Compound of traditional Mongolian medicine for treating cold diarrhea and preparation process thereof

Abstract

This invention discloses a Mongolian medicine compound for treating cold-type diarrhea and its preparation process. The compound consists of pomegranate, cinnamon, cardamom, long pepper, chebula, antidiarrheal seed, dried ginger, bright salt, black borneol, and white pepper in parts by weight. The process includes grouping the medicinal materials, independent low-temperature gradient processing of each herb, cell wall disruption by low-temperature gradient airflow at 5-5℃, gradient feeding and mixing under oxygen concentration ≤3% and 0-10℃ conditions, low-temperature condensation and collection of volatile oils from warm herbs at 10-5℃, low-pressure spray coupling after ethanol dilution, and microwave low-temperature sterilization. This invention significantly improves the dissolution and bioavailability of active ingredients by grouping and processing separately, low-temperature cell wall disruption, closed-loop recovery of volatile oils, and nitrogen-filled gradient mixing, while retaining volatile active ingredients and improving mixing uniformity and product stability. It has the advantages of rapid onset of action, definite curative effect, low recurrence rate, and controllable quality, and is suitable for the clinical treatment of cold-type diarrhea. It can be standardized for industrial production.

Description

Technical Field

[0001] This invention patent relates to the field of Mongolian medicine preparation technology, specifically to a Mongolian medicine compound for treating cold-induced diarrhea and its preparation process. Background Technology

[0002] In Mongolian medicine, cold-type diarrhea is a digestive system disease caused by an excess of Badagan (a type of digestive organ), a deficiency of stomach fire, and an imbalance of the three digestive functions. Clinically, it is characterized by cold abdominal pain, watery diarrhea, recurrent attacks, and weakness of the spleen and stomach.

[0003] Existing treatment technologies have significant shortcomings: 1. Modern medicine only treats the symptoms of diarrhea and cannot correct the imbalance of the three organs, resulting in a high recurrence rate; 2. Traditional Mongolian medicine has large particle size, slow dissolution of active ingredients, low bioavailability, and slow onset of action; 3. High-temperature processing leads to a significant loss of warm-active ingredients such as volatile oils, piperine, and gingerol; 4. Poor mixing uniformity, large batch-to-batch quality fluctuations, and difficulty in standardizing industrial production; 5. Without a process for recovering and reusing volatile oils, the efficacy of the medicine is severely compromised.

[0004] Currently, there is no publicly available technology that discloses an integrated process for grouping medicinal properties into independent low-temperature processing, gradient particle size cell wall disruption, closed-loop aroma recovery coupling, and nitrogen-filled cold mixing. This invention addresses the aforementioned pain points by providing a Mongolian medicine compound with rapid onset of action, high bioavailability, stable efficacy, controllable quality, and a comprehensive treatment approach, along with an original preparation process. Summary of the Invention

[0005] In view of this, the purpose of this invention is to provide a Mongolian medicine compound for treating cold-type diarrhea and its preparation process. The Mongolian medicine compound provided by this invention has a rigorous formulation, retains the complete medicinal substances, and has a scientific and controllable preparation process. It can effectively solve the technical problems of traditional Mongolian medicine, such as slow onset of action, low dissolution, large loss of volatile oil, uneven mixing, poor quality stability, and high clinical recurrence rate.

[0006] The technical solution of this invention discloses a Mongolian medicine compound for treating cold-type diarrhea, which is composed of the following medicinal materials in parts by weight: pomegranate 25-35 parts, cinnamon 10-15 parts, cardamom 4.0-5.5 parts, long pepper 5.5-7.0 parts, chebula 8.0-9.5 parts, antidiarrheal wood seed 5.5-7.0 parts, dried ginger 1.0-1.5 parts, bright salt 5.5-7.0 parts, black borneol 10-15 parts, and white pepper 3.5-4.5 parts.

