A method for preparing a gastroenteritis preparation with good taste

Abstract

This invention discloses a method for preparing a gastroenteritis preparation with good taste. The steps include: (1) chopping and mixing jujube pulp and ginger, enzymatically hydrolyzing them, separating them to obtain filtrate and residue, concentrating the filtrate under reduced pressure to obtain component I; (2) adding the residue to deionized water, collecting the oil phase by steam distillation to obtain component II; (3) preparing intermediate extract powder; (4) mixing the intermediate extract powder, component I, and component II evenly, adding a binder for fluidized bed granulation, drying to obtain intermediate particles; mixing the intermediate particles with magnesium stearate evenly, compressing into tablets to obtain the gastroenteritis preparation. Adding the excipients prepared in this invention to traditional formulations can improve antibacterial activity, and by adding jujube and ginger extracts, the taste can be improved, infused with fruity aroma, and the ginger extract can mask some of the bitterness of the medicinal materials, making the gastroenteritis preparation taste better.

Description

Technical Field

[0001] This invention relates to the field of plant extraction technology, and in particular to a method for preparing a gastroenteritis preparation with good taste. Background Technology

[0002] Enteritis is an intestinal disease caused by bacteria, viruses, fungi, and parasites. Clinical manifestations mainly include abdominal pain, diarrhea, watery stools, or bloody and mucous stools; hence, it is also called infectious diarrhea. Enteritis can be divided into acute and chronic types. The main symptoms of acute enteritis are nausea, vomiting, and diarrhea. In my country, the incidence is higher in summer and autumn, with an incubation period of 12–36 hours. Chronic enteritis is clinically characterized by long-term, chronic, or recurrent abdominal pain, diarrhea, and indigestion. This condition seriously affects the patient's daily life, and if the condition worsens, there is a possibility of it developing into colorectal cancer. Currently, antibiotics are generally used clinically to treat gastrointestinal inflammation and other diseases, leading to overuse of antibiotics, an increase in drug-resistant patients, and significant side effects. Meanwhile, traditional Chinese medicine compound preparations with strong efficacy and fewer side effects for gastrointestinal inflammation currently occupy a small market share. Summary of the Invention

[0003] Therefore, the present invention provides a method for preparing a gastroenteritis preparation with good taste, the steps of which include:

[0004] (1) Prepare an aqueous solution of cellulase, heat the aqueous solution of cellulase to 50±5℃ in a water bath and keep it warm, then adjust the pH of the solution to 5.5~6.5 to obtain the enzymatic hydrolysate; chop the jujube pulp and ginger into jujube cubes and ginger cubes respectively, then mix the jujube cubes and ginger cubes evenly, add the mixture to the enzymatic hydrolysate, and enzymatically hydrolyze at a constant temperature of 50±5℃ under stirring. After enzymatic hydrolysis, separate the solid and liquid to obtain the filtrate and the residue. Concentrate the filtrate under reduced pressure to obtain component I;

[0005] (2) The filter residue is added to deionized water, and the oil phase is collected by steam distillation to obtain component II;

[0006] (3) Weigh out the Chinese medicinal materials: Euphorbia humifusa, Aristolochia debilis, Camphor tree root, Elsholtzia ciliata and Liquidambar formosana leaves. Crush Euphorbia humifusa and some Elsholtzia ciliata to obtain fine powder of Euphorbia humifusa and fine powder of Elsholtzia ciliata. Chop the remaining Elsholtzia ciliata and other Chinese medicinal materials and decoct them in water. Filter the decoction. Add water to the residue after decoction and decoct again. Filter the residue. Combine the two filtrates and concentrate under reduced pressure. Add the fine powder of Euphorbia humifusa and fine powder of Elsholtzia ciliata to the concentrated product, stir evenly, dry, crush and obtain intermediate extract powder.

[0007] (4) Mix the intermediate extract powder, component I and component II evenly, then add a binder for fluidized bed granulation and drying to obtain intermediate particles; mix the intermediate particles and magnesium stearate evenly, compress into tablets to obtain the gastroenteritis preparation.

[0008] Further, in step (1), the concentration of cellulase in the aqueous solution of cellulase is 0.8-1.2 g / 100 mL, and the solvent is water; the mass ratio of diced jujube and diced ginger is diced jujube: diced ginger = 10: 1-6; the ratio of the mixture added to the enzymatic hydrolysate is mixture: enzymatic hydrolysate = 1 g: 5-10 mL.

[0009] Furthermore, in step (1), the enzymatic hydrolysis time is 2 to 3 hours.

[0010] Furthermore, in step (2), the process parameters for steam distillation are: material-to-liquid ratio: material:water = 1g:2-2.5mL; heating to boiling, extracting oil by timing for 6-7 hours after oil extraction, and collecting the condensed oil phase.

