Herbal ointment formula and preparation process thereof

Abstract

The invention discloses a herbal ointment formula and a preparation process thereof, and belongs to the field of pharmaceutical preparations. The herbal cream formula comprises the following components in parts by weight: 10-30 parts of astragalus membranaceus, 10-20 parts of prepared rehmannia root, 5-15 parts of ginseng, 3-15 parts of codonopsis pilosula, 5-15 parts of bighead atractylodes rhizome, 10-20 parts of Chinese yam, 5-15 parts of angelica sinensis, 10-30 parts of donkey-hide gelatin, 3-15 parts of radix paeoniae alba, 10-20 parts of hawthorn, 2-10 parts of rhizoma pinellinae praeparata, 5-15 parts of herba lycopi, 5-15 parts of schisandra chinensis, 5-10 parts of dendrobe, 3-8 parts of bamboo leaves, 5-15 parts of elsholtzia, 3-10 parts of cassia twig, 10-20 parts of red dates, 2-10 parts of liquorice and auxiliary materials. The herbal ointment has the effects of tonifying qi and blood, harmonizing spleen and stomach, consolidating basis, reducing lipid and protecting liver, has the overall conditioning mechanisms of qi and blood tonifying, spleen and stomach transportation and transformation, liver and kidney harmonizing and the like, and has the effect of remarkably reducing fatty liver; in addition, the herbal paste formula disclosed by the invention has remarkably improved stability and good flavor.

Description

TECHNICAL FIELD

[0001] The present application belongs to the field of pharmaceutical preparations, and particularly relates to a herbal paste and a preparation process thereof. BACKGROUND

[0002] As a traditional tonifying and conditioning preparation, the herbal paste is widely used in conditioning of chronic deficiency diseases such as deficiency of qi and blood, weakness of the spleen and stomach, and low immunity, and improvement of sub-health state. In the prior art, tonifying herbal pastes are mostly centered on the effects of tonifying qi and blood, invigorating the spleen and nourishing the kidney, and common ingredients include Chinese medicinal materials such as Astragalus, Codonopsis, Angelica and Radix Rehmanniae Preparata, which play a role through oral administration and are mainly targeted at the middle-aged and elderly, postpartum women and people with weak constitution.

[0003] Traditional Chinese medicine decocted paste, also known as paste and paste tonic, refers to a kind of semi-liquid oral preparation prepared by decocting, filtering and concentrating Chinese medicinal pieces into a clear paste, and then adding sugar and glue. It has the characteristics of high drug concentration, convenient carrying and taking, and easy acceptance by patients. The decocted paste of large aconite and pig paste recorded in Synopsis of Golden Chamber is the earliest oral paste. The application population of paste has gradually expanded and is widely used in urban sub-health white-collar workers, patients with chronic diseases and patients with deficiency diseases.

[0004] Although the existing tonifying herbal paste has certain application in conditioning deficiency diseases, it still has many problems to be improved, such as insufficient taste and acceptance, obvious bitterness of natural Chinese medicinal materials (such as Radix Rehmanniae Preparata and Angelica), and high sugar content due to the addition of a large amount of sucrose to mask the bitterness, which is not suitable for people with diabetes or sugar control. The paste body of some products is sticky and easy to adhere to the oral cavity or esophagus, causing discomfort during taking. In addition, the traditional process needs to be manually operated through steps such as soaking (8-24 hours), decocting (2-3 times, 1-2 hours each time), filtering and concentrating, which takes 2-3 days and is easy to cause loss of effective components (such as decomposition of heat-sensitive components such as astragaloside and ginsenoside under high-temperature long decocting) due to improper control of fire and time. Incomplete filtering of dregs will also cause the paste to have many impurities and a rough taste. The existing paste often uses a single glue (such as only using donkey-hide gelatin) or sucrose as the matrix, which is easy to cause the paste to be too hard (low-temperature solidification) or too dilute (high-temperature melting) due to imbalance of the proportion of glue, poor stability, and short shelf life (usually only 6-12 months). Some products add artificial sweeteners (such as aspartame) to improve the taste, which is controversial in safety. The existing paste is mostly tonifying qi and blood, and lacks attention to the overall conditioning mechanism of "spleen and stomach transportation" and "liver and kidney regulation", which causes some people (such as those with spleen deficiency and excessive dampness) to have abdominal distension, indigestion and other "deficiency not receiving tonification" problems after taking the paste. For the complex symptoms such as fatigue, pale and yellowish complexion and low immunity commonly seen in sub-health people, the conditioning effect of the existing products is slow, and long-term taking (more than 3 months) is needed to see the effect.

[0005] In order to overcome the existing technical problems, there is an urgent need to provide herbal pastes that are effective, have a good taste, and are stable in storage. Summary of the Invention

[0006] To overcome the shortcomings of existing technologies, this invention provides a herbal paste that nourishes both Qi and blood, regulates the spleen and stomach, strengthens the body's foundation, and lowers lipids and protects the liver. This herbal paste nourishes both Qi and blood while taking into account the overall conditioning mechanism of spleen and stomach function and liver and kidney regulation, and has a significant effect on reducing fatty liver.

[0007] This invention provides the following technical solution: A herbal paste formula that nourishes both Qi and blood, regulates the spleen and stomach, strengthens the body's foundation, lowers lipids, and protects the liver comprises the following components by weight: Astragalus membranaceus 10-30 parts, Rehmannia glutinosa 10-20 parts, Ginseng 5-15 parts, Codonopsis pilosula 3-15 parts, Atractylodes macrocephala 5-15 parts, Dioscorea opposita 10-20 parts, Angelica sinensis 5-15 parts, Colla corii asini 10-30 parts, Paeonia lactiflora 3-15 parts, Crataegus pinnatifida 10-20 parts, Pinellia ternata 2-10 parts, Lycopus lucidus 5-15 parts, Schisandra chinensis 5-15 parts, Dendrobium nobile 5-10 parts, Lophatherum gracile 3-8 parts, Elsholtzia ciliata 5-15 parts, Cinnamomum cassia 3-10 parts, Jujube 10-20 parts, Glycyrrhiza uralensis 2-10 parts, and excipients.

