Traditional Chinese medicine extract with effects of clearing heat, relieving swelling and pain as well as preparation method and application of traditional Chinese medicine extract

Abstract

The invention relates to a traditional Chinese medicine extract with effects of clearing heat, diminishing swelling and relieving pain as well as a preparation method and application of the traditional Chinese medicine extract. The traditional Chinese medicine extract with the effects of clearing heat, diminishing swelling and relieving pain comprises geniposide, baicalin and berberine hydrochloride. The preparation raw materials comprise cortex phellodendri, radix scutellariae, fructus gardeniae and radix curcumae. The traditional Chinese medicine composition has the functions of clearing away heat and toxic materials, relieving swelling and pain, dispelling wind and eliminating dampness and promoting blood circulation to remove blood stasis, has strong and rapid anti-inflammatory, swelling and pain relieving effects, can rapidly relieve symptoms such as arthralgia, swelling and dysfunction caused by gouty arthritis, and effectively recovers the joint function; the compound can be used for preparing medicines for treating acute gouty arthritis. The medicine can be an external skin preparation such as emplastrum or gel, and is convenient to use.

Description

Technical Field

[0001] The invention relates to a plaster, in particular to a Chinese medicinal extract with the effects of clearing away heat, reducing swelling and relieving pain, and a preparation method and application thereof. Background Art

[0002] The incidence of acute gouty arthritis (AGA) continues to rise worldwide, becoming one of the major diseases affecting human health. According to statistics, there are more than 55.8 million gout patients worldwide. With the aging of society and changes in lifestyle and diet, the age of onset of gouty arthritis is showing a trend of getting younger.

[0003] Clinical treatments for gouty arthritis include drug therapy, physical therapy, surgical treatment, and traditional Chinese medicine treatment. Drug therapy is the main treatment method in the acute phase, including uric acid-lowering drugs (febuxostat, benzbromarone, etc.), nonsteroidal anti-inflammatory drugs, colchicine, etc., which have obvious effects, but are not clinical specific drugs, and have a small safety range and serious adverse reactions. Physical therapy is also widely used in clinical practice as an auxiliary treatment method, such as cold compresses and massages to relieve pain and inflammation, and ultrasound therapy is used to promote drug absorption. For patients with stubborn gout who are not ideal for medical treatment, as well as patients with severe joint damage and deformity, appropriate surgical intervention is also an indispensable treatment method, such as joint stone removal and joint replacement. Traditional Chinese medicine treatments such as acupuncture and Chinese medicine have also been used to treat gout and have a long history.

[0004] Traditional Chinese medicine has achieved some results in the treatment of acute gouty arthritis. Similar medicines that have been approved for marketing, such as Tongfengshu tablets, Tongfengfengshu pills, Betel nut and Huo gout mixture, and Tongfengding tablets (capsules), are all oral preparations. However, there are currently no topical medicines specifically for the treatment of acute gouty arthritis, and it is difficult to quickly relieve the symptoms of acute attacks of gouty arthritis. Summary of the invention

[0005] In order to determine the specific effective ingredients of a Chinese medicine extract with the effect of clearing heat, reducing swelling and relieving pain, and whether the medicine can be further simplified to retain the effect of treating gouty arthritis, the present invention retains the extraction method of the extract when preparing the plaster, and further uses the system solvent extraction method to extract and separate different extraction parts of the heat-clearing, swelling-relieving and pain-relieving plaster (total polysaccharides, petroleum ether, chloroform, ethyl acetate, n-butanol extract and water-soluble substances, etc. 6 chemical parts). Through basic anti-inflammatory and analgesic experiments, that is, two mouse inflammation models (mouse ear swelling and foot swelling) to explore the anti-inflammatory effects of different extraction parts; two mouse pain models (hot plate experiment, twisting experiment) are used to study the analgesic effects of different extraction parts; by local injection of sodium urate to induce an acute gout model in rats, the anti-gouty arthritis effect of the extracts of each part is evaluated. Combining the above three experiments, the effective parts of the heat-clearing, swelling-relieving and pain-relieving plaster are determined. After determining the effective part, according to the experience and suggestions of clinicians, some drugs were deleted from the 7 drugs in the heat-clearing, swelling-relieving and analgesic ointment, and the remaining drugs were named the reduced prescription. The effective part was extracted in the same way, and the specific effective ingredients of the effective part of the original prescription (heat-clearing, swelling-relieving and analgesic ointment) and the reduced prescription were preliminarily determined by high performance liquid chromatography. At the same time, the rat acute gout model was used to determine whether the reduced prescription has the effect of treating acute gouty arthritis. Through experiments, the present application obtains a Chinese medicine extract with heat-clearing, swelling-relieving and analgesic effects, and its preparation method and application, which are as follows:

[0006] The present application provides a Chinese medicine extract with the effects of clearing away heat, reducing swelling and relieving pain, the active ingredients of which include gardenia glycoside, baicalin and berberine hydrochloride.

[0007] Optionally, the Chinese medicine extract is prepared from a Chinese medicine composition comprising the following raw materials: Phellodendron chinense, Scutellaria baicalensis, Gardenia jasminoides, and Curcuma aromatica.

[0008] Preferably, the Chinese medicine extract is prepared from a Chinese medicine composition comprising the following raw materials, in parts by weight: 450-510 parts of Phellodendron chinense, 210-270 parts of Scutellaria baicalensis, 210-270 parts of Gardenia jasminoides, and 160-220 parts of Curcuma aromatica.

[0009] Optionally, the Chinese medicine composition further comprises: rhubarb, cyperus rotundus and liquorice.

[0010] Preferably, the Chinese medicine extract is prepared from a Chinese medicine composition comprising the following raw materials, in parts by weight: 450-510 parts of Phellodendron chinense, 360-420 parts of Rhubarb, 210-270 parts of Scutellaria baicalensis, 210-270 parts of Gardenia jasminoides, 210-270 parts of Cyperus rotundus, 160-220 parts of Curcuma aromatica, and 160-220 parts of Licorice.

[0011] The present application provides a method for preparing a Chinese medicine extract having the effects of clearing away heat, reducing swelling and relieving pain, comprising the following steps:

[0012] Take Phellodendron chinense, Scutellaria baicalensis, Gardenia jasminoides and Curcuma aromatica, and mix them evenly to obtain a Chinese medicine mixture;

[0013] The Chinese medicine mixture is extracted by ethanol reflux extraction to obtain extract A;

[0014] Concentrate extract A to obtain an extract;

[0015] Adding an appropriate amount of water to disperse the extract to obtain a concentrated solution;

[0016] Degreasing the concentrate with petroleum ether;

[0017] Adjust the pH of the aqueous phase after petroleum ether extraction to 10-14, and then extract with chloroform several times;

[0018] The pH of the aqueous phase after chloroform extraction is adjusted to 3-4, and then extracted with ethyl acetate. The extract is concentrated under reduced pressure, dried and weighed to obtain the traditional Chinese medicine extract.

