A method for preparing a tablet for treating gastrointestinal inflammation

Abstract

The application discloses a preparation method of a gastrointestinal inflammation treating tablet, and steps of the method comprise the following steps: (1) preparing an extract solution of lotus leaves and red dates to obtain extract solution I; preparing an extract solution of eggshell membrane powder to obtain extract solution II; combining the extract solution I and the extract solution II, performing enzyme inactivation treatment, and concentrating the combined solution to a paste under reduced pressure to obtain an extract paste; (2) adding pueraria powder, threonine and tryptophan into the extract paste, and uniformly stirring the mixture after the addition is completed to obtain an auxiliary material; and (3) preparing a paste body, adding the auxiliary material, compressing the paste body into a tablet, and coating the tablet with sugar or film coating to obtain the tablet. The auxiliary material prepared by the method has good bacteriostasis, and has good inhibition effect on escherichia coli and staphylococcus aureus; after being added into the tablet, the auxiliary material can effectively improve the bactericidal and bacteriostatic effect of the tablet; meanwhile, the prepared tablet has low friability, so that the tablet is not prone to powder dropping, fragmentation and other phenomena during packaging, transportation and processing, and the qualified rate of the finished product is high.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of preparing tablets for treating gastrointestinal inflammation, and in particular to a preparation method of tablets for treating gastrointestinal inflammation. BACKGROUND

[0002] Gastrointestinal inflammation refers to an inflammatory disease of the gastrointestinal tract (including the stomach and small intestine), usually caused by infection, food poisoning, drug irritation or autoimmune reaction. According to the course of the disease, gastrointestinal inflammation can be divided into acute and chronic types. Acute gastrointestinal inflammation is usually caused by bacterial, viral or parasitic infection, and common pathogens include norovirus, salmonella, escherichia coli, etc. Chronic gastrointestinal inflammation may be related to long-term poor dietary habits, drug use (such as non-steroidal anti-inflammatory drugs), helicobacter pylori infection. The main symptoms of gastrointestinal inflammation include abdominal pain, diarrhea, nausea, vomiting, fever and loss of appetite, and in severe cases, it can lead to dehydration and electrolyte imbalance.

[0003] In recent years, the application of plant extracts in the treatment of gastrointestinal inflammation has gradually attracted attention. Due to its natural source, multi-target effect and relatively low adverse reactions, plant extracts have become a research hotspot in the field of gastrointestinal inflammation treatment. SUMMARY

[0004] To this end, the present application provides a preparation method of tablets for treating gastrointestinal inflammation, comprising the following steps:

[0005] (1) Dry and crush lotus leaves and red dates respectively to obtain lotus leaf powder and red date powder, mix the lotus leaf powder and red date powder to form a mixed raw material powder; prepare an aqueous solution of cellulase, and then add the mixed raw material powder after the aqueous solution of cellulase is kept constant at 45±2℃ in a water bath, and extract for 90min or more at 45±2℃ constant temperature, and the solution is placed in an ultrasonic environment during the extraction process and condenses backflow; after the extraction is completed, solid-liquid separation is performed to obtain extract I; prepare an aqueous solution of neutral protease, heat the aqueous solution of neutral protease to 47±2℃ and keep constant, then add eggshell membrane powder, and extract for 2h or more at 47±2℃ constant temperature, and condense backflow during the extraction process; after the extraction is completed, solid-liquid separation is performed to obtain extract II; combine the extract I and extract II, perform enzyme inactivation treatment, and reduce pressure to concentrate to a paste to obtain an extract;

[0006] (2) Add pueraria powder, threonine and tryptophan to the extract, and stir uniformly after the addition is completed to obtain a supplementary material;

[0007] (3) crushing the Euphorbia humilis, the Elatostema umbellatum and the Cinnamomum camphora root into fine powder respectively, frying the Euphorbia humilis fine powder with gentle fire until it is light brown to obtain the Euphorbia humilis component, mixing the fine powder of the Elatostema umbellatum and the Cinnamomum camphora root into a mixed powder; adding the mixed powder into water, boiling for more than 1 hour, condensing reflux during the boiling process; then solid-liquid separation to obtain the filtrate A and the residue, adding water into the residue again, boiling for more than 1 hour, condensing reflux during the boiling process; solid-liquid separation to obtain the filtrate B; combining the filtrate A and the filtrate B, reducing pressure to concentrate into a paste, adding the Euphorbia humilis component and the excipient, compressing into tablets, coating with sugar or film coating to obtain the tablets.

[0008] Further, in the step (1), the mixed mass ratio of the lotus leaf powder and the red date powder is lotus leaf powder:red date powder = 10:4-8; the concentration of the cellulase in the aqueous solution of the cellulase is 30-35 mg / g, and the solvent is water; the mass ratio of the mixed raw material powder added into the aqueous solution of the cellulase is mixed raw material powder:aqueous solution of cellulase = 1:40-50.

