Potassium chloride composition oral solution with excellent taste and preparation method thereof

Abstract

The invention relates to the technical field of oral preparation preparation processes, in particular to a potassium chloride composition oral solution with excellent taste and a preparation method thereof. According to the potassium chloride composition oral solution, a solvent and a solute are improved, so that the mouth feel of the oral solution is improved, the medicine taking compliance of a patient is improved, meanwhile, the technical problems that a potassium chloride oral solution in the prior art is poor in mouth feel, easy to freeze and the like can be solved, and the potassium chloride composition oral solution has ideal popularization and application prospects.

Description

Technical Field

[0001] The invention relates to the technical field of oral preparation preparation technology, and in particular to a potassium chloride composition oral solution with excellent taste and a preparation method thereof. Background Art

[0002] Hypokalemia is a common electrolyte disorder in clinical practice. Oral potassium supplementation is the safest. Existing oral potassium supplement preparations mainly include oral liquid, sustained-release tablets, sustained-release capsules, granules, powders, etc. Compared with solid preparations, liquid preparations are dispersed in the medium as particles or ions, with a large dispersion and fast absorption, and can exert their efficacy more quickly. Since the drug in the solution exists in an ionic state, it can be absorbed without dissolving. The absorption effect of oral liquid potassium chloride is better than that of tablets. Oral or nasogastric administration of liquid potassium chloride is still considered to be the preferred route of administration. The intestinal absorption is fast and complete, and can rapidly increase the potassium concentration in the extracellular fluid. Potassium chloride liquid itself is colorless and has no volatile odor, but it tastes salty, bitter, and astringent. Using traditional methods of administration, the taste is poor, causing nausea and loss of appetite.

[0003] The potassium chloride oral solution currently listed or produced by the prior art mainly has the problems of heavy bitter taste and bad mouthfeel, and the patient's medication compliance is not strong. Moreover, the potassium chloride oral solution is easily frozen in winter and needs to be taken after thawing, which is inconvenient to use. In addition, the potassium chloride oral solution produced by the prior art such as CN115969783A (a potassium chloride oral solution and its preparation method) is a colorless transparent solution. When taking it, it is not easy to identify the scale dosage due to the transparent color when using a plastic cup for dosage. At the same time, in order to prevent the oral solution from freezing, the patent adds a large dose of PEG 400 (containing 100mg of potassium chloride and 10-30mg of polyethylene glycol 400 in every 1mL) to ensure the stability of the properties of the potassium chloride oral solution when stored and transported under low temperature (-10°C). But the defect of this technology is that a large dose of PEG 400 increases the probability of side effects such as gastrointestinal discomfort (such as nausea and vomiting). In order to solve the above-mentioned defects, the Chinese invention patent with document number CN118384105A (a potassium chloride oral solution and its preparation method) discloses a potassium chloride oral preparation, which improves the stability and taste of the oral solution by adding a mixture of xanthan gum, gallic acid and hydroxyethyl cellulose as a stabilizer, and a mixture of glycerol and ethyl maltol as a flavoring agent, while meeting the requirements of low-temperature transportation and long-term storage. However, the defect of this technology is that the stabilizer and flavoring agent are too complicated, resulting in an increase in production and feeding costs and may affect product quality testing. At the same time, the overly complicated ingredients may increase the risk of allergies in patients during the use of the drug.

[0004] Therefore, in order to improve the taste of the existing potassium chloride oral solution and prevent the potassium chloride oral solution from freezing at low temperatures, it is urgent to develop a potassium chloride oral solution that has a good taste, can solve the problem of freezing of the oral solution and can be easily identified in divided doses. Summary of the invention

[0005] The present invention aims to provide a potassium chloride composition oral solution with good taste, so as to solve the technical problems of the potassium chloride oral solution in the prior art, such as poor taste and easy freezing.

[0006] In order to achieve the above object, the present invention adopts the following technical scheme:

[0007] A potassium chloride composition oral solution with excellent taste comprises a solvent and a solute, wherein the solute comprises potassium chloride, a sweetener, a preservative and a stabilizer, and the potassium chloride has a potassium ion concentration of 1.3 to 2.6 mEq / ml.

[0008] Furthermore, the oral solution also includes at least one of a flavor and a colorant.

[0009] Furthermore, the stabilizer is any one of glycerol and propylene glycol or a mixture of the two.

