Mesona chinensis granules and preparation method for improving quality of effective components in Mesona chinensis granules

Abstract

The invention relates to the technical field of Chinese patent medicine preparation, in particular to mesona chinensis granules and a preparation method for improving the quality of active ingredients in the mesona chinensis granules, and the mesona chinensis granules comprise the following raw materials: cleavers, caulis spatholobi, wine-treated rhubarb, semen coicis, semen euryales, radix pseudostellariae, pseudo-ginseng, gynostemma pentaphyllum and liquorice. Compared with the prior art, the method has the advantages that the coix seeds and the gordon euryale seeds are prevented from being decocted and gelatinized in a steam explosion and acid extraction mode, the liquorice roots, the caulis spatholobi, the radix pseudostellariae, the pseudo-ginseng, the fiveleaf gynostemma herb and the wine-treated rhubarb are decocted separately, the content of chlorogenic acid, flavone and emodin in dry paste is increased, and the curative effect of the mesona chinensis granules is improved.

Description

Technical Field

[0001] The present invention relates to the technical field of preparation of Chinese patent medicines, and in particular to a herbal granule and a preparation method thereof for improving the quality of effective ingredients in the herbal granule. Background Art

[0002] With the extension of human life expectancy and the improvement of living standards, the number of patients with diabetic nephropathy has increased significantly, with an increasing incidence rate and a younger age group. The increasing harm to human health has attracted the attention of the medical community. Currently, the number of people with diabetes worldwide has reached 194 million, and diabetes has become the fourth leading cause of death in the world. Globally, more than 3.8 million people die from diabetes and its complications each year.

[0003] Diabetes is a common endocrine and metabolic disorder, a clinical syndrome caused by the interaction of genetic and environmental factors. The onset of diabetes is complex and multifactorial, and its etiology and pathogenesis have not yet been fully elucidated.

[0004] At present, Huang Guodong, chief physician of the Nephrology Department of our hospital, has formulated compound herbal xiancao granules with pigweed, Panax notoginseng, coix seed, processed rhubarb, astragalus and licorice, which has certain therapeutic effects on diabetes. However, during the extraction of effective ingredients, the dissolution rate of effective ingredients decreases due to improper extraction methods or physical or chemical reactions that may occur during the co-extraction of some Chinese medicinal materials. In order to improve the efficacy of herbal xiancao granules, the present invention improves the compound herbal xiancao granules on the basis of the formula, and improves the extraction method based on some effective ingredients to obtain herbal xiancao granules with a higher quality of effective active ingredients, so as to achieve therapeutic effects while reducing the amount of medicine used by patients. Summary of the Invention

[0005] The purpose of the present invention is to provide a herbal granule and a preparation method thereof for improving the quality of the effective ingredients in the herbal granule, aiming to increase the quality of the effective active ingredients in the herbal granule and improve the efficacy of treating diabetic nephropathy.

[0006] To achieve the above object, the present invention provides a grass jelly granule, the raw materials of which include: cleaver, millettia reticulata, wine rhubarb, coix seed, euryale ferox, pseudostellaria, panax notoginseng, gynostemma pentaphyllum and liquorice.

[0007] Preferably, in the above technical solution, the mass-to-volume ratio of Glehnia littoralis: Millettia reticulata: Coix lachryma-jobi: Pseudostellaria baicalensis: Gynostemma pentaphyllum: Euryale ferox: Rhubarb wine-soaked = 6:3:3:3:2:2:1, and the ratio of Glehnia littoralis: Panax notoginseng: Licorice root = 10:3:2.

[0008] A preparation method for improving the quality of effective ingredients in xiancao granules, the preparation method comprising: S1, taking Glechoma longituba, Coix seed and Euryale ferox, steam-exploding them, placing them in an extraction tank, adding weak acid for the first time, extracting, separating the liquid and residue, obtaining a first filtrate, adding weak acid to the residue, extracting, separating the liquid and residue, obtaining a second filtrate; S2, taking Pseudostellariae Radix, Panax Notoginseng, Gynostemma Pentaphyllum, Millettia Spatholobi and Glycyrrhizae Radix, placing them in an extraction tank, adding water, soaking, decocting and extracting, separating the liquid and residue to obtain a third filtrate, adding purified water to the filter residue, decocting and extracting, separating the liquid and residue to obtain a fourth filtrate; S3, weighing wine rhubarb, placing it in a multifunctional extraction tank, adding purified water, soaking, boiling and extracting, separating the liquid and residue, and obtaining a fifth filtrate; adding purified water to the filter residue, boiling and extracting, separating the liquid and residue, and obtaining a sixth filtrate; S4, the first filtrate, the second filtrate, the third filtrate, the fourth filtrate, the fifth filtrate and the sixth filtrate are mixed and concentrated to form a clear paste, the clear paste is further concentrated, and finally concentrated into a thick paste with a relative density of 1.24-1.30; the auxiliary materials and the thick paste are placed in a blender according to a preset ratio and stirred, and then 80%-90% ethanol is added and stirred to form a soft material; the prepared soft material is transferred to a swing granulator, sieved, granulated, dried, taken out, and cooled to obtain the grass jelly granules.

[0009] Preferably, in the above technical solution, the weak acid is 1%-5% citric acid.

[0010] Preferably, in the above technical solution, the steam explosion is carried out by placing the product in a steam explosion machine at a temperature of 80-90° C. for 30-40 minutes.

[0011] Preferably, in the above technical solution, the preparation methods of the third filtrate and the fourth filtrate are as follows: Weigh Pseudostellariae Radix, Panax notoginseng, Gynostemma pentaphyllum and Licorice, place them in an extraction tank, add 12-13 times the amount of purified water, soak for 50-60 minutes, heat to boiling, decoct and extract for 30-35 minutes, separate the liquid and residue, and obtain a third filtrate. Add 10-11 times the amount of purified water to the residue, heat to boiling, decoct and extract for 30-40 minutes, separate the liquid and residue, and obtain a fourth filtrate.

[0012] Preferably, in the above technical solution, the preparation methods of the fifth filtrate and the sixth filtrate are as follows: Weigh wine rhubarb, place it in a multifunctional extraction tank, add 10-11 times the amount of pure water, soak for 30-60 minutes, heat to boiling, decoct and extract for 50-60 minutes, separate the liquid and residue, and obtain a fifth filtrate; add 8-9 times the amount of pure water to the filter residue, heat to boiling, decoct and extract for 50-60 minutes, separate the liquid and residue, and obtain a sixth filtrate.

[0013] Preferably, in the above technical solution, in step S4, the auxiliary material and the thick paste are placed in a blender and stirred at a mass ratio of 1.5-1.8:1, wherein the auxiliary material is dextrin.

[0014] Preferably, in the above technical solution, in step S4, the concentration process is performed at a concentration temperature of 70-90° C. and a vacuum degree of -0.06 to -0.08 MPa.

[0015] Gnaphalium: This product is Gnaphalium rubiaceae Galium aparine The dried whole herb of L. is harvested during the summer flowering and fruiting period, impurities are removed, and the herb is sun-dried.

[0016] Panax notoginseng (Zhuang name: Godienzcaet, Kedianzhen): This product is Panax notoginseng, a plant of the Araliaceae family. Panax notoginseng The dried roots and rhizomes of (Burk.) FHChen are dug in autumn before the flowers bloom, washed, separated from the main root, side roots and rhizomes, and dried.

[0017] Millettia repens: Dried stems of Spatholobus suberectus Dunn, a plant in the Leguminosae family. Harvested in autumn and winter, the leaves and branches are removed, sliced, and sun-dried.

[0018] Gorgon fruit: Gorgon fruit of the Nymphaeaceae family Euryale ferox The dried mature seed kernels of Salisb. are harvested in late autumn and early winter. The ripe fruits are removed from the peel and the seeds are harvested. They are washed, the hard shell (outer seed coat) is removed and the seeds are sun-dried.