[0011] Further, in step (3), the Chinese medicinal materials are as follows by weight: 660 parts of Euphorbia humifusa, 900 parts of Euphorbia pekinensis, 660 parts of camphor tree root, 330 parts of Elsholtzia ciliata, and 330 parts of Liquidambar formosana leaves; 5wt% to 10wt% of Elsholtzia ciliata are pulverized to make Elsholtzia ciliata fine powder.

[0012] Furthermore, in step (3), the mass ratio of the decoction to the liquid is 1:6 to 10; the decoction time is 1 to 2 hours.

[0013] Further, in step (4), the intermediate extract powder, component I, component II, binder and magnesium stearate are in the following weight parts: 150 parts of intermediate extract powder, 25-30 parts of component I, 10-15 parts of component II, 10-12 parts of binder and 1-2 parts of magnesium stearate.

[0014] Further, the adhesive is an ethanol solution, a mixture of sorbitol and polyvinylpyrrolidone with a mass ratio of ethanol solution: sorbitol: polyvinylpyrrolidone = 100: (10-50): (10-50); or an ethanol solution and a mixture of sorbitol with a mass ratio of ethanol solution: sorbitol = 100: (10-50); or an ethanol solution and a mixture of polyvinylpyrrolidone with a mass ratio of ethanol solution: polyvinylpyrrolidone = 100: (10-50); wherein the volume percentage of ethanol in the ethanol solution is 50% to 95%, and the solvent is water.

[0015] The beneficial effects of this invention are as follows: adding the excipients prepared according to this invention to a traditional formula can improve antibacterial activity; the jujube extract and ginger extract have a significant synergistic effect on the antibacterial and promoting effects of gastroenteritis preparations. Furthermore, by adding jujube and ginger extracts, the taste of gastroenteritis preparations can be improved, incorporating a fruity aroma; the ginger extract can also mask some of the bitterness of the medicinal materials, resulting in a better taste for the gastroenteritis preparation. Attached Figure Description

[0016] Figure 1 This is a comparative diagram showing the in vitro antibacterial activity of the gastroenteritis preparations prepared by the methods described in the various embodiments and comparative examples. Detailed Implementation

[0017] The present invention will be further described below with reference to the embodiments.

[0018] Example 1

[0019] A method for preparing a gastroenteritis preparation with good taste, comprising the following steps:

[0020] (1) Prepare an aqueous solution of cellulase, wherein the concentration of cellulase in the aqueous solution is 0.8 g / 100 mL and the solvent is water; heat the aqueous solution of cellulase to 50 °C in a water bath and keep it warm, then add citric acid to adjust the pH of the solution to 6 to obtain an enzymatic hydrolysate; chop the jujube pulp and ginger into jujube cubes and ginger cubes respectively, then mix the jujube cubes and ginger cubes evenly, wherein the mass ratio of jujube cubes to ginger cubes is 10:1; add the mixture to the enzymatic hydrolysate, wherein the mass ratio of the mixture to the enzymatic hydrolysate is 1 g: 5 mL; under stirring, keep the enzymatic hydrolysate at 50 °C for 2 h, and after enzymatic hydrolysis, separate the solid and liquid to obtain filtrate and filter residue, concentrate the filtrate under reduced pressure to 1 / 3 of the original volume to obtain component I;

[0021] (2) The filter residue is added to deionized water and steam distilled. The process parameters of the steam distillation are: material-to-liquid ratio: material:water = 1g:2mL; heating to boiling, starting the extraction time after oil is extracted, and collecting the condensed oil phase; obtaining component II;

[0022] (3) Weigh out the Chinese medicinal materials *Euphorbia humifusa*, *Euphorbia pekinensis*, camphor tree root, *Elsholtzia ciliata*, and *Liquidambar formosana* leaves. The weight percentages of each Chinese medicinal material are as follows: 660 parts of *Euphorbia humifusa*, 900 parts of *Euphorbia pekinensis*, 660 parts of camphor tree root, 330 parts of *Elsholtzia ciliata*, and 330 parts of *Liquidambar formosana* leaves. Crush *Euphorbia humifusa* and 5 wt% of *Elsholtzia ciliata* to obtain fine powder of *Euphorbia humifusa* and fine powder of *Elsholtzia ciliata*. Chop the remaining *Elsholtzia ciliata* and other Chinese medicinal materials and decoct them in water. The mass ratio of the decoction to the liquid is 1:8. The decoction time is 1 hour. Filter the mixture. Add water to the residue after decoction and decoct it again. The mass ratio of the decoction to the liquid is 1:8. The decoction time is 1 hour. Filter the mixture. Combine the two filtrates and concentrate them under reduced pressure to 1 / 4 of the original volume. Add the fine powder of *Euphorbia humifusa* and fine powder of *Elsholtzia ciliata* to the concentrated mixture, stir evenly, freeze dry, and crush to obtain intermediate extract powder.