[0019] Preferably, the pH of the aqueous phase after petroleum ether extraction is adjusted to 12.

[0020] The present application also provides another method for preparing the above-mentioned Chinese medicine extract, comprising the following steps:

[0021] Take Phellodendron chinense, Rhubarb, Scutellaria baicalensis, Gardenia jasminoides, Cyperus rotundus, Curcuma aromatica, and Licorice, and mix them evenly to obtain a Chinese medicine mixture;

[0022] The Chinese medicine mixture is extracted by ethanol reflux extraction to obtain extract A;

[0023] Concentrate extract A to obtain an extract;

[0024] Adding an appropriate amount of water to disperse the extract to obtain a concentrated solution;

[0025] Degreasing the concentrate with petroleum ether;

[0026] Adjust the pH of the aqueous phase after petroleum ether extraction to 10-14, and then extract with chloroform several times;

[0027] The pH of the aqueous phase after chloroform extraction is adjusted to 3-4, and then extracted with ethyl acetate. The extract is concentrated under reduced pressure, dried and weighed to obtain the traditional Chinese medicine extract.

[0028] The Chinese herbal extract with the effects of clearing away heat, reducing swelling and relieving pain can be used to prepare a medicine for treating acute gouty arthritis; the medicine can be a skin external preparation such as a plaster or a gel.

[0029] Compared with the prior art, this application has at least the following beneficial effects:

[0030] The Chinese medicine extract with heat-clearing, swelling-removing and analgesic effects of the present application has the functions of clearing away heat and detoxifying, reducing swelling and relieving pain, dispelling wind and dampness, and promoting blood circulation and removing blood stasis, and has a strong and rapid anti-inflammatory, swelling-removing and analgesic effect, and can quickly relieve the symptoms of joint pain, swelling, and functional impairment caused by gouty arthritis, and effectively restore joint function. The Chinese medicine extract of the present application can be prepared into an external preparation such as a plaster or a gel. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for use in the embodiments will be briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present invention and should not be regarded as limiting the scope.

[0032] Figure 1 This is a diagram showing the effect of different extraction sites on the mouse ear swelling model in the embodiment;

[0033] Figure 2 The effects of different extraction parts on the egg white-induced mouse foot swelling model (foot volume) in the examples;

[0034] Figure 3 The figure is a graph showing the effect of different extraction parts on the egg white-induced mouse foot swelling model (foot thickness) in the example;

[0035] Figure 4 Graph showing the effects of different extraction sites on the mouse hot plate stimulation model in the embodiment;

[0036] Figure 5 The figure is a graph showing the effects of different extraction parts on the acetic acid-induced writhing model in mice in the examples;

[0037] Figure 6 The graphs are the results of rat gait assessment and inflammation rating at 24h and 48h after modeling in the embodiment;

[0038] Figure 7 The figure is the measurement result of the swelling degree of the right hind foot of the rats 2h, 4h, 8h, 24h and 48h after modeling in the embodiment;

[0039] Figure 8 4 HPLC spectra in the embodiment: A is the HPLC spectra of the mixture of 6 reference substances, B is the HPLC spectra of the original prescription of the Qingre Xiaozhong Zhitong ointment, C is the HPLC spectra of the ethyl acetate part of the original prescription, and D is the HPLC spectra of the ethyl acetate part of the reduced prescription;

[0040] In the figure, 1 represents geniposide, 2 represents baicalein, 3 represents ferulic acid, 4 represents berberine hydrochloride, 5 represents emodin, and 6 represents chrysophanol;

[0041] Fig. 9 This is a graph showing the swelling degree of rat ankles in the embodiment;

[0042] Fig.10 These are the H&E staining images of the ankle joints of rats in the examples: A is the H&E staining image of the blank group, B is the H&E staining image of the model group, C is the H&E staining image of the positive drug group, D is the H&E staining image of the original prescription group, and E is the H&E staining image of the reduced prescription group. DETAILED DESCRIPTION

[0043] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the present invention will be clearly and completely described below in conjunction with the drawings in specific embodiments. Obviously, the described embodiments are only part of the embodiments of the present invention, rather than all of the embodiments.

[0044] The original dosage form of a Chinese medicine extract with heat-clearing, swelling-removing and analgesic effects of the present invention is an external powder, and through clinical observation, the efficacy is excellent. The prescription is composed of pure Chinese medicine Phellodendron, Rhubarb, Scutellaria, Gardenia, Cyperus, Curcuma, Licorice seven Chinese medicines, non-toxic medicinal materials, no 18 anti-19 fears of incompatibility, mainly including alkaloids, anthraquinones, glycosides, iridoids and other pharmacodynamic components. Functions of clearing heat and detoxicating, swelling and analgesic, dispelling wind and dampness and promoting blood circulation and removing blood stasis, with strong and rapid anti-inflammatory, swelling and analgesic effects, can quickly relieve the symptoms of joint pain, swelling, activity dysfunction caused by gouty arthritis, and effectively restore joint function. The powder is applied externally to the local part of the diseased joint, and most of them are pain controlled in about 4-8 hours of application, swelling subsides, joint function is restored, joints are free to move, no adverse reactions are seen, long-term use without addiction worries, analgesic effect is lasting, and it is easy for patients to accept. A clinical trial was conducted with 96 cases in each group. The results showed that both groups could improve the TCM syndrome score of acute attack gouty arthritis (damp-heat accumulation syndrome), improve joint pain, joint swelling and joint function scores, and reduce blood uric acid and erythrocyte sedimentation rate, indicating that both groups were effective in treating acute attack gouty arthritis. There was no statistically significant difference between the two groups in the main efficacy index (TCM syndrome effective rate) of treating acute attack gouty arthritis (damp-heat accumulation syndrome) (P>0.05), and the experimental group was non-inferior to the control group; there was no statistically significant difference between the two groups in key secondary efficacy indexes (joint pain score) and secondary efficacy indexes (joint function score, total score of TCM syndrome main symptoms and TCM syndrome secondary symptoms, blood uric acid and erythrocyte sedimentation rate) (all P>0.05); although the experimental group showed better effect than the control group in reducing joint swelling score, there was no statistical difference between the two groups in improving joint swelling degree and joint swelling disappearance rate (all P>0.05). In summary, it is effective to treat acute attack gouty arthritis (damp-heat accumulation syndrome). This embodiment is based on the original dosage form, according to the research and development standards of Chinese medicine preparations in medical institutions, uses modern pharmaceutical new technologies, incorporates transdermal absorption theory, conducts systematic drug and clinical research, develops pure Chinese medicine external therapeutic drugs for treating gouty arthritis, and plans to develop them into skin external preparations such as plasters or gels to increase drug loading and efficacy for easy use by patients.

