A compound sulfate oral composition and a method for preparing the same

Abstract

The application provides a compound sulfate oral composition, which comprises the following raw and auxiliary materials in parts by weight: 16.66-20.36 parts of magnesium sulfate, 88.98-108.75 parts of sodium sulfate, 15.91-19.44 parts of potassium sulfate, 1.0 part of a bacteriostatic agent, 3.0 parts of a sweetening agent, 2.0 parts of a flavoring agent, 5.0 parts of a pH regulator, and the balance is pure water. The application is composed of main drugs (potassium sulfate, sodium sulfate and magnesium sulfate), a bacteriostatic agent, a sweetening agent, a pH regulator and a flavoring agent. The pH regulator in the components is fixed in a reasonable amount, and the pH value of the medicine solution is adjusted at the same time when the raw and auxiliary materials are dissolved, so that the process steps are simplified and the production time is saved. Meanwhile, the bacteriostatic agent and the pH regulator have a synergistic effect, which can improve the stability of the compound sulfate oral composition.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical formulation technology, and in particular to a compound sulfate oral composition and its preparation method. Background Technology

[0002] Colonoscopy is currently the simplest, safest, and most effective method for detecting intestinal tumors and precancerous lesions. The cleanliness of the intestines is a key factor in the success of a colonoscopy; inadequate bowel preparation before the examination will affect the insertion of the endoscope and observation, leading to missed diagnoses or examination failure. Therefore, high-quality bowel preparation is an essential step before a colonoscopy.

[0003] There are many methods for bowel preparation before colonoscopy. Traditionally, oral laxatives are used in conjunction with cleansing enemas, but this method has gradually decreased in clinical use due to the need for dietary restrictions, the cumbersome procedure, and potential damage to the colon. Methods of bowel preparation using oral medications are gaining increasing attention.

[0004] Commonly used oral medications include: (1) Traditional Chinese medicine preparations: such as senna leaves, castor oil, etc. However, due to their high irritation to the intestines and unsatisfactory cleansing effect, they are now rarely used. (2) Bulk-forming laxatives: such as polyethylene glycol electrolyte powder, sodium phosphate solution, etc. (3) Osmotic laxatives: such as magnesium sulfate, mannitol, etc. These medications are convenient to use and have a satisfactory cleansing effect, but they may cause electrolyte imbalance due to osmotic diarrhea. There are also clinical reports that the use of mannitol can cause altered consciousness and painful shock.

[0005] Compound sulfate preparations are a new type of intestinal cleansing drug. Because they contain sodium, potassium and magnesium ions, they can correct electrolyte imbalances in the human body, significantly reduce the incidence of adverse reactions, and also have the advantages of convenient use, significant intestinal cleansing effect, low irritation and good patient compliance.

[0006] Most existing preparation processes are quite cumbersome. Specifically, they require heating purified water and cooling the drug solution, which is time-consuming. Furthermore, most involve two filtration steps: first, filtering the concentrated solution through a 0.45μm membrane, and then filtering it again through a 0.22μm membrane after adjusting the volume. Therefore, the production process is complex and inefficient.

[0007] The present invention aims to address the shortcomings of existing technologies by providing a compound sulfate oral solution with relatively simple components, convenient production, and stable quality, as well as its preparation method. Summary of the Invention

[0008] In view of this, the method for preparing the compound sulfate oral composition provided by the present invention is simple and has good stability.

[0009] This invention provides a compound sulfate oral composition comprising the following raw and excipient materials in parts by weight: 16.66-20.36 parts magnesium sulfate, 88.98-108.75 parts sodium sulfate, 15.91-19.44 parts potassium sulfate, 1.0 part antibacterial agent, 3.0 parts sweetener, 2.0 parts flavoring, 5.0 parts pH adjuster, and the balance being purified water.

