Radix rehmanniae and radix asparagi compound granules and preparation method thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicine, and discloses a radix rehmanniae and radix asparagi compound granule and a preparation method thereof.The compound granule comprises, by weight, 6-10 parts of radix rehmanniae, 6-10 parts of radix asparagi, 8-12 parts of radix ophiopogonis, 4-8 parts of rhizoma anemarrhenae, 5-7 parts of radix puerariae, 3-5 parts of radix trichosanthis, 3-5 parts of rhizoma coptidis, 3-5 parts of prepared radix polygonati officinalis, 1-2 parts of ginseng and 1-2 parts of liquorice. And 2 to 3 parts of a hydroxypropyl-beta-cyclodextrin inclusion compound. The radix rehmanniae, the radix puerariae, the rhizoma coptidis and the prepared rhizoma polygonati odorati are added on the basis of the radix asparagi soup, a system of nourishing yin, clearing heat, promoting salivation and reducing blood glucose is subjected to quaternary composite linkage, and glucose metabolism is adjusted in a multi-target manner; through the flow process of plate-and-frame pressure filtration and rough filtration, ceramic membrane fine filtration, triple-effect energy-saving concentration and liquid nitrogen freeze-drying granulation, the component loss of traditional Chinese medicine granules is reduced, the production energy consumption is reduced, and the utilization rate and the extraction rate of raw materials are improved; hydroxypropyl-beta-cyclodextrin is used for inclusion of insoluble traditional Chinese medicine components, stabilizing and solubilizing of effective components are achieved, the taste of the medicine is improved, and the hydroxypropyl-beta-cyclodextrin serves as an auxiliary material to enhance the storage stability of the traditional Chinese medicine granules.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of traditional Chinese medicine, and particularly relates to a radix rehmanniae and radix ophiopogonis compound granule and a preparation method thereof. BACKGROUND

[0002] Diabetes is a metabolic disease mainly characterized by high blood sugar. Long-term poor blood sugar control can cause damage to multiple systems. According to traditional Chinese medicine, diabetes is classified into the category of 'consumption' (Xiao Ke). According to different pathogenesis and clinical manifestations, consumption can be divided into three types: upper consumption, middle consumption and lower consumption. Upper consumption is mainly caused by lung dryness and fluid loss, and is manifested as polydipsia. Middle consumption is mainly caused by stomach heat, and is manifested as polyphagia and easy hunger. Lower consumption is mainly caused by kidney yin deficiency or yin and yang deficiency, and is mainly manifested as polyuria and emaciation. Modern medicine believes that the high blood sugar state can cause the osmotic pressure of blood to rise and the body fluid to be consumed. According to traditional Chinese medicine theory, it is summarized as 'fluid deficiency'. Chronic disease can further develop into deficiency of both qi and blood, and damage of both yin and yang.

[0003] In treatment, traditional Chinese medicine pays attention to the principles of nourishing yin and clearing heat, and tonifying qi and generating fluid. As a classic prescription, Erdong Decoction uses radix ophiopogonis and radix ophiopogonis as the monarch drug to nourish yin and moisten the lung. For the treatment of upper consumption of lung dryness, the compound granule is optimized on the basis of Erdong Decoction. The compound granule enhances the effects of the whole prescription in nourishing yin and generating fluid and clearing heat and reducing sugar by combination. The monarch drug is radix rehmanniae to nourish yin and moisten dryness. The ministerial drug is radix ophiopogonis, radix ophiopogonis, and rhizoma anemarrhenae to enhance the effects of clearing heat, cooling blood, generating fluid and stopping thirst. The auxiliary drug is pueraria to ascend yang and generate fluid, radix bupleuri to clear heat and moisten the lung, rhizoma coptidis to clear stomach heat, and processed rhizoma polygonati to nourish yin and moisten dryness, which takes into account the upper, middle and lower consumption. The ministerial drug is radix ginseng to tonify qi and generate fluid, and liquorice to harmonize all drugs, which takes into account the root and branch. In modern medicine, radix rehmanniae contains radix rehmanniae root polysaccharide, radix ophiopogonis contains radix ophiopogonis polysaccharide, pueraria contains puerarin, rhizoma coptidis contains berberine, and processed rhizoma polygonati contains polygonatum polysaccharide, which have a significant effect on relieving dry mouth and improving insulin resistance.

[0004] CN113813361A is a composition for treating diabetes and a preparation method thereof. The composition is prepared by extracting effective components from traditional Chinese medicine raw materials to enhance the effect, but it has defects in nourishing yin and moistening dryness, nourishing yin and generating fluid, and treating diabetes, and cannot take into account the treatment of upper, middle and lower consumption of diabetes. In addition, the use of ethanol infiltration can lead to insufficient dissolution of macromolecular components. The use of microcrystalline cellulose and gelatin for wrapping can adsorb part of the effective components, reduce the in vitro dissolution rate, have strong hygroscopicity, and cause problems such as instability of the preparation.

[0005] In summary, the optimization of the Erdong Decoction formula to treat diabetes mellitus and consumption has application in the technical field of traditional Chinese medicine, but there are still problems such as single effect of treating consumption, large loss of raw materials, low absorption rate of granules in the human body, low molding rate, high hygroscopicity, instability of the preparation, etc. Therefore, a stable radix rehmanniae and radix ophiopogonis compound granule needs to be developed to achieve the treatment of upper, middle and lower consumption of diabetes mellitus and consumption, reduce the loss of raw materials, and improve the absorption rate of the preparation in the human body. Summary of the Invention

[0006] The purpose of this invention is to provide a compound granule containing Rehmannia glutinosa and Ophiopogon japonicus. Based on the traditional Erdong Decoction, this compound granule innovatively introduces four medicinal herbs: Rehmannia glutinosa, Anemarrhena asphodeloides, Pueraria lobata, and processed Polygonatum odoratum. These herbs synergistically enhance the effects of the principal herbs, Asparagus cochinchinensis and Ophiopogon japonicus, forming a multi-target, multi-pathway compound preparation that nourishes Yin and clears heat, promotes body fluid production and quenches thirst, and invigorates Qi and strengthens the body. This invention targets the core pathogenesis of diabetes mellitus, optimizing the formulation to enhance the comprehensive efficacy of nourishing Yin and moistening dryness, clearing heat and purging fire, promoting body fluid production and quenching thirst, and invigorating Qi and strengthening the body's foundation. It also considers modern pharmacological mechanisms to improve glucose metabolism disorders and related symptoms.

[0007] The objective of this invention is achieved through the following solution: A compound granule containing Rehmannia glutinosa, Asparagus cochinchinensis, and Ophiopogon japonicus, comprising the following components by weight: 6-10 parts Rehmannia glutinosa, 6-10 parts Asparagus cochinchinensis, 8-12 parts Ophiopogon japonicus, and 4-8 parts Anemarrhena asphodeloides.