[0008] Preferably, the herbal paste comprises the following components in parts by weight: Astragalus membranaceus 15-20 parts, Rehmannia glutinosa 10-15 parts, Ginseng 5-10 parts, Codonopsis pilosula 3-8 parts, Atractylodes macrocephala 6-12 parts, Dioscorea opposita 10-15 parts, Angelica sinensis 5-10 parts, Colla corii asini 10-20 parts, Paeonia lactiflora 5-12 parts, Crataegus pinnatifida 10-15 parts, Pinellia ternata 5-8 parts, Lycopus lucidus 6-10 parts, Schisandra chinensis 5-10 parts, Dendrobium nobile 6-10 parts, Lophatherum gracile 5-8 parts, Elsholtzia ciliata 5-10 parts, Cinnamomum cassia 3-8 parts, Ziziphus jujuba 10-15 parts, Glycyrrhiza uralensis 5-10 parts, and excipients.

[0009] In a preferred embodiment, the herbal paste comprises the following components in parts by weight: 18 parts Astragalus membranaceus, 13 parts Rehmannia glutinosa, 8 parts Ginseng, 6 parts Codonopsis pilosula, 10 parts Atractylodes macrocephala, 12 parts Dioscorea opposita, 7 parts Angelica sinensis, 15 parts Colla corii asini, 8 parts Paeonia lactiflora, 13 parts Crataegus pinnatifida, 6 parts Pinellia ternata, 8 parts Lycopus lucidus, 10 parts Schisandra chinensis, 7 parts Dendrobium nobile, 6 parts Lophatherum gracile, 5 parts Elsholtzia ciliata, 5 parts Cinnamomum cassia, 15 parts Ziziphus jujuba, 8 parts Glycyrrhiza uralensis, and excipients.

[0010] Preferably, the excipients include flavor modifiers and thickeners / stabilizers.

[0011] In a preferred embodiment, the flavor modifier is fructooligosaccharide.

[0012] In a preferred embodiment, the thickening stabilizer is hydroxypropyl distarch phosphate.

[0013] The present invention further provides a preparation process for herbal pastes, including the following steps: raw material pretreatment, enzymatic extraction, concentration and purification of the paste, paste collection and addition of excipients.

[0014] The specific steps include: Step 1, Raw material preparation: Take the Chinese herbal medicines Astragalus membranaceus, Rehmannia glutinosa, Ginseng, Codonopsis pilosula, Atractylodes macrocephala, Dioscorea opposita, Angelica sinensis, Paeonia lactiflora, Pinellia ternata, Lycopus lucidus, Dendrobium nobile, Cinnamomum cassia, Glycyrrhiza uralensis, Schisandra chinensis, Crataegus pinnatifida, Jujube, Bambusa textilis, and Elsholtzia ciliata. Remove impurities, clean and select, then crush into coarse particles and treat with infrared irradiation for later use; take donkey-hide gelatin, crush it, soak it in an appropriate amount of rice wine to soften it, steam it until melted, and stir until there are no particles for later use; Step 2, Enzymatic Extraction: Weigh an appropriate amount of the compound enzyme and add it to an appropriate amount of buffer solution to prepare an enzyme solution; add an appropriate amount of buffer solution to the coarse particles of the Chinese herbal medicine from Step 1, stir and disperse evenly, add the enzyme solution, and control the temperature and pH value for enzymatic hydrolysis; after enzymatic hydrolysis, heat up to inactivate the compound enzyme, and then cool to room temperature; filter and collect the enzymatic hydrolysate; wash the residue with distilled water, combine the filtrates, and obtain the enzymatic extract; Step 3, Concentrate the extract: Concentrate the extract from Step 2 under vacuum to obtain the concentrated extract; Step 4, Completing the paste and adding excipients: While stirring, slowly pour the melted donkey-hide gelatin liquid from Step 1 into the clear paste; add the paste-like thickener and stabilizer made with pure water and the flavor regulator to the clear paste; keep stirring over low heat until the paste is dark, glossy, delicate and uniform in color, turn off the heat, and divide into portions to obtain the herbal paste formula.

[0015] Preferably, the infrared processing temperature in step 1 is 40~60℃, the processing time is 20-30min, the infrared physical field parameters are set as follows: mid-wave infrared wavelength range of 3~5μm, infrared processing distance of 15~20cm, and material thickness of 3~5cm.

[0016] Preferably, the amount of rice wine used in step 1 is 2 to 5 times the amount of donkey-hide gelatin.

[0017] Preferably, the complex enzyme in step 2 is a combination of pectinase and hemicellulase, wherein the mass ratio of pectinase to hemicellulase is 1:1~2.

[0018] Preferably, the amount of compound enzyme added in step 2 is 2-5% of the weight of the coarse Chinese herbal medicine particles.

[0019] Preferably, the buffer solution in step 2 is a citrate-disodium hydrogen phosphate buffer solution with a concentration preferably of 0.1 mol / L and a pH preferably of 4.5-5.0, which can be prepared using conventional methods. In a preferred embodiment, it can be prepared by weighing 21.02 g of citric acid monohydrate and 14.20 g of anhydrous disodium hydrogen phosphate, adding distilled water to a final volume of 1000 mL to obtain a 0.1 mol / L citrate-disodium hydrogen phosphate buffer solution, and adjusting the pH by adding HCl or NaOH.

[0020] Preferably, the mass-to-volume ratio of the complex enzyme to the buffer solution in the complex enzyme solution described in step 2 is 1:20~30, g / ml.

[0021] Preferably, the mass-to-volume ratio of the coarse herbal particles to the buffer solution in step 2 is 1:5~15, g / ml.

[0022] Preferably, the enzymatic hydrolysis temperature in step 2 is 30~50℃; more preferably, it is 35~45℃.

[0023] Preferably, the pH value of the enzymatic hydrolysis process in step 2 is controlled at 4.5~5.0.

[0024] Preferably, the enzymatic hydrolysis time in step 2 is 2 to 5 hours.

[0025] Preferably, the fire extinguishing temperature of the compound enzyme in step 2 is 70~90℃.

[0026] Preferably, the vacuum decompression conditions in step 3 are set to a vacuum degree of 0.07-0.09 MPa and a temperature of 40-60℃.

[0027] Preferably, the flavor modifier in step 4 is fructooligosaccharide, and its addition amount is 3-5% of the weight of the extract.

[0028] Preferably, the thickening stabilizer in step 4 is hydroxypropyl distarch phosphate, and its addition amount is 0.1~0.5% of the weight of the extract.