[0010] In some specific embodiments of the present invention, the compound sulfate oral composition comprises the following raw and auxiliary materials in parts by weight: 17-20 parts magnesium sulfate, 90-106 parts sodium sulfate, 16-19 parts potassium sulfate, 1.0 part antibacterial agent, 3.0 parts sweetener, 2.0 parts flavoring, 5.0 parts pH adjuster, and the balance being purified water.

[0011] In one specific embodiment of the present invention, the compound sulfate oral composition comprises the following raw and auxiliary materials in parts by weight: 18.51 parts magnesium sulfate, 98.87 parts sodium sulfate, 17.68 parts potassium sulfate, 1.0 part antibacterial agent, 3.0 parts sweetener, 2.0 parts flavoring, 5.0 parts pH adjuster, and the balance being purified water.

[0012] In some specific embodiments of the present invention, each 1000 mL of the compound sulfate oral composition contains the following components: 16.66–20.36 g magnesium sulfate, 88.98–108.75 g sodium sulfate, 15.91–19.44 g potassium sulfate, 1.0 g antibacterial agent, 3.0 g sweetener, 2.0 g flavoring, 5.0 g pH adjuster, and the balance being purified water.

[0013] In one specific embodiment of the present invention, each 1000 mL of the compound sulfate oral composition contains the following components: 18.51 g magnesium sulfate, 98.87 g sodium sulfate, 17.68 g potassium sulfate, 1.0 g antibacterial agent, 3.0 g sweetener, 2.0 g flavoring, 5.0 g pH adjuster, and the balance being purified water.

[0014] According to the present invention, the magnesium sulfate is magnesium sulfate heptahydrate, and the dosage is 16.66 g / L to 20.36 g / L; specifically, it can be 16.66 g / L, 17.66 g / L, 18.66 g / L, 19.66 g / L, 20.36 g / L; or any value within the range of the above two. The preferred dosage is 18.51 g / L.

[0015] According to the present invention, the sodium sulfate is anhydrous sodium sulfate, and the dosage is 88.98 g / L to 108.75 g / L; specifically, it can be: 88.98 g / L, 89.98 g / L, 90.98 g / L, 91.98 g / L, 92.98 g / L, 93.98 g / L, 94.98 g / L, 95.98 g / L, 96.98 g / L, 97.98 g / L, 98.98 g / L, 99.98 g / L, 100.98 g / L, 101.98 g / L, 102.98 g / L, 103.98 g / L, 104.98 g / L, 105.98 g / L, 106.98 g / L, 107.98 g / L, 108.75 g / L; or any value within the range of the above two. The preferred dosage is 98.87 g / L.

[0016] Specifically, the potassium sulfate is anhydrous potassium sulfate, and the dosage is 15.91 g / L to 19.44 g / L. Specifically, it can be 15.91 g / L, 16.91 g / L, 17.91 g / L, 18.91 g / L, or 19.44 g / L. The preferred dosage is 17.68 g / L.

[0017] The above refers only to the working concentration. The actual reserve concentration can be 2 to 100 times higher, and then diluted to obtain the final concentration. This invention does not limit the concentration.

[0018] According to the present invention, a compound sulfate oral composition comprises 1.0 part of an antibacterial agent; said antibacterial agent includes one or more of sodium benzoate, potassium sorbate, and sodium ethylparaben;

[0019] A compound sulfate oral composition comprising 5.0 parts of a pH adjuster; wherein the pH adjuster is one or more of malic acid, citric acid and tartaric acid.

[0020] The inventors have made a creative discovery that the above-mentioned antibacterial agent and pH adjuster have a synergistic effect, which can improve the stability of the compound sulfate oral composition of the present invention.

[0021] The present invention relates to a compound sulfate oral composition comprising 3.0 parts of sweetener and 2.0 parts of flavoring.

[0022] The sweeteners of this invention include one or more of sodium saccharin, sucralose, and aspartame. The flavorings include one or more of sweet orange, strawberry, and banana flavorings.