[0019] Pseudostellaria heterophylla: Pseudostellaria heterophylla of the Caryophyllaceae family Pseudostellaria heterophylla The dried root tubers of (Miq.)pax ex Paxet Hoffm. are collected in summer when most of the stems and leaves have withered, washed, and the fibrous roots removed. They are then briefly blanched in boiling water and then dried in the sun or directly in the sun.

[0020] Gynostemma pentaphyllum: Gynostemma pentaphyllum (scientific name: Gynostemma pentaphyllum Thunb. Makino is a herbaceous climbing plant of the Cucurbitaceae family and the genus Gynostemma. It is harvested in summer and autumn and the whole plant is sun-dried.

[0021] Wine rhubarb: This product is Rheum palmatum, a plant of the Polygonaceae family. Rheum palmatum L., Rheum tanguticum Rheum tanguticum Maxim.ex Balf. or medicinal rhubarb Rheumofficinale The dried roots and rhizomes of Baill. are dug up in late autumn when the stems and leaves wither or before budding in the following spring, the fine roots are removed, the outer skin is scraped off, the petals or segments are cut, strung into strings and dried or dried directly, and then stir-fried according to the wine-roasting method (General Rule 0213). Job's tears: (Zhuang name: Haeuxroeg) is a plant of the grass family Job's tears. Coix lacryma-jobiL.var. mayuen The dried, mature kernels of the Roman Stapf plant are harvested in autumn when the fruit is ripe, sun-dried, and the fruit is removed and sun-dried again. The outer shell, yellow-brown seed coat, and impurities are removed, and the kernels are collected.

[0022] Licorice: This product comes from the legume plant Licorice Glycyrrhiza uralensis Fisch.、Glycyrrhiza inflata Glycyrrhiza inflata Ba. or Glycyrrhiza glabra Glycyrrhiza glabra Dried roots and rhizomes of L. Dig in spring and autumn, remove fibrous roots, and sun-dry. Remove impurities, wash, soak thoroughly, cut into thick slices, and dry.

[0023] Compared with the prior art, the present invention has the following beneficial effects: (1) This herbal granule is made of pigweed, Millettia reticulata, coix seed, Euryale ferox, Pseudostellaria chinensis, Panax notoginseng, Gynostemma pentaphyllum, licorice and wine-made rhubarb. Pigweed is diuretic and detumescent, Millettia reticulata regulates qi and relieves pain, and Gynostemma pentaphyllum clears heat and purges fire as the main ingredients; coix seed clears heat and dampness, Pseudostellaria chinensis replenishes qi and promotes fluid production, Euryale ferox strengthens the kidneys and strengthens the kidneys, and wine-made rhubarb is diuretic and relieves stranguria as the assistant ingredients; Panax notoginseng promotes blood circulation and disperses blood stasis as the adjuvant ingredient; and licorice is the guiding ingredient.

[0024] (2) The steam explosion and acid extraction of Glechoma longituba, Coix seed and Euryale ferox seed were used to avoid gelatinization during decoction. Licorice root, Millettia reticulata, Pseudostellaria baicalensis, Panax notoginseng, Gynostemma pentaphyllum and Rhubarb were decocted separately to increase the content of chlorogenic acid, flavonoids and emodin in the dry paste, thereby improving the efficacy of Xiancao granules. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] The purpose, features and advantages of the present invention will be further described with reference to the accompanying drawings and in conjunction with the embodiments.

[0026] Figure 1 It is the histological diagram of the effects on the renal cortex of diabetic rats; Figure 2 This is a diagram showing the tissue structure of the medulla layer in the kidneys of diabetic rats. DETAILED DESCRIPTION

[0027] The technical solutions in the embodiments of the present invention are clearly and completely described. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without making any creative efforts shall fall within the scope of protection of the present invention. Example 1

[0028] A method for preparing a herbal jelly reagent, comprising: S1, weighing galangal, coix seed, and gorgon fruit, placing them in a steam explosion machine at 80°C for 30 minutes, transferring them to a multifunctional extraction tank, adding citric acid for the first time, extracting, and separating the liquid and residue to obtain a first filtrate, adding citric acid to the residue, extracting, and separating the liquid and residue to obtain a second filtrate, mixing the first filtrate and the second filtrate, filtering, and concentrating; Considering the properties of the extract, the factors affecting the extraction process include: the amount of extract, the concentration of the extract, the extraction time, the number of extractions, etc. Combined with the actual production, the extraction was performed twice, and the soaking time, extraction time, and the amount of water added were used as the investigation factors. The L9 (3 3 An orthogonal experiment was conducted using an orthogonal table. Because chlorogenic acid is the active ingredient in the formula's main herb, Glechoma longituba, the dry paste yield and chlorogenic acid transfer rate were used as evaluation indicators. (Orthogonal Experiment Method: Each group of crude drugs was weighed according to the prescription ratio, totaling 85g.) The orthogonal experiment method and results are shown in Tables 1 and 2.

[0029] Table 1 Level factor diagram level Extraction time (h) A Extraction volume (times) B Extract concentration (%) C 1 1 8+6 1% 2 2 10+8 5% 3 3 12+10 8% Table 2 Dry paste yield and chlorogenic acid transfer rate of each group of factors Serial number factor factor factor Evaluation indicators Evaluation indicators A B C Dry paste yield (%) Chlorogenic acid transfer rate (%) 1 1 1 1 22.72 39.91 2 1 2 2 29.55 35.92 3 1 3 3 27.48 36.32 4 2 1 2 28.79 30.98 5 2 2 3 25.46 35.29 6 2 3 1 25.86 45.25 7 3 1 3 26.63 31.40 8 3 2 1 26.68 44.63 9 3 3 2 28.35 39.83 Dry paste yield (%) K1 26.58 26.05 25.09 Dry paste yield (%) K2 26.70 27.23 28.90 Dry paste yield (%) K3 27.22 27.23 26.52 Dry paste yield (%) R 0.64 2.99 31.56 Chlorogenic acid transfer rate (%) K1 35.58 35.88 36.97 Chlorogenic acid transfer rate (%) K2 43.26 38.34 40.47 Chlorogenic acid transfer rate (%) K3 34.34 38.96 35.74 Chlorogenic acid transfer rate (%) R 1.45 6.37 8.93 It can be concluded from Table 2 above that the best extraction method for Glechoma longituba, Coix seed and Euryale ferox is: placing them in a steam explosion machine at 80°C for 30 minutes, moving them to a multi-functional extraction tank, adding 12 times 5% citric acid for the first time, extracting for 2 hours, separating the liquid and residue to obtain a first filtrate, adding 10 times 5% citric acid to the residue, extracting for 2 hours, separating the liquid and residue to obtain a second filtrate, mixing the first filtrate and the second filtrate, filtering and concentrating, and the obtained dry paste yield and chlorogenic acid transfer rate are the best.

[0030] S2, weighing licorice, Millettia reticulata, Pseudostellaria baicalensis, Panax notoginseng, and Gynostemma pentaphyllum, placing them in a multifunctional extraction tank, adding purified water, heating to boiling, extracting, and separating the liquid and residue to obtain a third filtrate, adding purified water to the filter residue, heating to boiling, extracting, and separating the liquid and residue to obtain a fourth filtrate, mixing the third filtrate and the fourth filtrate, filtering, and concentrating; during the decoction process, the steam pressure is controlled at 0.25 MPa before the medicinal liquid boils; and the steam pressure is controlled at 0.10 MPa after the medicinal liquid boils to keep the medicinal liquid boiling; Considering the properties of the extract, the factors affecting the extraction process include: soaking time, amount of extracting solution, extraction time, number of extractions, etc. Combined with the actual production, extraction was performed twice, and soaking time, extraction time, and amount of water were used as the investigation factors. L9 (3 3An orthogonal experiment was conducted using an orthogonal table. Because chlorogenic acid is the active ingredient in the formula's main herb, Glechoma longituba, the dry extract yield and flavonoid transfer rate were used as evaluation criteria. (Orthogonal experiment method: Each group of crude drugs was weighed according to the prescription ratio, totaling 85g.) The orthogonal experiment method and results are shown in Tables 3 and 4.

