A suspension of ibuprofen and a method for preparing the same

Abstract

The present application relates to the technical field of medicine, in particular to a kind of ibuprofen suspension and preparation method thereof. Every 100ml ibuprofen suspension, according to weight fraction: ibuprofen raw drug 2.0 parts suspending agent 0.5~3.5 parts, wetting agent 0.01~0.07 parts, humectant 5~25 parts, pH regulator 0.1~0.5 parts, bacteriostatic agent 0.1~0.5 parts, sweetener 20~40 parts, flavoring agent 0.03~0.7 parts, colorant 0.05~0.1 parts, the rest is pure water;Wherein, suspending agent is microcrystalline cellulose-sodium carboxymethyl cellulose and sodium alginate. The present application increases homogenization process while stirring in preparation process, accelerates suspending agent dispersion and dissolution, improves drug dispersion uniformity, shortens production solution time, improves production efficiency, reduces production cost.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical technology, and in particular to an ibuprofen suspension and its preparation method. Background Technology

[0002] Ibuprofen is an antipyretic and analgesic used to treat fever caused by the common cold or influenza in children. It is also used to relieve mild to moderate pain in children, such as headaches, joint pain, migraines, toothaches, muscle pain, and neuralgia. Ibuprofen suspension was developed by Johnson and Johnson and launched in the United States in 1995 under the brand name Children's. It was launched in Australia in 2000 under the brand name CHILDREN'S. Original research and localization It was launched in China in 1999, with a specification of 100ml: 2g. The recommended dose is 75mg, once daily, orally, with or without food.

[0003] Ibuprofen suspensions currently suffer from poor stability and uniformity after long-term storage. Chinese patent application CN202211688494.8 discloses a preparation process to improve the uniformity of ibuprofen suspension content. In this process, xanthan gum is added to purified water, stirred for 5–15 minutes, and then sealed for 8–20 hours to allow swelling. Furthermore, the prepared solution needs to be left to stand overnight. This process is too time-consuming and increases the risk of microbial contamination, making it difficult to commercialize. Therefore, improving the stability, uniformity, and production efficiency of ibuprofen suspensions remains a pressing technical problem that needs to be solved. Summary of the Invention

[0004] The purpose of this invention is to provide an ibuprofen suspension and its preparation method.

[0005] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0006] Per 100ml of ibuprofen suspension, by weight: 2.0 parts ibuprofen raw material, 0.5-3.5 parts suspending agent, 0.01-0.07 parts wetting agent, 5-25 parts humectant, 0.1-0.5 parts pH adjuster, 0.1-0.5 parts antibacterial agent, 20-40 parts sweetener, 0.03-0.7 parts flavoring agent, 0.05-0.1 parts coloring agent, and the remainder is purified water;

[0007] Preferably, each 100ml ibuprofen suspension comprises, by weight: 2.0 parts ibuprofen raw material, 0.5-3.5 parts suspending agent, 0.01-0.07 parts wetting agent, 5-25 parts humectant, 0.1-0.5 parts pH adjuster, 0.1-0.5 parts antibacterial agent, 20-40 parts sweetener, 0.03-0.7 parts flavoring agent, 0.05-0.1 parts coloring agent, and the remainder being purified water.

[0008] The suspending agents are sodium carboxymethyl cellulose and sodium alginate.

[0009] The weight ratio of the suspending agent microcrystalline cellulose-sodium carboxymethyl cellulose and sodium alginate is 6:1 to 2:1, preferably 4:1.

[0010] The wetting agent is polysorbate 80;

[0011] The humectant is glycerin;

[0012] The pH adjuster is one or more of citric acid, citrate, hydrogen citrate, tartrate, hydrogen tartrate, and phosphate.

[0013] The antibacterial agent is sodium benzoate;

[0014] The sweetener is sucrose;

[0015] The flavoring agent is an edible flavoring.

[0016] The colorant is a food coloring.

[0017] The pH adjuster is preferably citric acid.

[0018] A method for preparing an ibuprofen suspension.

