safflower and the medlar into water for two times to obtain decoction;
s2, merging the decoctions obtained in the step S1, filtering and concentrating to a relative density of 1.05-1.10 (60 ℃), thus obtaining a concentrated solution;
s3, adding dextrin accounting for 5% of the total weight of the peach kernel, the polygonum multiflorum, the gynostemma pentaphylla, the schisandra chinensis, the red sage root, the safflower and the medlar in the step S1 into the concentrated solution obtained in the step S2, and performing spray drying to obtain spray-dried powder;
s4, adding the cordyceps sinensis powder with the formula amount into the spray-dried powder obtained in the step S3, and uniformly mixing to obtain the dry medicinal powder for rat experiments.
1. Evaluation of efficacy for treating hepatic fibrosis
1. Animal pharmacodynamics verification
(1) Grouping, modeling and administration
130 male SD rats with 6-8 weeks of age and the body mass of 180-200g. After 1 week of adaptive feeding, the animals were randomly divided into 13 groups according to mass, namely, a blank control group, a model control group, an implementation group 1-6 groups and a comparison group 1-5 groups, and 10 animals in each group. The blank control group was intraperitoneally injected with equal volume of olive oil, the remaining groups were abdominally injected with equal volume of olive oilCavity injection of 40% CCL 4 (CCL 4 The volume ratio to olive oil was 4:6, the dose was 2 ml/kg), 2 times per week for 8 weeks.
Starting administration after molding for 1 week, and performing gastric lavage on the normal control group and the model control group to obtain an equal volume of physiological saline, wherein the administration volume is 10ml/kg; performing group 1-6 by gavage administration of the dry powder for rat test prepared from the Chinese medicinal composition of example 1-6, and comparative group 1-4 by gavage administration of the dry powder for rat test prepared from the Chinese medicinal composition of comparative example 1-4 in an amount of 7.5g/kg and an administration volume of 10ml/kg; comparative group 5 the dry powder for rat test prepared in comparative example 5 was administered by gavage at an amount of 7.5g/kg and a volume of 10ml/kg. The administration is continued for 7 weeks, after the last administration, the rats are fasted and not forbidden for 12 hours, the rats are anesthetized by intraperitoneal injection of 40mg/kg sodium pentobarbital, the abdominal aorta is taken for blood, the abdominal aorta is kept stand for 2 hours at 4 ℃, the abdominal aorta is centrifuged for 10 minutes at 4000r/min, and the supernatant is taken and split-packed in a centrifuge tube for storage at-80 ℃ for standby.
Detecting the contents of alanine Aminotransferase (ALT) and aspartate transferase (AST) in serum by using a full-automatic biochemical analyzer; according to (Liu Fahe, zeng Hailian, zheng Xiaojiang, etc.. Serum liver fibrosis index, AST/ALT ratio and platelet assay function in diagnosis of liver fibrosis [ J ]. Experimental and test medicine, 2011,29 (03): 251-252) section 2.2 references liver fibrosis index has a correlation (P < 0.05) with AST/ALT ratio, even a significant correlation (P < 0.01); in the present application, the degree of liver injury in rats was characterized by AST and ALT, and the degree of liver fibrosis in rats was characterized by AST/ALT ratio, and the results are shown below.
(2) Results
TABLE 2 influence on liver fibrosis rat serum ALT and AST
| Group of | ALT(U/L) | AST(U/L) | AST/ALT |
| Blank control group | 41.12±7.79 | 71.96±24.43 | 1.75±0.12 |
| Model control group | 138.57±34.23 * | 428.19±78.56 * | 3.09±0.65 ** |
| Group 1 of the examples | 93.07±21.89 ## | 181.37±20.24 ## | 1.95±0.20 ## |
| Group 2 of the examples | 95.24±19.68 ## | 188.24±25.59 ## | 1.98±0.18 ## |
| Group 3 of the examples | 97.61±17.15 ## | 194.28±31.54 ## | 1.99±0.52 ## |
| Group 4 of the examples | 77.19±18.23 ## | 135.25±26.81 ## | 1.76±0.14 ## |
| Group 5 of the examples | 86.65±14.74 ## | 156.02±25.97 ## | 1.80±0.26 ## |
| Group 6 of the examples | 87.13±22.27 ## | 158.61±28.65 ## | 1.82±0.37 ## |
| Comparative group 1 group | 120.08±24.35 #Δ | 266.77±21.34 #Δ | 2.21±0.64 #Δ |
| Comparative group 2 groups | 119.35±30.02 #Δ | 267.43±38.12 #Δ | 2.24±0.71 #Δ |
| Comparative group 3 groups | 124.21±25.12 #Δ | 289.22±42.68 #Δ | 2.33±0.57 #Δ |
| Comparative group 4 groups | 110.58±15.93 #Δ | 236.46±30.73 #Δ | 2.14±0.49 #Δ |
| Comparative group 5 | 112.32±10.81 #Δ | 244.86±34.98 #Δ | 2.18±0.42 #Δ |
Note that: p <0.05 compared to the blank; * P <0.01; compared to model control group, #p <0.05; # P <0.01; Δp <0.05 compared to the run group 4.
