Oral suspension of sucralfate and preparation method thereof

Abstract

According to the sucralfate oral suspension and the preparation method thereof, compared with a commercially available reference preparation # imgabs0 #, the sucralfate oral suspension has the advantages that the aluminum element release rate and the total release amount are obviously low while the dissolution and stability are equivalent, so that the release of the aluminum element is low, the side effects of medication can be reduced, the medication safety is improved, and the clinical application prospect is broad. The whole preparation method is simple, has low requirements on production equipment, reduces the production energy consumption, simplifies the production steps, can ensure the product quality, and is suitable for large-scale industrial production.

Description

Technical Field

[0001] The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to an oral suspension of sucralfate and a preparation method thereof. Background Art

[0002] Sucralfate is tasteless. Sucralfate is the basic aluminum salt of sucrose sulfate. It is a gastric mucosal protective agent that protects the ulcer surface and promotes ulcer healing. In an acidic environment, sucralfate can dissociate into sucrose octasulfate and polymerize insoluble colloids to protect the gastric mucosa; it can bind to positively charged exudate proteins in ulcers or inflammation, forming a thin film on the ulcer surface or inflammation, protecting the ulcer or inflamed mucosa from the invasion of gastric acid and promoting ulcer healing. However, aluminum will be released during use, and long-term use will lead to aluminum encephalopathy, aluminum bone disease, etc. Therefore, on the premise of ensuring that the release rate of sucrose octasulfate is equivalent to that of the reference preparation, that is, the efficacy is equivalent, the lower the amount of aluminum released, the lower the side effects of the medication can be. Summary of the invention

[0003] The purpose of the present invention is to provide an oral suspension of sucralfate based on the prior art, which is comparable to the commercially available reference preparation. Compared with the above, it has the advantages of significantly lower aluminum release rate and total release while having comparable dissolution and stability, which results in lower aluminum release. While having comparable dissolution and stability, it can reduce the side effects of medication and improve the safety of medication.

[0004] Another object of the present invention is to provide a method for preparing the above-mentioned sucralfate oral suspension.

[0005] The technical solution of the present invention is as follows:

[0006] The invention discloses an oral suspension of sucralfate. Every 1000 parts of the oral suspension are prepared from the following components in parts by weight: 100 parts of sucralfate, 10-40 parts of a suspending agent, 0.05-0.2 parts of an antibacterial agent, 5-20 parts of ethanol, 20-60 parts of glycerol and 0.1-0.5 parts of a flavoring agent; wherein the suspending agent is hydroxypropyl distarch phosphate, hydroxypropyl starch or pregelatinized hydroxypropyl starch.

[0007] In the present invention, the flavoring agent is saccharin sodium and / or essence; the antibacterial agent is potassium sorbate.

[0008] In the present invention, the raw material sucralfate is crushed to control its particle size D90 to be no higher than 30 μm. In a preferred embodiment, the particle size D90 is controlled to be 5 μm-20 μm.

[0009] For the present invention, controlling the particle size D90 of the raw material sucralfate to be no higher than 30 μm and the temperature of the raw material and the suspending agent under high shear dispersion can make the dispersibility of the raw material sucralfate better, so that it can be better adsorbed with the suspending agent, which can reduce the release rate and total release amount of aluminum element, and further reduce the release of aluminum element.

[0010] In a preferred embodiment, the oral suspension of sucralfate provided by the present invention is prepared from the following components in parts by weight per 1000 parts of the oral suspension: 100 parts of sucralfate, 25-35 parts of suspending agent, 0.08-0.12 parts of potassium sorbate, 8-12 parts of ethanol, 35-45 parts of glycerol, 0.1-0.2 parts of saccharin sodium, and 0.05-0.15 parts of flavor.

[0011] In a more preferred embodiment, the oral suspension of sucralfate provided by the present invention is prepared from the following components in parts by weight per 1000 parts of the oral suspension: 100 parts of sucralfate, 30 parts of suspending agent, 0.1 part of potassium sorbate, 10 parts of ethanol, 40 parts of glycerol, 0.12 parts of saccharin sodium, and 0.1 part of flavor.

