CN114129675B

CN114129675B - Traditional Chinese medicine composition and application thereof

Info

Publication number: CN114129675B
Application number: CN202111632693.2A
Authority: CN
Inventors: 陈君; 顾晨晖; 陈亭; 傅小玲; 李萍
Original assignee: China Pharmaceutical University
Current assignee: China Pharmaceutical University
Priority date: 2021-12-29
Filing date: 2021-12-29
Publication date: 2023-05-09
Anticipated expiration: 2041-12-29
Also published as: CN114129675A

Abstract

The invention relates to a traditional Chinese medicine composition and application thereof, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition is characterized by comprising a phellodendron alkaloid part, an atractylis ovata volatile oil part, a achyranthes root sterone saponin part, a coix seed fatty oil part, a yam rhizome saponin part or a yam rhizome extract part, wherein the mass ratio of the phellodendron alkaloid part to the atractylis ovata volatile oil part to the achyranthes root sterone saponin part to the coix seed fatty oil part to the yam rhizome saponin part to the yam rhizome extract part is about 2.8:1:2.8:3:3.9/8.7. The invention adopts the modern separation technology of traditional Chinese medicine and combines the macroporous resin chromatography technology to extract the effective components of phellodendron, rhizoma atractylodis, achyranthes root, coix seed and yam rhizome for resisting gout. The traditional Chinese medicine provided by the invention has the advantages of definite components, controllable quality, definite curative effect and feasible preparation. The invention is beneficial to the optimization and improvement of traditional Chinese medicine compounds, and has good application prospect in the aspect of gout resistance.

Description

Traditional Chinese medicine composition and application thereof

Technical Field

The invention belongs to the technical field of traditional Chinese medicines, and in particular relates to a traditional Chinese medicine composition and a preparation method thereof.

Background

Along with the development of social economy, the living standard is improved, the dietary structure is changed, the content of blood uric acid is increased due to purine metabolic disorder in a human body, uric acid supersaturation causes deposition of urate crystals in tissues, joints and the like, and then pathological injury and inflammatory reaction of joint tissues are stimulated, and the affected joints and surrounding tissues are red, swelling, heat and pain, namely Gout (Gout) are shown. Gout may be associated with high purine diets, alcoholism, strenuous exercise, sudden cooling, irregular work and rest, obesity, diuretics and other medications, and has recurrent episodes of high prevalence and younger tendencies. In addition, gout is often interdependent and promoted, repeatedly attacks, intractable and prolonged and difficult to heal with chronic complex diseases such as hypertension, diabetes, hyperlipidemia, metabolic syndrome, chronic kidney disease and the like, and causes complications such as gouty arthritis, gout nodular swelling, uric acid kidney disease and the like, which become one of important metabolic diseases seriously threatening the health of human beings.

At present, the clinical treatment of gout mainly depends on anti-inflammatory analgesic treatment in the gout attack stage and uric acid reduction treatment in the non-acute attack stage. However, in the course of long-term treatment, it was found that although the chemical drug can improve the clinical symptoms of the patient in a short time, there are certain adverse effects and side effects such as rash and digestive tract reaction of allopurinol, etc., and the nonsteroidal anti-inflammatory drug is not applicable to the patient with renal function damage, cardiovascular disease or gastrointestinal disease, and febuxostat is warned by the us FDA of black box due to its cardiovascular risk. These have all limited the long-term application of the existing anti-gout drugs, find anti-gout drugs with good effects and small side effects, and are the current clinical urgent problems to be solved.

