An agilating analgesic traditional Chinese medicine compound preparation based on eaglewood and a preparation method thereof

Abstract

This invention relates to the field of compound preparation technology, specifically to a traditional Chinese medicine compound preparation based on agarwood for promoting qi circulation and relieving pain, and its preparation method. The preparation comprises the following raw materials in parts by weight: 35-45 parts agarwood extract, 25-35 parts corydalis extract, 15-25 parts white peony root extract, 5-10 parts costus root, 6-10 parts cyperus rhizome, 8-12 parts licorice root, and 20-35 parts pharmaceutical excipients. In this invention, the agarwood extract exerts its qi-regulating and pain-relieving effects; the corydalis extract synergistically invigorates blood circulation and promotes qi circulation, enhancing the analgesic effect; and the white peony root extract nourishes blood, softens the liver, and relieves spasms and pain. The synergistic effect of these three materials effectively enhances the overall qi-regulating and pain-relieving efficacy of the formula, while simultaneously mitigating the drying and pungent properties of the pungent herbs, demonstrating a synergistic effect and balancing the medicinal properties.

Description

Technical Field

[0001] This invention relates to the field of compound preparation technology, specifically to a traditional Chinese medicine compound preparation based on agarwood for promoting qi circulation and relieving pain, and its preparation method. Background Technology

[0002] Traditional Chinese medicine compound preparations for promoting qi circulation and relieving pain are based on the TCM theory of promoting qi circulation and blood circulation, and the principle that "where there is free flow, there is no pain". They are made from a combination of Chinese herbs with the effects of promoting qi circulation, blood circulation and relieving pain, and are processed into Chinese medicine products (common dosage forms include tablets, capsules, granules, oral liquids, etc.). The core of these preparations is to regulate the body's qi mechanism and dredge the meridians to relieve pain caused by qi stagnation or blood stasis.

[0003] In existing technologies, there is an overemphasis on pungent and aromatic properties that promote qi circulation, while lacking synergistic components that nourish blood and soothe the liver. This can easily lead to an imbalance of the medicinal properties, which can be dry and strong. Conventional preparation processes often use single extraction methods, which cannot efficiently enrich the active ingredients of different medicinal materials. This results in insufficient extraction of key active substances, unstable efficacy of the preparation, and difficulty in fully realizing its potential.

[0004] Based on this, the present invention provides a traditional Chinese medicine compound preparation for promoting qi circulation and relieving pain based on agarwood and its preparation method. Summary of the Invention

[0005] The purpose of this invention is to provide a traditional Chinese medicine compound preparation based on agarwood for promoting qi circulation and relieving pain, and its preparation method. The compound preparation prepared by this invention has a high level of acetic acid writhing inhibition rate, foot swelling inhibition rate, and hot plate pain threshold improvement rate, indicating that it has good analgesic and anti-inflammatory effects.

[0006] To achieve the above objectives, the present invention provides the following technical solution: a traditional Chinese medicine compound preparation based on agarwood for promoting qi circulation and relieving pain, and its preparation method, comprising the following raw materials in parts by weight: 35-45 parts agarwood extract, 25-35 parts corydalis extract, 15-25 parts white peony extract, 5-10 parts costus root, 6-10 parts cyperus rhizome, 8-12 parts licorice root, and 20-35 parts pharmaceutical excipients; The agarwood extract is obtained by supercritical CO2 extraction of agarwood. The Corydalis extract is obtained by Corydalis through complex enzymatic hydrolysis and ultrasonic-assisted extraction. The white peony extract was obtained by reflux extraction of white peony with ethanol.

[0007] Preferably, the preparation steps of the agarwood extract are as follows: Crushed and dried agarwood that has passed through a 40-60 mesh sieve is loaded into a supercritical CO2 extraction device, and the extraction pressure is set to 25-35 MPa and the extraction temperature to 45-55℃; then, an entrainer is injected and mixed with supercritical CO2 fluid, and the mixture is circulated for 2-3 hours to fully dissolve and carry out the volatile oils and resinous active ingredients in the agarwood; subsequently, the fluid containing the extract is introduced into a separation vessel and analyzed under conditions of 5-7 MPa and 55-60℃, and finally the precipitated oleoresin complex is collected to obtain the agarwood extract.

[0008] Preferably, the solid-liquid ratio of the agarwood to the entrainer is 1:(0.1-0.2), and the entrainer is ethanol; the circulation flow rate of the supercritical CO2 extraction is 20-30 L / h.

