Composition containing acetylcysteine and defoaming agent

Abstract

The invention relates to a composition containing acetylcysteine and a defoaming agent and application of the composition in endoscopy.

Description

Technical Field

[0001] This invention relates to a composition containing acetylcysteine ​​and an antifoaming agent and its application in endoscopic examination. Background Technology

[0002] The prognosis of gastric cancer patients is closely related to the stage at diagnosis. The 5-year survival rate after surgery for advanced gastric cancer is less than 30%, while the 5-year survival rate for early-stage gastric cancer exceeds 90% after aggressive treatment. Therefore, early diagnosis and treatment are key to treating gastric cancer. Gastroscopy screening in high-risk groups is an important measure to detect early gastric cancer, but foam and mucus in the stomach often affect the clarity of the endoscope, easily leading to missed diagnoses of early gastric cancer.

[0003] To improve clarity during endoscopic examinations and minimize missed diagnoses, oral defoaming and antimucus agents are particularly necessary before the procedure. The 2021 joint consensus of the Spanish Society of Gastroenterology (AEG), the Spanish Society of Gastrointestinal Endoscopy (SEED), and the Spanish Society of Anatomical Pathology (SEAP) recommends: oral administration of 200 mg simethicone + 500 or 1000 mg acetylcysteine ​​before endoscopy to improve gastric mucosal visualization (high level of evidence; strongly recommended). The 2020 Japanese Society of Gastrointestinal Endoscopy's guidelines for the endoscopic diagnosis of early gastric cancer strongly recommend the use of antimucus agents and defoaming agents to improve mucosal clarity, specifically recommending streptomycin + NaHCO3 + simethicone or acetylcysteine ​​+ simethicone.

[0004] Both simethicone powder and methyl silicone oil have antifoaming properties, mainly due to their primary ingredient, methyl silicone oil. However, methyl silicone oil can only eliminate foam in the gastric cavity and cannot remove mucus adhering to the gastric mucosa. Streptomycin has a significant mucus-removing effect, but its antifoaming effect is relatively weak. Acetylcysteine ​​is also a mucus-removing agent; it can break the disulfide bonds of mucin in mucus, thereby decomposing the mucin and reducing the viscosity of the mucus. Using antifoaming agents or mucus-removing agents alone is insufficient to achieve ideal pre-endoscopic preparation results; clinical practice usually requires the combined use of multiple products.

[0005] Lumevis (trade name / brand name) is a CE-certified medical device from the European Union. It is a 50mL oral suspension containing water, silicone oil, acetic acid, acetylcysteine, fragrance, sodium hydroxide, potassium sorbate, sodium benzoate, xanthan gum, sucralose, etc. Lumevis has both defoaming and mucus-reducing effects, improving the clarity of the operating field and patient compliance. The acetylcysteine ​​and acetic acid in the formula have a synergistic mucus-reducing effect, while silicone oil primarily acts as a defoaming agent. Summary of the Invention

[0006] A first aspect of the present invention provides a composition containing acetylcysteine ​​and an antifoaming agent, characterized in that the composition comprises acetylcysteine, an antifoaming agent, maltodextrin, and a binder;

[0007] The defoamer is dimethicone or simethicone;

[0008] The mass ratio of acetylcysteine ​​to defoamer is 200:(20-100);

[0009] The mass ratio of acetylcysteine ​​to maltodextrin is 200:(600-1000) or 200:(1000-3500);

[0010] The mass ratio of the adhesive to the defoamer is 30:(40-80) or 30:(80-120).

[0011] In one embodiment of the present invention, the adhesive is selected from one or more of polyethylene glycol, methylcellulose, ethylcellulose, povidone, hydroxypropyl methylcellulose, hydroxypropyl cellulose, hydroxyethylcellulose, carboxymethylcellulose, sodium alginate, and gum arabic.

