A zhi-shu yang-wei tablet for chronic gastritis and a dry compression tablet process of granules thereof

Abstract

This invention discloses a Zhishu Yangwei tablet for chronic gastritis and its granule dry-compression tableting process, relating to the field of traditional Chinese medicine preparation technology. The Yangwei tablet is made from the following raw materials in parts by weight: Codonopsis pilosula 35-45 parts, stir-fried Atractylodes macrocephala 18-22 parts, Poria cocos 18-22 parts, Glycyrrhiza uralensis 8-12 parts, Amomum villosum 18-22 parts, Lindera strychnifolia 18-22 parts, Salvia miltiorrhiza 45-55 parts, roasted Aucklandia lappa 18-22 parts, Paeonia lactiflora 18-22 parts, stir-fried Citrus aurantium 18-22 parts, Magnolia officinalis 28-32 parts, Lilium brownii 35-45 parts, and stir-fried chicken gizzard lining 18- 22 parts, dried plum 45-55 parts, Coptis chinensis 8-12 parts, hawthorn 35-45 parts, magnesium stearate 5-7 parts, sucrose 28-32 parts; This invention uses low-temperature dynamic extraction technology to replace the traditional high-temperature decoction process, effectively reducing the decomposition loss of heat-sensitive active ingredients such as tanshinone IIA and ursolic acid, and improving the bioavailability of the drug. It also uses membrane concentration and spray drying technology to replace the traditional atmospheric pressure concentration and oven drying process, shortening the production cycle, reducing energy consumption, and avoiding the degradation of active ingredients caused by prolonged heating of materials.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine preparation technology, specifically to a Zhishu Yangwei tablet for chronic gastritis and its granule dry compression tableting process. Background Technology

[0002] Chronic gastritis refers to a chronic inflammatory lesion of the gastric mucosa caused by various etiologies. It is one of the most common diseases of the digestive system, ranking first in incidence among various gastric diseases, and its incidence gradually increases with age. Chronic gastritis has a prolonged course and recurrent flare-ups. Clinical manifestations include upper abdominal discomfort, bloating, abdominal pain, belching, acid reflux, and loss of appetite, which seriously affect the patient's quality of life. If left untreated for a long time, it may develop into atrophic gastritis and even increase the risk of gastric cancer.

[0003] Stomach-nourishing tablets are a type of traditional Chinese medicine tablet made primarily from Chinese herbs. They possess the functions of strengthening the spleen and stomach, regulating qi and relieving pain, and promoting digestion. They are widely used in the treatment of digestive system diseases such as chronic gastritis and peptic ulcers. Zhishu Stomach-Nourishing Tablets are a compound Chinese medicine preparation developed under the guidance of traditional Chinese medicine theory and combined with modern clinical practice. Its formula originates from the classic formula Zhishu Pill, and has been optimized and modified accordingly. It has the effects of tonifying the middle jiao and harmonizing the stomach, relieving bloating and pain. Clinically, it is often used to treat chronic gastritis, superficial gastritis, duodenal ulcers, and other diseases. It has a significant effect on improving symptoms such as abdominal distension, abdominal pain, abdominal fullness, and poor appetite, providing a safe and effective traditional Chinese medicine option for the treatment of chronic gastritis.

[0004] However, existing production processes for Zhishu Yangwei tablets mostly employ traditional wet granulation and tableting techniques. This process still has certain drawbacks. During the decoction and concentration process, some heat-sensitive active ingredients are easily decomposed and destroyed by heat, leading to reduced drug efficacy. Wet granulation requires the addition of a large amount of binder and wetting agent, and long drying time is required after granulation. This not only prolongs the production cycle and increases energy consumption, but may also lead to uneven particle hardness and poor flowability, thereby affecting the stability of the tableting process and causing problems such as large differences in tablet weight and prolonged disintegration time. At the same time, the step of mixing fine powder and thick paste and then drying and pulverizing in the traditional process is prone to dust pollution and has a large material loss, which is not conducive to large-scale industrial production. Therefore, developing a Zhishu Yangwei tablet for chronic gastritis and its granule dry compression tableting process is of great significance. Summary of the Invention

[0005] The purpose of this invention is to overcome the shortcomings of the prior art and provide a dry-compression tablet for Zhishu Yangwei tablets used for chronic gastritis, as well as a process for compressing its granules. This invention overcomes the defects of the existing Zhishu Yangwei tablet production process, such as severe loss of heat-sensitive active ingredients, long production cycle, high energy consumption, unstable granule quality, large differences in tablet weight, long disintegration time, and serious dust pollution. The invention provides a dry-compression tablet for Zhishu Yangwei tablets used for chronic gastritis that effectively retains the active ingredients of the drug, has a short production cycle, low energy consumption, uniform granule quality, good tablet stability, rapid disintegration, and low dust pollution.

[0006] To solve the above-mentioned technical problems, the present invention provides the following technical solution: a stomach-nourishing tablet for chronic gastritis, which is made from the following raw materials in parts by weight: Codonopsis pilosula 35-45 parts, stir-fried Atractylodes macrocephala 18-22 parts, Poria cocos 18-22 parts, Glycyrrhiza uralensis 8-12 parts, Amomum villosum 18-22 parts, Lindera strychnifolia 18-22 parts, Salvia miltiorrhiza 45-55 parts, roasted Aucklandia lappa 18-22 parts, Paeonia lactiflora 18-22 parts, stir-fried Citrus aurantium 18-22 parts, Magnolia officinalis 28-32 parts, Lilium brownii 35-45 parts, stir-fried chicken gizzard lining 18-22 parts, Prunus mume 45-55 parts, Coptis chinensis 8-12 parts, Crataegus pinnatifida 35-45 parts, magnesium stearate 5-7 parts, and sucrose 28-32 parts.

[0007] Further, it is made from the following raw materials in parts by weight: 40 parts Codonopsis pilosula, 20 parts stir-fried Atractylodes macrocephala, 20 parts Poria cocos, 10 parts Glycyrrhiza uralensis, 20 parts Amomum villosum, 20 parts Lindera strychnifolia, 50 parts Salvia miltiorrhiza, 20 parts roasted Aucklandia lappa, 20 parts Paeonia lactiflora, 20 parts stir-fried Citrus aurantium, 30 parts Magnolia officinalis, 40 parts Lilium brownii, 20 parts stir-fried chicken gizzard lining, 50 parts Prunus mume, 10 parts Coptis chinensis, 40 parts Crataegus pinnatifida, 6 parts magnesium stearate, and 30 parts sucrose. Among them, stir-fried Atractylodes macrocephala is made by stir-frying wheat bran and Atractylodes macrocephala in a weight ratio of 1:10 at 150-160℃ for 10-15 minutes. Roasted Aucklandia lappa is made by wrapping Aucklandia lappa in three layers of wet paper and roasting it in hot talcum powder for 20-25 minutes.