[0009] Preferably, the preparation steps of the Corydalis extract are as follows: Dry Corydalis, pulverized and passed through a 30-50 mesh sieve, is placed in an ultrasonic extractor, and a buffer solution is added to adjust the pH of the system to 4.5-5.5; a compound enzyme composed of compound cellulase and pectinase is added, and the mixture is stirred thoroughly to ensure uniform mixing of the compound enzyme and the powder; the parameters of the ultrasonic extractor are set and started, and enzymatic hydrolysis-ultrasonic synergistic extraction is performed for 40-60 minutes; after extraction, the temperature is raised to above 90°C and maintained for 10-15 minutes, and then the material is added to a centrifuge for solid-liquid separation and the filtrate is collected; the filtrate is concentrated to obtain a thick extract, and the thick extract is spray-dried and pulverized through an 80 mesh sieve to obtain an alkaloid-enriched Corydalis extract.

[0010] Preferably, the buffer solution is a 0.1 mol / L citrate-disodium hydrogen phosphate solution, and the amount of buffer solution added is 8-12 times the mass of Corydalis rhizome; the complex enzyme is composed of complex cellulase and pectinase in a mass ratio of 1:(1-2), and the total amount of complex enzyme added is 1-2% of the mass of Corydalis rhizome.

[0011] Preferably, the preparation steps of the white peony extract are as follows: pulverized and dried white peony that has passed through a 20-40 mesh sieve is placed into a reflux extraction tank, ethanol is added as the extraction solvent, the heating temperature is set to 80-90℃ and the condensation temperature to ≤10℃, and the extraction is performed 2-3 times, with each extraction lasting 1-2 hours; the extracts obtained from multiple reflux extractions are combined and centrifuged to obtain a clear extract; the clear extract is concentrated under reduced pressure to obtain a thick extract, and the thick extract is dried to obtain the white peony extract.

[0012] Preferably, the volume ratio of the ethanol solution is 70-80%, and the mass of the ethanol solution added is 8-10 times the mass of the white peony root.

[0013] Preferably, the pharmaceutical excipients include microcrystalline cellulose as a filler, sodium carboxymethyl starch as a disintegrant, and magnesium stearate as a lubricant, wherein the mass ratio of microcrystalline cellulose, sodium carboxymethyl starch, and magnesium stearate is (15-25):(3-5):(0.5-1).

[0014] Preferably, the costus root, cyperus rhizome, and licorice root are cleaned, dried, and then pulverized into the finest powder and passed through an 80-100 mesh sieve for later use; the pharmaceutical excipients need to be sieved separately before use, wherein microcrystalline cellulose and sodium carboxymethyl starch pass through an 80-100 mesh sieve, and magnesium stearate passes through a 60-80 mesh sieve.

[0015] A method for preparing a traditional Chinese medicine compound preparation based on agarwood for promoting qi circulation and relieving pain includes the following steps: S1: Agarwood extract, Corydalis extract, and Paeonia lactiflora extract are mixed evenly with pretreated Costus root, Cyperus rotundus, and Glycyrrhiza uralensis powder using an equal-incrementing method to obtain the active ingredients. S2: Mix the active pharmaceutical ingredients with the sieved microcrystalline cellulose and sodium carboxymethyl starch evenly to obtain the total mixture; S3: Add an ethanol solution with a volume concentration of 70-80% to the total mixture as a wetting agent to form a soft material, granulate it through a 14-20 mesh sieve, dry it at 60-70℃ until the moisture content is ≤5%, granulate it, and obtain dry granules. S4: Add sieved magnesium stearate to dry granules, mix evenly, and then fill into capsules, compress into tablets or dispense into granules to obtain a traditional Chinese medicine compound preparation.

[0016] Compared with the prior art, the beneficial effects of the present invention are: 1. This invention prepares agarwood extract using supercritical CO2 extraction technology, which can efficiently and completely enrich the volatile oils and resinous core medicinal substances in agarwood, thereby enhancing its qi-regulating and pain-relieving effects. The extract works together with Corydalis extract to achieve the effects of regulating qi and promoting blood circulation, effectively improving the analgesic efficacy by targeting the core pathogenesis of qi stagnation and blood stasis. At the same time, its pungent and warm properties are regulated by Paeonia lactiflora extract, avoiding the problems of qi depletion and fluid damage that may occur when used alone or in excess.