[0010] Further, the sweetener includes 2 to 4 mg / ml of sucralose, and the preservative includes 0.7 to 0.9 mg / ml of sodium benzoate;

[0011] Preferably, the oral solution solute also includes flavors and colorants;

[0012] Preferably, the stabilizer is any one of glycerol and propylene glycol or a mixture of the two.

[0013] Furthermore, the stabilizer is a 20-30 mg / ml glycerol propylene glycol mixture; preferably, the concentration of the glycerol propylene glycol mixture is 25 mg / ml.

[0014] Furthermore, in the glycerol propylene glycol mixture, the mass ratio of glycerol to propylene glycol is 1:1 to 1:1.5; more preferably, the mass ratio of glycerol to propylene glycol is 1:1.

[0015] Furthermore, the concentration of potassium chloride is 1.3mEq / ml or 2.6mEq / ml in terms of potassium ions; preferably, the concentration of the toner is 0.015mg / ml; preferably, the concentration of sucralose is 3mg / ml; preferably, the concentration of the flavor is 0.4mg / ml.

[0016] Furthermore, the solvent is citric acid-sodium citrate buffer.

[0017] Furthermore, the pH value of the citric acid-sodium citrate buffer is 3.8-4.2; preferably, the pH value of the citric acid-sodium citrate buffer is 4.0.

[0018] The technical solution also provides a method for preparing a potassium chloride composition oral solution with excellent taste, comprising the following steps performed in sequence:

[0019] S1: under stirring, sequentially adding sucralose and sodium benzoate to a glycerol propylene glycol mixture to obtain a mixture A;

[0020] S2: adding 50% to 95% of citric acid-sodium citrate buffer to mixture A, and stirring and mixing thoroughly to obtain mixture B;

[0021] S3: adding potassium chloride, flavor and colorant under stirring, dissolving and clarifying, and then using citric acid-sodium citrate buffer to make up the volume, stirring and mixing for 5 to 20 minutes to obtain mixture C;

[0022] S4: After the mixture C is filtered, a potassium chloride composition oral solution is obtained.

[0023] The principle and beneficial effects of this technical solution are:

[0024] The present invention uses potassium chloride as an active ingredient, and citric acid-sodium citrate buffer as a taste regulator, so that the potassium chloride oral solution has a comfortable citric acid taste, which masks the saltiness of potassium chloride, can well improve the taste of the oral solution, and improve the patient's medication compliance. At the same time, by adding a toner, the dosage scale can be well identified and distinguished, so that the sub-dosage is accurate, and the effectiveness and safety of the drug are improved. In addition, compared with other types of flavors, the sweet orange flavor added in the prescription contains almost no potassium ions, and does not affect the determination of potassium ions in the oral solution by ion chromatography. Finally, the innovation of the present invention also includes: the glycerol propylene glycol mixture is used as a stabilizer and a sweetener to adjust the astringency of the oral solution, improve the taste of the oral solution, and improve the patient's medication compliance. At the same time, the glycerol propylene glycol mixture is also used as an antifreeze, which can significantly prevent the oral solution from freezing at low temperatures, and is convenient for the transportation and storage of medicines.

[0025] Specifically, with regard to the stabilizer used in the present invention, in the glycerol propylene glycol mixture, the mixing ratio of glycerol and propylene glycol, and the addition amount of the glycerol propylene glycol mixture in the oral solution are very critical for the antifreeze performance and mouthfeel of the oral solution. Glycerol alone, or propylene glycol alone, can not effectively improve the mouthfeel of the oral solution (the astringency of the oral solution is not eliminated), nor can the antifreeze performance of the finished product be effectively improved (-5°C, -10°C preservation, the finished product freezes). Although the two substances alone can not show obvious improvement, after glycerol and propylene glycol are mixed in a specific ratio, the above problems can be overcome completely, which shows that after glycerol and propylene glycol are mixed, there is a certain synergistic effect in improving the mouthfeel and improving the antifreeze performance of the product. The proposal of this discovery uses a simpler way to solve the problem of poor stability of the existing potassium chloride oral solution. DETAILED DESCRIPTION

[0026] The following examples are only used to more clearly illustrate the technical solutions of the present invention, and are therefore only used as examples, and cannot be used to limit the scope of protection of the present invention. The specific embodiments listed in the present invention are only examples of the present invention, and the present invention is not limited to the specific embodiments described below. For those skilled in the art, any equivalent modifications and substitutions to the embodiments described below are also within the scope of the present invention. Therefore, equal transformations and modifications made without departing from the spirit and scope of the present invention should be included in the scope of the present invention. In order to better illustrate the present invention, numerous specific details are given in the specific embodiments below. Those skilled in the art should understand that the present invention can also be implemented without certain specific details. In other embodiments, methods, means, equipment and steps well known to those skilled in the art are not described in detail in order to highlight the purport of the present invention.

