CN114796135B - Sucralfate oral preparation and preparation method thereof - Google Patents

Sucralfate oral preparation and preparation method thereof Download PDF

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CN114796135B
CN114796135B CN202210317293.0A CN202210317293A CN114796135B CN 114796135 B CN114796135 B CN 114796135B CN 202210317293 A CN202210317293 A CN 202210317293A CN 114796135 B CN114796135 B CN 114796135B
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sucralfate
porous film
oral preparation
film material
oral
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CN114796135A (en
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魏雪纹
戴宏旭
吴海锋
彭琪
王宗达
纪新明
许宇丽
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Hainan Jiuchang Pharmaceutical Co ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

The invention provides a sucralfate oral preparation and a preparation method thereof, and the sucralfate oral preparation comprises the following components by mass percent: 30-55wt% of sucralfate, 28-50wt% of diluent, 0.2-2.2wt% of aromatic flavoring agent, 3-11wt% of cosolvent, 8-17wt% of porous film material and 2-20wt% of adhesive, wherein the cosolvent is thioglycerol, the porous film material is poloxamer and galactomannan, and the mass ratio of the poloxamer to the galactomannan is 0.2-0.3:0.8-1.6. The invention also provides a preparation method of the sucralfate oral preparation. The sucralfate oral preparation obtained by the invention has the accumulated release rate of 18h, has the excellent performances of quick response, stable effect lasting material, high dissolution and the like, and simultaneously has higher adhesive action on gastric mucosa and in-vitro biological adhesive force of 28.72g/cm 2 。

Description

Sucralfate oral preparation and preparation method thereof
Technical Field
The invention relates to the technical field of pharmaceutical oral preparations, in particular to a sucralfate oral preparation and a preparation method thereof.
Background
Gastric ulcer is a type of peptic ulcer, and when the gastric mucosa is broken, ulcer easily occurs at the site, i.e., gastric ulcer is formed. Sucralfate is one of effective medicines for treating gastric ulcer, and has functions of protecting ulcer surface and promoting ulcer healing. The action mechanism is as follows: under an acidic environment, sucralfate can dissociate sucrose sulfate complex ions, and the complex ions are polymerized into insoluble colloid with negative charges, and the insoluble colloid can be combined with protein exudates with positive charges on ulcer surfaces to form a layer of protective film to cover the ulcer surfaces and promote ulcer healing. However, because of the gastric emptying effect, sucralfate is usually retained in the stomach for a short time, which results in undesirable therapeutic effect and low bioavailability, and the dissolution of sucralfate requires low acid conditions, which is limited to a certain extent.
Disclosure of Invention
In view of this, the present invention aims to provide an oral sucralfate preparation and a method for preparing the same, which solves the above problems.
The technical scheme of the invention is realized as follows:
an sucralfate oral preparation, which comprises the following components by mass percent: 30-55wt% of sucralfate, 28-50wt% of diluent, 0.2-2.2wt% of aromatic flavoring agent, 3-11wt% of cosolvent, 8-17wt% of porous film material and 2-20wt% of adhesive;
the cosolvent is thioglycerol; according to the invention, the thioglycerol is selected to be beneficial to improving the compatibility among the components, so that a buffer system is formed between the prepared soft material and the porous film material, and the stability and the sustainability of release of the medicine are improved; the mixing of the thioglycerol and the xylo-oligosaccharide is also beneficial to the dispersion uniformity of the raw material components, so that the raw material components have compressibility and form certain mechanical strength, the tabletting is free from the phenomena of fragments and loose tablets, and the moisture absorption influence of the xylo-oligosaccharide is also avoided.
The porous film material is poloxamer and galactomannan, and the mass ratio of the poloxamer to the galactomannan is (0.2-0.3): 0.8 to 1.6; poloxamer and galactomannan are preferably selected to prepare the porous film material, so that the porous film material is beneficial to gradually dissociating sucralfate by controlling the size of pores when the medicine is released, and the slow release effect is achieved.
Further explaining, the composite material comprises the following components in percentage by mass: 30-45wt% of sucralfate, 32-48wt% of diluent, 0.2-2.2wt% of aromatic flavoring agent, 4-10wt% of cosolvent, 9-15wt% of porous film material and 2-10wt% of adhesive.
More preferably, the method comprises the following steps by mass percent: 30-40wt% of sucralfate, 40-48wt% of diluent, 0.2-2.2wt% of aromatic flavoring agent, 4-6wt% of cosolvent, 9-12wt% of porous film material and 2-10wt% of adhesive.
