Traditional Chinese medicine composition for treating spleen and stomach diseases and preparation method thereof

Abstract

The invention relates to the technical field of traditional Chinese medicine preparations, in particular to a traditional Chinese medicine composition for treating spleen and stomach diseases and a preparation method thereof. The traditional Chinese medicine composition comprises the following components in parts by mass: 5-8 parts of vinegar-processed rhizoma corydalis, 2-4 parts of bran-fried immature bitter orange, 2-4 parts of fingered citron, 2-4 parts of pseudo-ginseng, 5-8 parts of cuttlebone, 5-8 parts of cynanchum paniculatum, 5-8 parts of rhizoma bletillae, 2-4 parts of cynanchum auriculatum, 2-4 parts of radix pseudostellariae, 5-8 parts of radix tetrastigme and 2-4 parts of thunberg fritillary bulb. The preparation method comprises the following steps: preparing dry paste powder, preparing a soft material and granulating. The traditional Chinese medicine composition provided by the invention has a good curative effect on symptoms such as stomachache, abdominal distension, sour regurgitation, belching and nausea caused by liver-stomach qi stagnation as well as erosive gastritis and chronic superficial gastritis with the symptoms, is simple in formula and simple, stable and feasible in preparation process, is of great significance in relieving pain of patients and improving life quality of the patients, and has a wide application prospect. Wide clinical popularization prospects are realized.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine preparations, and in particular to a traditional Chinese medicine composition for treating spleen and stomach diseases and a preparation method thereof. Background Art

[0002] The diagnostic criteria for spleen and stomach disorders in Traditional Chinese Medicine Internal Medicine include "stomach pain, acid reflux, noisy stomach, stomach fullness, vomiting, choking, regurgitation, hiccups, abdominal pain, and diarrhea." Stomach fullness and pain are the primary clinical manifestations of spleen and stomach disorders. Currently, modern medicine primarily treats spleen and stomach disorders with symptomatic supportive care. While effective, this approach is associated with high recurrence rates and numerous adverse reactions.

[0003] According to Traditional Chinese Medicine (TCM), the spleen and stomach's ability to receive, transport, and transform qi, as well as the rise and fall of qi in the middle burner, depends on the liver's function of dispersing and dispersing qi. When the liver is overactive and overpowers the spleen, this can lead to gradual deficiency of qi in the spleen and stomach over time, leading to pain caused by lack of nourishment. Over time, liver depression can transform into fire and generate heat, which in turn invades the stomach, causing liver and stomach heat and pain. If the liver fails to disperse and dissipate qi, qi flow is sluggish, and blood circulation is insufficient, leading to blood stasis and, in turn, blood stasis, accompanied by stomach pain caused by blood stasis. Therefore, the main treatment for spleen and stomach diseases focuses on soothing the liver and regulating qi, and reducing acid and relieving pain. Currently, a large number of traditional Chinese medicine preparations are used clinically to treat spleen and stomach diseases. These preparations are widely favored by clinicians and patients due to their significant therapeutic effects and minimal toxic and side effects.

[0004] In the prior art, the Chinese invention patent application with application number CN116570691A, "A Chinese medicine composition for treating stomachache and its application", discloses a Chinese medicine composition for treating stomachache caused by chronic superficial gastritis, gastric ulcer, duodenal ulcer, functional dyspepsia, etc. The Chinese medicine composition is made from eight Chinese medicinal materials such as Piper scutellariae and Cyperus rotundus as raw materials. The above Chinese medicine composition is prepared into a Chinese medicine plaster for treating stomachache, which has the advantages of good efficacy and low adverse reactions. However, there are still the following problems: (1) The total effective rate is about 80%, and the clinical treatment effect is limited; (2) A large number of excipients are used, and the preparation process is complicated, resulting in high production costs.

[0005] Based on this, our hospital's national grassroots famous old Chinese medicine practitioners, based on the traditional Chinese medicine thinking of treating spleen and stomach diseases, formulated the "Yuanhu Hewei Granules". The whole prescription is composed of vinegar Corydalis, cuttlebone, white ginseng, three leaves green, Cynanchum chinense, Panax notoginseng, Glycyrrhiza uralensis, bergamot, bran-fried Citrus aurantium, Pseudostellaria baicalensis, and Fritillaria thunbergii. It has been approved by the Medical Affairs Department of our hospital as a hospital agreement prescription. After long-term clinical observation results, it has been shown that the prescription has significant efficacy in treating spleen and stomach diseases and a low incidence of adverse reactions. This application, combined with modern preparation technology, prepares the prescription into granules that are convenient for clinical application, aiming to provide a safer and more effective Chinese medicine preparation for treating spleen and stomach diseases for clinical use, to relieve patients' pain and improve their quality of life. Summary of the Invention

[0006] The purpose of the present invention is to provide a traditional Chinese medicine composition for treating spleen and stomach diseases and a preparation method thereof.

[0007] Another object of the present invention is to provide the use of the above-mentioned traditional Chinese medicine composition in the preparation of medicines for treating spleen and stomach diseases.

[0008] To achieve the above object, the technical solution adopted by the present invention is as follows:

[0009] The traditional Chinese medicine composition for treating spleen and stomach diseases of the present invention comprises the following components in parts by mass: 5-8 parts of vinegared Corydalis yanhusuo, 2-4 parts of bran-fried immature bitter orange, 2-4 parts of citron, 2-4 parts of Panax notoginseng, 5-8 parts of cuttlebone, 5-8 parts of Cynanchum chinense, 5-8 parts of Bletilla striata, 2-4 parts of Cynanchum wilfordii, 2-4 parts of Pseudostellaria heterophylla, 5-8 parts of Tripterygium wilfordii, and 2-4 parts of Fritillaria thunbergii.

[0010] Preferably, the traditional Chinese medicine composition for treating spleen and stomach diseases of the present invention comprises the following components in parts by mass: 5-7 parts of vinegar Corydalis yanhusuo, 2.5-3.5 parts of bran-fried Citrus aurantium, 2.5-3.5 parts of bergamot, 2.5-3.5 parts of Panax notoginseng, 5-7 parts of cuttlebone, 5-7 parts of Cynanchum chinense, 5-7 parts of Bletilla striata, 2.5-3.5 parts of Cynanchum wilfordii, 2.5-3.5 parts of Pseudostellaria baicalensis, 5-7 parts of Tripterygium wilfordii, and 2.5-3.5 parts of Fritillaria thunbergii.