[0027] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by those of ordinary skill in the art. Unless otherwise specified, the units used in this specification are international standard units, and the numerical values ​​and numerical ranges appearing in the present invention should be understood to include inevitable systematic errors in industrial production. Unless otherwise specified, the experimental methods used in the following implementations are all conventional methods; the materials, reagents or instruments used without indicating the manufacturer are all reagents and materials available from commercial channels. Those without indicating specific conditions in the examples are all carried out according to conventional conditions or conditions recommended by the manufacturer. At the same time, the present invention does not limit the source of the raw materials used. Unless otherwise specified, the raw materials used in the present invention are all common commercial products in the field of this technology.

[0028] It should be noted that the raw material compositions used in the following examples are uniformly described in Table 1:

[0029] Table 1: Raw material composition (potassium chloride oral solution)

[0030] Name of raw materials and auxiliary materials content Potassium chloride (as potassium ion) 1.3–2.6 mEq / mL Sucralose 2~4mg / ml Sodium Benzoate 0.7~0.9mg / ml Sweet orange flavor 0.2~0.6mg / ml FD&C Yellow No. 6 0.01~0.02mg / ml Glycerin Propylene Glycol Mixture 20~30mg / ml

[0031] Use citric acid-sodium citrate buffer with a pH value of 3.8 to 4.2 as a solvent to prepare the oral solution, and use 0.1 mol / L citric acid solution and 0.1 mol / L sodium citrate solution to prepare it. Preferably, citric acid-sodium citrate buffer with a pH value of 4.0 is used to prepare the oral solution, and 0.1 mol / L citric acid solution and 0.1 mol / L sodium citrate solution are mixed in a volume ratio of 13.1:6.9 to obtain it. In the glycerol propylene glycol mixture, the mass ratio of glycerol to propylene glycol is 1:1 to 1:1.5. The specific preparation method of potassium chloride oral solution is as follows:

[0032] S1: Take the prescribed amount of glycerol propylene glycol mixture and add it to the liquid filling, add sucralose and sodium benzoate in sequence under stirring (20-30 rpm), and stir to dissolve;

[0033] S2: Add 70% to 80% (optional range 50% to 95%) of citric acid-sodium citrate buffer with a pH value of 3.8 to 4.2 to the above preparation tank, stir, stir (preferably using low speed stirring, for example, 20 to 30 rpm) and mix for 5 to 10 minutes;

[0034] S3: Add potassium chloride, sweet orange flavor, and FD&C Yellow No. 6 under stirring (20-30 rpm), dissolve and clarify, and finally make up to volume with citric acid-sodium citrate buffer with a pH value of 4.0, and stir and mix for 50-20 minutes;

[0035] S4: Filter with 600-mesh nylon filter cloth and dispense into oral liquid medicinal high-density polyethylene bottles (473 ml / bottle).

[0036] Example 1

[0037] Formula composition: 130mEq potassium (equivalent to about 10g potassium chloride), 0.3g sucralose, 0.08g sodium benzoate, 40mg sweet orange flavor, 1.5mg FD&C Yellow No. 6, 25g glycerol propylene glycol mixture (mass ratio of glycerol and propylene glycol: 1:1), use citric acid-sodium citrate buffer with a pH value of 4.0 as the solvent to prepare a 10% potassium chloride oral solution, with a total volume of 100mL.

[0038] Preparation process:

[0039] (1) Preparation of citric acid-sodium citrate buffer with a pH value of 4.0: Mix 0.1 mol / L citric acid solution and 0.1 mol / L sodium citrate solution (13.1:6.9).