As can be seen from the data in table 2, the model control group after molding has significantly increased ALT and AST levels compared with the blank control group by P <0.05, and the AST/ALT ratio is significantly increased compared with the blank control group, which indicates that the rats in the molding control group have significant liver injury and liver fibrosis; the rats in examples 1-6 showed very significantly reduced levels of ALT and AST in the blood of <0.01 compared to the model control group after using the dry powder prepared from the traditional Chinese medicine composition of examples 1-6; the traditional Chinese medicine composition provided by the application has good treatment effect on liver injury; and rats in comparative examples 1 to 5 showed significantly decreased ALT and AST levels in blood of # P <0.05 compared with the model control group after using the dry powder prepared from the Chinese medicinal composition in comparative examples 1 to 4 and the dry powder in comparative example 5, indicating that the Chinese medicinal composition in comparative examples has a significant therapeutic effect on liver injury, but the therapeutic effect thereof is significantly different from that of the Chinese medicinal composition in example 4 of the present application by less ΔP <0.05.
In the treatment of liver fibrosis; after the rats in the implementation groups 1-6 use the dry medicinal powder worth of the traditional Chinese medicine composition in the examples 1-6, the AST/ALT level in blood is extremely obviously reduced by # P <0.01 compared with a model control group, which proves that the traditional Chinese medicine composition provided by the application can effectively reverse liver fibrosis and has obvious efficacy on treating the liver fibrosis; the rats in comparative examples 1 to 5 showed significantly decreased AST/ALT level of # P <0.05 in blood compared to the model control after using the dry powder prepared from the traditional Chinese medicine composition of comparative examples 1 to 4 and the dry powder of comparative example 5, indicating that the traditional Chinese medicine composition of comparative example has a significant therapeutic effect on liver fibrosis, but the therapeutic effect is significantly different from the therapeutic effect of the traditional Chinese medicine composition of example 4 on liver fibrosis by less Δp <0.05.
2. Clinical effect verification
100 patients all meet the Western diagnosis standard of hepatitis B and hepatic fibrosis and the diagnosis standard of 'blood stasis obstruction of collaterals and liver and kidney deficiency' of the traditional Chinese medicine. After informed consent, the treatment group and the control group were randomized into 50 cases. In the control group, 19 men and 31 women; age 42-67 years. 24 men and 26 women in the treatment group; age 43-66 years. The difference between the general data of the two groups of patients was not statistically significant (P > 0.05).
50 patients in the control group of the study were orally administered entecavir dispersible tablets at a dose of 0.5mg each time, 1 time per day; the granules prepared in comparative example 5 were orally taken on the basis of 10g each time, 2 times daily. The entecavir dispersible tablet is orally taken by 50 patients in a treatment group, wherein the dosage is 0.5mg each time and 1 time a day; the granules prepared from the traditional Chinese medicine composition of example 4 were taken orally on the basis of the above, 10g each time, 2 times daily. Both groups were treated for 8 weeks and after the treatment was completed, the clinical treatment effect of both groups was evaluated in comparison.
The treatment effect is evaluated by referring to the treatment effect evaluation criterion of liver fibrosis diagnosis and treatment effect evaluation consensus. The effect is shown: checking that liver function index is normal, and clinical symptoms and signs disappear; the method is effective: subjective symptoms and signs are improved, and liver function indexes are improved; invalidation: no improvement of subjective symptoms and signs, even aggravation, and no improvement of liver function indexes. Total effective rate = (effective + effective) number of cases/total number of cases x 100%
2.1 therapeutic results
(1) Clinical efficacy
Comparing clinical curative effects; see table 3.
Table 3 comparison of two clinical efficacy
| Group of | n | Has obvious effect | Effective and effective | Invalidation of | Total effective rate |
| Treatment group | 50 | 31 | 15 | 4 | 92.0* |
| Control group | 50 | 27 | 10 | 13 | 74.0 |
Note that: comparison of the two groups of curative effects, wherein P <0.05
As can be seen from Table 3, in the treatment group for treating patients by adopting the granule prepared by the traditional Chinese medicine composition in the embodiment 4 of the application and the entecavir dispersible tablet, the number of people with obvious and effective treatment effects in 50 patients is 31 and 15 respectively, and the total effective rate can reach 92.0%; and the granule prepared in the comparative example 5 is combined with the entecavir dispersible tablet to treat a control group of patients, the number of people with obvious and effective treatment effects in 50 patients is 27 and 10 respectively, and the total effective rate can reach 74%. It is known that, from the examination of clinical effects, the treatment effect of the traditional Chinese medicine composition provided by the application on hepatic fibrosis is better than that of the traditional Chinese medicine composition provided in the prior art of comparative example 5, and the traditional Chinese medicine composition has better treatment effect on hepatic fibrosis.