[0023] (4) The intermediate extract powder, component I and component II are mixed evenly, and then a binder is added for fluidized bed granulation and freeze drying to obtain intermediate particles; the intermediate particles and magnesium stearate are mixed evenly; the intermediate extract powder, component I, component II, binder and magnesium stearate are used in the following weight parts: 150 parts of intermediate extract powder, 25 parts of component I, 15 parts of component II, 10 parts of binder and 1 part of magnesium stearate; wherein the binder is a mixture of ethanol solution and sorbitol with a mass ratio of ethanol solution: sorbitol = 100:20; the volume percentage of ethanol in the ethanol solution is 50% and the solvent is water; tableting is performed to obtain the gastroenteritis preparation.

[0024] Example 2

[0025] A method for preparing a gastroenteritis preparation with good taste, comprising the following steps:

[0026] (1) Prepare an aqueous solution of cellulase, wherein the concentration of cellulase in the aqueous solution is 1g / 100mL and the solvent is water; heat the aqueous solution of cellulase to 50℃ in a water bath and keep it warm, then add citric acid to adjust the pH of the solution to 6 to obtain the enzymatic hydrolysate; chop the jujube pulp and ginger into jujube cubes and ginger cubes respectively, then mix the jujube cubes and ginger cubes evenly, wherein the mass ratio of jujube cubes to ginger cubes is 10:2; add the mixture to the enzymatic hydrolysate, wherein the mass ratio of the mixture to the enzymatic hydrolysate is 1g:5mL; under stirring, keep the temperature at 50℃ for 2h for enzymatic hydrolysis, and after enzymatic hydrolysis, separate the solid and liquid to obtain filtrate and filter residue, concentrate the filtrate under reduced pressure to 1 / 3 of the original volume to obtain component I;

[0027] (2) The filter residue is added to deionized water and steam distilled. The process parameters of the steam distillation are: material-to-liquid ratio: material:water = 1g:2mL; heating to boiling, starting the extraction time after oil is extracted, and collecting the condensed oil phase; obtaining component II;

[0028] (3) Weigh out the Chinese medicinal materials *Euphorbia humifusa*, *Euphorbia pekinensis*, camphor tree root, *Elsholtzia ciliata*, and *Liquidambar formosana* leaves. The weight percentages of each Chinese medicinal material are as follows: 660 parts of *Euphorbia humifusa*, 900 parts of *Euphorbia pekinensis*, 660 parts of camphor tree root, 330 parts of *Elsholtzia ciliata*, and 330 parts of *Liquidambar formosana* leaves. Crush *Euphorbia humifusa* and 5 wt% of *Elsholtzia ciliata* to obtain fine powder of *Euphorbia humifusa* and fine powder of *Elsholtzia ciliata*. Chop the remaining *Elsholtzia ciliata* and other Chinese medicinal materials and decoct them in water. The mass ratio of the decoction to the liquid is 1:8. The decoction time is 1 hour. Filter the mixture. Add water to the residue after decoction and decoct it again. The mass ratio of the decoction to the liquid is 1:8. The decoction time is 1 hour. Filter the mixture. Combine the two filtrates and concentrate them under reduced pressure to 1 / 4 of the original volume. Add the fine powder of *Euphorbia humifusa* and fine powder of *Elsholtzia ciliata* to the concentrated mixture, stir evenly, freeze dry, and crush to obtain intermediate extract powder.

[0029] (4) The intermediate extract powder, component I and component II are mixed evenly, and then a binder is added for fluidized bed granulation and freeze drying to obtain intermediate particles; the intermediate particles and magnesium stearate are mixed evenly; the intermediate extract powder, component I, component II, binder and magnesium stearate are used in the following weight parts: 150 parts of intermediate extract powder, 25 parts of component I, 15 parts of component II, 11 parts of binder and 1 part of magnesium stearate; wherein the binder is a mixture of ethanol solution and sorbitol with a mass ratio of ethanol solution: sorbitol = 100:20; the volume percentage of ethanol in the ethanol solution is 50% and the solvent is water; tableting is performed to obtain the gastroenteritis preparation.

[0030] Example 3

[0031] A method for preparing a gastroenteritis preparation with good taste, comprising the following steps:

[0032] (1) Prepare an aqueous solution of cellulase, wherein the concentration of cellulase in the aqueous solution is 1g / 100mL and the solvent is water; heat the aqueous solution of cellulase to 50℃ in a water bath and keep it warm, then add citric acid to adjust the pH of the solution to 6 to obtain the enzymatic hydrolysate; chop the jujube pulp and ginger into jujube cubes and ginger cubes respectively, then mix the jujube cubes and ginger cubes evenly, wherein the mass ratio of jujube cubes to ginger cubes is 10:4; add the mixture to the enzymatic hydrolysate, wherein the mass ratio of the mixture to the enzymatic hydrolysate is 1g:5mL; under stirring, keep the temperature at 50℃ for 2h for enzymatic hydrolysis, and after enzymatic hydrolysis, separate the solid and liquid to obtain filtrate and filter residue, concentrate the filtrate under reduced pressure to 1 / 3 of the original volume to obtain component I;