[0017] 2. The Corydalis extract prepared by the present invention through compound enzymatic hydrolysis-ultrasound-assisted extraction technology can significantly improve the dissolution rate and enrichment of total alkaloids of Corydalis, making its effects of promoting blood circulation, regulating qi, and relieving pain more prominent. The extract, in synergy with Aquilaria extract, can significantly enhance the analgesic effect of the whole formula. In addition, its blood-activating effect complements the blood-nourishing effect of Paeonia lactiflora extract, further optimizing the therapeutic effect.

[0018] 3. This invention prepares white peony extract using ethanol reflux extraction technology, which fully preserves the core components such as total peony glycosides, which nourish blood, soothe the liver, relieve pain, and have other effects. This extract not only directly exerts its analgesic effect, but more importantly, its blood-nourishing and liver-soothing effects can effectively counteract the warming and drying properties of pungent herbs such as agarwood, corydalis, and costus root, thus improving the shortcomings of traditional qi-regulating formulas that are too hot and dry, and enhancing the safety of medication. Detailed Implementation

[0019] The technical solutions of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0020] To enable those skilled in the art to better understand the present application, the technical solutions in the embodiments of the present application are described clearly and completely.

[0021] Example 1: A traditional Chinese medicine compound preparation based on agarwood for promoting qi circulation and relieving pain, comprising the following raw materials in parts by weight: 35 parts agarwood extract, 25 parts corydalis extract, 15 parts white peony extract, 5 parts costus root, 6 parts cyperus rhizome, 8 parts licorice root, and 20 parts pharmaceutical excipients. Agarwood extract is obtained by supercritical CO2 extraction of agarwood. Corydalis extract is obtained by compound enzymatic hydrolysis and ultrasonic-assisted extraction of Corydalis. White peony extract is obtained by reflux extraction of white peony with ethanol.

[0022] The preparation steps of agarwood extract are as follows: dried agarwood that has been crushed and passed through a 40-mesh sieve is loaded into a supercritical CO2 extraction device, and the extraction pressure is set to 25 MPa and the extraction temperature to 45℃; then an entrainer is injected and mixed with supercritical CO2 fluid, and the mixture is circulated for 2 hours to fully dissolve and carry out the volatile oil and resinous active ingredients in the agarwood; then the fluid containing the extract is introduced into a separation vessel and analyzed under the conditions of 5 MPa and 55℃. A brownish-yellow oleoresin complex with a strong agarwood aroma is collected from the bottom outlet of the separation vessel, thus obtaining the agarwood extract.

[0023] The solid-liquid ratio of agarwood to entrainer was 1:0.1, and the entrainer was ethanol; the circulation flow rate of supercritical CO2 extraction was 20 L / h.

[0024] The preparation steps of Corydalis extract are as follows: Dry Corydalis, pulverized and passed through a 30-mesh sieve, is placed in an ultrasonic extractor. A buffer solution is added, and the pH of the system is adjusted to 4.5. A complex enzyme composed of compound cellulase and pectinase is added, and the mixture is stirred thoroughly to ensure uniform mixing of the enzyme and the powder. The ultrasonic extractor is set to an ultrasonic power of 300W, an ultrasonic frequency of 40kHz, and a processing temperature of 45℃. Enzymatic hydrolysis-ultrasonic synergistic extraction is initiated for 40 minutes. After extraction, the temperature is raised to above 90℃ and maintained for 10 minutes to completely inactivate the complex enzyme. The resulting filtrate is transferred to a vacuum concentrator and concentrated to a thick extract with a relative density of 1.10 under conditions of 60℃ and a vacuum of -0.05MPa. The thick extract is spray-dried with an inlet air temperature of 160℃ and an outlet air temperature of 80℃. The dried material is pulverized and passed through an 80-mesh sieve to obtain Corydalis extract enriched with alkaloids.

[0025] The buffer solution was a 0.1 mol / L citrate-disodium hydrogen phosphate solution, and the amount of buffer solution added was 8 times the mass of Corydalis rhizome. The complex enzyme was prepared by mixing complex cellulase and pectinase in a mass ratio of 1:1, and the total amount of complex enzyme added was 1% of the mass of Corydalis rhizome.

[0026] The preparation steps of white peony extract are as follows: Pulverized and dried white peony root that has passed through a 20-mesh sieve is placed into a reflux extraction tank, ethanol is added as the extraction solvent, the heating temperature is set to 80℃ and the condensation temperature to ≤10℃, and extraction is performed twice, each time for 1 hour; the combined clarified extract is pumped into a vacuum concentrator, the vacuum degree is set to -0.06MPa and the water bath temperature is set to 60℃, and the extract is concentrated to a thick paste with a relative density of 1.15; the thick paste is transferred to a peristaltic pump for spray drying, the centrifugal spray dryer is turned on, the inlet air temperature is set to 160℃, the outlet air temperature to 80℃, the peristaltic pump feed rate to 20mL / min, and the atomizer speed to 8000rpm; after drying, white peony extract is obtained.