[0012] In a particularly preferred embodiment, the oral suspension of sucralfate provided by the present invention is prepared from the following components in parts by weight per 1000 parts of the oral suspension:

[0013] For example, 100 parts of sucralfate, 30 parts of hydroxypropyl distarch phosphate, 0.1 parts of potassium sorbate, 10 parts of ethanol, 40 parts of glycerol, 0.12 parts of saccharin sodium, and 0.1 parts of flavor;

[0014] For example, 100 parts of sucralfate, 30 parts of hydroxypropyl starch, 0.1 parts of potassium sorbate, 10 parts of ethanol, 40 parts of glycerol, 0.12 parts of saccharin sodium, and 0.1 parts of flavor;

[0015] For example, 100 parts of sucralfate, 30 parts of pregelatinized hydroxypropyl starch, 0.1 parts of potassium sorbate, 10 parts of ethanol, 40 parts of glycerol, 0.12 parts of saccharin sodium, and 0.1 parts of flavor.

[0016] The present invention also provides a method for preparing the above-mentioned sucralfate oral suspension, which comprises the following steps:

[0017] (1) crushing the raw material sucralfate to control its particle size D90 to be no greater than 30 μm;

[0018] (2) mixing the sucralfate crushed in step (1) with purified water, stirring to make it evenly dispersed, and then performing high shear dispersion at 50-90° C. to obtain a drug-containing solution;

[0019] (3) mixing the suspending agent with purified water, stirring to make them uniformly dispersed, and then stirring at 50-90° C. to make them completely gelatinized to obtain a suspending agent colloidal solution;

[0020] (4) mixing the antibacterial agent potassium sorbate with ethanol, stirring to completely dissolve it, and then adding glycerol and stirring evenly to obtain an oily component solution;

[0021] (5) mixing the drug-containing solution obtained in step (2) with the suspending agent colloidal solution obtained in step (3), stirring at 50-90° C. to make them uniformly dispersed, cooling the resulting mixed solution to 20-30° C., mixing it with the oily component solution obtained in step (4), and stirring again to make them uniformly dispersed;

[0022] (6) Dissolve the flavoring agent in purified water, and then transfer it to the mixed solution obtained in step (5), add the remaining purified water to make up the volume, stir and mix evenly, and fill to obtain an oral suspension.

[0023] In the present invention, the suspending agent is hydroxypropyl distarch phosphate, hydroxypropyl starch or pregelatinized hydroxypropyl starch. The flavoring agent is saccharin sodium and / or essence; and the antibacterial agent is potassium sorbate.

[0024] In the present invention, in step (1), the raw material sucralfate is crushed to control its particle size D90 to be no higher than 30 μm. In a preferred embodiment, the particle size D90 is controlled to be 5 μm-20 μm.

[0025] In the present invention, in step (2), during high shear dispersion, the shear rate is 2000-4000 rpm, and the shear dispersion time is 15-45 min, preferably 30 min.

[0026] In step (2), during high shear dispersion, the temperature is 50-90°C, which can be but not limited to 50°C, 60°C, 70°C, 80°C or 50°C. In order to improve the dispersibility of the raw material sucralfate, so that it can be better adsorbed with the suspending agent, the release rate and total release amount of aluminum can be reduced, and the release of aluminum can be further reduced. In a preferred embodiment, the temperature is 60-80°C; in a more preferred embodiment, the temperature is 70°C.

[0027] For the present invention, in step (3), during stirring, the temperature is 50-90°C, which may be but is not limited to 50°C, 60°C, 70°C, 80°C or 50°C. In order to improve the dispersibility of the raw material sucralfate so that it can be better adsorbed with the suspending agent, the release rate and total release amount of aluminum element can be reduced, and the release of aluminum element can be further reduced. In a preferred embodiment, the temperature is 60-80°C; in a more preferred embodiment, the temperature is 70°C.

[0028] For the present invention, in step (5), when the dispersion is uniform, the temperature is 50-90°C, and can be but not limited to 50°C, 60°C, 70°C, 80°C or 50°C.