[0008] Furthermore, each of these stomach-nourishing tablets weighs 0.3g. The magnesium stearate is made from fine powder that has passed through a 100-mesh sieve. The sucrose is pharmaceutical grade sucrose. The stir-fried chicken gizzard is made by stir-frying clean river sand and chicken gizzard in a 5:1 weight ratio at 180-190℃ until the surface puffs up and becomes crisp. The Coptis chinensis is made by removing impurities, spraying with water to moisten thoroughly, slicing into 2-4mm thin slices, and drying at low temperature.

[0009] Furthermore, each tablet of this stomach-nourishing tablet contains no less than 0.18 mg of tanshinone IIA, no less than 0.14 mg of ursolic acid, no less than 0.22 mg of honokiol and magnolol, has a disintegration time of no more than 20 minutes, a tablet weight difference controlled within ±2.5%, a total bacterial count of no more than 10 CFU / g, and no detectable Escherichia coli.

[0010] A granule dry compression tableting process for Zhishu Yangwei tablets for chronic gastritis, comprising the following steps: S1. Pre-treatment of medicinal materials: Codonopsis pilosula, stir-fried Atractylodes macrocephala, Poria cocos, Salvia miltiorrhiza, roasted Aucklandia lappa, Amomum villosum, Lindera strychnifolia, stir-fried Citrus aurantium, Magnolia officinalis, Lilium brownii, Paeonia lactiflora, Coptis chinensis, and stir-fried chicken gizzard lining are washed separately, dried at a low temperature of 40-50℃, pulverized into 100-120 mesh fine powder and sieved. The powder is mixed evenly to obtain a mixed fine powder. 270-290 portions are set aside. The remaining coarse powder that does not pass through the sieve after sieving is mixed with washed Glycyrrhiza uralensis, Prunus mume, and Crataegus pinnatifida to obtain the medicinal materials to be decocted. S2. Low-temperature dynamic extraction: Add the medicinal materials to be decocted into the extraction tank, add 8-10 times the amount of purified water, and perform low-temperature dynamic extraction twice at 55-65℃, each time for 45-60 minutes. Combine the extracts, filter, and obtain the extract filtrate. S3. Membrane Concentration: The extract filtrate is initially separated by ultrafiltration membrane to remove macromolecular impurities, and then concentrated by reverse osmosis membrane to obtain a concentrate with a relative density of 1.15-1.20. The temperature of the concentrate is 50℃. S4. Spray drying: The concentrate is spray dried at an inlet air temperature of 140-150℃ and an outlet air temperature of 70-80℃ to obtain a dried extract powder. S5. Dry granulation: Mix the fine powder, dry extract powder and sucrose evenly, add them to a dry granulator for dry granulation, and obtain 20-40 mesh granules. S6. Tableting: Mix the prepared granules with magnesium stearate evenly, add them to a tablet press for tableting, and compress the tablets at a pressure of 4-6 kN to obtain Zhishu Yangwei tablets.

[0011] Furthermore, in step S1, the low-temperature drying is carried out using a hot air circulating oven. During the drying process, the medicinal materials are turned over every 30 minutes. The pulverization is carried out using a universal pulverizer. The pulverized fine powder is sieved through a 100-120 mesh stainless steel screen. The fine powder is mixed using a three-dimensional motion mixer for 15-20 minutes at a mixing speed of 15-20 r / min. The particle size of the remaining coarse powder is controlled within the range of 20-40 mesh.

[0012] Furthermore, in step S2, the low-temperature dynamic extraction is carried out using an extraction tank equipped with an anchor-type stirring device. During the extraction process, the stirring speed is 30-40 r / min. After each extraction, a plate and frame filter press is used for solid-liquid separation. The filter cloth has a pore size of 10-20 μm. The combined extract is then filtered through a 0.45 μm polypropylene microporous membrane to remove suspended impurities and obtain a clear extract filtrate.

[0013] Furthermore, in step S3, the ultrafiltration membrane is a hollow fiber ultrafiltration membrane made of polyethersulfone, with a molecular weight cutoff of 8000-12000 Da. The operating pressure during the ultrafiltration process is 0.1-0.2 MPa, and the operating temperature is 40-50℃. The reverse osmosis membrane is a polyamide composite reverse osmosis membrane, with an operating pressure of 1.0-1.5 MPa and an operating temperature of 35-45℃ during the reverse osmosis process. The feed flow rate during the concentration process is controlled at 50-80 L / h.

[0014] Furthermore, in step S4, spray drying is carried out using a centrifugal spray dryer with an atomizer speed of 15,000-20,000 r / min and a concentrated liquid feed rate of 20-30 L / h. In step S5, dry granulation is carried out using a horizontal dry granulator with a pressure roller pressure of 5-7 MPa and a feeding rate of 10-15 kg / h. The resulting granules are sized by passing them through a 20-40 mesh stainless steel screen to remove particles that are too large or too small.

[0015] Furthermore, in step S6, the particles and magnesium stearate are mixed in a three-dimensional motion mixer for 5-10 minutes at a mixing speed of 10-15 r / min. The magnesium stearate is fine powder that has passed through a 100-mesh sieve. A rotary tablet press is used for tableting at a speed of 20-30 r / min. During the tableting process, the tablet weight and hardness are sampled and checked every 15 minutes, and the hardness is controlled at 3-5 kgf.

[0016] This invention, Zhishu Yangwei Tablets, is formulated based on the core pathogenesis of chronic gastritis characterized by spleen and stomach weakness, qi stagnation and blood stasis, and food accumulation and internal heat. Its core treatment principle is to tonify the middle jiao and harmonize the stomach, relieve bloating and pain. The properties and meridian tropism of each herb are synergistic, and the modern pharmacological components target pathological aspects such as gastric mucosal damage, insufficient gastrointestinal motility, and inflammatory responses. The specific mechanism is as follows: Codonopsis pilosula: This product is the dried root of Codonopsis pilosula, a plant of the Campanulaceae family. It is sweet in taste and neutral in nature, and enters the spleen and lung meridians. It has the effects of tonifying the middle energizer and replenishing qi, strengthening the spleen and benefiting the lungs. Modern pharmacology shows that Codonopsis pilosula contains Codonopsis pilosula polysaccharides, Codonopsis pilosula saponins, sterols and other components. Codonopsis pilosula polysaccharides can enhance the gastric mucosal barrier function, promote the repair of gastric mucosal epithelial cells, regulate gastrointestinal motility, improve poor appetite and fatigue caused by spleen and stomach weakness, and reduce the level of inflammatory factors in the gastric mucosa.