[0009] Further, in the step (1), the concentration of the neutral protease in the aqueous solution of the neutral protease is 40-50 kU / g, and the mass ratio of the eggshell membrane powder added into the aqueous solution of the neutral protease is eggshell membrane powder:aqueous solution of neutral protease = 1:40-50.

[0010] Further, the power of the ultrasonic wave is 200-300 W, and the frequency is 40 kHz.

[0011] Further, in the step (2), the mass ratio of the extract, the Pueraria lobata powder, the threonine and the tryptophan added into the extract is extract:Pueraria lobata powder:threonine:tryptophan = 1 g:30-40 mg:20-25 mg:20-25 mg.

[0012] Further, in the step (3), the used Euphorbia humilis, the Elatostema umbellatum and the Cinnamomum camphora root are 660 parts of Euphorbia humilis, 900 parts of Elatostema umbellatum and 660 parts of Cinnamomum camphora root by weight.

[0013] Further, in the step (3), the mass ratio of the mixed powder added into water is mixed powder:water = 1:50-60, and the mass ratio of the residue added into water again is residue:water = 1:50-60.

[0014] Further, in the step (3), the mixed mass ratio of the excipient and the paste is paste:excipient = 10:2-3.

[0015] The application has the advantages that the adjuvant prepared by the method has good bacteriostasis, has good inhibition effect on Escherichia coli and Staphylococcus aureus, and can effectively improve the bactericidal and bacteriostatic effect of the tablet after being added into the tablet; meanwhile, the tablet has low friability, so that the phenomenon of powder dropping and fragmentation is not easy to occur in packaging, transportation and processing, and the qualified rate of the finished product is high. The addition of lotus leaf and red date extract in the adjuvant can significantly improve the bacteriostasis of the adjuvant, and the effect of adding the compound extract of lotus leaf and red date is significantly better than that of adding the lotus leaf extract or the red date extract alone, which shows a synergistic effect. This may be because the isoquinoline alkaloids and terpenoids in the compound extract inhibit bacteria according to different bacteriostasis mechanisms, and the combination shows a synergistic bacteriostasis effect. The subsequent addition of eggshell membrane powder enzymatic hydrolysate as a natural binder improves the quality of the tablet, and the friability of the tablet is obviously reduced. In addition, the addition of pueraria powder is beneficial to the regulation of intestinal environment, the addition of threonine plays a role in improving intestinal function, and the addition of tryptophan can protect the intestinal epithelial layer and play an auxiliary role in treating gastrointestinal inflammation. DETAILED DESCRIPTION

[0016] The application will be further described below in combination with examples.

[0017] Example 1

[0018] A preparation method of a tablet for treating gastrointestinal inflammation, the steps comprising:

[0019] (1) drying and crushing lotus leaf and red dates to obtain lotus leaf powder and red date powder, mixing the lotus leaf powder and red date powder to form a mixed raw material powder; the mass ratio of the lotus leaf powder and red date powder is lotus leaf powder: red date powder = 10:4; configuring a cellulase aqueous solution, in the cellulase aqueous solution, the concentration of cellulase is 30 mg / g, and the solvent is water; water-bath constant temperature of the cellulase aqueous solution to 45±2℃, then adding the mixed raw material powder, the mass ratio of the mixed raw material powder and the cellulase aqueous solution is mixed raw material powder: cellulase aqueous solution = 1:40; constant temperature extraction for 90 min at 45±2℃, and the solution is placed in an ultrasonic environment (ultrasonic power is 300 W; frequency is 40 kHz) during the extraction process, and condensation reflux; after the extraction is completed, solid-liquid separation is performed to obtain an extract I; configuring a neutral protease aqueous solution, in the neutral protease aqueous solution, the amount of neutral protease is 40 kU / g, heating the neutral protease aqueous solution to 47±2℃, then adding eggshell membrane powder, the mass ratio of the eggshell membrane powder and the neutral protease aqueous solution is eggshell membrane powder: neutral protease aqueous solution = 1:40; constant temperature extraction for 2 h at 47±2℃, and condensation reflux during the extraction process; after the extraction is completed, solid-liquid separation is performed to obtain an extract II; combining the extract I and the extract II, enzyme inactivation treatment, and reducing pressure concentration to obtain an extract paste;

[0020] (2) adding pueraria powder, threonine and tryptophan to the extract paste, and stirring uniformly after the addition is completed to obtain an auxiliary material; the mass ratio of the pueraria powder, threonine and tryptophan added to the extract paste is extract paste: pueraria powder: threonine: tryptophan = 1 g: 30 mg: 20 mg: 20 mg;