Further, the porous film material is prepared from poloxamer and galactomannan according to a mass ratio of 0.2-0.3:0.8-1.6, and irradiating with 570-700nm red light to obtain porous film material with pore diameter of 0.8-1.2 μm.
Preferably, the weight ratio of poloxamer to galactomannan is 0.3:1.6.
further, the oral preparation also comprises 2.2 to 4.8 weight percent of absorption promoting agent xylo-oligosaccharide; the acid and thermal stability of the xylo-oligosaccharide are good, the xylo-oligosaccharide is added, so that the moisture in the components can be absorbed, the affinity of the raw material components can be promoted, the dryness of the sucralfate can be kept after granulation and drying, and the problems of adhesion, raw material loss and the like caused by tabletting after subsequent secondary mixing can be solved; meanwhile, the xylo-oligosaccharide is functional polysaccharide, and the xylo-oligosaccharide is screened and controlled in addition, so that the sucralfate oral preparation is endowed with the health-care effect of regulating intestinal probiotics, and the growth of helicobacter pylori can be inhibited.
The invention also provides a preparation method of the sucralfate oral preparation, which comprises the following steps:
step S1: sieving sucralfate and diluent with 70-90 mesh sieve respectively to obtain premix 1, and sieving aromatic correctant with 90-110 mesh sieve to obtain premix 2;
step S2: adding adhesive and absorption promoter into premix 1, making into soft material, adding cosolvent and porous film material, stirring at 20-30 deg.C for 10-60min, ultrasonic treating for 10-60min, sieving with 10-30 mesh sieve, granulating, and drying at 40-60 deg.C until water content is less than or equal to 3.0% to obtain granule;
and step S3: taking the granules, sieving with a 10-30 mesh sieve, grading, adding premix 2, mixing, and tabletting with a flat arc punch with diameter of 8-10mm to obtain sucralfate oral preparation.
Further, the diluent is at least one of sucrose, mannitol, porous starch and pregelatinized starch; the adhesive is sodium carboxymethylcellulose aqueous solution with the mass concentration of 2-3%; the aromatic correctant is at least one of oleum Menthae Dementholatum, herba Menthae essence, and fructus Citri Tangerinae essence.
Further, in step S2, the stirring temperature is 25 ℃ and the stirring time is 30min.
Further, in step S2, the ultrasonic power is 600-800W.
Compared with the prior art, the invention has the following beneficial effects:
(1) According to the invention, thioglycerol is used as a cosolvent, xylo-oligosaccharide is used as an absorption promoter, a porous film material formed by poloxamer and galactomannan is combined with a diluent, an adhesive and an aromatic flavoring agent to prepare the sucralfate oral preparation, the proportion among the components is optimized, the components are mutually cooperated, the dissociation requirement of a sucralfate low-acid environment is favorably reduced, the sucralfate oral preparation can promote the dissociation and sustained release of sucralfate under a higher acidic condition (hydrochloric acid solution with a pH value of 5.5), the curative effect and action time of sucralfate in the stomach is prolonged, and the sucralfate oral preparation has excellent performances of quick response, sustained and stable effect, high dissolution and the like; meanwhile, the sucralfate oral preparation has stronger binding capacity with the injured surface of the gastric mucosa, has better gastric retention characteristic, and can improve and prolong the curative effects of the sucralfate oral preparation in repairing ulcer, neutralizing gastric acid and adjusting the pH of the mucosa.
(2) The water content and the acidity of the sucralfate oral preparation prepared by the invention meet the regulations, the acidity value is 4.0-4.4, the sucralfate oral preparation is white and smooth, has no phenomena of cracking and loosening, has good compressibility of raw material components, and has stable and controllable product quality; the invention discovers that when the dosage of the auxiliary materials is relatively reduced, a proper amount of disintegrant and/or lubricant is required to be added so as to meet the quality requirement standard, so that the control of reasonable component proportion is favorable for stably controlling the product quality of the sucralfate oral preparation.
(3) In addition, the raw material components are optimized, and when sucralfate, a diluent, an adhesive and an absorption enhancer are prepared into a soft material in the combination step, cosolvent thioglycerol, porous film material poloxamer and galactomannan are added, so that the dispersion degree of the main drug is promoted, the compatibility and affinity among the components are improved, a layer of protective film formed by colloid and sucralfate on the surface of gastric mucosa is formed, strong adhesion to gastric mucosa is generated, the coverage area is wide, the ulcer healing is continuously promoted, and the rapid dissociation of sucralfate is further avoided; meanwhile, the porous film material is prevented from being dissolved out in advance, so that the formation of a protective film of sucralfate on ulcer is prevented, the stability of the preparation is easily reduced, the quality problem of the preparation is caused, and the safety of medication is ensured.