[0029] Adopt the technical scheme of the present invention, the advantages are as follows:

[0030] The oral suspension of sucralfate provided by the present invention is comparable to the commercially available reference preparation Compared with the above-mentioned preparation methods, the dissolution and stability are comparable, while the release rate and total release amount of aluminum are significantly lower, so that the release of aluminum is lower, which can reduce the side effects of medication and improve the safety of medication. The whole preparation method is simple, has low requirements on production equipment, reduces production energy consumption, simplifies the production steps, can ensure product quality and is suitable for large-scale industrial production. DETAILED DESCRIPTION

[0031] The present invention can be better understood according to the following examples. However, it is easy for those skilled in the art to understand that the contents described in the examples are only used to illustrate the present invention, and should not and will not limit the present invention described in detail in the claims.

[0032] Example 1

[0033] An oral suspension of sucralfate, wherein each 1000 parts of the oral suspension is prepared from the following components in parts by weight:

[0034]

[0035]

[0036] The preparation method is as follows:

[0037] (1) crushing the raw material sucralfate to control the particle size D90 to 5 μm-20 μm;

[0038] (2) mixing the sucralfate crushed in step (1) with purified water, stirring to make it evenly dispersed, and then performing high shear dispersion at 70° C., a shear speed of 2000-4000 rpm, and shear dispersion for 30 minutes to obtain a drug-containing solution;

[0039] (3) mixing the suspending agent hydroxypropyl distarch phosphate with purified water, stirring to make them evenly dispersed, and then stirring at 70° C. to make them completely gelatinized to obtain a suspending agent colloidal solution;

[0040] (4) mixing the antibacterial agent potassium sorbate with ethanol, stirring to completely dissolve it, and then adding glycerol and stirring evenly to obtain an oily component solution;

[0041] (5) mixing the drug-containing solution obtained in step (2) with the suspending agent colloidal solution obtained in step (3), stirring at 70° C. to make them uniformly dispersed, cooling the resulting mixed solution to 20-30° C., mixing it with the oily component solution obtained in step (4), and stirring again to make them uniformly dispersed;

[0042] 6) Dissolve the flavoring agent saccharin sodium and the flavoring agent essence in purified water, transfer the mixture to the mixed solution obtained in step (5), add the remaining purified water to make up the volume, stir and mix evenly, and fill to obtain an oral suspension.

[0043] Example 2

[0044] An oral suspension of sucralfate, wherein each 1000 parts of the oral suspension is prepared from the following components in parts by weight:

[0045] Sucralfate 100 copies Hydroxypropyl starch 30 servings Saccharin Sodium 0.12 parts Potassium Sorbate 0.1 part Ethanol 10 servings glycerin 40 servings essence 0.1 part Purified water Add to 1000 copies

[0046] The preparation method is as follows:

[0047] (1) crushing the raw material sucralfate to control the particle size D90 to 5 μm-20 μm;

[0048] (2) mixing the sucralfate crushed in step (1) with purified water, stirring to make it evenly dispersed, and then performing high shear dispersion at 70° C., a shear speed of 2000-4000 rpm, and shear dispersion for 30 minutes to obtain a drug-containing solution;

[0049] (3) mixing the suspending agent hydroxypropyl distarch phosphate with purified water, stirring to make them evenly dispersed, and then stirring at 70° C. to make them completely gelatinized to obtain a suspending agent colloidal solution;

[0050] (4) mixing the antibacterial agent potassium sorbate with ethanol, stirring to completely dissolve it, and then adding glycerol and stirring evenly to obtain an oily component solution;

[0051] (5) mixing the drug-containing solution obtained in step (2) with the suspending agent colloidal solution obtained in step (3), stirring at 70° C. to make them uniformly dispersed, cooling the resulting mixed solution to 20-30° C., mixing it with the oily component solution obtained in step (4), and stirring again to make them uniformly dispersed;

[0052] 6) Dissolve the flavoring agent saccharin sodium and the flavoring agent essence in purified water, transfer the mixture to the mixed solution obtained in step (5), add the remaining purified water to make up the volume, stir and mix evenly, and fill to obtain an oral suspension.