[0031] Table 3 Level factor table level Soaking time (min) A Extraction volume (times) B Extraction time (min) C 1 0 8+6 30 2 30 10+8 40 3 60 12+10 60 Table 4 Dry paste yield and flavonoid transfer rate of each group of factors Serial number factor factor factor Evaluation indicators Evaluation indicators A B C Dry paste yield (%) Flavonoid transfer rate (%) 1 1 1 1 23.51 40.26 2 1 2 2 26.38 36.41 3 1 3 3 27.62 36.68 4 2 1 2 25.03 32.71 5 2 2 3 29.21 36.19 6 2 3 1 26.65 46.62 7 3 1 3 26.72 34.48 8 3 2 1 27.18 48.24 9 3 3 2 28.36 41.63 Dry paste yield (%) K1 25.84 25.09 25.78 Dry paste yield (%) K2 26.96 27.59 26.59 Dry paste yield (%) K3 27.42 27.54 27.85 Dry paste yield (%) R 2.34 1.68 1.62 Flavonoid transfer rate (%) K1 37.78 35.82 45.04 Flavonoid transfer rate (%) K2 38.51 40.28 36.83 Flavonoid transfer rate (%) K3 41.36 41.55 35.78 Flavonoid transfer rate (%) R 2.73 5.26 6.48 As can be seen from Table 4, the optimal extraction process for weighing licorice, Millettia reticulata, Pseudostellaria baicalensis, Panax notoginseng, and Gynostemma pentaphyllum is as follows: adding 12 times the amount of purified water, soaking for 60 minutes, heating to boiling, extracting for 30 minutes, separating the liquid and residue, and obtaining a third filtrate; adding 10 times the amount of purified water to the filter residue, heating to boiling, extracting for 30 minutes, separating the liquid and residue, and obtaining a fourth filtrate; the third filtrate and the fourth filtrate are mixed, filtered, and concentrated; during the decoction process, the steam pressure is controlled at 0.1-0.25 MPa before the medicinal liquid boils; the steam pressure is controlled at 0.05-0.10 MPa after the medicinal liquid boils to keep the medicinal liquid boiling.

[0032] S3, weighing wine rhubarb and placing it in a multifunctional extraction tank, adding purified water, heating to boiling, extracting, and separating the liquid and residue to obtain a fifth filtrate; adding purified water to the filter residue, heating to boiling, extracting, and separating the liquid and residue to obtain a sixth filtrate; mixing the fifth filtrate and the sixth filtrate, filtering, and concentrating; during the decoction process, the steam pressure is controlled at 0.1-0.25MPa before the medicinal liquid boils; the steam pressure is controlled at 0.05-0.10MPa after the medicinal liquid boils, so that the medicinal liquid keeps boiling.

[0033] Considering the properties of the extract, the factors affecting the extraction process include extraction time, number of extractions, amount of water added, and soaking time. Combined with the actual production, the extraction was performed twice, and soaking time, extraction time, and amount of water added were used as the investigation factors. L9 (3 3 An orthogonal experiment was conducted using an orthogonal table. Because chlorogenic acid is the active ingredient in the formula's main herb, Glechoma longituba, the dry paste yield and chlorogenic acid transfer rate were used as evaluation criteria. (Orthogonal experiment method: Each group of crude drugs was weighed according to the prescription ratio, totaling 85g.) The orthogonal experiment method and results are shown in Tables 5 and 6.

[0034] Table 5 Level factor table level Soaking time (min) A Extraction volume (times) B Extraction time (min) C 1 0 8+6 30 2 30 10+8 40 3 60 12+10 60 Table 6 Dry paste yield and emodin transfer rate of each group of factors Serial number factor factor factor Evaluation indicators Evaluation indicators A B C Dry paste yield (%) Rhein transfer rate (%) 1 1 1 1 16.59 29.37 2 1 2 2 21.48 35.63 3 1 3 3 23.63 35.17 4 2 1 2 20.56 34.31 5 2 2 3 21.72 36.64 6 2 3 1 23.67 31.47 7 3 1 3 23.59 36.23 8 3 2 1 21.37 34.46 9 3 3 2 22.21 32.58 Dry paste yield (%) K1 20.57 20.25 20.54 Dry paste yield (%) K2 21.98 21.52 21.42 Dry paste yield (%) K3 22.39 23.17 22.98 Dry paste yield (%) R 3.68 3.91 2.73 Rhein transfer rate (%) K1 33.39 33.30 31.77 Rhein transfer rate (%) K2 34.14 35.58 34.17 Rhein transfer rate (%) K3 34.42 33.07 36.01 Rhein transfer rate (%) R 6.89 8.49 6.35 It can be concluded from Table 6 that the optimal extraction process of wine rhubarb is: adding 10 times the amount of pure water, soaking for 30-60 minutes, heating to boiling, extracting for 1 hour, separating the liquid and residue, and obtaining the fifth filtrate; adding 8 times the amount of pure water to the filter residue, heating to boiling, extracting for 1 hour, separating the liquid and residue, and obtaining the sixth filtrate; mixing the fifth filtrate and the sixth filtrate, filtering, and concentrating.

[0035] Example 2 A preparation method for improving the quality of active ingredients in xiancao granules, the method comprising: S1, weighing three medicinal materials, namely, Glechoma longifolia, Coix seed, and Euryale ferox, placing them in a steam explosion machine at a temperature of 80-90°C for 30-40 minutes, transferring them to a multifunctional extraction tank, adding 12 times 5% citric acid for the first time, extracting for 2 hours, separating the liquid and residue to obtain a first filtrate, adding 10 times 5% citric acid to the residue, extracting for 2 hours, separating the liquid and residue to obtain a second filtrate; S2, weighing five medicinal materials, namely, Pseudostellaria baicalensis, Millettia reticulata, Panax notoginseng, Gynostemma pentaphyllum and Licorice, placing them in a multifunctional extraction tank, adding 12-13 times the amount of purified water, soaking for 30-60 minutes, heating to boiling, extracting for 30-35 minutes, separating the liquid and residue, and obtaining a third filtrate, adding 10-11 times the amount of purified water to the filter residue, heating to boiling, extracting for 30-40 minutes, separating the liquid and residue, and obtaining a fourth filtrate; wherein, during the decoction process, the steam pressure before the medicinal liquid boils is controlled at 0.1-0.25 MPa; after the medicinal liquid boils, the steam pressure is controlled at 0.05-0.10 MPa to keep the medicinal liquid boiling; S3, weighing wine rhubarb, placing it in a multifunctional extraction tank, adding 10-11 times the amount of purified water, soaking for 30-60 minutes, heating to boiling, extracting for 50-60 minutes, and separating the liquid and residue to obtain a fifth filtrate; adding 8-9 times the amount of purified water to the residue, heating to boiling, extracting for 50-60 minutes, and separating the liquid and residue to obtain a sixth filtrate; S4, pump the first filtrate, the second filtrate, the third filtrate, the fourth filtrate, the fifth filtrate and the sixth filtrate into a single-effect concentrator unit, the concentration temperature is 90°C, the vacuum degree is -0.06~-0.08 MPa, and the filtrate is concentrated into a clear paste with a relative density of 1.10-1.15 (60°C), and the clear paste is transferred to a jacketed kettle for further concentration, and finally concentrated into a thick paste with a relative density of 1.24-1.30 (60°C); add dextrin in a ratio of 1:1.5-1.8 and place it in a blender, add the Herba Xiancao granules thick paste, stir, and then add 80-90% ethanol and stir to make a soft material until it "can be held in a ball and falls apart when pressed lightly"; transfer the prepared soft material to a swing granulator, pass through a 14-mesh sieve, and granulate; spread the prepared wet granules flat on a stainless steel tray, place them in an 85°C forced air drying oven to dry, take them out, and cool them.