[0021] (3) weighing the herba euphorbiae humifusae, gold ear grass and camphor root, the herba euphorbiae humifusae, gold ear grass and camphor root are crushed into fine powder, the herba euphorbiae humifusae fine powder is fried with a small fire to a light brown color to obtain a herba euphorbiae humifusae component, and the gold ear grass and camphor root fine powder are mixed into a mixed powder; adding water to the mixed powder, the mass ratio of the mixed powder and water is mixed powder: water = 1:50; boiling for 1 h, and condensation reflux during the boiling process; then solid-liquid separation is performed to obtain a filtrate A and a residue, the residue is added with water again, the mass ratio of the residue and water is residue: water = 1:50; boiling for 1 h, and condensation reflux during the boiling process; solid-liquid separation is performed to obtain a filtrate B; combining the filtrate A and the filtrate B, reducing pressure concentration to an extract paste, adding the herba euphorbiae humifusae component and the auxiliary material, the mass ratio of the auxiliary material and the extract paste is extract paste: auxiliary material = 10:2; compressing into tablets, and sugar-coating to obtain the tablets.

[0022] Example 2

[0023] A preparation method of a gastrointestinal inflammation treating tablet, comprising the steps of:

[0024] (1) drying and crushing lotus leaf and red dates respectively to obtain lotus leaf powder and red date powder, mixing the lotus leaf powder and the red date powder to form a mixed raw material powder, the mass ratio of the lotus leaf powder to the red date powder being 10:6, configuring a cellulase aqueous solution, the concentration of the cellulase in the cellulase aqueous solution being 32 mg / g, and the solvent being water, water-bathing the cellulase aqueous solution to a constant temperature of 45±2℃, then adding the mixed raw material powder, the mass ratio of the mixed raw material powder to the cellulase aqueous solution being 1:40, extracting for 90 min at a constant temperature of 45±2℃, the solution being placed in an ultrasonic environment (the power of the ultrasonic wave being 300 W, and the frequency being 40 kHz) during the extraction, and the solution being condensed and refluxed, and then performing solid-liquid separation to obtain an extract I;

[0025] (2) adding pueraria powder, threonine and tryptophan to the extract, stirring uniformly after the addition is completed to obtain an auxiliary material, the mass ratio of the extract to the pueraria powder, the threonine and the tryptophan being 1 g:35 mg:20 mg:20 mg;

[0026] (3) weighing and crushing the herba euphorbiae humifusae, the herba bazzia japonica and the root of cinnamomum camphora into fine powders, frying the herba euphorbiae humifusae fine powder on a small fire until it is light brown to obtain a herba euphorbiae humifusae component, and mixing the herba bazzia japonica fine powder and the root of cinnamomum camphora fine powder into a mixed powder, adding water to the mixed powder, the mass ratio of the mixed powder to water being 1:50, boiling for 1 h, the solution being condensed and refluxed during the boiling, then performing solid-liquid separation to obtain a filtrate A and a residue, adding water to the residue again, the mass ratio of the residue to water being 1:50, boiling for 1 h, the solution being condensed and refluxed during the boiling, performing solid-liquid separation to obtain a filtrate B, combining the filtrate A and the filtrate B, reducing and concentrating the combined filtrate to a paste, adding the herba euphorbiae humifusae component and the auxiliary material, the mass ratio of the paste to the auxiliary material being 10:2, and then compressing and sugar-coating to obtain the tablet.

[0027] Example 3

[0028] A preparation method of a tablet for treating gastrointestinal inflammation, comprising the steps of:

[0029] (1) drying and crushing lotus leaf and red dates respectively to obtain lotus leaf powder and red date powder, mixing the lotus leaf powder and the red date powder to form a mixed raw material powder, the mass ratio of the lotus leaf powder to the red date powder being 10:6, preparing a cellulase aqueous solution, the concentration of the cellulase in the cellulase aqueous solution being 34 mg / g, and the solvent being water, water-bathing the cellulase aqueous solution to a constant temperature of 45±2℃, then adding the mixed raw material powder, the mass ratio of the mixed raw material powder to the cellulase aqueous solution being 1:40, extracting for 90 min at a constant temperature of 45±2℃, the solution being placed in an ultrasonic environment (the power of the ultrasonic wave being 300 W, and the frequency being 40 kHz) during the extraction, and being condensed and refluxed, solid-liquid separation after the extraction is completed to obtain an extract I, preparing a neutral protease aqueous solution, the amount of the neutral protease in the neutral protease aqueous solution being 40 kU / g, heating the neutral protease aqueous solution to a constant temperature of 47±2℃, then adding eggshell membrane powder, the mass ratio of the eggshell membrane powder to the neutral protease aqueous solution being 1:40, extracting for 2 h at a constant temperature of 47±2℃, the solution being condensed and refluxed during the extraction, solid-liquid separation after the extraction is completed to obtain an extract II, combining the extract I and the extract II, enzyme inactivation treatment, and reducing-pressure concentration to a paste to obtain an extract paste;