[0045] Preferably, the prescription comprises, by weight, 450-510 parts of Phellodendron chinense, 360-420 parts of Rhubarb, 210-270 parts of Scutellaria baicalensis, 210-270 parts of Gardenia jasminoides, 210-270 parts of Cyperus rotundus, 160-220 parts of Curcuma aromatica, and 160-220 parts of Licorice.

[0046] Example 1

[0047] 1. Obtaining Chinese herbal medicine extracts from different parts, including the following steps:

[0048] Step 1. Preparation:

[0049] 1.1 Prepare experimental materials: Chinese medicinal materials Phellodendron chinense, Rhubarb, Scutellaria baicalensis, Gardenia jasminoides, Curcuma aromatica, Licorice root; Chinese medicinal material Cyperus rotundus; compound dexamethasone acetate cream; diclofenac diethylamine emulsion (specification: 20g / tube); 95% ethanol, petroleum ether (60-90℃), chloroform, ethyl acetate, n-butanol, sodium hydroxide (NaOH), concentrated hydrochloric acid (HCl), sodium chloride, glacial acetic acid are all analytical grade; sodium urate (specification: 1g / bottle).

[0050] Reference substances: berberine hydrochloride, baicalein, emodin, chrysophanol, gardenia glycoside, and ferulic acid.

[0051] Chromatographic grade: methanol, acetonitrile, phosphoric acid, triethylamine.

[0052] G1140 hematoxylin, G1100 eosin; xylene, 4% paraformaldehyde fixative.

[0053] 1.2 Experimental animals: Several SPF-grade Kunming mice, half male and half female, weighing 27-32g; several SPF-grade SD rats, half male and half female, weighing 180-200g. The experimental animals must have an animal production license number.

[0054] Step 2, taking Chinese herbal medicine pieces of Phellodendron chinense 24.4g, Rhubarb 19.5g, Scutellaria baicalensis, Gardenia jasminoides and Cyperus rotundus 12.2g, Curcuma aromatica and Licorice root 9.75g each, and mixing them evenly to obtain a Chinese medicine mixture;

[0055] Step 3, one-time extraction: add the Chinese medicine mixture to 6 times the amount of 50%-70% ethanol, soak for 20-40 minutes, reflux extraction for 1-2 hours, filter, and obtain residue A and filtrate A;

[0056] Preferably, the ethanol concentration in this step is 60%, the soaking is 30 minutes, and the reflux extraction is 1.5 hours.

[0057] Step 4, adding 5 times the amount of 50%-70% ethanol to the residue A, reflux extraction for 1-2 hours, and filtering to obtain the residue B and filtrate B;

[0058] Preferably, the ethanol concentration in this step is 60%, and the reflux extraction is performed for 1.5 hours.

[0059] Step 5, combining the filtrate A and the filtrate B from the two extractions and concentrating under reduced pressure to obtain an ethanol extract, i.e., an extract; and evaporating the residue B in step 4 under natural conditions until there is no alcohol taste, and set aside.

[0060] Step 6, adding an appropriate amount of water to disperse the extract to obtain a concentrated solution with a relative density of 1.02-1.08;

[0061] Preferably, the relative density of the concentrated solution in this step is 1.05.

[0062] Step 7, defatting the concentrate twice with an equal volume of petroleum ether to obtain a petroleum ether extract A.

[0063] Among them, the petroleum ether will be separated into layers after extraction, the layer of solution dissolved in petroleum ether will be retained, and the other layer of water phase will be left for use.

[0064] Step 8, adjusting the pH of the remaining aqueous phase after the petroleum ether extraction in step 7 to 13-14 with 1 mol / L NaOH solution, then extracting with an equal volume of chloroform 5 times, and finally concentrating the extract under reduced pressure, drying and weighing to obtain chloroform extract B.

[0065] Preferably, the pH of the remaining aqueous phase after petroleum ether extraction is adjusted to 12 with 1 mol / L NaOH solution.

[0066] Step 9, the remaining aqueous phase after the chloroform extraction in step 8 is adjusted to pH 3-4 with HCl and then extracted with ethyl acetate, the extract is concentrated under reduced pressure, dried and weighed to obtain ethyl acetate extract C.

[0067] Among them, after ethyl acetate extraction, the layers will be separated, the layer of solution dissolved in ethyl acetate will be retained, and the other layer of water phase will be reserved for later use.

[0068] Step 10, extracting the remaining aqueous phase after the ethyl acetate extraction in step 9 with saturated n-butanol, concentrating the extract under reduced pressure, freeze-drying and weighing to obtain n-butanol extract D.

[0069] Among them, after the n-butanol extraction, the layers will be separated, the layer of solution dissolved in the n-butanol extraction will be retained, and the other layer of water phase will be reserved for later use.

[0070] Step 11, freeze-dry and weigh the remaining aqueous phase after the n-butanol extraction in step 10 to obtain a residual aqueous phase material fraction E.

[0071] Step 12, add water to the residue B in step 5, reflux and extract twice, the amount of water used is 6 times the amount of the residue, the extraction time is 1.5 hours, then filter and combine the extracts, evaporate to dryness, concentrate and dry, weigh, and obtain the total polysaccharide fraction F.

[0072] 2. Study the anti-inflammatory and analgesic effects of different extraction parts, as follows:

[0073] 2.1. Effects of different extraction sites on animal models of inflammation.

[0074] 2.1.1 Effects of different extraction sites on mouse ear swelling model: 160 SPF Kunming mice, half male and half female, were randomly divided into 8 groups according to body weight (10 female mice and 10 male mice in each group), namely blank control group, model control group, positive control group, total polysaccharide site group, ethyl acetate extraction site group, petroleum ether extraction site group, n-butanol extraction site group and aqueous site group. 0.1 ml of the corresponding drug was applied to the right ear of each mouse in each group, the model control group was applied with an equal amount of normal saline, and the negative control group was evenly applied with compound dexamethasone acetate cream with a thickness of about 0.2 mm. The drugs were administered continuously for seven days. 0.5 h after the last administration, 30 μl of xylene solution was applied to both sides of the right ear of each mouse. After 1 h of inflammation, the mice were killed by cervical dislocation, and holes were punched at the same position of the left and right ears of each mouse with a puncher, and their weight was weighed.

[0075] Swelling degree (mg) = mass of swollen ear piece - mass of unswollen ear piece;

[0076] Swelling inhibition rate (%) = (average swelling degree of model group - average swelling degree of drug administration group) / average swelling degree of model group × 100%.