[0019] (1) Pass ibuprofen raw material through a 40-mesh sieve and set aside; mix sodium alginate with 50% of the prescribed amount of sweetener and set aside;

[0020] (2) Add 55% of the prescribed amount of purified water to the mixing tank, and add the sodium alginate and sweetener mixture from step (1) under homogeneous stirring to dissolve until no lumps are observed.

[0021] (3) Under homogeneous stirring, add microcrystalline cellulose-sodium carboxymethyl cellulose, the remaining 50% of sweetener, humectant, wetting agent, antibacterial agent and pH adjuster to the mixing tank and stir until no lumps are observed.

[0022] (4) Add the colorant to the mixing tank under homogeneous stirring and stir for 5 minutes;

[0023] (5) Add the flavoring agent to the mixing tank under homogenization and stirring for 5 minutes;

[0024] (6) Add the sieved ibuprofen raw material from step (1) into the mixing tank under homogenized stirring, and homogenize for 15 minutes.

[0025] (7) Add the remaining purified water to the mixing tank to make up the volume;

[0026] (8) Under homogeneous stirring, vacuum defoaming is performed until the negative pressure reaches above -0.05Mpa, and defoaming is carried out for 15 minutes;

[0027] (9) After the defoaming solution is removed, it is filled into a container to obtain ibuprofen suspension.

[0028] Compared with the prior art, the advantages of the present invention are:

[0029] This invention screens the types and amounts of suspending agents, and finally selects microcrystalline cellulose-sodium carboxymethyl cellulose and sodium alginate as suspending agents. When their dosage is 0.5 to 3.5 parts, the sedimentation volume ratio and the uniformity of the suspension content meet the requirements.

[0030] The present invention incorporates a homogenization process during the preparation process, which accelerates the dispersion and dissolution of the suspending agent, improves the uniformity of drug dispersion, shortens the preparation time, increases production efficiency, and reduces production costs. Attached Figure Description

[0031] Figure 1 This is a schematic diagram showing the sampling of ingredients to ensure uniformity of mixing in the mixing tank. Detailed Implementation

[0032] The present invention will be further described 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.

[0033] Ibuprofen suspensions for each example were prepared. The resulting products, after studies on dissolution, content determination, related substances testing, sedimentation volume ratio, and redispersibility, all met the relevant national regulations.

[0034] Example 1

[0035] The composition of ibuprofen suspension is as follows (batch size 1000ml):

[0036] The ingredients are: 20g ibuprofen raw material, 12g sodium carboxymethyl cellulose, 3g sodium alginate, 0.5g polysorbate 80, 80g glycerin, 300g sucrose, 2g citric acid, 2g sodium benzoate, 1g food coloring, and 0.5g food flavoring.

[0037] The preparation method is as follows:

[0038] (1) Pass ibuprofen raw material through a 40-mesh sieve and set aside; mix sodium alginate with 50% of the prescribed amount of sucrose and set aside;

[0039] (2) Add 55% of the prescribed amount of purified water to the mixing tank, and add the mixture of sodium alginate and sucrose under homogeneous stirring to dissolve until no lumps are observed.

[0040] (3) Under homogeneous stirring, add microcrystalline cellulose-sodium carboxymethyl cellulose, the remaining 50% of sucrose, glycerol, polysorbate 80, sodium benzoate and citric acid to the mixing tank and stir until no lumps are observed.

[0041] (4) Add the food coloring to the mixing tank under homogenization stirring and stir for 5 minutes;

[0042] (5) Add the edible flavoring to the ingredient container under homogenization and stirring for 5 minutes;

[0043] (6) Add the sieved ibuprofen raw material from step (1) into the mixing tank under homogenized stirring, and homogenize for 15 minutes.

[0044] (7) Add the remaining purified water to the mixing tank to make up the volume;

[0045] (8) Under homogeneous stirring, vacuum defoaming is performed until the negative pressure reaches above -0.05Mpa, and defoaming is carried out for 15 minutes;

[0046] (9) After defoaming, the medicine solution is filled into 100ml bottles to obtain ibuprofen suspension.