[0023] The present invention provides a method for preparing a compound sulfate oral composition, comprising the following steps:

[0024] A) Mix magnesium sulfate, sodium sulfate, potassium sulfate, antibacterial agent, sweetener, pH adjuster, flavoring and purified water at room temperature and stir to obtain a mixture;

[0025] B) The mixture is filtered while the medicine is filled into bottles and sealed to obtain the product.

[0026] The present invention provides a compound sulfate oral composition, which firstly mixes magnesium sulfate, sodium sulfate, potassium sulfate, antibacterial agent, sweetener, pH adjuster, flavoring and purified water at room temperature;

[0027] The preferred option is as follows:

[0028] Take 60% of the prepared volume of room temperature purified water into a preparation tank, turn on the stirrer, and add magnesium sulfate, sodium sulfate, potassium sulfate, antibacterial agent, sweetener, pH adjuster, and flavoring in sequence. Then, use the weight-volume method to add room temperature purified water to make up the total volume. Continue stirring until all raw and auxiliary materials are completely dissolved and mixed evenly. Then, turn off the stirrer to obtain the intermediate product.

[0029] The method for adjusting the volume of the medicine solution used in this invention is the weight-based volume adjustment method, which involves converting the theoretical volume of the prepared solution into weight based on the known relative density of the finished medicine solution.

[0030] Specifically, when the compound sulfate oral composition contains the following parts by weight of raw and excipient materials: 18.51 parts magnesium sulfate, 98.87 parts sodium sulfate, 17.68 parts potassium sulfate, 1.0 part antibacterial agent, 3.0 parts sweetener, 2.0 parts flavoring, and 5.0 parts pH adjuster, the relative density of the finished drug solution used for conversion is 1.105±0.003.

[0031] This invention innovatively uses room temperature mixing, which saves energy consumption and steps compared to heating mixing, making the solution simpler.

[0032] Meanwhile, this invention uses weight to determine volume, making the quantitative determination simpler and eliminating the need for multi-step mixing. In addition, this invention adds a specific pH adjuster, eliminating the need for additional pH adjustment steps.

[0033] The present invention has already clearly described the above components and proportions, and will not repeat them here.

[0034] The pH value of the mixture described in this invention is 2.5 to 3.5.

[0035] The mixture is filtered while the medicine is filled into bottles, and then sealed to obtain the product.

[0036] According to the present invention, the method of simultaneously filtering and filling the medicine is as follows: the preparation tank, sanitary pump, filter, medicine storage tank and filling machine are connected by pipeline; the sanitary pump and filling machine are turned on in sequence, and the filtered medicine is filled and sealed at the same time as filtering to obtain the finished product.

[0037] Specifically: the liquid outlet of the preparation tank is connected to the liquid inlet of the sanitary pump, the liquid outlet of the sanitary pump is connected to the liquid inlet of the filter, the liquid outlet of the filter is connected to the liquid inlet of the medicine storage tank, and the medicine storage tank has one liquid outlet at the top and one at the bottom, which are respectively connected to the liquid inlet of the preparation tank and the filling machine.

[0038] The medicine storage tank has an outlet at the top and a outlet at the bottom. The bottom outlet is connected to the filling machine, where the filtered medicine can be filled and sealed. The top outlet is connected to the inlet of the preparation tank, where any filtered medicine exceeding the capacity of the storage tank can be returned to the preparation tank.

[0039] This invention creatively utilizes the above-mentioned filtration method to save steps and time in filling the medicine solution, making the method more convenient.

[0040] In this invention, the filter element used for filtration has a pore size of 0.8μm to 1.2μm; specifically, it can be 0.8μm, 0.9μm, 1.0μm, 1.1μm, 1.2μm; or any value between the two mentioned above.

[0041] The filter element is made of one of the following materials: polypropylene, titanium, or polytetrafluoroethylene.

[0042] This invention provides a compound sulfate oral preparation comprising the composition described in any one of the above technical solutions.