[0012] In one embodiment of the present invention, the mass ratio of acetylcysteine ​​to defoamer is 200:(30-32), or 200:(32-34), or 200:(34-36), or 200:(36-38), or 200:(38-40), or 200:(40-80). In another embodiment of the present invention, the mass ratio of acetylcysteine ​​to defoamer is 200:30, or 200:33, or 200:35, or 200:40, or 200:45, or 200:50, or 200:55, or 200:60, or 200:65, or 200:70, or 200:75, or 200:80.

[0013] In one embodiment of the present invention, the mass ratio of acetylcysteine ​​to maltodextrin is 200:(600-1000), or 200:(1000-1500), or 200:(1500-3000).

[0014] In one embodiment of the present invention, the mass ratio of acetylcysteine ​​to maltodextrin is 200:(600-700), or 200:(700-800), or 200:(800-900), or 200:(900-1000), or 200:(1000-1100), or 200:(1100-1200), or 200:(1200-1300), or 200:(1300-1400), or 200:(1400-1500), or 200:(1500-1600), or 200:(1600-1700), or 200:(1700-2800).

[0015] In one embodiment of the present invention, the mass ratio of acetylcysteine ​​to maltodextrin is 200:(1000-1400), or 200:(1200-1600), or 200:(1400-1800), or 200:(1600-2000), or 200:(1800-2200), or 200:(2000-2400), or 200:(2200-2600), or 200:(2400-2800), or 200:(2600-3000), or 200:(2800-3200), or 200:(3000-3500).

[0016] In one embodiment of the present invention, the composition further comprises one or more of a sweetener, a fruit flavoring, and a food coloring.

[0017] In one embodiment of the present invention, the composition further comprises a sweetener. In another embodiment of the present invention, the sweetener is selected from one or more of sucrose, sucralose, glucose, aspartame, xylitol, fructose, fructooligosaccharides, and steviol glycosides. Preferably, the sweetener is present in the composition at a mass percentage of 0.05%–1%, 0.05%–0.7%, 0.05%–0.5%, 0.05%–0.35%, 0.05%–0.25%, or 0.05%–0.2%.

[0018] In one embodiment of the present invention, the composition further comprises fruit flavoring and / or food coloring.

[0019] Acetylcysteine, also known as N-acetylcysteine ​​or N-acetyl-L-cysteine, is sometimes abbreviated as NAC. Common related substances of acetylcysteine ​​include L-cysteine, L-cysteine ​​(CAS number 56-89-3), N,S-diacetyl-L-cysteine ​​(CAS number 18725-37-6, also referred to as N,S-diacetylcysteine ​​in this invention), and N,N-diacetyl-L-cysteine ​​(CAS number 5545-17-5, also referred to as N,N-diacetylcysteine ​​in this invention).

[0020] Dimethicone is a dimethylsiloxane polymer, a colorless and clear oily liquid; it has been included in the Chinese Pharmacopoeia.

[0021] Simethicone, also known as silica dimethicone, is a mixture of dimethicone and silica.

[0022] Maltodextrin, also known as maltodextrin, is commonly used as a coating material, diluent for tablets and capsules, tablet binder, and thickener, as recorded in the Handbook of Pharmaceutical Excipients (4th edition, edited by Raymond C. Rowe et al.).

[0023] The term "food coloring" refers to a type of pigment, a substance that can be consumed in moderation by humans to alter the original color of products (such as food, medicine, and health products) to a certain extent. Food colorings can be of natural origin or artificially synthesized.

[0024] The term "fruit flavoring" refers to a flavoring that mimics the aroma of natural fruits and is formulated using natural and natural equivalent flavorings and synthetic flavorings.

[0025] A second aspect of the present invention provides a method for preparing the composition described in the first aspect of the present invention, comprising the steps of:

[0026] (a) Mix the adhesive with water to obtain an aqueous solution of the adhesive; mix the defoamer with the aqueous solution of the adhesive evenly;

[0027] (b) Spray the liquid containing the defoamer obtained in step (a) onto the maltodextrin for granulation and drying;

[0028] (c) Mix the dried particles obtained in step (b) with acetylcysteine.

[0029] In pharmaceutics, granulation is the process of turning powdered, lumpy, molten, or aqueous materials into granules of a specific shape and size.