[0008] Preferably, the compound granules comprise the following components by weight: 7-9 parts Rehmannia glutinosa, 7-9 parts Asparagus cochinchinensis, 9-11 parts Ophiopogon japonicus, and 5-7 parts Anemarrhena asphodeloides.

[0009] Rehmannia glutinosa: Clears heat and nourishes yin, promotes the production of body fluids, relieves symptoms of diabetes such as frequent thirst and excessive drinking, and frequent urination. The rehmannia glutinosa alcohol contained therein can inhibit advanced glycation end products and prevent diabetic nephropathy. Asparagus: Nourishes kidney yin, clears lung and stomach dryness and heat, relieves symptoms of upper wasting disease, and contains asparagus polysaccharides that stimulate salivary gland secretion and relieve dry mouth; Ophiopogon japonicus: Nourishes lung and stomach yin, improves symptoms of upper and middle wasting disease such as dry mouth and dry throat, and contains Ophiopogon japonicus polysaccharides that repair salivary gland cells and relieve dry mouth; Anemarrhena asphodeloides: Clears lung heat and excess heat, improves excessive thirst and appetite. The anemarrhena saponins it contains can activate the adenosine monophosphate-activated protein kinase pathway, promote glucose uptake, and improve insulin resistance.

[0010] Rehmannia root directly enters the kidney meridian, nourishing kidney yin and fundamentally resolving the yin deficiency in diabetes, targeting the root cause of the disease, and is used as the principal herb. Asparagus root, Ophiopogon root, and Anemarrhena root are used as assistant herbs. The two herbs work together with Rehmannia root to nourish kidney yin and stomach yin, improve lung fire and stomach fire, and help expand the scope of yin nourishment. Anemarrhena root and Rehmannia root are a classic herb pair, working together to nourish yin and reduce fire. The four herbs cover all symptoms of diabetes, such as dry mouth, excessive appetite, and frequent urination.

[0011] Preferably, the compound granules further include the following components in parts by weight: 5-7 parts of kudzu root, 3-5 parts of trichosanthes root, 3-5 parts of coptis root, 3-5 parts of prepared polygonatum root, 1-2 parts of ginseng, 1-2 parts of licorice root, and 2-3 parts of hydroxypropyl-β-cyclodextrin inclusion complex.

[0012] Kudzu root: It invigorates the stomach qi and promotes the upward flow of body fluids, directly relieving symptoms of thirst and other symptoms of upper thirst. It also assists the two winters in generating body fluids and quenching thirst. The puerarin it contains can improve insulin sensitivity and glucose tolerance. Trichosanthes kirilowii: Clears lung and stomach heat, promotes body fluid production and moistens dryness, can treat diabetes, assists Anemarrhena asphodeloides and Coptis chinensis in enhancing the heat-clearing and fire-reducing effects, assists in clearing heat and detoxifying to relieve skin infections, and can reduce pancreatic β-cell apoptosis; Coptis chinensis: Coptis chinensis directly clears stomach fire and is suitable for symptoms of wasting disease such as excessive hunger, dry mouth and bitter taste. When used with Anemarrhena asphodeloides, it can clear dryness and heat in the lungs and stomach. Coptis chinensis is bitter and cold and can balance the internal damp heat of Yin-nourishing herbs such as Rehmannia glutinosa. Berberine contained in it can inhibit α-glucosidase and reduce intestinal sugar absorption. Processed Solomon's Seal: Nourishing without being greasy, it gently nourishes the spleen and stomach, can improve the deficiency of both qi and yin in the later stage of diabetes, and assists the two winters in enhancing the effects of nourishing yin and generating fluids. The Solomon's Seal polysaccharide it contains can promote saliva secretion and enhance the moisture of the oral cavity and digestive mucosa. Ginseng: It tonifies the Qi of the spleen and lungs, can improve the Qi deficiency symptoms in the later stage of diabetes mellitus, promote the production of body fluids, assist Rehmannia glutinosa in forming a "Qi and Yin tonifying" structure, assist Ophiopogon japonicus and Asparagus cochinchinensis in relieving dry mouth, restrain the cold nature of Coptis chinensis and Anemarrhena asphodeloides, protect the middle Jiao, and the ginsenoside Rg3 contained therein can promote β cell regeneration. Licorice: It assists ginseng in enhancing its qi-tonifying effect, combined with its "strengthening the earth to generate metal" effect, assists kudzu root in raising yang and benefiting the stomach, improves gastrointestinal dysfunction in diabetes, and neutralizes the cold nature of coptis and anemarrhena. The glycyrrhizic acid it contains has a liver-protecting effect, reducing the liver burden of long-term medication.

[0013] Kudzu root, trichosanthes root, coptis root, and prepared polygonatum root are used as adjuvant herbs to enhance the efficacy of the main herbs on the basis of nourishing yin and clearing heat in the whole formula. At the same time, they also take into account the symptoms of excessive heat, fluid depletion, and qi deficiency in diabetes mellitus, and improve the symptoms of upper, middle and lower diabetes. Ginseng and licorice are used as guiding herbs to harmonize and enhance the effects of the whole formula. They work together with the principal, assistant and adjuvant herbs to build a more complete system of nourishing yin, clearing heat, generating fluid and quenching thirst.

[0014] Hydroxypropyl-β-cyclodextrin inclusion complex: improves the solubility of active ingredients in traditional Chinese medicine, enhances the stability of traditional Chinese medicine, increases the granule formation rate, and reduces its moisture absorption rate.

[0015] Preferably, the raw Rehmannia is one or both of fresh Rehmannia or dried Rehmannia, and the thickness of the slices is 1-3 mm.

[0016] Fresh and dried Rehmannia glutinosa contain a large amount of catalpol, an active ingredient that has hypoglycemic and anti-inflammatory effects. However, the catalpol content in processed Rehmannia glutinosa is significantly reduced, and processed Rehmannia glutinosa is warm and greasy in nature, which aggravates yin deficiency and damp-heat.

[0017] Preferably, the processed Solomon's Seal is steamed Solomon's Seal with a sheet thickness of 1-3 mm; the ginseng is crushed ginseng with a particle size of 0.6-1.5 mm.