[0011] Further preferably, the traditional Chinese medicine composition for treating spleen and stomach diseases of the present invention comprises the following components in parts by mass: 6 parts of vinegar Corydalis, 3 parts of stir-fried Citrus aurantium, 3 parts of bergamot, 3 parts of Panax notoginseng, 6 parts of cuttlebone, 6 parts of Cynanchum wilfordii, 6 parts of Bletilla striata, 3 parts of Cynanchum wilfordii, 3 parts of Pseudostellaria baicalensis, 6 parts of Tripterygium wilfordii, and 3 parts of Fritillaria thunbergii.

[0012] The preparation method of the Chinese medicine composition for treating spleen and stomach diseases of the present invention comprises the following steps:

[0013] S1 Preparation of dry paste powder:

[0014] Weigh each medicinal material slice according to the recipe, add water and boil for 1-5 times, adding 6-14 times the weight of the medicinal material each time, and boil for 0.5-2.5 hours. For the first decoction, add 1 times more water and soak for 1 hour before decoction; filter the decoction, combine the filtrates, and concentrate under reduced pressure to a clear paste with a density of 1.05-1.20 at 80°C, dry in an oven, and grind to obtain a dry paste powder;

[0015] S2 preparation of soft materials:

[0016] Take the dry paste powder prepared in the above steps, add auxiliary materials, and use 70% to 80% ethanol solution as a wetting agent to make a soft material. The standard of the soft material is that it can form a ball when held by hand and falls apart when touched lightly.

[0017] The auxiliary material is at least one of dextrin, soluble starch and microcrystalline cellulose;

[0018] The mass ratio of the dry paste powder to the auxiliary materials is 5:4;

[0019] S3 Granulation:

[0020] The prepared soft material is squeezed through a No. 1 sieve to granulate, and after air drying, it is sized using a No. 1 sieve and a No. 5 sieve, and the particles between the No. 1 sieve and the No. 5 sieve are collected to obtain the product.

[0021] Preferably, in the preparation method of the traditional Chinese medicine composition for treating spleen and stomach diseases described in the present invention, the specific process of preparing the dry paste powder in step S1 is: weighing the decoction pieces of each medicinal material according to the formula, adding water and decocting 3-5 times, adding 6-10 times the total mass of the medicinal materials each time, and decocting for 1-1.5 hours, adding 1 times more water for the first decoction and soaking for 1 hour before decoction; filtering the decoction, combining the filtrate, and concentrating under reduced pressure to a clear paste with a density of 1.05-1.20 at 80°C, drying and crushing in an oven to obtain the dry paste powder.

[0022] Further preferably, in the preparation method of the traditional Chinese medicine composition for treating spleen and stomach diseases described in the present invention, the specific process of preparing the dry paste powder in step S1 is: weigh each medicinal material according to the formula, add water and boil three times, add 9 times the weight of the medicinal material in water for the first time, soak for 1 hour and then boil for 1 hour, add 8 times the weight of the medicinal material in water for the second and third times, and boil for 1 hour each time; filter the decoction, combine the filtrate, and concentrate under reduced pressure to a clear paste with a density of 1.05 to 1.20 at 80°C, dry and grind in an oven at 105°C to obtain the dry paste powder.

[0023] Preferably, in the method for preparing the traditional Chinese medicine composition for treating spleen and stomach diseases of the present invention, the wetting agent in step S2 is a 70% ethanol solution.

[0024] Preferably, in the method for preparing the traditional Chinese medicine composition for treating spleen and stomach diseases of the present invention, the auxiliary material in step S2 is a mixed auxiliary material composed of dextrin and microcrystalline cellulose in a mass ratio of 7:1.

[0025] Preferably, in the method for preparing the traditional Chinese medicine composition for treating spleen and stomach diseases of the present invention, the temperature of the forced air drying in step S3 is 80°C.

[0026] The invention relates to an application of the traditional Chinese medicine composition in preparing medicines for treating spleen and stomach diseases.

[0027] Beneficial effects of the present invention:

[0028] 1. The present invention provides a Chinese medicine composition for treating spleen and stomach diseases. Retrospective clinical studies have shown that after patients with chronic superficial gastritis were treated with the prescription of this study, symptoms such as stomach pain, abdominal distension, acid reflux, belching, and nausea were greatly relieved, with the remission rate and complete remission rate reaching 97.92% / 91.67% (stomach pain), 98.91% / 92.39% (abdominal distension), 98.89% / 95.56% (acid reflux), 100% / 93.15% (belching), and 98.46% / 92.31% (nausea), respectively. In addition, no adverse reactions occurred in all enrolled patients, fully demonstrating that the Chinese medicine composition provided in this study has extremely high effectiveness and safety in treating spleen and stomach diseases. The Chinese medicine composition provided in this study is of great significance for alleviating the pain of patients with spleen and stomach diseases and improving the quality of life of patients, and has broad prospects for clinical promotion.

[0029] 2. The present invention provides a method for preparing the aforementioned traditional Chinese medicine composition for treating spleen and stomach diseases. By examining parameters influencing the extraction and formulation processes and combining these with actual production, the optimal preparation process for this traditional Chinese medicine composition is as follows: three decoctions; each decoction lasting one hour; eight times the total weight of the medicinal materials added, with one additional amount added for the first decoction; granulation using dry extract powder; a mixed excipient consisting of dextrin and microcrystalline cellulose in a mass ratio of 7:1; and a 70% ethanol solution as the wetting agent. Three pilot-scale process validation experiments confirmed the stability and feasibility of this preparation process. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 The relationship between the soaking time of medicinal materials and water absorption rate;

[0031] Figure 2 The relationship between water addition times and paste yield;

[0032] Figure 3 The relationship between extraction time and paste yield;

[0033] Figure 4 It is the relationship between extraction times and paste yield. DETAILED DESCRIPTION

[0034] The following is a detailed description of the technical solution of the present invention in conjunction with specific embodiments. The following embodiments are only for explanation and illustration, and do not constitute a limitation of the technical solution of the present invention.