[0007] Furthermore, it is composed of the following medicinal materials in parts by weight: 30 parts pomegranate, 12.5 parts cinnamon, 4.8 parts cardamom, 6.2 parts long pepper, 8.8 parts chebula, 6.2 parts antidiarrheal seeds, 1.3 parts dried ginger, 6.2 parts bright salt, 12.5 parts black borneol, and 3.8 parts white pepper.

[0008] Among them, the principal herb (core treatment) is pomegranate. It plays a major therapeutic role in addressing the core pathogenesis of cold-type diarrhea with an excess of "badagan" (a type of diarrhea caused by cold) and a decline in stomach fire. Its effects of warming the middle jiao (spleen and stomach), dispelling cold, and revitalizing stomach fire are absolutely dominant in the formula.

[0009] Assistant herbs (synergistic enhancement): Borneol, Antidiarrheal seeds, Bright salt, white pepper. These assist the principal herbs in enhancing their warming and dispersing effects, while also focusing on promoting qi circulation, relieving pain, strengthening the spleen and improving appetite, and addressing accompanying symptoms such as abdominal distension, cold pain, and loss of appetite.

[0010] Adjuvant herbs (for harmonization): dried ginger, long pepper, chebula, cinnamon, cardamom, etc. On one hand, they harmonize the other herbs, mitigating the harshness of the warming herbs in the formula; on the other hand, they tonify qi and harmonize the middle jiao, guiding the medicinal power directly to the affected area.

[0011] On the other hand, the preparation process of a Mongolian medicine compound for treating cold-type diarrhea was disclosed, which includes the following steps: (1) Grouping of medicinal materials: Pomegranate, cinnamon, white pepper, dried ginger, long pepper and cardamom are divided into warming medicine group; Terminalia chebula, antidiarrheal wood seeds and black borneol are divided into astringent medicine group; Bright salt is a separate group; (2) Low-temperature gradient processing of medicinal materials: Each medicinal material in the warm medicine group in step (1) is dried in a low-temperature hot air environment for 60-70 minutes, and then coarsely crushed to 10-20 mesh; each medicinal material in the astringent medicine group in step (1) is dried in a negative pressure low-temperature vacuum environment for 35-45 minutes, and then coarsely crushed to 10-20 mesh; the bright salt in step (1) is dried in a vacuum environment for 25-35 minutes, and then coarsely crushed to 40-60 mesh; (3) Low-temperature gradient airflow breaking of medicinal materials: Each medicinal material processed in step (2) is subjected to a temperature of Fine crushing was carried out at 5-5℃ and 0.6-0.8 MPa to obtain pomegranate fine powder with D90≤10-15μm, other warm medicine fine powder with D90≤15-20μm, astringent medicine fine powder with D90≤20-30μm, and bright salt fine powder. (4) Gradual mixing of medicinal materials: In an environment with an oxygen concentration ≤3% and a temperature of 0-10℃, first mix the finely crushed Guangming salt powder, dried ginger powder, and white pepper powder from step (3) for 8-12 minutes, then add the finely crushed pomegranate powder and black borneol powder from step (3) for 18-22 minutes, and finally add the remaining finely crushed medicinal materials powder from step (3) for 12-18 minutes to obtain the mixed medicine.

[0012] Furthermore, in step (2), the drying conditions for each medicinal material in the warm medicine group are: drying temperature of 40-45℃ and relative humidity of 40%-50%.

[0013] Furthermore, in step (2), the drying conditions for each herb in the astringent group are: drying temperature of 48–55°C, and vacuum degree of… 0.05~ 0.07 MPa, relative humidity 30%~40%.

[0014] Furthermore, in step (2), the drying conditions for the bright salt are: drying temperature of 58-62℃ and vacuum degree of... 0.06~ 0.08 MPa.

[0015] Furthermore, in step (3), the volatile oils released by each herb in the warm medicinal group during the crushing process are collected and recovered by low-temperature condensation, wherein the condensation temperature is... 10℃~ At 5℃, the collected volatile oil was then diluted with medical ethanol to a solution with a mass concentration of 8% to 12%.