[0018] After being steamed, the polysaccharides in Polygonatum odoratum can be hydrolyzed into smaller molecule polysaccharides that are more easily absorbed by the human body, resulting in a higher dissolution rate and enhanced hypoglycemic effect. Other processed Polygonatum odoratum, such as honey-processed or wine-processed Polygonatum odoratum, affect blood sugar levels and are not suitable for this compound granule. 1-3mm thick slices ensure the dissolution of active ingredients and are compatible with various extraction processes. Ginseng is crushed to a particle size of 0.6-1.5mm to reduce raw material loss and improve raw material utilization. Controlling the size of the slices and particles can enhance the dissolution rate of Chinese medicine components in aqueous solution and fully release intracellular active ingredients.

[0019] Preferably, the hydroxypropyl-β-cyclodextrin inclusion complex is prepared by combining anemarrhena saponin, hydroxypropyl-β-cyclodextrin inclusion complex, and erythritol in a 3:2:1 ratio.

[0020] Anemarrhena saponins have anti-inflammatory and hypoglycemic effects, help improve complications of diabetes, directly activate the adenosine monophosphate-activated protein kinase pathway, and enhance insulin sensitivity. Anemarrhena saponins are lipid-soluble components and belong to poorly soluble drugs. Hydroxypropyl-β-cyclodextrin has a cyclic cavity structure; the hydrophobic cavity encapsulates the hydrophobic portion of anemarrhena saponins, while the hydrophilic group improves the solubility of anemarrhena saponins. Hydroxypropyl-β-cyclodextrin can reduce hygroscopicity, resulting in a particle repose angle <40 degrees. Its cyclic structure forms intermolecular forces with the traditional Chinese medicine extract, improving binding capacity and particle mechanical strength. Hydroxypropyl-β-cyclodextrin has a low absorption rate in the human body, while erythritol is passively absorbed in the small intestine. Neither participates in energy metabolism and does not affect blood glucose levels. Simultaneously, erythritol acts as a flavoring agent, reducing the bitterness of the compound granules.

[0021] A method for preparing the above-mentioned Rehmannia glutinosa and Ophiopogon japonicus compound granules includes the following steps: S1. Ginseng is crushed at low temperature and then weighed out asparagus, ophiopogon japonicus, rehmannia glutinosa, anemarrhena asphodeloides, kudzu root, trichosanthes kirilowii, coptis chinensis, prepared polygonatum odoratum, licorice and ginseng and placed in a decoction container. Add 0.5% cellulase and pectinase solution prepared in a 1:1 ratio and soak in a constant temperature water bath for 30-60 minutes. S2, add water to the soaked solid-liquid mixture to make up to 8 times the volume, decoct for 40-60 minutes, and filter out the liquid; add water to the dregs to make up to 6 times the volume, decoct for 30-50 minutes, and filter out the liquid; combine the two decoctions, filter through a plate and frame filter press, and then finely filter through a ceramic membrane; concentrate the liquid to a clear paste using a triple-effect energy-saving process. S3, mix the extract and hydroxypropyl-β-cyclodextrin inclusion complex in a 5:1 ratio, and granulate by freeze-drying to obtain the compound granules of Rehmannia glutinosa and Ophiopogon japonicus.

[0022] Preferably, the specific conditions for filtration and concentration in step S2 are as follows: the decoction is filtered twice while hot, a 10-20 μm filter cloth is selected and maintained at 50-60°C, initially at 0.1 MPa, gradually increasing to 0.3-0.6 MPa, and then filtered through a plate and frame filter press with gradual pressure increase and heat preservation. After passing through a 100-mesh sieve, it is finely filtered through a ceramic membrane at 40°C. The filtrate is pumped into a first-effect evaporator at 70-80°C, a second-effect evaporator at 60-70°C, and a third-effect evaporator at 50-60°C, and concentrated to 1.10-1.20 g / mL to obtain a clear extract.

[0023] Plate and frame filter presses perform coarse filtration to remove large particulate impurities, avoiding clogging of ceramic membranes during fine filtration. Ceramic membranes can trap tiny particles, retaining small-molecule active ingredients, and can be repeatedly sterilized and regenerated. Triple-effect energy-saving concentration utilizes the waste heat of secondary steam to reduce energy consumption and minimize damage to heat-sensitive components. Gradual pressure filtration in plate and frame filter presses can prevent large-molecule components in the liquid from clogging the filter membrane, reducing damage to the molecular structure and protecting heat-sensitive active ingredients.

[0024] Preferably, the specific conditions for freeze-drying granulation in step S3 are as follows: the extract is passed through a 100-mesh sieve, atomized in liquid nitrogen at -196°C and frozen at a pressure of 5-10 MPa, vacuum sublimated and dried, then injected into a mold, pre-frozen at -80 to -50°C for 2-3 hours, sublimated at -30 to -20°C, pulverized and sieved to obtain compound granules.

[0025] Liquid nitrogen instantly freezes the extract at -196℃, avoiding the damage to heat-sensitive components of traditional Chinese medicine at the temperature of traditional dry granulation and protecting easily oxidized components; after freeze sublimation, a porous network structure is left inside the granules, improving the rehydration and solubility of the granules; after freeze drying, the low water content reduces the risk of mold growth, enhances the stability of the granules, and extends the storage time.

[0026] The beneficial effects of this invention are as follows: (1) Add Rehmannia glutinosa, Pueraria lobata, Coptis chinensis and Polygonatum odoratum to Erdong Decoction. The four-element compound linkage system of "nourishing yin-clearing heat-generating fluid-lowering blood sugar" regulates sugar metabolism at multiple targets. (2) By using the process of plate and frame filter press coarse filtration - ceramic membrane fine filtration - triple-effect energy-saving concentration - liquid nitrogen freeze drying granulation, the production process is optimized, the loss of Chinese medicine granule components is reduced, the energy consumption of the process is reduced, and the utilization rate and extraction rate of raw materials are improved. (3) Hydroxypropyl-β-cyclodextrin is used to encapsulate poorly soluble Chinese medicine components, stabilize and solubilize the active ingredients, improve the taste of the medicine, and enhance the stability of Chinese medicine granules as an excipient. Detailed Implementation

[0027] The following will describe the concept and technical effects of the present invention clearly and completely with reference to embodiments, so as to fully understand the purpose, features and effects of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are all within the scope of protection of the present invention.

[0028] Example 1: This embodiment provides a compound granule of Rehmannia glutinosa and Ophiopogon japonicus, which specifically comprises the following components in parts by weight: Asparagus root 8 parts, Ophiopogon japonicus 10 parts, Rehmannia glutinosa 8 parts, Anemarrhena asphodeloides 6 parts, Pueraria lobata 6 parts, Trichosanthes kirilowii 4 parts, Coptis chinensis 4 parts, Polygonatum odoratum 4 parts, Glycyrrhiza uralensis 2 parts, Panax ginseng 2 parts, Hydroxypropyl-β-cyclodextrin inclusion complex 2 parts.