Drawings
FIG. 1 is a graph showing the results of measurement of cumulative release degrees of example 1 of the present invention and comparative examples 1 to 4.
Detailed Description
In order that the technical contents of the invention may be better understood, specific examples are provided below to further illustrate the invention.
The experimental methods used in the examples of the present invention are all conventional methods unless otherwise specified.
The materials, reagents and the like used in the examples of the present invention are commercially available unless otherwise specified.
Example 1
An oral sucralfate formulation, formulated as follows:
serial number Composition of matter Ratio (g)
1 Sucralfate 350
2 Sucrose 250
3 Mannitol 150
4 Porous starch 50
5 Sodium carboxymethylcellulose Proper amount of
6 Mint oil 7.4
7 Orange essence Proper amount of
8 Thioglycerol 50
9 Poloxamers 15
10 Galactomannans 80
11 Xylo-oligosaccharide 37
(1) Preparing raw materials: the porous film material is prepared by mixing poloxamer and galactomannan at a mass ratio of 0.3 to 1.6, and irradiating with 630nm red light to obtain the porous film material with the pore diameter of 1.0 μm.
(2) The preparation method of the sucralfate oral preparation comprises the following steps:
step S1: sieving sucralfate and diluent with 80 mesh sieve to obtain premix 1, and sieving aromatic correctant with 100 mesh sieve to obtain premix 2;
step S2: adding adhesive and absorption promoter into premix 1, making into soft material, adding cosolvent and porous film material, stirring at 25 deg.C for 30min, ultrasonic treating at 700W for 40min, sieving with 20 mesh sieve, granulating, and drying at 50 deg.C until water content is less than or equal to 3.0% to obtain granule;
and step S3: and (3) taking the granules, sieving the granules by a 20-mesh sieve, granulating, adding premix 2, mixing, and tabletting by a flat arc punch with the diameter of 9mm to obtain the sucralfate oral preparation.
Comparative examples 1 to 4
Following the same preparation as in example 1, except for the different additions and amounts of raw materials, the formula is as follows:
Figure BDA0003570218880000051
the sucralfate oral preparations obtained in example 1 and comparative examples 1 to 4 were subjected to quality inspection according to "chinese pharmacopoeia" 2020 edition two, and 900mL of hydrochloric acid solution having a pH of 5.5 was used as a dissolution medium to measure the release rate, and the experimental results are shown in fig. 1.
As can be seen from figure 1, the release degree of the preparation in example 1 is excellent and can reach 18 hours, and the preparation method shows that the sucralfate oral preparation is prepared by selecting thioglycerol as a cosolvent, xylooligosaccharide as an absorption promoter and a porous film material formed by poloxamer and galactomannan, and combining a diluent, an adhesive and an aromatic flavoring agent, the proportion among the components is optimized, the dissociation and sustained release of sucralfate can be promoted under a higher acidic condition, the curative effect and action time of the sucralfate is prolonged, and the preparation method has the excellent performances of quick response, sustained and stable effect, high dissolution and the like.
Compared with the comparative example 1, the dosage of the thioglycerol and the xylo-oligosaccharide is increased, the release rate is slow, the release degree is low at 1h, and the effect is slow; compared with the comparative example 2 and the comparative example 3, both the chitosan and the Tween-80 have the function of retarding the release of sucralfate, and the release degree is stable after 6 hours; by adjusting the poloxamer to galactomannan ratio, the release of sucralfate is significantly reduced compared to comparative example 4.
Examples 2 to 5
An oral sucralfate formulation, formulated as follows:
Figure BDA0003570218880000061
(1) Preparing raw materials: the porous film material is prepared by irradiating poloxamer and galactomannan with 630nm red light to obtain porous film material with pore diameter of 1.0 μm.