[0017] Stir-fried Atractylodes macrocephala: This product is made from the dried rhizome of Atractylodes macrocephala (a plant in the Asteraceae family) stir-fried with wheat bran. It has a bitter and sweet taste, is warm in nature, and enters the spleen and stomach meridians. It has the effects of strengthening the spleen and replenishing qi, drying dampness and promoting diuresis. After being stir-fried with wheat bran, its drying properties are milder. It mainly contains atractylodes macrocephala lactone, atractylodes macrocephala polysaccharide, volatile oil and other components, which can regulate gastrointestinal motility, inhibit excessive gastric acid secretion, reduce gastric mucosal damage, enhance the spleen and stomach's digestive capacity, and improve abdominal distension and fullness caused by spleen deficiency and dampness.

[0018] Poria cocos: This product is the dried sclerotium of the fungus Poria cocos (family Polyporaceae). It has a sweet and bland taste, is neutral in nature, and enters the heart, lung, spleen, and kidney meridians. It has the effects of promoting diuresis and eliminating dampness, strengthening the spleen and calming the mind. It mainly contains Poria cocos polysaccharides, triterpenoids, sterols, and other components. Poria cocos polysaccharides can regulate gastrointestinal immune function, reduce chronic inflammation of the gastric mucosa, relieve epigastric fullness caused by water retention, and work synergistically with Atractylodes macrocephala to strengthen the spleen and stomach.

[0019] Licorice: This product is the dried root and rhizome of the legume plant *Glycyrrhiza uralensis*. It has a sweet taste and neutral properties, and enters the heart, lung, spleen, and stomach meridians. It has the effects of tonifying the spleen and replenishing qi, harmonizing other herbs, and relieving pain. It mainly contains glycyrrhizic acid, glycyrrhizin, isoglycyrrhizin, and other components, which can inhibit gastric mucosal inflammation, relieve gastrointestinal smooth muscle spasms, protect the gastric mucosal barrier, harmonize the properties of other herbs in the formula, and reduce dryness and harshness.

[0020] Amomum villosum: This product is the dried, mature fruit of Amomum villosum, a plant in the ginger family. It has a pungent taste and warm properties, and enters the spleen, stomach, and kidney meridians. It has the effects of resolving dampness and stimulating appetite, warming the spleen and stopping diarrhea, and regulating qi and relieving chest congestion. It mainly contains volatile oils, bornyl acetate, and other components, which can promote the secretion of gastric juice and digestive enzymes, enhance gastrointestinal motility, eliminate abdominal distension and bloating, and improve loss of appetite.

[0021] Lindera root: This product is the dried tuberous root of Lindera root, a plant of the Lauraceae family. It has a pungent taste and warm properties, and enters the lung, spleen, kidney, and bladder meridians. It has the effects of promoting qi circulation and relieving pain, warming the kidneys and dispelling cold. It mainly contains lindera lactone, alkaloids, volatile oils, and other components, which can relax the smooth muscles of the gastrointestinal tract, relieve abdominal pain caused by gastrointestinal spasms, promote qi circulation and relieve bloating, and is particularly effective for stomach pain caused by qi stagnation.

[0022] Danshen: This product is the dried root and rhizome of *Salvia miltiorrhiza*, a plant in the Lamiaceae family. It has a bitter taste and slightly cold nature, and enters the heart and liver meridians. It has the effects of promoting blood circulation and removing blood stasis, regulating menstruation and relieving pain, cooling blood and reducing swelling. It mainly contains tanshinone IIA, salvianolic acid B, tanshinone, and other components, which can improve gastric mucosal microcirculation, increase local blood flow, reduce ischemic damage to the gastric mucosa, inhibit inflammatory infiltration, and promote the repair of damaged mucosa.

[0023] Stewed Costus Root: This product is made from the dried root of Costus Root (a plant in the Asteraceae family) through stewing. It has a pungent, sweet, and bitter taste, and is warm in nature. It enters the spleen, stomach, and large intestine meridians, and has the effects of promoting qi circulation, relieving pain, strengthening the spleen, and aiding digestion. After stewing, its strong properties are mitigated. It mainly contains costunolactone, volatile oils, and other components, which can bidirectionally regulate gastrointestinal motility, promote qi circulation, relieve bloating, and alleviate abdominal distension and indigestion.

[0024] White peony root: This product is the dried root of the peony plant (Paeonia lactiflora), belonging to the Ranunculaceae family. It tastes bitter and sour, is slightly cold in nature, and enters the liver and spleen meridians. It has the effects of nourishing blood and astringing yin, softening the liver and relieving pain, and calming liver yang. It mainly contains paeoniflorin, paeoniflorin lactone, and other components, which can relieve gastrointestinal smooth muscle spasms, soften the liver and relieve pain, inhibit gastric mucosal inflammation, and improve stomach distension and pain caused by liver-stomach disharmony.

[0025] Fried Citrus aurantium: This product is made by frying the dried, immature fruit of Citrus aurantium (a plant in the Rutaceae family) with wheat bran. It has a bitter, pungent, and sour taste, and is slightly cold in nature. It enters the spleen, stomach, and large intestine meridians and has the effects of promoting qi circulation, resolving phlegm, eliminating food stagnation, and relieving indigestion. After being fried with wheat bran, its strong properties are mitigated. It mainly contains volatile oils and flavonoids, which can promote gastrointestinal emptying, eliminate abdominal distension and pain, and improve food stagnation and qi stagnation.

[0026] Magnolia officinalis: This product is the dried bark, root bark, and branch bark of Magnolia officinalis, a plant of the Magnoliaceae family. It has a bitter and pungent taste, is warm in nature, and enters the spleen, stomach, lung, and large intestine meridians. It has the effects of drying dampness and resolving phlegm, and relieving abdominal distension. It mainly contains magnolol and honokiol, which can regulate gastrointestinal motility, dry dampness and relieve abdominal distension, and inhibit gastric mucosal inflammation. It is particularly effective for abdominal distension caused by dampness obstructing qi.

[0027] Lily: This product is the dried, fleshy scale leaf of *Lilium tigrinum*, a plant in the Liliaceae family. It has a sweet taste and cold nature, and enters the heart and lung meridians. It has the effects of nourishing yin and moistening the lungs, clearing the heart and calming the mind, and nourishing yin and harmonizing the stomach. It mainly contains lily polysaccharides, alkaloids, steroidal saponins, and other components, which can nourish stomach yin, relieve stomach pain and dry mouth caused by insufficient stomach yin, and reduce inflammation of the gastric mucosa due to deficiency heat.

[0028] Fried Chicken Gizzard Lining: This product is made from the dried inner lining of the gizzard of the domestic chicken (Pheasantidae), which is fried. It has a sweet taste and neutral properties, and enters the spleen, stomach, small intestine, and bladder meridians. It has the effects of strengthening the stomach and promoting digestion, and resolving food stagnation. It mainly contains gastric hormones, amino acids, amylase, and other components, which can promote gastric juice secretion, enhance digestive function, and improve poor appetite and abdominal distension caused by food stagnation.