[0029] In the raw material components of this invention, Astragalus membranaceus, as the chief herb for tonifying Qi, has the effects of tonifying Qi and strengthening the spleen, promoting diuresis and reducing swelling, and restoring the spleen and stomach's digestive function to reduce the generation of phlegm and dampness; Rehmannia glutinosa, as the chief herb for nourishing the liver, has the effects of nourishing Yin and blood, replenishing essence and marrow, and directly nourishing liver Yin and liver blood; Ginseng has the effect of greatly tonifying vital energy, enhancing the Qi-tonifying power of Astragalus membranaceus, and also assisting in the circulation of Qi and blood to improve the effects of Qi stagnation and dampness obstruction in fatty liver; Codonopsis pilosula, Atractylodes macrocephala, and Dioscorea opposita assist Astragalus membranaceus and Ginseng in tonifying Qi, enhancing the spleen and stomach's digestive function, reducing dampness, and tonifying Qi and strengthening the spleen; Angelica sinensis, donkey-hide gelatin, and Paeonia lactiflora assist Rehmannia glutinosa in nourishing liver blood and promoting blood circulation. This formula promotes blood circulation, improves liver meridian obstruction, nourishes blood, and soothes the liver; hawthorn aids digestion, reduces lipids, and disperses blood stasis; prepared pinellia dries dampness and resolves phlegm, directly targeting the pathological products of fatty liver such as "phlegm-dampness and food stagnation"; zeylan invigorates blood and promotes diuresis; schisandra chinensis nourishes the kidneys, calms the liver, and protects liver cells; dendrobium nourishes yin and benefits the stomach, preventing the warming and drying effects of qi-tonifying herbs from damaging yin; bamboo leaves clear heat and relieve irritability, clearing heat from liver stagnation; cinnamon twig warms and unblocks the meridians, preventing the blood stasis caused by nourishing herbs; red dates assist in nourishing blood and harmonize the spleen and stomach; elsholtzia reticulata resolves dampness and harmonizes the middle jiao, assisting pinellia twig in removing dampness; licorice tonifies the spleen and benefits qi, harmonizes all herbs, alleviates the warming and drying properties of pinellia twig and cinnamon twig, and protects spleen and stomach function.

[0030] The beneficial effects of this invention are: 1. The herbal paste of this invention has the effects of nourishing both qi and blood, regulating the spleen and stomach, strengthening the body and nourishing the source, and lowering lipids and protecting the liver. While nourishing both qi and blood, it also takes into account the overall conditioning mechanism of spleen and stomach function and liver and kidney regulation, and has the effect of significantly reducing fatty liver.

[0031] 2. The herbal extract of this invention utilizes an infrared combined with enzymatic hydrolysis extraction process. Compared to the traditional multi-step manual process of "soaking, decocting, filtering, and concentrating," this significantly increases the extraction yield of effective components, is easier to operate, and greatly shortens the time required. Infrared treatment transforms the structure of the medicinal materials from a "dense barrier" to a "loose substrate," providing an ideal reaction environment for subsequent enzymatic hydrolysis. Enzymatic hydrolysis, through biocatalysis, precisely degrades residual cell wall components. The synergistic effect of these two processes achieves a comprehensive advantage of efficient extraction, low-temperature protection, and reduced impurities.

[0032] 3. The herbal paste of this invention incorporates hydroxypropyl distarch phosphate as an auxiliary fructooligosaccharide, significantly improving its stability and enhancing its flavor. Hydroxypropyl distarch phosphate constructs a stable system through a molecular network, ensuring the paste's texture and shelf life; fructooligosaccharides, with their low sweetness and prebiotic properties, improve palatability and bioavailability. The synergistic effect of these two components upgrades the herbal paste of this invention from "high sugar and high viscosity" to "low sugar and functional," balancing therapeutic efficacy, taste, and modern health needs. Detailed Implementation

[0033] The present invention will be further described below with reference to specific embodiments. It should be understood that the following embodiments are for illustrative purposes only and not for limiting the scope of the invention. Unless otherwise specified, all materials and raw materials used in the present invention are commercially available.

[0034] Example 1 Herbal paste combination prescription: Astragalus membranaceus 18g, Rehmannia glutinosa 13g, Ginseng 8g, Codonopsis pilosula 6g, Atractylodes macrocephala 10g, Dioscorea opposita 12g, Angelica sinensis 7g, Colla corii asini 15g, Paeonia lactiflora 8g, Crataegus pinnatifida 13g, Pinellia ternata 6g, Lycopus lucidus 8g, Schisandra chinensis 10g, Dendrobium nobile 7g, Lophatherum gracile 6g, Elsholtzia ciliata 5g, Cinnamomum cassia 5g, Ziziphus jujuba 15g, Glycyrrhiza uralensis 8g.

[0035] The specific preparation process is as follows: 1) Take the prescribed amount of Astragalus membranaceus, Rehmannia glutinosa, Ginseng, Codonopsis pilosula, Atractylodes macrocephala, Dioscorea opposita, Angelica sinensis, Paeonia lactiflora, Pinellia ternata, Lycopus lucidus, Dendrobium nobile, Cinnamomum cassia, Glycyrrhiza uralensis, Schisandra chinensis, Crataegus pinnatifida, Ziziphus jujuba, Lophatherum gracile, and Elsholtzia ciliata. Remove impurities, clean and select, then grind into coarse particles. Treat with infrared irradiation at a temperature of 45℃ for 30 minutes. Set aside. Take the prescribed amount of donkey-hide gelatin, crush it, soak it in 50g of rice wine to soften it, steam it in a double boiler until melted, and stir until there are no particles. Set aside. 2) Take 5g of the compound enzyme (pectinase: hemicellulase = 1:1.5) and add it to 125ml of citrate-disodium hydrogen phosphate buffer to prepare the enzyme solution; take 1000ml of citrate-disodium hydrogen phosphate buffer and add it to the coarse particles from step 1, stir and disperse evenly, add the enzyme solution, and carry out enzymatic hydrolysis under the conditions of 40℃ and pH 4.5; the enzymatic hydrolysis is completed in about 3 hours, then the compound enzyme is inactivated by heating to 80℃ for 10 minutes, and then cooled to room temperature; filter and collect the enzymatic hydrolysate; wash the residue twice with 500ml of distilled water, combine the filtrates, and obtain the enzymatic hydrolysate extract; 3) The extract from step 2 was concentrated under vacuum at -0.08 MPa and 50°C to obtain a concentrated extract; 4) While stirring, slowly pour the melted donkey-hide gelatin liquid from step 1 into the clear paste; add the paste-like hydroxypropyl distarch phosphate (0.3%) and fructooligosaccharides (4%) prepared with pure water to the clear paste; keep stirring over low heat until the paste is dark, smooth, and uniform in color, turn off the heat, and divide it into portions to obtain the herbal paste formula.