[0036] Example 3 A preparation method for improving the quality of active ingredients in xiancao granules, the method comprising: S1, weighing 5100g of Glehnia littoralis, 2550g of Coix seed, and 1700g of Euryale ferox, placing them in a steam explosion machine at 80°C for 30 minutes, transferring them to a multifunctional extraction tank, adding 12 times 5% citric acid for the first time, extracting for 2 hours, separating the liquid and residue to obtain a first filtrate, adding 10 times 5% citric acid to the residue, extracting for 2 hours, separating the liquid and residue to obtain a second filtrate; S2, weighing 2550g of Pseudostellariae Radix, 2550g of Millettia reticulata, 1530g of Panax notoginseng, 1700g of Gynostemma pentaphyllum and 1020g of Glycyrrhiza uralensis, placing them in a multifunctional extraction tank, adding 12 times the amount of purified water, soaking for 60 minutes, heating to boiling, extracting for 30 minutes, separating the liquid and residue, and obtaining a third filtrate, adding 10 times the amount of purified water to the filter residue, heating to boiling, extracting for 30 minutes, separating the liquid and residue, and obtaining a fourth filtrate; wherein, during the decoction process, the steam pressure before the medicinal liquid boils is controlled at 0.25 MPa; after the medicinal liquid boils, the steam pressure is controlled at 0.10 MPa to keep the medicinal liquid boiling; S3, weighing 850g of wine rhubarb, placing it in a multifunctional extraction tank, adding 10 times the amount of purified water, soaking for 60 minutes, heating to boiling, extracting for 1 hour, and separating the liquid and residue to obtain a fifth filtrate; adding 8 times the amount of purified water to the residue, heating to boiling, extracting for 1 hour, and separating the liquid and residue to obtain a sixth filtrate; S4, pump the first filtrate, the second filtrate, the third filtrate, the fourth filtrate, the fifth filtrate and the sixth filtrate into a single-effect concentrator unit, the concentration temperature is 90℃, the vacuum degree is -0.06 MPa, and the filtrate is concentrated into a clear paste with a relative density of 1.10-1.15 (60℃). The clear paste is transferred to a jacketed kettle for further concentration, and finally concentrated into a thick paste with a relative density of 1.25 (60℃); dextrin is added in a ratio of 1:1.5 and placed in a blender, and the thick paste of grass jelly granules is added and stirred, and then 80% ethanol is added and stirred to make a soft material until it "can be held in a ball and falls apart when pressed lightly"; the prepared soft material is transferred to a swing granulator, passed through a 14-mesh sieve, and granulated; the prepared wet granules are spread flat on a stainless steel tray, placed in an 85℃ forced air drying oven to dry, taken out, and cooled to obtain grass jelly granules.

[0037] Comparative Example 1 A method for preparing grass jelly granules 1, the method comprising: S1, weighing 5100g of Glechoma longituba and 2550g of Coix lachryma-jobi, placing them in a steam explosion machine at 80°C for 30 minutes, transferring them to a multifunctional extraction tank, adding 12 times 5% citric acid for the first time, extracting for 2 hours, separating the liquid and residue to obtain a first filtrate, adding 10 times 5% citric acid to the residue, extracting for 2 hours, separating the liquid and residue to obtain a second filtrate; S2, weighing 1530g of Panax notoginseng, 1700g of Astragalus, and 1020g of Licorice, placing the four medicinal materials into a multifunctional extraction tank, adding 12 times the amount of purified water, soaking for 60 minutes, heating to boiling, extracting for 30 minutes, and separating the liquid from the residue to obtain a third filtrate, adding 10 times the amount of purified water to the filter residue, heating to boiling, extracting for 30 minutes, and separating the liquid from the residue to obtain a fourth filtrate; wherein, during the decoction process, the steam pressure before the medicinal liquid boils is controlled at 0.25 MPa; after the medicinal liquid boils, the steam pressure is controlled at 0.10 MPa to keep the medicinal liquid boiling; S3, weighing 1700g of wine rhubarb, placing it in a multifunctional extraction tank, adding 10 times the amount of purified water, soaking for 60 minutes, heating to boiling, extracting for 1 hour, and separating the liquid and residue to obtain a fifth filtrate; adding 8 times the amount of purified water to the residue, heating to boiling, extracting for 1 hour, and separating the liquid and residue to obtain a sixth filtrate; S4, pump the first filtrate, the second filtrate, the third filtrate, the fourth filtrate, the fifth filtrate and the sixth filtrate into a single-effect concentrator unit, the concentration temperature is 90℃, the vacuum degree is -0.06 MPa, and the filtrate is concentrated into a clear paste with a relative density of 1.10-1.15 (60℃). The clear paste is transferred to a jacketed kettle for further concentration, and finally concentrated into a thick paste with a relative density of 1.25 (60℃); add dextrin in a ratio of 1:1.5 and place it in a blender, add the Herba Xiancao granules thick paste, stir, and then add 80% ethanol and stir to make a soft material until it "can be held in a ball and falls apart when pressed lightly"; transfer the prepared soft material to a swing granulator, pass through a 14-mesh sieve, and granulate; spread the prepared wet granules flat on a stainless steel tray, place them in an 85℃ forced air drying oven to dry, take them out, and cool them.

[0038] Comparative Example 2 A method for preparing grass jelly granules 2, the method comprising: S1, weigh 5100g of Glehnia littoralis and crush it to 30 mesh to obtain powder 1; weigh 2550g of Pseudostellariae Radix, 850g of Rhubarb (wine-processed), 2550g of Millettia reticulata, 1700g of Gynostemma pentaphyllum and 1020g of Licorice, mix and crush to 60 mesh to obtain powder 2; weigh 2550g of Coix seed, 1700g of Euryale ferox and 1530g of Panax notoginseng, mix and crush to 200 mesh to obtain powder 3; S2, adding 12 times the volume of purified water to the powder 1, extracting by ultrasonic-immersion combined method for 3 hours, filtering to obtain filtrate 1; adding 10 times the volume of 95% ethanol to the filter residue, reflux extraction, filtering, and obtaining filtrate 2; S3, adding 15 times the volume fraction of 60% ethanol to the powder 2, reflux extraction, filtering, and obtaining filtrate 3; adding 8 times the volume fraction of 80% ethanol to the filter residue, reflux extraction, filtering, and obtaining filtrate 4; S4, adding 15 times the volume fraction of 50% ethanol to the powder 3, extracting by ultrasonic-immersion combined method for 4 hours, filtering to obtain filtrate 5; S5, uniformly mixing the filtrate 1, filtrate 2, filtrate 3, filtrate 4 and filtrate 5, concentrating and granulating to obtain the Herbal Grass Granules 2.

[0039] 1. Animals and Drugs (1) Medication Test drug: Batch number 240103, provided by the Preparation Center of Guangxi International Zhuang Hospital. Clinical dosage: Oral, one bag at a time, three times a day. Specification: Each 1g is equivalent to 2.02g of the medicinal piece.

[0040] Normal control: distilled water; negative control: irbesartan tablets, batch number: 210709JS, Jiangsu Hengrui Medicine Co., Ltd.; enteric-coated aspirin tablets, batch number: BJ50920, Bayer HealthCare Co., Ltd.

[0041] (2) Animals KM mice, SPF grade, both male and female, 18-22 g, Guangxi Medical University Experimental Animal Center, certificate number: SCXK Gui 2020-0003; SD rats, SPF grade, both male and female, 180-220 g, Changsha Tianqin Biotechnology Co., Ltd., certificate number: SCXK (Xiang) 2019-0014.

[0042] 2. Main Reagents and Instruments Streptozotocin, SIGMA, batch number: WXBD4533V; pH 4.5 citric acid-sodium citrate buffer, Beijing Biotoda Technology Co., Ltd., batch number: 20200310; urine glucose qualitative test kit (reduction method), urine protein quantitative test kit (CBB method), urea nitrogen test kit (urease method), creatinine determination kit (sarcosine oxidase method), and albumin determination kit (bromocresol green colorimetric method) are all from Nanjing Jiancheng Technology Co., Ltd.; glacial acetic acid and formaldehyde are both from Guangdong Guanghua Technology Co., Ltd.; chloral hydrate, Sinopharm Chemical Reagent Co., Ltd., batch number: 20180420; hematoxylin and eosin (HE) staining solution, Regen Biotech, batch number: 0104A21; blood glucose test strips (glucose dehydrogenase method), Roche Blood Glucose Health Care Co., Ltd., batch number: 479718.