[0030] (2) adding pueraria powder, threonine and tryptophan to the extract paste, stirring uniformly after the addition is completed to obtain an auxiliary material, the mass ratio of the pueraria powder, the threonine and the tryptophan to the extract paste being 1 g:35 mg:25 mg:25 mg;

[0031] (3) Take Euphorbia humifusa, Goldie and camphor root, Euphorbia humifusa, Goldie and camphor root are calculated by weight fraction: Euphorbia humifusa 660 parts, Goldie 900 parts, camphor root 660 parts; Euphorbia humifusa, Goldie and camphor root are crushed into fine powder, Euphorbia humifusa fine powder is fried to light brown with gentle fire to obtain Euphorbia humifusa component, and the fine powder of Goldie and camphor root is mixed into mixed powder; the mixed powder is added into water, and the mass ratio of mixed powder to water is 1:50; boiling for 1h, condensation reflux during boiling; then solid-liquid separation to obtain filtrate A and residue, the residue is added into water again, and the mass ratio of residue to water is 1:50; boiling for 1h, condensation reflux during boiling; solid-liquid separation to obtain filtrate B; combine filtrate A and filtrate B, reduce pressure to concentrate to paste, add the Euphorbia humifusa component and the adjuvant, and the mixing mass ratio of paste to adjuvant is 10:3; compress into tablets, coat with sugar, and obtain the tablets.

[0032] Example 4

[0033] A preparation method of a tablet for treating gastrointestinal inflammation, the steps comprising:

[0034] (1) Dry and crush lotus leaf and red dates respectively to obtain lotus leaf powder and red date powder, and mix the lotus leaf powder and red date powder to form mixed raw material powder; the mixing mass ratio of lotus leaf powder to red date powder is 10:8; prepare an aqueous solution of cellulase, wherein the concentration of cellulase in the aqueous solution of cellulase is 30-35 mg / g, and the solvent is water; water-bath the aqueous solution of cellulase to 45±2°C for constant temperature preservation, and then add the mixed raw material powder, wherein the mass ratio of mixed raw material powder to aqueous solution of cellulase is 1:40; constant temperature extraction at 45±2°C for 90 min, and the solution is placed in an ultrasonic environment (ultrasonic power is 300 W; frequency is 40 kHz) and condensation reflux during extraction; after extraction, solid-liquid separation is performed to obtain extraction liquid I; prepare an aqueous solution of neutral protease, wherein the amount of neutral protease in the aqueous solution of neutral protease is 40 kU / g; heat the aqueous solution of neutral protease to 47±2°C for constant temperature preservation, and then add eggshell membrane powder, wherein the mass ratio of eggshell membrane powder to aqueous solution of neutral protease is 1:40; constant temperature extraction at 47±2°C for 2h, and condensation reflux during extraction; after extraction, solid-liquid separation is performed to obtain extraction liquid II; combine the extraction liquid I and extraction liquid II, perform enzyme inactivation treatment, reduce pressure to concentrate to paste, and obtain an extract;

[0035] (2) adding pueraria powder, threonine and tryptophan to the extract, and stirring until uniform to obtain an excipient; the mass ratio of the extract, pueraria powder, threonine and tryptophan is 1g:40mg:25mg:25mg;

[0036] (3) weighing the Euphorbia humifusa, gold eared grass and camphor root, the weight ratio of Euphorbia humifusa, gold eared grass and camphor root is: Euphorbia humifusa 660 parts, gold eared grass 900 parts, camphor root 660 parts; grinding Euphorbia humifusa, gold eared grass and camphor root into fine powder respectively, frying Euphorbia humifusa fine powder to light brown on low heat to obtain Euphorbia humifusa component, and mixing gold eared grass and camphor root fine powder into mixed powder; adding water to the mixed powder, the mass ratio of mixed powder to water is 1:50; boiling for 1h, condensing and refluxing during boiling; then solid-liquid separation to obtain filtrate A and residue, adding water to the residue again, the mass ratio of residue to water is 1:50; boiling for 1h, condensing and refluxing during boiling; solid-liquid separation to obtain filtrate B; combining filtrate A and filtrate B, concentrating under reduced pressure to paste, adding the Euphorbia humifusa component and the excipient, the mixing mass ratio of paste to excipient is 10:3; compressing into tablets, sugar-coating, to obtain the tablets.