[0077] 2.1.2, Effect of different extraction parts on the mouse foot swelling model: 160 SPF grade Kunming mice were taken and grouped in the same way as 2.1.1. Each group applied 0.1 ml of the corresponding drug to the right hind foot of each mouse, the model control group applied an equal amount of normal saline, and the positive control group evenly applied compound dexamethasone acetate cream with a thickness of about 0.2 mm. The drug was administered continuously for 6 days. 0.5 h after the last administration, the same position of the right hind ankle joint of each mouse was marked with a marker pen, and the right hind foot volume and foot thickness of each mouse were measured with a homemade foot volume measuring instrument and vernier caliper, which were recorded as the initial value. After the initial value measurement was completed, 30 μL of the newly prepared 10% fresh egg white solution was subcutaneously injected into the right hind toe of each mouse. The volume and thickness of the right hind toe of the mice were measured again with a homemade toe volume meter and vernier caliper at 1h, 2h, 4h and 6h after the administration of egg white, and the swelling degree of the right toe was calculated.

[0078] Toe swelling rate = (toe volume after egg white injection - toe volume before egg white injection) / toe volume before egg white injection.

[0079] 2.2 Effects of different extraction sites on pain animal models

[0080] 2.2.1, Effect of different extraction parts on the hot plate-induced pain model in mice: 70 female mice were randomly divided into seven groups according to body weight, namely blank control group, positive control group, total polysaccharide part group, ethyl acetate extraction part group, petroleum ether extraction part group, n-butanol extraction part group and aqueous phase part group, with 10 mice in each group. Each group applied the corresponding drug on the right hind foot, the blank control group was given an equal volume of normal saline, and the administration volume was 0.1 ml per mouse, and the positive control group was evenly applied with Voltaren cream with a thickness of 0.2 mm. The experiment was carried out on a hot plate instrument at a temperature of (55±0.5)℃, and the time for the mouse to lick the right hind foot was used as the pain response of the mouse, that is, the pain threshold. Mice with a pain threshold between 6s and 30s were selected as test subjects, and the pain threshold of the mouse was measured before and at 0, 30, 60, 90, and 120min after administration. If the mouse was placed in the hot plate instrument for 60s without reaction, the mouse was taken out, and the pain threshold was calculated as 60s.

[0081] 2.2.2, Effect of different extraction sites on acetic acid-induced pain model in mice: 140 SPF mice, half male and half female, were randomly divided into seven groups, 20 mice in each group, including 10 female mice and 10 male mice. The day before administration, the abdomen of the mice was shaved. 24 hours later, each group applied the corresponding drug to the depilated position of the abdomen. The blank control group was given an equal volume of saline, and the administration volume was 0.1 ml per mouse. The positive control group was evenly applied with Voltaren cream with a thickness of 0.2 mm. The drug was administered twice a day, once in the morning and once in the afternoon, for 3 consecutive days. 0.5 hours after the last administration, 0.6% glacial acetic acid was injected intraperitoneally to stimulate the peritoneum to produce pain, and the injection dose was 10 mL / kg. The latency and number of twisting reactions of mice in each group were observed within 15 minutes.

[0082] 3. Study the therapeutic effects of different extraction parts of Qingrexiaozhongzhitong ointment on gouty arthritis in rats

[0083] 3.1, Drug administration and intervention: After the animals were fed normally for 3 days, 60 rats were divided into 6 groups. The drug groups to be tested (total polysaccharides, ethyl acetate extraction parts, and n-butanol extraction parts) were smeared with 0.1 ml of the corresponding drugs, the positive control group was smeared with 0.7 cm of Voltaren, and the model control group and the blank control group were smeared with an equal amount of normal saline. After smearing, each group was bandaged with gauze. The drug was applied externally for 1 hour each time, twice a day. The Voltaren emulsion treatment group was applied with Voltaren emulsion externally, and the right ankle joint was covered each time, twice a day. Each medication group was administered for a total of 9 days.

[0084] 3.2, Modeling: 30 minutes after the last administration on the 7th day, all the rats except the blank control group were injected with urate crystals for local modeling. The gouty arthritis rat modeling method designed by CODERRE et al. was adopted. Weigh 0.2g of sodium urate, grind it into powder, add 0.9% sodium chloride injection to make a 5% sodium urate suspension. Shave the right hind ankle of the rat, take 0.1mL of 5% sodium urate solution, and inject it into the tibiotarsal joint cavity of the right hind ankle of the rat with a No. 4 injection needle. Each rat was injected once, 0.1ml each time. After the needle probed the joint capsule and felt the empty feeling, the injection was injected. After the injection, the degree of swelling of the tibiotarsal joint cavity was observed.

[0085] 3.3, Gait assessment and inflammation rating: Gait assessment: Observe and record the gait changes of rats 24 and 48 hours after modeling. Grade 0: normal walking, four-footed; Grade 1: right hind foot slightly lifted; Grade 2, slope walking, right hind foot slightly lifted, slow walking; Grade 3: severe slope walking, right hind foot dare not touch the ground, slow walking, showing a three-foot walking style with only the front two feet and the back left foot.

[0086] Inflammation rating: Observe and record the inflammatory changes of rats 24 and 48 hours after modeling. Grade 0: normal joint state; Grade 1: obvious bone marks, slight redness and swelling of the skin around the joints; Grade 2: slight bone marks, obvious redness and swelling of the skin around the joints; Grade 3: no bone marks, redness and swelling of the joints and around the joints.

[0087] 3.4. Determination of the swelling of the ankle joints of rats: The thickness of the right hind ankle joint was measured with a vernier caliper before the experiment and at different times after induction of inflammation (the right hind ankle joint of each rat was marked with a marker before the experiment). The joint thickness was measured at 2, 4, 8, 24 and 48 h after modeling to evaluate the swelling of the joints.

[0088] 4. Preliminary comparison of the components of the effective parts of the heat-clearing, swelling-removing and analgesic ointment

[0089] 4.1. Reduced prescription of the heat-clearing, swelling-removing and analgesic ointment: After determining the effect of the heat-clearing, swelling-removing and analgesic ointment, the prescription was further simplified based on the experience of clinical doctors, and the seven herbs were reduced to four herbs: Phellodendron amurense, Scutellaria baicalensis, Gardenia jasminoides, and Curcuma aromatica. This was named the reduced prescription, and the extraction and separation were performed according to the methods of steps 2 to 12, and the effective extraction part that was the same as that of the original prescription was used as the effective part.

[0090] 4.2 Preliminary determination of the original and reduced ingredients of the Qingrexiaozhongzhitong ointment

[0091] The specific components in the effective part of Qingre Xiaozhong Zhitong Ointment were determined by high performance liquid chromatography. By selecting the representative components of 7 drugs in Qingre Xiaozhong Zhitong Ointment, an HPLC method was established to simultaneously perform preliminary identification of 6 components in Qingre Xiaozhong Zhitong Ointment, including berberine hydrochloride, emodin, chrysophanol, baicalin, gardenia glycoside, and ferulic acid.