[0029] Ume (dried plum): This product is the dried, nearly mature fruit of the plum plant (Prunus mume), belonging to the Rosaceae family. It has a sour and astringent taste, is neutral in nature, and enters the liver, spleen, lung, and large intestine meridians. It has the effects of promoting body fluid production and quenching thirst, astringing yin and harmonizing the stomach, and astringing and protecting the gastric mucosa. It mainly contains citric acid, malic acid, flavonoids, and other components, which can promote body fluid production and harmonize the stomach, protect the gastric mucosa, and relieve acid reflux and dull pain caused by damage to the gastric mucosa.

[0030] Coptis chinensis: This product is the dried rhizome of Coptis chinensis, a plant of the Ranunculaceae family. It is bitter and cold in nature, and enters the heart, liver, stomach, gallbladder, and large intestine meridians. It has the effects of clearing heat and drying dampness, purging fire and detoxifying. It mainly contains berberine, coptisine and other components, which can inhibit pathogenic bacteria in the gastric mucosa, clear damp heat in the stomach, reduce gastric mucosal congestion and edema, and have anti-inflammatory and protective effects on the gastric mucosa.

[0031] Hawthorn: This product is the dried, ripe fruit of the hawthorn plant (Rosa laevigata), belonging to the Rosaceae family. It has a sour and sweet taste, is slightly warm in nature, and enters the spleen, stomach, and liver meridians. It has the effects of promoting digestion, strengthening the stomach, and invigorating blood circulation. It mainly contains hawthorn acid, citric acid, flavonoids, and other components, which can help digestion, especially meat, promote gastrointestinal digestion, improve poor appetite and abdominal distension, and work synergistically with danshen (Salvia miltiorrhiza) to invigorate blood circulation and unblock collaterals.

[0032] The compatibility principle is as follows: This formula uses Codonopsis pilosula and stir-fried Atractylodes macrocephala as the principal herbs to directly replenish the spleen and stomach qi deficiency, strengthen the spleen and stomach's digestive function, and address the core pathogenesis of spleen and stomach weakness in chronic gastritis. It uses Poria cocos, Glycyrrhiza uralensis, Amomum villosum, and roasted Aucklandia lappa as the assistant herbs to strengthen the spleen, eliminate dampness, regulate qi and harmonize the stomach, relieve bloating and pain, and assist the principal herbs in strengthening the spleen and stomach, regulating qi and relieving bloating. It uses Lindera strychnifolia, Paeonia lactiflora, stir-fried Citrus aurantium, Magnolia officinalis, Salvia miltiorrhiza, Lilium brownii, stir-fried chicken gizzard lining, Prunus mume, Coptis chinensis, and Crataegus pinnatifida as adjuvant herbs to regulate qi and relieve pain, invigorate blood circulation, nourish yin and protect the membranes, promote digestion, clear heat and dry dampness, addressing concurrent symptoms such as qi stagnation, blood stasis, food stagnation, stomach heat, and stomach yin deficiency, replenishing without causing stagnation and eliminating without harming the body's vital energy. Glycyrrhiza uralensis is used as the guiding herb to harmonize the properties of all the herbs, relieve urgency and pain. The entire formula works synergistically to replenish the spleen and stomach, relieve bloating and pain.

[0033] The proportions of each herb in the formula have been optimized and synergistic. The ratio of Codonopsis pilosula and stir-fried Atractylodes macrocephala is 2:1, which balances the effects of strengthening the spleen and replenishing qi. Amomum villosum, roasted Aucklandia lappa, Lindera strychnifolia, Magnolia officinalis, and stir-fried Citrus aurantium are used together to promote qi circulation and relieve bloating without depleting qi. Salvia miltiorrhiza and Crataegus pinnatifida invigorate blood circulation and unblock collaterals without depleting blood. Coptis chinensis and Prunus mume clear heat and astringe yin without harming the stomach. Lilium brownii and Paeonia lactiflora nourish yin and soften the liver. The whole formula is warm without being drying, tonifying without being stagnant, eliminating without being harmful, and clearing without being cold. It precisely targets symptoms such as abdominal distension, abdominal pain, abdominal fullness, and poor appetite caused by chronic gastritis, superficial gastritis, and duodenal ulcers. It acts on multiple components, multiple targets, and multiple pathways to repair the gastrointestinal mucosa, regulate gastrointestinal motility, and inhibit inflammation, with stable efficacy and high safety.

[0034] Compared with existing technologies, the Zhishu Yangwei tablets for chronic gastritis and their granule dry compression tableting process have the following beneficial effects: This invention replaces the traditional high-temperature decoction process with low-temperature dynamic extraction technology, effectively reducing the decomposition loss of heat-sensitive active ingredients such as tanshinone IIA and ursolic acid, and improving the bioavailability of the drug. It replaces the traditional atmospheric pressure concentration and oven drying processes with membrane concentration and spray drying technology, shortening the production cycle and reducing energy consumption, while avoiding the degradation of active ingredients caused by prolonged heating of materials. By using dry compression tableting process instead of the traditional wet granulation tableting process, no additional binders and wetting agents are needed, reducing the amount of excipients. The resulting granules have good flowability and uniform hardness, stable tableting process, small tablet weight difference, and a disintegration time shortened to 16-20 minutes. It also effectively avoids dust pollution and material loss, improves production efficiency and product quality, and is suitable for large-scale industrial production.

[0035] Other advantages, objectives and features of the invention will be set forth in part in the description which follows, and in part will be apparent to those skilled in the art from the following examination or study, or may be learned from the practice of the invention. Attached Figure Description

[0036] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the accompanying drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are merely some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without any creative effort.

[0037] Figure 1 A flowchart of the granule dry compression tableting process for Zhishu Yangwei tablets used for chronic gastritis; Figure 2 This is a flowchart illustrating the steps of a dry compression process for making Zhishu Yangwei tablets, a product used for chronic gastritis. Detailed Implementation

[0038] To further illustrate the technical means and effects of the present invention in achieving its intended purpose, the following detailed description of the specific implementation methods, structures, features and effects of the present invention, in conjunction with the accompanying drawings and preferred embodiments, is provided below.

[0039] This invention provides a Zhishu Yangwei tablet for chronic gastritis and its granule dry compression tableting process, which solves the problems of heat-sensitive component loss, long production cycle and uneven tablet quality in traditional processes, and provides a traditional Chinese medicine preparation solution with complete component retention, high production efficiency and stable quality.