[0033] (2) The filter residue is added to deionized water and steam distilled. The process parameters for steam distillation are: material to water ratio = 1g: 2.5mL; heating to boiling, and starting the extraction timer for 6 hours after oil is extracted; collecting the condensed oil phase; obtaining component II;

[0034] (3) Weigh out the Chinese medicinal materials *Euphorbia humifusa*, *Euphorbia pekinensis*, camphor tree root, *Elsholtzia ciliata*, and *Liquidambar formosana* leaves. The weight parts of each Chinese medicinal material are as follows: 660 parts of *Euphorbia humifusa*, 900 parts of *Euphorbia pekinensis*, 660 parts of camphor tree root, 330 parts of *Elsholtzia ciliata*, and 330 parts of *Liquidambar formosana* leaves. Crush *Euphorbia humifusa* and 10 wt% of *Elsholtzia ciliata* to obtain fine powder of *Euphorbia humifusa* and fine powder of *Elsholtzia ciliata*. Chop the remaining *Elsholtzia ciliata* and other Chinese medicinal materials and decoct them in water. The mass ratio of the decoction to the liquid is 1:8. The decoction time is 1 hour. Filter the mixture. Add water to the residue after decoction and decoct it again. The mass ratio of the decoction to the liquid is 1:8. The decoction time is 1 hour. Filter the mixture. Combine the two filtrates and concentrate them under reduced pressure to 1 / 4 of the original volume. Add the fine powder of *Euphorbia humifusa* and fine powder of *Elsholtzia ciliata* to the concentrated mixture, stir evenly, freeze dry, and crush to obtain intermediate extract powder.

[0035] (4) The intermediate extract powder, component I and component II are mixed evenly, and then a binder is added for fluidized bed granulation and freeze drying to obtain intermediate particles; the intermediate particles and magnesium stearate are mixed evenly; the intermediate extract powder, component I, component II, binder and magnesium stearate are in the following weight parts: 150 parts of intermediate extract powder, 30 parts of component I, 10 parts of component II, 11 parts of binder and 2 parts of magnesium stearate; wherein the binder is a mixture of ethanol solution and sorbitol with a mass ratio of ethanol solution: sorbitol = 100:20; the volume percentage of ethanol in the ethanol solution is 50% and the solvent is water; tableting is performed to obtain the gastroenteritis preparation.

[0036] Example 4

[0037] A method for preparing a gastroenteritis preparation with good taste, comprising the following steps:

[0038] (1) Prepare an aqueous solution of cellulase, wherein the concentration of cellulase in the aqueous solution is 1.2 g / 100 mL and the solvent is water; heat the aqueous solution of cellulase to 50 °C in a water bath and keep it warm, then add citric acid to adjust the pH of the solution to 6 to obtain an enzymatic hydrolysate; chop the jujube pulp and ginger into jujube cubes and ginger cubes respectively, then mix the jujube cubes and ginger cubes evenly, wherein the mass ratio of jujube cubes to ginger cubes is 10:6; add the mixture to the enzymatic hydrolysate, wherein the mass ratio of the mixture to the enzymatic hydrolysate is 1 g: 5 mL; under stirring, keep the temperature at 50 °C for 2 h for enzymatic hydrolysis, and after enzymatic hydrolysis, separate the solid and liquid to obtain filtrate and filter residue, concentrate the filtrate under reduced pressure to 1 / 3 of the original volume to obtain component I;

[0039] (2) The filter residue is added to deionized water and steam distilled. The process parameters for steam distillation are: material to water ratio = 1g: 2.5mL; heating to boiling, and starting the extraction timer for 6 hours after oil is extracted; collecting the condensed oil phase; obtaining component II;

[0040] (3) Weigh out the Chinese medicinal materials *Euphorbia humifusa*, *Euphorbia pekinensis*, camphor tree root, *Elsholtzia ciliata*, and *Liquidambar formosana* leaves. The weight parts of each Chinese medicinal material are as follows: 660 parts of *Euphorbia humifusa*, 900 parts of *Euphorbia pekinensis*, 660 parts of camphor tree root, 330 parts of *Elsholtzia ciliata*, and 330 parts of *Liquidambar formosana* leaves. Crush *Euphorbia humifusa* and 10 wt% of *Elsholtzia ciliata* to obtain fine powder of *Euphorbia humifusa* and fine powder of *Elsholtzia ciliata*. Chop the remaining *Elsholtzia ciliata* and other Chinese medicinal materials and decoct them in water. The mass ratio of the decoction to the liquid is 1:8. The decoction time is 1 hour. Filter the mixture. Add water to the residue after decoction and decoct it again. The mass ratio of the decoction to the liquid is 1:8. The decoction time is 1 hour. Filter the mixture. Combine the two filtrates and concentrate them under reduced pressure to 1 / 4 of the original volume. Add the fine powder of *Euphorbia humifusa* and fine powder of *Elsholtzia ciliata* to the concentrated mixture, stir evenly, freeze dry, and crush to obtain intermediate extract powder.