[0037] Comparative Example 1

[0038] A preparation method of a tablet as a comparison, the steps comprising:

[0039] (1) drying and grinding lotus leaf to obtain lotus leaf powder; preparing a cellulase aqueous solution, the concentration of cellulase in the cellulase aqueous solution is 34mg / g, and the solvent is water; water-bathing the cellulase aqueous solution to constant temperature at 45±2℃, then adding the lotus leaf powder, the mass ratio of lotus leaf powder to cellulase aqueous solution is 1:40; constant temperature extraction at 45±2℃ for 90min, the solution is placed in an ultrasonic environment (the power of ultrasonic wave is 300W, and the frequency is 40kHz) during extraction, and condensing and refluxing; solid-liquid separation after extraction to obtain extract I; preparing a neutral protease aqueous solution, the amount of neutral protease in the neutral protease aqueous solution is 40kU / g, heating the neutral protease aqueous solution to 47±2℃, then adding eggshell membrane powder, the mass ratio of eggshell membrane powder to neutral protease aqueous solution is 1:40; constant temperature extraction at 47±2℃ for 2h, condensing and refluxing during extraction; solid-liquid separation after extraction to obtain extract II; combining the extract I and extract II, enzyme inactivation treatment, concentrating under reduced pressure to paste to obtain extract;

[0040] (2) adding Pueraria lobata powder, threonine and tryptophan to the extract, and stirring until uniform to obtain an excipient; the mass ratio of the extract, Pueraria lobata powder, threonine and tryptophan is 1g: 35mg: 25mg: 25mg;

[0041] (3) weighing Euphorbia humifusa, gold eared grass and camphor root, the weight ratio of Euphorbia humifusa, gold eared grass and camphor root is: Euphorbia humifusa 660 parts, gold eared grass 900 parts, camphor root 660 parts; grinding Euphorbia humifusa, gold eared grass and camphor root into fine powder respectively, frying Euphorbia humifusa fine powder with small fire until light brown to obtain Euphorbia humifusa component, and mixing gold eared grass and camphor root fine powder into mixed powder; adding water to the mixed powder, the mass ratio of mixed powder to water is 1:50; boiling for 1h, condensing and refluxing during boiling; then solid-liquid separation to obtain filtrate A and residue, adding water to the residue again, the mass ratio of residue to water is 1:50; boiling for 1h, condensing and refluxing during boiling; solid-liquid separation to obtain filtrate B; combining filtrate A and filtrate B, reducing pressure to concentrate to paste, adding the Euphorbia humifusa component and the excipient, the mixing mass ratio of paste to excipient is 10:3; compressing into tablets, sugar coating, to obtain the tablets of the present comparative example.

[0042] Comparative Example 2

[0043] A preparation method of a tablet as a comparative example, the steps comprising:

[0044] (1) drying and grinding red dates to obtain red date powder; preparing a cellulase aqueous solution, the concentration of cellulase in the cellulase aqueous solution is 34mg / g, and the solvent is water; water-bathing the cellulase aqueous solution to constant temperature at 45±2℃, and then adding the red date powder, the mass ratio of red date powder to cellulase aqueous solution is 1:40; constant temperature extraction at 45±2℃ for 90min, and the solution is placed in an ultrasonic environment (the power of ultrasonic wave is 300W, and the frequency is 40kHz) and condenses and refluxes during extraction; solid-liquid separation after extraction to obtain extract I; preparing a neutral protease aqueous solution, the amount of neutral protease in the neutral protease aqueous solution is 40kU / g, heating the neutral protease aqueous solution to constant temperature at 47±2℃, and then adding eggshell membrane powder, the mass ratio of eggshell membrane powder to neutral protease aqueous solution is 1:40; constant temperature extraction at 47±2℃ for 2h, and condenses and refluxes during extraction; solid-liquid separation after extraction to obtain extract II; combining the extract I and extract II, enzyme inactivation treatment, reducing pressure to concentrate to paste to obtain an extract;

[0045] (2) adding Puerariae radix powder, threonine and tryptophan into the extract, and stirring to obtain an auxiliary material; the mass ratio of the extract, Puerariae radix powder, threonine and tryptophan is 1g: 35mg: 25mg: 25mg;

[0046] (3) weighing Euphorbia humifusa, Goldie and camphor root, the weight ratio of Euphorbia humifusa, Goldie and camphor root is: Euphorbia humifusa 660 parts, Goldie 900 parts, camphor root 660 parts; grinding Euphorbia humifusa, Goldie and camphor root into fine powder respectively, frying Euphorbia humifusa fine powder to light brown on low heat to obtain Euphorbia humifusa component, and mixing Goldie and camphor root fine powder into mixed powder; adding water into the mixed powder, the mass ratio of mixed powder to water is 1:50; boiling for 1h, condensing reflux during boiling; then solid-liquid separation to obtain filtrate A and residue, adding water into the residue again, the mass ratio of residue to water is 1:50; boiling for 1h, condensing reflux during boiling; solid-liquid separation to obtain filtrate B; combining filtrate A and filtrate B, concentrating to paste under reduced pressure, adding the Euphorbia humifusa component and the auxiliary material, the mixing mass ratio of paste to auxiliary material is 10:3; compressing into tablets, sugar-coating, to obtain the tablets of the present comparative example.