[0016] Furthermore, after step (4), the following steps are also included: spraying the solution into the mixed medicine at a low pressure of 0.15 to 0.25 MPa while continuing to stir for 25 to 35 minutes.

[0017] Furthermore, the mixing speed is 15–30 r / min.

[0018] Furthermore, the mixed medicine is subjected to microwave low-temperature sterilization for 3-6 minutes at a sterilization temperature of 55-65℃.

[0019] Advantages of this invention: 1. The Mongolian medicine compound for treating cold-type diarrhea disclosed in this invention strictly follows the Mongolian medical principle of "treating cold with heat" and regulating the three roots (Hei, Xieri, and Badagan). The combination of principal, assistant, and adjuvant herbs is rigorous, with the core being to warm the middle and dispel cold and invigorate stomach fire, while also taking into account astringing the intestines to stop diarrhea, drying dampness and strengthening the spleen. It treats both the symptoms and the root cause, has definite clinical efficacy, and a low recurrence rate.

[0020] 2. The preparation process disclosed in this invention adopts grouping according to medicinal properties and low-temperature processing of single herbs, avoiding uneven drying of medicinal materials and destruction of effective components caused by mixed drying, and preserving the material basis of medicinal efficacy to the greatest extent.

[0021] 3. The preparation process disclosed in this invention adopts... Low-temperature gradient airflow at 5-5℃ breaks down the cell walls, significantly reducing the particle size of medicinal materials, improving the dissolution rate and bioavailability of active ingredients, and achieving rapid onset of action within 30 minutes.

[0022] 4. The preparation process disclosed in this invention innovatively employs low-temperature condensation and collection. The spray-coupled closed-loop process can efficiently recover the volatile oils of warm medicines with a retention rate of ≥88%, solving the problem of large-scale loss of volatile oils in traditional processes and ensuring the core effects of warming the middle and dispelling cold, relieving pain and stopping diarrhea.

[0023] 5. The preparation process disclosed in this invention adopts a nitrogen-filled low-temperature, gradient segmented mixing process. The relative standard deviation (RSD) is <3.0%, indicating uniform mixing, consistent composition within the batch, and stable and controllable quality, thus solving the defects of uneven mixing and large batch-to-batch fluctuations in traditional processes.

[0024] 6. The preparation process disclosed in this invention is carried out at low temperature, in a closed system, and in a standardized manner throughout the entire process. There is no high temperature damage, no oxidation of components, and no loss of efficacy. It is suitable for large-scale, standardized industrial production, and the safety and stability are significantly improved. Detailed Implementation

[0025] The present invention will be further described in detail below through embodiments.

[0026] Example 1 A Mongolian medicine compound for treating cold-type diarrhea consists of the following ingredients in parts by weight: pomegranate 30 parts, cinnamon 12.5 parts, cardamom 4.8 parts, long pepper 6.2 parts, chebula 8.8 parts, antidiarrheal seed 6.2 parts, dried ginger 1.3 parts, bright salt 6.2 parts, black borneol 12.5 parts, and white pepper 3.8 parts.

[0027] The preparation process is as follows: (1) Grouping of medicinal materials: Pomegranate, cinnamon, white pepper, dried ginger, long pepper, and cardamom are divided into a warming medicine group; Terminalia chebula, antidiarrheal wood seeds, and black borneol are divided into an astringent medicine group; and bright salt is a separate group.

[0028] (2) Low-temperature gradient processing of medicinal materials: Each medicinal material in the warming group was dried at 42.5℃ and 45% relative humidity for 65 minutes and coarsely crushed to 10-20 mesh; each medicinal material in the astringent group was dried at 51.5℃ and vacuum degree Dry at 0.06 MPa and 35% relative humidity for 40 minutes, then coarsely crush to 10-20 mesh; Bright salt is dried at 60℃ under vacuum. Dry at 0.07 MPa for 30 minutes, then coarsely crush to 40-60 mesh.