[0030] In one embodiment of the present invention, when the composition contains a sweetener, the sweetener may be added to a liquid containing an antifoaming agent [method 101], or the sweetener may be mixed with maltodextrin and then granulated with a liquid containing an antifoaming agent [method 201], or the sweetener may be mixed with the dried granules obtained in step (b) [method 301]; the sweetener may also be partially added to a liquid containing an antifoaming agent [method 101] and the remaining portion mixed with the dried granules obtained in step (b) [method 301], or the sweetener may be partially in method 201 and the remaining portion in method 301, or the sweetener may be partially in method 101 and the remaining portion in method 201; or the sweetener may be a first portion in method 101, a second portion in method 201, and a third portion in method 301.

[0031] In one embodiment of the present invention, when the composition contains a fruit flavoring, the fruit flavoring can be added to a liquid containing an antifoaming agent [method 102], or the fruit flavoring can be mixed with maltodextrin and then granulated with a liquid containing an antifoaming agent [method 202], or the fruit flavoring can be mixed with the dried granules obtained in step (b) [method 302]; the fruit flavoring can also be partially added to a liquid containing an antifoaming agent [method 102] and the remaining portion mixed with the dried granules obtained in step (b) [method 302]; the fruit flavoring can also be partially in method 202 and the remaining portion in method 302; the fruit flavoring can also be partially in method 102 and the remaining portion in method 202; the fruit flavoring can also be a first portion in method 102, a second portion in method 202, and a third portion in method 302.

[0032] In one embodiment of the present invention, when the composition contains food coloring, the food coloring may be added to a liquid containing an antifoaming agent [method 103], or the food coloring may be mixed with maltodextrin and then granulated with a liquid containing an antifoaming agent [method 203], or the food coloring may be mixed with the dried granules obtained in step (b) [method 303]; the food coloring may also be partially added to a liquid containing an antifoaming agent [method 103] and the remaining portion mixed with the dried granules obtained in step (b) [method 303]; the food coloring may also be partially in method 203 and the remaining portion in method 303, or partially in method 103 and the remaining portion in method 203; the food coloring may also be a first portion in method 103, a second portion in method 203, and a third portion in method 303.

[0033] A third aspect of the invention provides the use of the composition described in the first aspect of the invention in the preparation of endoscopic examination products.

[0034] A third aspect of the invention also provides the use of the composition described in the first aspect of the invention in endoscopic examination.

[0035] The composition containing acetylcysteine ​​and an antifoaming agent described in the first aspect of this invention may be classified as a pharmaceutical product, a medical device, or another product that complies with regulatory requirements, according to administrative classification.

[0036] The term "pharmaceutical acceptable" refers to compounds, materials, compositions, and / or dosage forms that, within the bounds of reliable medical judgment, are suitable for use in contact with human and animal tissues without excessive toxicity, irritation, allergic reactions, or other problems or complications, in proportion to a reasonable benefit / risk ratio.

[0037] In this invention, the terms "containing" or "including (comprising)" can be open-ended, semi-closed, or closed-ended. In other words, the terms also include "consisting substantially of" or "consisting of".

[0038] In this invention, "percentage by mass volume" or "% (w / v)" or "% w / v" is a way of expressing mass volume concentration, which indicates the number of grams of solute contained in 100 ml of solution. For example, 20% (w / v) means that 100 ml of solution contains 20 g of solute.

[0039] The present invention contains a composition of acetylcysteine ​​and an antifoaming agent, which has the advantages of good defoaming and mucus removal effects and good stability when used in endoscopic examination. Detailed Implementation

[0040] The present invention will be further illustrated below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Experimental methods in the following embodiments, unless otherwise specified, are generally performed under conventional conditions or as recommended by the manufacturer.

[0041] Example 1 investigated the effect of excipients on the stability of acetylcysteine.

[0042] Acetylcysteine ​​was mixed with maltodextrin, mannitol, sucrose, and dried maltodextrin at a mass ratio of 1:10. Acetylcysteine ​​was mixed with simethicone at a mass ratio of 5:1. Acetylcysteine ​​was mixed with povidone K30, hydroxypropyl methylcellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, orange powder flavoring, sweet orange powder flavoring, lemon powder flavoring, sucralose, and sodium saccharin at a mass ratio of 10:1.