[0043] Dosage method and frequency All experiments were performed by gavage, with a volume of 20 mL / kg for mice and 10 mL / kg for rats. Dosing was performed twice daily, once in the morning and once in the afternoon, for 3 to 14 days, depending on the experimental requirements.

[0044] Experiment 1: Diabetic nephropathy rat experiment Preparation of a diabetic nephropathy rat model: After 3 days of adaptive feeding, 100 Sprague-Dawley rats were fed a high-fat, high-sugar diet, while the remaining 10 (serving as a normal control group) were fed a normal diet. After 4 weeks of feeding, all rats in each group were fasted for 12 hours. The modeling group received a single intraperitoneal (ip) injection of 35 mg / kg streptozotocin (STZ) in citrate buffer, while the normal control group received an equivalent volume of citrate buffer. After another 2 weeks of feeding, the Sprague-Dawley rats were placed in metabolic cages, and urine was collected for glucose measurement. Blood glucose was measured by tail bleed using a glucometer. Successful modeling was defined as a blood glucose level >11.1 mmol / L, a urine volume at least twice that of the control group, and a urine glucose level (quantitatively measured using a urine glucose reagent, with urine glucose calculated as ++ = 5 g / L, +++ = 10 g / L, and ++++ = 20 g / L) exceeding "++."

[0045] Rats with successfully established diabetic nephropathy were randomly divided into a model control group, an irbesartan (27.5 mg / kg) group, and Xiancao Granules group 1, group 2, and group 3 based on their blood glucose levels. Each group received oral administration of 10 ml / kg of the drug once daily in the morning and afternoon for 14 consecutive days. The normal control and model groups received an equal volume of distilled water. Each group was weighed weekly, and blood glucose was measured before and after dosing. Urine was collected for measurement of urine volume, glucose, protein, creatinine, and urea nitrogen. After the last dose, rats were anesthetized with 10% chloral hydrate, and 1 mL of blood was drawn from the abdominal aorta for measurement of serum albumin, creatinine, and urea nitrogen. Another 3 mL of blood was collected for measurement of hemorheological parameters, including whole blood viscosity, plasma viscosity, hematocrit, erythrocyte electrophoresis time, and rigidity index. Kidneys were then harvested for wet weight calculation and pathological examination with hematoxylin and eosin staining.

[0046] Table 7 Effects of different treatment groups on body weight of diabetic nephropathy rats Group Dosage (g / kg) Before medication (g) 7 days before medication (g) 14g after taking the medicine 14d weight gain (g) Normal control group - 341.4±82.9 364.1±96.2 387.7±108.1 46.3±26.8 Model Group - 323.6±73.3 303.1±74.0 <![CDATA[263.8±68.3 * ]]> <![CDATA[-59.8±30.1 ** ]]> Irbesartan group 27.5mg 320.3±43.4 301.9±42.7 248.0±36.6 -72.3±29.1 Grass jelly granules 1 15.6 335.1±55.4 323.9±54.1 288.9±46.1 -46.2±15.4 Grass jelly granules 2 15.6 315.7±41.7 297.4±41.2 259.4±34.6 -56.3±33.8 Grass jelly granules 15.6 312.9±39.3 294.6±49.3 286.0±50.2 <![CDATA[-26.9±24.2 ∆ ]]> Compared with the normal control group, *p<0.05; **p<0.01; compared with the model group, ∆p<0.05 Table 8 Effects of different treatment groups on blood glucose in rats with diabetic nephropathy Group Dosage (g / kg) Blood glucose before medication (mmol / L) Blood glucose 14 days after medication (mmol / L) Urine sugar 14 days after medication (g / L) Normal control group - 7.21±0.49 7.80±1.15 0.00±0.00 Model Group - 18.03±1.16 <![CDATA[22.11±2.79 ** ]]> <![CDATA[16.00±5.6 ** ]]> Irbesartan group 27.5mg 17.77±1.73 <![CDATA[13.98±1.20 ∆∆ ]]> <![CDATA[6.50±2.42 ∆∆ ]]> Grass jelly granules 1 15.6 17.75±1.54 <![CDATA[15.04±2.08 ∆∆ ]]> <![CDATA[7.50±2.64 ∆∆ ]]> Grass jelly granules 2 15.6 17.73±1.52 <![CDATA[16.00±1.59 ∆∆ ]]> <![CDATA[8.50±2.42 ∆∆ ]]> Grass jelly granules 15.6 17.58±1.62 <![CDATA[15.29±2.57 ∆∆ ]]> <![CDATA[6.50±2.42 ∆∆ ]]> Compared with the normal control group, **p<0.01; compared with the model group, ∆∆p<0.01.

[0047] Table 9 Effects of different treatment groups on urine volume in diabetic nephropathy rats Group Dosage (g / kg) Before medication (mL) 14 days after medication (mL) Normal control group - 9.6±2.9 16.2±7.0 Model Group - <![CDATA[126.0±46.5 ** ]]> <![CDATA[186.0±39.5 ** ]]> Irbesartan group 27.5mg 114.0±49.6 <![CDATA[126.5±22.4 ∆∆ ]]> Grass jelly granules 1 15.6 95.5±44.9 <![CDATA[108.0±36.7 ∆∆ ]]> Grass jelly granules 2 15.6 102.5±28.5 <![CDATA[112.0±24.4 ∆∆ ]]> Grass jelly granules 15.6 123.5±51.7 <![CDATA[113.0±22.1 ∆∆ ]]> Compared with the normal control group, **p<0.01; compared with the model group, ∆∆p<0.01.

[0048] As can be seen from Tables 7-9, the body weight of rats in the model group gradually decreased over time, while blood sugar and 24-hour urine sugar volume increased significantly, showing significant differences compared with the normal control group. The body weight of rats given Xiancao Granules was better than that of the model group, and there was a significant difference in the Xiancao Granules group compared with the model group. The blood sugar and 24-hour urine sugar volume of the drug-treated groups were significantly lower than those of the model group. Compared with the model group, there were significant differences in blood sugar and 24-hour urine sugar volume in Xiancao Granules Group 1, Xiancao Granules Group 2, and Xiancao Granules Group 14 days after administration. Xiancao Granules Group 1, Xiancao Granules Group 2, and Xiancao Granules Group 14 days after administration can reduce blood sugar, urine sugar, and urine volume in rats with diabetic nephropathy. The Xiancao Granules group can alleviate the weight loss of rats. The results show that Xiancao Granules has a therapeutic effect on high blood sugar, high urine sugar, and urine volume in diabetic nephropathy.

[0049] Table 10 Effects of different treatment groups on serum renal function indices in diabetic nephropathy rats Group Dosage (g / kg) Albumin (g / L) Urea nitrogen (mmol / L) Creatinine (μmol / L) Normal control group - 31.34±6.82 1.38±0.53 42.05±8.88 Model Group - 31.55±2.90 <![CDATA[4.84±1.96 ** ]]> <![CDATA[75.00±13.46 ** ]]> Irbesartan group 27.5mg 31.13±2.56 <![CDATA[3.45±0.96 ∆ ]]> <![CDATA[50.26±18.59 ∆ ]]> Grass jelly granules 1 15.6 29.97±2.00 <![CDATA[3.28±1.35 ∆ ]]> <![CDATA[38.82±18.17 ∆∆ ]]> Grass jelly granules 2 15.6 30.89±3.02 <![CDATA[3.41±1.02 ∆ ]]> <![CDATA[50.17±14.00 ∆∆ ]]> Grass jelly granules 15.6 28.60±4.26 <![CDATA[2.34±1.07 ∆ ]]> <![CDATA[30.22±5.36 ∆∆ ]]> Compared with the normal control group, **p<0.01; compared with the model group, ∆p<0.05, ∆∆p<0.01.