[0036] Example 2 Herbal paste combination prescription: Astragalus membranaceus 15g, Rehmannia glutinosa 10g, Ginseng 5g, Codonopsis pilosula 3g, Atractylodes macrocephala 6g, Dioscorea opposita 10g, Angelica sinensis 5g, Colla corii asini 10g, Paeonia lactiflora 5g, Crataegus pinnatifida 10g, Pinellia ternata 5g, Lycopus lucidus 6g, Schisandra chinensis 5g, Dendrobium nobile 6g, Lophatherum gracile 5g, Elsholtzia ciliata 5g, Cinnamomum cassia 3g, Ziziphus jujuba 10g, Glycyrrhiza uralensis 5g.

[0037] The specific preparation process is as follows: 1) Take the prescribed amount of Astragalus membranaceus, Rehmannia glutinosa, Ginseng, Codonopsis pilosula, Atractylodes macrocephala, Dioscorea opposita, Angelica sinensis, Paeonia lactiflora, Pinellia ternata, Lycopus lucidus, Dendrobium nobile, Cinnamomum cassia, Glycyrrhiza uralensis, Schisandra chinensis, Crataegus pinnatifida, Ziziphus jujuba, Lophatherum gracile, and Elsholtzia ciliata. Remove impurities, clean and select, and then crush into coarse particles. Treat with infrared irradiation at a temperature of 60℃ for 20 minutes. Set aside. Take the prescribed amount of donkey-hide gelatin, crush it, soak it in 30g of rice wine to soften it, steam it in a double boiler until it melts, and stir until there are no particles. Set aside. 2) Take 2.5g of the complex enzyme (pectinase: hemicellulase = 1:2) and add it to 50ml of citrate-disodium hydrogen phosphate buffer to prepare the enzyme solution; take 700ml of citrate-disodium hydrogen phosphate buffer and add it to the coarse particles from step 1, stir and disperse evenly, add the enzyme solution, and carry out enzymatic hydrolysis under the conditions of 45℃ and pH 4.5; the enzymatic hydrolysis is completed in about 3 hours, then the complex enzyme is inactivated by heating to 70℃ for 15min, and then cooled to room temperature; filter and collect the enzymatic hydrolysate; wash the residue twice with 500ml of distilled water, combine the filtrates, and obtain the enzymatic hydrolysate extract; 3) The extract from step 2 was concentrated under vacuum at -0.07 MPa and 55°C to obtain a concentrated extract; 4) While stirring, slowly pour the melted donkey-hide gelatin liquid from step 1 into the clear paste; add the paste-like hydroxypropyl distarch phosphate (0.1%) and fructooligosaccharides (5%) prepared with pure water to the clear paste; keep stirring over low heat until the paste is dark, smooth, and uniform in color, turn off the heat, and divide into portions to obtain the herbal paste formula.

[0038] Example 3 Herbal paste combination prescription: Astragalus membranaceus 20g, Rehmannia glutinosa 15g, Ginseng 10g, Codonopsis pilosula 8g, Atractylodes macrocephala 12g, Dioscorea opposita 15g, Angelica sinensis 10g, Colla corii asini 20g, Paeonia lactiflora 12g, Crataegus pinnatifida 15g, Pinellia ternata 8g, Lycopus lucidus 10g, Schisandra chinensis 10g, Dendrobium nobile 10g, Lophatherum gracile 8g, Elsholtzia ciliata 10g, Cinnamomum cassia 8g, Ziziphus jujuba 15g, Glycyrrhiza uralensis 10g.

[0039] The specific preparation process is as follows: 1) Take the prescribed amount of Astragalus membranaceus, Rehmannia glutinosa, Ginseng, Codonopsis pilosula, Atractylodes macrocephala, Dioscorea opposita, Angelica sinensis, Paeonia lactiflora, Pinellia ternata, Lycopus lucidus, Dendrobium nobile, Cinnamomum cassia, Glycyrrhiza uralensis, Schisandra chinensis, Crataegus pinnatifida, Ziziphus jujuba, Lophatherum gracile, and Elsholtzia ciliata. Remove impurities, clean and select, and then crush into coarse particles. Treat with infrared irradiation at a temperature of 40℃ for 30 minutes. Set aside. Take the prescribed amount of donkey-hide gelatin, crush it, soak it in 60g of rice wine to soften it, steam it in a double boiler until melted, and stir until there are no particles. Set aside. 2) Take 10g of the compound enzyme (pectinase: hemicellulase = 1:1) and add it to 300ml of citrate-disodium hydrogen phosphate buffer to prepare the enzyme solution; take 2000ml of citrate-disodium hydrogen phosphate buffer and add it to the coarse particles from step 1, stir and disperse evenly, add the enzyme solution, and carry out enzymatic hydrolysis under the conditions of 50℃ and pH 5; the enzymatic hydrolysis is completed in about 3 hours, then the compound enzyme is inactivated by heating to 80℃ for 10 minutes, and then cooled to room temperature; filter and collect the enzymatic hydrolysate; wash the residue twice with 500ml of distilled water, combine the filtrates, and obtain the enzymatic hydrolysate extract; 3) The extract from step 2 was concentrated under vacuum at -0.09 MPa and 40°C to obtain a concentrated extract; 4) While stirring, slowly pour the melted donkey-hide gelatin liquid from step 1 into the clear paste; add the paste-like hydroxypropyl distarch phosphate (0.5%) and fructooligosaccharides (3%) prepared with pure water to the clear paste; keep stirring over low heat until the paste is dark, smooth, and uniform in color, turn off the heat, and divide into portions to obtain the herbal paste formula.

[0040] Comparative Example 1 Herbal paste combination prescription Astragalus membranaceus 18g, Rehmannia glutinosa 13g, Ginseng 8g, Codonopsis pilosula 6g, Atractylodes macrocephala 10g, Dioscorea opposita 12g, Angelica sinensis 7g, Colla corii asini 15g, Paeonia lactiflora 8g, Crataegus pinnatifida 13g, Cinnamomum cassia 5g, Ziziphus jujuba 15g, Glycyrrhiza uralensis 8g.

[0041] Herbal paste was prepared according to the process described in Example 1.