[0027] The volume ratio of the ethanol solution is 70%, and the mass of the ethanol solution added is 8 times the mass of the white peony root.

[0028] The pharmaceutical excipients include microcrystalline cellulose as a filler, sodium carboxymethyl starch as a disintegrant, and magnesium stearate as a lubricant, wherein the mass ratio of microcrystalline cellulose, sodium carboxymethyl starch, and magnesium stearate is 15:3:0.5.

[0029] After being cleaned, dried, and ground into the finest powder, the costus root, cyperus rhizome, and licorice root are sieved through an 80-mesh sieve for later use. The pharmaceutical excipients must be sieved separately before use, with microcrystalline cellulose and sodium carboxymethyl starch sieved through an 80-mesh sieve and magnesium stearate sieved through a 60-mesh sieve.

[0030] A method for preparing a traditional Chinese medicine compound preparation based on agarwood for promoting qi circulation and relieving pain includes the following steps: S1: Agarwood extract, Corydalis extract, and Paeonia lactiflora extract are mixed evenly with pretreated Costus root, Cyperus rotundus, and Glycyrrhiza uralensis powder using an equal-incrementing method to obtain the active ingredients. S2: Mix the active pharmaceutical ingredients with the sieved microcrystalline cellulose and sodium carboxymethyl starch evenly to obtain the total mixture; S3: Add a 70% volume concentration ethanol solution to the total mixture as a wetting agent to form a soft material, granulate it through a 14-mesh sieve, dry it at 60℃ until the moisture content is ≤5%, granulate it, and obtain dry granules. S4: Add sieved magnesium stearate to dry granules, mix evenly, and then fill into capsules, compress into tablets or dispense into granules to obtain a traditional Chinese medicine compound preparation.

[0031] Example 2: A traditional Chinese medicine compound preparation based on agarwood for promoting qi circulation and relieving pain, comprising the following raw materials in parts by weight: 40 parts agarwood extract, 30 parts corydalis extract, 20 parts white peony extract, 7.5 parts costus root, 8 parts cyperus rhizome, 10 parts licorice root, and 27.5 parts pharmaceutical excipients. Agarwood extract is obtained by supercritical CO2 extraction of agarwood. Corydalis extract is obtained by compound enzymatic hydrolysis and ultrasonic-assisted extraction of Corydalis. White peony extract is obtained by reflux extraction of white peony with ethanol.

[0032] The preparation steps of agarwood extract are as follows: dried agarwood that has been crushed and passed through a 50-mesh sieve is loaded into a supercritical CO2 extraction device, and the extraction pressure is set to 30 MPa and the extraction temperature to 50℃; then an entrainer is injected and mixed with supercritical CO2 fluid, and the mixture is circulated for 2.5 hours to fully dissolve and carry out the volatile oil and resinous active ingredients in the agarwood; then the fluid containing the extract is introduced into a separation vessel and analyzed under the conditions of 6 MPa and 57℃. A brownish-yellow oleoresin complex with a strong agarwood aroma is collected from the bottom outlet of the separation vessel, thus obtaining the agarwood extract.

[0033] The solid-liquid ratio of agarwood to entrainer was 1:0.15, and the entrainer was ethanol; the circulation flow rate of supercritical CO2 extraction was 25 L / h.

[0034] The preparation steps of Corydalis extract are as follows: Dry Corydalis, pulverized and passed through a 40-mesh sieve, is placed in an ultrasonic extractor. A buffer solution is added, and the pH of the system is adjusted to 5.0. A complex enzyme composed of compound cellulase and pectinase is added, and the mixture is stirred thoroughly to ensure uniform mixing of the enzyme and the powder. The ultrasonic extractor is set to an ultrasonic power of 400W, an ultrasonic frequency of 40kHz, and a processing temperature of 50℃. Enzymatic hydrolysis-ultrasonic synergistic extraction is initiated for 50 minutes. After extraction, the temperature is raised to above 90℃ and maintained for 12 minutes to completely inactivate the complex enzyme. The resulting filtrate is transferred to a vacuum concentrator and concentrated to a thick extract with a relative density of 1.12 under conditions of 62℃ and a vacuum of -0.065MPa. The thick extract is spray-dried with an inlet air temperature of 170℃ and an outlet air temperature of 85℃. The dried material is pulverized and passed through an 80-mesh sieve to obtain Corydalis extract enriched with alkaloids.