Gout belongs to the category of damp-heat arthralgia syndrome in traditional Chinese medicine, is generally clinically treated by methods of activating blood circulation to dissipate blood stasis, clearing damp-heat, dredging collaterals and relieving pain, has obvious curative effect on acute attack stage of gout, can prolong intermittent stage, prevents disease recurrence, and has less adverse reaction after long-term use. The four-component pill, which is written in the patent convenient read by Qing dynasty Zhang Bingcheng, is composed of four medicines of phellodendron, rhizoma atractylodis, achyranthes and coix seed, and is a classical prescription for treating arthralgia caused by downward flow of damp-heat. Wherein, huang Bai is bitter and cold, clears heat and eliminates dampness, and is good at removing damp-heat from lower-jiao; rhizoma Atractylodis has warm nature, and has effects of clearing heat, eliminating dampness, and dispelling pathogenic wind and dampness; achyranthes root has the effects of promoting blood circulation, removing blood stasis, dredging collaterals, tonifying liver and kidney and guiding blood downwards; coix seed is slightly cold in nature and has the effects of promoting diuresis, removing dampness, strengthening spleen and eliminating arthralgia. In addition, the yam rhizome has long history of taking medicine, has bitter and flat taste, enters kidney and stomach channels, has the effects of promoting diuresis, removing turbid pathogen, dispelling wind and removing arthralgia, and is used for treating symptoms such as stranguria, turbid white, leukorrhagia, rheumatalgia, joint discomfort, lumbago and gonalgia and the like. Modern pharmacology shows that the yam rhizome has the effects of resisting tumor, reducing uric acid, resisting inflammation, regulating immunity, resisting atherosclerosis, resisting myocardial ischemia and the like, and is a common medicinal material in the ancient formula for treating gout, so that the invention selects the yam rhizome to increase the efficacy of the four-ingredient pill for resisting gout.

The traditional Chinese medicine prescription is based on the theoretical guidance of traditional Chinese medicine, and is prepared by the compatibility of decoction pieces, which is a main mode of traditional Chinese medicine application, and has the advantages of compatibility theory and abundant clinical application experience. However, due to the complex components, the problems of weak scientific research foundation such as pharmacodynamic substances, action mechanisms and the like exist, the stable exertion of the curative effect of the traditional Chinese medicine is affected, and the improvement of the quality of the traditional Chinese medicine product is hindered. The traditional Chinese medicine is a way of innovating the research of traditional Chinese medicines, and is based on the theory and principle of prescription compatibility, and absorbs the development method and technology of modern medicines, and the traditional Chinese medicine is prepared from the effective components. On the basis of the active components of the traditional Chinese medicine with the prescription of the definite prescription, the optimal design of the component proportion is carried out, the traditional Chinese medicine with the composition higher than Jing Fang is developed from the prescription, and is one of the directions of the development of the modern traditional Chinese medicine. The Chinese pharmacopoeia 2020 edition one specifies that the four-wonderful pill is prepared by pulverizing cortex phellodendri, rhizoma atractylodis, achyranthes bidentata and coix seed into fine powder according to the proportion of 2:1:1:2, sieving, mixing uniformly, making pills with water, and drying. The traditional preparation method has the problems of complex medicinal components, undefined medicinal substance basis, difficult quality control and the like. Through systematic research on the four-effect pill, on the basis of elucidating the effective parts, the effective components are extracted and prepared, invalid impurities in the four-effect pill are removed, the dosage is smaller, the product quality can be improved, and the anti-gout curative effect of the four-effect pill is improved.

Disclosure of Invention

Object of the Invention

The invention provides a preparation method of a traditional Chinese medicine composition on the basis of defining effective components of four wonderful pills, and the first aim of the invention is to prepare each component of the traditional Chinese medicine composition; the second purpose of the invention is to optimize the compatibility of the effective components of the four-component pill to obtain a curative effect superior to that of the original prescription; the third purpose of the invention is to evaluate the activity of the traditional Chinese medicine composition in the aspect of resisting gout, and prove the application value of the traditional Chinese medicine composition in the aspect of treating gout.