[0042] Comparative Example 2 Herbal paste combination prescription: Astragalus membranaceus 20g, Poria cocos 18g, Crataegus pinnatifida 20g, Alisma plantago-aquatica 15g, Nelumbo nucifera leaf 12g, Codonopsis pilosula 15g, Atractylodes macrocephala 18g, Dioscorea opposita 15g, Lycium barbarum 20g, Coix lacryma-jobi 15g, Citrus reticulata peel 10g, Glycyrrhiza uralensis 8g, Colla corii asini 10g.

[0043] Herbal paste was prepared according to the process described in Example 1.

[0044] Comparative Example 3 Herbal paste combination prescription: Astragalus membranaceus 9g, Codonopsis pilosula 9g, Jujube 18g, Donkey-hide gelatin 10g, Licorice 3g.

[0045] Take the prescribed amounts of Astragalus membranaceus, Codonopsis pilosula, jujube, and licorice root, wash and set aside; add 400g of water to the mixed herbs, soak for 2 hours, then decoct twice under high pressure for 1 hour each time; add 310g of water for the third time and decoct under high pressure for 1 hour; filter the decoction through an 80-mesh sieve, let it stand and settle for 3 hours, and combine the supernatant to obtain the original liquid; concentrate the original liquid under reduced pressure and filter it through a 60-mesh sieve to obtain a thick paste-like medicinal liquid; add the thick paste-like medicinal liquid to the melted donkey-hide gelatin liquid and heat over low heat to concentrate and form a paste; finally add an appropriate amount of yellow gelatin (2%), rock sugar (4%), and fructooligosaccharides (4%), and keep stirring over low heat until the paste is dark, smooth, and uniform in color, then turn off the heat to obtain the herbal paste formula.

[0046] Comparative Example 4 Herbal paste combination prescription: Prepared Atractylodes lancea 15g, stir-fried Atractylodes macrocephala 15g, Astragalus membranaceus 30g, Poria cocos 20g, Alisma plantago-aquatica 10g, raw malt 30g, Artemisia capillaris 30g, Cinnamomum cassia 10g, Sparganium stoloniferum 10g, Curcuma zedoaria 10g, Crataegus pinnatifida 30g, raw chicken gizzard lining 10g, raw Paeonia lactiflora 15g, green tangerine peel 10g, dried ginger 6g.

[0047] The specific preparation process is as follows: 1) Place the prescribed amount of ingredients into a clay pot, add water to cover the herbs by 20cm, and soak for 3 hours; 2) After boiling the medicine for 2 hours, remove the decoction, add water to 20cm above the surface of the medicine, and boil for 2 hours. Combine the two decoctions, press out the decoction from the dregs and add it to the above decoction to obtain the final mixed decoction. Place it in a container and let it settle for 8 hours. After filtering the mixed decoction through an 80-mesh sieve, place it in a clay pot and skim off the foam to obtain a concentrated decoction. 3) Add appropriate amounts of yellow gelatin (2%), rock sugar (4%), and fructooligosaccharides (4%) to the concentrated medicinal liquid obtained in step 2). Keep stirring over low heat until the paste is dark, smooth, and uniform in color. Turn off the heat to obtain the herbal paste formula.

[0048] Comparative Example 5 Herbal paste combination prescription: Astragalus membranaceus 18g, Rehmannia glutinosa 13g, Ginseng 8g, Codonopsis pilosula 6g, Atractylodes macrocephala 10g, Dioscorea opposita 12g, Angelica sinensis 7g, Colla corii asini 15g, Paeonia lactiflora 8g, Crataegus pinnatifida 13g, Pinellia ternata 6g, Lycopus lucidus 8g, Schisandra chinensis 10g, Dendrobium nobile 7g, Lophatherum gracile 6g, Elsholtzia ciliata 5g, Cinnamomum cassia 5g, Ziziphus jujuba 15g, Glycyrrhiza uralensis 8g.

[0049] The specific preparation process is as follows: 1) Quickly rinse the prescribed amounts of Astragalus membranaceus, Rehmannia glutinosa, Codonopsis pilosula, Atractylodes macrocephala, Dioscorea opposita, Angelica sinensis, Paeonia lactiflora, Crataegus pinnatifida, Pinellia ternata, Lycopus lucidus, Schisandra chinensis, Dendrobium nobile, Lophatherum gracile, Elsholtzia ciliata, Cinnamomum cassia, Ziziphus jujuba, and Glycyrrhiza uralensis with purified water to remove surface impurities. After draining, place them in a stainless steel pot, add purified water to 10cm above the herbs, and soak for 12 hours. Take the prescribed amount of donkey-hide gelatin, crush it, soak it in 30g of rice wine to soften it, steam it until melted, and stir until there are no granules. Set aside. Take the prescribed amount of ginseng and 200ml of purified water, simmer over low heat for 2 hours, and take about 50ml of concentrated juice. Grind the dregs into a fine powder, pass it through a 100-mesh sieve, and set aside. 2) Boil the soaked herbs from step 1 over high heat, then reduce to a simmer and maintain a gentle boil for 1 hour. Filter through a 100-mesh sieve and collect the liquid. Add purified water to the dregs until it is 5cm above the herbs, bring to a boil over high heat, then reduce to a simmer and cook for 40 minutes. Filter and collect the liquid. Add purified water to the dregs until it just covers the herbs, bring to a boil over high heat, then reduce to a simmer and cook for 30 minutes. Filter and collect the liquid. Combine the three liquids, let stand for 2 hours, and filter the supernatant through an 80-mesh sieve to remove sediment and impurities. Press the dregs to extract the juice and discard it. 3) Pour the clarified medicinal liquid into a stainless steel pot, concentrate it over high heat, stirring constantly and skimming off the surface foam, until the liquid volume is reduced by 1 / 2; turn to low heat and continue to concentrate, stirring until the liquid becomes thick, to obtain a clear paste, turn off the heat and cool to 60℃. 4) While stirring, slowly pour the melted donkey-hide gelatin liquid from step 1 into the clear paste; add the paste-like hydroxypropyl distarch phosphate (0.3%) and fructooligosaccharides (4%) prepared with pure water to the clear paste; keep stirring over low heat until the paste is dark, smooth, and uniform in color, turn off the heat, and divide it into portions to obtain the herbal paste formula.