(2) Index of serology liver fibrosis
Detecting serological liver fibrosis indexes (HA is hyaluronic acid, LN is laminin, PCIII is type III procollagen, and IV-C is type IV collagen) of the 100 patients before and after treatment; the average value of the change in the index of 4 of serological hepatic fibrosis before and after the treatment was calculated and is shown in Table 4.
Table 4 serological index comparison of liver fibrosis groups 2 before and after treatment
Note that: HA is hyaluronic acid; LN is laminin; PCIII is type III procollagen; IV-C is type IV collagen; p <0.05 compared to pre-treatment; compared to the control group, #p <0.05.
As can be seen from table 4, the serological indexes before and after the treatment of the patients treated with the Chinese medicinal composition preparation of the present application and the Chinese medicinal composition preparation of comparative example 5, respectively, were examined, and the patients treated with the Chinese medicinal composition particles of the present application (treatment group) and the patients treated with the Chinese medicinal composition particles of comparative example 5 (control group) had significantly decreased serological indexes of hyaluronic acid, laminin, type III procollagen and type IV collagen, respectively, by P <0.05, compared to before the treatment, indicating that the Chinese medicinal composition of the present application and the Chinese medicinal composition of comparative example 5 had the effect of treating liver fibrosis. Comparing the four serological indexes of the treated patients with the control groups, the serological indexes (hyaluronic acid, laminin, type III procollagen and type IV collagen) of the treated patients adopting the traditional Chinese medicine composition particles disclosed by the application are obviously reduced by #P0.05 compared with the patients with the control groups, so that the traditional Chinese medicine composition provided by the application has better liver fibrosis treatment effect compared with the traditional Chinese medicine composition provided by the prior art in comparative example 5.
Finally, it should be noted that the above description is only for illustrating the technical solution of the present application, and not for limiting the scope of the present application, and that the simple modification and equivalent substitution of the technical solution of the present application can be made by those skilled in the art without departing from the spirit and scope of the technical solution of the present application.
Claims (10)
1. A traditional Chinese medicine composition for treating liver fibrosis is characterized in that: comprises semen Persicae, cordyceps, polygoni Multiflori radix, herba Gynostemmatis and fructus Schisandrae.
2. The traditional Chinese medicine composition according to claim 1, wherein: comprises the following components in parts by weight:
6-18 parts of peach kernel, 1-9 parts of cordyceps sinensis, 8-19 parts of polygonum multiflorum, 8-19 parts of gynostemma pentaphylla and 8-19 parts of schisandra chinensis.
3. The traditional Chinese medicine composition according to claim 1, wherein: comprises the following components in parts by weight:
12 parts of peach kernel, 5 parts of cordyceps sinensis, 13 parts of polygonum multiflorum, 13 parts of gynostemma pentaphylla and 13 parts of schisandra chinensis.
4. The traditional Chinese medicine composition according to claim 1, wherein: also comprises radix Salviae Miltiorrhizae, flos Carthami, and fructus Lycii.
5. The traditional Chinese medicine composition according to claim 4, wherein: the composition also comprises the following components in parts by weight:
10-20 parts of red sage root, 6-18 parts of safflower and 5-12 parts of medlar.
6. The traditional Chinese medicine composition according to claim 4, wherein: the composition also comprises the following components in parts by weight:
15 parts of red sage root, 12 parts of safflower and 8 parts of medlar.
7. Use of a Chinese medicinal composition according to any one of claims 1-6 in the preparation of a formulation for treating liver fibrosis.
8. The use according to claim 7, characterized in that: the preparation formulation of the preparation is as follows: granule, tablet, capsule, pill or oral liquid.
9. A granule for treating liver fibrosis, characterized in that: comprising the Chinese medicinal composition according to any one of claims 1-6 and pharmaceutically acceptable excipients.
10. A method of preparing particles for treating liver fibrosis according to claim 9 wherein: the method comprises the following steps:
s1, decocting peach kernels, polygonum multiflorum, gynostemma pentaphylla, schisandra chinensis, red sage roots, safflower and medlar in water to obtain decoction;
s2, filtering and concentrating the decoction obtained in the step S1 to obtain a concentrated solution;
s3, adding dextrin into the concentrated solution obtained in the step S2, and drying to obtain dry powder;
s4, adding the cordyceps sinensis powder and dextrin with the formula amount into the dry powder obtained in the step S3, and uniformly mixing to obtain the granules.
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