Technical proposal

Based on the above object, the present invention provides a preparation method of a traditional Chinese medicine composition, which comprises an phellodendron alkaloid part, an atractylis ovata volatile oil part, a achyranthes root sterone saponin part, a coix seed fatty oil part and a yam rhizome saponin part or a yam rhizome extract part, wherein the mass ratio of the phellodendron alkaloid part, the atractylis ovata volatile oil part, the achyranthes root sterone saponin part, the coix seed fatty oil part and the yam rhizome saponin part/the yam rhizome extract part is about 2.8:1:2.8:3:3.9/8.7. The preparation method comprises the following specific steps:

(1) The phellodendron alkaloid part is prepared by the following steps: reflux-extracting cortex Phellodendri with 10 times of 75% ethanol under heating for 4 times, each time for 1 hr, filtering, concentrating the filtrate under reduced pressure, adjusting pH to acidity, precipitating, filtering, adjusting pH to neutrality, adsorbing with macroporous resin for 12 hr, eluting with distilled water, 20% ethanol solution, and 50% ethanol solution sequentially, collecting 50% ethanol eluate, concentrating, and drying to obtain cortex Phellodendri alkaloid fraction;

(2) The rhizoma atractylodis volatile oil part is prepared by the following steps: adding 12 times of distilled water into rhizoma Atractylodis, and extracting by steam distillation to obtain rhizoma Atractylodis volatile oil;

(3) The achyranthes aspera sterone saponin part is prepared by the following steps: reflux extracting Achyranthis radix with 10 times of 70% ethanol for 2 times, each time for 90min, filtering, concentrating the filtrate under reduced pressure, dissolving the extract with water, removing impurities with equal amount of petroleum ether, extracting with water saturated n-butanol, concentrating the extractive solution, and drying to obtain achyranthes root sterone saponin part;

(4) The coix seed fatty oil part is prepared by the following steps: pulverizing Coicis semen, loading into extraction kettle of supercritical extraction device, and pumping CO with plunger pump ₂ Injecting into extraction kettle to reach required pressure, extracting, and separating to obtain semen Coicis fatty oil. Supercritical CO ₂ Conditions for extracting coix seed fatty oil: the water content of the coix seed medicinal material is controlled below 9%, the pressure of an extraction kettle is controlled at about 20MPa, the temperature of the extraction kettle is 40 ℃, the pressure of a separation column is 10MPa, the temperature of a separation column is 46 ℃, the temperature of an analysis kettle is 30 ℃, the extraction time is 3h, and the fluid quantity is 25L/h;

(5) The yam rhizome saponin part is prepared by the following steps: reflux extracting rhizoma Dioscoreae Septemlobae with 10 times of 70% ethanol under heating for 2 times, each for 90min, filtering, concentrating the filtrate under reduced pressure, dissolving the extract in water, removing impurities with petroleum ether, extracting with water saturated n-butanol, concentrating the extractive solution, and drying to obtain rhizoma Dioscoreae Septemlobae saponin fraction;

(6) The yam rhizome extract part is prepared by the following steps: reflux-extracting rhizoma Dioscoreae Septemlobae with 10 times of 70% ethanol for 2 times, each time for 90min, concentrating under reduced pressure, and drying to obtain rhizoma Dioscoreae Septemlobae extract.

The invention also protects the application of the traditional Chinese medicine composition in preparing medicines for preventing and/or treating gout related diseases.

Advantageous effects

Compared with the prior art, the traditional Chinese medicine composition provided by the invention has the following beneficial effects:

(1) The invention firstly re-formulates the main components in the four-effect pill, namely, the effective parts replace the original medicinal materials, and the result shows that after the formed effective components are compatible, the obvious difference is generated between the formed effective components and the medicinal effects of the original four-effect pill, namely, the effective components are superior to the original formula. The requirements of modernization of traditional Chinese medicine are met, the effective parts are used for replacing medicinal materials, the quality is more controllable, the dosage is smaller, and the medicinal effect is increased.

(2) The preparation method disclosed by the invention is mild in condition, high in efficiency and environment-friendly, the effective components in the medicinal materials of the four-effect pill are prepared and compatibility is optimized, a plurality of impurities in the four-effect pill are removed, the effect of treating gout of the four-effect pill is improved, and the preparation method has a very strong popularization and application value.