[0035] The buffer solution was a 0.1 mol / L citrate-disodium hydrogen phosphate solution, and the amount of buffer solution added was 10 times the mass of Corydalis rhizome. The complex enzyme was prepared by mixing complex cellulase and pectinase at a mass ratio of 1:1.5, and the total amount of complex enzyme added was 1.5% of the mass of Corydalis rhizome.

[0036] The preparation steps of white peony extract are as follows: Pulverized and dried white peony root that has passed through a 30-mesh sieve is placed into a reflux extraction tank, ethanol is added as the extraction solvent, the heating temperature is set to 85℃ and the condensation temperature to ≤10℃, and extraction is performed twice, each extraction lasting 1.5 hours; the combined clarified extract is pumped into a vacuum concentrator, the vacuum degree is set to -0.07MPa and the water bath temperature to 62℃, and concentrated to a thick extract with a relative density of 1.17; the thick extract is transferred to a peristaltic pump for spray drying, the centrifugal spray dryer is turned on, the inlet air temperature is set to 170℃, the outlet air temperature to 85℃, the peristaltic pump feed rate to 30mL / min, and the atomizer speed to 11500rpm; after drying, white peony extract is obtained.

[0037] The volume ratio of the ethanol solution is 75%, and the mass of the ethanol solution added is 9 times the mass of the white peony root.

[0038] The pharmaceutical excipients include microcrystalline cellulose as a filler, sodium carboxymethyl starch as a disintegrant, and magnesium stearate as a lubricant, wherein the mass ratio of microcrystalline cellulose, sodium carboxymethyl starch, and magnesium stearate is 20:4:0.75.

[0039] After being cleaned, dried, and ground into the finest powder, the costus root, cyperus rhizome, and licorice root are sieved through a 90-mesh sieve and set aside. The pharmaceutical excipients must be sieved separately before use, with microcrystalline cellulose and sodium carboxymethyl starch sieved through a 90-mesh sieve and magnesium stearate sieved through a 70-mesh sieve.

[0040] A method for preparing a traditional Chinese medicine compound preparation based on agarwood for promoting qi circulation and relieving pain includes the following steps: S1: Agarwood extract, Corydalis extract, and Paeonia lactiflora extract are mixed evenly with pretreated Costus root, Cyperus rotundus, and Glycyrrhiza uralensis powder using an equal-incrementing method to obtain the active ingredients. S2: Mix the active pharmaceutical ingredients with the sieved microcrystalline cellulose and sodium carboxymethyl starch evenly to obtain the total mixture; S3: Add a 75% ethanol solution as a wetting agent to the total mixture to form a soft material, granulate it through a 17-mesh sieve, dry it at 65°C until the moisture content is ≤5%, granulate it, and obtain dry granules. S4: Add sieved magnesium stearate to dry granules, mix evenly, and then fill into capsules, compress into tablets or dispense into granules to obtain a traditional Chinese medicine compound preparation.

[0041] Example 3: A traditional Chinese medicine compound preparation based on agarwood for promoting qi circulation and relieving pain, comprising the following raw materials in parts by weight: 45 parts agarwood extract, 35 parts corydalis extract, 25 parts white peony extract, 10 parts costus root, 10 parts cyperus rhizome, 12 parts licorice root, and 35 parts pharmaceutical excipients. Agarwood extract is obtained by supercritical CO2 extraction of agarwood. Corydalis extract is obtained by compound enzymatic hydrolysis and ultrasonic-assisted extraction of Corydalis. White peony extract is obtained by reflux extraction of white peony with ethanol.

[0042] The preparation steps of agarwood extract are as follows: dried agarwood that has been crushed and passed through a 60-mesh sieve is loaded into a supercritical CO2 extraction device, and the extraction pressure is set to 35 MPa and the extraction temperature to 55℃; then an entrainer is injected and mixed with supercritical CO2 fluid, and the mixture is circulated for 3 hours to fully dissolve and carry out the volatile oil and resinous active ingredients in the agarwood; then the fluid containing the extract is introduced into a separation vessel and analyzed under the conditions of 7 MPa and 60℃. A brownish-yellow oleoresin complex with a strong agarwood aroma is collected from the bottom outlet of the separation vessel, thus obtaining the agarwood extract.