[0053] Example 3

[0054] An oral suspension of sucralfate, wherein each 1000 parts of the oral suspension is prepared from the following components in parts by weight:

[0055] Sucralfate 100 copies Pregelatinized Hydroxypropyl Starch 30 servings Saccharin Sodium 0.12 parts Potassium Sorbate 0.1 part Ethanol 10 servings glycerin 40 servings essence 0.1 part Purified water Add to 1000 copies

[0056] The preparation method is as follows:

[0057] (1) crushing the raw material sucralfate to control the particle size D90 to 5 μm-20 μm;

[0058] (2) mixing the sucralfate crushed in step (1) with purified water, stirring to make it evenly dispersed, and then performing high shear dispersion at 70° C., a shear speed of 2000-4000 rpm, and shear dispersion for 30 minutes to obtain a drug-containing solution;

[0059] (3) mixing the suspending agent hydroxypropyl distarch phosphate with purified water, stirring to make them evenly dispersed, and then stirring at 70° C. to make them completely gelatinized to obtain a suspending agent colloidal solution;

[0060] (4) mixing the antibacterial agent potassium sorbate with ethanol, stirring to completely dissolve it, and then adding glycerol and stirring evenly to obtain an oily component solution;

[0061] (5) mixing the drug-containing solution obtained in step (2) with the suspending agent colloidal solution obtained in step (3), stirring at 70° C. to make them uniformly dispersed, cooling the resulting mixed solution to 20-30° C., mixing it with the oily component solution obtained in step (4), and stirring again to make them uniformly dispersed;

[0062] 6) Dissolve the flavoring agent saccharin sodium and the flavoring agent essence in purified water, transfer the mixture to the mixed solution obtained in step (5), add the remaining purified water to make up the volume, stir and mix evenly, and fill to obtain an oral suspension.

[0063] Comparative Example 1

[0064] An oral suspension of sucralfate, wherein each 1000 parts of the oral suspension is prepared from the following components in parts by weight:

[0065] Sucralfate 100 copies Sodium Carboxymethyl Cellulose 30 servings Saccharin Sodium 0.12 parts Potassium Sorbate 0.1 part Ethanol 10 servings glycerin 40 servings essence 0.1 part Purified water Add to 1000 copies

[0066] The preparation method is as follows:

[0067] (1) crushing the raw material sucralfate to control the particle size D90 to 5 μm-20 μm;

[0068] (2) mixing the sucralfate crushed in step (1) with purified water, stirring to make it evenly dispersed, and then performing high shear dispersion at 70° C., a shear speed of 2000-4000 rpm, and shear dispersion for 30 minutes to obtain a drug-containing solution;

[0069] (3) mixing the suspending agent hydroxypropyl distarch phosphate with purified water, stirring to make them evenly dispersed, and then stirring at 70° C. to make them completely gelatinized to obtain a suspending agent colloidal solution;

[0070] (4) mixing the antibacterial agent potassium sorbate with ethanol, stirring to completely dissolve it, and then adding glycerol and stirring evenly to obtain an oily component solution;

[0071] (5) mixing the drug-containing solution obtained in step (2) with the suspending agent colloidal solution obtained in step (3), stirring at 70° C. to make them uniformly dispersed, cooling the resulting mixed solution to 20-30° C., mixing it with the oily component solution obtained in step (4), and stirring again to make them uniformly dispersed;

[0072] 6) Dissolve the flavoring agent saccharin sodium and the flavoring agent essence in purified water, transfer the mixture to the mixed solution obtained in step (5), add the remaining purified water to make up the volume, stir and mix evenly, and fill to obtain an oral suspension.

[0073] Comparative Example 2

[0074] An oral suspension of sucralfate, wherein each 1000 parts of the oral suspension is prepared from the following components in parts by weight:

[0075]

[0076]

[0077] The preparation method is as follows:

[0078] (1) crushing the raw material sucralfate to control the particle size D90 to 35 μm-40 μm;

[0079] (2) mixing the sucralfate crushed in step (1) with purified water, stirring to make it evenly dispersed, and then performing high shear dispersion at 70° C., a shear speed of 2000-4000 rpm, and shear dispersion for 30 minutes to obtain a drug-containing solution;

[0080] (3) mixing the suspending agent hydroxypropyl distarch phosphate with purified water, stirring to make them evenly dispersed, and then stirring at 70° C. to make them completely gelatinized to obtain a suspending agent colloidal solution;