[0041] (4) The intermediate extract powder, component I and component II are mixed evenly, and then a binder is added for fluidized bed granulation and freeze drying to obtain intermediate particles; the intermediate particles and magnesium stearate are mixed evenly; the intermediate extract powder, component I, component II, binder and magnesium stearate are used in the following weight parts: 150 parts of intermediate extract powder, 30 parts of component I, 10 parts of component II, 12 parts of binder and 2 parts of magnesium stearate; wherein the binder is a mixture of ethanol solution and sorbitol with a mass ratio of ethanol solution: sorbitol = 100:20; the volume percentage of ethanol in the ethanol solution is 50% and the solvent is water; tableting is performed to obtain the gastroenteritis preparation.

[0042] Comparative Example 1

[0043] A method for preparing a gastroenteritis preparation as a comparison, comprising the steps of:

[0044] (1) Weigh out the Chinese medicinal materials *Euphorbia humifusa*, *Euphorbia pekinensis*, camphor tree root, *Elsholtzia ciliata*, and *Liquidambar formosana* leaves. The weight parts of each Chinese medicinal material are as follows: 660 parts of *Euphorbia humifusa*, 900 parts of *Euphorbia pekinensis*, 660 parts of camphor tree root, 330 parts of *Elsholtzia ciliata*, and 330 parts of *Liquidambar formosana* leaves. Crush *Euphorbia humifusa* and 10 wt% of *Elsholtzia ciliata* to obtain fine powder of *Euphorbia humifusa* and fine powder of *Elsholtzia ciliata*. Chop the remaining *Elsholtzia ciliata* and other Chinese medicinal materials and decoct them in water. The mass ratio of the decoction to the liquid is 1:8. The decoction time is 1 hour. Filter the mixture. Add water to the residue after decoction and decoct it again. The mass ratio of the decoction to the liquid is 1:8. The decoction time is 1 hour. Filter the mixture. Combine the two filtrates and concentrate them under reduced pressure to 1 / 4 of the original volume. Add the fine powder of *Euphorbia humifusa* and fine powder of *Elsholtzia ciliata* to the concentrated mixture, stir evenly, freeze dry, and crush to obtain intermediate extract powder.

[0045] (2) Add binder to the intermediate extract powder and perform fluidized bed granulation, freeze drying to obtain intermediate particles; mix the intermediate particles and magnesium stearate evenly; the intermediate extract powder, binder and magnesium stearate used are in the following weight parts: 150 parts intermediate extract powder, 8 parts binder, 1.5 parts magnesium stearate; wherein the binder is a mixture of ethanol solution and sorbitol with a mass ratio of ethanol solution: sorbitol = 100:20; the volume percentage of ethanol in the ethanol solution is 50%, and the solvent is water; compress tablets to obtain the gastroenteritis preparation.

[0046] Comparative Example 2

[0047] A method for preparing a gastroenteritis preparation as a comparison, comprising the steps of:

[0048] (1) Prepare an aqueous solution of cellulase, wherein the concentration of cellulase in the aqueous solution is 1g / 100mL and the solvent is water; heat the aqueous solution of cellulase to 50℃ in a water bath and keep it warm, then add citric acid to adjust the pH of the solution to 6 to obtain an enzymatic hydrolysate; chop the jujube pulp into jujube pieces, then add the jujube pieces to the enzymatic hydrolysate, wherein the ratio of jujube pieces to enzymatic hydrolysate is jujube pieces:enzymatic hydrolysate = 1g:5mL; under stirring, keep the enzymatic hydrolysate at 50℃ for 2h, and after enzymatic hydrolysis, separate the solid and liquid to obtain filtrate and filter residue, concentrate the filtrate under reduced pressure to 1 / 3 of the original volume to obtain component I;

[0049] (2) The filter residue is added to deionized water and steam distilled. The process parameters for steam distillation are: material to water ratio = 1g: 2.5mL; heating to boiling, and starting the extraction timer for 6 hours after oil is extracted; collecting the condensed oil phase; obtaining component II;

[0050] (3) Weigh out the Chinese medicinal materials *Euphorbia humifusa*, *Euphorbia pekinensis*, camphor tree root, *Elsholtzia ciliata*, and *Liquidambar formosana* leaves. The weight parts of each Chinese medicinal material are as follows: 660 parts of *Euphorbia humifusa*, 900 parts of *Euphorbia pekinensis*, 660 parts of camphor tree root, 330 parts of *Elsholtzia ciliata*, and 330 parts of *Liquidambar formosana* leaves. Crush *Euphorbia humifusa* and 10 wt% of *Elsholtzia ciliata* to obtain fine powder of *Euphorbia humifusa* and fine powder of *Elsholtzia ciliata*. Chop the remaining *Elsholtzia ciliata* and other Chinese medicinal materials and decoct them in water. The mass ratio of the decoction to the liquid is 1:8. The decoction time is 1 hour. Filter the mixture. Add water to the residue after decoction and decoct it again. The mass ratio of the decoction to the liquid is 1:8. The decoction time is 1 hour. Filter the mixture. Combine the two filtrates and concentrate them under reduced pressure to 1 / 4 of the original volume. Add the fine powder of *Euphorbia humifusa* and fine powder of *Elsholtzia ciliata* to the concentrated mixture, stir evenly, freeze dry, and crush to obtain intermediate extract powder.