[0029] The raw rehmannia root is fresh Rehmannia glutinosa; the hydroxypropyl-β-cyclodextrin inclusion complex is prepared by anemarrhena saponin, hydroxypropyl-β-cyclodextrin and erythritol in a ratio of 3:2:1.

[0030] This embodiment also provides a method for preparing compound granules of Rehmannia glutinosa and Ophiopogon japonicus, which specifically includes the following steps: S1. Ginseng is crushed at low temperature and then weighed out asparagus root 8 parts, ophiopogon root 10 parts, rehmannia root 8 parts, anemarrhena rhizome 6 parts, kudzu root 6 parts, trichosanthes root 4 parts, coptis root 4 parts, prepared polygonatum root 4 parts, licorice root 2 parts, and crushed ginseng 2 parts. They are placed together in a decoction container and soaked in a constant temperature water bath for 30-60 minutes with a 1:1 mixture of 0.5% cellulase and pectinase solution. S2, add water to the soaked solid-liquid mixture to make up to 8 times the volume, decoct for 40-60 minutes, and filter out the liquid; add water to the dregs to make up to 6 times the volume, decoct for 30-50 minutes, and filter out the liquid; combine the two decoctions, filter while hot, select a 10-20μm filter cloth to maintain 50-60℃, initially 0.1MPa, gradually increase to 0.3-0.6MPa and filter through a plate and frame filter press for gradual pressure increase and heat preservation. After passing through a 100-mesh sieve, perform ceramic membrane fine filtration at 40℃. Pump the filtrate into a first-effect evaporator at 70-80℃, a second-effect evaporator at 60-70℃, and a third-effect evaporator at 50-60℃, concentrate to 1.10-1.20g / mL to obtain a clear extract; S3. Mix the extract and hydroxypropyl-β-cyclodextrin in a 5:1 ratio, pass through a 100-mesh sieve, atomize in liquid nitrogen at -196℃ and freeze at a pressure of 5-10MPa, vacuum sublimate and dry, then inject into a mold, pre-freeze at -80~-50℃ for 2-3 hours, sublimate at -30~-20℃, pulverize and sieve to obtain the compound granules of Rehmannia glutinosa and Ophiopogon japonicus.

[0031] Example 2: This embodiment provides a compound granule of Rehmannia glutinosa and Ophiopogon japonicus, which specifically comprises the following components in parts by weight: Asparagus root 8 parts, Ophiopogon japonicus 10 parts, Rehmannia glutinosa 9 parts, Anemarrhena asphodeloides 6 parts, Pueraria lobata 6 parts, Trichosanthes kirilowii 4 parts, Coptis chinensis 4 parts, Polygonatum odoratum 4 parts, Glycyrrhiza uralensis 2 parts, Panax ginseng 2 parts, Hydroxypropyl-β-cyclodextrin inclusion complex 2 parts.

[0032] The raw rehmannia root is fresh Rehmannia glutinosa; the hydroxypropyl-β-cyclodextrin inclusion complex is prepared by anemarrhena saponin, hydroxypropyl-β-cyclodextrin and erythritol in a ratio of 3:2:1.

[0033] This embodiment also provides a method for preparing compound granules of Rehmannia glutinosa and Ophiopogon japonicus, which specifically includes the following steps: S1. Ginseng is crushed at low temperature and then weighed out as follows: 8 parts of Asparagus cochinchinensis, 10 parts of Ophiopogon japonicus, 9 parts of Rehmannia glutinosa, 6 parts of Anemarrhena asphodeloides, 6 parts of Pueraria lobata, 4 parts of Trichosanthes kirilowii, 4 parts of Coptis chinensis, 4 parts of Polygonatum odoratum, 2 parts of Glycyrrhiza uralensis, and 2 parts of crushed ginseng. They are placed together in a decoction container and soaked in a 1:1 mixture of 0.5% cellulase and pectinase solution in a constant temperature water bath for 30-60 minutes. S2, add water to the soaked solid-liquid mixture to make up to 8 times the volume, decoct for 40-60 minutes, and filter out the liquid; add water to the dregs to make up to 6 times the volume, decoct for 30-50 minutes, and filter out the liquid; combine the two decoctions, filter while hot, select a 10-20μm filter cloth to maintain 50-60℃, initially 0.1MPa, gradually increase to 0.3-0.6MPa and filter through a plate and frame filter press for gradual pressure increase and heat preservation. After passing through a 100-mesh sieve, perform ceramic membrane fine filtration at 40℃. Pump the filtrate into a first-effect evaporator at 70-80℃, a second-effect evaporator at 60-70℃, and a third-effect evaporator at 50-60℃, concentrate to 1.10-1.20g / mL to obtain a clear extract; S3. Mix the extract and hydroxypropyl-β-cyclodextrin in a 5:1 ratio, pass through a 100-mesh sieve, atomize in liquid nitrogen at -196℃ and freeze at a pressure of 5-10MPa, vacuum sublimate and dry, then inject into a mold, pre-freeze at -80~-50℃ for 2-3 hours, sublimate at -30~-20℃, pulverize and sieve to obtain the compound granules of Rehmannia glutinosa and Ophiopogon japonicus.

[0034] Example 3: This embodiment provides a compound granule of Rehmannia glutinosa and Ophiopogon japonicus, which specifically comprises the following components in parts by weight: Asparagus root 8 parts, Ophiopogon japonicus 10 parts, Rehmannia glutinosa 7 parts, Anemarrhena asphodeloides 6 parts, Pueraria lobata 6 parts, Trichosanthes kirilowii 4 parts, Coptis chinensis 4 parts, Polygonatum odoratum 4 parts, Glycyrrhiza uralensis 2 parts, Panax ginseng 2 parts, Hydroxypropyl-β-cyclodextrin inclusion complex 2 parts.

[0035] The raw rehmannia root is fresh Rehmannia glutinosa; the hydroxypropyl-β-cyclodextrin inclusion complex is prepared by anemarrhena saponin, hydroxypropyl-β-cyclodextrin and erythritol in a ratio of 3:2:1.