(3) In order to obtain better curative effect, the invention adds the yam rhizome saponin part or the yam rhizome extract on the basis of the original effective component compatibility formula, namely the yam rhizome saponin group or the yam rhizome extract group of the four wonderful pills, the efficacy of the yam rhizome extract group is obviously better than that of the four wonderful pills, and the yam rhizome saponin group or the yam rhizome extract group has obvious synergistic effect on acute gouty arthritis. The formula of the traditional Chinese medicine composition has remarkable capability of resisting acute gouty arthritis and has wide application value.

Drawings

FIG. 1A rat ankle swelling degree (A) and area under the curve AUC (B) of the four-mular pill effective component compatibility optimization experiment in example 4 of the present invention.

FIG. 2 shows the rat ankle swelling degree (A) and the area under the curve AUC (B) of the drug effect verification of the optimization of the compatibility of the effective components of the four-mul pill in example 5 of the present invention.

FIG. 3 shows the ankle swelling degree (A) and area under the curve AUC (B) of the rat in the evaluation of the efficacy of the four-Miao pill-optimizing component of example 6 of the present invention in combination with Dioscorea septemloba.

FIG. 4A shows the degree of ankle swelling (A) and the area under the curve AUC (B) of rats for evaluation of the efficacy of the Chinese medicinal composition in example 7 of the present invention.

In the figure, # # represents p <0.0001, # represents p <0.05, # represents p <0.01, # represents p <0.001, # represents p <0.0001, and n.s. represents no statistical significance of the difference.

Detailed Description

The present invention will be described in further detail with reference to examples. The embodiments described below are only some, but not all, embodiments of the invention. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

EXAMPLE 1 preparation of the various Components of the Chinese medicinal composition

(1) Reflux-extracting cortex Phellodendri with 10 times of 75% ethanol under heating for 4 times, each time for 1 hr, filtering, concentrating the filtrate under reduced pressure, adjusting pH to acidity, precipitating, filtering, adjusting pH to neutrality, adsorbing with macroporous resin for 12 hr, eluting with distilled water, 20% ethanol solution, and 50% ethanol solution sequentially, collecting 50% ethanol eluate, concentrating, and drying to obtain cortex Phellodendri alkaloid fraction.

(2) Adding 12 times of distilled water into rhizoma Atractylodis, and extracting by steam distillation to obtain rhizoma Atractylodis volatile oil.

(3) Reflux-extracting Achyranthis radix with 10 times of 70% ethanol for 2 times, each time for 90min, filtering, concentrating the filtrate under reduced pressure, dissolving the extract with water, removing impurities with equal amount of petroleum ether, extracting with water saturated n-butanol, concentrating the extractive solution, and drying to obtain achyranthes root sterone saponin fraction.

(4) Pulverizing Coicis semen, loading into extraction kettle of supercritical extraction device, and pumping CO with plunger pump ₂ Injecting into extraction kettle to reach required pressure, extracting, and separating to obtain semen Coicis fatty oil. Supercritical CO ₂ Conditions for extracting coix seed fatty oil: the water content of Coicis semen is controlled below 9%, the pressure of extraction kettle is controlled at about 20MPa, and the temperature of extraction kettle is 40 deg.CThe pressure of the separation column is 10MPa, the temperature of the separation column is 46 ℃, the temperature of the analysis kettle is 30 ℃, the extraction time is 3h, and the fluid volume is 25L/h.

(5) Reflux extracting rhizoma Dioscoreae Septemlobae with 10 times of 70% ethanol for 2 times, each for 90min, filtering, concentrating the filtrate under reduced pressure, dissolving the extract in water, removing impurities with petroleum ether, extracting with water saturated n-butanol, concentrating the extractive solution, and drying to obtain rhizoma Dioscoreae Septemlobae saponin fraction.

(6) Reflux-extracting rhizoma Dioscoreae Septemlobae with 10 times of 70% ethanol for 2 times, each time for 90min, concentrating under reduced pressure, and drying to obtain rhizoma Dioscoreae Septemlobae extract.

Example 2 preparation of the remaining portion of yam rhizome, comprising:

dissolving rhizoma Dioscoreae Septemlobae extract in water, removing impurities with petroleum ether of equal volume, extracting with n-butanol saturated with water of equal volume, concentrating the water part under reduced pressure, and drying to obtain the rest part of rhizoma Dioscoreae Septemlobae.