[0043] Accelerated stability testing was conducted (with a separate acetylcysteine ​​sample placed as a control). Testing conditions: temperature 40℃±2℃, relative humidity 75%±5%. Testing indicators: related substances; results are shown in Table 1. Table 1 shows that the total impurity content of the mixtures of acetylcysteine ​​and maltodextrin, the mixture with dried maltodextrin, and the mixture with simethicone oil did not change significantly during accelerated stability testing.

[0044] After obtaining data for 10 days of sampling and before obtaining data for 30 days of sampling, the inventors noticed that the mixture of acetylcysteine ​​and maltodextrin, and the mixture of acetylcysteine ​​and maltodextrin (dried), after 10 days of sampling, showed a decrease in the amount of some related substances and the amount of total impurities compared to day 0. The applicant reviewed / retested the data, and the data for day 0 after review / retesting are shown in parentheses.

[0045] Table 1

[0046]

[0047]

[0048] Example 2: Preparation of Granules (Method A) and Stability Study

[0049] 2.1# 2.2# 2.3# Simethicone 80g 80g 80g Povidone K30 30g 30g 30g Mannitol 2690g / / sucrose / 2690g / maltodextrin / / 2690g Acetylcysteine 200g 200g 200g Purified water Appropriate amount Appropriate amount Appropriate amount

[0050] Preparation method (Method A):

[0051] (1) Pass acetylcysteine ​​through a 24-mesh sieve and set aside;

[0052] (2) Prepare a solution of povidone K30 with an appropriate amount of purified water;

[0053] (3) Add simethicone to the polyvinyl chloride solution prepared in step (2) and shear homogenize until the simethicone is evenly dispersed;

[0054] (4) The mixture prepared in step (3) is sprayed evenly onto mannitol (or sucrose, or maltodextrin) as a binder and wet granulation is carried out.

[0055] (5) Prepare wet granules using a 20-mesh sieve;

[0056] (6) Dry in an oven at 60℃;

[0057] (7) Prepare dry granules using a 20-mesh sieve;

[0058] (8) Mix the dry granules prepared in step (7) with the acetylcysteine ​​that has been sieved in step (1) evenly.

[0059] (9) The mixture prepared in step (8) is dry granulated and then packaged into 1000 bags (3 grams per bag).

[0060] The prepared samples were subjected to accelerated stability testing. Testing conditions: temperature 40℃±2℃, relative humidity 75%±5%. Testing index: related substances; results are shown in Table 2. Table 2 shows that after 10, 20, and 30 days of storage, the total impurity content of group 2.3# was significantly lower than that of groups 2.1# and 2.2#.

[0061] Meanwhile, the inventors noted that the total impurities in group 2.3# decreased slightly after 10 and 20 days of sampling compared to day 0.

[0062] Table 2

[0063]

[0064] Example 3: Preparation of Granules (Method B) and Stability Study

[0065] 3.1# 3.2# 3.3# Simethicone 80g 80g 80g Povidone K30 30g 30g 30g Mannitol 2690g / / sucrose / 2690g / maltodextrin / / 2690g Acetylcysteine 200g 200g 200g Purified water Appropriate amount Appropriate amount Appropriate amount

[0066] Preparation method (Method B):

[0067] Steps (1) to (7) are consistent with the corresponding steps (1) to (7) in Example 2;

[0068] (8) Mix the dry granules prepared in step (7) with the acetylcysteine ​​that has been sieved in step (1) evenly, and then package them into 1000 bags (3 grams per bag).

[0069] The prepared samples were subjected to accelerated stability testing. Testing conditions: temperature 40℃±2℃, relative humidity 75%±5%. Testing index: related substances; results are shown in Table 3. Table 3 shows that after 10, 20, and 30 days of storage, the total impurity content of group 3.3# was significantly lower than that of groups 3.1# and 3.2#.