[0040] This stomach-nourishing tablet uses a precise weight ratio of raw materials, with the optimal proportions being: Codonopsis pilosula 40 parts, stir-fried Atractylodes macrocephala 20 parts, Poria cocos 20 parts, Glycyrrhiza uralensis 10 parts, Amomum villosum 20 parts, Lindera strychnifolia 20 parts, Salvia miltiorrhiza 50 parts, roasted Aucklandia lappa 20 parts, Paeonia lactiflora 20 parts, stir-fried Citrus aurantium 20 parts, Magnolia officinalis 30 parts, Lilium brownii 40 parts, stir-fried chicken gizzard lining 20 parts, Prunus mume 50 parts, Coptis chinensis 10 parts, Crataegus pinnatifida 40 parts, magnesium stearate 6 parts, and sucrose 30 parts. All raw materials are processed according to standard procedures, with stir-fried Atractylodes macrocephala, roasted Aucklandia lappa, stir-fried chicken gizzard lining, and Coptis chinensis prepared using a proprietary process to ensure the efficacy of the medicinal materials. Each tablet weighs 0.3g and adheres to strict quality standards. The content of tanshinone IIA is not less than 0.18mg, the content of ursolic acid is not less than 0.14mg, the total content of magnolol and honokiol is not less than 0.22mg, the disintegration time is not more than 20min, the tablet weight difference is controlled within ±2.5%, the total bacterial count is not more than 10CFU / g, and Escherichia coli is not detectable.

[0041] The granulation and dry compression tableting process consists of six core steps. The first step is herbal pretreatment: a portion of the herbs are dried at a low temperature of 40-50℃, pulverized into a fine powder of 100-120 mesh, and 270-290 portions are reserved. The remaining coarse powder that does not pass through the sieve is mixed with the remaining herbs to be decocted. The second step is low-temperature dynamic extraction: 8-10 times the amount of purified water is added to the herbs to be decocted, and extraction is performed twice at 55-65℃, each time for 45-60 minutes. The extract is then filtered to obtain the filtrate. The third step is membrane concentration: the extract filtrate is treated with ultrafiltration and reverse osmosis membranes to obtain a concentrated solution with a relative density of 1.15-1.20. The fourth step is spray drying: the concentrated solution is spray dried at an inlet air temperature of 140-150℃ and an outlet air temperature of 70-80℃ to obtain a dried extract powder. The fifth step is dry granulation: the fine powder, the dried extract powder, and sucrose are mixed to obtain 20-40 mesh granules. The sixth step is tableting. After mixing the granules with magnesium stearate, the mixture is compressed into tablets under a pressure of 4-6 kN to obtain the finished product.

[0042] This process replaces high-temperature decoction with low-temperature dynamic extraction, reducing the decomposition of heat-sensitive components. Membrane concentration and spray drying shorten the production cycle and reduce energy consumption. Dry granulation eliminates the need for additional binders, resulting in good particle flowability and stable tablet compression, while reducing dust pollution and material loss. The formulation of the stomach-nourishing tablets follows the principles of tonifying the middle jiao and harmonizing the stomach, relieving bloating and pain. The precise combination of principal, assistant, and adjuvant herbs targets the pathogenesis of chronic gastritis characterized by spleen and stomach weakness, qi stagnation and blood stasis, and food accumulation with internal heat. It improves stomach discomfort symptoms through multiple targets, offering stable efficacy and high safety, making it suitable for large-scale industrial production. Example 1

[0043] This embodiment provides a Zhishu Yangwei tablet for chronic gastritis and its granulation and dry compression tableting process. Using an optimal weight ratio of raw materials, combined with low-temperature dynamic extraction, membrane concentration, spray drying, and dry granulation and tableting processes, the prepared Zhishu Yangwei tablets have high content of effective ingredients, rapid disintegration, and small tablet weight variation. After a 12-month accelerated stability study, the properties, microbial limits, and identification of effective ingredients all meet the requirements. The production cycle is short, energy consumption is low, and it is suitable for large-scale industrial production. See also Figure 1 and Figure 2 The specific implementation process of this embodiment is as follows: Weigh out the following ingredients by weight: 40 parts Codonopsis pilosula, 20 parts stir-fried Atractylodes macrocephala, 20 parts Poria cocos, 10 parts Glycyrrhiza uralensis, 20 parts Amomum villosum, 20 parts Lindera strychnifolia, 50 parts Salvia miltiorrhiza, 20 parts roasted Aucklandia lappa, 20 parts Paeonia lactiflora, 20 parts stir-fried Citrus aurantium, 30 parts Magnolia officinalis, 40 parts Lilium brownii, 20 parts stir-fried chicken gizzard lining, 50 parts Prunus mume, 10 parts Coptis chinensis, 40 parts Crataegus pinnatifida, 6 parts magnesium stearate, and 30 parts sucrose. Among them, stir-fried Atractylodes macrocephala is prepared by stir-frying wheat bran and Atractylodes macrocephala at a weight ratio of 1:10 at 155℃ for 12 minutes; roasted Aucklandia lappa is prepared by wrapping Aucklandia lappa in three layers of wet paper and roasting it in hot talcum powder for 22 minutes; stir-fried chicken gizzard lining is prepared by stir-frying clean river sand and chicken gizzard lining at a weight ratio of 5:1 at 185℃ until the surface puffs up and becomes crisp; and Coptis chinensis is prepared by removing impurities, moistening thoroughly, slicing into 3mm thin slices, and drying at low temperature.

[0044] S1. Pretreatment of medicinal materials: Codonopsis pilosula, stir-fried Atractylodes macrocephala, Poria cocos, Salvia miltiorrhiza, roasted Aucklandia lappa, Amomum villosum, Lindera strychnifolia, stir-fried Citrus aurantium, Magnolia officinalis, Lilium brownii, Paeonia lactiflora, Coptis chinensis, and stir-fried chicken gizzard are placed in a hot air circulating oven and dried at a low temperature of 45℃, turning them over once every 30 minutes; they are then pulverized into 100-mesh fine powder using a universal pulverizer, sieved through a stainless steel sieve, and mixed with a three-dimensional motion mixer at 18 r / min for 18 minutes, and 280 portions of the mixed fine powder are taken for later use; the remaining coarse powder is pulverized into 20-40 mesh and mixed with washed Glycyrrhiza uralensis, Prunus mume, and Crataegus pinnatifida to obtain the medicinal materials to be decocted.

[0045] S2. Low-temperature dynamic extraction: The medicinal materials to be decocted are put into an extraction tank with an anchor-type stirrer, 9 times the amount of purified water is added, the stirring is turned on, the speed is 35 r / min, and the low-temperature dynamic extraction is carried out twice at 60℃, each time for 50 min; solid-liquid separation is carried out using a plate and frame filter press with a filter cloth pore size of 15 μm, and the combined extracts are then filtered through a 0.45 μm polypropylene microporous membrane to obtain a clear extract filtrate.

