An electrolyte composition, a preparation method thereof, and an application thereof

Abstract

The present invention provides an electrolyte composition, a preparation method and an application thereof, relating to the technical field of medicine. The electrolyte composition of the present invention comprises components: glucose, sodium citrate, sodium chloride, potassium chloride, magnesium chloride, magnesium sulfate, sodium dihydrogen phosphate, sucralose and water, etc.; through the selection of specific components, the limitation of contents and a specific preparation method, the composition can achieve the effect of balancing the contents of water and electrolytes in the body, and is beneficial to relieving thirst. For diarrhea patients, it can balance the osmotic pressure in the body and promote the cure of diarrhea; the electrolyte composition remains stable after long-term storage.

Description

Technical Field

[0001] The present invention belongs to the field of pharmaceutical technology, and particularly relates to an electrolyte composition, a preparation method thereof, and an application thereof. Background Art

[0002] Diarrhea is a common disease in daily life, which refers to the number of bowel movements significantly exceeding the normal 2 - 3 times per day, or even more, presenting symptoms such as thin stools, a significantly increased proportion of water, and containing undigested food and / or mucus. Diarrhea is caused by the disruption of the normal continuous transfer of electrolytes and water through the intestinal mucosa. Usually, secretion (from blood to the intestinal lumen) and absorption (from the intestinal lumen to blood) occur simultaneously. In the balance between this secretion and absorption, even a 1% change can lead to significant fluid loss and diarrhea.

[0003] In the study of the pathogenesis mechanism, the main mechanisms leading to diarrhea are: increased osmotic pressure, excessive secretion, and villus damage. The increased osmotic pressure caused by inflammation in the intestine can be accompanied by an increase in the "pore size" of the intestinal mucosa, which increases the flow through the membrane and reduces the pressure gradient from blood to the intestinal lumen. If the amount of exudate exceeds the intestinal absorption capacity, diarrhea is caused. The size of the substances leaking through the mucosa varies according to the degree of increase in pore size. A large increase in pore size allows plasma proteins to leak out, easily leading to protein - losing enteropathy (e.g., canine lymphangiectasia, bovine tuberculosis, nematode infection). A huge increase in pore size causes red blood cell loss, resulting in hemorrhagic diarrhea (e.g., hemorrhagic gastroenteritis, parvovirus infection, severe hookworm infection). Most commonly, when diarrhea occurs or lasts for a long time, patients will not only experience anal discomfort and a sense of urgency to defecate, but severe or long - term diarrhea patients will also develop dehydration, as well as electrolyte and acid - base imbalance in the body.

[0004] Therefore, it is necessary to promptly replenish water and electrolytes for severe diarrhea patients. At the same time, various energy molecules and ions are beneficial to human absorption and do not impose an additional burden on the absorption and secretion of the gastrointestinal tract or blood. Oral Rehydration Salts (ORS) is a drug recommended by the World Health Organization for the treatment of acute diarrhea dehydration with excellent curative effects. The treatment principle is based on supplying simple nutrients that can be directly absorbed by cells called enterocytes arranged on the small intestine. It is widely used in clinical practice. Its prescription composition is reasonable, and the main components contain a certain amount of sodium, potassium, and various other electrolytes. It is inexpensive, easily available, convenient and efficient, and the speed of correcting dehydration is superior to intravenous drip, becoming a common rehydration method.

[0005] Chinese invention patent CN104857019B discloses a novel oral rehydration salt and its preparation method and use. The oral rehydration salt includes components: sodium chloride, sodium citrate, sodium carboxymethyl cellulose, potassium sodium tartrate, potassium chloride, zinc acetate, zinc chloride, anhydrous glucose and deionized water. Through the selection of specific components, the limitation of the content of specific ions, and a specific preparation method, etc., the invention obtains an oral rehydration salt with good performance in treating diarrhea and / or dehydration, and has an excellent cure rate for diarrhea.