[0081] (4) mixing the antibacterial agent potassium sorbate with ethanol, stirring to completely dissolve it, and then adding glycerol and stirring evenly to obtain an oily component solution;

[0082] (5) mixing the drug-containing solution obtained in step (2) with the suspending agent colloidal solution obtained in step (3), stirring at 70° C. to make them uniformly dispersed, cooling the resulting mixed solution to 20-30° C., mixing it with the oily component solution obtained in step (4), and stirring again to make them uniformly dispersed;

[0083] 6) Dissolve the flavoring agent saccharin sodium and the flavoring agent essence in purified water, transfer the mixture to the mixed solution obtained in step (5), add the remaining purified water to make up the volume, stir and mix evenly, and fill to obtain an oral suspension.

[0084] Effect verification:

[0085] 1. Viscosity test

[0086] The commercial reference preparation was tested by rotational viscometer. The products in the embodiments and comparative examples were compared and investigated, and the measurement results are shown in Table 1.

[0087] Table 1 Summary of viscosity results

[0088]

[0089] As shown in Table 1, the viscosity of the samples in Examples 1-3 is similar to that of the commercially available reference preparations. The viscosity of the samples in Comparative Examples 1 and 2 is similar, while the viscosity of the samples in Comparative Examples 1 and 2 is lower. It can be seen that the oral suspension prepared by the suspending agent selected by the present invention is comparable to the commercially available reference preparation in terms of viscosity. The larger particle size of the API sucralfate also leads to a decrease in viscosity.

[0090] 2. Investigation of sedimentation volume ratio

[0091] Refer to the provisions of the Chinese Pharmacopoeia 2020 edition, Part IV, General Chapter 0123, Oral Suspension, for the commercially available reference preparations. The products in the embodiments and comparative examples were investigated, and the measurement results are shown in Table 2.

[0092] Table 2 Summary of sedimentation volume ratio results

[0093]

[0094] As shown in Table 2, the oral suspensions prepared by different suspending agents have great differences in sedimentation volume ratio. Among them, Example 1 (suspending agent is hydroxypropyl distarch phosphate) and Example 2 (suspending agent is hydroxypropyl starch) have better suspending effect, which is comparable to the commercially available reference preparation. Comparatively, Example 3 (suspending agent is pregelatinized hydroxypropyl starch) can also prepare a product with a qualified sedimentation volume ratio. However, in Comparative Example 1, the sample prepared with sodium carboxymethylcellulose as a suspending agent does not meet the requirements of the pharmacopoeia. At the same time, the results of Comparative Example 2 show that even if hydroxypropyl distarch phosphate is used as a suspending agent, the excessive particle size of the raw material sucralfate will also cause the prepared sample to fail to meet the requirements of the pharmacopoeia.

[0095] 3. Dissolution study

[0096] Dissolution medium: 0.1M hydrochloric acid + 0.067M KCl, pH4.5 acetate buffer, pH6.8 phosphate buffer, 900ml; Dissolution method: Paddle method, 50rpm; Medium temperature: 37.0±0.5℃; Sampling: 10ml was sampled at 5min, 10min, 15min, 30min, 45min, and 60min, respectively, filtered through a polyethersulfone membrane, and the same medium was added at the same temperature; Samples: Samples were randomly selected from the embodiments and comparative examples, 6 samples for each medium. The dissolution amount of sucrose octasulfate was used as the investigation index, and the measurement results are shown in Table 3.

[0097] Table 3 Summary of dissolution results

[0098]

[0099]

[0100] It should be noted that the present invention refers to the United States Pharmacopoeia for detecting sucrose octasulfate, the content of which ranges from 30.0 to 38.0%. Taking the median value of 34% as 100%, the dissolution amount of sucrose octasulfate is 117%, which meets the standard and is normal.