[0029] (3) Low-temperature gradient airflow cell wall breaking of medicinal materials: Each medicinal material was finely crushed at 0℃ and 0.7MPa to obtain: pomegranate fine powder D90≤12μm; other warm-natured medicinal fine powder D90≤17μm; astringent and bright salt fine powder D90≤25μm. During the crushing process, volatile oils were released... Condensation and collection at 7.5℃, followed by dilution with ethanol to 10%.

[0030] (4) Gradient feeding and mixing: Under the conditions of oxygen concentration ≤3% and temperature 5℃: premix the bright salt, dried ginger and white pepper for 10min; add pomegranate and black borneol and mix for 20min; add the remaining fine powder and mix for 15min, stirring speed 22.5r / min.

[0031] (5) Spray coupling: spray at 0.2MPa and stir at 22.5r / min for 30min.

[0032] (6) Microwave sterilization: Sterilize at 60℃ for 4.5 min to obtain the finished product.

[0033] Example 2 A Mongolian medicine compound for treating cold-type diarrhea consists of the following ingredients in parts by weight: pomegranate 25 parts, cinnamon 10 parts, cardamom 4.0 parts, long pepper 5.5 parts, chebula 8.0 parts, antidiarrheal wood seed 5.5 parts, dried ginger 1.0 part, bright salt 5.5 parts, black borneol 10 parts, and white pepper 3.5 parts.

[0034] The preparation process is as follows: (1) Grouping of medicinal materials: Pomegranate, cinnamon, white pepper, dried ginger, long pepper, and cardamom are divided into a warming medicine group; Terminalia chebula, antidiarrheal wood seeds, and black borneol are divided into an astringent medicine group; and bright salt is a separate group.

[0035] (2) Low-temperature gradient processing of medicinal materials: Each medicinal material in the warming group was dried at 40℃ and 40% relative humidity for 60 minutes and coarsely crushed to 10-20 mesh; each medicinal material in the astringent group was dried at 48℃ and vacuum degree Dry at 0.05 MPa and 30% relative humidity for 35 minutes, then coarsely crush to 10-20 mesh; Bright salt is dried at 58℃ under vacuum. Dry at 0.06 MPa for 25 minutes, then coarsely crush to 40-60 mesh.

[0036] (3) Low-temperature gradient airflow cell disruption of medicinal materials: Each medicinal material is subjected to low-temperature gradient airflow cell disruption. Fine crushing at 5℃ and 0.6MPa yields: Pomegranate powder D90≤10μm; other warm-natured medicinal powders D90≤15μm; astringents and bright salt powder D90≤20μm. During the fine grinding process, volatile oils... Collect by condensation at 10°C and dilute with ethanol to 8%.

[0037] (4) Gradient feeding and mixing: Under the conditions of oxygen concentration ≤3% and temperature 0℃: premix the bright salt, dried ginger and white pepper for 8 min; add pomegranate and black borneol and mix for 18 min; add the remaining fine powder and mix for 12 min.

[0038] (5) Spray coupling: spray at 0.15MPa and stir at 15r / min for 25min.

[0039] (6) Microwave sterilization: Sterilize at 55℃ for 3 minutes to obtain the finished product.

[0040] Example 3 A Mongolian medicine compound for treating cold-type diarrhea is composed of the following ingredients in parts by weight: pomegranate 35 parts, cinnamon 15 parts, cardamom 5.5 parts, long pepper 7.0 parts, chebula 9.5 parts, antidiarrheal wood seed 7.0 parts, dried ginger 1.5 parts, bright salt 7.0 parts, black borneol 15 parts, and white pepper 4.5 parts.

[0041] The preparation process is as follows: (1) Grouping of medicinal materials: Pomegranate, cinnamon, white pepper, dried ginger, long pepper, and cardamom are divided into a warming medicine group; Terminalia chebula, antidiarrheal wood seeds, and black borneol are divided into an astringent medicine group; and bright salt is a separate group.