[0047] Example 2

[0048] The composition of ibuprofen suspension is as follows (batch size 1000ml):

[0049] The ingredients are: 20g ibuprofen raw material, 12.86g sodium carboxymethyl cellulose, 2.14g sodium alginate, 0.5g polysorbate 80, 80g glycerin, 300g sucrose, 2g citric acid, 2g sodium benzoate, 1g food coloring, and 0.5g food flavoring.

[0050] The preparation method is as follows:

[0051] (1) Pass ibuprofen raw material through a 40-mesh sieve and set aside; mix sodium alginate with 50% of the prescribed amount of sucrose and set aside;

[0052] (2) Add 55% of the prescribed amount of purified water to the mixing tank, and add the mixture of sodium alginate and sucrose under homogeneous stirring to dissolve until no lumps are observed.

[0053] (3) Under homogeneous stirring, add microcrystalline cellulose-sodium carboxymethyl cellulose, the remaining 50% of sucrose, glycerol, polysorbate 80, sodium benzoate and citric acid to the mixing tank and stir until no lumps are observed.

[0054] (4) Add the food coloring to the mixing tank under homogenization stirring and stir for 5 minutes;

[0055] (5) Add the edible flavoring to the ingredient container under homogenization and stirring for 5 minutes;

[0056] (6) Add the sieved ibuprofen raw material from step (1) into the mixing tank under homogenized stirring, and homogenize for 15 minutes.

[0057] (7) Add the remaining purified water to the mixing tank to make up the volume;

[0058] (8) Under homogeneous stirring, vacuum defoaming is performed until the negative pressure reaches above -0.05Mpa, and defoaming is carried out for 15 minutes;

[0059] (9) After defoaming, the medicine solution is filled into 100ml bottles to obtain ibuprofen suspension.

[0060] Homogenization

[0061] Example 3

[0062] The composition of ibuprofen suspension is as follows (batch size 1000ml):

[0063] The ingredients are: 20g ibuprofen raw material, 10g sodium carboxymethyl cellulose, 5g sodium alginate, 0.5g polysorbate 80, 80g glycerin, 300g sucrose, 2g citric acid, 2g sodium benzoate, 1g food coloring, and 0.5g food flavoring.

[0064] The preparation method is as follows:

[0065] (1) Pass ibuprofen raw material through a 40-mesh sieve and set aside; mix sodium alginate with 50% of the prescribed amount of sucrose and set aside;

[0066] (2) Add 55% of the prescribed amount of purified water to the mixing tank, and add the mixture of sodium alginate and sucrose under homogeneous stirring to dissolve until no lumps are observed.

[0067] (3) Under homogeneous stirring, add microcrystalline cellulose-sodium carboxymethyl cellulose, the remaining 50% of sucrose, glycerol, polysorbate 80, sodium benzoate and citric acid to the mixing tank and stir until no lumps are observed.

[0068] (4) Add the food coloring to the mixing tank under homogenization stirring and stir for 5 minutes;

[0069] (5) Add the edible flavoring to the ingredient container under homogenization and stirring for 5 minutes;

[0070] (6) Add the sieved ibuprofen raw material from step (1) into the mixing tank under homogenized stirring, and homogenize for 15 minutes.

[0071] (7) Add the remaining purified water to the mixing tank to make up the volume;

[0072] (8) Under homogeneous stirring, vacuum defoaming is performed until the negative pressure reaches above -0.05Mpa, and defoaming is carried out for 15 minutes;

[0073] (9) After defoaming, the medicine solution is filled into 100ml bottles to obtain ibuprofen suspension.

[0074] Homogenization

[0075] Comparative Example 1

[0076] The difference from Example 1 is that the suspending agent is hydroxypropyl methylcellulose, while everything else is the same as in Example 1, specifically:

[0077] The composition of ibuprofen suspension is as follows (batch size 1000ml):

[0078] The ingredients are: 20g ibuprofen raw material, 15g hydroxypropyl methylcellulose, 0.5g polysorbate 80, 80g glycerin, 300g sucrose, 2g citric acid, 2g sodium benzoate, 1g food coloring, and 0.5g food flavoring.