[0043] The solid-liquid ratio of agarwood to entrainer was 1:0.2, and the entrainer was ethanol; the circulation flow rate of supercritical CO2 extraction was 30 L / h.

[0044] The preparation steps of Corydalis extract are as follows: Dry Corydalis, pulverized and passed through a 50-mesh sieve, is placed in an ultrasonic extractor. A buffer solution is added, and the pH of the system is adjusted to 5.5. A complex enzyme composed of compound cellulase and pectinase is added, and the mixture is stirred thoroughly to ensure uniform mixing of the enzyme and the powder. The ultrasonic extractor is set to an ultrasonic power of 500W, an ultrasonic frequency of 40kHz, and a processing temperature of 55℃. Enzymatic hydrolysis-ultrasonic synergistic extraction is initiated for 60 minutes. After extraction, the temperature is raised to above 90℃ and maintained for 15 minutes to completely inactivate the complex enzyme. The resulting filtrate is transferred to a vacuum concentrator and concentrated to a thick extract with a relative density of 1.15 under conditions of 65℃ and a vacuum of -0.08MPa. The thick extract is spray-dried with an inlet air temperature of 180℃ and an outlet air temperature of 90℃. The dried material is pulverized and passed through an 80-mesh sieve to obtain Corydalis extract enriched with alkaloids.

[0045] The buffer solution was a 0.1 mol / L citrate-disodium hydrogen phosphate solution, and the amount of buffer solution added was 12 times the mass of Corydalis rhizome. The complex enzyme was prepared by mixing complex cellulase and pectinase at a mass ratio of 1:2, and the total amount of complex enzyme added was 2% of the mass of Corydalis rhizome.

[0046] The preparation steps of white peony extract are as follows: Pulverized and dried white peony root that has passed through a 40-mesh sieve is placed into a reflux extraction tank, ethanol is added as the extraction solvent, the heating temperature is set to 90℃ and the condensation temperature to ≤10℃, and extraction is performed three times, each time for 2 hours; the combined clarified extract is pumped into a vacuum concentrator, the vacuum degree is set to -0.08MPa and the water bath temperature is set to 65℃, and the extract is concentrated to a thick paste with a relative density of 1.20; the thick paste is transferred to a peristaltic pump for spray drying, the centrifugal spray dryer is turned on, the inlet air temperature is set to 180℃, the outlet air temperature to 90℃, the peristaltic pump feed rate to 40mL / min, and the atomizer speed to 15000rpm; after drying, white peony extract is obtained.

[0047] The volume ratio of the ethanol solution is 80%, and the mass of the ethanol solution added is 10 times the mass of the white peony root.

[0048] Pharmaceutical excipients include filler microcrystalline cellulose, disintegrant sodium carboxymethyl starch and lubricant magnesium stearate, wherein the mass ratio of microcrystalline cellulose, sodium carboxymethyl starch and magnesium stearate is 25:5:1.

[0049] Costus root, Cyperus rhizome, and licorice root are cleaned, dried, and then pulverized into the finest powder, passing through a 100-mesh sieve for later use. Pharmaceutical excipients need to be sieved separately before use, with microcrystalline cellulose and sodium carboxymethyl starch passing through a 100-mesh sieve, and magnesium stearate passing through an 80-mesh sieve.

[0050] A method for preparing a traditional Chinese medicine compound preparation based on agarwood for promoting qi circulation and relieving pain includes the following steps: S1: Agarwood extract, Corydalis extract, and Paeonia lactiflora extract are mixed evenly with pretreated Costus root, Cyperus rotundus, and Glycyrrhiza uralensis powder using an equal-incrementing method to obtain the active ingredients. S2: Mix the active pharmaceutical ingredients with the sieved microcrystalline cellulose and sodium carboxymethyl starch evenly to obtain the total mixture; S3: Add an 80% volume concentration ethanol solution to the total mixture as a wetting agent to form a soft material, granulate it through a 20-mesh sieve, dry it at 70℃ until the moisture content is ≤5%, granulate it, and obtain dry granules. S4: Add sieved magnesium stearate to dry granules, mix evenly, and then fill into capsules, compress into tablets or dispense into granules to obtain a traditional Chinese medicine compound preparation.

[0051] Comparative Example 1: The difference between this comparative example and Example 1 is that this comparative example uses commercially available untreated agarwood.

[0052] Comparative Example 2 differs from Example 1 in that it uses commercially available unprocessed Corydalis rhizome.