[0047] Comparative Example 3

[0048] A preparation method of a tablet as a comparative example, the steps comprising:

[0049] (1) drying and grinding Folium Nelumbinis and Fructus Jujubae respectively to obtain Folium Nelumbinis powder and Fructus Jujubae powder, and mixing the two powders to form a mixed raw material powder; the mass ratio of Folium Nelumbinis powder to Fructus Jujubae powder is 10:6; preparing a cellulase aqueous solution, in which the concentration of cellulase is 34mg / g and the solvent is water; water-bathing the cellulase aqueous solution to 45±2℃, and then adding the mixed raw material powder, the mass ratio of mixed raw material powder to cellulase aqueous solution is 1:40; constant-temperature extraction at 45±2℃ for 90min, and the solution is placed in an ultrasonic environment (ultrasonic power is 300W and frequency is 40kHz) and condensed reflux during extraction; after extraction, solid-liquid separation is performed to obtain extract I; enzyme inactivation treatment is performed on extract I, and extract I is concentrated to a paste under reduced pressure to obtain an extract;

[0050] (2) adding Puerariae radix powder, threonine and tryptophan into the extract, and stirring to obtain an auxiliary material; the mass ratio of the extract, Puerariae radix powder, threonine and tryptophan is 1g: 35mg: 25mg: 25mg;

[0051] (3) weighing Euphorbia humifusa, Goldie and Cinnamomum camphora root, Euphorbia humifusa, Goldie and Cinnamomum camphora root are in weight parts: Euphorbia humifusa 660 parts, Goldie 900 parts, Cinnamomum camphora root 660 parts; Euphorbia humifusa, Goldie and Cinnamomum camphora root are crushed into fine powder respectively, Euphorbia humifusa fine powder is fried to light brown with gentle fire to obtain Euphorbia humifusa component, and the fine powder of Goldie and Cinnamomum camphora root is mixed into a mixed powder; the mixed powder is added into water, and the mass ratio of the mixed powder to water is 1:50; boiling for 1h, condensation reflux during boiling; then solid-liquid separation is performed to obtain filtrate A and residue, the residue is added into water again, and the mass ratio of the residue to water is 1:50; boiling for 1h, condensation reflux during boiling; solid-liquid separation is performed to obtain filtrate B; the filtrate A and the filtrate B are combined, concentrated under reduced pressure to a paste, the Euphorbia humifusa component and the excipient are added, and the mixing mass ratio of the paste to the excipient is 10:3; compressed into tablets, sugar-coated, and the tablet of the present comparative example is obtained.

[0052] Comparative Example 4

[0053] A preparation method of a tablet as a comparison, the steps comprising:

[0054] (1) configuring a neutral protease aqueous solution, in the neutral protease aqueous solution, the amount of neutral protease is 40 kU / g, heating the neutral protease aqueous solution to 47±2℃ for preservation, then adding eggshell membrane powder, and the mass ratio of eggshell membrane powder to neutral protease aqueous solution is 1:40; 47±2℃ constant temperature extraction for 2h, condensation reflux during extraction; after extraction is completed, solid-liquid separation is performed to obtain the extraction liquid II of the present comparative example; the extraction liquid II is subjected to enzyme inactivation treatment, concentrated under reduced pressure to a paste, and the extract is obtained;

[0055] (2) adding Pueraria powder, threonine and tryptophan to the extract, and stirring uniformly after adding, an excipient is obtained; the mass ratio of Pueraria powder, threonine and tryptophan added to the extract is 1g: 35mg: 25mg: 25mg;

[0056] (3) Take the Euphorbia humifusa, gold hair and camphor tree roots, Euphorbia humifusa, gold hair and camphor tree roots are calculated by weight fraction: Euphorbia humifusa 660 parts, gold hair 900 parts, camphor tree roots 660 parts; the Euphorbia humifusa, gold hair and camphor tree roots are crushed into fine powder, the Euphorbia humifusa fine powder is fried to light brown with a small fire to obtain the Euphorbia humifusa component, and the fine powder of gold hair and camphor tree roots is mixed into a mixed powder; the mixed powder is added to water, and the mass ratio of the mixed powder to water is 1:50; boil for 1h, and condense backflow during boiling; then solid-liquid separation is performed to obtain filtrate A and residue, the residue is added to water again, and the mass ratio of the residue to water is 1:50; boil for 1h, and condense backflow during boiling; solid-liquid separation is performed to obtain filtrate B; combine the filtrate A and the filtrate B, reduce pressure and concentrate to a paste, add the Euphorbia humifusa component and the adjuvant, and the mixing mass ratio of the paste to the adjuvant is 10:3; compress into tablets, coat with sugar, and obtain the tablets of the present comparative example.