[0040] (2) Preparation of oral solution: Take the prescribed amount of glycerol-propylene glycol mixture and add it to the liquid preparation tank. Add sucralose and sodium benzoate in turn while stirring (about 25 rpm) and stir to dissolve; add 80% of the amount of citric acid-sodium citrate buffer with a pH value of 4.0 to the above preparation tank, stir, and mix for about 10 minutes; add potassium chloride, sweet orange flavor, and FD&C Yellow No. 6 while stirring (about 25 rpm), dissolve and clarify, and finally make up to volume with citric acid-sodium citrate buffer with a pH value of 4.0, and stir and mix for about 20 minutes. Filter with a 600-mesh nylon filter cloth to obtain the finished product. If it is a large-scale preparation, it can be divided into oral liquid medicinal high-density polyethylene bottles (473 ml / bottle) to obtain the finished product.

[0041] Example 2

[0042] This embodiment is basically the same as embodiment 1, except that the content of potassium chloride is increased to 20%, that is, 260 mEq potassium (equivalent to about 20 g potassium chloride) is added.

[0043] Example 3

[0044] This embodiment is basically the same as Embodiment 1, except that in the glycerol propylene glycol mixture, the mass ratio of glycerol to propylene glycol is 1:1.5.

[0045] Example 4

[0046] This embodiment is basically the same as Embodiment 1, except that the amount of the glycerol propylene glycol mixture is 20 g.

[0047] Example 5

[0048] This embodiment is basically the same as Embodiment 1, except that the amount of the glycerol propylene glycol mixture is 30 g.

[0049] Experimental Example 1: Screening of Sodium Benzoate

[0050] Based on Example 1, experiments were designed with sodium benzoate dosages of 0, 0.6, 0.7, 0.8 and 0.9 mg / ml, 1000 ml of solution was prepared in the clean area of ​​the workshop, and the preservative efficacy test was carried out with reference to USP41—ANTIMICROBIAL EFFECTIVENESS TESTING. The test results are shown in Tables 2-6.

[0051] Table 2: Preservative efficacy test (benzoic acid concentration: 0 mg / ml)

[0052]

[0053]

[0054] Table 3: Preservative efficacy test (benzoic acid concentration: 0.6 mg / ml)

[0055]

[0056] Table 4: Preservative efficacy test (benzoic acid concentration: 0.7 mg / ml)

[0057]

[0058] Table 5: Preservative efficacy test (benzoic acid concentration: 0.8 mg / ml)

[0059]

[0060] Table 6: Preservative efficacy test (benzoic acid concentration: 0.9 mg / ml)

[0061]

[0062]

[0063] The samples without preservatives had no antibacterial properties, and bacteria multiplied in large numbers after 14 and 28 days. When the dosage of sodium benzoate was 0.6 mg / ml, the antibacterial properties against bacteria were good, and the antibacterial properties against fungi were slightly poor. The samples with dosages ranging from 0.7 to 0.9 mg / ml all had good antibacterial properties, and the number of bacteria decreased significantly after 14 and 28 days, which met the standard requirements; with the increase in dosage, the antibacterial properties gradually increased. In order to ensure the antiseptic properties of the samples in long-term storage, it is more appropriate to select a sodium benzoate dosage between 0.7 and 0.9 mg / ml.

[0064] Experimental Example 2: FD&C Yellow No. 6 Dosage Screening

[0065] Based on Example 1, the dosage of FD&C Yellow No. 6 was designed to be 0 mg / ml, 0.008 mg / ml, 0.01 mg / ml, 0.015 mg / ml, and 0.020 mg / ml, respectively, and potassium chloride oral solutions were prepared respectively, and the scale transparent plastic measuring cup was used for packaging, and the accuracy of the scale for distinguishing the color of the divided dose was investigated. The test results are shown in Table 7. The research results show that FD&C Yellow No. 6 0.01 mg / ml and above can achieve scale recognition during divided doses.

[0066] Table 7: FD&C Yellow No. 6 dosage screening results

[0067] FD&C Yellow No. 6 dosage (mg / ml) Solution color Measuring cup scale recognition 0 Colorless, transparent, clear solution Transparent and clear, difficult to identify 0.008 Slightly yellow transparent clear solution Can be identified, but the effect is not good 0.01 Light yellow transparent clear solution Easy to identify 0.015 Yellow transparent clear solution Easy to identify 0.020 Dark yellow transparent clear solution Easy to identify

[0068] Experimental Example 3: Screening of the ratio and dosage of glycerol propylene glycol mixture

[0069] Based on Example 1, the ratio and amount of the glycerol propylene glycol mixture were designed, as shown in Table 8, and the test results of taste and low-temperature freezing were shown in Tables 9 and 10. The mass ratios of glycerol and propylene glycol were 1:0, 0:1, 0.75:1, 1:1, 1:1.25, 1:1.5, and 1:1.75, respectively.