[0035] Example 1

[0036] The formula of the traditional Chinese medicine composition for treating spleen and stomach diseases is: 6g vinegar Corydalis, 3g bran fried Citrus aurantium, 3g bergamot, 3g Panax notoginseng, 6g cuttlebone, 6g Cynanchum wilfordii, 6g Bletilla striata, 3g Cynanchum wilfordii, 3g Pseudostellaria baicalensis, 6g Tripterygium wilfordii, and 3g Fritillaria thunbergii.

[0037] Example 2

[0038] The formula of the traditional Chinese medicine composition for treating spleen and stomach diseases is: 5g vinegar Corydalis, 2g bran fried Citrus aurantium, 2g bergamot, 2g Panax notoginseng, 5g cuttlebone, 5g Cynanchum wilfordii, 5g Bletilla striata, 2g Gynostemma pentaphyllum, 2g Pseudostellaria baicalensis, 5g Tripterygium wilfordii, and 2g Fritillaria thunbergii.

[0039] Example 3

[0040] The formula of the traditional Chinese medicine composition for treating spleen and stomach diseases is: 8g vinegar Corydalis, 4g bran fried Citrus aurantium, 4g bergamot, 4g Panax notoginseng, 8g cuttlebone, 8g Cynanchum wilfordii, 8g Bletilla striata, 4g Cynanchum wilfordii, 4g Pseudostellaria baicalensis, 8g Tripterygium wilfordii, and 4g Fritillaria thunbergii.

[0041] Example 4

[0042] The formula of the traditional Chinese medicine composition for treating spleen and stomach diseases is: 5g vinegar Corydalis, 2.5g bran fried Citrus aurantium, 2.5g bergamot, 2.5g Panax notoginseng, 5g cuttlebone, 5g Cynanchum wilfordii, 5g Bletilla striata, 2.5g Gynostemma pentaphyllum, 2.5g Pseudostellaria baicalensis, 5g Tripterygium wilfordii, and 2.5g Fritillaria thunbergii.

[0043] Example 5

[0044] The formula of the traditional Chinese medicine composition for treating spleen and stomach diseases is: 7g vinegar Corydalis, 3.5g bran-fried Citrus aurantium, 3.5g bergamot, 3.5g Panax notoginseng, 7g cuttlebone, 7g Cynanchum wilfordii, 7g Bletilla striata, 3.5g Cynanchum wilfordii, 3.5g Pseudostellaria baicalensis, 7g Tripterygium wilfordii, and 3.5g Fritillaria thunbergii.

[0045] Example 6

[0046] Preparation method of a traditional Chinese medicine composition for treating spleen and stomach diseases:

[0047] S1 Preparation of dry paste powder:

[0048] Weigh each medicinal ingredient according to the formula and decoct it three times with water. For the first decoction, add 9 times the weight of the medicinal ingredient, soak for 1 hour, and then decoct for 1 hour. For the second and third decoctions, add 8 times the weight of the medicinal ingredient in water, and decoct for 1 hour each time. The decoction is filtered, and the filtrates are combined and concentrated under reduced pressure to a clear paste with a density of 1.05-1.20 at 80°C. The paste is then dried and pulverized in an oven at 105°C to obtain a dry paste powder.

[0049] S2 preparation of soft materials:

[0050] The dry paste powder prepared in the above steps was added with a mixed excipient consisting of dextrin and microcrystalline cellulose in a mass ratio of 7:1, and a 70% ethanol solution was used as a wetting agent to prepare a soft material. The standard for the soft material was that it could be clumped when held by hand and fell apart when touched lightly. The mass ratio of the dry paste powder to the mixed excipient was 5:4.

[0051] S3 Granulation:

[0052] The prepared soft material is squeezed through a No. 1 sieve to be granulated, dried by forced air at 80°C, sized using a No. 1 sieve and a No. 5 sieve, and the particles between the No. 1 sieve and the No. 5 sieve are collected to obtain the product.

[0053] Example 7

[0054] Preparation method of a traditional Chinese medicine composition for treating spleen and stomach diseases:

[0055] S1 Preparation of dry paste powder:

[0056] Weigh each medicinal ingredient according to the formula and decoct it four times with water. For the first decoction, add 9 times the weight of the medicinal ingredient, soak for 1 hour, and then decoct for 1 hour. For the second, third, and fourth decoctions, add 8 times the weight of the medicinal ingredient with water, and decoct for 1 hour each time. Filter the decoction, combine the filtrates, and concentrate under reduced pressure to a clear paste with a density of 1.05-1.20 at 80°C. Dry and pulverize in an oven at 105°C to obtain a dry paste powder.

[0057] S2 preparation of soft materials:

[0058] The dry paste powder prepared in the above steps was added with a mixed excipient consisting of dextrin and microcrystalline cellulose in a mass ratio of 7:1, and 80% ethanol solution was used as a wetting agent to prepare a soft material. The standard for the soft material was that it could be clumped when held by hand and fell apart when touched lightly. The mass ratio of the dry paste powder to the mixed excipient was 5:4.

[0059] S3 Granulation:

[0060] The prepared soft material is squeezed through a No. 1 sieve to be granulated, dried by forced air at 80°C, sized using a No. 1 sieve and a No. 5 sieve, and the particles between the No. 1 sieve and the No. 5 sieve are collected to obtain the product.

[0061] Example 8

[0062] Preparation method of a traditional Chinese medicine composition for treating spleen and stomach diseases:

[0063] S1 Preparation of dry paste powder:

[0064] Weigh each medicinal ingredient according to the formula and decoct it five times with water. For the first decoction, add 7 times the weight of the medicinal ingredient, soak for 1 hour, and then decoct for 1.5 hours. For the second, third, fourth, and fifth decoctions, add 6 times the weight of the medicinal ingredient with water, and decoct for 1.5 hours each time. Filter the decoction, combine the filtrates, and concentrate under reduced pressure to a clear paste with a density of 1.05-1.20 at 80°C. Dry and pulverize in an oven at 105°C to obtain a dry paste powder.