[0057] Comparative Example 5

[0058] A preparation method of a tablet as a comparison, the steps comprising:

[0059] (1) The lotus leaf and red dates are dried and crushed respectively to obtain lotus leaf powder and red date powder, and the lotus leaf powder and red date powder are mixed to form a mixed raw material powder; the mixing mass ratio of the lotus leaf powder to the red date powder is 10:6; a cellulase aqueous solution is prepared, the concentration of the cellulase in the cellulase aqueous solution is 34 mg / g, and the solvent is water; the cellulase aqueous solution is water-bathed and kept at 45±2℃, and then the mixed raw material powder is added, the mass ratio of the mixed raw material powder to the cellulase aqueous solution is 1:40; the solution is kept at 45±2℃ for 90 min in an ultrasonic environment (the power of the ultrasonic wave is 300 W, and the frequency is 40 kHz), and condenses backflow during the extraction; after the extraction is completed, solid-liquid separation is performed to obtain an extraction liquid I; a neutral protease aqueous solution is prepared, the amount of the neutral protease in the neutral protease aqueous solution is 40 kU / g, the neutral protease aqueous solution is heated to 47±2℃, and then the eggshell membrane powder is added, the mass ratio of the eggshell membrane powder to the neutral protease aqueous solution is 1:40; the solution is kept at 47±2℃ for 2h, and condenses backflow during the extraction; after the extraction is completed, solid-liquid separation is performed to obtain an extraction liquid II; the extraction liquid I and the extraction liquid II are combined, enzyme inactivation treatment is performed, and the solution is reduced pressure and concentrated to a paste to obtain an extract;

[0060] (2) adding threonine and tryptophan to the extract, and stirring to obtain a mixture; the mass ratio of the extract, threonine and tryptophan is 1 g: 25 mg: 25 mg;

[0061] (3) weighing the Euphorbia humifusa, Goldie and camphor root, and grinding the Euphorbia humifusa, Goldie and camphor root into fine powder; the Euphorbia humifusa fine powder is fried with a small fire until light brown to obtain an Euphorbia humifusa component; the Goldie and camphor root fine powder are mixed into a mixed powder; the mixed powder is added into water, and the mass ratio of the mixed powder and water is 1:50; boiling for 1 h, and condensing reflux during boiling; then solid-liquid separation is performed to obtain a filtrate A and a residue; the residue is added into water again, and the mass ratio of the residue and water is 1:50; boiling for 1 h, and condensing reflux during boiling; solid-liquid separation is performed to obtain a filtrate B; the filtrate A and the filtrate B are combined, concentrated under reduced pressure to obtain a paste, and the Euphorbia humifusa component and the auxiliary material are added; the mass ratio of the paste and the auxiliary material is 10:3; and then compressed into a tablet, and coated with a sugar coating to obtain the tablet of the present comparative example.

[0062] Example 5

[0063] The antibacterial properties of the auxiliary materials prepared by the methods of the above examples and comparative examples are tested respectively; 1, Escherichia coli and Staphylococcus aureus are activated respectively, and then cultured at 37°C until OD600nm is 0.6; then the two activated test bacteria are added into LB medium, and the adding ratio is test bacteria solution / medium = 1 μL / mL; the mixed solution is poured into a glass dish and spread flat; 2, each auxiliary material to be tested is added into sterile water to prepare a test solution according to the ratio of auxiliary material / sterile water = 1 g / 1 mL; a 8 mm diameter sterile filter paper is placed in the middle of the glass dish, and 10 μL of the test solution is dropped on the sterile filter paper; the glass dish is cultured at 37°C for 12 h, and the diameter of the antibacterial circle is measured. Each group of auxiliary materials is tested for 3 times for each test bacteria, and the average value is taken, and the results are shown in Table 1. In addition, the friability of the tablets prepared by the methods of the above examples and comparative examples is tested, and the results are shown in Table 1.

[0064] Test group Diameter of E. coli inhibition zone / mm Diameter of S. aureus inhibition zone / mm Fragility / % Example 1 13.41±0.15 16.77±0.31 0.28 Example 2 13.53±0.21 16.93±0.38 0.26 Example 3 13.56±0.16 17.01±0.33 0.25 Example 4 13.51±0.18 16.96±0.35 0.25 Comparative Example 1 9.29±0.12 11.82±0.24 0.26 Comparative Example 2 9.90±0.19 12.68±0.29 0.26 Comparative Example 3 12.87±0.23 16.12±0.33 0.46 Comparative Example 4 7.08±0.14 9.25±0.20 0.27 Comparative Example 5 13.05±0.18 16.34±0.26 0.29