Example 3 preparation of Simiao pill extract

The four-ingredient pill is prepared by mixing cortex Phellodendri, rhizoma Atractylodis, achyranthis radix, and Coicis semen at a ratio of 2:1:1:2, adding 10 times of 70% ethanol, reflux extracting for 2 times, each time for 90min, filtering, concentrating under reduced pressure, and drying.

Example 4 optimization experiment of the effective component compatibility of the Simiao pill in the invention

4.1 laboratory animals

The SPF-class SD male mice with weight of 200-220g are purchased from laboratory animal center of Hangzhou medical college and are bred in SPF-class animal laboratory center of Chinese medical university. Feeding conditions: humidity is 40-60%, temperature is 24-26 ℃, lighting environment is circulated in 12h illumination/darkness, and water is freely drunk. Animal feeding and treatment are carried out according to the regulations of experimental animal management in Jiangsu province.

4.2 pharmaceutical formulation

The separated parts of the medicinal materials of the four wonderful pills are respectively weighed and dissolved in 0.5 percent sodium carboxymethyl cellulose solution, and the solution is dissolved by ultrasonic, so that the final animal administration concentration is shown in the following table 1-2, and a four-factor three-level orthogonal design table L9 (3) is designed by taking the area under the curve (AUC) of the ankle joint swelling degree of the rat as an evaluation index ⁴ )。

TABLE 1 factor level Table

Table 2L9 (3) ⁴ ) Orthogonal test design table

4.3 anti-acute gouty arthritis experiment

Animals were dosed for 4 days. After the first day of dosing, the ankle swelling degree of animals was measured for 0 h. The following day, animals were dosed, anesthetized, 0.2mL sodium urate was injected into the ankle of each animal, and the ankle swelling levels were measured for 2h, 4h, 6h, 8h, 10h, and for the third day, for 24 h. Fourth day, after animal administration, ankle swelling was measured for 48 h. And taking time as a horizontal axis and ankle joint swelling degree as an ordinate, performing ankle joint swelling degree change curves of rats in different treatment groups, and quantitatively calculating the area under the curve (AUC).

4.4 data analysis method

Analysis was performed using GraphPadPrism 9.0 statistical software, experimental data were expressed as Mean ± standard deviation (Mean ± SD), comparisons between two groups were performed using t-test, and comparisons between groups were performed using one-way anova. The results are statistically analyzed through orthogonal visual analysis and variance analysis, and the differences among groups have statistical significance when P is less than 0.05.

4.5 experimental results

As shown in fig. 1, the ankle joint swelling degree of the rats in the model group is significantly different from that of the rats in the blank group, which indicates that the model modeling of the acute gouty arthritis model is successful; the ankle swelling AUC was significantly reduced in the rats in the orthogonal 1, 2, 5 groups compared to the model group. As shown in table 3, wherein a is a phellodendron alkaloid part, B is an atractylis ovata volatile oil part, C is a achyranthes bidentata sterone saponin part, D is a coix seed fatty oil part, from four factors, the comparison of the magnitudes of the R values (factor extreme values) is combined, the extreme differences are a > C > D > B from large to small, which means that the factors influence the magnitude of the phellodendron alkaloid part > achyranthes bidentata sterone saponin part > coix seed fatty oil part > atractylis a volatile oil part; as shown in Table 4, the P values were less than 0.01 from the analysis of variance of the orthogonal test results, indicating that four factors A, B, C, D had a significant effect on the degree of swelling in rats.