[0051] (4) The intermediate extract powder, component I and component II are mixed evenly, and then a binder is added for fluidized bed granulation and freeze drying to obtain intermediate particles; the intermediate particles and magnesium stearate are mixed evenly; the intermediate extract powder, component I, component II, binder and magnesium stearate are in the following weight parts: 150 parts of intermediate extract powder, 30 parts of component I, 10 parts of component II, 11 parts of binder and 2 parts of magnesium stearate; wherein the binder is a mixture of ethanol solution and sorbitol with a mass ratio of ethanol solution: sorbitol = 100:20; the volume percentage of ethanol in the ethanol solution is 50% and the solvent is water; tableting is performed to obtain the gastroenteritis preparation.

[0052] Comparative Example 3

[0053] A method for preparing a gastroenteritis preparation as a comparison, comprising the steps of:

[0054] (1) Prepare an aqueous solution of cellulase, wherein the concentration of cellulase in the aqueous solution is 1g / 100mL and the solvent is water; heat the aqueous solution of cellulase to 50℃ in a water bath and keep it warm, then add citric acid to adjust the pH of the solution to 6 to obtain an enzymatic hydrolysate; chop ginger into ginger cubes, then add the ginger cubes to the enzymatic hydrolysate, wherein the ratio of ginger cubes to enzymatic hydrolysate is 1g: 5mL; hydrolyze at 50℃ for 2 hours under stirring, and after enzymatic hydrolysis, separate the solid and liquid to obtain filtrate and filter residue, concentrate the filtrate under reduced pressure to 1 / 3 of the original volume to obtain component I;

[0055] (2) The filter residue is added to deionized water and steam distilled. The process parameters for steam distillation are: material to water ratio = 1g: 2.5mL; heating to boiling, and starting the extraction timer for 6 hours after oil is extracted; collecting the condensed oil phase; obtaining component II;

[0056] (3) Weigh out the Chinese medicinal materials *Euphorbia humifusa*, *Euphorbia pekinensis*, camphor tree root, *Elsholtzia ciliata*, and *Liquidambar formosana* leaves. The weight parts of each Chinese medicinal material are as follows: 660 parts of *Euphorbia humifusa*, 900 parts of *Euphorbia pekinensis*, 660 parts of camphor tree root, 330 parts of *Elsholtzia ciliata*, and 330 parts of *Liquidambar formosana* leaves. Crush *Euphorbia humifusa* and 10 wt% of *Elsholtzia ciliata* to obtain fine powder of *Euphorbia humifusa* and fine powder of *Elsholtzia ciliata*. Chop the remaining *Elsholtzia ciliata* and other Chinese medicinal materials and decoct them in water. The mass ratio of the decoction to the liquid is 1:8. The decoction time is 1 hour. Filter the mixture. Add water to the residue after decoction and decoct it again. The mass ratio of the decoction to the liquid is 1:8. The decoction time is 1 hour. Filter the mixture. Combine the two filtrates and concentrate them under reduced pressure to 1 / 4 of the original volume. Add the fine powder of *Euphorbia humifusa* and fine powder of *Elsholtzia ciliata* to the concentrated mixture, stir evenly, freeze dry, and crush to obtain intermediate extract powder.

[0057] (4) The intermediate extract powder, component I and component II are mixed evenly, and then a binder is added for fluidized bed granulation and freeze drying to obtain intermediate particles; the intermediate particles and magnesium stearate are mixed evenly; the intermediate extract powder, component I, component II, binder and magnesium stearate are in the following weight parts: 150 parts of intermediate extract powder, 30 parts of component I, 10 parts of component II, 11 parts of binder and 2 parts of magnesium stearate; wherein the binder is a mixture of ethanol solution and sorbitol with a mass ratio of ethanol solution: sorbitol = 100:20; the volume percentage of ethanol in the ethanol solution is 50% and the solvent is water; tableting is performed to obtain the gastroenteritis preparation.