[0050] Comparative Example 6 Herbal paste combination prescription: Astragalus membranaceus 18g, Rehmannia glutinosa 13g, Ginseng 8g, Codonopsis pilosula 6g, Atractylodes macrocephala 10g, Dioscorea opposita 12g, Angelica sinensis 7g, Colla corii asini 15g, Paeonia lactiflora 8g, Crataegus pinnatifida 13g, Pinellia ternata 6g, Lycopus lucidus 8g, Schisandra chinensis 10g, Dendrobium nobile 7g, Lophatherum gracile 6g, Elsholtzia ciliata 5g, Cinnamomum cassia 5g, Ziziphus jujuba 15g, Glycyrrhiza uralensis 8g.

[0051] The specific preparation process is as follows: 1) Take the prescribed amount of Astragalus membranaceus, Rehmannia glutinosa, Ginseng, Codonopsis pilosula, Atractylodes macrocephala, Dioscorea opposita, Angelica sinensis, Paeonia lactiflora, Pinellia ternata, Lycopus lucidus, Dendrobium nobile, Cinnamomum cassia, Glycyrrhiza uralensis, Schisandra chinensis, Crataegus pinnatifida, Ziziphus jujuba, Lophatherum gracile, and Elsholtzia ciliata. Remove impurities, clean and select, then grind into coarse particles. Treat with infrared irradiation at a temperature of 45℃ for 30 minutes. Set aside. Take the prescribed amount of donkey-hide gelatin, crush it, soak it in 50g of rice wine to soften it, steam it in a double boiler until melted, and stir until there are no particles. Set aside. 2) Take 5g of the compound enzyme (pectinase: hemicellulase = 1:1.5) and add it to 125ml of citrate-disodium hydrogen phosphate buffer to prepare the enzyme solution; take 1000ml of citrate-disodium hydrogen phosphate buffer and add it to the coarse particles from step 1, stir and disperse evenly, add the enzyme solution, and carry out enzymatic hydrolysis under the conditions of 40℃ and pH 4.5; the enzymatic hydrolysis is completed in about 3 hours, then the compound enzyme is inactivated by heating to 80℃ for 10 minutes, and then cooled to room temperature; filter and collect the enzymatic hydrolysate; wash the residue twice with 500ml of distilled water, combine the filtrates, and obtain the enzymatic hydrolysate extract; 3) The extract from step 2 was concentrated under vacuum at -0.08 MPa and 50°C to obtain a concentrated extract; 4) While stirring, slowly pour the melted donkey-hide gelatin liquid from step 1 into the clear paste; add yellow gelatin (2%), rock sugar (4%), and fructooligosaccharides (4%) to the clear paste; keep stirring over low heat until the paste is dark, smooth, and uniform in color, turn off the heat, and divide it into portions to obtain the herbal paste formula.

[0052] Comparative Example 7 Herbal paste combination prescription: Astragalus membranaceus 18g, Rehmannia glutinosa 13g, Ginseng 8g, Codonopsis pilosula 6g, Atractylodes macrocephala 10g, Dioscorea opposita 12g, Angelica sinensis 7g, Colla corii asini 15g, Paeonia lactiflora 8g, Crataegus pinnatifida 13g, Pinellia ternata 6g, Lycopus lucidus 8g, Schisandra chinensis 10g, Dendrobium nobile 7g, Lophatherum gracile 6g, Elsholtzia ciliata 5g, Cinnamomum cassia 5g, Ziziphus jujuba 15g, Glycyrrhiza uralensis 8g.

[0053] The preparation process is the same as in Example 1, except that step 1) does not involve infrared treatment and enzyme extraction is performed directly.

[0054] Verification of Examples 1. Yield of pure medicinal materials and content of astragaloside A extracted Take a portion (1 / 5) of the concentrated extract (concentrated clear extract before adding donkey-hide gelatin and excipients) of Examples 1-3 and Comparative Examples 1-7 respectively, place them in an evaporating dish, evaporate to constant weight, cool and weigh (deduct the weight of the evaporating dish), and calculate the extract yield (the total weight of the net medicinal materials is calculated as 1 / 5 of the weight of the remaining pure medicinal materials excluding donkey-hide gelatin). Extract yield (%) = final extract weight (g) / total net medicinal material weight (g) × 100%.

[0055] All sample samples contained Scutellaria baicalensis. Astragaloside A was selected as the indicator for testing extraction performance. The astragaloside A content extracted per gram of Scutellaria baicalensis was calculated by comparing it with the amount of Scutellaria baicalensis added in the prescription. The content of astragaloside A was detected with reference to the pharmacopoeia standard.

[0056] Table 1. Yield of pure medicinal materials and content of astragaloside A extracted from them Comparative Example 7 57.38 2.06 This invention utilizes a low-temperature extraction process combining infrared and enzymatic hydrolysis, which is superior to the traditional methods of "soaking, boiling, filtering, and concentration." High-temperature extraction significantly increases the content of active ingredients and the yield of extract.

[0057] Stability test Herbal pastes prepared in Examples 1-3 and Comparative Examples 1-7 were sealed and packaged under conditions of 40℃±2℃ and RH 75%±5%. Storage stability was investigated according to pharmacopoeia methods at 0 days, 1 month, 3 months, and 6 months. The decrease rate of astragaloside A, i.e., the change in the tested amount compared to the initial extracted astragaloside A content, was measured. For ordinary pastes containing sugar and gum, the relative density was measured at 20℃; a range of 1.30–1.45 met the requirements, while a value less than 1.30 or greater than 1.45 was considered unqualified. The results of accelerated stability tests are shown in Tables 2 and 3.

[0058] Table 2. Appearance and properties of accelerated stability test Table 3. Accelerated stability study: decrease rate of astragaloside A content and relative density Comparative Example 7 1.25 1.43 1.74 1.34 1.37 1.42 1.44 The present invention adds hydroxypropyl distarch phosphate to assist fructooligosaccharides in the herbal paste, which significantly improves the stability and enhances the flavor of the herbal paste.

[0059] Investigation on the effect of improving digestive problems in rats with weak spleen and stomach Several healthy 1-week-old SPF-grade SD rat pups were maintained in an SPF environment, with standard rodent food, water, and light-dark cycles every 12 hours, relative humidity of 45%–55%, and room temperature of (23±2)℃. Before the experiment, the rats were acclimatized for 7 days. Twelve rats were randomly selected as the control group, and the remaining rats were used to establish a spleen and stomach deficiency type FD rat model using a comprehensive modeling method (iodoacetamide gavage + starvation / fullness disorder + swimming exhaustion): each rat was gavaged with a 2% sucrose solution containing 0.1% iodoacetamide, 0.2 mL, once daily for 6 consecutive days. During this period, the control group rats were gavaged with the same dose of 2% sucrose solution. Rats were fed normally until they were weaned at 3 weeks of age and then separated into different cages. At 6 weeks of age, except for the control group, each group of rats was forced to swim to exhaustion every day and fed every other day. During the modeling period, all experimental rats were given normal drinking water and the modeling was carried out for 14 consecutive days. Six rats from the control group and six rats from the modeling group were taken for model verification. The model reconstruction criteria were the decrease in body weight, food intake, gastric emptying rate and intestinal propulsion rate.