[0092] 4.2.1, Establishment of chromatographic conditions

[0093] Chromatographic column: ThermoSyncronis C18 (5μm, 250×4.6mm)

[0094] Mobile phase: acetonitrile-water (0.3% phosphoric acid and 0.2% triethylamine)

[0095] Gradient elution:

[0096] Table 1: Gradient elution mobile phase table

[0097]

[0098] Flow rate: 1.0ml / min

[0099] Detection wavelength: 270nm

[0100] Column temperature: room temperature (25℃)

[0101] Injection volume: 10 μl

[0102] 4.2.2, Preparation of reference substance solution: Take appropriate amount of berberine hydrochloride, emodin, chrysophanol, baicalin, gardenia glycoside and ferulic acid reference substances, weigh accurately, add methanol to dissolve, and prepare a mixed reference substance solution containing 250 μg of the above ingredients per 1.0 ml of solution, and store in a refrigerator at 4°C for later use.

[0103] 4.2.3, Preparation of test solution: Take the effective parts of the original and reduced formulas of Qingre Xiaozhong Zhitong Plaster respectively, concentrate them under reduced pressure to form dry extracts, grind them in a mortar, accurately weigh about 1.0 g, put it in a stoppered conical flask, accurately add 10 ml of methanol, stopper it, ultrasonically treat it for 30 min, let it stand and cool, weigh it again, make up the lost weight with methanol, shake it well, centrifuge it at 1000 rpm for 10 min, take the supernatant, filter it with a membrane, and set it aside.

[0104] 4.2.4, Preliminary comparison of ingredients: Take the test sample solution under step "4.2.3" and analyze it according to the chromatographic conditions under "4.2.1", record the chromatogram within 120 minutes, and use the mixed reference substances (berberine hydrochloride, emodin, chrysophanol, baicalin, gardenia glycoside, ferulic acid) for peak positioning to preliminarily determine the specific ingredients of the effective parts of the original and reduced prescriptions of the Qingre Xiaozhong Zhitong Ointment.

[0105] 5. The effects of the original and reduced effective parts of the heat-clearing, swelling-removing and analgesic ointment on anti-acute gouty arthritis include the following steps:

[0106] 5.1, Animal grouping: The experimental animals were 30 SPF grade SD male rats with a body weight of 180-220g. The feeding room was illuminated with a 12-hour day and night cycle, the temperature was maintained at 22-26°C, the humidity was 50-60%, and the animals were free to eat and drink. The rats were randomly divided into 5 groups, namely: normal group, model group, positive drug (diclofenac diethylamine emulsion) group, Qingre Xiaozhong Zhitong ointment original formula group, Qingre Xiaozhong Zhitong ointment reduced formula group.

[0107] 5.2, Drug preparation and administration: According to previous studies, the high-dose group of Qingre Xiaozhong Zhitong ointment administered to animals is 14 times the clinical dosage, that is, 1.0g crude drug / kg. The ethyl acetate part of 100g crude drug is dried to obtain 580mg, that is, 5.8mg / kg. At the same time, considering that the extract is used instead of the whole extract, the rat is administered 5mg / 200g. The drug is made into a suspension with 2% Tween-80 physiological saline, about 1ml.

[0108] The ethyl acetate part of 60g of the Qingre Xiaozhong Zhitong ointment of the reduced prescription was dried to obtain 75mg, i.e. 1.25mg / kg. Considering the same dosage as the whole prescription, 5mg / 200g was also used for rats. The drug was made into a suspension with 2% Tween-80 saline, about 1ml.

[0109] For the positive drug group, each rat was given 0.2 g of the drug according to calculations made in previous experiments.

[0110] 5.3 Model replication

[0111] Since GA can be relieved on its own after a few days of onset, and the entire medication cycle is as long as seven days, the traditional treatment mode of first establishing a model and then administering medication cannot explain whether the GA in experimental animals is the result of drug treatment or the result of self-healing. Therefore, all GA animal experiments first give adaptive medication for 4 days and then establish a model. This method has also been adopted by a large number of studies and recognized by the academic community.

[0112] Weigh 2.5 g of sodium urate crystals, add 5 mL of 0.9% saline and grind thoroughly, then add 45 mL. After ultrasonic treatment in a water bath for 1 h, a 5% sodium urate suspension is obtained. The suspension is sterilized at high temperature and set aside based on the standard of not clogging the needle of a 1 mL syringe.

[0113] All rats except the normal group were anesthetized by gas. After they had no obvious pain, they were disinfected with 75% medical alcohol, and their right hind ankle joints were bent 90°. 200 μl of sodium urate suspension was drawn with a 1 ml syringe. The needle was inserted into the ankle joint capsule from top to bottom at the posterior side of the right ankle joint of the rat, with the bevel of the needle port parallel to the tibia, and then injected. The bulging of the contralateral joint capsule was used as the injection standard. The joints were moderately moved for full integration to prepare the AGA pathological model. The blank group was injected with sterile saline in the ankle joint in the same way.

[0114] 5.4, ​​Observation Indicators

[0115] 5.4.1. Gait observation: referring to the gait grading standard table in Table 2, the gait of the model group, western medicine positive group and treatment group was observed and recorded.

[0116] Table 2: Gait classification standard table

[0117]

[0118] 5.4.2, Determination of joint swelling and joint swelling index: 2h before modeling, 2h after modeling, 6h after modeling, 12h after modeling, 24h after modeling, and 48h after modeling, the ankle diameter was measured using a stainless steel digital caliper with the medial and lateral malleolus as the mark. The measurement was repeated three times in parallel, and the average value was taken as the final result.

[0119] The calculation formula of joint swelling index is as follows: Swelling index (%) = (swelling degree of ankle joint at measurement point in time - initial swelling degree of ankle joint) / initial swelling degree of ankle joint × 100%

[0120] 5.5 Pathological examination: Paraffin embedding technique was performed according to conventional methods. The rat ankles were dissected, with a size of about 1 cm × 1 cm × 1 cm, fixed with 4% paraformaldehyde, embedded in paraffin, sliced, dewaxed with xylene, hydrated with different concentrations of alcohol, stained with hematoxylin-eosin (HE), and photographed under a BX51 microscope.

[0121] 6. Statistical analysis: All data are expressed as mean ± standard deviation. At least three samples were drawn for each test for statistical analysis. Statistical comparisons were performed using analysis of variance (ANOVA) and t-test. GraphPad Prism 9 software was used for statistical analysis. When p < 0.05, it was considered statistically significant, where *p < 0.05, ns means no significant difference.

[0122] 7. Research results on a Chinese herbal extract with heat-clearing, swelling-reducing and analgesic effects in the treatment of acute gouty arthritis

[0123] 7.1. Anti-inflammatory and analgesic effects of different extraction parts of Qingrexiaozhongzhitong ointment

[0124] 7.1.1, Effects of different extraction sites on mouse ear swelling model: Compared with the model group, the ethyl acetate site, petroleum ether extraction site, n-butanol extraction site, aqueous phase site and compound dexamethasone acetate cream positive group can significantly reduce the degree of xylene-induced mouse ear swelling (p < 0.05 or p < 0.01). See Table 3, Figure 1 .