[0065] S2 preparation of soft materials:

[0066] The dry paste powder prepared in the above steps was added with a mixed excipient consisting of dextrin and microcrystalline cellulose in a mass ratio of 7:1, and a 70% ethanol solution was used as a wetting agent to prepare a soft material. The standard for the soft material was that it could be clumped when held by hand and fell apart when touched lightly. The mass ratio of the dry paste powder to the mixed excipient was 5:4.

[0067] S3 Granulation:

[0068] The prepared soft material is squeezed through a No. 1 sieve to be granulated, dried by forced air at 80°C, sized using a No. 1 sieve and a No. 5 sieve, and the particles between the No. 1 sieve and the No. 5 sieve are collected to obtain the product.

[0069] In order to further verify the reliability of the present invention and screen out the best solution, the inventors conducted a series of experiments, as follows:

[0070] 1. Source of formula

[0071] 1.1 Prescription composition

[0072] The formula in this study consisted of: vinegar-soaked Corydalis 6g, stir-fried Citrus aurantium 3g, Citrus palm 3g, Panax notoginseng 3g, cuttlebone 6g, Cynanchum chinense 6g, Bletilla striata 6g, Gynostemma pentaphyllum 3g, Pseudostellaria pseudoginseng 3g, Tripterygium wilfordii 6g, and Fritillaria thunbergii 3g. This formula was prepared into granules, named Yuanhu Hewei Granules.

[0073] 1.2 Basis of formula

[0074] The three ingredients in this preparation, vinegar-soaked Corydalis yanhusuo, bran-fried Citrus aurantium, and bergamot, are all the main drugs, which directly address the pathogenesis of liver-stomach qi stagnation and target liver-stomach disorders. This is the treatment principle of "dredging the blood and qi and regulating them" in "Suwen Zhizhen Yao Dalun". Among them, vinegar-cured Corydalis yanhusuo, with its pungent, dispersing, warming, and unblocking properties, can both invigorate blood circulation and promote qi circulation, with significant analgesic effects, making it a key herb for promoting blood circulation, promoting qi circulation, and relieving pain. Li Shizhen described Corydalis yanhusuo as pungent, dispersing, warming, and unblocking, uniquely capable of "moving qi stagnation in blood and blood stagnation in qi," particularly effective in unblocking qi and blood stagnation in the liver and stomach, making it a key herb for alleviating pain. Sautéed Citrus aurantium with bran has a sharp and potent nature, dispersing qi and eliminating stagnation, effectively relieving qi stagnation in the liver meridian and clearing gastric congestion. "Ming Yi Bie Lu" notes its effectiveness in relieving "acute pain and fullness below the heart." Buddha's hand, with its refreshing fragrance invigorating the spleen and its bitterness relieving liver stagnation, evokes the remarkable efficacy of "treating qi, soothing the liver, harmonizing the stomach, and resolving phlegm" as described in "Compendium of Materia Medica." These three herbs complement each other, regulating qi and blood, and ascending and descending in unison. Together, they soothe the liver and harmonize the stomach, relieving pain, and forming a three-dimensional attack against the pathogenesis of liver qi rebelliously invading the stomach. Panax notoginseng, combined with sea cucumber as a supporting ingredient, establishes a framework for the simultaneous treatment of qi and blood. Panax notoginseng dissolves blood stasis and stops bleeding, dredging the middle and maintaining circulation. It assists Corydalis yanhusuo in dispersing blood stasis and preventing excessive Qi-dispersing effects from Citrus aurantium. Cuttlebone, with its acid-reducing and protective properties, offers astringency while also dispersing, alleviating the urgency of stomach acid reflux and coordinating with Buddha's hand to harmonize the liver and stomach. The combination of these two herbs not only enhances the analgesic effect of the main herb but also addresses complications such as blood stasis and acid reflux caused by Qi stagnation. Six herbs, including Cynanchum cyrtonema, Bletilla striata, Radix Pseudostellariae, Tripterygium wilfordii, and Fritillaria thunbergii, serve as adjuvants, creating a multi-faceted synergistic effect. Cynanchum cyrtonema dissipates dampness, dredges the meridians, and relieves pain, assisting the main herb in dispelling Qi stagnation and dampness. Bletilla striata adheres and astringes, promoting tissue regeneration and repairing damaged gastric meridians. The combination of Cynanchum cyrtonemae and Radix Pseudostellariae, one dispersing and one tonic, invigorates the middle jiao while preventing Qi-disrupting Yin. Tripterygium wilfordii clears stagnant heat, while Fritillaria thunbergii resolves phlegm and disperses stagnation, collectively eliminating the phlegm, heat, and toxic stasis that can result from prolonged Qi stagnation. These six herbs may aid in promoting bowel movements, strengthen the body's vital essence, or clear away residual pathogenic factors, ensuring that the formula's attacking power does not harm vital energy, and its dispersing power does not deplete yin. The formula's key focus is regulating the liver and stomach. The three main herbs are like commanders-in-chief, each fulfilling their respective roles. Corydalis yanhusuo clears blood vessels, Citrus aurantium dissolves qi blockage, and Citrus shou harmonizes the liver and stomach. The auxiliary herbs either pave the way or provide support, collectively forming a three-dimensional therapeutic system that soothes the liver, regulates qi, and harmonizes the stomach to relieve pain. This formula is particularly effective for stomachache, bloating, belching, and acid reflux caused by liver depression and qi stagnation, which invade the stomach. Its unique formula promotes qi circulation without depleting qi, resolves blood stasis without damaging blood, and suppresses acid without astringing pathogenic factors. This formula perfectly aligns with the pathogenesis of chronic superficial gastritis, characterized by chronic disease entering the meridians and a mixture of deficiency and excess. Combined, these herbs soothe the liver, regulate qi, suppress acid, and relieve pain. It is used for stomach pain, abdominal distension, acid reflux, belching, and nausea caused by liver and stomach qi stagnation; and for patients with chronic superficial gastritis with the above symptoms.