(2) The preparation method of the sucralfate oral preparation of the above example 2-5 comprises the following steps:
step S1: sieving sucralfate and diluent with 80 mesh sieve to obtain premix 1, and sieving aromatic correctant with 100 mesh sieve to obtain premix 2;
step S2: adding adhesive and absorption promoter into premix 1, making into soft material, adding cosolvent and porous film material, stirring at 25 deg.C for 30min, ultrasonic treating at 700W for 40min, sieving with 20 mesh sieve, granulating, and drying at 50 deg.C until water content is less than or equal to 3.0% to obtain granule;
step S301: taking the granules, sieving with a 20-mesh sieve, granulating, adding premix 2, sodium carboxymethyl starch and magnesium stearate, mixing, and tabletting by using a flat arc punch with the diameter of 9mm to obtain the sucralfate oral preparation of example 2;
step S302: taking the granules, sieving the granules by a 20-mesh sieve, granulating, adding the premix 2, mixing, and tabletting by a flat arc punch with the diameter of 9mm to obtain the sucralfate oral preparation of the embodiment 3;
step S303: taking granules, sieving the granules by a 20-mesh sieve, granulating, adding premix 2 and magnesium stearate, mixing, and tabletting by a flat arc punch with the diameter of 9mm to obtain the sucralfate oral preparation of example 4;
step S304: and (3) taking the granules, sieving the granules by a 20-mesh sieve, granulating the granules, adding the premix 2 and the talcum powder, mixing, and tabletting by a flat arc punch with the diameter of 9mm to obtain the sucralfate oral preparation of the embodiment 5.
The sucralfate oral preparations obtained in examples 1 to 5 were subjected to quality inspection of the products according to the "Chinese pharmacopoeia" 2020 edition two, and moisture content and acidity value after tableting of the oral preparations were measured, and the results are shown in the following table:
item Moisture content (%) Acidity value Capacity of producing acid Traits
Example 1 9.5 4.2 Compliance with regulations White, smooth, no splinters and loose pieces
Example 2 8.7 4.4 Compliance with regulations White, smooth, without splinters and loose pieces
Example 3 10.2 4.0 Compliance with regulations White, smooth, without splinters and loose pieces
Example 4 8.2 4.3 Compliance with regulations White, smooth, without splinters and loose pieces
Example 5 8.9 4.2 Compliance with regulations White, smooth, without splinters and loose pieces
As can be seen from the above table, by adopting the scientific proportioning of the invention, the sucralfate oral preparation obtained in examples 1-5 has a moisture content of 8.2% -10.2%, meets the specification of a moisture content of 8.0% -12.0%, has an acidity value of 4.0-4.4, meets the specification of an acidity-making capacity, and has white and flat sucralfate oral preparation, and no phenomena of splintering and loosening.
Example 6
The difference between the embodiment and the embodiment 1 is that the preparation method of the sucralfate oral preparation is different, and the specific steps are as follows:
step S1: respectively sieving sucralfate and diluent with a 70-mesh sieve to obtain premix 1, and sieving aromatic correctant with a 100-mesh sieve to obtain premix 2;
step S2: adding adhesive and absorption promoter into premix 1, making into soft material, adding cosolvent and porous film material, stirring at 25 deg.C for 30min, ultrasonic treating at 800W for 60min, sieving with 20 mesh sieve, granulating, and drying at 50 deg.C until water content is less than or equal to 3.0% to obtain granule;
and step S3: and (3) taking the granules, sieving the granules by a 20-mesh sieve, granulating, adding the premix 2, sodium carboxymethyl starch and magnesium stearate, mixing, and tabletting by using a flat arc punch with the diameter of 9mm to obtain the sucralfate oral preparation.
Example 7
The difference between the embodiment and the embodiment 1 is that the cosolvent and the porous film material are added finally, and the specific steps are as follows:
step S1: sieving sucralfate and diluent with 80 mesh sieve to obtain premix 1, and sieving aromatic correctant with 100 mesh sieve to obtain premix 2;
step S2: adding adhesive and absorption promoter into premix 1, making into soft material, sieving with 20 mesh sieve, granulating, and drying at 50 deg.C until water content is less than or equal to 3.0% to obtain granule;
and step S3: taking the granules, sieving with a 20-mesh sieve, granulating, adding premix 2, cosolvent and porous film material, mixing, stirring at 25 deg.C for 30min, performing 700W ultrasonic treatment for 40min, sieving with a 20-mesh sieve, granulating, drying, and tabletting with a flat arc punch with a diameter of 9mm to obtain sucralfate oral preparation.