[0070] Table 8: Glycerol propylene glycol mixture ratio and dosage design

[0071]

[0072] Table 9: Effect of glycerol propylene glycol mixture on astringency of oral solution

[0073]

[0074] Table 10: Test results of glycerol propylene glycol mixture against freezing of oral solution (6 months storage time)

[0075]

[0076] Note: + indicates that the solution is frozen, - indicates that the solution is not frozen and remains clear and transparent.

[0077] From the above experimental results, it can be seen that the mixing ratio of the glycerol propylene glycol mixture is between 1:1 and 1:1.5, and the total dosage is 20 mg / ml or more to improve the astringency of potassium chloride (preferably 20 to 30 mg / ml to avoid excessive viscosity of the oral solution), and it will not freeze even if it is placed at a low temperature of -10°C for 6 months, indicating that the glycerol propylene glycol combination solvent can well solve the astringency of this product and improve the taste of the product. The oral solution has strong antifreeze ability and is convenient for transportation and storage in cold weather. Using glycerol alone or propylene glycol alone cannot alleviate the astringency of the oral solution, and the antifreeze effect is not ideal. Glycerol and propylene glycol form a mixture in a certain ratio and are used in the preparation of oral solution, which is very necessary for improving the taste and antifreeze effect.

[0078] Experimental Example 4: Screening of Citrate-Citrate Buffers with Different pH Values

[0079] Based on Example 1, citric acid-citric acid buffer solutions with different pH values ​​were designed to prepare oral solutions to investigate the masking of saltiness. The experimental results are shown in Table 11.

[0080] Table 11: Masking results of salty taste of solutions using citrate-citrate buffers with different pH values

[0081] 0.1mol / l citric acid solution: 0.1mol / l sodium citrate solution pH of the solution Salty taste masks results 18.6:1.4 3.0 It can mask the salty taste of potassium chloride, but it tastes too sour 14.9:5.1 3.6 It can mask the salty taste of potassium chloride, but the taste is also sour 13.1:6.9 4.0 Can cover the salty taste of potassium chloride, suitable for sour taste 10.3:9.7 4.6 Can cover the salty taste of potassium chloride, the sour taste is light 8.2:11.8 5.0 Cannot cover up the salty taste of potassium chloride, the sour taste is light 5.5:14.5 4.6 Cannot cover up the salty taste of potassium chloride, the sour taste is light 3.8:16.2 6.0 Cannot cover up the salty taste of potassium chloride, the sour taste is light

[0082] Experimental Example 5: Fragrance Type Screening

[0083] Based on the dosage of Example 1, strawberry flavor, lemon flavor, chocolate flavor, sweet orange flavor, raspberry flavor and other flavors are respectively selected for testing to investigate whether the flavor interferes with the determination of potassium ions. The test results show that various flavors are acceptable to people, but strawberry flavor, lemon flavor, chocolate flavor and raspberry flavor all contain a small amount of potassium ions. When the content of potassium chloride oral solution is determined by ion chromatography, its specificity is not strong, which affects the final calculation of the content; wherein sweet orange flavor contains almost no potassium ions, does not affect the determination of potassium ions, and its determination has strong specificity, which can be used as the flavor regulator of this product.

[0084] Comparative Example 1

[0085] This technical solution is the first to apply a glycerol-propylene glycol mixture to the preparation of potassium chloride oral solution. The inventors have made many attempts to ensure that the effects of glycerol and propylene glycol as stabilizers, sweeteners, and antifreeze agents are fully exerted. In addition to the aforementioned mixing ratio and addition amount of glycerol and propylene glycol, the preparation process of adding glycerol and propylene glycol to potassium chloride oral solution will also affect the taste and antifreeze effect of the oral solution to a certain extent.