[0050] Table 11 Effects of different treatment groups on urine renal function indicators in diabetic nephropathy rats Group Dosage (g / kg) Urine protein (mg / day) Urine protein (mg / day) Urea nitrogen (mmol / d) Urea nitrogen (mmol / d) Creatinine (μmol / d) Creatinine (μmol / d) Group Dosage (g / kg) Before medication After taking the medicine Before medication After taking the medicine Before medication After taking the medicine Normal control group - 7.17±1.64 6.97±1.90 16.45±4.68 21.84±8.77 89.25±16.05 75.16±17.24 Model Group - <![CDATA[27.55±11.79 ** ]]> <![CDATA[23.16±9.86 ** ]]> <![CDATA[44.05±16.28 ** ]]> <![CDATA[35.46±11.44 ** ]]> <![CDATA[70.38±22.41 ** ]]> <![CDATA[55.78±22.73 * ]]> Irbesartan group 27.5mg 24.96±18.16 24.38±10.89 41.53±19.32 32.01±10.69 66.42±27.12 66.53±12.81 Grass jelly granules 1 15.6 20.53±11.46 <![CDATA[25.39±8.22 ∆ ]]> 35.51±19.05 28.41±11.54 66.48±27.74 48.21±17.01 Grass jelly granules 2 15.6 21.99±11.45 <![CDATA[20.12±9.91 ∆ ]]> 31.99±13.62 <![CDATA[21.20±9.35 ∆∆ ]]> 61.86±18.71 56.62±14.51 Grass jelly granules 15.6 23.79±10.45 <![CDATA[24.50±12.63 ∆∆ ]]> 38.40±19.89 <![CDATA[31.42±6.33 ∆ ]]> 64.72±23.51 54.17±18.91 Compared with the normal control group, *p<0.05, **p<0.01; compared with the model group, ∆p<0.05, ∆∆p<0.01 As can be seen from Tables 10-11, the serum creatinine and serum urea nitrogen of diabetic nephropathy rats were significantly increased, and the daily excretion of protein, urea and creatinine in urine also increased significantly, which was significantly different from the normal control group; Xiancao granules were given to diabetic nephropathy rats by continuous gavage for 14 days, which significantly reduced the concentrations of urea nitrogen and creatinine in the blood. Compared with the model group, there were significant differences in serum urea nitrogen and creatinine indicators; Xiancao granules can reduce the daily excretion of urea nitrogen in urine to varying degrees, and reduce the serum urea and creatinine levels of diabetic nephropathy rats. The results show that the different components of Xiancao granules have different protective effects on renal function of diabetic nephropathy.

[0051] Table 12 Effects of different treatment groups on hemorheological parameters in rats with diabetic nephropathy Group Dosage (g / kg) Whole blood high resection Whole blood cut Whole blood low shear Normal control group - 3.42±0.81 5.51±0.80 6.98±0.65 Model Group - <![CDATA[4.90±1.02 ** ]]> <![CDATA[7.24±1.00 ** ]]> <![CDATA[8.87±0.84 ** ]]> Irbesartan group 27.5mg <![CDATA[3.86±0.93 ∆ ]]> <![CDATA[5.96±0.72 ∆ ]]> <![CDATA[7.47±1.38 ∆ ]]> Grass jelly granules group 1 15.6 <![CDATA[3.78±0.63 ∆ ]]> <![CDATA[5.97±0.66 ∆ ]]> <![CDATA[7.68±1.19 ∆ ]]> Grass jelly granules group 2 15.6 <![CDATA[4.10±0.71 ∆ ]]> <![CDATA[5.96±1.04 ∆ ]]> <![CDATA[7.53±1.18 ∆ ]]> Herba Immortal Granules 15.6 <![CDATA[4.06±1.00 ∆ ]]> <![CDATA[6.69±0.38 ∆ ]]> <![CDATA[8.28±1.68 ∆ ]]> Compared with the normal control group, *p<0.05, **p<0.01; compared with the model group, ∆p<0.05, ∆∆p<0.01 Table 13 Effects of different treatment groups on hemorheological parameters in diabetic nephropathy rats Group Dosage (g / kg) Plasma viscosity hematocrit ESR Red blood cell aggregation index Normal control group - 3.73±0.70 0.38±0.10 15.06±2.54 1.69±0.20 Model Group - <![CDATA[6.10±1.26 ** ]]> <![CDATA[0.49±0.12 * ]]> <![CDATA[19.11±1.23 ** ]]> <![CDATA[2.82±0.99 * ]]> Irbesartan group 27.5mg <![CDATA[4.02±0.56 ∆∆ ]]> <![CDATA[0.35±0.06 ∆ ]]> <![CDATA[16.10±0.95 ∆∆ ]]> <![CDATA[1.90±0.51 ∆ ]]> Grass jelly granules 1 15.6 <![CDATA[4.85±0.78 ∆ ]]> <![CDATA[0.39±0.06 ∆ ]]> <![CDATA[16.46±3.77 ∆ ]]> <![CDATA[2.01±0.57 ∆ ]]> Grass jelly granules 2 15.6 5.90±0.78 <![CDATA[0.39±0.06 ∆ ]]> <![CDATA[17.13±1.23 ∆ ]]> <![CDATA[2.31±0.63 ∆ ]]> Grass jelly granules 15.6 5.24±0.94 <![CDATA[0.41±0.14 ∆ ]]> <![CDATA[27.84±1.72 ∆ ]]> <![CDATA[2.89±1.19 ∆ ]]> Compared with the normal control group, *p<0.05, **p<0.01; compared with the model group, ∆p<0.05, ∆∆p<0.01 As can be seen from Tables 12-13, the whole blood viscosity high shear, medium shear, low shear and plasma concentration, hematocrit, erythrocyte sedimentation rate and red blood cell aggregation index of diabetic nephropathy rats were significantly increased, and there were significant differences compared with the normal control group. Xiancao Granules Group 1, Xiancao Granules Group 2 and Xiancao Granules Group were given to diabetic nephropathy rats by continuous gavage for 14 days, and the whole blood viscosity high shear, medium shear, low shear and plasma viscosity, hematocrit, erythrocyte sedimentation rate and red blood cell aggregation index were reduced to varying degrees. Compared with the model group, the whole blood viscosity high shear, medium shear, low shear and hematocrit, erythrocyte sedimentation rate and red blood cell aggregation index of Xiancao Granules Group 1, Xiancao Granules Group 2 and Xiancao Granules Group were significantly different. The results showed that Xiancao Granules Group 1, Xiancao Granules Group 2 and Xiancao Granules Group had an improving effect on the abnormal blood rheology indicators of diabetic nephropathy.

[0052] Table 14 Effects of different treatment groups on the renal coefficient of diabetic nephropathy rats Group Dosage (g / kg) Kidney coefficient (g / 100g) Normal control group - 0.61±0.05 Model Group - <![CDATA[1.00±0.09 ** ]]> Irbesartan group 27.5mg 1.03±0.06 Grass jelly granules 1 15.6 1.03±0.06 Grass jelly granules 2 15.6 1.07±0.19 Grass jelly granules 15.6 0.96±0.05 Compared with the normal control group, **p<0.01.

[0053] From Table 14 and Figure 1-2 It can be seen that diabetic nephropathy patients had larger kidneys and a significantly increased renal coefficient, showing significant differences compared with the normal control group. Kidneys from each group were sampled, sectioned, and stained with hematoxylin and eosin (HE) staining. Histopathological examination under a 100x optical microscope revealed that in the normal control group, the renal cortical corpuscles and glomeruli were small, evenly distributed, and dense, with smaller tubular diameters, a uniform and dense medulla, and smaller collecting duct diameters. In the model group, the renal cortical corpuscles and glomeruli were large, prominently round or oval, unevenly distributed, and less dense. Glomeruli showed frequent eosinophilic infiltration, with wider tubular diameters, a lighter, looser medulla, and enlarged collecting duct diameters. In all treatment groups, the renal cortical corpuscles and glomeruli were smaller, with normal shape, distribution, density, and tubular diameters. Glomerular eosinophilic infiltration was less, the medulla showed improved color, and the collecting duct diameters were significantly smaller than those in the model group. This suggests that Xiancao granules have little effect on the renal coefficient in diabetic nephropathy, but do have a protective effect on renal tissue changes.