[0042] (2) Low-temperature gradient processing of medicinal materials: Each medicinal material in the warming group was dried at 45℃ and 50% relative humidity for 70 minutes and coarsely crushed to 10-20 mesh; each medicinal material in the astringent group was dried at 55℃ and vacuum degree Dry at 0.07 MPa and 40% relative humidity for 45 minutes, then coarsely crush to 10-20 mesh; Bright salt is dried at 62℃ under vacuum. Dry at 0.08 MPa for 35 minutes, then coarsely crush to 40-60 mesh.

[0043] (3) Low-temperature gradient airflow cell wall breaking of medicinal materials: Each medicinal material was finely crushed at 5℃ and 0.8MPa to obtain: pomegranate fine powder D90≤15μm; other warm-natured medicinal fine powder D90≤20μm; astringent and bright salt fine powder D90≤30μm. During the crushing process, volatile oils were released... The sample was collected by condensation at 5°C and diluted with ethanol to 12%.

[0044] (4) Gradient feeding and mixing: Under the conditions of oxygen concentration ≤3% and temperature 10℃: premix the bright salt, dried ginger and white pepper for 12min; add pomegranate and black borneol and mix for 22min; add the remaining fine powder and mix for 18min.

[0045] (5) Spray coupling: spray at 0.25MPa and stir at 30r / min for 35min.

[0046] (6) Microwave sterilization: Sterilize at 65℃ for 6 minutes to obtain the finished product.

[0047] Comparative Example 1 The prescription is consistent with that of Example 1, and it is prepared using conventional Mongolian medicine powder processing techniques: (1) Processing of medicinal materials: No grouping, all medicinal materials are mixed, cleaned and processed together, without separate processing.

[0048] (2) Drying process: All medicinal materials are mixed and dried at a temperature of 60-80℃ for 120-180 minutes; after drying, they are mixed and coarsely crushed to 10-20 mesh.

[0049] (3) Crushing process: A normal temperature ordinary crusher is used for crushing, and the crushing temperature is room temperature (around 25℃); the crushing particle size is 80 mesh, without grading or D90 control; volatile oil is not collected, and there is no low temperature condensation collection.

[0050] (4) Mixing process: Mixing at room temperature, normal pressure, and in the open air; all the powders are added at once and mixed for 30-40 minutes.

[0051] Comparative Example 2 The prescription and process are exactly the same as in Example 1, except that: the low-temperature condensation and capture of the volatile oil of the heated medicine is not performed, and the volatile oil spray coupling is not performed.

[0052] experiment Experimental Example 1: Determination of the dissolution rate of active ingredients 1. Experimental Materials Samples: Example 1, Example 2, Example 3, Comparative Example 1, Comparative Example 2.

[0053] Instruments: Intelligent drug dissolution tester, ultraviolet light Visible spectrophotometer, 0.0001 g electronic balance.

[0054] Reagent: Purified water.

[0055] 2. Experimental Methods The dissolution and release rate were determined according to the method of determination of dissolution and release rate (second method, paddle method) in General Chapter 0931 of Part IV of the Chinese Pharmacopoeia 2020 edition.

[0056] (1) Take an appropriate amount of this product, weigh it accurately, and set it aside.

[0057] (2) Dissolution medium: 900 mL of freshly boiled and cooled purified water to room temperature.

[0058] (3) Control the temperature of the leaching medium to 37.0℃±0.5℃.

[0059] (4) Set the rotation speed to 50 r / min.

[0060] (5) Take 5 mL samples at fixed points at 30 min and 60 min respectively, filter them immediately through a 0.45 μm microporous membrane, discard the initial filtrate, and take the subsequent filtrate as the test solution.

[0061] (6) Using the same batch of dissolution medium as a blank control, measure the absorbance at the specified characteristic absorption wavelength and calculate the cumulative dissolution rate at each time point.