[0053] Comparative Example 3 differs from Example 1 in that it uses commercially available untreated white peony root.

[0054] Performance testing: Performance tests were conducted on the products prepared in Examples 1, 2, 3, Comparative Examples 1, 2, and 3. Acetic acid writhing inhibition rate (analgesic effect) test: Mice were randomly divided into groups and given different preparations by gavage. Then, dilute acetic acid solution was injected intraperitoneally to induce pain response. The number of writhing episodes of each group of mice was observed and recorded within a specific time period. The analgesic inhibition rate was calculated by comparing with the control group, thereby objectively quantifying the analgesic effect of the preparations. Test basis: "Experimental Methodology of Traditional Chinese Medicine Pharmacology". Foot swelling inhibition rate (anti-inflammatory effect) test: Acute inflammation was induced by subcutaneous injection of carrageenan into the hind paw of rats. The change in paw volume before and after inflammation was measured using a foot volume analyzer. Foot swelling was used to quantify the degree of inflammation. The swelling inhibition rate was calculated by comparing with the model control group, thereby objectively verifying the anti-inflammatory efficacy of the preparation. Test basis: "Experimental Methodology of Traditional Chinese Medicine Pharmacology". Hot plate test for pain threshold elevation (analgesic effect): By placing pre-selected qualified female mice on a constant high-temperature plate, the latency period for pain response such as licking the hind paw or jumping was measured as the pain threshold. The changes in pain threshold before and after administration were compared and the pain threshold elevation rate was calculated, thereby objectively quantifying the analgesic effect of the preparation through the central mechanism. The test was conducted in accordance with the "Experimental Methodology of Traditional Chinese Medicine Pharmacology".

[0055] The obtained test data are recorded in Table 1 below: By comparing and analyzing the relevant data in Table 1, it can be seen that the compound preparation prepared by the present invention using an agarwood-based traditional Chinese medicine compound for promoting qi circulation and relieving pain, and its preparation method, exhibits high levels of acetic acid-induced writhing inhibition rate, foot swelling inhibition rate, and hot plate pain threshold enhancement rate, indicating its superior analgesic and anti-inflammatory effects. This suggests that the agarwood-based traditional Chinese medicine compound for promoting qi circulation and relieving pain, and its preparation method provided by the present invention, has a broader market prospect and is more suitable for widespread application.

[0056] In the description of this specification, references to terms such as "an embodiment," "example," and "specific example" indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the invention. In this specification, illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0057] The preferred embodiments of the present invention disclosed above are merely illustrative of the invention. These preferred embodiments do not exhaustively describe all details, nor do they limit the invention to the specific implementations described. Clearly, many modifications and variations can be made based on the content of this specification. This specification selects and specifically describes these embodiments to better explain the principles and practical applications of the invention, thereby enabling those skilled in the art to better understand and utilize the invention. The invention is limited only by the claims and their full scope and equivalents.

Claims

1. An eaglewood-based qi-regulating analgesic traditional Chinese medicine compound preparation, characterized in that, The ingredients include the following parts by weight: 35-45 parts agarwood extract, 25-35 parts corydalis extract, 15-25 parts white peony extract, 5-10 parts costus root, 6-10 parts cyperus rhizome, 8-12 parts licorice root, and 20-35 parts pharmaceutical excipients. The agarwood extract is obtained by supercritical CO2 extraction of agarwood. The Corydalis extract is obtained by Corydalis through complex enzymatic hydrolysis and ultrasonic-assisted extraction. The white peony extract was obtained by reflux extraction of white peony with ethanol.

2. The eaglewood-based qi-moving analgesic traditional Chinese medicine compound preparation according to claim 1, characterized in that, The preparation steps of the agarwood extract are as follows: Pulverized and dried agarwood that has passed through a 40-60 mesh sieve is loaded into a supercritical CO2 extraction device, and the extraction pressure is set to 25-35 MPa and the extraction temperature to 45-55℃; then, an entrainer is injected and mixed with supercritical CO2 fluid, and the mixture is circulated for 2-3 hours to fully dissolve and carry out the volatile oils and resinous active ingredients in the agarwood; subsequently, the fluid containing the extract is introduced into a separation vessel and analyzed under conditions of 5-7 MPa and 55-60℃, and finally the precipitated oleoresin complex is collected to obtain the agarwood extract.

3. The eaglewood-based qi-regulating analgesic traditional Chinese medicine compound preparation according to claim 2, characterized in that: The solid-liquid ratio of agarwood to entrainer is 1:(0.1-0.2), and the entrainer is ethanol; the circulation flow rate of the supercritical CO2 extraction is 20-30 L / h.