[0054] Experiment 2: Water-loaded rat experiment Seventy healthy rats, half male and half female, were gavaged with 22 mL / kg of distilled water based on body weight to achieve water balance. Urine was collected over a 24-hour period. Rats with urine output exceeding 40% of water load were considered to meet water load requirements. Sixty rats with water load requirements were randomly divided into a model group, an irbesartan (27.5 mg / kg) group, and Xiancao Granules 1, 2, and 3 groups, with 10 rats in each group. Ten healthy rats served as a control group. All groups received 10 mL / kg of distilled water via gavage once daily in the morning and afternoon for 14 consecutive days. The control and model groups received an equal volume of distilled water via gavage. The day before the last dose, the animals were fasted for 16 hours. One hour after the last dose, they were gavaged with 50 mL / kg of 1% sodium chloride solution. The bladders were squeezed empty, and the rats were placed in metabolic cages and their urine output and time of first urination were recorded over a 6-hour period.

[0055] Table 15 Effects of water loading on urine volume in rats treated with different groups Group Dosage (g / kg) Urine volume within 6 hours (mL) Time to first urination (min) Normal control group - 8.0±2.7 17.6±4.3 Irbesartan group 27.5mg <![CDATA[11.7±3.6 * ]]> <![CDATA[31.4±12.7 * ]]> Grass jelly granules 1 15.6 8.9±2.7 <![CDATA[36.3±9.1 ** <!-- 11 -->]]> Grass jelly granules 2 15.6 6.5±3.0 <![CDATA[37.9±8.5 ** ]]> Grass jelly granules 15.6 7.6±2.1 <![CDATA[40.8±7.0 ** ]]> Compared with the normal control group, *p<0.05; **p<0.01.

[0056] As can be seen from Table 15, the first urination time of rats given Xiancao Granules 1, Xiancao Granules 2 and Xiancao Granules with water was significantly prolonged, indicating that they all have the effect of delaying urination time.

[0057] Experiment 3: Acetic acid-induced pain in mice Fifty mice, half male and half female, were randomly divided into a normal control group, aspirin (0.2 g / kg), and Xiancao Granule 1, Xiancao Granule 2, and Xiancao Granule groups, with 10 mice in each group. Each group received oral administration of 20 mL / kg of distilled water once daily in the morning and afternoon for three consecutive days. The normal and model control groups received an equal volume of distilled water. One hour after the last administration, each mouse received 0.6% acetic acid solution intravenously at 10 mL / kg body weight. The time to first writhing and the number of writhing reactions within 15 minutes were recorded. The time to first writhing and the number of writhing reactions were used as pain response indicators. The mean and variance of each group were calculated, and a t-test was performed between groups. The depression rate (%) for each group was calculated as (number of writhing reactions in the blank group - number of writhing reactions in the treated group) / number of writhing reactions in the blank group × 100%.

[0058] Table 16 Effects of acetic acid-induced pain in mice treated with different groups Group Dosage (g / kg) Number of twists (times) Twist time (sec) Normal control group - 17.0±6.4 312.8±105.7 Aspirin group 0.2 <![CDATA[6.1±5.8 ** ]]> <![CDATA[485.0±238.3 * ]]> Grass jelly granules 1 15.6 15.2±9.3 311.2±154.2 Grass jelly granules 2 15.6 <![CDATA[10.6±5.6 * ]]> 254.7±57.8 Grass jelly granules 15.6 <![CDATA[9.5±6.1 * ]]> 347.2±169.3 Compared with the normal control group, *p<0.05, **p<0.01.

[0059] As can be seen from Table 16, the number of writhing times of mice given Xiancao Granules 1, Xiancao Granules 2 and Xiancao Granules was reduced, indicating that Xiancao Granules 1, Xiancao Granules 2 and Xiancao Granules all have analgesic effects to a certain extent, which shows that the Xiancao Granules prepared by the method of the present invention are better than Xiancao Granules 2. It may be that the product obtained by this preparation method has more effective ingredients and therefore has the best analgesic effect.

[0060] Comparative Example 3 The filtrates of S1, S2 and S3 of Example 1 were concentrated. S4, pump the filtrate into a single-effect concentrator unit, with a concentration temperature of 90°C and a vacuum degree of -0.06 MPa, and concentrate it into a clear paste with a relative density of 1.10-1.15 (60°C). The clear paste is transferred to a jacketed kettle for further concentration, and finally concentrated into a thick paste with a relative density of 1.20 (60°C); add an appropriate amount of dextrin to the thick paste, mix, and granulate.

[0061] Comparative Example 4 The filtrates of S1, S2 and S3 of Example 1 were concentrated. S4, pump the filtrate into a single-effect concentrator unit, with a concentration temperature of 90°C and a vacuum degree of -0.06 MPa, and concentrate it into a clear paste with a relative density of 1.10-1.15 (60°C). The clear paste is transferred to a jacketed kettle for further concentration, and finally concentrated into a thick paste with a relative density of 1.30 (60°C); add an appropriate amount of dextrin to the thick paste, mix, and granulate.

[0062] Example 3, Comparative Example 3 and Comparative Example 4 were used to investigate the effect of thick pastes with different relative densities on granulation. The concentration process conditions were evaluated using the wet material condition after mixing and the granulation effect as indicators. The results are shown in Table 17.

[0063] Table 17 Concentration process conditions test results serial number Relative density (60-70℃) Thick paste amount (g) Soft material situation Particle properties Example 3 1.25 100 Easy to make soft material, no sticking, falls apart when touched by hand, no lumps Easy to sift, no sticking to the sieve Comparative Example 3 1.20 100 Soft materials are sticky and difficult to granulate Not easy to sieve, slightly sticky Comparative Example 4 1.30 100 Adhesion, loose, difficult to granulate Easy to sift, no sticking to the sieve Table 17 shows that when the relative density of the thick paste is 1.25 (60-70°C), the water content is moderate, making it easy to mix with the medicinal material powder. The wet material can be picked up and formed into a mass, and it disperses easily. However, if the density of the thick paste is too high, it will result in significant losses during production; if the density is too low, excessive excipients will be used, resulting in low drug loading. Therefore, when the relative density of the thick paste is 1.25 (60-70°C), the granulation effect of the prepared wet material is optimal.

[0064] Comparative Example 5 The filtrates of S1, S2 and S3 of Example 1 were concentrated. S4, pump the filtrate into a single-effect concentrator unit, the concentration temperature is 90℃, the vacuum degree is -0.06 MPa, and it is concentrated into a clear paste with a relative density of 1.10-1.15 (60℃). The clear paste is transferred to a double-layer pot for further concentration, and finally concentrated into a thick paste with a relative density of 1.25 (60℃); take about 100g of the thick paste and add starch in a ratio of 1:1.5 and place it in a blender, add the Herba Xiancao granules thick paste, stir, and then add 80% ethanol and stir to make a soft material until it "can be held in the hand and falls apart when pressed lightly"; transfer the prepared soft material to a swing granulator, pass through a 14-mesh sieve, and granulate; spread the prepared wet granules flat on a stainless steel tray, place them in an 85℃ forced air drying oven and dry for 3 hours, sieve the granules with a No. 1 sieve, and obtain granules.

[0065] Comparative Example 6 The filtrates of S1, S2 and S3 of Example 1 were concentrated. S4, pump the filtrate into a single-effect concentrator unit, the concentration temperature is 90℃, the vacuum degree is -0.06 MPa, and it is concentrated into a clear paste with a relative density of 1.10-1.15 (60℃). The clear paste is transferred to a double-layer pot for further concentration, and finally concentrated into a thick paste with a relative density of 1.25 (60℃); about 100g of the thick paste is added with sucrose in a ratio of 1:1.5 and placed in a blender, and the Herba Xiancao granules thick paste is added and stirred, and then 80% ethanol is added and stirred to make a soft material until it "can be held in a ball and falls apart when pressed lightly"; the prepared soft material is transferred to a swing granulator, passed through a 14-mesh sieve, and granulated; the prepared wet granules are spread flat on a stainless steel tray, placed in an 85℃ forced air drying oven and dried for 3 hours, and sieved through a No. 1 sieve to obtain granules.