[0046] S3. Membrane Concentration: The extract filtrate is separated from macromolecular impurities by a polyethersulfone hollow fiber ultrafiltration membrane with a molecular weight cutoff of 10,000 Da, an operating pressure of 0.15 MPa, and a temperature of 45 °C. The filtrate is then concentrated by a polyamide composite reverse osmosis membrane with an operating pressure of 1.2 MPa, a temperature of 40 °C, and a feed flow rate of 65 L / h to obtain a concentrate with a relative density of 1.18 at 50 °C.

[0047] S4. Spray drying: The concentrate is dried using a centrifugal spray dryer with an atomizer speed of 18000 r / min, a feed rate of 25 L / h, an inlet air temperature of 145℃, and an outlet air temperature of 75℃ to obtain a dried extract powder.

[0048] S5. Dry granulation: Mix the fine powder, dry extract powder and sucrose evenly, and feed them into a horizontal dry granulator with a pressure roller of 6MPa and a feeding speed of 12kg / h. After granulation, the granules are sized through a 30-mesh stainless steel sieve to obtain uniform granules of 20-40 mesh.

[0049] S6. Tableting: The granules and magnesium stearate are mixed in a three-dimensional motion mixer at 12 r / min for 8 min, and then fed into a rotary tablet press. The tableting pressure is 5 kN and the tablet press speed is 25 r / min. The tablet weight and hardness are sampled and tested every 15 min. The hardness is controlled at 3-5 kgf. The tablets are then compressed into 0.3 g / tablet Zhishu Yangwei tablets.

[0050] To verify the long-term stability of the Zhishu Yangwei tablets prepared in this embodiment, a 12-month stability test was conducted on the samples under sealed, room-temperature storage conditions. The test indicators included appearance, microbial limits, thin-layer chromatography identification of active ingredients, weight variation, and disintegration time. The test results are shown in the table below: In summary, the Zhishu Yangwei tablets prepared in this embodiment, when tested according to the quality standard method of this product, showed the following: tanshinone IIA content was 0.21 mg / tablet, ursolic acid content was 0.16 mg / tablet, and the total content of magnolol and honokiol was 0.23 mg / tablet; the disintegration time was 18 min, and the tablet weight difference was ±2.1%. After a 12-month stability study, all indicators met the requirements, with no changes in appearance, excessive microorganisms, or other issues. The retention rate of effective ingredients was increased by 28% compared to traditional processes, the production cycle was shortened by 40%, and there was no dust pollution, demonstrating excellent overall performance.

[0051] Example 2

[0052] This embodiment uses the lower limit weight parts of the raw material formulation to prepare Zhishu Yangwei tablets, strictly following the granule dry compression tableting process parameters. The resulting tablets meet the standards for active ingredient content, disintegration time, and tablet weight variation. The production process has low energy consumption and minimal material loss, meeting the needs of low-cost industrial production. See also Figure 1 and Figure 2 The specific implementation process of this embodiment is as follows: Weigh out the following ingredients by weight: 35 parts of Codonopsis pilosula, 18 parts of stir-fried Atractylodes macrocephala, 18 parts of Poria cocos, 8 parts of Glycyrrhiza uralensis, 18 parts of Amomum villosum, 18 parts of Lindera strychnifolia, 45 parts of Salvia miltiorrhiza, 18 parts of roasted Aucklandia lappa, 18 parts of Paeonia lactiflora, 18 parts of stir-fried Citrus aurantium, 28 parts of Magnolia officinalis, 35 parts of Lilium brownii, 18 parts of stir-fried chicken gizzard lining, 45 parts of Prunus mume, 8 parts of Coptis chinensis, 35 parts of Crataegus pinnatifida, 5 parts of magnesium stearate, and 28 parts of sucrose. Process each medicinal material according to the same processing method as in Example 1.

[0053] S1. Pretreatment of medicinal materials: Dry the medicinal materials at a low temperature of 40℃, pulverize them into 100-mesh fine powder, mix them in a three-dimensional mixer at 15r / min for 15min, take 270 portions of the mixed fine powder for later use, and control the remaining coarse powder to 20-40 mesh, and mix it with licorice, dried plum and hawthorn.

[0054] S2. Low-temperature dynamic extraction: Add 8 times the amount of purified water, extract twice at 55℃ for 45 minutes each time, with a stirring speed of 30 r / min, and then filter through a 10 μm filter cloth and a 0.45 μm microporous membrane.

[0055] S3. Membrane Concentration: Ultrafiltration membrane with a molecular weight cutoff of 8000 Da, operating pressure of 0.1 MPa, and temperature of 40℃; reverse osmosis membrane with an operating pressure of 1.0 MPa, temperature of 35℃, and feed flow rate of 50 L / h, yielding a concentrate with a relative density of 1.15 at 50℃.

[0056] S4. Spray drying: Atomizer speed 15000r / min, feed rate 20L / h, inlet air temperature 140℃, outlet air temperature 70℃, to obtain dried extract powder.

[0057] S5. Dry granulation: The dry granulator has a pressure roller of 5MPa, a feeding speed of 10kg / h, and uses a 20-mesh sieve for granulation.

[0058] S6. Tableting: Mix for 5 minutes, rotate at 10 r / min, compress at a pressure of 4 kN and a rotation speed of 20 r / min to compress into 0.3 g / tablet of Zhishu Yangwei tablets.

[0059] In summary, the Zhishu Yangwei tablets prepared in this embodiment, when tested according to the quality standard method of this product, showed the following: tanshinone IIA content was 0.19 mg / tablet, ursolic acid content was 0.14 mg / tablet, magnolol and total magnolol content was 0.22 mg / tablet, disintegration time was 19 min, and tablet weight difference was ±2.3%; all effective ingredients met the standards, the formulation performance was stable, production energy consumption was reduced by 35% compared with traditional processes, material loss was reduced by 20%, and the overall effect was good.

[0060] Example 3

[0061] This embodiment uses the upper limit of the raw material composition by weight to prepare Zhishu Yangwei tablets, and optimizes the core process parameters of granule dry compression tableting. The content of effective ingredients in the tablets is significantly increased, disintegration is faster, tablet weight uniformity is better, and clinical efficacy is more prominent. This method is suitable for production scenarios with high requirements for formulation quality. See also Figure 1 and Figure 2 The specific implementation process of this embodiment is as follows: Weigh out the following ingredients by weight: 45 parts of Codonopsis pilosula, 22 parts of stir-fried Atractylodes macrocephala, 22 parts of Poria cocos, 12 parts of Glycyrrhiza uralensis, 22 parts of Amomum villosum, 22 parts of Lindera strychnifolia, 55 parts of Salvia miltiorrhiza, 22 parts of roasted Aucklandia lappa, 22 parts of Paeonia lactiflora, 22 parts of stir-fried Citrus aurantium, 32 parts of Magnolia officinalis, 45 parts of Lilium brownii, 22 parts of stir-fried chicken gizzard lining, 55 parts of Prunus mume, 12 parts of Coptis chinensis, 45 parts of Crataegus pinnatifida, 7 parts of magnesium stearate, and 32 parts of sucrose. Process each medicinal material according to the same processing method as in Example 1.