[0079] The preparation method is as follows:

[0080] (1) Pass ibuprofen raw material through a 40-mesh sieve and set aside; mix hydroxypropyl methylcellulose with 50% of the prescribed amount of sucrose and set aside;

[0081] (2) Add 55% of the prescribed amount of purified water to the mixing tank, and add the mixture of hydroxypropyl methylcellulose and sucrose under homogeneous stirring to dissolve until no lumps are observed.

[0082] (3) Under homogeneous stirring, add the remaining 50% of sucrose, glycerin, polysorbate 80, sodium benzoate and citric acid to the mixing tank and stir until no lumps are observed.

[0083] (4) Add the food coloring to the mixing tank under homogenization stirring and stir for 5 minutes;

[0084] (5) Add the edible flavoring to the ingredient container under homogenization and stirring for 5 minutes;

[0085] (6) Add the sieved ibuprofen raw material from step (1) into the mixing tank under homogenized stirring, and homogenize for 15 minutes.

[0086] (7) Add the remaining purified water to the mixing tank to make up the volume;

[0087] (8) Under homogeneous stirring, vacuum defoaming is performed until the negative pressure reaches above -0.05Mpa, and defoaming is carried out for 15 minutes;

[0088] (9) After defoaming, the medicine solution is filled into 100ml bottles to obtain ibuprofen suspension.

[0089] Comparative Example 2

[0090] The difference from Example 1 is that the suspending agent is hydroxypropyl cellulose and xanthan gum; otherwise, it is the same as Example 1.

[0091] The composition of ibuprofen suspension is as follows (batch size 1000ml):

[0092] The ingredients are: 20g ibuprofen raw material, 12g hydroxypropyl cellulose, 3g xanthan gum, 0.5g polysorbate 80, 80g glycerin, 300g sucrose, 2g citric acid, 2g sodium benzoate, 1g food coloring, and 0.5g food flavoring.

[0093] The preparation method is as follows:

[0094] (1) Pass ibuprofen raw material through a 40-mesh sieve and set aside; mix xanthan gum with 50% of the prescribed amount of sucrose and set aside;

[0095] (2) Add 55% of the prescribed amount of purified water to the mixing tank, and add the mixture of xanthan gum and sucrose under homogeneous stirring to dissolve until no lumps are observed.

[0096] (3) Under homogeneous stirring, add hydroxypropyl cellulose, the remaining 50% of sucrose, glycerin, polysorbate 80, sodium benzoate and citric acid to the mixing tank and stir until no lumps are observed.

[0097] (4) Add the food coloring to the mixing tank under homogenization stirring and stir for 5 minutes;

[0098] (5) Add the edible flavoring to the ingredient container under homogenization and stirring for 5 minutes;

[0099] (6) Add the sieved ibuprofen raw material from step (1) into the mixing tank under homogenized stirring, and homogenize for 15 minutes.

[0100] (7) Add the remaining purified water to the mixing tank to make up the volume;

[0101] (8) Under homogeneous stirring, vacuum defoaming is performed until the negative pressure reaches above -0.05Mpa, and defoaming is carried out for 15 minutes;

[0102] (9) After defoaming, the medicine solution is filled into 100ml bottles to obtain ibuprofen suspension.

[0103] Comparative Example 3

[0104] The difference from Example 1 is that the mass ratio of the suspending agent microcrystalline cellulose-sodium carboxymethyl cellulose and sodium alginate is 7:1, while the rest is the same as in Example 1.

[0105] The composition of ibuprofen suspension is as follows (batch size 1000ml):

[0106] The ingredients are: 20g ibuprofen raw material, 13.12g sodium carboxymethyl cellulose, 1.88g sodium alginate, 0.5g polysorbate 80, 80g glycerin, 300g sucrose, 2g citric acid, 2g sodium benzoate, 1g food coloring, and 0.5g food flavoring.

[0107] The preparation method is as follows:

[0108] (1) Pass ibuprofen raw material through a 40-mesh sieve and set aside; mix sodium alginate with 50% of the prescribed amount of sucrose and set aside;

[0109] (2) Add 55% of the prescribed amount of purified water to the mixing tank, and add the mixture of sodium alginate and sucrose under homogeneous stirring to dissolve until no lumps are observed.