[0075] Modern pharmacological research has confirmed that among the prescription drugs, Bletilla striata has the effects of stopping bleeding, promoting wound healing and anti-inflammatory; Corydalis yanhusuo with vinegar has the effects of analgesia, sedation and anti-inflammatory; Citrus aurantium has the effects of regulating gastrointestinal motility, anti-inflammatory and anti-ulcer; Buddha's hand has the effects of antibacterial and anti-tumor; Glycyrrhiza uralensis has the effects of anti-tumor and antioxidant; Panax notoginseng has the effects of promoting blood circulation, stopping bleeding, anti-inflammatory and analgesia; Tripterygium wilfordii has the effects of anti-tumor and anti-inflammatory; Pseudostellaria baicalensis has the effects of lowering blood sugar, anti-inflammatory and anti-cancer; Cynanchum wilfordii has the effects of analgesia, anti-tumor, anti-inflammatory and antiviral; Fritillaria thunbergii has the effects of anti-ulcer, analgesia and anti-tumor; and Cuttlebone has the effect of neutralizing gastric acid.

[0076] 2. Preparation process research

[0077] 2.1 Extraction process research

[0078] This study used the yield of the extract as an indicator to examine the water addition ratio, extraction time, and number of extractions in the extraction process, and optimized the extraction process of Yuanhu Hewei Granules. The dry extract weight was determined by decocting the supernatant of the decoction filtrate with water to a thick extract, transferring it to a constant-weight evaporating dish, drying it at 105°C for 3 hours, cooling it in a desiccator for 30 minutes, and then quickly and accurately weighing it. The dry extract weight was calculated according to the following formula:

[0079] Dry paste weight = m1-m2

[0080] Where m1 is the total weight of the evaporating dish and the dry paste, and m2 is the weight of the evaporating dish.

[0081] 2.1.1 Investigation of water absorption

[0082] Weigh 144g of 3 times the amount of the prescription medicinal material slices, add enough water to soak (about 12 times the amount), compact, and submerge the medicinal material in water. Drain the water every 20 minutes until it is no longer dripping, then weigh it. Repeat the operation for 120 minutes, and parallel 3 groups. Calculate the water absorption of the medicinal material, and calculate the water absorption rate of the medicinal material according to the following formula. The results are shown in Table 1. The relationship between the medicinal material soaking time and water absorption rate is shown in Figure 1 .

[0083]

[0084] Table 1 Relationship between soaking time and water absorption rate of medicinal materials (n=3)

[0085]

[0086] The results show that the mixed herbs absorb water rapidly before 20 minutes, then gradually slow down after 20 minutes, and reach saturation after 80 minutes, with the final water absorption reaching 101.79% of the herbs' weight. Therefore, it was determined that double the amount of water should be added during the first decoction.

[0087] 2.1.2 Single Factor Investigation

[0088] (1) Investigation of water addition multiples

[0089] Weigh 144g of 3 times the amount of the prescription medicinal material slices, add 6, 8, 10, 12, and 14 times the total weight of the medicinal material in water, soak for 1 hour, decoct and extract 3 times, each time for 1 hour, combine the decoctions, let it stand, take the supernatant and decoct it into a thick paste, dry it, calculate the paste yield, and repeat 3 times. The results are shown in Table 2 and Table 3. The relationship between the water addition multiple and the paste yield is as follows Figure 2 .

[0090] Table 2 Effect of water addition ratio on paste yield (n=3)

[0091]

[0092]

[0093] Table 3 Variance analysis results of water addition multiple-cream yield (n=3)

[0094]

[0095] Note: *p<0.05 **p<0.01.

[0096] The statistical analysis results showed that there was a significant difference between the water addition ratio and the paste yield (p<0.05). Combined with actual production, the water addition ratio was selected as 8 times.

[0097] (2) Extraction time investigation

[0098] Weigh 144g of 3 times the amount of the prescription medicinal material slices, add 8 times the total weight of the medicinal material water, soak for 1 hour, decoct and extract 3 times, each extraction time is 0.5h, 1h, 1.5h, 2h, 2.5h, combine the decoction, let it stand, take the supernatant and decoct it into a thick paste, dry it, calculate the paste rate, and repeat 3 times. The results are shown in Table 4 and Table 5. The relationship between extraction time and paste rate is shown in Table 4. Figure 3 .

[0099] Table 4 Effect of extraction time on paste yield (n=3)

[0100]

[0101]

[0102] Note: *p<0.05 **p<0.01.

[0103] The statistical analysis results showed that there was a significant difference between the extraction time and the paste yield (p < 0.05). In combination with actual production, the extraction time was selected as 1 hour.

[0104] (3) Investigation of extraction times

[0105] Weigh 144g of 3 times the amount of the prescription medicinal material slices, add 8 times the total weight of the medicinal material water, soak for 1 hour, extract 1, 2, 3, 4, 5 times, each time for 1 hour, combine the decoction, let it stand, take the supernatant and decoct it into a thick paste, dry it, calculate the paste rate, and repeat 3 times. The results are shown in Table 6 and Table 7. The relationship between the number of extractions and the paste rate is as follows Figure 4 .

[0106] Table 6 Effect of extraction times on paste yield (n=3)

[0107]

[0108] Table 7 Results of variance analysis of extraction times-paste yield (n=3)

[0109]

[0110]

[0111] Note: *p<0.05 **p<0.01.

[0112] The statistical analysis results showed that there was a significant difference between the number of extractions and the yield of paste (p < 0.05). In combination with actual production, the number of extractions was selected as 3.

[0113] In summary, using the yield of the herbal paste as an indicator, the single-factor experiments revealed that the effects of water addition, extraction time, and number of extractions on the yield of the herbal paste were all significant (p < 0.05), indicating that these factors significantly impacted the extraction process. Taking into account factors such as production cycle, resources, and energy, the extraction process was determined as follows: three extractions; the first extraction was performed with 9 times the total weight of the herbal paste in water, decocted for 1 hour; the second and third extractions were performed with 8 times the total weight of the herbal paste in water, decocted for 1 hour each time.

[0114] 2.2 Concentration process

[0115] Combined with actual production conditions, the concentration process is as follows: take the filtered liquid and decompress it to concentrate it to a clear paste with a density of 1.05-1.20 at 80°C, and dry it in an oven.