[0062] S1. Pretreatment of medicinal materials: Dry the medicinal materials at a low temperature of 50℃, pulverize them into 120-mesh fine powder, mix them in a three-dimensional mixer at 20r / min for 20min, take 290 portions of the mixed fine powder for later use, and control the remaining coarse powder to 20-40 mesh.

[0063] S2. Low-temperature dynamic extraction: Add 10 times the amount of purified water, extract twice at 65℃ for 60 minutes each time, with a stirring speed of 40 r / min, and then filter through a 20 μm filter cloth and a 0.45 μm microporous membrane.

[0064] S3. Membrane Concentration: Ultrafiltration membrane with a molecular weight cutoff of 12000 Da, operating pressure of 0.2 MPa, and temperature of 50℃; reverse osmosis membrane with an operating pressure of 1.5 MPa, temperature of 45℃, and feed flow rate of 80 L / h, yielding a concentrate with a relative density of 1.20 at 50℃.

[0065] S4. Spray drying: Atomizer speed 20000r / min, feed rate 30L / h, inlet air temperature 150℃, outlet air temperature 80℃, to obtain dried extract powder.

[0066] S5. Dry granulation: The dry granulator has a pressure roller of 7MPa, a feeding speed of 15kg / h, and uses a 40-mesh sieve for granulation.

[0067] S6. Tableting: Mix for 10 minutes, rotate at 15 r / min, compress at 6 kN pressure and 30 r / min to form 0.3 g / tablet of Zhishu Yangwei tablets.

[0068] In summary, the Zhishu Yangwei tablets prepared in this embodiment, when tested according to the quality standard method of this product, showed the following: tanshinone IIA content was 0.22 mg / tablet, ursolic acid content was 0.17 mg / tablet, magnolol and total magnolol content was 0.24 mg / tablet, disintegration time was 17 min, and tablet weight difference was ±2.0%. The content of active ingredients was the highest among the three groups of embodiments, the disintegration rate was the fastest, the tablet weight uniformity was the best, and the stability indicators after 12 months showed no abnormalities, indicating excellent overall performance.

[0069] Comparative Example This comparative example uses the traditional wet granulation and tableting process to prepare Zhishu Yangwei tablets, without employing low-temperature extraction, membrane concentration, or dry granulation. This latter method serves as a control sample to compare the superiority of the process of this invention. The specific implementation process of this comparative example is as follows: Weigh all raw materials according to the weight proportions of Example 1, and the processing method of the medicinal materials is the same as that of Example 1.

[0070] S1. Grind and prepare fine powder of medicinal materials: Grind Codonopsis pilosula, stir-fried Atractylodes macrocephala, Poria cocos, Salvia miltiorrhiza, roasted Aucklandia lappa, Amomum villosum, Lindera strychnifolia, stir-fried Citrus aurantium, Magnolia officinalis, Lilium brownii, Paeonia lactiflora, Coptis chinensis, and stir-fried chicken gizzard into fine powder, pass through a 100-mesh sieve, and take 280g for later use.

[0071] S2. Decoction and Concentration: The coarse powder, licorice, dried plum, and hawthorn are decocted twice with purified water, 1 hour each time. The decoctions are combined, filtered, and the filtrate is concentrated under normal pressure to a thick paste with a relative density of 1.25-1.30 at 50°C.

[0072] S3. Mixing, granulation and drying: Mix the thick paste and fine powder evenly, dry and pulverize in an oven at 60℃, add sucrose, granulate using a wet granulation method, add ethanol as a wetting agent for granulation, and dry at 60℃.

[0073] S4, Total Mixed Tableting: Add magnesium stearate, mix well, and compress into 0.3g / tablet Zhishu Yangwei Tablets.

[0074] In summary, the Zhishu Yangwei tablets prepared in this comparative example, when tested according to the quality standard method of this product, showed the following results: tanshinone IIA content was 0.15 mg / tablet, ursolic acid content was 0.11 mg / tablet, magnolol and total magnolol content was 0.18 mg / tablet, disintegration time was 21 min, and tablet weight difference was ±3.5%. The product suffered from severe loss of active ingredients, a long production cycle, high energy consumption, and was prone to dust pollution, resulting in poor overall performance.

[0075]

[0076] As can be seen from the comparison table above, the three embodiments of the present invention employ a dry granulation tableting process, which has significant advantages over the traditional wet granulation process of the comparative example in terms of retention of active ingredients, formulation performance, and production efficiency. The contents of tanshinone IIA and ursolic acid in Examples 1-3 are much higher than those in the comparative example, the disintegration time is shortened by more than 33%, the tablet weight difference is more precisely controlled, the production cycle is shortened by 40%, and energy consumption is reduced by more than 35%. Among them, Example 1 uses the optimal ratio and process parameters, resulting in the best overall effect. The lower limit ratio of Example 2 can meet the requirements for low-cost production, and the upper limit ratio of Example 3 has the highest content of active ingredients. All three meet the formulation quality standards and have good stability. The comparative example suffers from a large loss of heat-sensitive components due to high-temperature decoction and wet granulation, resulting in uneven tablet quality and low production efficiency. This fully demonstrates the innovation and superiority of the technical solution of the present invention.

[0077] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some modifications or alterations to the above-disclosed technical content to create equivalent embodiments without departing from the scope of the present invention. Any simple modifications, equivalent changes and alterations made to the above embodiments based on the technical essence of the present invention without departing from the scope of the present invention shall still fall within the scope of the present invention.

Claims

1. A Zhishuyangwei tablet for chronic gastritis, characterized in that, This stomach-nourishing tablet is made from the following ingredients in parts by weight: Codonopsis pilosula 35-45 parts, stir-fried Atractylodes macrocephala 18-22 parts, Poria cocos 18-22 parts, Glycyrrhiza uralensis 8-12 parts, Amomum villosum 18-22 parts, Lindera strychnifolia 18-22 parts, Salvia miltiorrhiza 45-55 parts, roasted Aucklandia lappa 18-22 parts, Paeonia lactiflora 18-22 parts, stir-fried Citrus aurantium 18-22 parts, Magnolia officinalis 28-32 parts, Lilium brownii 35-45 parts, stir-fried chicken gizzard lining 18-22 parts, Prunus mume 45-55 parts, Coptis chinensis 8-12 parts, Crataegus pinnatifida 35-45 parts, magnesium stearate 5-7 parts, and sucrose 28-32 parts.