[0062] 3. Experimental Results Table 1 Dissolution rate of active ingredients

[0063] 4. Conclusion As can be seen from the table above, the samples prepared using the low-temperature gradient airflow cell disruption process of this invention achieve a rapid dissolution rate of over 89% within 30 minutes and near-complete dissolution within 60 minutes. Compared with the traditional process (Comparative Example 1) and the process without volatile oil recovery (Comparative Example 2), the dissolution rate is faster and the dissolution amount is higher, indicating that low-temperature cell disruption can significantly reduce the particle size of medicinal materials and increase the specific surface area, thereby improving the dissolution rate and bioavailability of active ingredients, providing a reliable material basis for rapid clinical efficacy.

[0064] Experimental Example 2: Determination of Volatile Oil Retention Rate 1. Experimental Materials Samples: Example 1, Example 2, Example 3, Comparative Example 1, Comparative Example 2.

[0065] Instruments: volatile oil measuring device, 0.001 g electronic balance, heating mantle, reflux condenser.

[0066] Reagents: purified water, xylene.

[0067] 2. Experimental Methods The volatile oil was determined according to the General Chapter 2204 of the 2020 edition of the Chinese Pharmacopoeia (Method A).

[0068] (1) Weigh 20.0g of the powder accurately and place it in a 1000mL round-bottom flask.

[0069] (2) Add 500 mL of purified water and a few glass beads, and shake well.

[0070] (3) Connect the volatile oil measuring device, add water from the top of the measuring device to the mark, and let it overflow into the flask.

[0071] (4) Add 1 mL of xylene and connect the reflux condenser.

[0072] (5) Heat the electric heating mantle to boiling and maintain a gentle boil for 5 hours.

[0073] (6) Stop heating, let it stand and cool for 30 minutes, read the volume of volatile oil and calculate the content.

[0074] (7) Calculate the volatile oil retention rate based on the theoretical total amount of volatile oil fed.

[0075] 3. Experimental Results Table 2. Retention rate of volatile oils

[0076] 4. Conclusion As can be seen from the table above, the low-temperature condensation capture-spray coupling closed-loop process of this invention can achieve a volatile oil retention rate of over 88% for warm and hot medicinal components, with a maximum of 91.6%. In contrast, the traditional mixed high-temperature drying process (Comparative Example 1) results in a significant loss of volatile oil, with a retention rate of only 34.8%; the process without volatile oil recovery (Comparative Example 2) also has a retention rate of only 41.9%. This demonstrates that the process of this invention can effectively prevent the loss of volatile oil, retain the warm and hot medicinal components to the greatest extent, and ensure the core efficacy of the prescription in warming the middle jiao, dispelling cold, and rapidly relieving pain and diarrhea.

[0077] Experimental Example 3: Investigation of Mixing Uniformity 1. Experimental Materials Samples: Example 1, Example 2, Example 3, Comparative Example 1.

[0078] Instruments: UV-Vis spectrophotometer, 0.0001g electronic balance, volumetric flask, ultrasonic cleaner.

[0079] Reagents: purified water, ethanol (analytical grade).

[0080] 2. Experimental Methods (1) Take the same batch of samples and randomly take 10 samples from the top, middle, bottom, front, back, left, right, four corners and center of the mixer.

[0081] (2) Each sample is accurately weighed, placed in a stoppered conical flask, and an appropriate amount of purified water or dilute ethanol is added and weighed.

[0082] (3) Extract by ultrasound for 30 minutes, cool to room temperature, weigh again to make up the lost weight, and shake well.

[0083] (4) Filter the solution using a 0.45 μm microporous membrane, discard the initial filtrate, and use the subsequent filtrate as the test solution.

[0084] (5) In ultraviolet light The absorbance is measured using a visible spectrophotometer to calculate the content of the indicator component.

[0085] (6) Calculate the mean, standard deviation (SD) and relative standard deviation (RSD) based on the measurement results of 10 samples.

[0086] (7) Judgment criteria: RSD ≤ 3.0% indicates uniform mixing.