[0070] Comparing Tables 2 and 3; Groups 2.3# and 3.3# show that there is no significant difference between Method A and Method B in terms of total impurities after 10, 20, and 30 days of sampling; Groups 2.1# and 3.1# show that Method B is slightly better than Method A in terms of total impurities after 10, 20, and 30 days of sampling; Groups 2.2# and 3.2# show that Method B is slightly better than Method A in terms of total impurities after 10, 20, and 30 days of sampling.

[0071] Table 3

[0072]

[0073] Example 4: Effect of Acetylcysteine ​​with Different Particle Sizes

[0074] prescription:

[0075]

[0076] Preparation method: Same as in Example 3, but the step (1) of the preparation method in Example 3 is changed from passing through a 24-mesh sieve to passing through a 20-mesh sieve, a 24-mesh sieve, a 60-mesh sieve, or a 40-70-mesh sieve.

[0077] The prepared samples were subjected to accelerated stability testing. Testing conditions: temperature 40℃±2℃, relative humidity 75%±5%. Testing indicators: related substances; results are shown in Table 4. The results in Table 4 indicate that different particle sizes of acetylcysteine ​​have no significant effect on the stability of the final formulation.

[0078] Table 4

[0079]

[0080]

[0081] Example 5: Effect of Maltodextrin from Different Suppliers

[0082] prescription:

[0083]

[0084] Preparation method:

[0085] (1) Pass acetylcysteine ​​through a 24-mesh sieve and dry maltodextrin in an oven at 60°C for later use;

[0086] Steps (2) and (3) are consistent with the corresponding steps (2) and (3) in Example 2;

[0087] (4) The mixture prepared in step (3) is sprayed evenly onto mannitol as a binder and wet granulation is performed.

[0088] Steps (5) to (7) are consistent with the corresponding steps (5) to (7) in Example 2;

[0089] (8) Mix the dry granules prepared in step (7) with the acetylcysteine ​​and dried maltodextrin that have been sieved in step (1) evenly, and then package them into 1000 bags (3 grams per bag).

[0090] The prepared samples were subjected to accelerated stability testing. Testing conditions: temperature 40℃±2℃, relative humidity 75%±5%. Testing index: related substances; results are shown in Table 5. The results in Table 5 indicate that maltodextrin from different suppliers had no significant effect on the stability of the final formulation.

[0091] Table 5

[0092]

[0093] Example 6: Preparation and stability study of maltodextrin granules with different moisture content

[0094] prescription:

[0095]

[0096] Preparation method: Same as in Example 5; however, in step (1), the maltodextrin is provided with two different degrees of dryness.

[0097] The prepared samples were subjected to accelerated stability testing. Testing conditions: temperature 40℃±2℃, relative humidity 75%±5%. Testing index: related substances; results are shown in Table 6. The results in Table 6 indicate that maltodextrin at different drying degrees had no significant effect on the stability of the final formulation.

[0098] Table 6

[0099]

[0100]

[0101] Example 7

[0102] prescription:

[0103]

[0104] Preparation method:

[0105] Steps (1) to (3) are consistent with the corresponding steps (1) to (3) in Example 2;

[0106] (4) The mixture prepared in step (3) is sprayed evenly onto the maltodextrin as a binder and then granulated in a fluidized bed.

[0107] (5) Dry in an oven at 60℃;

[0108] (6) Prepare dry granules using a 20-mesh sieve;

[0109] (7) Mix the dry granules prepared in step (6) with the acetylcysteine ​​that has been sieved in step (1) evenly, and then package them into 1000 bags (3 grams per bag).

[0110] The prepared samples were subjected to accelerated stability testing. Testing conditions: temperature 40℃±2℃, relative humidity 75%±5%. Testing indicators: related substances; results are shown in Table 7.

[0111] Table 7

[0112]

[0113] Example 8

[0114] prescription:

[0115]

[0116] Preparation method: Same as in Example 5; however, in step (8), sweet orange powder flavoring and sucralose were added.