[0043] This invention also includes excipients commonly used in the pharmaceutical field, but this invention does not limit these excipients.

[0044] The compound sulfate oral composition provided by this invention has a relatively simple composition, consisting of the main drug (potassium sulfate, sodium sulfate, magnesium sulfate), antibacterial agent, sweetener, pH adjuster, and flavoring. The pH adjuster in the composition is fixed at a reasonable dosage, and the pH adjustment of the drug solution is completed at the same time as dissolving the raw materials and excipients, which simplifies the process steps and saves production time.

[0045] The preparation method of the compound sulfate oral composition provided by the present invention adopts the weight-to-volume method for preparing the drug solution. It does not require waiting for all raw and excipient materials to be completely dissolved before volume adjustment. Therefore, a large amount of purified water is needed to dissolve the raw and excipient materials. Room temperature purified water can meet the requirements for solution preparation. The purified water and drug solution do not need to be heated or cooled, which greatly saves solution preparation time and simplifies the process steps.

[0046] The method for preparing compound sulfate oral composition provided by the present invention connects the filtration process and the filling process in series through a clever pipeline connection, so that the filling of the drug solution can be completed at the same time as filtration, which simplifies the process steps and improves production efficiency.

[0047] In summary, the compound sulfate oral composition and its preparation method provided by the present invention require only two process steps to prepare the raw materials into a finished drug product. The prescription process is simple, the production is fast, and the finished drug product is of stable quality, safe and effective. Detailed Implementation

[0048] This invention provides a compound sulfate oral composition and its preparation method. Those skilled in the art can refer to the content of this document and appropriately modify the process parameters to achieve the desired result. It should be particularly noted that all similar substitutions and modifications are obvious to those skilled in the art and fall within the scope of protection of this invention. The method and application of this invention have been described through preferred embodiments. Those skilled in the art can clearly modify or appropriately change and combine the method and application described herein without departing from the content, spirit, and scope of this invention to realize and apply the technology of this invention.

[0049] It should be understood that the expression “one or more of…” individually includes each of the objects described after the expression, as well as various different combinations of two or more of the described objects, unless otherwise understood from the context and usage. The expression “and / or” combined with three or more described objects should be understood to have the same meaning, unless otherwise understood from the context.

[0050] The terms “including,” “having,” or “containing,” including the use of their grammatical synonyms, should generally be understood as open-ended and non-restrictive, for example, not excluding other unstated elements or steps, unless otherwise specifically stated or understood from the context.

[0051] In this application, the term "and / or" describes the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent: A existing alone, A and B existing simultaneously, or B existing alone. A and B can be singular or plural.

[0052] In this application, "at least one" means one or more, and "more than one" means two or more. "At least one of the following" or similar expressions refer to any combination of these items, including any combination of single or multiple items.

[0053] It should be understood that the order of the steps or the order in which certain actions are performed is not important as long as the invention remains operational. Furthermore, two or more steps or actions can be performed simultaneously.

[0054] The use of any and all instances or exemplary language such as “e.g.” or “including” in this document is merely intended to better illustrate the invention and is not intended to limit the scope of the invention unless the claims are made. No language in this specification should be construed as indicating that any unclaimed element is essential to the practice of the invention.

[0055] Furthermore, the numerical ranges and parameters used to define the present invention are approximate values, and the relevant values ​​in the specific embodiments have been presented as precisely as possible. However, any value inevitably contains standard deviations due to individual test methods. Therefore, unless explicitly stated otherwise, it should be understood that all ranges, quantities, values, and percentages used in this disclosure are modified with the word "approximately." Here, "approximately" generally means an actual value within plus or minus 10%, 5%, 1%, or 0.5% of a particular value or range.

[0056] It should be understood that in the various embodiments of this application, the order of the above processes does not imply the order of execution. Some or all steps may be executed in parallel or sequentially. The execution order of each process should be determined by its function and internal logic, and should not constitute any limitation on the implementation process of the embodiments of this application.