Based on the anti-gout efficacy, combining with an visual analysis table, the minimum K value of the alkaloid part of the cortex phellodendri A is K1=199.5, which indicates that the highest capacity of treating acute gout arthritis ankle swelling is achieved at a level, and the optimal level of the alkaloid part of the cortex phellodendri A is 67.5mg/kg; the K1 value of the volatile oil part of the rhizoma atractylodis is minimum, and the optimal level of the volatile oil part is 24mg/kg; the K1 value of the C achyranthes aspera sterone saponin part is minimum, and the optimal level is 68.4mg/kg; the K1 value of the fatty oil fraction of D coix seed is minimum and its optimum level is a level of 76.5mg/kg. The experiment can obtain the optimal combination of all the components of the four-effect pill: 67.5mg/kg of phellodendron alkaloid, 24mg/kg of rhizoma atractylodis volatile oil, 68.4mg/kg of achyranthes aspera sterone saponin and 76.5mg/kg of coix seed fatty oil, wherein the mass ratio is about 2.8:1:2.8:3.

Table 3 visual analysis table for orthogonal test

TABLE 4 analysis of variance table

Example 5 efficacy verification of optimization of the compatibility of the effective Components of the Simiao pills in the invention

5.1 laboratory animals

SPF-class SD male mice, 48, 200-220g in weight, purchased from Hangzhou medical college laboratory animal center and fed to China university SPF-class animal center. Feeding conditions: humidity is 40-60%, temperature is 24-26 ℃, lighting environment is circulated in 12h illumination/darkness, and water is freely drunk. Animal feeding and treatment are carried out according to the regulations of experimental animal management in Jiangsu province.

5.2 pharmaceutical formulation

The preparation method comprises the steps of respectively weighing the separated parts of the medicinal materials of the four wonderful pills, dissolving the parts in 0.5% sodium carboxymethyl cellulose solution, and carrying out ultrasonic dissolution to ensure that the administration concentration of each group of final animals is as follows: optimized four-component pill group (containing cortex Phellodendri alkaloid 67.5mg/kg, rhizoma Atractylodis volatile oil 24mg/kg, achyranthes bidentata sterone saponin 68.4mg/kg, coicis semen fatty oil 76.5 mg/kg), original four-component pill group (containing four-component pill extract 1008 mg/kg), and positive drug group (containing colchicine 0.4 mg/kg).

5.3 anti-acute gouty arthritis experiment

As in 4.3.

5.4 data analysis method

As in 4.4.

5.5 experimental results

As shown in fig. 2, the ankle swelling AUC of the rats in the model group was significantly increased compared to the blank group, indicating that the acute gouty arthritis model was successfully established. Meanwhile, compared with a model group, the four-effect pill optimizing group and the four-effect pill original group have obvious reduction of the rat ankle swelling degree AUC, and the four-effect pill optimizing group has more obvious effect. The result proves that the optimal combination of the components of the four-effect pill in the traditional four-effect pill effective component compatibility optimization experiment has obvious drug effect and is higher than the experimental result of the original prescription group of the four-effect pill. The optimal combination ratio of the four wonderful pills is that phellodendron alkaloid part, rhizoma atractylodis volatile oil part, achyranthes bidentata sterone saponin part, coix seed fatty oil part=2.8:1:2.8:3.

EXAMPLE 6 evaluation of the efficacy of the optimized component of the Simiao pill of the invention in combination with Dioscorea opposite

6.1 laboratory animals

SPF SD male rats 40, weight 200-220g, purchased from Hangzhou medical college laboratory animal center, and raised in China university of medical science SPF animal center. Feeding conditions: humidity is 40-60%, temperature is 24-26 ℃, lighting environment is circulated in 12h illumination/darkness, and water is freely drunk. Animal feeding and treatment are carried out according to the regulations of experimental animal management in Jiangsu province.

6.2 pharmaceutical formulation

The separated parts of the medicinal materials of the four wonderful pills are respectively weighed and dissolved in 0.5 percent of sodium carboxymethyl cellulose solution, and the solution is ultrasonically dissolved, so that the final animal administration concentration is the optimized group of the four wonderful pills (including 67.5mg/kg of phellodendron alkaloid part, 24mg/kg of rhizoma atractylodis volatile oil part, 68.4mg/kg of achyranthes root sterone saponin part, 76.5mg/kg of coix seed fatty oil part) and the added yam rhizome group (including 67.5mg/kg of phellodendron alkaloid part, 24mg/kg of rhizoma atractylodis volatile oil part, 68.4mg/kg of achyranthes root sterone saponin part, 76.5mg/kg of coix seed fatty oil part and 208.26mg/kg of yam rhizome extract part).