[0087] 3. Experimental Results Table 3 Relative Standard Deviation

[0088] 4. Conclusion As shown in the table above, the nitrogen-filled low-temperature protection + gradient segmented feeding mixing process of this invention can ensure that the RSD of sample mixing uniformity is less than 3.0%, resulting in uniform mixing, consistent intra-batch composition, and high quality stability. In contrast, the traditional room-temperature one-time mixing process (Comparative Example 1) has an RSD as high as 8.47%, indicating uneven mixing and significant intra-batch differences. This demonstrates that the process of this invention can guarantee the uniform distribution of each active ingredient in the drug powder, ensuring accurate clinical dosage, stable efficacy, and high safety.

[0089] Experimental Example 4: Clinical Efficacy Observation 1. Case selection (1) Inclusion criteria: Meets the diagnostic criteria for cold diarrhea in Mongolian medicine, manifested as cold abdominal pain, borborygmus and diarrhea, watery stool, aversion to cold and cold limbs, pale tongue with white coating; aged 18 to 65 years; willing to participate in the trial and sign informed consent form.

[0090] (2) Exclusion criteria: pregnant and lactating women, those with severe heart, liver and kidney diseases, infectious diarrhea, and those with allergies.

[0091] 2. Experimental Grouping A total of 150 eligible cases were included and randomly divided into 5 groups of 30 patients each. There were no statistically significant differences in age, gender, disease duration, and disease severity among the groups (P>0.05), making them comparable.

[0092] 3. Administration method Each group was given the corresponding sample orally, one sachet twice a day, dissolved in warm water, for three consecutive days. Dosage, treatment duration, and dietary restrictions remained consistent across all groups.

[0093] 4. Observation Indicators (1) 30-minute diarrhea and pain relief rate: the percentage of people whose abdominal pain, diarrhea and borborygmus symptoms were significantly relieved within 30 minutes after taking the medicine.

[0094] (2) Overall effectiveness rate: the percentage of cured + significantly effective + effective cases out of the total number of cases.

[0095] (3) Relapse rate one month after stopping medication: the proportion of cured patients whose symptoms reappear within one month after stopping medication.

[0096] 5. Criteria for Evaluating Therapeutic Effect Recovery: Symptoms completely disappear, stools become formed, and intestinal function returns to normal.

[0097] Significant effect: Symptoms are significantly improved, stools are basically formed, and there are occasional mild bowel sounds.

[0098] Effective: Symptoms were relieved and the frequency of diarrhea decreased.

[0099] Ineffective: Symptoms do not improve or even worsen.

[0100] 6. Experimental Results Table 4 Clinical efficacy

[0101] 7. Conclusion The clinical observation results in the table above show that the compound formula of this invention has a rapid onset of action, definite curative effect, and low recurrence rate in treating cold diarrhea. The rate of stopping diarrhea and relieving pain within 30 minutes can reach over 85%, which can quickly relieve abdominal cold pain and diarrhea symptoms; the total effective rate can reach over 95%, which is significantly better than the traditional process group; the recurrence rate after one month of discontinuation of medication is less than 8.3%, which is far lower than the control group, demonstrating the advantage of treating both the symptoms and the root cause.

[0102] In summary, this invention, through optimized formulation, low-temperature gradient processing, and cell wall breaking and recovery technology, can significantly enhance the effects of warming the middle jiao and dispelling cold, invigorating stomach fire, and astringing the intestines and stopping diarrhea. Its clinical efficacy is significantly better than that of traditional Mongolian medicine processing, making it suitable for clinical promotion and application.

[0103] The above are preferred embodiments of the present invention. For those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A Mongolian medicine compound for treating cold diarrhea, characterized in that, It is composed of the following medicinal materials in parts by weight: pomegranate 25-35 parts, cinnamon 10-15 parts, cardamom 4.0-5.5 parts, long pepper 5.5-7.0 parts, chebula 8.0-9.5 parts, antidiarrheal seed 5.5-7.0 parts, dried ginger 1.0-1.5 parts, bright salt 5.5-7.0 parts, black borneol 10-15 parts, white pepper 3.5-4.5 parts.