[0101] As shown in Table 3, the samples in the present invention and the commercially available reference preparations The dissolution in conventional media is similar, but the overall dissolution rate of comparative example 1 in each medium is relatively fast because the suspending effect is relatively poor when sodium carboxymethyl cellulose is used as a suspending agent, and the quality of the product cannot be well guaranteed. At the same time, due to the large particle size of the raw material drug, the dissolution of comparative example 2 in each medium is relatively slow, and it is difficult to quickly dissociate sucrose octasulfate, and it cannot effectively play a therapeutic role. When Examples 1-3 use hydroxypropyl distarch phosphate, hydroxypropyl starch, and pregelatinized hydroxypropyl starch as suspending agents, the dissolution behavior of the prepared samples is similar to that of the commercially available reference preparation. That is, the efficacy is equivalent.

[0102] 4. Stability test

[0103] Samples from the embodiments and comparative examples were randomly selected and placed under accelerated conditions of 40°C±2°C / RH75%±5% for 6 months to observe changes in related substances, antacidity, and aluminum content. The specific results are shown in Table 4.

[0104] Table 4 Summary of stability results

[0105]

[0106]

[0107] According to the requirements of sucralfate suspension in Part II of the 2020 edition of the Chinese Pharmacopoeia, the content of this product, calculated as aluminum, ranges from 16% to 24%. In order to more intuitively compare the changing trend of the content, the median value of 20% is recorded as 100%; the relevant substances are indicated by the reaction value ratio of sucrose heptasulfate to the main component sucrose octasulfate.

[0108] As can be seen from Table 4, in the embodiments and comparative examples, during the stability period, the content of the finished preparations and related substances did not fluctuate significantly, the acid-making capacity met the requirements, and qualified products could be prepared.

[0109] 5. Investigation of aluminum content during dissolution process

[0110] With reference to the requirements of the in vitro BE guidelines, samples from the examples and comparative examples were randomly selected and compared with the commercially available reference preparations. Comparison of aluminum content in pH 1.2 medium, specific results are shown in Table 5.

[0111] Table 5 Summary of aluminum content results

[0112]

[0113] This product will release aluminum after taking it, and long-term use will lead to aluminum encephalopathy, aluminum bone disease, etc. If the release of aluminum can be reduced, the side effects of the drug can be reduced and the safety of medication can be improved. Therefore, in vitro dissolution is used for comparison to simulate the release of aluminum in the body.

[0114] Referring to the requirements of sucralfate suspension in Part II of the 2020 edition of the Chinese Pharmacopoeia, the range of this product, calculated in terms of aluminum, is 16% to 24%. In order to more intuitively compare the differences in aluminum release, the median value of 20% is taken as 100% to compare the aluminum release rates of different samples.

[0115] As shown in Table 5, the commercially available reference preparations The aluminum release at each time point in Comparative Examples 1-2 is significantly higher than that in Examples 1-3, indicating that the commercially available reference preparation And the aluminum release rate and total release amount in comparative examples 1-2 are obviously high. It can be seen from this that the suspending agent and preparation method used in the samples of Examples 1-3 can ensure that the bulk drug is better combined with it. At the same time, from the results of Example 1 and Comparative Example 2, it can be seen that when selecting a suitable suspending agent, it is also necessary to control the particle size of the bulk drug sucralfate and the temperature of the preparation process, which can ensure that the bulk drug sucralfate is fully adsorbed with the suspending agent, thereby reducing the release of aluminum, which can further reduce side effects and improve the safety of medication.

[0116] It can be seen that the product of the present invention is comparable to the commercially available reference preparation. Compared with other drugs, it has the advantages of significantly lower aluminum release rate and total release while having comparable dissolution and stability, which results in lower aluminum release, can reduce the side effects of medication and improve the safety of medication.

[0117] The above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, a person skilled in the art should understand that it is still possible to modify the technical solutions described in the aforementioned embodiments, or to perform equivalent replacements on some of the technical features therein. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. An oral suspension of sucralfate, characterized in that: Every 1000 parts of the oral suspension is made of the following components in parts by weight: 100 parts of sucralfate, 10-40 parts of a suspending agent, 0.05-0.2 parts of an antibacterial agent, 5-20 parts of ethanol, 20-60 parts of glycerol, and 0.1-0.5 parts of a flavoring agent; wherein the suspending agent is hydroxypropyl distarch phosphate, hydroxypropyl starch, or pregelatinized hydroxypropyl starch.