[0116] 2.3 Investigation of formulation molding process

[0117] The selection of excipients for Chinese herbal granules should be based on the principles of low excipient dosage, high water solubility, and good formability. This product, composed of Chinese herbal extracts, has a bitter taste, which may affect patient compliance. However, considering the special medication requirements of diabetic patients, the granules were prepared as sugar-free granules. Previous extraction process studies revealed that the maximum yield of this compound was approximately 18%. Based on our hospital's original prescription, one dose per day, decocted with water to form a decoction, and taken three times per dose, this translates to a patient intake of 2.8g of extract per dose. If sugar-free granules were prepared, the excipient dosage would be minimized to 2.24g, i.e., a powder:excipient ratio of 5:4.

[0118] 2.3.1 Evaluation index measurement method

[0119] (1) Particle yield

[0120] According to the provisions of the granules in Part IV (General Rule 0104) of the 2020 edition of the Chinese Pharmacopoeia, the granules that can pass through the No. 1 sieve but cannot pass through the No. 5 sieve are qualified granules. Take an appropriate amount of Yuanhu Hewei granules, weigh them accurately, and record the total mass as M 总 , take the particles that can pass through the No. 1 sieve but cannot pass through the No. 5 sieve, weigh them, record them as M, and calculate the particle yield according to the following formula:

[0121] Particle yield (%) = M / M 总 ×100%

[0122] Unless otherwise specified, the total of the particles that cannot pass through the No. 1 sieve and the particles that can pass through the No. 5 sieve shall not exceed 15% as determined by the particle size and particle size distribution determination method (General Rule 0982 Method 2 Double Screening Method).

[0123] (2) Solubility

[0124] Unless otherwise specified, granules shall be inspected according to the following method and their solubility shall comply with the requirements.

[0125] Soluble particle test method: Take 10g of the test sample, add 200mL of hot water, stir for 5 minutes, and observe immediately. The soluble particles should be completely dissolved or slightly turbid.

[0126] (3) Angle of repose

[0127] The angle of repose of a powder is determined using the fixed funnel method: The funnel is fixed a certain distance (approximately 1 cm) above horizontal drawing paper. The distance from the bottom of the funnel to the drawing paper is H. Pour the particles into the funnel until the tip of the cone formed below the funnel touches the bottom of the funnel. The radius of the disk at the bottom of the cone (R) is measured. Three parallel measurements are taken and the average is taken. Angle of repose: tanθ = H / R. θ < 30° indicates excellent flow properties; θ ≤ 40° meets the flow requirements of the production process; θ > 45° indicates poor flow properties.

[0128] 2.3.2 Granulation process investigation

[0129] (1) Granulation of dry extract powder

[0130] Take dry extract powder, add auxiliary material dextrin (mass ratio of drug powder to auxiliary material is 5:4), use 70% ethanol as wetting agent, make soft material, squeeze through No. 1 sieve to granulate, dry with forced air at 80℃ for 2h, use No. 1 sieve and No. 5 sieve to resize the granules, collect the granules between No. 1 and No. 5 sieves, and evaluate according to the method under "2.3.1".

[0131] (2) Fluid extract granulation

[0132] Take twice the amount of fluid extract prescribed, add dextrin as the auxiliary material (equivalent to the ratio of powder to auxiliary material of 5:4), make a soft material, squeeze it through a No. 16 sieve to make granules, dry it with forced air at 80℃ for 2h, resize the granules through a No. 1 sieve and a No. 5 sieve, collect the granules between the No. 1 and No. 5 sieves, and evaluate it according to the method under "2.3.1".

[0133] The results show that the granules obtained by dry extract powder granulation are more uniform, with higher yield, better fluidity and moderate solubility. However, the granules obtained by fluid extract granulation are more complicated because the fluid extract density is lower (about 1.0), the paste is thinner and the total volume is large, and the excipients are relatively few. Therefore, after the paste and excipients are mixed, they need to be dried, powdered, and then made into soft materials. Therefore, the procedure is more complicated. Therefore, after comprehensive consideration, dry extract powder granulation was chosen. The results of the granulation process investigation are shown in Table 8.

[0134] Table 8 Granulation method investigation results

[0135]

[0136]

[0137] 2.3.3 Selection of auxiliary materials

[0138] (1) Investigation of auxiliary materials

[0139] By consulting the literature, soluble starch, dextrin and microcrystalline cellulose (Mcc) were selected for preliminary testing. The dry extract powder granulation method was used for granulation. The granulation conditions, particle properties, particle size, angle of repose, solubility and other evaluation indicators were used for screening. The results are shown in Table 9.

[0140] Table 9 Results of investigation on the types of auxiliary materials

[0141]

[0142]

[0143] The results show that microcrystalline cellulose granules have extremely poor solubility and are difficult to dissolve, as evaluated in terms of granulation, granule properties, angle of repose, granule yield, and solubility. While dextrin and soluble starch have poor solubility and produce significant precipitation after dissolution, they have a higher yield, making them the preferred excipients. When the drug powder:excipient ratio remains constant at 5:4, granules produced with a dextrin:Mcc (7:1) mixture performed best in terms of granulation, granule properties, angle of repose, granule yield, and solubility. Ultimately, a dextrin:Mcc (7:1) excipient ratio was selected.

[0144] (2) Wetting agent investigation

[0145] Because the dry extract powder and excipients lack good viscosity when mixed, adding a wetting agent can increase viscosity and facilitate granulation. This experiment proposed using a higher concentration of ethanol solution as the wetting agent. Five parts of dry extract powder were added to ethanol solutions of varying concentrations to prepare a soft material. The material was sized to form a ball when held in the hand and disintegrate upon light touch. Granulation was performed using the dry extract powder granulation method described in "2.3.2." The effects of different ethanol concentrations on granulation are shown in Table 10. Based on the experimental results, an ethanol concentration of 70% was ultimately selected.