[0086] In Example 1, glycerol and propylene glycol were mixed in a specified ratio in advance, stirred at 20 to 30 rpm for 5 to 10 minutes until fully mixed (preferably 25 rpm, stirred for 10 minutes) to form a glycerol propylene glycol mixture, and then the oral solution was prepared. In this comparative example, the inventors tried the following:

[0087] Process 1: This process and formula are basically the same as Example 1, except that some preparation processes are different, as follows:

[0088] Take the prescribed amount of glycerol, propylene glycol (the two are not mixed in advance), sucralose and sodium benzoate and add them to the preparation tank, stir (about 25 rpm) until fully dissolved, and the subsequent operation is the same as Example 1. Although the 10% potassium chloride oral solution prepared by this process is also added with glycerol and propylene glycol in a ratio of 1:1, and the total amount of glycerol and propylene glycol added remains unchanged, the finished product has a light astringent taste, and the finished product is frozen after being placed at -10°C for 6 months. The above situation shows that mixing glycerol and propylene glycol in advance to form a mixture is very critical for improving the anti-freezing performance and taste of the oral solution.

[0089] Process 2: This process and formula are basically the same as Example 1, except that some preparation processes are different, as follows:

[0090] Add 80% of the amount of citric acid-sodium citrate buffer with a pH value of 4.0 to the preparation tank, add sucralose and sodium benzoate in turn, stir (about 25 rpm) and mix for about 10 minutes. Then add potassium chloride, sweet orange flavor, and FD&C Yellow No. 6 under stirring (about 25 rpm). After dissolving and clarifying, add the glycerol propylene glycol mixture and fully dissolve it under stirring (about 25 rpm), stirring for about 10 minutes. The remaining pH value adjustment, constant volume and filtration steps are the same as in Example 1. The 10% potassium chloride oral solution prepared by this process, although glycerol and propylene glycol are also added in a ratio of 1:1, and the total amount of glycerol and propylene glycol added remains unchanged, the finished product has a light astringent taste, and the finished product is frozen after being placed at -10°C for 6 months. The above situation shows that the glycerol propylene glycol mixture is added to the system last, which is not conducive to improving the antifreeze performance and taste of the oral solution.

[0091] Process 3: This process and formula are basically the same as Example 1, except that some preparation processes are different, as follows:

[0092] Add 80% of the amount of citric acid-sodium citrate buffer with a pH value of 4.0 to the preparation tank, add sucralose and sodium benzoate in turn, and stir (about 25 rpm) and mix for about 10 minutes. Then add potassium chloride, sweet orange flavor, and FD&C Yellow No. 6 under stirring (about 25 rpm). After dissolving and clarifying, add glycerol and propylene glycol (not mixed in advance) and fully dissolve under stirring (about 25 rpm), stirring for about 10 minutes. The remaining pH adjustment, constant volume and filtration steps are the same as in Example 1. The 10% potassium chloride oral solution prepared by this process, although glycerol and propylene glycol are also added in a ratio of 1:1, the finished product has a light astringent taste, and the finished product is frozen after being placed at -5°C and -10°C for 6 months. The above situation shows that glycerol and propylene glycol are not mixed in advance to form a mixture, and are added to the system at the end of the process, which is not conducive to improving the anti-freezing performance of the oral solution.

[0093] Process 4: This process and formula are basically the same as Example 1, except that some preparation processes are different, as follows:

[0094] Add 80% of the amount of citric acid-sodium citrate buffer with a pH value of 4.0 to the preparation tank, add sucralose and sodium benzoate in turn, and stir (about 25 rpm) for about 10 minutes. After dissolving and clarifying, add the glycerol propylene glycol mixture and fully dissolve it under stirring (about 25 rpm), and stir for about 10 minutes. Then add potassium chloride, sweet orange flavor, and FD&C Yellow No. 6 under stirring (about 25 rpm). The remaining pH adjustment, constant volume and filtration steps are the same as in Example 1. The 10% potassium chloride oral solution prepared by this process, although glycerol and propylene glycol are also added in a ratio of 1:1, the finished product has a light astringent taste, and the finished product is frozen after being placed at -10°C for 6 months. The above situation shows that the order of adding the glycerol propylene glycol mixture is very critical for improving the antifreeze performance and taste of the oral solution. The glycerol propylene glycol mixture needs to be mixed with sucralose and sodium benzoate first, and then the buffer solution is added. This preparation process sequence can ensure that the glycerol propylene glycol mixture can fully exert its taste-enhancing and antifreeze effects.