6.3 anti-acute gouty arthritis experiment

As in 4.3.

6.4 data analysis method

As in 4.4.

6.5 experimental results

As shown in FIG. 3, after the MSU is injected into the model group, the ankle joint of the model group begins to gradually swell, the joint swelling degree of the model group for molding 2h is rapidly increased compared with that of the blank group, and peaks at 10-24h, so that the model is successful. Compared with the model group, the ankle joint swelling degree of rats in both administration groups is reduced, wherein the drug effect of the flavored yam rhizome group on resisting the acute gouty arthritis is most obvious. Compared with the optimized group of the four-ingredient pill, the modified yam rhizome group has obviously stronger capability of resisting acute gouty arthritis and generates obvious compatibility synergistic effect, which indicates that the modified yam rhizome group can obviously enhance the capability of the four-ingredient pill for treating gout. The mass ratio of the raw materials is about that the mass ratio of the phellodendron alkaloid part, the rhizoma atractylodis volatile oil part, the achyranthes sterone saponin part, the coix seed fatty oil part and the yam rhizome extract part=2.8:1:2.8:3:8.7.

EXAMPLE 7 evaluation of efficacy of the Chinese medicinal composition of the present invention

7.1 laboratory animals

SPF-class SD male rats, 70, weighing 200-220g, purchased from Hangzhou medical college laboratory animal center and fed to China university SPF-class animal center. Feeding conditions: humidity is 40-60%, temperature is 24-26 ℃, lighting environment is circulated in 12h illumination/darkness, and water is freely drunk. Animal feeding and treatment are carried out according to the regulations of experimental animal management in Jiangsu province.

7.2 pharmaceutical formulation

The preparation method comprises the steps of respectively weighing the separated parts of the medicinal materials of the four wonderful pills, dissolving the parts in 0.5% sodium carboxymethyl cellulose solution, and carrying out ultrasonic dissolution to ensure that the final animal administration concentration is as follows: the positive drug group (colchicine-containing 0.4 mg/kg) and the other drug groups were given at the concentrations shown in Table 5 below.

Table 5 dosing amounts of each group

7.3 anti-acute gouty arthritis experiment

As in 4.3.

7.4 data analysis method

As in 4.4.

7.5 experimental results

As shown in FIG. 4, the ankle swelling degree was decreased in each of the administration groups compared to the model group, in which the decrease was most remarkable in the sevenlobed yam rhizome saponin group and the sevenlobed yam rhizome group. Compared with the four-effect pill optimized group, the residual group of the sevenlobed yam rhizome does not show a synergistic effect, which indicates that the residual group of the sevenlobed yam rhizome does not basically contribute to the effect of the compound for resisting the acute gouty arthritis; compared with the optimized group of the four wonderful pills, the medicine effect of the added yam rhizome saponin group is far better than that of the optimized group of the four wonderful pills, and the added yam rhizome saponin group has obvious synergistic effect on resisting acute gouty arthritis. Compared with the yam rhizome saponin groups, the yam rhizome saponin groups have no significant difference, which indicates that the efficacy of the yam rhizome groups is basically equivalent. The experimental result shows that the yam rhizome saponin part is an effective part of yam rhizome for resisting acute gouty arthritis, and the yam rhizome saponin part has the effect of enhancing the activity of the four-effect pill for resisting acute gouty arthritis. The traditional Chinese medicine composition provided by the invention can obviously improve the capability of the four-effect pill in resisting acute gouty arthritis, has obvious medicine effect in treating gout, has the mass ratio of the components of the traditional Chinese medicine composition about phellodendron alkaloid part, rhizoma atractylodis volatile oil part, achyranthes root sterone saponin part, coix seed fatty oil part, yam rhizome saponin part/yam rhizome extract part = 2.8:1:2.8:3:3.9/8.7, and has wide application value in treating gout.