[0117] The prepared samples were subjected to pharmacological experiments, and the experimental steps are as follows:

[0118] Preparation of 1.5% mucin solution: Dissolve 6g of mucin in 120ml of water by stirring at room temperature, and let stand overnight to remove foam.

[0119] 2. Sample solution preparation: Dissolve one sample bag in 25 ml of water to obtain the sample solution.

[0120] 3. Reaction system: 2.5ml mucin solution + 0.5ml sample solution, vortex thoroughly, and let stand at 37℃ for 0.5h to 1h.

[0121] 4.0 Point Setup: 2.5ml mucin solution + 0.5ml water, vortex thoroughly, then mix in a vertical suspension at room temperature.

[0122] 5. Reaction termination: Place the reaction solution that was reacted at 37℃ at room temperature and mix it in a vertical suspension apparatus for 1 hour.

[0123] 6. Viscosity test: Take 3 ml of the reaction solution and test the viscosity using a rheometer (RST-CPS).

[0124] The rheometer parameters were set as follows: Shear Rate (1 / s): 64; Detection time (s): 5; Number of detections: 10. The final measurement value was the average of 10 detections. The results are shown in Table 8 below. The results indicate that the sample is superior to streptoprotein granules + 80mg simethicone oil and superior to streptoprotein granules.

[0125] Table 8

[0126]

[0127]

[0128] Example 9

[0129] prescription:

[0130]

[0131] Preparation method:

[0132] (1) Pass acetylcysteine ​​through a 24-mesh sieve and set aside; dry maltodextrin in an oven at 60°C and mix it with orange powder flavoring and sucralose and set aside.

[0133] (2) Prepare a solution of povidone K30 with an appropriate amount of purified water;

[0134] (3) Add simethicone to the polyvinyl chloride solution prepared in step (2) and shear homogenize until the simethicone is evenly dispersed;

[0135] (4) The mixture prepared in step (3) is sprayed evenly onto maltodextrin (a mixture of maltodextrin mixed with orange powder flavoring and sucralose) as a binder, and then granulated, dried, sized and sieved in a fluidized bed.

[0136] (5) Mix the dry granules prepared in step (4) with the acetylcysteine ​​that has been sieved in step (1) evenly, and then package them into 6000 bags (3 grams per bag).

[0137] Example 10

[0138] prescription:

[0139]

[0140]

[0141] Preparation method:

[0142] Steps (1) to (3) are consistent with the corresponding steps (1) to (3) in Example 2;

[0143] (4) The mixture prepared in step (3) is sprayed evenly onto the mixture of maltodextrin, lemon powder flavoring and sucralose as a binder, and then granulated and dried in a fluidized bed. Samples are taken during the drying process to obtain dry granules with different drying weight loss.

[0144] (5) Prepare dry granules using a 20-mesh sieve;

[0145] (6) Mix the dry granules prepared in step (5) with the acetylcysteine ​​that has been sieved in step (1) evenly, and then package them into 1000 bags (3 grams per bag).

[0146] The prepared samples were subjected to accelerated stability testing. Testing conditions: temperature 40℃±2℃, relative humidity 75%±5%. Testing indicators: related substances; results are shown in Table 9.

[0147] Table 9

[0148]

[0149] Example 11

[0150] The sample prepared in Example 9 was subjected to pharmacological experiments, and the experimental steps are as follows:

[0151] 1. Preparation of gastric acid simulation solution: Measure 3.84 ml of hydrochloric acid and dilute it with water to 1000 ml for later use.

[0152] Preparation of 2.5% mucin acid solution: Dissolve 6g of mucin in 120ml of gastric acid simulation solution by stirring under 37℃ conditions.

[0153] 3. Foam model establishment: Measure 10 ml of 5% mucin acidic solution into each beaker, add a stir bar, and start high-speed stirring on the same magnetic stirrer with the same parameters for about 20 minutes until the same foam height is produced.

[0154] 4. Sample solution preparation: Dissolve one bag of sample from Example 9 in 25 ml of warm water to obtain sample solution 2; dissolve 1 g of sodium bicarbonate in 25 ml of warm water to obtain sample solution 3.