[0146] Table 10 Effect of different concentrations of ethanol on granulation

[0147]

[0148]

[0149] (3) Molding process verification

[0150] The soft material was prepared using 70% ethanol as a wetting agent and granulated using the dry extract powder granulation method. Two portions were prepared and evaluated according to the method under "2.3.1". The results are shown in Table 11.

[0151] Table 11 Molding process verification

[0152]

[0153] (4) Three batches of small-scale process verification

[0154] Three batches of pilot tests were conducted based on the optimized process parameters to verify the process feasibility. The results are shown in Table 12, which show that the above process is feasible.

[0155] Table 12 Three batches of small-scale process verification

[0156]

[0157] 3. Retrospective study on the clinical efficacy of Yuanhu Hewei prescription

[0158] 3.1 Research subjects

[0159] This study adopted a retrospective research method and collected 100 outpatient and inpatient cases from Puding County Traditional Chinese Medicine Hospital from 2021 to 2025 as research subjects to evaluate the clinical efficacy and safety of Yuanhu Hewei Decoction in the treatment of chronic superficial gastritis (liver and stomach qi stagnation syndrome).

[0160] 3.2 Diagnostic criteria

[0161] 3.2.1 Western medicine diagnostic criteria for chronic superficial gastritis

[0162] Formulated with reference to "Internal Medicine" (Textbook 11th Edition).

[0163] The diagnostic criteria for chronic superficial gastritis are as follows: ① Symptoms: Most patients are asymptomatic; those with symptoms may experience irregular upper abdominal pain or discomfort, upper abdominal distension, early satiety, belching, nausea, and other indigestion symptoms; ② Signs: Apart from mild tenderness in the upper abdomen, there are generally no obvious signs; ③ Endoscopic examination: Endoscopic findings include erythema in the form of dots, patches, or strips, rough mucosa, bleeding spots or spots, mucosal edema, and exudation; ④ Pathology: Inflammation is mainly characterized by infiltration of the mucosal layer by lymphocytes and plasma cells in the gastric mucosa; ⑤ Ultrasound and other examinations (such as CT and MRI) can help with differentiation.

[0164] 3.2.2 Traditional Chinese Medicine Diagnostic Criteria for Chronic Superficial Gastritis

[0165] Formulated with reference to "Traditional Chinese Medicine Internal Medicine" (Textbook 4th Edition).

[0166] Liver-stomach Qi stagnation syndrome: distension and pain in the stomach, pain radiating to the flanks and back, pain relieved by belching, pain aggravated by anger, loss of appetite, chest and epigastric fullness, sighing, irregular bowel movements, red tongue, thin white fur, and wiry pulse.

[0167] 3.3 Clinical study inclusion and exclusion criteria

[0168] 3.3.1 Inclusion criteria

[0169] (1) Those who meet the Western medical diagnostic criteria for chronic superficial gastritis;

[0170] (2) TCM diagnosis is liver and stomach qi stagnation syndrome;

[0171] (3) No age limit;

[0172] (4) The information is complete, and the records and data are traceable.

[0173] 3.3.2 Exclusion criteria

[0174] (1) Those who do not meet the above inclusion criteria;

[0175] (2) Pregnant or lactating women;

[0176] (3) The researcher believes that the medical records have an impact on the evaluator.

[0177] 3.4 Treatment options

[0178] The patient was given Yuanhu Hewei prescription for treatment. Usage and dosage: one dose per day, decocted in water and taken orally, three times a day, 100-300 mL each time.

[0179] 3.5 Concomitant medication

[0180] If the subject meets the inclusion criteria and has other comorbidities and needs to continue taking medication in the clinical trial, or if other drugs or treatment methods are indeed needed for the treatment of the disease, the name of the drug used (or treatment method), dosage, number of times of use, time of use, etc. should be recorded in detail in the case report form.

[0181] 3.6 Data Collection

[0182] Design a case observation form and complete it truthfully, recording in detail the patient's general condition (age, medical history, diagnosis, etc.), TCM syndrome type, four diagnostic data, treatment plan, concomitant medications, and other clinical information. General records include the first and last dates of medication use, and demographic characteristics include the patient's age, height, weight, and marital history.

[0183] 3.7 Clinical efficacy evaluation criteria

[0184] The clinical efficacy of Yuanhu Hewei prescription was evaluated by observing TCM clinical symptoms (including stomach pain, abdominal distension, acid reflux, belching, nausea, etc.) and physical signs, and the safety of Yuanhu Hewei prescription was evaluated by recording adverse events, symptoms and signs of adverse reactions.

[0185] (1) Clinical efficacy evaluation criteria

[0186] Aggravation: symptoms become more severe or more severe than before;

[0187] Unchanged: Symptoms remain unchanged compared to the original symptoms;

[0188] Improvement: Symptoms have improved, decreased, or become better compared to the original symptoms;

[0189] Disappeared: Symptoms are completely relieved.

[0190] Among them: improvement or disappearance of symptoms is considered as remission; disappearance of symptoms is considered as complete remission.

[0191] (2) Observation of adverse events

[0192] Record in detail the main symptoms, signs, onset, end time, duration, and severity of adverse reactions. Analyze whether the cause of the adverse reaction is related to the study drug and whether it has an impact on the clinical study. Accurately record whether measures were taken to address the adverse event. If so, record the specific measures in detail. At the end of the adverse event or the study, record the outcome of the adverse event and whether the patient withdrew from the trial due to the adverse event.

[0193] 3.8 Clinical Study Results

[0194] A total of 100 outpatient and inpatient cases from Puding County Traditional Chinese Medicine Hospital who met the inclusion criteria were included in this study. The general information of the included patients is shown in Table 13, the statistics of clinical diagnosis and medication time are shown in Table 14, the clinical symptoms and signs before treatment are shown in Table 15, the statistics of the efficacy of single symptom are shown in Table 16, the remission rate of single symptom is shown in Table 17, and the statistics of adverse reactions are shown in Table 18.