[0125] Table 3: Effects of different extraction sites on mouse ear swelling model ( n=20)

[0126]

[0127] Note: Compared with the model control group: **p<0.01, *p<0.05.

[0128] 7.1.2, Effects of different extraction parts on the mouse foot swelling model: The results of the foot volume experiment showed that compared with the model group, the positive group reduced the degree of foot swelling of mice induced by formaldehyde at 1, 2, 4, and 6 hours after inflammation (p < 0.05 or p < 0.01). The total polysaccharide part, petroleum ether part, and n-butanol part could significantly reduce the degree of foot swelling of mice induced by formaldehyde 4 hours after inflammation in mice (p < 005). See Table 4, Figure 2 .

[0129] Table 4: Comparison of the effects of different extraction sites on the mouse foot swelling model using the foot volume method ( n=20)

[0130]

[0131]

[0132] Note: Compared with the model control group: **p<0.01, *p<0.05.

[0133] The results of the foot thickness experiment showed that compared with the model group, the total polysaccharide fraction, the aqueous fraction and the positive group significantly reduced the swelling of the mouse foot caused by formaldehyde (p < 0.05 or p < 0.01). There was no significant difference between the ethyl acetate fraction, petroleum ether fraction and the aqueous fraction at 1 and 2 hours and the model group, but at 4 and 6 hours, the swelling of the mouse foot caused by formaldehyde was significantly reduced (p < 0.05 or p < 0.01). See Table 5, Figure 3 .

[0134] Table 5: Comparison of the effects of different extraction sites on the mouse foot swelling model using the foot thickness method ( n=20)

[0135]

[0136] Note: Compared with the model control group: **p<0.01, *p<0.05.

[0137] 7.1.3 Effects of different extraction sites on the hot plate-induced pain model in mice

[0138] Compared with the model group, the pain thresholds of the Voltaren positive group at 30min, 60min, and 90min after administration were significantly higher than those before administration (p < 0.05 or p < 0.01). In addition, except for the significant increase in the pain threshold of the total polysaccharide part at 60min after administration, the effects of other administration groups were not obvious. See Table 6, Figure 4 .

[0139] Table 6: Effects of different extraction sites on the hot plate-induced pain model in mice ( n=10)

[0140]

[0141]

[0142] Note: Compared with the model control group: **p<0.01, *p<0.05.

[0143] 7.1.4 Effects of different extraction parts on acetic acid-induced pain model in mice

[0144] Compared with the model group, the total polysaccharide fraction, ethyl acetate fraction and Voltaren positive group can significantly prolong the latency of the writhing reaction of mice induced by acetic acid (p < 0.05 or p < 0.01); the total polysaccharide fraction, ethyl acetate extract fraction, petroleum ether extract fraction, n-butanol extract fraction and Voltaren positive group can significantly reduce the number of writhing reactions of mice induced by acetic acid within 15 minutes (P < 0.01). See Table 7, Figure 5 .

[0145] Table 7: Effects of different extraction parts on acetic acid-induced pain model in mice ( n=20)

[0146]

[0147] Note: Compared with the model control group: **p<0.01, *p<0.05.

[0148] Conclusion: This experiment used two mouse inflammation models to explore the anti-inflammatory effects of different extraction parts of a Chinese medicine. The results showed that the ethyl acetate extraction part, petroleum ether extraction part, n-butanol extraction part and aqueous phase extraction part could significantly inhibit the swelling of mouse ears caused by xylene; all drug-treated groups could significantly inhibit the swelling of mouse feet caused by formaldehyde. The results of this anti-inflammatory experiment showed that each extraction part had good inhibitory activity on the inflammation model, so it was not possible to screen out the better extraction part only through the anti-inflammatory experiment. At the same time, this experiment used two mouse pain models to study the analgesic effect of different extraction parts. The experimental results showed that the total polysaccharide part had a certain inhibitory effect on the mouse pain model caused by hot plate stimulation, and the total polysaccharide part and the ethyl acetate extraction part could prolong the latency of the pain response of mice caused by acetic acid and reduce the number of twisting within 15 minutes. It suggests that the total polysaccharide extraction part and the ethyl acetate extraction part have a certain analgesic effect.

[0149] 7.2 Effects of different extraction parts of Qingrexiaozhongzhitong ointment on gouty arthritis

[0150] 7.2.1, Effects of different extraction parts on gait of gout rat model: As shown in Table 8, after modeling, the gait assessment of rats in each group except the blank group increased to varying degrees. The gait of rats in the model group was the most serious 24 hours after modeling, and was relieved after 48 hours. The positive group, ethyl acetate extraction part group, and n-butanol extraction part group could alleviate the effect of sodium urate on rat gait at 24 hours (p < 0.05), and at 48 hours, the effect of sodium urate on rat gait could be significantly alleviated (p < 0.01). There was no significant difference between the total polysaccharide group and the model group.

[0151] Table 8: Gait assessment results of rats after modeling

[0152]

[0153] Note: Compared with the model control group: **p<0.01, *p<0.05.

[0154] 7.2.2 Effects of different extraction parts on inflammation in gout rat model: According to Table 9, Figure 6 It can be seen that after modeling, except for the blank control group, rats in other groups showed different degrees of redness, swelling and fever, among which the rats in the model group had the most obvious redness, swelling and fever, followed by the total polysaccharide group and the n-butanol extraction group, which showed no significant difference from the model group. The redness, swelling and fever symptoms of rats in the positive group were significantly relieved at 24h and 48h (p < 0.01); the redness, swelling and fever of rats in the ethyl acetate extraction group were alleviated at 24h (p < 0.05) and significantly relieved at 48h (p < 0.01).

[0155] Table 9: Inflammation rating results after rat modeling

[0156]

[0157] Note: Compared with the model control group: **p<0.01, *p<0.05.

[0158] 7.2.3 Effects of different extraction sites on the degree of foot swelling in gout rat models: According to Table 10 and Figure 7 It can be seen that the right hind ankle joint of the model group rats showed obvious swelling after modeling, and it was most obvious at 24h. The positive group, total polysaccharide group, ethyl acetate extraction group, and n-butanol extraction group all significantly inhibited the foot swelling of the rat model at 2, 4, 8, 24, and 48h (p < 0.01).

[0159] Table 10: Results of rat joint thickness measurements

[0160]

[0161] Note: Compared with the model control group: **p<0.01, *p<0.05.