2. The Zhishu Yangwei tablets for chronic gastritis according to claim 1, characterized in that, It is made from the following ingredients in parts by weight: Codonopsis pilosula 40 parts, stir-fried Atractylodes macrocephala 20 parts, Poria cocos 20 parts, Glycyrrhiza uralensis 10 parts, Amomum villosum 20 parts, Lindera strychnifolia 20 parts, Salvia miltiorrhiza 50 parts, roasted Aucklandia lappa 20 parts, Paeonia lactiflora 20 parts, stir-fried Citrus aurantium 20 parts, Magnolia officinalis 30 parts, Lilium brownii 40 parts, stir-fried chicken gizzard lining 20 parts, Prunus mume 50 parts, Coptis chinensis 10 parts, Crataegus pinnatifida 40 parts, magnesium stearate 6 parts, and sucrose 30 parts. Among them, stir-fried Atractylodes macrocephala is made by stir-frying wheat bran and Atractylodes macrocephala in a weight ratio of 1:10 at 150-160℃ for 10-15 minutes. Roasted Aucklandia lappa is made by wrapping Aucklandia lappa in three layers of wet paper and roasting it in hot talcum powder for 20-25 minutes.

3. The Zhishu Yangwei tablets for chronic gastritis according to claim 1, characterized in that, The magnesium stearate is fine powder that has passed through a 100-mesh sieve, the sucrose is pharmaceutical grade sucrose, the stir-fried chicken gizzard is made by stir-frying clean river sand and chicken gizzard at a weight ratio of 5:1 at 180-190℃ until the surface puffs up and becomes crisp, and the Coptis chinensis is made by removing impurities, spraying with water to moisten thoroughly, slicing into 2-4mm thin slices, and drying at low temperature.

4. The Zhishu Yangwei tablets for chronic gastritis according to claim 1, characterized in that, Each tablet of this stomach-nourishing tablet contains no less than 0.18 mg of tanshinone IIA, no less than 0.14 mg of ursolic acid, no less than 0.22 mg of magnolol and honokiol, and the total bacterial count does not exceed 10 CFU / g.

5. A granule dry compression tableting process for Zhishu Yangwei tablets for chronic gastritis, used to prepare the Zhishu Yangwei tablets for chronic gastritis as described in any one of claims 1-4, characterized in that, The process includes the following steps: S1. Pre-treatment of medicinal materials: Codonopsis pilosula, stir-fried Atractylodes macrocephala, Poria cocos, Salvia miltiorrhiza, roasted Aucklandia lappa, Amomum villosum, Lindera strychnifolia, stir-fried Citrus aurantium, Magnolia officinalis, Lilium brownii, Paeonia lactiflora, Coptis chinensis, and stir-fried chicken gizzard lining are washed separately, dried at a low temperature of 40-50℃, pulverized into 100-120 mesh fine powder and sieved. The powder is mixed evenly to obtain a mixed fine powder. 270-290 portions are set aside. The remaining coarse powder that does not pass through the sieve after sieving is mixed with washed Glycyrrhiza uralensis, Prunus mume, and Crataegus pinnatifida to obtain the medicinal materials to be decocted. S2. Low-temperature dynamic extraction: Add the medicinal materials to be decocted into the extraction tank, add 8-10 times the amount of purified water, and perform low-temperature dynamic extraction twice at 55-65℃, each time for 45-60 minutes. Combine the extracts, filter, and obtain the extract filtrate. S3. Membrane Concentration: The extract filtrate is initially separated by ultrafiltration membrane to remove macromolecular impurities, and then concentrated by reverse osmosis membrane to obtain a concentrate with a relative density of 1.15-1.

20. The temperature of the concentrate is 50℃. S4. Spray drying: The concentrate is spray dried at an inlet air temperature of 140-150℃ and an outlet air temperature of 70-80℃ to obtain a dried extract powder. S5. Dry granulation: Mix the fine powder, dry extract powder and sucrose evenly, add them to a dry granulator for dry granulation, and obtain 20-40 mesh granules. S6. Tableting: Mix the prepared granules with magnesium stearate evenly, add them to a tablet press for tableting, and compress the tablets at a pressure of 4-6 kN to obtain Zhishu Yangwei tablets.

6. The granule dry compression tableting process for Zhishu Yangwei tablets for chronic gastritis according to claim 5, characterized in that, In step S1, low-temperature drying is carried out using a hot air circulating oven. During the drying process, the medicinal materials are turned over every 30 minutes. The pulverizing is carried out using a universal pulverizer. The pulverized fine powder is sieved through a 100-120 mesh stainless steel screen. The fine powder is mixed using a three-dimensional motion mixer for 15-20 minutes at a mixing speed of 15-20 r / min. The particle size of the remaining coarse powder is controlled within the range of 20-40 mesh.

7. The granule dry compression tableting process for Zhishu Yangwei tablets for chronic gastritis according to claim 5, characterized in that, In step S2, the low-temperature dynamic extraction is carried out in an extraction tank equipped with an anchor-type stirring device. The stirring speed during the extraction process is 30-40 r / min. After each extraction, a plate and frame filter press is used for solid-liquid separation. The pore size of the filter cloth is 10-20 μm. The combined extract is then filtered through a 0.45 μm polypropylene microporous membrane to remove suspended impurities and obtain a clear extract filtrate.

8. The granule dry compression tableting process for Zhishu Yangwei tablets for chronic gastritis according to claim 5, characterized in that, In step S3, the ultrafiltration membrane is a hollow fiber ultrafiltration membrane made of polyethersulfone with a molecular weight cutoff of 8000-12000 Da. The operating pressure during the ultrafiltration process is 0.1-0.2 MPa and the operating temperature is 40-50℃. The reverse osmosis membrane is a polyamide composite reverse osmosis membrane with an operating pressure of 1.0-1.5 MPa and an operating temperature of 35-45℃. The feed flow rate during the concentration process is controlled at 50-80 L / h.

9. The granule dry compression tableting process for Zhishu Yangwei tablets for chronic gastritis according to claim 5, characterized in that, In step S4, spray drying is carried out using a centrifugal spray dryer with an atomizer speed of 15,000-20,000 r / min and a concentrate feed rate of 20-30 L / h. In step S5, dry granulation is carried out using a horizontal dry granulator with a pressure roller pressure of 5-7 MPa and a feeding rate of 10-15 kg / h. The resulting granules are sized by passing them through a 20-40 mesh stainless steel sieve to remove particles that are too large or too small.

10. The granule dry compression tableting process for Zhishu Yangwei tablets for chronic gastritis according to claim 5, characterized in that, In step S6, the particles and magnesium stearate are mixed in a three-dimensional motion mixer for 5-10 minutes at a mixing speed of 10-15 r / min. The magnesium stearate is fine powder that has passed through a 100-mesh sieve. A rotary tablet press is used for tableting at a speed of 20-30 r / min. During the tableting process, the tablet weight and hardness are sampled and checked every 15 minutes, and the hardness is controlled at 3-5 kgf.

Images