[0036] This embodiment also provides a method for preparing compound granules of Rehmannia glutinosa and Ophiopogon japonicus, which specifically includes the following steps: S1. Ginseng is crushed at low temperature and then weighed out as follows: 8 parts of Asparagus cochinchinensis, 10 parts of Ophiopogon japonicus, 9 parts of Rehmannia glutinosa, 6 parts of Anemarrhena asphodeloides, 6 parts of Pueraria lobata, 4 parts of Trichosanthes kirilowii, 4 parts of Coptis chinensis, 4 parts of Polygonatum odoratum, 2 parts of Glycyrrhiza uralensis, and 2 parts of crushed ginseng. They are placed together in a decoction container and soaked in a 1:1 mixture of 0.5% cellulase and pectinase solution in a constant temperature water bath for 30-60 minutes. S2, add water to the soaked solid-liquid mixture to make up to 8 times the volume, decoct for 40-60 minutes, and filter out the liquid; add water to the dregs to make up to 6 times the volume, decoct for 30-50 minutes, and filter out the liquid; combine the two decoctions, filter while hot, select a 10-20μm filter cloth to maintain 50-60℃, initially 0.1MPa, gradually increase to 0.3-0.6MPa and filter through a plate and frame filter press for gradual pressure increase and heat preservation. After passing through a 100-mesh sieve, perform ceramic membrane fine filtration at 40℃. Pump the filtrate into a first-effect evaporator at 70-80℃, a second-effect evaporator at 60-70℃, and a third-effect evaporator at 50-60℃, concentrate to 1.10-1.20g / mL to obtain a clear extract; S3. Mix the extract and hydroxypropyl-β-cyclodextrin in a 5:1 ratio, pass through a 100-mesh sieve, atomize in liquid nitrogen at -196℃ and freeze at a pressure of 5-10MPa, vacuum sublimate and dry, then inject into a mold, pre-freeze at -80~-50℃ for 2-3 hours, sublimate at -30~-20℃, pulverize and sieve to obtain the compound granules of Rehmannia glutinosa and Ophiopogon japonicus.

[0037] Comparative Example 1: This comparative example provides a compound granule of Rehmannia glutinosa and Ophiopogon japonicus, which specifically contains the following components in parts by weight: Asparagus root 8 parts, Ophiopogon japonicus 10 parts, Rehmannia glutinosa 8 parts, Anemarrhena asphodeloides 6 parts, Pueraria lobata 6 parts, Trichosanthes kirilowii 4 parts, Coptis chinensis 4 parts, Polygonatum odoratum 4 parts, Glycyrrhiza uralensis 2 parts, Panax ginseng 2 parts, Hydroxypropyl-β-cyclodextrin inclusion complex 2 parts.

[0038] The raw rehmannia root is fresh Rehmannia glutinosa; the hydroxypropyl-β-cyclodextrin inclusion complex is prepared by anemarrhena saponin, hydroxypropyl-β-cyclodextrin and erythritol in a ratio of 3:2:1.

[0039] This comparative example also provides a method for preparing compound granules of Rehmannia glutinosa and Ophiopogon japonicus, specifically including the following steps: S1. Ginseng is crushed at low temperature and then weighed out as follows: 8 parts of Asparagus cochinchinensis, 10 parts of Ophiopogon japonicus, 8 parts of Rehmannia glutinosa, 6 parts of Anemarrhena asphodeloides, 6 parts of Pueraria lobata, 4 parts of Trichosanthes kirilowii, 4 parts of Coptis chinensis, 4 parts of Polygonatum odoratum, 2 parts of Glycyrrhiza uralensis, and 2 parts of crushed ginseng. They are placed together in a decoction container and soaked in a 1:1 mixture of 0.5% cellulase and pectinase solution in a constant temperature water bath for 30-60 minutes. S2, add water to the soaked solid-liquid mixture to make up to 8 times the volume, decoct for 40-60 minutes, and filter out the liquid; add water to the dregs to make up to 6 times the volume, decoct for 30-50 minutes, and filter out the liquid; combine the two decoctions, filter while hot, select a 10-20μm filter cloth to maintain 50-60℃, initially 0.1MPa, gradually increase to 0.3-0.6MPa and filter through a plate and frame filter press for gradual pressure increase and heat preservation. After passing through a 100-mesh sieve, perform ceramic membrane fine filtration at 40℃. Pump the filtrate into a first-effect evaporator at 70-80℃, a second-effect evaporator at 60-70℃, and a third-effect evaporator at 50-60℃, concentrate to 1.10-1.20g / mL to obtain a clear extract; S3. Mix the extract and hydroxypropyl-β-cyclodextrin inclusion complex in a 5:1 ratio, pass through a 100-mesh sieve, atomize in liquid nitrogen at -196℃ and freeze at a pressure of 5-10MPa, vacuum sublimate and dry, then inject into a mold, pre-freeze at -80~-50℃ for 2-3 hours, sublimate at -30~-20℃, pulverize and sieve to obtain the compound granules of Rehmannia glutinosa and Ophiopogon japonicus.

[0040] The difference between this comparative example and Example 1 is that the processed Solomon's Seal is replaced with raw Solomon's Seal.

[0041] Comparative Example 2: This comparative example provides a compound granule of Rehmannia glutinosa and Ophiopogon japonicus, which specifically contains the following components in parts by weight: 8 parts Asparagus root, 10 parts Ophiopogon root, 8 parts Rehmannia root, 6 parts Anemarrhena rhizome, 6 parts Pueraria root, 4 parts Trichosanthes root, 4 parts Coptis root, 4 parts processed Polygonatum rhizome, 2 parts Licorice root, 2 parts Ginseng, and 2 parts chitosan composition.

[0042] The raw rehmannia root is fresh Rehmannia glutinosa; the chitosan composition is prepared by anemarrhena saponin, chitosan and erythritol in a ratio of 3:2:1.

[0043] This comparative example also provides a method for preparing compound granules of Rehmannia glutinosa and Ophiopogon japonicus, specifically including the following steps: S1. Ginseng is crushed at low temperature and then weighed out asparagus root 8 parts, ophiopogon root 10 parts, rehmannia root 8 parts, anemarrhena rhizome 6 parts, kudzu root 6 parts, trichosanthes root 4 parts, coptis root 4 parts, prepared polygonatum root 4 parts, licorice root 2 parts, and crushed ginseng 2 parts. They are placed together in a decoction container and soaked in a constant temperature water bath for 30-60 minutes with a 1:1 mixture of 0.5% cellulase and pectinase solution. S2, add water to the soaked solid-liquid mixture to make up to 8 times the volume, decoct for 40-60 minutes, and filter out the liquid; add water to the dregs to make up to 6 times the volume, decoct for 30-50 minutes, and filter out the liquid; combine the two decoctions, filter while hot, select a 10-20μm filter cloth to maintain 50-60℃, initially 0.1MPa, gradually increase to 0.3-0.6MPa and filter through a plate and frame filter press for gradual pressure increase and heat preservation. After passing through a 100-mesh sieve, perform ceramic membrane fine filtration at 40℃. Pump the filtrate into a first-effect evaporator at 70-80℃, a second-effect evaporator at 60-70℃, and a third-effect evaporator at 50-60℃, concentrate to 1.10-1.20g / mL to obtain a clear extract; S3. Mix the clear extract and chitosan composition in a 5:1 ratio, pass through a 100-mesh sieve, atomize in liquid nitrogen at -196℃ and freeze at a pressure of 5-10MPa, vacuum sublimate and dry, then inject into a mold, pre-freeze at -80~-50℃ for 2-3 hours, sublimate at -30~-20℃, pulverize and sieve to obtain the Rehmannia and Ophiopogon compound granules.