[0162] Conclusion: This example uses a rat acute gout model induced by local injection of sodium urate, and uses gait assessment and inflammation rating to evaluate whether the rat modeling is successful, and the swelling degree of the right posterior ankle joint of the rats after modeling is regularly detected to preliminarily determine the effect of different extraction sites on anti-gouty arthritis. The results show that the gait assessment and inflammation rating of the model group and other drug-administered groups are higher than those of the blank control group, indicating that the modeling is successful. In the extract group, the gait assessment of the ethyl acetate extraction site group and the n-butanol extraction site group is significantly different from the model group, and the verification rating of the ethyl acetate extraction site group is significantly different from the model group, indicating that the extract has a clear anti-gouty arthritis effect, and the ethyl acetate extraction site is more obvious. In addition, the ankle swelling measurement results show that the three extraction sites all have a good effect on the swelling of the ankle joints of gout model rats, and the ethyl acetate extraction site group is better than the other two groups in inhibiting swelling at each time period, so it is inferred that the ethyl acetate extraction site is the dominant site for the treatment of gouty arthritis.

[0163] 7.3 Preliminary determination of the components of the effective parts of the original and reduced prescriptions of the Qingre Xiaozhong Zhitong Ointment

[0164] like Figure 8As shown in the figure, the six representative effective ingredients selected are present in the original prescription. Ferulic acid, as an effective ingredient of Cyperus rotundus, has a low content in it. The contents of emodin and chrysophanol in the original prescription are also low, which proves that these two ingredients can be removed when selecting simplified drugs. Further comparison of the ethyl acetate part shows that emodin is almost not found in the ethyl acetate part of the original prescription, the content of chrysophanol is low, and the content of ferulic acid is also low. Because Cyperus rotundus and rhubarb are removed in the reduced prescription, the three characteristic peaks 3, 5, and 6 do not appear in the spectrum, and gardenia glycoside, baicalin, and berberine hydrochloride can be detected. The preliminary comparison shows that the ethyl acetate part where the heat-clearing, swelling-removing, and analgesic ointment works contains gardenia glycoside, baicalin, berberine hydrochloride and other ingredients, which lays the foundation for further in-depth research on the heat-clearing, swelling-removing, and analgesic ointment.

[0165] 7.4. Effects of the effective parts of the original and reduced prescriptions of Qingrexiaozhongzhitong ointment on acute gouty arthritis

[0166] 7.4.1 Effect of Qingrexiaozhongzhitong Ointment on Gait Index of Mice

[0167] When MSU is injected into the ankle of the rat, the ankle joint of the rat will swell and become red, which will affect the movement of the rat. Different drug treatments will cause different phenomena. As shown in Table 11, for the blank group, normal saline was injected at the ankle. The inconvenience in movement at the beginning may be due to the pain caused by the needle hole during injection, but this pain will disappear over time and there is no significant difference from before. The model group was injected with MSU. After the modeling was formed, it was obvious that the ankle had redness, swelling and fever, and as time went on, this phenomenon became more and more obvious, reaching its peak at 24 hours. At this time, the rats moved slowly and had lameness, and this phenomenon continued for a long time. The movements of the rats in the positive drug group, the original prescription group, and the reduced prescription group were improved to varying degrees. Among them, the colchicine group was better, with mild slope feet and even some rats did not have slope feet. The original prescription group and the reduced prescription group, although slightly improved, still had slow movement and lameness due to the problem of drug dosage.

[0168] Table 11: Gait assessment results of rats after modeling

[0169]

[0170] Note: Compared with the model control group: ** p<0.01, * p<0.05.

[0171] 7.4.2 Effect on the swelling of rat paws

[0172] like Fig. 9As shown in the figure, there was no significant difference in the toes of rats in each group before modeling. Six hours after modeling, the affected toes of rats showed obvious redness and swelling. The toe volume of AGA model rats in each group was significantly higher than that in the blank group before treatment; after treatment, the swelling of the toes of rats in each group decreased to varying degrees at each time point, and the redness and swelling of the toes of each group were relieved to a certain extent, among which the positive drug group had the most significant effect. Comparing the effects of the original and reduced prescriptions of Qingrexiaozhongzhitong ointment on gouty arthritis in rats, the swelling of the forefoot of rats in the original prescription group was slightly reduced compared with the model group, but not as significant as the positive control group; the swelling of the forefoot of rats in the reduced prescription group was not significantly different from that in the original prescription group, although not as good as the positive drug group, but better than the model group. It proves that after the reduction of the prescription, there is no significant difference in effect with the original prescription, and it can play the role of treating acute gouty arthritis.

[0173] 7.4.3 Effects of Platycodon grandiflorum saponins on rat ankle tissue morphology

[0174] H&E staining was used to observe the changes in cell morphology among the groups. Fig.10 As shown, first of all, the analysis of the blank group shows that the tissue morphology and arrangement in this group are normal and regular, the cell morphology and cell membrane boundaries are clear, and the cells do not show infiltration. However, the cell infiltration in the model group is obvious, the tissue structure is disordered, the synovial epithelial tissue is shed, the cell morphology changes, and obvious arthritis pathological changes are shown. The two treatment groups of the positive drug group and the heat-clearing, swelling-clearing and analgesic ointment have improved to varying degrees compared with the model group. The cells in the positive drug group have become clear, the infiltration of inflammatory cells has been significantly reduced, and the boundaries between the cell membranes have gradually become obvious. For the original prescription and the reduced prescription, although not as good as the positive drug group, there are also improvements to varying degrees. This shows that the dose of the heat-clearing, swelling-clearing and analgesic ointment will have a certain effect on the relief effect of gouty arthritis.

[0175] 8. Conclusion

[0176] (I) Determination of the effective part of the heat-clearing, swelling-removing and analgesic ointment

[0177] ① Two mouse inflammation models were used to explore the anti-inflammatory effects of different extraction parts of a certain traditional Chinese medicine. The results showed that except for the total polysaccharide part group, which showed no significant effect, the ethyl acetate extraction part group, petroleum ether extraction part group, n-butanol extraction part group and aqueous phase extraction part group could significantly inhibit the swelling of the mouse ear caused by xylene; each drug-treated group could also significantly inhibit the swelling of the mouse foot caused by formaldehyde. The results of the anti-inflammatory experiment showed that each extraction part had a certain inhibitory activity on the inflammation model, so it is not possible to screen out the better extraction part only through the anti-inflammatory experiment.

[0178] ② Two mouse pain models were used to study the analgesic effects of different extraction parts. The experimental results showed that none of the experimental groups showed a significant inhibitory effect on the mouse pain model caused by hot plate stimulation. The total polysaccharide part and the ethyl acetate extraction part can prolong the latency of the pain response of mice induced by acetic acid and reduce the number of twisting within 15 minutes. This suggests that the total polysaccharide extraction part and the ethyl acetate extraction part have a certain analgesic effect.