2. The oral suspension of sucralfate according to claim 1, characterized in that The flavoring agent is sodium saccharin and / or essence; the antibacterial agent is potassium sorbate; the particle size of sucralfate D90 is not higher than 30 μm, preferably, the particle size of sucralfate D90 is 5 μm-20 μm.

3. The oral suspension of sucralfate according to claim 2, characterized in that, Each 1000 parts of the oral suspension is prepared from the following components in parts by weight: 100 parts of sucralfate, 25-35 parts of suspending agent, 0.08-0.12 parts of potassium sorbate, 8-12 parts of ethanol, 35-45 parts of glycerol, 0.1-0.2 parts of saccharin sodium, and 0.05-0.15 parts of flavor.

4. The oral suspension of sucralfate according to claim 3, characterized in that, Each 1000 parts of the oral suspension is prepared from the following components in parts by weight: 100 parts of sucralfate, 30 parts of suspending agent, 0.1 part of potassium sorbate, 10 parts of ethanol, 40 parts of glycerol, 0.12 parts of saccharin sodium, and 0.1 part of flavor.

5. The oral suspension of sucralfate according to claim 4, characterized in that, Each 1000 parts of oral suspension is made up of the following components in parts by weight: 100 parts of sucralfate, 30 parts of hydroxypropyl distarch phosphate, 0.1 parts of potassium sorbate, 10 parts of ethanol, 40 parts of glycerol, 0.12 parts of saccharin sodium, and 0.1 parts of flavor; 100 parts of sucralfate, 30 parts of hydroxypropyl starch, 0.1 parts of potassium sorbate, 10 parts of ethanol, 40 parts of glycerol, 0.12 parts of saccharin sodium, and 0.1 parts of flavor; 100 parts of sucralfate, 30 parts of pregelatinized hydroxypropyl starch, 0.1 parts of potassium sorbate, 10 parts of ethanol, 40 parts of glycerol, 0.12 parts of saccharin sodium, and 0.1 parts of flavor.

6. The method for preparing the oral suspension of sucralfate according to claim 1, characterized in that: It includes the following steps: (1) crushing the raw material sucralfate to control its particle size D90 to be no greater than 30 μm; (2) mixing the sucralfate crushed in step (1) with purified water, stirring to make it evenly dispersed, and then performing high shear dispersion at 50-90° C. to obtain a drug-containing solution; (3) mixing the suspending agent with purified water, stirring to make them uniformly dispersed, and then stirring at 50-90° C. to make them completely gelatinized to obtain a suspending agent colloidal solution; (4) mixing the antibacterial agent potassium sorbate with ethanol, stirring to completely dissolve it, and then adding glycerol and stirring evenly to obtain an oily component solution; (5) mixing the drug-containing solution obtained in step (2) with the suspending agent colloidal solution obtained in step (3), stirring at 50-90° C. to make them uniformly dispersed, cooling the resulting mixed solution to 20-30° C., mixing it with the oily component solution obtained in step (4), and stirring again to make them uniformly dispersed; (6) Dissolve the flavoring agent in purified water, and then transfer it to the mixed solution obtained in step (5), add the remaining purified water to make up the volume, stir and mix evenly, and fill to obtain an oral suspension.

7. The method for preparing the oral suspension of sucralfate according to claim 6, characterized in that: The flavoring agent is sodium saccharin and / or essence; the antibacterial agent is potassium sorbate.

8. The method for preparing the oral suspension of sucralfate according to claim 6, characterized in that: In step (1), the particle size D90 of sucralfate is 5 μm-20 μm; in step (2), during high shear dispersion, the shear rate is 2000-4000 rpm, and the shear dispersion time is 15-45 min, preferably 30 min.

9. The method for preparing the oral suspension of sucralfate according to claim 6, characterized in that: In step (2), during high shear dispersion, the temperature is 60-80°C, preferably 70°C; in step (3), during stirring, the temperature is 60-80°C, preferably 70°C.

10. The method for preparing the oral suspension of sucralfate according to claim 6, characterized in that: In step (5), when the dispersion is uniform, the temperature is 60-80°C, preferably 70°C.

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