[0058] Comparative Example 4

[0059] A method for preparing a gastroenteritis preparation as a comparison, comprising the steps of:

[0060] (1) Prepare an aqueous solution of cellulase, wherein the concentration of cellulase in the aqueous solution is 1g / 100mL and the solvent is water; heat the aqueous solution of cellulase to 50℃ in a water bath and keep it warm, then add citric acid to adjust the pH of the solution to 6 to obtain the enzymatic hydrolysate; chop the jujube pulp and ginger into jujube cubes and ginger cubes respectively, then mix the jujube cubes and ginger cubes evenly, wherein the mass ratio of jujube cubes to ginger cubes is 10:4; add the mixture to the enzymatic hydrolysate, wherein the mass ratio of the mixture to the enzymatic hydrolysate is 1g:5mL; under stirring, keep the temperature at 50℃ for 2h for enzymatic hydrolysis, and after enzymatic hydrolysis, separate the solid and liquid to obtain filtrate and filter residue, concentrate the filtrate under reduced pressure to 1 / 3 of the original volume to obtain component I;

[0061] (2) Weigh out the Chinese medicinal materials *Euphorbia humifusa*, *Euphorbia pekinensis*, camphor tree root, *Elsholtzia ciliata*, and *Liquidambar formosana* leaves. The weight parts of each Chinese medicinal material are as follows: 660 parts of *Euphorbia humifusa*, 900 parts of *Euphorbia pekinensis*, 660 parts of camphor tree root, 330 parts of *Elsholtzia ciliata*, and 330 parts of *Liquidambar formosana* leaves. Crush *Euphorbia humifusa* and 10 wt% of *Elsholtzia ciliata* to obtain fine powder of *Euphorbia humifusa* and fine powder of *Elsholtzia ciliata*. Chop the remaining *Elsholtzia ciliata* and other Chinese medicinal materials and decoct them in water. The mass ratio of the decoction to the liquid is 1:8. The decoction time is 1 hour. Filter the liquid. Add water to the residue after decoction and decoct it again. The mass ratio of the decoction to the liquid is 1:8. The decoction time is 1 hour. Filter the liquid. Combine the two filtrates and concentrate them under reduced pressure to 1 / 4 of the original volume. Add the fine powder of *Euphorbia humifusa* and fine powder of *Elsholtzia ciliata* to the concentrated liquid. Stir evenly, freeze dry, and crush to obtain intermediate extract powder.

[0062] (3) The intermediate extract powder and component I are mixed evenly, and then a binder is added for fluidized bed granulation and freeze drying to obtain intermediate particles; the intermediate particles and magnesium stearate are mixed evenly; the intermediate extract powder, component I, binder and magnesium stearate are used in the following weight parts: 150 parts of intermediate extract powder, 40 parts of component I, 11 parts of binder and 2 parts of magnesium stearate; wherein the binder is a mixture of ethanol solution and sorbitol with a mass ratio of ethanol solution: sorbitol = 100:20; the volume percentage of ethanol in the ethanol solution is 50% and the solvent is water; tableting is performed to obtain the gastroenteritis preparation.

[0063] Example 5

[0064] The in vitro antibacterial activity of the gastroenteritis preparations prepared by the methods described in the above examples and comparative examples was tested respectively. The antibacterial activity test method was as follows: 1. The tested Escherichia coli and Staphylococcus aureus were activated separately and cultured at 37°C until OD200. 600nm To a concentration of 0.6, the activated two test bacteria were then added to LB medium at a ratio of 1 μL / mL (test bacteria / medium). The mixture was poured into a glass dish and leveled. 2. The gastroenteritis preparation to be tested was crushed and added to sterile water at a ratio of 1 g / 1 mL (gastroenteritis preparation / sterile water) to prepare the test solution. An 8 mm diameter sterile filter paper was placed in the center of the glass dish, and 10 μL of the test solution was dropped onto the filter paper. The mixture was incubated at 37°C for 12 hours, and the diameter of the inhibition zone was measured. Each group of samples was tested 5 times for each of the two test bacteria, and the average value was taken. The results are as follows: Figure 1 As shown.

[0065] Depend on Figure 1It is evident that adding the excipients prepared according to this invention to traditional formulations can enhance the antibacterial activity of gastroenteritis preparations. Furthermore, comparative examples 3 and 1-3 demonstrate that jujube extract and ginger extract exhibit a significant synergistic effect on the antibacterial and promoting effects of gastroenteritis preparations. Additionally, the addition of jujube and ginger extracts improves the taste of gastroenteritis preparations, infusing them with fruity aroma. The ginger extract also helps to mask some of the bitterness of the medicinal materials, resulting in a better overall palatability for the gastroenteritis preparation.

[0066] The technical solutions provided by the present invention have been described in detail above. For those skilled in the art, there will be changes in specific implementation methods and application scope based on the ideas of the embodiments of the present invention. Therefore, the content of this specification should not be construed as a limitation of the present invention.