[0179] ③The results of ankle joint swelling measurement showed that several extraction sites all had a good effect on anti-ankle joint swelling in gout model rats, and the ethyl acetate extraction site group had better inhibition of swelling than the other two groups at all time periods. Therefore, it is inferred that the ethyl acetate extraction site is the dominant site for the treatment of gouty arthritis.

[0180] (II) Reduction of prescription and determination of active ingredients in effective parts

[0181] The results of ingredient comparison showed that the six ingredients of gardenia glycoside, baicalin, berberine hydrochloride, ferulic acid, emodin and chrysophanol can be detected in the original recipe and ethyl acetate part of the Qingre Xiaozhong Zhitong Plaster, but the contents of ferulic acid, emodin and chrysophanol are relatively low, so the proposed reduction of cyperus rotundus, rhubarb and licorice is feasible. The remaining three ingredients can be detected in the ethyl acetate part of the reduced recipe, which can preliminarily prove that the effective part of the Qingre Xiaozhong Zhitong Plaster contains active ingredients such as gardenia glycoside, baicalin and berberine hydrochloride. These active ingredients can be used to prepare topical drugs for the treatment of acute gouty arthritis, such as plasters or gels.

[0182] (III) Treatment of gouty arthritis with the original and reduced ethyl acetate parts of the Qingrexiaozhongzhitong ointment

[0183] Through research, it was found that the heat-clearing, swelling-removing and analgesic ointment can effectively reduce the redness, swelling and inflammation of arthritis. The evaluation of the rat gait behavior index showed that it can improve the slope foot phenomenon after modeling. From the side, it can be shown that the heat-clearing, swelling-removing and analgesic ointment (original and reduced) can improve its pain. In addition, the change of ankle diameter in each time period was measured, and it was found that the original and reduced formulas can inhibit the swelling and redness of the ankle. At the same time, by observing the tissue sections of the ankle joints of rats, it can be found that the heat-clearing, swelling-removing and analgesic ointment (original and reduced formula) has a good anti-inflammatory effect, which can improve cell infiltration, make the disordered cells orderly, and make the boundaries between cells clear.

[0184] In summary, this embodiment intends to treat the heat-clearing, swelling-relieving and analgesic paste prescription Chinese medicine as a whole, adopts system solvent extraction method to extract and separate multiple chemical substance parts, and screens and determines the effective substance parts of the heat-clearing, swelling-relieving and analgesic paste for gouty arthritis. HPLC technology is used to perform preliminary separation and component identification of the effective parts, and the therapeutic effect on gouty arthritis after the prescription is reduced is studied. This embodiment preliminarily verifies its material basis by studying the effect of the active ingredients in the heat-clearing, swelling-relieving and analgesic paste on acute gouty arthritis, aims to explore the effect of Chinese medicine external application for the treatment of acute gouty arthritis, fill the gap in the research on the mechanism of action of the external treatment of acute gouty arthritis by Chinese medicine in China, and has great practical significance and clinical practicality.

[0185] The above are only preferred embodiments of the present invention and are not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A Chinese herbal medicine extract having the effects of clearing away heat, reducing swelling and relieving pain, characterized in that: Contains geniposide, baicalin and berberine hydrochloride.

2. A Chinese medicinal extract with heat-clearing, swelling-removing and analgesic effects according to claim 1, characterized in that: The Chinese medicine extract is prepared from a Chinese medicine composition comprising the following raw materials: phellodendron chinense, scutellaria baicalensis, gardenia jasmine and curcuma.

3. A Chinese medicinal extract with heat-clearing, swelling-removing and analgesic effects according to claim 2, characterized in that: In parts by weight, the Chinese medicine extract is prepared from a Chinese medicine composition comprising the following raw materials: 450-510 parts of Phellodendron chinense, 210-270 parts of Scutellaria baicalensis, 210-270 parts of Gardenia jasminoides, and 160-220 parts of Curcuma aromatica.

4. A Chinese medicinal extract having the effects of clearing away heat, reducing swelling and relieving pain according to claim 2 or 3, characterized in that: The Chinese medicine composition also includes rhubarb, cyperus rotundus and liquorice.

5. A Chinese medicinal extract with heat-clearing, swelling-removing and analgesic effects according to claim 4, characterized in that: In parts by weight, the Chinese medicine extract is prepared from a Chinese medicine composition comprising the following raw materials: 450-510 parts of Phellodendron chinense, 360-420 parts of Rhubarb, 210-270 parts of Scutellaria baicalensis, 210-270 parts of Gardenia jasminoides, 210-270 parts of Cyperus rotundus, 160-220 parts of Curcuma aromatica, and 160-220 parts of Licorice.

6. The method for preparing the Chinese medicinal extract having the effects of clearing away heat, reducing swelling and relieving pain as claimed in any one of claims 1 to 5, characterized in that: The following steps are involved: Take Phellodendron chinense, Scutellaria baicalensis, Gardenia jasminoides and Curcuma aromatica, and mix them evenly to obtain a Chinese medicine mixture; The Chinese medicine mixture is extracted by ethanol reflux extraction to obtain extract A; Concentrate extract A to obtain an extract; Adding an appropriate amount of water to disperse the extract to obtain a concentrated solution; Degreasing the concentrate with petroleum ether; Adjust the pH of the aqueous phase after petroleum ether extraction to 10-14, and then extract with chloroform several times; The pH of the aqueous phase after chloroform extraction is adjusted to 3-4, and then extracted with ethyl acetate. The extract is concentrated under reduced pressure, dried and weighed to obtain the traditional Chinese medicine extract.

7. The method for preparing the Chinese medicinal extract having the effects of clearing away heat, reducing swelling and relieving pain as claimed in any one of claims 1 to 5, characterized in that: The following steps are involved: Take Phellodendron chinense, Rhubarb, Scutellaria baicalensis, Gardenia jasminoides, Cyperus rotundus, Curcuma aromatica, and Licorice, and mix them evenly to obtain a Chinese medicine mixture; The Chinese medicine mixture is extracted by ethanol reflux extraction to obtain extract A; Concentrate extract A to obtain an extract; Adding an appropriate amount of water to disperse the extract to obtain a concentrated solution; Degreasing the concentrate with petroleum ether; Adjust the pH of the aqueous phase after petroleum ether extraction to 10-14, and then extract with chloroform several times; The pH of the aqueous phase after chloroform extraction is adjusted to 3-4, and then extracted with ethyl acetate. The extract is concentrated under reduced pressure, dried and weighed to obtain the traditional Chinese medicine extract.

8. Use of the Chinese medicinal extract with heat-clearing, swelling-removing and analgesic effects as claimed in any one of claims 1 to 5 in the preparation of a drug for treating acute gouty arthritis.

9. The use according to claim 8, wherein the medicine is an external preparation for skin application.

10. The use according to claim 9, wherein the skin external preparation is a plaster or a gel.

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