[0057] The embodiments and comparative examples of this invention describe some examples, in which the embodiments illustrate certain implementations of the invention. However, this does not mean that the effects of the invention can only be achieved in these examples.

[0058] To further illustrate the present invention, the following describes in detail, with reference to embodiments, a compound sulfate oral composition and its preparation method provided by the present invention.

[0059] Example 1

[0060] (1) Components

[0061]

[0062] (2) Preparation method

[0063] ① Take 60 kg (about 60 L) of room temperature purified water into a 200 L preparation tank, turn on the stirrer, and add magnesium sulfate, sodium sulfate, potassium sulfate, potassium sorbate, sodium saccharin, tartaric acid, and banana flavoring in sequence. Add room temperature purified water to make up to 110.5 kg, stir until all raw and auxiliary materials are dissolved and mixed evenly, and then turn off the stirrer to obtain the intermediate product.

[0064] ② Install a 1.0μm pore size polytetrafluoroethylene filter element on the filter, connect the preparation tank, sanitary pump, filter, medicine storage tank and filling machine through pipelines, turn on the sanitary pump and filling machine in sequence, filter and fill the medicine to obtain the finished product.

[0065] Example 2

[0066] (1) Components

[0067]

[0068] (2) Preparation method

[0069] ① Take 180 kg (about 180 L) of room temperature purified water into a 500 L preparation tank, turn on the stirrer, and add magnesium sulfate, sodium sulfate, potassium sulfate, sodium benzoate, sucralose, malic acid, and sweet orange flavoring in sequence. Add room temperature purified water to make up to 331.5 kg, stir until all raw and auxiliary materials are dissolved and mixed evenly, and then turn off the stirrer to obtain the intermediate product.

[0070] ② Install a 0.8μm pore size polypropylene filter element on the filter, connect the preparation tank, sanitary pump, filter, medicine storage tank and filling machine through pipelines, turn on the sanitary pump and filling machine in sequence, filter and fill the medicine to obtain the finished product.

[0071] Example 3

[0072] (1) Components

[0073]

[0074]

[0075] (2) Preparation method

[0076] ① Take 300 kg (about 300 L) of room temperature purified water into a 1500 L preparation tank, turn on the stirrer, and add magnesium sulfate, sodium sulfate, potassium sulfate, sodium ethylparaben, aspartame, citric acid and strawberry flavoring in sequence. Add room temperature purified water to make up to 552.5 kg, stir until all raw and auxiliary materials are dissolved and mixed evenly, then turn off the stirrer to obtain the intermediate product.

[0077] ② Install a 1.0μm pore size polypropylene filter element on the filter, connect the preparation tank, sanitary pump, filter, medicine storage tank and filling machine through pipelines, turn on the sanitary pump and filling machine in sequence, filter and fill the medicine to obtain the finished product.

[0078] Example 4

[0079] (1) Components

[0080]

[0081] (2) Preparation method

[0082] ① Take 600 kg (about 600 L) of room temperature purified water into a 1500 L preparation tank, and add magnesium sulfate, sodium sulfate, potassium sulfate, sodium benzoate, sodium ethylparaben, sodium saccharin, aspartame, tartaric acid, citric acid, malic acid, banana flavor and strawberry flavor in sequence. Add room temperature purified water to make up to 1105.0 kg, stir until all raw and auxiliary materials are dissolved and mixed evenly, and then turn off the stirring to obtain the intermediate product;

[0083] ② Install a titanium rod filter element with a pore size of 1.2μm on the filter. Connect the preparation tank, sanitary pump, filter, medicine storage tank and filling machine through pipelines. Turn on the sanitary pump and filling machine in sequence to filter and fill the medicine to obtain the finished product.