[0110] (3) Under homogeneous stirring, add microcrystalline cellulose-sodium carboxymethyl cellulose, the remaining 50% of sucrose, glycerol, polysorbate 80, sodium benzoate and citric acid to the mixing tank and stir until no lumps are observed.

[0111] (4) Add the food coloring to the mixing tank under homogenization stirring and stir for 5 minutes;

[0112] (5) Add the edible flavoring to the ingredient container under homogenization and stirring for 5 minutes;

[0113] (6) Add the sieved ibuprofen raw material from step (1) into the mixing tank under homogenized stirring, and homogenize for 15 minutes.

[0114] (7) Add the remaining purified water to the mixing tank to make up the volume;

[0115] (8) Under homogeneous stirring, vacuum defoaming is performed until the negative pressure reaches above -0.05Mpa, and defoaming is carried out for 15 minutes;

[0116] (9) After defoaming, the medicine solution is filled into 100ml bottles to obtain ibuprofen suspension.

[0117] Comparative Example 4

[0118] The difference from Example 1 is that the mass ratio of the suspending agent microcrystalline cellulose-sodium carboxymethyl cellulose and sodium alginate is 1:1, while the rest is the same as in Example 1.

[0119] The composition of ibuprofen suspension is as follows (batch size 1000ml):

[0120] The ingredients are: 20g ibuprofen raw material, 7.5g sodium carboxymethyl cellulose, 7.5g sodium alginate, 0.5g polysorbate 80, 80g glycerin, 300g sucrose, 2g citric acid, 2g sodium benzoate, 1g food coloring, and 0.5g food flavoring.

[0121] The preparation method is as follows:

[0122] (1) Pass ibuprofen raw material through a 40-mesh sieve and set aside; mix sodium alginate with 50% of the prescribed amount of sucrose and set aside;

[0123] (2) Add 55% of the prescribed amount of purified water to the mixing tank, and add the mixture of sodium alginate and sucrose under homogeneous stirring to dissolve until no lumps are observed.

[0124] (3) Under homogeneous stirring, add microcrystalline cellulose-sodium carboxymethyl cellulose, the remaining 50% of sucrose, glycerol, polysorbate 80, sodium benzoate and citric acid to the mixing tank and stir until no lumps are observed.

[0125] (4) Add the food coloring to the mixing tank under homogenization stirring and stir for 5 minutes;

[0126] (5) Add the edible flavoring to the ingredient container under homogenization and stirring for 5 minutes;

[0127] (6) Add the sieved ibuprofen raw material from step (1) into the mixing tank under homogenized stirring, and homogenize for 15 minutes.

[0128] (7) Add the remaining purified water to the mixing tank to make up the volume;

[0129] (8) Under homogeneous stirring, vacuum defoaming is performed until the negative pressure reaches above -0.05Mpa, and defoaming is carried out for 15 minutes;

[0130] (9) After defoaming, the medicine solution is filled into 100ml bottles to obtain ibuprofen suspension.

[0131] Comparative Example 5

[0132] The difference from Example 1 is that the preparation method is different, and homogenization was not performed. Specifically:

[0133] The composition of ibuprofen suspension is as follows (batch size 1000ml):

[0134] The ingredients are: 20g ibuprofen raw material, 12g sodium carboxymethyl cellulose, 3g sodium alginate, 0.5g polysorbate 80, 80g glycerin, 300g sucrose, 2g citric acid, 2g sodium benzoate, 1g food coloring, and 0.5g food flavoring.

[0135] The preparation method is as follows:

[0136] (1) Pass ibuprofen raw material through a 40-mesh sieve and set aside. Mix sodium alginate with 50% of the prescribed amount of sucrose and set aside.

[0137] (2) Add 55% of the prescribed amount of purified water to the mixing tank, and add the mixture of sodium alginate and sucrose under stirring to dissolve. Dissolve for 8-12 hours until no lumps are observed.

[0138] (3) Under stirring conditions, add microcrystalline cellulose-sodium carboxymethyl cellulose, the remaining 50% sucrose, glycerol, polysorbate 80, sodium benzoate and citric acid to the mixing tank and stir for 4-6 hours until no lumps are observed.