The stomach of a rat with a gastric ulcer model was taken, gastric mucosa was separated, the sucralfate oral preparations of example 1, example 6 and example 7 were uniformly sprinkled on the surface of gastric mucosa (glandular stomach size: 2 × 2 cm), respectively, placed in a constant temperature and humidity chamber at an ambient temperature of 25 ± 2 ℃ and a relative humidity of 90 ± 2% for 20min, taken out, and the in vitro bioadhesion was measured at a pressure of 200g and a compression time of 15min, and the results are as follows:
item Example 1 Example 6 Example 7
Adhesion (g/cm) 2 ) 28.72 25.04 13.56
As can be seen from the above table, the sucralfate oral preparation of example 1 has a high adhesion to the gastric mucosa and an in vitro bioadhesive power of 28.72g/cm 2 Compared with the embodiment 7, the preparation method of the sucralfate oral preparation is adjusted, when sucralfate, a diluent, an adhesive and an absorption promoter are prepared into a soft material, cosolvent thioglycerol, porous film material poloxamer and galactomannan are added, the dispersion degree of main medicines is promoted, the compatibility and the affinity among the components are improved, a colloid is formed to cooperate with a protective film formed by sucralfate on the surface of gastric mucosa, strong adhesive force is generated on the gastric mucosa, the coverage area is wide, and the healing of the gastric ulcer is continuously promoted; meanwhile, the porous film material is prevented from being dissolved out in advance, so that the formation of a protective film of sucralfate on ulcer is prevented, and the stability of the preparation is easily reduced, so that the quality problem of the preparation is caused.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.

Claims (8)

1. An sucralfate oral preparation, characterized by comprising, by mass: 30-55wt% of sucralfate, 28-50wt% of diluent, 0.2-2.2wt% of aromatic flavoring agent, 3-11wt% of cosolvent, 8-17wt% of porous film material, 2-20wt% of adhesive and 2.2-4.8wt% of absorption promoter xylo-oligosaccharide;
the cosolvent is thioglycerol;
the porous film material is poloxamer and galactomannan, and the mass ratio of the poloxamer to the galactomannan is (0.2-0.3): 0.8-1.6;
the preparation method of the sucralfate oral preparation comprises the following steps:
step S1: sieving sucralfate and diluent with 70-90 mesh sieve respectively to obtain premix 1, and sieving aromatic correctant with 90-110 mesh sieve to obtain premix 2;
step S2: adding adhesive and absorption promoter into premix 1, making into soft material, adding cosolvent and porous film material, stirring at 20-30 deg.C for 10-60min, ultrasonic treating for 10-60min, sieving with 10-30 mesh sieve, granulating, and drying at 40-60 deg.C until water content is less than or equal to 3.0% to obtain granule;
and step S3: taking the granules, sieving with a 10-30 mesh sieve, grading, adding premix 2, mixing, and tabletting with a flat arc punch with diameter of 8-10mm to obtain sucralfate oral preparation.
2. An oral sucralfate formulation according to claim 1, characterized by comprising, in mass percent: 30-45wt% of sucralfate, 32-48wt% of diluent, 0.2-2.2wt% of aromatic flavoring agent, 4-10wt% of cosolvent, 9-15wt% of porous film material and 2-10wt% of adhesive.
3. An oral sucralfate formulation according to claim 1, characterized by comprising, in mass percent: 30-40wt% of sucralfate, 40-48wt% of diluent, 0.2-2.2wt% of aromatic flavoring agent, 4-6wt% of cosolvent, 9-12wt% of porous film material and 2-10wt% of adhesive.
4. The sucralfate oral preparation according to claim 1, characterized in that said porous film material is a mixture of poloxamer and galactomannan in a mass ratio of 0.2-0.3:0.8-1.6, and irradiating with 570-700nm red light to obtain porous film material with pore diameter of 0.8-1.2 μm.
5. An oral formulation of sucralfate according to claim 4, characterized in that the weight ratio of poloxamer to galactomannan is 0.3:1.6.
6. the sucralfate oral preparation according to claim 1, wherein the diluent is at least one of sucrose, mannitol, porous starch, pregelatinized starch; the adhesive is sodium carboxymethylcellulose aqueous solution with the mass concentration of 2-3%; the aromatic correctant is at least one of oleum Menthae Dementholatum, herba Menthae essence, and fructus Citri Tangerinae essence.
7. The sucralfate oral preparation according to claim 1, wherein in step S2, the stirring temperature is 25 ℃ and the stirring time is 30min.
8. The sucralfate oral preparation according to claim 1, wherein in step S2, the ultrasonic power is 600 to 800W.
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