The protection of the present invention is not limited to the above embodiments. Any omissions, modifications, equivalents, improvements, and the like, which are within the spirit and principles of the embodiments of the disclosure, are intended to be included within the scope of the disclosure.

Claims

1. The traditional Chinese medicine composition for treating gout is characterized by comprising a phellodendron alkaloid part, an atractylis ovata volatile oil part, a achyranthes root sterone saponin part and a coix seed fatty oil part, wherein the mass ratio of the phellodendron alkaloid part to the atractylis ovata volatile oil part to the achyranthes root sterone saponin part to the coix seed fatty oil part is 2.8:1:2.8:3; or comprises cortex Phellodendri alkaloid part, rhizoma Atractylodis volatile oil part, achyranthis radix sterone saponin part, coicis semen fatty oil part and rhizoma Dioscoreae Septemlobae saponin part/rhizoma Dioscoreae Septemlobae extract part, wherein the mass ratio of cortex Phellodendri alkaloid part, rhizoma Atractylodis volatile oil part, achyranthis radix sterone saponin part, coicis semen fatty oil part and rhizoma Dioscoreae Septemlobae saponin part/rhizoma Dioscoreae Septemlobae extract part is 2.8:1:2.8:3:3.9/8.7; wherein: (1) The phellodendron alkaloid part is prepared by the following steps: reflux-extracting cortex Phellodendri with 10 times of 75% ethanol under heating for 4 times, each time 1. 1h, filtering, concentrating the filtrate under reduced pressure, adjusting pH to acidity, precipitating, filtering, adjusting pH to neutrality, adsorbing with macroporous resin, 12. 12h, eluting with distilled water, 20% ethanol solution, and 50% ethanol solution sequentially, collecting 50% ethanol eluate, concentrating, and drying to obtain cortex Phellodendri alkaloid fraction; (2) The rhizoma atractylodis volatile oil part is prepared by the following steps: adding 12 times of distilled water into rhizoma Atractylodis, and extracting by steam distillation to obtain rhizoma Atractylodis volatile oil; (3) The achyranthes aspera sterone saponin part is prepared by the following steps: reflux extracting Achyranthis radix with 10 times of 70% ethanol for 2 times, each time for 90min, filtering, concentrating the filtrate under reduced pressure, dissolving the extract with water, removing impurities with petroleum ether, extracting with water saturated n-butanol, concentrating the extractive solution, and drying to obtain achyranthes root sterone saponin fraction; (4) The coix seed fatty oil part is prepared by the following steps: pulverizing Coicis semen, loading into extraction kettle of supercritical extraction device, injecting CO2 into the extraction kettle with plunger pump to reach required pressure, extracting, and separating to obtain Coicis semen fatty oil part; conditions for supercritical CO2 extraction of coix seed fatty oil: the water content of the coix seed medicinal material is controlled below 9%, the pressure of an extraction kettle is controlled at 20MPa, the temperature of the extraction kettle is 40 ℃, the pressure of a separation column is 10MPa, the temperature of a separation column is 46 ℃, the temperature of an analysis kettle is 30 ℃, the extraction time is 3h, and the fluid quantity is 25L/h; the yam rhizome saponin part (5) is prepared by the following steps: reflux extracting rhizoma Dioscoreae Septemlobae with 10 times of 70% ethanol for 2 times (each for 90 min), filtering, concentrating the filtrate under reduced pressure, dissolving the extract in water, removing impurities with petroleum ether, extracting with water saturated n-butanol, concentrating the extractive solution, and drying to obtain rhizoma Dioscoreae Septemlobae saponin fraction; (6) The yam rhizome extract part is prepared by the following steps: reflux-extracting rhizoma Dioscoreae Septemlobae with 10 times of 70% ethanol for 2 times, each time for 90min, concentrating under reduced pressure, and drying to obtain rhizoma Dioscoreae Septemlobae extract.

2. The use of a Chinese medicinal composition according to claim 1 in the preparation of a medicament for the treatment of gout.