[0139] (4) While stirring, add the food coloring to the ingredient container and stir for 5 minutes;

[0140] (5) Add the edible flavoring to the ingredient container while stirring, and stir for 5 minutes;

[0141] (6) Add the sieved ibuprofen raw material from step (1) into the mixing tank while stirring, and stir for 60 minutes;

[0142] (7) Add the remaining purified water to the mixing tank to make up the volume, stir for 15 minutes, and let stand overnight for about 12 hours;

[0143] (8) Under stirring, vacuum defoaming is performed until the negative pressure reaches above -0.05Mpa, and defoaming is carried out for 15 minutes;

[0144] (9) After defoaming, the medicine solution is filled into 100ml bottles to obtain ibuprofen suspension.

[0145] Application examples

[0146] 1. Determination of sedimentation volume ratio

[0147] The method is as follows:

[0148] Take 50 ml of sample and pour it into a 100 ml stoppered graduated cylinder. Seal the cylinder tightly and shake vigorously for 1 minute. Record the initial height H0 of the suspension. Let it stand for 3 hours and record the final height H of the suspension. Calculate the sedimentation volume ratio using the formula: sedimentation volume ratio = H / H0, which should not be less than 0.90.

[0149] The suspensions prepared in Examples 1-3 of this invention were in three batches, with batch numbers 2301601, 2301602 and 2301603 respectively; the suspensions prepared in Comparative Examples 1-5 were in five batches, with batch numbers 2301604, 2301605, 2301606, 2301607 and 2301608 respectively; the sedimentation volume ratio of a commercially available formulation suspension (batch number 221101124, Shanghai Johnson & Johnson) and the suspensions prepared in the Examples and Comparative Examples were determined according to the above method, and the results are shown in Tables 1 and 2.

[0150] Table 1. Sedimentation volume ratio test results of examples, comparative examples, and commercially available formulations.

[0151] sample Example 1 Example 2 Example 3 Commercially available formulations batch number 2301601 2301602 2301603 221101124 Settlement volume ratio 1.00 1.01 1.02 1.00 sample Comparative Example 1 Comparative Example 2 Comparative Example 3 Comparative Example 5 batch number 2301604 2301605 2301606 2301608 Settlement volume ratio 0.96 0.98 0.95 0.95

[0152] Table 2. Results of accelerated sedimentation volume ratio tests for the examples, comparative examples, and commercially available formulations (40℃±2℃ / not exceeding 25% RH)

[0153]

[0154] As shown in Tables 1 and 2, the sedimentation volume ratios of the drugs in the embodiments of the present invention all meet the requirements. During the accelerated testing period, the sedimentation volume ratios of Examples 1-3 and the commercially available formulations were consistent at day 0 and also consistent during the accelerated testing period, all meeting the requirements. Comparative Examples 1-2, due to changes in the suspending agent, resulted in sedimentation volume ratio issues. Therefore, the sedimentation volume ratios of Comparative Examples 1 and 2 were significantly worse than those of Examples 1-3, and showed a clear decreasing trend during the accelerated testing period, approaching the limit at 6 months, posing a significant stability risk.

[0155] 2. Measurement of mixing uniformity

[0156] The method is as follows:

[0157] After the medicine solution is prepared, samples are taken at 10 locations in the mixing tank to test the mixing uniformity. See the sampling diagram below. Figure 1 Mixing uniformity samples were taken from Example 1 and Comparative Examples 3-5, and the test results are shown in Table 3.

[0158] Table 3. Results of mixing uniformity testing in the mixing tanks of Example 1 and Comparative Examples 3-5

[0159]

[0160] As shown in Tables 1 and 2, Comparative Example 3 significantly affected the sedimentation volume ratio of the formulation due to the altered ratio of microcrystalline cellulose-sodium carboxymethyl cellulose and sodium alginate. Therefore, only the specific ratio of microcrystalline cellulose-sodium carboxymethyl cellulose and sodium alginate in the embodiments of this invention can achieve uniform drug dispersion. Comparative Example 5, due to the lack of homogenization during preparation, experienced a decrease in the dispersion and dissolution rate of the suspending agent. The sedimentation volume ratio of Comparative Example 5 was significantly worse than that of Examples 1-3, and it showed a clear decreasing trend during accelerated testing, approaching its limit after 6 months of accelerated testing, posing a significant stability risk.