[0065] As can be seen from Table 1, the excipient prepared by the method has good antibacterial property, and has good inhibitory effect on Escherichia coli and Staphylococcus aureus, and can effectively improve the bactericidal and bacteriostatic effect of the tablet after being added into the tablet; at the same time, the prepared tablet has low friability, so that the phenomenon of powder dropping and fragmentation is not easy to occur during packaging, transportation and processing, and the qualified rate of the finished product is high. As can be seen from Comparative Example 3 and each comparative example, the addition of lotus leaf and red date extract in the excipient can significantly improve the antibacterial property of the excipient, and the effect of adding the composite extract of lotus leaf and red date is significantly better than that of adding the lotus leaf extract or the red date extract alone in Comparative Example 1 and Comparative Example 2, which shows a synergistic effect. This may be due to the fact that the isoquinoline alkaloids and terpenoids in the composite extract inhibit bacteria according to different antibacterial mechanisms, and after compounding, the composite extract shows a synergistic effect. Subsequently, the eggshell membrane powder enzymatic hydrolysate is added as a natural adhesive to improve the quality of the tablet, so that the friability of the tablet is significantly reduced. In addition, the addition of pueraria powder is beneficial to the regulation of intestinal environment, the addition of threonine plays a role in improving intestinal function, and the addition of tryptophan can protect the intestinal epithelial layer and play an auxiliary role in the treatment of gastrointestinal inflammation.

[0066] The above describes the technical solutions provided by the present application in detail. For those skilled in the art, according to the idea of the embodiments of the present application, there will be changes in specific implementation manners and application ranges. In view of the above, the content of the present application should not be understood as a limitation of the present application.

Claims

1. A process for the preparation of a tablet for the treatment of gastrointestinal inflammation, characterized by the steps of The method comprises the following steps: (1) drying and crushing lotus leaves and red dates to obtain lotus leaf powder and red date powder, mixing the lotus leaf powder and the red date powder to form a mixed raw material powder, the mass ratio of the lotus leaf powder to the red date powder being 10:4-8, preparing a cellulase aqueous solution, the concentration of the cellulase in the cellulase aqueous solution being 30-35 mg / g, the solvent being water, water-bathing the cellulase aqueous solution to a constant temperature of 45±2 ℃, then adding the mixed raw material powder, the mass ratio of the mixed raw material powder to the cellulase aqueous solution being 1:40-50, extracting for 90 min or more under the constant temperature of 45±2 ℃, the solution being placed in an ultrasonic environment during the extraction, and the solution being condensed and refluxed, solid-liquid separation after the extraction to obtain an extract I, preparing a neutral protease aqueous solution, the amount of the neutral protease in the neutral protease aqueous solution being 40-50 kU / g, heating the neutral protease aqueous solution to a constant temperature of 47±2 ℃, then adding eggshell membrane powder, the mass ratio of the eggshell membrane powder to the neutral protease aqueous solution being 1:40-50, extracting for 2 h or more under the constant temperature of 47±2 ℃, the solution being condensed and refluxed during the extraction, solid-liquid separation after the extraction to obtain an extract II, combining the extract I and the extract II, enzyme inactivation treatment, and vacuum concentration to obtain a paste extract; (2) adding pueraria powder, threonine and tryptophan to the paste extract, and stirring to obtain a supplementary material; (3) crushing phyla acinaciformis, gold eared grass and camphor tree roots into fine powder, frying the phyla acinaciformis fine powder to a light brown color to obtain a phyla acinaciformis component, mixing the gold eared grass and camphor tree root fine powder to form a mixed powder, boiling the mixed powder in water for 1 h or more, the solution being condensed and refluxed during the boiling, solid-liquid separation to obtain a filtrate A and a residue, adding water to the residue again, boiling for 1 h or more, the solution being condensed and refluxed during the boiling, solid-liquid separation to obtain a filtrate B, combining the filtrate A and the filtrate B, vacuum concentration to obtain a paste, adding the phyla acinaciformis component and the supplementary material, the mass ratio of the paste to the supplementary material being 10:2-3, and compressing to form a tablet, the tablet being coated with sugar or film coating to obtain the tablet.

2. A process for the preparation of a tablet for the treatment of gastrointestinal inflammation according to claim 1, characterized in that, The power of the ultrasonic wave is 200-300 W, and the frequency is 40 kHz.

3. A process for the preparation of a tablet for the treatment of gastrointestinal inflammation according to claim 1, characterized in that, In the step (2), the mass ratio of the paste extract, the pueraria powder, the threonine and the tryptophan is 1 g:30-40 mg:20-25 mg:20-25 mg.

4. The method for preparing a tablet for treating gastroenteritis according to claim 1, wherein: In the step (3), the phyla acinaciformis, the gold eared grass and the camphor tree root are used in a weight ratio of 660 parts of phyla acinaciformis, 900 parts of gold eared grass and 660 parts of camphor tree root.

5. The method for preparing a tablet for treating gastroenteritis according to claim 1, wherein: In the step (3), the mass ratio of the mixed powder to water is 1:50-60, and the mass ratio of the residue to water is 1:50-60.