[0044] The difference between this comparative example and Example 1 is that the hydroxypropyl-β-cyclodextrin inclusion complex is replaced with a chitosan composition in this comparative example.

[0045] Comparative Example 3: This comparative example provides a compound granule of Rehmannia glutinosa and Ophiopogon japonicus, which specifically contains the following components in parts by weight: Asparagus root 8 parts, Ophiopogon japonicus 10 parts, Rehmannia glutinosa 8 parts, Anemarrhena asphodeloides 6 parts, Pueraria lobata 6 parts, Trichosanthes kirilowii 4 parts, Coptis chinensis 4 parts, Polygonatum odoratum 4 parts, Glycyrrhiza uralensis 2 parts, Panax ginseng 2 parts, and a combination of 2 parts.

[0046] The raw rehmannia root is fresh rehmannia root; the composition is prepared by anemarrhena saponin and erythritol in a 3:1 ratio.

[0047] This comparative example also provides a method for preparing compound granules of Rehmannia glutinosa and Ophiopogon japonicus, specifically including the following steps: S1. Ginseng is crushed at low temperature and then weighed out asparagus root 8 parts, ophiopogon root 10 parts, rehmannia root 8 parts, anemarrhena rhizome 6 parts, kudzu root 6 parts, trichosanthes root 4 parts, coptis root 4 parts, prepared polygonatum root 4 parts, licorice root 2 parts, and crushed ginseng 2 parts. They are placed together in a decoction container and soaked in a constant temperature water bath for 30-60 minutes with a 1:1 mixture of 0.5% cellulase and pectinase solution. S2, add water to the soaked solid-liquid mixture to make up to 8 times the volume, decoct for 40-60 minutes, and filter out the liquid; add water to the dregs to make up to 6 times the volume, decoct for 30-50 minutes, and filter out the liquid; combine the two decoctions, filter while hot, select a 10-20μm filter cloth to maintain 50-60℃, initially 0.1MPa, gradually increase to 0.3-0.6MPa and filter through a plate and frame filter press for gradual pressure increase and heat preservation. After passing through a 100-mesh sieve, perform ceramic membrane fine filtration at 40℃. Pump the filtrate into a first-effect evaporator at 70-80℃, a second-effect evaporator at 60-70℃, and a third-effect evaporator at 50-60℃, concentrate to 1.10-1.20g / mL to obtain a clear extract; S3. Mix the extract and Anemarrhena asphodeloides saponin composition in a 5:1 ratio, pass through a 100-mesh sieve, atomize in liquid nitrogen at -196℃ and freeze at a pressure of 5-10MPa, vacuum sublimate and dry, then inject into a mold, pre-freeze at -80~-50℃ for 2-3 hours, sublimate at -30~-20℃, pulverize and sieve to obtain Rehmannia glutinosa and Ophiopogon japonicus compound granules.

[0048] The difference between this comparative example and Example 1 is that hydroxypropyl-β-cyclodextrin is not added in this comparative example; instead, anemarrhena saponin and erythritol are directly added.

[0049] Comparative Example 4: This comparative example provides a compound granule of Rehmannia glutinosa and Ophiopogon japonicus, which specifically contains the following components in parts by weight: Asparagus root 8 parts, Ophiopogon japonicus 10 parts, Rehmannia glutinosa 8 parts, Anemarrhena asphodeloides 6 parts, Pueraria lobata 6 parts, Trichosanthes kirilowii 4 parts, Coptis chinensis 4 parts, Polygonatum odoratum 4 parts, Glycyrrhiza uralensis 2 parts, Panax ginseng 2 parts, Hydroxypropyl-β-cyclodextrin inclusion complex 2 parts.

[0050] The raw rehmannia root is fresh Rehmannia glutinosa; the hydroxypropyl-β-cyclodextrin inclusion complex is prepared by anemarrhena saponin, hydroxypropyl-β-cyclodextrin and erythritol in a ratio of 3:2:1.

[0051] This comparative example also provides a method for preparing compound granules of Rehmannia glutinosa and Ophiopogon japonicus, specifically including the following steps: S1. Ginseng is crushed at low temperature and then weighed out as follows: 8 parts of Asparagus, 10 parts of Ophiopogon japonicus, 8 parts of Rehmannia glutinosa, 6 parts of Anemarrhena asphodeloides, 6 parts of Pueraria lobata, 4 parts of Trichosanthes kirilowii, 4 parts of Coptis chinensis, 4 parts of Polygonatum odoratum, 2 parts of Glycyrrhiza uralensis, and 2 parts of crushed ginseng. They are placed together in a decoction container and soaked in cold water for 30-60 minutes. S2, add water to the soaked solid-liquid mixture to make up to 8 times the volume, decoct for 40-60 minutes, and filter out the liquid; add water to the dregs to make up to 6 times the volume, decoct for 30-50 minutes, and filter out the liquid; combine the two decoctions, filter while hot, select a 10-20μm filter cloth to maintain 50-60℃, initially 0.1MPa, gradually increase to 0.3-0.6MPa and filter through a plate and frame filter press for gradual pressure increase and heat preservation. After passing through a 100-mesh sieve, perform ceramic membrane fine filtration at 40℃. Pump the filtrate into a first-effect evaporator at 70-80℃, a second-effect evaporator at 60-70℃, and a third-effect evaporator at 50-60℃, concentrate to 1.10-1.20g / mL to obtain a clear extract; S3. Mix the extract and hydroxypropyl-β-cyclodextrin inclusion complex in a 5:1 ratio, pass through a 100-mesh sieve, atomize in liquid nitrogen at -196℃ and freeze at a pressure of 5-10MPa, vacuum sublimate and dry, then inject into a mold, pre-freeze at -80~-50℃ for 2-3 hours, sublimate at -30~-20℃, pulverize and sieve to obtain the compound granules of Rehmannia glutinosa and Ophiopogon japonicus.

[0052] The difference between this comparative example and Example 1 is that the medicinal materials weighed in step S2 of this comparative example were not soaked in enzyme solution, but soaked in cold water instead.