[0161] As shown in Table 3, compared with Comparative Examples 3-5, the RSD of the mixing uniformity of Example 1 is significantly lower than that of Comparative Examples 3-5. This indicates that the drug in Example 1 is fully and uniformly dispersed in the suspension. Furthermore, Example 1 does not require overnight storage; the drug solution can be filled immediately after preparation, shortening the production time and greatly improving production efficiency. Therefore, the ibuprofen suspension prepared by this invention can be directly filled after vacuum defoaming, while simultaneously solving the problems of poor stability and uniformity during long-term storage.

[0162] The embodiments are preferred embodiments of the present invention, but the embodiments of the present invention are not limited to the embodiments. Any changes, modifications, substitutions, combinations, or simplifications made without departing from the spirit and principle of the present invention shall be considered equivalent substitutions and shall be included within the protection scope of the present invention.

Claims

1. An ibuprofen suspension, characterized in that, Per 100ml of ibuprofen suspension, by weight: 2.0 parts ibuprofen raw material, 0.5-3.5 parts suspending agent, 0.01-0.07 parts wetting agent, 5-25 parts humectant, 0.1-0.5 parts pH adjuster, 0.1-0.5 parts antibacterial agent, 20-40 parts sweetener, 0.03-0.7 parts flavoring agent, 0.05-0.1 parts coloring agent, and the remainder is purified water; The suspending agents are sodium carboxymethyl cellulose and sodium alginate.

2. The ibuprofen suspension according to claim 1, characterized in that, The ibuprofen suspension per 100 ml by weight is as follows: 2.0 parts ibuprofen raw material, 0.5-3.5 parts suspending agent, 0.01-0.07 parts wetting agent, 5-25 parts humectant, 0.1-0.5 parts pH adjuster, 0.1-0.5 parts antibacterial agent, 20-40 parts sweetener, 0.03-0.7 parts flavoring agent, 0.05-0.1 parts coloring agent, and the balance being purified water.

3. The ibuprofen suspension according to claim 1, characterized in that, The suspending agent is a mixture of microcrystalline cellulose-sodium carboxymethyl cellulose and sodium alginate in a weight ratio of 6:1 to 2:

1.

4. The ibuprofen suspension according to claim 1, characterized in that, The wetting agent is polysorbate 80; The humectant is glycerin; The pH adjuster is one or more of citric acid, citrate, hydrogen citrate, tartrate, hydrogen tartrate, and phosphate. The antibacterial agent is sodium benzoate; The sweetener is sucrose; The flavoring agent is an edible flavoring. The colorant is a food coloring.

5. The ibuprofen suspension according to claim 4, characterized in that, The pH adjuster is preferably citric acid.

6. A method for preparing the ibuprofen suspension according to claim 3, characterized in that: (1) Pass ibuprofen raw material through a 40-mesh sieve and set aside; mix sodium alginate with 50% of the prescribed amount of sweetener and set aside; (2) Add 55% of the prescribed amount of purified water to the mixing tank, and add the sodium alginate and sweetener mixture from step (1) under homogeneous stirring to dissolve until no lumps are observed. (3) Under homogeneous stirring, add microcrystalline cellulose-sodium carboxymethyl cellulose, the remaining 50% of sweetener, humectant, wetting agent, antibacterial agent and pH adjuster to the mixing tank and stir until no lumps are observed. (4) Add the colorant to the mixing tank under homogeneous stirring and stir for 5 minutes; (5) Add the flavoring agent to the mixing tank under homogenization and stirring for 5 minutes; (6) Add the sieved ibuprofen raw material from step (1) into the mixing tank under homogenized stirring, and homogenize for 15 minutes. (7) Add the remaining purified water to the mixing tank to make up the volume; (8) Under homogeneous stirring, vacuum defoaming is performed until the negative pressure reaches above -0.05Mpa, and defoaming is carried out for 15 minutes; (9) After the defoaming solution is removed, it is filled into a container to obtain ibuprofen suspension.

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