Claims

1. A process for the preparation of a gastro-resistant formulation having a pleasant mouth feel, characterized by the steps of It comprises: (1) configure the aqueous solution of cellulase, the concentration of cellulase in the aqueous solution of cellulase is 0.8-1.2 g / 100 mL, and the solvent is water; the aqueous solution of cellulase is heated to 50±5℃ in water bath, then the pH of the solution is adjusted to 5.5-6.5 to obtain an enzymatic solution; the jujube pulp and ginger are respectively chopped into jujube bits and ginger bits, then the jujube bits and ginger bits are mixed uniformly, the mass ratio of the jujube bits to the ginger bits is 10:1-6; the mixture is added into the enzymatic solution, the amount of the mixture added into the enzymatic solution is 1 g:5-10 mL; the mixture is enzymolyzed at 50±5℃ under stirring, after enzymolysis, the mixture is separated into filtrate and residue, the filtrate is concentrated under reduced pressure to obtain component I; (2) the residue is added into deionized water, and the oil phase is collected by steam distillation to obtain component II; (3) the Chinese medicinal materials of Rubus corchorifolius L., Elatostema umbellatum, Cinnamomum camphora root, Elsholtzia and Liquidambar formosana Hance are weighed, Rubus corchorifolius L. and part of Elsholtzia are crushed to obtain Rubus corchorifolius L. fine powder and Elsholtzia fine powder; the rest of Elsholtzia and other Chinese medicinal materials are chopped and boiled with water, filtered, the residue after boiling is boiled with water again, filtered, the two filtrates are combined, concentrated under reduced pressure, the concentrated product is added into the Rubus corchorifolius L. fine powder and Elsholtzia fine powder, stirred uniformly, dried, broken to obtain intermediate extract powder; (4) the intermediate extract powder, the component I and the component II are mixed uniformly, then a binder is added to fluidized bed granulation, dried to obtain intermediate granules; the intermediate granules and magnesium stearate are mixed uniformly, tabletted to obtain the gastrointestinal inflammation preparation.

2. A process for the preparation of a gastroenteric dosage form having good mouth feel according to claim 1, characterized in that, In the step (1), the enzymolysis time is 2-3 h.

3. A process for the preparation of a gastroenteric dosage form having good mouth feel according to claim 1, characterized in that, In the step (2), the process parameters of steam distillation are as follows: the ratio of material to water is 1 g:2-2.5 mL; heated to boiling, the oil is collected after boiling, and the extraction is carried out for 6-7 h, and the oil phase after condensation is collected.

4. A process for the preparation of a gastroenteric dosage form having improved mouth feel as claimed in claim 1, wherein, In the step (3), the Chinese medicinal materials are as follows in terms of weight parts: Rubus corchorifolius L. 660 parts, Elatostema umbellatum 900 parts, Cinnamomum camphora root 660 parts, Elsholtzia 330 parts, and Liquidambar formosana Hance 330 parts; 5wt%-10wt% of Elsholtzia is crushed to obtain Elsholtzia fine powder.

5. A process for the preparation of a gastroenteritis formulation having a pleasant mouth feel as claimed in claim 1, wherein, In the step (3), the ratio of material to liquid in the boiling is 1:6-10, and the boiling time is 1-2 h.

6. A process for the preparation of a gastroenteric dosage form having improved mouth feel according to claim 1, characterized in that, In the step (4), the intermediate extract powder, the component I, the component II, the binder and magnesium stearate are as follows in terms of weight parts: intermediate extract powder 150 parts, component I 25-30 parts, component II 10-15 parts, binder 10-12 parts, and magnesium stearate 1-2 parts.

7. A process for the preparation of a gastroenteric dosage form having improved mouth feel according to claim 1, wherein, The adhesive is a mixture of ethanol solution, sorbitol and polyvinylpyrrolidone with a mass ratio of ethanol solution:sorbitol:polyvinylpyrrolidone=100:(10-50):(10-50); or a mixture of ethanol solution and sorbitol with a mass ratio of ethanol solution:sorbitol=100:(10-50); or a mixture of ethanol solution and polyvinylpyrrolidone with a mass ratio of ethanol solution:polyvinylpyrrolidone=100:(10-50); wherein the volume percentage of ethanol in the ethanol solution is 50%-95%, and the solvent is water. The adhesive is a mixture of ethanol solution, sorbitol and polyvinylpyrrolidone with a mass ratio of ethanol solution:sorbitol:polyvinylpyrrolidone=100:(10-50):(10-50); or a mixture of ethanol solution and sorbitol with a mass ratio of ethanol solution:sorbitol=100:(10-50); or a mixture of ethanol solution and polyvinylpyrrolidone with a mass ratio of ethanol solution:polyvinylpyrrolidone=100:(10-50); wherein the volume percentage of ethanol in the ethanol solution is 50%-95%, and the solvent is water. The adhesive is a mixture of ethanol solution, sorbitol and polyvinylpyrrolidone with a mass ratio of ethanol solution:sorbitol:polyvinylpyrrolidone=100:(10-50):(10-50); or a mixture of ethanol solution and sorbitol with a mass ratio of ethanol solution:sorbitol=100:(10-50); or a mixture of ethanol solution and polyvinylpyrrolidone with a mass ratio of ethanol solution:polyvinylpyr

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