[0195] Table 13 General information of enrolled patients

[0196]

[0197] Table 14 Statistics of clinical diagnosis and medication time of enrolled patients

[0198]

[0199] Table 15 Symptoms and signs before treatment

[0200]

[0201] Table 16 Statistics of efficacy of single symptom

[0202]

[0203]

[0204] Table 17 Statistics of relief rate of single symptom

[0205]

[0206] Table 18 Adverse reaction statistics

[0207]

[0208] 3.9 Summary and Analysis

[0209] The research team retrospectively collected 100 patients who used the prescription of this study to treat chronic superficial gastritis from 2021 to 2025, including 56 patients with chronic superficial gastritis and 44 patients with chronic superficial gastritis combined with other diagnoses. All cases met the diagnosis of liver and stomach qi stagnation syndrome.

[0210] The statistical tables for individual symptom efficacy and individual symptom remission rates show that after using the Yuanhu Hewei Formula in this study, the 100 patients experienced significant improvements in symptoms such as stomach pain, bloating, acid reflux, belching, and nausea, with remission and complete remission rates exceeding 90%. This demonstrates the high clinical effectiveness of the Yuanhu Hewei Formula provided in this study. Furthermore, the adverse reaction statistics show that none of the 100 patients experienced any adverse reactions, demonstrating the high safety of the Yuanhu Hewei Granules provided in this study.

[0211] Although the present invention has been described in detail above using general descriptions, specific embodiments, and experiments, it will be apparent to those skilled in the art that modifications and improvements may be made based on the present invention. Therefore, such modifications and improvements, which do not depart from the spirit of the present invention, are intended to be within the scope of protection claimed herein.

Claims

1. A Chinese medicine composition for treating spleen and stomach diseases, characterized in that: The invention comprises the following components in parts by mass: 5-8 parts of vinegared Corydalis yanhusuo, 2-4 parts of bran-fried immature bitter orange, 2-4 parts of citron, 2-4 parts of Panax notoginseng, 5-8 parts of cuttlebone, 5-8 parts of Cynanchum chinense, 5-8 parts of Bletilla striata, 2-4 parts of Cynanchum wilfordii, 2-4 parts of Pseudostellaria baicalensis, 5-8 parts of Tripterygium wilfordii, and 2-4 parts of Fritillaria thunbergii.

2. The Chinese medicine composition according to claim 1, characterized in that The invention comprises the following components in parts by mass: 5-7 parts of vinegared Corydalis yanhusuo, 2.5-3.5 parts of bran-fried immature bitter orange, 2.5-3.5 parts of citron, 2.5-3.5 parts of Panax notoginseng, 5-7 parts of cuttlebone, 5-7 parts of Cynanchum chinense, 5-7 parts of Bletilla striata, 2.5-3.5 parts of Cynanchum wilfordii, 2.5-3.5 parts of Pseudostellaria baicalensis, 5-7 parts of Tripterygium wilfordii, and 2.5-3.5 parts of Fritillaria thunbergii.

3. The Chinese medicine composition according to claim 2, characterized in that The invention comprises the following components in parts by weight: 6 parts of vinegared Corydalis yanhusuo, 3 parts of bran-fried immature bitter orange, 3 parts of citron, 3 parts of Panax notoginseng, 6 parts of cuttlebone, 6 parts of Cynanchum chinense, 6 parts of Bletilla striata, 3 parts of Cynanchum wilfordii, 3 parts of Pseudostellaria heterophylla, 6 parts of Tripterygium wilfordii, and 3 parts of Fritillaria thunbergii.

4. The method for preparing a Chinese medicine composition for treating spleen and stomach diseases according to any one of claims 1 to 3, wherein: The steps include: S1 Preparation of dry paste powder: Weigh each medicinal material slice according to the recipe, add water and boil for 1-5 times, adding 6-14 times the total weight of the medicinal material each time, and boil for 0.5-2.5 hours. For the first decoction, add 1 times more water and soak for 1 hour before decoction; filter the decoction, combine the filtrates, and concentrate under reduced pressure to a clear paste with a density of 1.05-1.20 at 80°C, dry in an oven, and grind to obtain a dry paste powder; S2 preparation of soft materials: Take the dry paste powder prepared in the above steps, add auxiliary materials, and use 70% to 80% ethanol solution as a wetting agent to make a soft material. The standard of the soft material is that it can form a ball when held by hand and falls apart when touched lightly. The auxiliary material is at least one of dextrin, soluble starch and microcrystalline cellulose; The mass ratio of the dry paste powder to the auxiliary materials is 5:4; S3 Granulation: The prepared soft material is squeezed through a No. 1 sieve to granulate, and after air drying, it is sized using a No. 1 sieve and a No. 5 sieve, and the particles between the No. 1 sieve and the No. 5 sieve are collected to obtain the product.

5. The preparation method according to claim 4, characterized in that The specific process of preparing the dry paste powder in step S1 is as follows: weighing each medicinal material slice according to the formula, adding water and decocting 3-5 times, adding 6-10 times the total weight of the medicinal material each time, and decocting for 1-1.5 hours. For the first decoction, 1 times more water needs to be added and the mixture needs to be soaked for 1 hour before decoction; filtering the decoction, combining the filtrate, and concentrating under reduced pressure to a clear paste with a density of 1.05-1.20 at 80° C., drying and crushing in an oven to obtain the dry paste powder.

6. The preparation method according to claim 5, characterized in that The specific process of preparing the dry paste powder in step S1 is as follows: weigh each medicinal material according to the formula, add water and boil for 3 times, add 9 times the total mass of the medicinal materials for the first time, soak for 1 hour and then boil for 1 hour, add 8 times the total mass of the medicinal materials for the second and third times, and boil for 1 hour each time; filter the decoction, combine the filtrate, and concentrate under reduced pressure to a clear paste with a density of 1.05 to 1.20 at 80°C, dry and crush in an oven at 105°C to obtain the dry paste powder.

7. The preparation method according to claim 4, characterized in that The wetting agent in step S2 is 70% ethanol solution.

8. The preparation method according to claim 4, characterized in that The auxiliary material in step S2 is a mixed auxiliary material consisting of dextrin and microcrystalline cellulose in a mass ratio of 7:

1.

9. The preparation method according to claim 4, characterized in that The temperature of the blast drying in step S3 is 80°C.

10. Use of the traditional Chinese medicine composition according to any one of claims 1 to 3 in preparing medicines for treating spleen and stomach diseases.

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