[0066] The granule formation rates of Example 3, Comparative Example 5, and Comparative Example 6 were examined to screen suitable excipients. The formation rate was determined by sequentially passing the prepared granules through a No. 1 sieve and a No. 5 sieve, and calculating the rate using the following formula: Formation rate = weight of granules passing through the No. 1 sieve and not passing through the No. 5 sieve / total granule weight × 100%.

[0067] Table 18 Granulation experiment results of different excipients Group Excipients-thick paste (g / g) Particle forming rate Granulation conditions Example 3 Dextrin 150.04 : Thick paste 100.14 90.0% Easy to granulate, suitable particle size Comparative Example 5 Starch 150.27 : Thick paste 100.68 75.7% More agglomerates, difficult to granulate Comparative Example 6 Sucrose 150.51 : Thick paste 100.56 65.1% Most of them clump together and are not easy to granulate. As can be seen from Table 18, Chinese herbal extracts are highly hygroscopic, and the addition of different excipients has a certain impact on the safety, effectiveness, and stability of the preparation. For example, using sucrose as an excipient results in a soft material that is too sticky and contains many lumps, making granulation difficult. Using starch as an excipient also results in a soft material with many lumps, making granulation difficult. Using dextrin as an excipient results in a soft material with fewer lumps. Dextrin-based granules have the highest molding rate and are more uniform. Therefore, choosing dextrin as an excipient not only makes it easier to prepare the soft material and produce granules with good properties, but also requires less dextrin for the same thick paste. For the same drug dosage, fewer granules are produced, resulting in a smaller dosage for the patient.

[0068] According to the method of the present invention, multiple batches of grass jelly granules were produced, and the yield rate is shown in Table 19 below.

[0069] Table 19: Pilot test results of granulation of Xiancao granules batch Feeding amount (kg) Thick paste weight (kg) Relative density (60℃) Dextrin weight (kg) Particle weight (kg) Theoretical finished product quantity (bag) Actual finished product quantity (bags) Yield rate (%) 20201201 24.74 7.65 1.2701 10.71 11.36 873 797 91.3 20201202 24.74 8.45 1.2638 13.52 12.03 873 845 96.8 20201203 24.74 9.06 1.2402 14.13 11.99 873 833 95.4 240101 38.44 11.53 1.2467 20.54 16.97 1357 1190 87.7 240102 38.44 12.37 1.2570 18.55 18.14 1357 1285 94.7 240103 38.44 15.57 1.2368 23.35 18.81 1357 1319 97.2 As can be seen from Table 19, the preparation process using the method of the present invention has a good yield for preparing grass jelly granules, and the method is stable and feasible.

[0070] The present invention can be implemented in various ways and is not limited to the embodiments described above. A person skilled in the art will appreciate that the present invention can be implemented in other specific ways without changing the technical concept or essential features of the present invention. Therefore, it should be understood that the embodiments described above are illustrative and not intended to limit the present invention.

Claims

1. A herbal jelly granule, characterized in that: The raw materials of the herbal jelly granules include: Pigweed, Millettia reticulata, Rhubarb, Coix seed, Euryale ferox, Pseudostellaria baicalensis, Panax notoginseng, Gynostemma pentaphyllum and Licorice.

2. The herbal jelly granules according to claim 1, characterized in that According to the mass-volume ratio, the ratio of Glehnia littoralis: Millettia reticulata: Coix lachryma-jobi: Pseudostellaria baicalensis: Gynostemma pentaphyllum: Euryale ferox: Rhubarb (wine-cooked) = 6:3:3:3:2:2:1; the ratio of Glehnia littoralis: Panax notoginseng: Licorice root = 10:3:

2.

3. A preparation method for improving the quality of the active ingredients in Xiancao granules, characterized in that: The preparation method comprises: S1, taking Glechoma longituba, Coix seed and Euryale ferox, steam-exploding them, placing them in an extraction tank, adding weak acid for the first time, extracting, separating the liquid and residue, obtaining a first filtrate, adding weak acid to the residue, extracting, separating the liquid and residue, obtaining a second filtrate; S2, taking Pseudostellariae Radix, Panax Notoginseng, Gynostemma Pentaphyllum, Millettia Spatholobi and Glycyrrhizae Radix, placing them in an extraction tank, adding water, soaking, decocting and extracting, separating the liquid and residue to obtain a third filtrate, adding purified water to the filter residue, decocting and extracting, separating the liquid and residue to obtain a fourth filtrate; S3, weighing wine rhubarb, placing it in a multifunctional extraction tank, adding purified water, soaking, boiling and extracting, separating the liquid and residue, and obtaining a fifth filtrate; adding purified water to the filter residue, boiling and extracting, separating the liquid and residue, and obtaining a sixth filtrate; S4, the first filtrate, the second filtrate, the third filtrate, the fourth filtrate, the fifth filtrate and the sixth filtrate are mixed and concentrated to form a clear paste, the clear paste is further concentrated, and finally concentrated into a thick paste with a relative density of 1.24-1.30; the auxiliary materials and the thick paste are placed in a blender according to a preset ratio and stirred, and then 80%-90% ethanol is added and stirred to form a soft material; the prepared soft material is transferred to a swing granulator, sieved, granulated, dried, taken out, and cooled to obtain the grass jelly granules.

4. The method for preparing the effective ingredient of the herbal granules according to claim 3, wherein: The weak acid is 1%-5% citric acid.

5. The method for preparing the effective ingredient of the herbal granules according to claim 3, wherein: The steam explosion is carried out by placing the mixture in a steam explosion machine at a temperature of 80-90° C. for 30-40 minutes.

6. The method for preparing the effective ingredient of Xiancao granules according to claim 3, wherein: The preparation methods of the third filtrate and the fourth filtrate are specifically as follows: Weigh Pseudostellariae Radix, Panax notoginseng, Gynostemma pentaphyllum and Licorice, place them in an extraction tank, add 12-13 times the amount of purified water, soak for 50-60 minutes, heat to boiling, decoct and extract for 30-35 minutes, separate the liquid and residue, and obtain a third filtrate. Add 10-11 times the amount of purified water to the residue, heat to boiling, decoct and extract for 30-40 minutes, separate the liquid and residue, and obtain a fourth filtrate.

7. The method for preparing the effective ingredient of the herbal granules according to claim 3, wherein: The preparation methods of the fifth filtrate and the sixth filtrate are as follows: Weigh wine rhubarb, place it in a multifunctional extraction tank, add 10-11 times the amount of pure water, soak for 30-60 minutes, heat to boiling, decoct and extract for 50-60 minutes, separate the liquid and residue, and obtain a fifth filtrate; add 8-9 times the amount of pure water to the filter residue, heat to boiling, decoct and extract for 50-60 minutes, separate the liquid and residue, and obtain a sixth filtrate.

8. The method for preparing the effective ingredients of Xiancao granules according to claim 6 or 7, characterized in that: In steps S2 and S3, the decoction extraction process is specifically controlled as follows: during the decoction process, the steam pressure is controlled at 0.1-0.25 MPa before the medicinal liquid boils; and the steam pressure is controlled at 0.05-0.10 MPa after the medicinal liquid boils, so that the medicinal liquid remains boiling.

9. The method for preparing the effective ingredient of Xiancao granules according to claim 3, wherein: In step S4, the auxiliary material and the thick paste are placed in a blender and stirred at a mass ratio of 1.5-1.8:1, wherein the auxiliary material is dextrin.

10. The method for preparing the effective ingredients of Xiancao granules according to claim 3, wherein: In step S4, the concentration process is performed at a concentration temperature of 70-90° C. and a vacuum degree of -0.06 to -0.08 MPa.

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