[0053] Comparative Example 5: This comparative example provides a compound granule of Rehmannia glutinosa and Ophiopogon japonicus, which specifically contains the following components in parts by weight: Asparagus root 8 parts, Ophiopogon japonicus 10 parts, Rehmannia glutinosa 8 parts, Anemarrhena asphodeloides 6 parts, Pueraria lobata 6 parts, Trichosanthes kirilowii 4 parts, Coptis chinensis 4 parts, Polygonatum odoratum 4 parts, Glycyrrhiza uralensis 2 parts, Panax ginseng 2 parts, Hydroxypropyl-β-cyclodextrin inclusion complex 2 parts.

[0054] The raw rehmannia root is fresh Rehmannia glutinosa; the hydroxypropyl-β-cyclodextrin inclusion complex is prepared by anemarrhena saponin, hydroxypropyl-β-cyclodextrin and erythritol in a ratio of 3:2:1.

[0055] This comparative example also provides a method for preparing compound granules of Rehmannia glutinosa and Ophiopogon japonicus, specifically including the following steps: S1. Ginseng is crushed at low temperature and then weighed out asparagus root 8 parts, ophiopogon root 10 parts, rehmannia root 8 parts, anemarrhena rhizome 6 parts, kudzu root 6 parts, trichosanthes root 4 parts, coptis root 4 parts, prepared polygonatum root 4 parts, licorice root 2 parts, and crushed ginseng 2 parts. They are placed together in a decoction container and soaked in a constant temperature water bath for 30-60 minutes with a 1:1 mixture of 0.5% cellulase and pectinase solution. S2, add 8 times the amount of water to the soaked solid-liquid mixture and decoct for 40-60 minutes, then filter out the liquid. Add 6 times the amount of water to the dregs and decoct for 30-50 minutes, then filter out the liquid. Combine the two decoctions and filter while hot. Use a 10-20μm filter cloth to maintain 50-60℃, initially 0.1MPa, and gradually increase to 0.3-0.6MPa. Filter through a plate and frame filter press with gradual pressure increase and heat preservation. After passing through a 100-mesh sieve, perform ceramic membrane fine filtration at 40℃. Pump the filtrate into a first-effect evaporator at 70-80℃, a second-effect evaporator at 60-70℃, and a third-effect evaporator at 50-60℃, and concentrate to 1.10-1.20g / mL to obtain a clear extract. S3, mix the clear extract and hydroxypropyl-β-cyclodextrin inclusion complex in a 5:1 ratio until homogeneous, dry at a low temperature of 50-60℃, pass through a 100-mesh sieve, and then dry under a roller pressure of 50kN / cm. 2 The powder was fed into a roller press at a speed of 10 rpm and a gap of 1.2 mm. After being output as thin sheets, it was crushed and sieved by a pulverizer and granule to obtain the compound granules of Rehmannia glutinosa and Ophiopogon japonicus.

[0056] The difference between this comparative example and Example 1 is that in step S3 of this comparative example, the frozen granulation method is replaced with the dry granulation method.

[0057] Experimental Example 1: This experimental example is the test of the effective active ingredient content of Examples 1-3 and Comparative Examples 1-5. The results are shown in Table 1.

[0058] The active components of Rehmannia glutinosa, including catalpol, anemarrhena asphodeloides BII, and mangiferin, were determined using high-performance liquid chromatography-evaporative light scattering detector (HPLC-ELSD): Three 1.0 g samples of the herbal powder were weighed. For the catalpol and mangiferin samples, 50% methanol aqueous solution was added; for the anemarrhena asphodeloides BII sample, 70% ethanol was added. Extraction was performed by ultrasonication for 30 min, followed by centrifugation at 10,000 rpm for 15 min, and then filtered through a 0.22 μm microporous membrane. The mobile phase for catalpol was eluted with a gradient of 0.1% formic acid (A)-acetonitrile (B). The mobile phases for anemarrhena asphodeloides BII and mangiferin were eluted with a gradient of 0.1% phosphoric acid (A)-acetonitrile (B). The flow rate was 1.0 mL / min, the column temperature was 30℃, the injection volume was 10 μL, the ELSD drift tube temperature was 80℃, the nitrogen pressure was 3.5 bar, and the gain was 8. Six parallel determinations were performed on the same sample, and the content was calculated using the external standard method.

[0059] Asparagus polysaccharide, Ophiopogon japonicus polysaccharide, and Polygonatum odoratum polysaccharide were determined using the phenol-sulfuric acid method: Three 1.0 g granular samples were weighed, and the polysaccharides were extracted by reflux in a hot water bath. 1 mL of phenol solution was added to 1 mL of the sample solution and mixed well. 5 mL of concentrated sulfuric acid was then quickly added and vortexed. The mixture was allowed to stand at room temperature. The absorbance was measured at 490 nm using a spectrophotometer. Six parallel determinations were performed on the same sample, and the concentrations were calculated.

[0060] Experimental Example 2: This experimental example tests the dry paste rate, particle moisture absorption rate, and molding rate of Examples 1-3 and Comparative Examples 1-5. The results are shown in Table 2.

[0061] Method for determining the dry extract yield: Measure 20 mL of the filtered decoction liquid and place it in an evaporating dish dried to constant weight (W1) at 105℃. Evaporate in a water bath until nearly dry, transfer to an oven to dry to constant weight, remove, cool, and weigh (W2). Calculate the dry extract yield using the formula: Dry extract yield = (W2 - W1) / extract mass * 100%.

[0062] Method for determining moisture absorption rate: Weigh 2g of Chinese herbal granules, spread them evenly in a weighing bottle (bottle weight m1), weigh the bottle (m2), and place the bottle in an environment with a temperature of 25℃±2℃ and a relative humidity of 60%±5% for 1 hour, then weigh the bottle (m3). Calculate the moisture absorption rate using the formula: Moisture absorption rate = (m3-m2) / (m2-m1)*100%. Group Dry paste rate / % Moisture absorption rate / % Molding rate / % Example 1 45.78 4.10 48.89 Example 2 45.89 4.46 48.76 Example 3 45.67 4.35 47.52 Comparative Example 1 45.71 4.55 46.12 Comparative Example 2 44.62 5.01 44.19 Comparative Example 3 44.37 5.87 42.06 Comparative Example 4 44.99 4.89 46.18 Comparative Example 5 45.02 5.24 44.87

[0063] Comparative Example 1 showed that replacing processed Polygonatum odoratum with raw Polygonatum odoratum resulted in a decrease in polysaccharide content. The mechanism is that the polysaccharide degradation products generated during the processing of Polygonatum odoratum have stronger hydrophilicity and moisture-absorbing and inhibiting ability. Raw Polygonatum odoratum, on the other hand, has not undergone this transformation, and more free hydroxyl groups are exposed, which are more likely to combine with moisture and cause moisture absorption and clumping, thereby reducing the hypoglycemic effect and physical stability of the particles.