[0084] Comparative Example 1 Low Temperature Stability

[0085] The compound sulfate oral composition provided by this invention is a high-concentration sulfate solution that easily precipitates crystals at low temperatures. The type and dosage of the pH adjuster provided by this invention can ensure the stability of the compound sulfate oral composition at low temperatures. According to the prescription components and dosages of Example 1, control sample 1 (without pH adjuster), control sample 2 (with 5.0 parts of fumaric acid as pH adjuster), and control sample 3 (with 2.0 parts of tartaric acid as pH adjuster) were prepared. These samples were placed at low temperature (2℃~8℃) for 5 days, and changes in properties were observed. Simultaneously, samples from Example 1, Example 2, Example 3, and Example 4 were tested. The sample comparison and test results are as follows.

[0086] Table 1: Low-temperature stability of the example samples and comparative sample

[0087]

[0088] As can be seen from the table above, the types and amounts of pH adjusters provided by this invention can effectively ensure the quality stability of the product at low temperatures.

[0089] Comparative Example 2 Antibacterial Efficacy Test

[0090] According to the formulation components and dosage of Example 1, a control sample 4 with an antibacterial agent dosage of 0.25 parts was prepared. The antibacterial efficacy of the Example 1 sample, control sample 1, control sample 3, and control sample 4 was tested according to the Chinese Pharmacopoeia 2020 edition, Part IV, General Chapter <1121 Antibacterial Efficacy Test Method>. The differences in formulation among the samples are shown in Table 2, and the results of the antibacterial efficacy test are shown in Tables 3 to 6.

[0091] Table 2: Differences in prescriptions among samples

[0092] sample Example 1 Comparison Sample 1 Comparison Sample 3 Comparison Sample 4 Types of antibacterial agents Potassium sorbate Potassium sorbate Potassium sorbate Potassium sorbate Dosage of antibacterial agent 1.0 copy 1.0 copy 1.0 copy 0.25 copies Types of pH adjusters tartaric acid none tartaric acid tartaric acid pH adjuster dosage 5.0 copies none 2.0 copies 5.0 copies

[0093] Table 3: Results of the antibacterial efficacy test of the sample in Example 1

[0094]

[0095] Table 4: Results of the antibacterial efficacy test for control sample 1

[0096]

[0097] Table 5: Results of the antibacterial efficacy test for control sample 3

[0098]

[0099] Table 6: Results of the antibacterial efficacy test for control sample 4

[0100]

[0101] As can be seen from the antibacterial efficacy test results in Tables 3 to 6, the selected pH adjuster and antibacterial agent have a synergistic effect at the dosage provided by this invention. The product has excellent antibacterial ability and can better ensure that the product will not change in quality due to microbial contamination during storage and use.

[0102] Example 5

[0103] Samples from Example 1 were taken and, in accordance with the relevant provisions of the Chinese Pharmacopoeia 2020 Edition, Part IV, <9001 Guidelines for Stability Testing of Raw Materials and Preparations>, were placed in a 60℃ constant temperature incubator and a light exposure chamber for drug influencing factor investigation tests, and freeze-thaw cycle tests were also conducted. The results of the influencing factor tests and freeze-thaw cycle tests are as follows:

[0104] Table 7: Results of Influencing Factor Test and Freeze-Thaw Cycle Test for Samples in Example 1

[0105]

[0106]

[0107] After high temperature, light exposure, and freeze-thaw cycle tests, the pH value, clarity and color, relative density, potassium sorbate, sodium, potassium, magnesium and total sulfate of the sample in Example 1 did not change significantly compared with day 0, indicating that the compound sulfate oral composition prepared according to the component ratio and preparation method provided in this patent has relatively stable quality.