4. The eaglewood-based qi-moving analgesic traditional Chinese medicine compound preparation according to claim 1, characterized in that, The preparation steps of the Corydalis extract are as follows: Dry Corydalis, pulverized and passed through a 30-50 mesh sieve, is placed in an ultrasonic extractor. A buffer solution is added, and the pH of the system is adjusted to 4.5-5.

5. A compound enzyme composed of a compound cellulase and a pectinase is added, and the mixture is stirred thoroughly to ensure uniform mixing of the compound enzyme and the powder. The parameters of the ultrasonic extractor are set and started, and enzymatic hydrolysis-ultrasonic synergistic extraction is performed for 40-60 minutes. After extraction, the temperature is raised to above 90℃ and maintained for 10-15 minutes. The material is then added to a centrifuge for solid-liquid separation, and the filtrate is collected. The filtrate is concentrated to obtain a thick extract. The thick extract is spray-dried and then pulverized through an 80-mesh sieve to obtain an alkaloid-enriched Corydalis extract.

5. The eaglewood-based qi-regulating analgesic traditional Chinese medicine compound preparation according to claim 4, characterized in that: The buffer solution is a 0.1 mol / L citrate-disodium hydrogen phosphate solution, and the amount of buffer solution added is 8-12 times the mass of Corydalis rhizome; the complex enzyme is composed of complex cellulase and pectinase in a mass ratio of 1:(1-2), and the total amount of complex enzyme added is 1-2% of the mass of Corydalis rhizome.

6. The eaglewood-based qi-moving analgesic traditional Chinese medicine compound preparation according to claim 1, characterized in that, The preparation steps of the white peony extract are as follows: Pulverized and dried white peony root that has passed through a 20-40 mesh sieve is placed into a reflux extraction tank, ethanol is added as the extraction solvent, the heating temperature is set to 80-90℃ and the condensation temperature to ≤10℃, and the extraction is performed 2-3 times, with each extraction lasting 1-2 hours; the extracts obtained from multiple reflux extractions are combined and centrifuged to obtain a clear extract; the clear extract is concentrated under reduced pressure to obtain a thick extract, and the thick extract is dried to obtain the white peony extract.

7. The eaglewood-based qi-moving analgesic traditional Chinese medicine compound preparation according to claim 1, characterized in that: The volume ratio of the ethanol solution is 70-80%, and the mass of the ethanol solution added is 8-10 times the mass of the white peony root.

8. The eaglewood-based qi-moving analgesic traditional Chinese medicine compound preparation according to claim 1, characterized in that: The pharmaceutical excipients include microcrystalline cellulose as a filler, sodium carboxymethyl starch as a disintegrant, and magnesium stearate as a lubricant, wherein the mass ratio of microcrystalline cellulose, sodium carboxymethyl starch, and magnesium stearate is (15-25):(3-5):(0.5-1).

9. The eaglewood-based qi-moving analgesic traditional Chinese medicine compound preparation according to claim 1, characterized in that: The costus root, cyperus rhizome, and licorice root are cleaned, dried, and then pulverized into the finest powder, passing through an 80-100 mesh sieve for later use. The pharmaceutical excipients need to be sieved separately before use, with microcrystalline cellulose and sodium carboxymethyl starch passing through an 80-100 mesh sieve, and magnesium stearate passing through a 60-80 mesh sieve.

10. A preparation method of the Chinese medicine compound preparation for promoting blood circulation and relieving pain based on eaglewood, according to any one of claims 1-9, characterized in that, Includes the following steps: S1: Agarwood extract, Corydalis extract, and Paeonia lactiflora extract are mixed evenly with pretreated Costus root, Cyperus rotundus, and Glycyrrhiza uralensis powder using an equal-incrementing method to obtain the active ingredients. S2: Mix the active pharmaceutical ingredients with the sieved microcrystalline cellulose and sodium carboxymethyl starch evenly to obtain the total mixture; S3: Add an ethanol solution with a volume concentration of 70-80% to the total mixture as a wetting agent to form a soft material, granulate it through a 14-20 mesh sieve, dry it at 60-70℃ until the moisture content is ≤5%, granulate it, and obtain dry granules. S4: Add sieved magnesium stearate to dry granules, mix evenly, and then fill into capsules, compress into tablets or dispense into granules to obtain a traditional Chinese medicine compound preparation.

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