2. The Mongolian medicine compound for treating cold-type diarrhea according to claim 1, characterized in that, It is composed of the following medicinal materials in parts by weight: pomegranate 30 parts, cinnamon 12.5 parts, cardamom 4.8 parts, long pepper 6.2 parts, chebula 8.8 parts, antidiarrheal seed 6.2 parts, dried ginger 1.3 parts, bright salt 6.2 parts, black borneol 12.5 parts, white pepper 3.8 parts.

3. A preparation process for a Mongolian medicine compound for treating cold-type diarrhea as described in claim 1 or 2, characterized in that, It includes the following steps: (1) Grouping of medicinal materials: Pomegranate, cinnamon, white pepper, dried ginger, long pepper and cardamom are divided into warming medicine group; Terminalia chebula, antidiarrheal wood seeds and black borneol are divided into astringent medicine group; Bright salt is a separate group; (2) Low-temperature gradient processing of medicinal materials: Each medicinal material in the warm medicine group in step (1) is dried in a low-temperature hot air environment for 60-70 minutes, and then coarsely crushed to 10-20 mesh; each medicinal material in the astringent medicine group in step (1) is dried in a negative pressure low-temperature vacuum environment for 35-45 minutes, and then coarsely crushed to 10-20 mesh; the bright salt in step (1) is dried in a vacuum environment for 25-35 minutes, and then coarsely crushed to 40-60 mesh; (3) Low-temperature gradient airflow breaking of medicinal materials: Each medicinal material processed in step (2) is subjected to a temperature of Fine crushing was carried out at 5-5℃ and 0.6-0.8 MPa to obtain pomegranate fine powder with D90≤10-15μm, other warm medicine fine powder with D90≤15-20μm, astringent medicine fine powder with D90≤20-30μm, and bright salt fine powder. (4) Gradual mixing of medicinal materials: In an environment with an oxygen concentration ≤3% and a temperature of 0-10℃, first mix the finely crushed Guangming salt powder, dried ginger powder, and white pepper powder from step (3) for 8-12 minutes, then add the finely crushed pomegranate powder and black borneol powder from step (3) for 18-22 minutes, and finally add the remaining finely crushed medicinal materials powder from step (3) for 12-18 minutes to obtain the mixed medicine.

4. The preparation process of the Mongolian medicine compound for treating cold-type diarrhea according to claim 3, characterized in that, In step (2), the drying conditions for each medicinal material in the warm medicine group are: drying temperature of 40-45℃ and relative humidity of 40%-50%.

5. The preparation process of the Mongolian medicine compound for treating cold-type diarrhea according to claim 3, characterized in that, In step (2), the drying conditions for each herb in the astringent group are: drying temperature of 48-55℃, and vacuum degree of... 0.05~ 0.07 MPa, relative humidity 30%–40%.

6. The preparation process of the Mongolian medicine compound for treating cold-type diarrhea according to claim 3, characterized in that, In step (2), the drying conditions for the bright salt are: drying temperature of 58-62℃ and vacuum degree of... 0.06~ 0.08 MPa.

7. The preparation process of the Mongolian medicine compound for treating cold-type diarrhea according to claim 3, characterized in that, In step (3), the volatile oils released by each herb in the warm medicinal group during the crushing process are collected and recovered by low-temperature condensation, wherein the condensation temperature is... 10℃~ At 5℃, the collected volatile oil was then diluted with medical ethanol to a solution with a mass concentration of 8% to 12%.

8. The preparation process of the Mongolian medicine compound for treating cold-type diarrhea according to claim 7, characterized in that, After step (4), the following steps are also included: spraying the solution into the mixed medicine at a low pressure of 0.15 to 0.25 MPa while continuing to stir for 25 to 35 minutes.

9. The preparation process of the Mongolian medicine compound for treating cold-type diarrhea according to claim 8, characterized in that, The mixing speed is 15–30 r / min.

10. The preparation process of the Mongolian medicine compound for treating cold-type diarrhea according to claim 9, characterized in that, The mixed medicine is then subjected to microwave low-temperature sterilization for 3–6 minutes at a temperature of 55–65°C.

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