[0060] After successful modeling, rats were randomly divided into a model group and a treatment group (Examples 1 and Comparative Examples 1-4), with 6 rats in each group. The treatment group was administered 10 g / kg / day by gavage for 2 consecutive weeks, while the control group and model group were administered the same dose of 0.9% NaCl by gavage. Changes in body weight and 3-hour food intake were recorded during the feeding process.

[0061] After fasting for 24 hours, rats were administered 2 mL of a semi-solid nutritional paste containing activated charcoal (10 g sodium carboxymethyl cellulose, 16 g milk powder, 8 g starch, 8 g sugar, and 2 g activated charcoal powder, dissolved in 250 mL of distilled water to make 300 mL, approximately 300 g of black semi-solid paste). 0.5 hours later, the rats were anesthetized by intraperitoneal injection of 3% sodium pentobarbital at 5 mL / kg. The entire stomach was removed and weighed. The stomach was cut along the greater curvature, thoroughly rinsed with 0.9% NaCl, and the net stomach mass was measured. The gastric emptying rate and intestinal propulsion rate were calculated. Gastric emptying rate = [1 - (total stomach mass - net stomach mass) ÷ mass of given paste] × 100%; Intestinal propulsion rate = distance of the black paste propelled from the pylorus / total distance of the small intestine × 100%.

[0062] Table 4. Results of the improvement test in rats with spleen and stomach deficiency and indigestion. Experimental results show that the herbal paste of the present invention has a significant effect on weight loss and increased appetite, effectively improving problems such as weak spleen and stomach and indigestion.

[0063] Investigation on the improvement effect on mice with qi and blood deficiency model Several clean-grade Kunming mice, weighing 20-25g, were maintained in an SPF environment with standard rodent food, water, and light / dark cycles every 12 hours. The relative humidity was 45%-55%, and the room temperature was (23±2)℃. Mice were acclimatized for 7 days before the experiment. Six mice were randomly selected as the control group, and the rest were used for modeling. On days 1, 3, 5, 7, and 9, 0.3-0.5 mL of blood was excised from the orbital region of each mouse. On days 2, 4, 6, and 8, each mouse (fasted for 12 hours but allowed free access to water) was intraperitoneally injected with cyclophosphamide 80 mg / kg (administration volume 8 mL / kg). The control group received the same volume of physiological saline.

[0064] The modeling mice were randomly divided into a model control group and a drug administration group (Examples 1 and Comparative Examples 1-4), with 6 mice in each group. The drug administration group was administered 5 g / kg / day by gavage for 2 consecutive weeks, while the blank control group and the model group were administered the same dose of 0.9% NaCl by gavage.

[0065] After the last administration, mice in each group were tied to the tail with a stainless steel wire equal to 6% of their body weight and placed in water at a temperature of (30±3)℃ and a depth of 40cm. The swimming termination time was recorded as the time it took for the mouse's head to fail to surface within 10 seconds. The duration from entry into the water to the end of swimming was recorded as an indicator of fatigue resistance. Blood was collected from the orbital fossa and allowed to stand for 15 minutes. After centrifugation at 3000 rpm for 20 minutes, serum was collected, and the levels of IL-6 and IL-1β were measured according to the ELISA kit instructions.

[0066] Table 5. Improvement test results of the Qi and Blood Deficiency Model Mice To assess the anti-fatigue ability of mice, this experiment used the classic weight-bearing swimming time test to directly reflect the muscle exercise capacity of mice. The results showed that the herbal paste of this invention increased the weight-bearing swimming time of mice, exerted an anti-fatigue effect, and had a qi-tonifying effect. As a pluripotent hematopoietic stem cell growth factor, IL-1β can induce fibroblasts and endothelial cells to release colony-stimulating factors, promote the proliferation of bone marrow primitive hematopoietic cell colonies, and synergistically stimulate blood cell growth with its induced cytokines. At the same time, IL-1β can promote the survival of bone marrow hematopoietic stem cells by accelerating cell circulation, playing a positive regulatory role in the body's hematopoiesis. The dynamic changes in its content directly reflect the strength of bone marrow hematopoietic function. The cytokine IL-6 is induced by IL-1β and can exert multiple immunomodulatory functions. IL-6 acts as a coordinator of the systemic host defense response, enhancing immunity by promoting the activation and aggregation of neutrophils. The test results showed that the herbal paste of this invention simultaneously upregulates the expression of IL-1β and IL-6 in mouse serum, synergistically promotes the body's hematopoiesis, and can also effectively exert an immunomodulatory effect.

[0067] Investigation on the ameliorative effect of high-fat liver injury model in rats Several SPF-grade SD rats, weighing 200-220g, were acclimatized for 7 days. Six rats were randomly selected as the blank control group, and the rest were used as the model experimental group. The blank control group was fed a normal diet, while the model experimental group was fed a high-fat diet. After 8 weeks of feeding the high-fat diet, the blood lipid levels of the rats fed the high-fat diet were measured. Rats with triglyceride levels above 2.0 mmol / L were selected for the experimental drug administration phase.

[0068] Rats entering the experimental stage were randomly divided into a model control group and a treatment group (Examples 1 and Comparative Examples 1-4), with 6 rats in each group. The treatment group continued to be fed a high-fat diet while receiving a herbal paste at a dose of 10 g / kg / day via gavage. The control group continued to be fed a normal diet while receiving an equal dose of 0.9% NaCl via gavage. The model control group continued to be fed a high-fat diet while receiving an equal dose of 0.9% NaCl via gavage. This feeding was continued for 8 weeks. During the feeding period, rats were weighed weekly, and food intake was recorded. After 8 weeks, rats were fasted on the evening of the first day but allowed free access to water. On the second day, blood was collected from the abdominal aorta under anesthesia to measure blood lipid biochemical indicators. After dissection, the liver was harvested, and the liver index was calculated as: liver index = liver weight / body weight × 100%.