[0155] 5. Sample testing: Add 2.5 ml of sample solution 2 and 2.5 ml of sample solution 3 to the foam model and react under the condition of keeping warm at 37℃. Observe and record the foam situation in the beaker at 15 min and 30 min respectively.

[0156] 6. Blank control: Add 5 ml of warm water (blank control liquid 1) to the foam model and react under the condition of keeping warm at 37℃. Observe and record the foam situation in the beaker at 15 min and 30 min respectively.

[0157] 7. Experimental results: The amount of foam in the sample group decreased significantly after 15 minutes, and there was almost no foam in the beaker after 30 minutes; the amount of foam in the blank control group decreased.

[0158] 8. Experimental conclusion: In the mucin acidic liquid foam model, the sample of Example 9 has a defoaming effect.

[0159] All documents mentioned in this invention are incorporated herein by reference as if each document were individually incorporated by reference. Furthermore, it should be understood that after reading the foregoing description of this invention, those skilled in the art can make various alterations or modifications to this invention, and these equivalent forms also fall within the scope defined by the appended claims.

Claims

1. A composition containing acetylcysteine ​​and an antifoaming agent, characterized in that, The composition includes acetylcysteine, an antifoaming agent, maltodextrin, and a binder; The defoamer is dimethicone or simethicone; The mass ratio of acetylcysteine ​​to defoamer is 200:(20-100); The mass ratio of acetylcysteine ​​to maltodextrin is 200:(600-1000) or 200:(1000-3500); The mass ratio of the adhesive to the defoamer is 30:(40-80) or 30:(80-120).

2. The composition according to claim 1, characterized in that, The adhesive is selected from one or more of polyethylene glycol, methylcellulose, ethylcellulose, povidone, hydroxypropyl methylcellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, carboxymethyl cellulose, sodium alginate, and gum arabic.

3. The composition according to claim 1, characterized in that, The mass ratio of acetylcysteine ​​to defoamer is 200:(30-32), or 200:(32-34), or 200:(34-36), or 200:(36-38), or 200:(38-40), or 200:(40-80).

4. The composition according to claim 1, characterized in that, The mass ratio of acetylcysteine ​​to defoamer is 200:30, 200:33, 200:35, 200:40, 200:45, 200:50, 200:55, 200:60, 200:65, 200:70, 200:75, or 200:

80.

5. The composition according to claim 1, characterized in that, The mass ratio of acetylcysteine ​​to maltodextrin is 200:(600-1000), or 200:(1000-1500), or 200:(1500-3000).

6. The composition according to claim 1, characterized in that, The mass ratio of acetylcysteine ​​to maltodextrin is 200:(600-700), or 200:(700-800), or 200:(800-900), or 200:(900-1000), or 200:(1000-1100), or 200:(1100-1200), or 200:(1200-1300), or 200:(1300-1400), or 200:(1400-1500), or 200:(1500-1600), or 200:(1600-1700), or 200:(1700-2800).

7. The composition according to claim 1, characterized in that, The composition also contains a sweetener; The sweetener is selected from one or more of sucrose, sucralose, glucose, aspartame, xylitol, fructose, fructooligosaccharides, and steviol glycosides. Preferably, the sweetener is present in the composition at a mass percentage of 0.05% to 1%, 0.05% to 0.7%, 0.05% to 0.5%, 0.05% to 0.35%, 0.05% to 0.25%, or 0.05% to 0.2%.

8. The composition according to claim 1, characterized in that, The composition also contains fruit flavorings and / or food colorings.

9. A method for preparing the composition according to any one of claims 1 to 8, comprising the steps of: (a) Mix the adhesive with water to obtain an aqueous solution of the adhesive; mix the defoamer with the aqueous solution of the adhesive evenly; (b) Spray the liquid containing the defoamer obtained in step (a) onto the maltodextrin for granulation and drying; (c) Mix the dried particles obtained in step (b) with acetylcysteine.

10. The use of the composition according to any one of claims 1 to 8 in the preparation of endoscopic examination products.

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