[0108] Example 6

[0109] Samples from Example 2 were taken and subjected to accelerated drug stability testing according to the relevant provisions of the Chinese Pharmacopoeia 2020 Edition, Part IV, <9001 Guidelines for Stability Testing of Drug Substances and Preparations>, at a temperature of 40℃±2℃ and a relative humidity of 25%±5%. The testing period was 6 months, with samples taken and tested in January, February, March, and June. The results of the accelerated testing are as follows:

[0110] Table 8: Accelerated Test Results of Samples in Example 2

[0111]

[0112]

[0113] The sample in Example 2 was subjected to accelerated testing for up to 6 months. Compared with 0 months, the quality indicators such as appearance, pH value, clarity and color, relative density, sodium benzoate, sodium, potassium, magnesium and total sulfate did not change significantly, indicating that the compound sulfate oral composition prepared according to the component ratio and preparation method provided in this patent has relatively stable quality.

[0114] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A compound sulfate oral composition, characterized in that, The raw materials and excipients contain the following parts by weight: magnesium sulfate 16.66-20.36 parts, sodium sulfate 88.98-108.75 parts, potassium sulfate 15.91-19.44 parts, antibacterial agent 1.0 part, sweetener 3.0 parts, flavoring 2.0 parts, pH adjuster 5.0 parts, and the balance is purified water.

2. The composition according to claim 1, characterized in that, The compound sulfate oral composition comprises the following raw and auxiliary materials in parts by weight: 17-20 parts magnesium sulfate, 90-106 parts sodium sulfate, 16-19 parts potassium sulfate, 1.0 part antibacterial agent, 3.0 parts sweetener, 2.0 parts flavoring, 5.0 parts pH adjuster, and the balance being purified water.

3. The composition according to claim 2, characterized in that, The compound sulfate oral composition comprises the following raw and excipient materials in parts by weight: 18.51 parts magnesium sulfate, 98.87 parts sodium sulfate, 17.68 parts potassium sulfate, 1.0 part antibacterial agent, 3.0 parts sweetener, 2.0 parts flavoring, 5.0 parts pH adjuster, and the balance being purified water.

4. The composition according to claim 1, characterized in that, The magnesium sulfate in question is magnesium sulfate heptahydrate, and the dosage is 16.66 g / L to 20.36 g / L. The sodium sulfate is anhydrous sodium sulfate, and the dosage is 88.98 g / L to 108.75 g / L; The potassium sulfate is anhydrous potassium sulfate, and the dosage is 15.91 g / L to 19.44 g / L.

5. The composition according to claim 1, characterized in that, The antibacterial agent includes one or more of sodium benzoate, potassium sorbate, and sodium ethylparaben; The sweetener includes one or more of sodium saccharin, sucralose, and aspartame.

6. The composition according to claim 1, characterized in that, The flavoring includes one or more of sweet orange flavoring, strawberry flavoring, and banana flavoring; The pH adjuster is one or more of malic acid, citric acid, and tartaric acid.

7. A method for preparing a compound sulfate oral composition, characterized in that, Includes the following steps: A) Mix magnesium sulfate, sodium sulfate, potassium sulfate, antibacterial agent, sweetener, pH adjuster, flavoring and purified water at room temperature and stir to obtain a mixture; B) The mixture is filtered while the medicine is filled into bottles and sealed to obtain the product.

8. The preparation method according to claim 7, characterized in that, The filter element used in the filtration process has a pore size of 0.8μm to 1.2μm; the filter element is made of one of polypropylene, titanium, or polytetrafluoroethylene; and the pH value of the mixture is 2.5 to 3.

5.

9. The preparation method according to claim 7, characterized in that, The method for simultaneously filtering and filling the medicine solution is as follows: the preparation tank, sanitary pump, filter, medicine solution storage tank, and filling machine are connected by pipelines; Specifically: the liquid outlet of the preparation tank is connected to the liquid inlet of the sanitary pump, the liquid outlet of the sanitary pump is connected to the liquid inlet of the filter, the liquid outlet of the filter is connected to the liquid inlet of the medicine storage tank, and the medicine storage tank has one liquid outlet at the top and one at the bottom, which are respectively connected to the liquid inlet of the preparation tank and the filling machine.

10. A compound sulfate oral preparation, characterized in that, Includes the composition according to any one of claims 1 to 6.

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