[0069] Table 6. Blood lipid test results in rats with hyperlipidemia-induced liver injury. Table 7. Liver function test results in a high-fat liver injury model rat. Experimental results show that the herbal ointment of the present invention can effectively reduce blood lipid levels and liver function enzyme levels, and also reduce weight and fatty liver to a certain extent.

[0070] In summary, the herbal paste of this invention has the effects of simultaneously replenishing qi and blood, regulating the spleen and stomach, strengthening the body's foundation, and lowering lipids and protecting the liver. While replenishing qi and blood, it also takes into account the overall conditioning mechanism of spleen and stomach function and liver and kidney regulation, and has the effect of significantly reducing fatty liver.

Claims

1. A herbal paste formula that nourishes both qi and blood, regulates the spleen and stomach, strengthens the body's foundation, lowers lipids, and protects the liver, characterized in that... The product comprises the following components by weight: Astragalus membranaceus 10-30 parts, Rehmannia glutinosa 10-20 parts, Ginseng 5-15 parts, Codonopsis pilosula 3-15 parts, Atractylodes macrocephala 5-15 parts, Dioscorea opposita 10-20 parts, Angelica sinensis 5-15 parts, Colla corii asini 10-30 parts, Paeonia lactiflora 3-15 parts, Crataegus pinnatifida 10-20 parts, Pinellia ternata 2-10 parts, Lycopus lucidus 5-15 parts, Schisandra chinensis 5-15 parts, Dendrobium nobile 5-10 parts, Lophatherum gracile 3-8 parts, Elsholtzia ciliata 5-15 parts, Cinnamomum cassia 3-10 parts, Ziziphus jujuba 10-20 parts, Glycyrrhiza uralensis 2-10 parts, and excipients.

2. The herbal paste formula as described in claim 1, characterized in that, The herbal ointment described herein comprises the following components by weight: Astragalus membranaceus 15-20 parts, Rehmannia glutinosa 10-15 parts, Ginseng 5-10 parts, Codonopsis pilosula 3-8 parts, Atractylodes macrocephala 6-12 parts, Dioscorea opposita 10-15 parts, Angelica sinensis 5-10 parts, Colla corii asini 10-20 parts, Paeonia lactiflora 5-12 parts, Crataegus pinnatifida 10-15 parts, Pinellia ternata 5-8 parts, Lycopus lucidus 6-10 parts, Schisandra chinensis 5-10 parts, Dendrobium nobile 6-10 parts, Lophatherum gracile 5-8 parts, Elsholtzia ciliata 5-10 parts, Cinnamomum cassia 3-8 parts, Ziziphus jujuba 10-15 parts, Glycyrrhiza uralensis 5-10 parts, and excipients.

3. The herbal paste formula as described in claim 1, characterized in that, The herbal ointment comprises the following components by weight: Astragalus membranaceus 18 parts, Rehmannia glutinosa 13 parts, Ginseng 8 parts, Codonopsis pilosula 6 parts, Atractylodes macrocephala 10 parts, Dioscorea opposita 12 parts, Angelica sinensis 7 parts, Colla corii asini 15 parts, Paeonia lactiflora 8 parts, Crataegus pinnatifida 13 parts, Pinellia ternata 6 parts, Lycopus lucidus 8 parts, Schisandra chinensis 10 parts, Dendrobium nobile 7 parts, Lophatherum gracile 6 parts, Elsholtzia ciliata 5 parts, Cinnamomum cassia 5 parts, Jujube 15 parts, Glycyrrhiza uralensis 8 parts, and excipients.

4. The herbal paste formula according to any one of claims 1-3, characterized in that, The excipients are flavor modifiers and thickeners / stabilizers.

5. The herbal paste formula as described in claim 4, characterized in that, The flavor modifier is fructooligosaccharide, and the thickening and stabilizing agent is hydroxypropyl distarch phosphate.

6. A preparation process for the herbal paste as described in claim 1, characterized in that, The process includes the following steps: raw material preparation, enzymatic extraction, concentrated extract, paste collection, and addition of excipients.

7. The preparation process according to claim 6, characterized in that, The specific steps include: Step 1) Raw material preparation: Take the Chinese herbal medicines Astragalus membranaceus, Rehmannia glutinosa, Ginseng, Codonopsis pilosula, Atractylodes macrocephala, Dioscorea opposita, Angelica sinensis, Paeonia lactiflora, Pinellia ternata, Lycopus lucidus, Dendrobium nobile, Cinnamomum cassia, Glycyrrhiza uralensis, Schisandra chinensis, Crataegus pinnatifida, Jujube, Bambusa textilis, and Elsholtzia ciliata. Remove impurities, clean and select, then crush into coarse particles. Treat with infrared irradiation and set aside. Take the donkey-hide gelatin, crush it, soak it in an appropriate amount of rice wine to soften it, steam it in water until melted, and stir until there are no particles. Set aside. Step 2) Enzymatic extraction: Weigh an appropriate amount of the compound enzyme and add an appropriate amount of buffer solution to prepare an enzyme solution; add an appropriate amount of buffer solution to the coarse particles of the Chinese herbal medicine from Step 1, stir and disperse evenly, add the enzyme solution, and control the temperature and pH value for enzymatic hydrolysis; after enzymatic hydrolysis, heat to inactivate the compound enzyme, and then cool to room temperature; filter and collect the enzymatic hydrolysate; wash the residue with distilled water, combine the filtrates, and obtain the enzymatic extract; Step 3) Concentrate the extract: Concentrate the extract from Step 2 under vacuum to obtain the concentrated extract; Step 4) Completing the paste and adding excipients: While stirring, slowly pour the melted donkey-hide gelatin liquid from Step 1 into the clear paste; add the paste-like thickener and stabilizer made with pure water and the flavor regulator to the clear paste; keep stirring over low heat until the paste is dark, smooth, and uniform in color, turn off the heat, and divide it into portions to obtain the herbal paste formula.

8. The preparation process according to claim 7, characterized in that, The infrared processing temperature in step 1 is 40~60℃, the processing time is 20-30min, the infrared physical field parameters are set as follows: mid-wave infrared wavelength range of 3~5μm, infrared processing distance of 15~20cm, and material thickness of 3~5cm.

9. The preparation process according to claim 7, characterized in that, The complex enzyme described in step 2 is a combination of pectinase and hemicellulase, wherein the mass ratio of pectinase to hemicellulase is 1:1~2.

10. The preparation process according to claim 7, characterized in that, The amount of compound enzyme added in step 2 is 2-5% of the weight of the coarse Chinese herbal medicine particles.

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