[0095] In summary, the inventor tried to add a glycerol propylene glycol mixture to a potassium chloride oral solution for the first time, and the effect has certain requirements on the process. Glycerol and propylene glycol need to be first prepared as a mixture of the two, and then mixed with other components in the oral solution composition to prepare the product. In addition, the glycerol propylene glycol mixture needs to be mixed with sucralose and sodium benzoate first, then citric acid-sodium citrate buffer is added, and finally potassium chloride and sweet orange flavor, FD&C Yellow No. 6 are added. The potassium chloride oral solution prepared in the above order has an ideal taste and good antifreeze effect. Changing the process sequence will affect the quality of the finished product to a certain extent.

[0096] The above is only an embodiment of the present invention, and the common knowledge such as the known specific technical solutions and / or characteristics in the solution is not described in detail here. It should be pointed out that for those skilled in the art, without departing from the technical solution of the present invention, several modifications and improvements can be made, which should also be regarded as the protection scope of the present invention, and these will not affect the effect of the implementation of the present invention and the practicality of the patent. The scope of protection required by this application shall be based on the content of its claims, and the specific implementation methods and other records in the specification can be used to interpret the content of the claims.

Claims

1. A potassium chloride composition oral solution with excellent taste, characterized in that: The invention comprises a solvent and a solute, wherein the solute comprises potassium chloride, a sweetener, a preservative and a stabilizer, and the potassium chloride has a potassium ion concentration of 1.3 to 2.6 mEq / ml.

2. The potassium chloride composition oral solution with excellent taste according to claim 1, characterized in that: The oral solution further comprises at least one of a flavor and a colorant.

3. The potassium chloride composition oral solution with excellent taste according to claim 1, characterized in that: The stabilizer is any one of glycerol and propylene glycol or a mixture of the two.

4. The potassium chloride composition oral solution with excellent taste according to claim 1, characterized in that: The sweetener includes 2 to 4 mg / ml of sucralose, and the preservative includes 0.7 to 0.9 mg / ml of sodium benzoate; Preferably, the oral solution solute also includes flavors and colorants; Preferably, the stabilizer is any one of glycerol and propylene glycol or a mixture of the two.

5. The potassium chloride composition oral solution with excellent taste according to claim 4, characterized in that: The stabilizer is a glycerol-propylene glycol mixture at a concentration of 20-30 mg / ml; preferably, the concentration of the glycerol-propylene glycol mixture is 25 mg / ml.

6. The potassium chloride composition oral solution with excellent taste according to claim 5, characterized in that: In the glycerol-propylene glycol mixture, the mass ratio of glycerol to propylene glycol is 1:1 to 1:1.5; more preferably, the mass ratio of glycerol to propylene glycol is 1:

1.

7. The potassium chloride composition oral solution with excellent taste according to claim 4, characterized in that: The concentration of potassium chloride is 1.3mEq / ml or 2.6mEq / ml in terms of potassium ions; preferably, the concentration of the toner is 0.015mg / ml; preferably, the concentration of sucralose is 3mg / ml; preferably, the concentration of the flavor is 0.4mg / ml.

8. The potassium chloride composition oral solution with excellent taste according to claim 4, characterized in that: The solvent is citric acid-sodium citrate buffer.

9. The potassium chloride composition oral solution with excellent taste according to claim 8, characterized in that: The pH value of the citric acid-sodium citrate buffer is 3.8-4.2; preferably, the pH value of the citric acid-sodium citrate buffer is 4.

0.

10. The method for preparing a potassium chloride composition oral solution with excellent taste according to any one of claims 4 to 9, characterized in that: The method includes the following steps: S1: under stirring, sequentially adding sucralose and sodium benzoate to a glycerol propylene glycol mixture to obtain a mixture A; S2: adding 50% to 95% of citric acid-sodium citrate buffer to mixture A, and stirring and mixing thoroughly to obtain mixture B; S3: adding potassium chloride, flavor and colorant under stirring, dissolving and clarifying, and then using citric acid-sodium citrate buffer to make up the volume, stirring and mixing for 5 to 20 minutes to obtain mixture C; S4: After the mixture C is filtered, a potassium chloride composition oral solution is obtained.

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