[0064] Comparative Example 2 replaced the hydroxypropyl-β-cyclodextrin inclusion complex with a chitosan composition, while Comparative Example 3 did not add hydroxypropyl-β-cyclodextrin but directly added anemarrhena saponins and erythritol. This directly led to a decrease in the dissolution rate of anemarrhena saponins, a reduction in the content of active ingredients, low bioavailability, and a significant decrease in the dry extract rate, moisture absorption rate, and forming rate of the granules. The defects of replacing hydroxypropyl-β-cyclodextrin with chitosan composition stem from the difference in molecular inclusion ability. The hydrophobic cavity of hydroxypropyl-β-cyclodextrin can encapsulate lipid-soluble components such as anemarrhena saponins through van der Waals forces, forming soluble supramolecular complexes, significantly improving dissolution rate and bioavailability. In contrast, chitosan relies solely on electrostatic interactions to bind with anionic components, and its capacity to solubilize nonpolar components is limited, resulting in a decrease in dry extract rate and slow reconstitution. Furthermore, the absence of hydroxypropyl-β-cyclodextrin weakens the bitterness masking function, affecting patient compliance.

[0065] In Comparative Example 4, step S2 did not employ enzymatic pretreatment and was directly decocted in cold water. As the barrier effect of cell wall cellulose and pectin was not destroyed by enzymatic hydrolysis, the release of intracellular active ingredients was insufficient. At the same time, prolonged high-temperature decoction aggravated the degradation of heat-sensitive components, resulting in the loss of effective ingredients.

[0066] The limitations of dry granulation as a substitute for freeze drying in step S3 of Comparative Example 5 are reflected in both thermodynamic and structural factors: the mechanical compression and heating process of dry granulation not only promotes the oxidative decomposition of thermally unstable components, but also forms a dense particle structure due to high pressure, reducing porosity and exacerbating hygroscopicity; while freeze drying forms a porous network structure through ice crystal sublimation, which can both protect the integrity of the components and optimize dissolution performance.

[0067] The above description is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.

Claims

1. A compound granule of Rehmannia glutinosa and Ophiopogon japonicus, characterized in that, It contains the following components by weight: 6-10 parts Rehmannia glutinosa, 6-10 parts Asparagus cochinchinensis, 8-12 parts Ophiopogon japonicus, and 4-8 parts Anemarrhena asphodeloides.

2. The compound granules of Rehmannia glutinosa and Ophiopogon japonicus according to claim 1, characterized in that, The compound granules comprise the following components by weight: 7-9 parts Rehmannia glutinosa, 7-9 parts Asparagus cochinchinensis, 9-11 parts Ophiopogon japonicus, and 5-7 parts Anemarrhena asphodeloides.

3. The compound granules of Rehmannia glutinosa and Ophiopogon japonicus according to claim 1 or 2, wherein the compound granules further include the following components in parts by weight: 5-7 parts of Pueraria lobata, 3-5 parts of Trichosanthes kirilowii, 3-5 parts of Coptis chinensis, 3-5 parts of processed Polygonatum odoratum, 1-2 parts of ginseng, 1-2 parts of licorice, and 2-3 parts of hydroxypropyl-β-cyclodextrin inclusion complex.

4. The compound granules of Rehmannia glutinosa and Ophiopogon japonicus according to claim 1 or 2, characterized in that, The raw rehmannia root is one or both of fresh and dried rehmannia root, and the thickness of the slices is 1-3 mm.

5. The compound granules of Rehmannia glutinosa and Ophiopogon japonicus according to claim 3, characterized in that, The prepared Solomon's Seal is steamed Solomon's Seal with a sheet thickness of 1-3 mm; the ginseng is crushed ginseng with a particle size of 0.6-1.5 mm.

6. The compound granules of Rehmannia glutinosa and Ophiopogon japonicus according to claim 3, characterized in that, The hydroxypropyl-β-cyclodextrin inclusion complex is an anemarrhena saponin hydroxypropyl-β-cyclodextrin inclusion complex.

7. The compound granules of Rehmannia glutinosa and Ophiopogon japonicus according to claim 6, characterized in that, The hydroxypropyl-β-cyclodextrin inclusion complex was prepared from anemarrhena saponin, hydroxypropyl-β-cyclodextrin, and erythritol in a ratio of 3:2:

1.

8. A method for preparing the compound granules of Rehmannia glutinosa and Ophiopogon japonicus according to any one of claims 1-7, characterized in that, Includes the following steps: S1. Ginseng is subjected to low-temperature ultrafine crushing. Asparagus root, Ophiopogon root, Rehmannia root, Anemarrhena rhizome, Pueraria root, Trichosanthes root, Coptis root, processed Polygonatum rhizome, and licorice root are weighed out and placed in a container with ginseng. A 1:1 mixture of 0.5% cellulase and pectinase solution is added and soaked in a constant temperature water bath for 30-60 minutes. S2, add water to the soaked solid-liquid mixture to make up to 8 times the volume, decoct for 40-60 minutes, and filter out the liquid; add 6 times the volume of water to the dregs and decoct again for 30-50 minutes, and filter out the liquid. The decoctions from the two processes are combined, filtered through a plate and frame filter press, and then finely filtered through a ceramic membrane; the mixture is then concentrated to a clear paste using a triple-effect energy-saving process. S3, mix the extract and hydroxypropyl-β-cyclodextrin inclusion complex in a 5:1 ratio, and granulate by freeze-drying to obtain the compound granules of Rehmannia glutinosa and Ophiopogon japonicus.

9. The preparation method according to claim 8, characterized in that, The specific conditions for filtration and concentration in step S2 are as follows: filter the decoction twice while it is still hot, select a 10-20μm filter cloth and maintain it at 50-60℃, initially at 0.1MPa, gradually increase it to 0.3-0.6MPa, and filter it by gradually increasing the pressure and keeping it warm through a plate and frame filter press. After passing through a 100-mesh sieve, perform fine filtration with a ceramic membrane at 40℃. Pump the filtrate into a first-effect evaporator at 70-80℃, a second-effect evaporator at 60-70℃, and a third-effect evaporator at 50-60℃, and concentrate it to 1.10-1.20g / mL to obtain a clear extract.

10. The preparation method according to claim 8, characterized in that, The specific conditions for freeze-drying granulation in step S3 are as follows: the extract is passed through a 100-mesh sieve, atomized in liquid nitrogen at -196℃ and frozen at a pressure of 5-10MPa, vacuum sublimated and dried, then injected into a mold, pre-frozen at -80~-50℃ for 2-3 hours, sublimated at -30~-20℃, pulverized and sieved to obtain compound granules.

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