[0006] Chinese invention patent CN103479664A discloses a liquid oral rehydration salt containing components: sodium chloride 0.056 - 0.96%, potassium chloride 0.034 - 0.042%, sodium citrate 0.065 - 0.079%, glucose 0.31 - 0.37%, and water 94.5 - 104.5%. The pH value is adjusted to 3 - 6 with an acid, and a flavoring agent for improving the taste is added. It is used to treat mild to moderate dehydration caused by diarrhea and dehydration caused by children's diarrhea. By precisely controlling the amount of water used and performing aseptic treatment, etc., the quality of the high-liquid rehydration salt is stable, it is more convenient to use, and the drug effect can be better exerted. It is suitable for the elderly, children, and for taking under water-deficient conditions such as in the wild and in emergencies.

[0007] As described above, although there have been a large number of studies and improvements on oral rehydration salts after severe diarrhea, merely supplementing water and electrolytes and improving the taste are not enough. A composition containing electrolytes is also of great significance for improving the treatment efficiency of diarrhea, effectively relieving the thirst of patients, regulating the intestinal absorption and blood sugar of diarrhea patients, and promoting the cure of diarrhea. In order to obtain the electrolyte composition, the inventors have conducted in-depth research on this. Summary of the Invention

[0008] Aiming at the problems existing in the prior art, the present invention provides an electrolyte composition, its preparation method and application. The prepared electrolyte composition is used for patients with severe diarrhea, can supplement water and electrolytes, balance the content of water and electrolytes in the body, and at the same time is beneficial to relieving thirst, regulating the intestinal absorption and blood sugar of diarrhea patients, promoting the cure of diarrhea and improving the treatment efficiency.

[0009] To achieve the above object, the technical solution adopted by the present invention is as follows:

[0010] First of all, the present invention provides an electrolyte composition, including the following components: glucose, sodium citrate, sodium chloride, potassium chloride, magnesium chloride, magnesium sulfate, sodium dihydrogen phosphate, sucralose, berberine, vitamin B1 and water.

[0011] Preferably, the electrolyte composition, by weight, comprises the following components: 19 - 21.8 parts of glucose, 1.55 - 1.9 parts of sodium citrate, 1.5 - 1.78 parts of sodium chloride, 1.33 - 1.65 parts of potassium chloride, 0.14 - 0.26 parts of magnesium chloride, 0.025 - 0.051 parts of magnesium sulfate, 0.17 - 0.28 parts of sodium dihydrogen phosphate, 0.05 - 0.098 parts of sucralose, 0.007 - 0.013 parts of berberine, 0.066 - 0.1 parts of vitamin B1, and 960 - 1035 parts of water.

[0012] More preferably, the electrolyte composition, by weight, comprises the following components: 20 - 21 parts of glucose, 1.6 - 1.82 parts of sodium citrate, 1.55 - 1.71 parts of sodium chloride, 1.35 - 1.6 parts of potassium chloride, 0.16 - 0.23 parts of magnesium chloride, 0.03 - 0.046 parts of magnesium sulfate, 0.19 - 0.25 parts of sodium dihydrogen phosphate, 0.06 - 0.09 parts of sucralose, 0.009 - 0.011 parts of berberine, 0.07 - 0.09 parts of vitamin B1, and 985 - 1015 parts of water.

[0013] Most preferably, the electrolyte composition, by weight, comprises the following components: 20.45 parts of glucose, 1.79 parts of sodium citrate, 1.63 parts of sodium chloride, 1.50 parts of potassium chloride, 0.20 parts of magnesium chloride, 0.04 parts of magnesium sulfate, 0.22 parts of sodium dihydrogen phosphate, 0.08 parts of sucralose, 0.01 parts of berberine, 0.08 parts of vitamin B1, and 1000 parts of water.

[0014] Preferably, the weight ratio of the glucose, sodium citrate, berberine, and vitamin B1 is 19 - 21.8:1.55 - 1.9:0.007 - 0.013:0.066 - 0.1.

[0015] More preferably, the weight ratio of the glucose, sodium citrate, berberine, and vitamin B1 is 20 - 21:1.6 - 1.82:0.009 - 0.011:0.07 - 0.09.

[0016] Most preferably, the weight ratio of the glucose, sodium citrate, berberine, and vitamin B1 is 20.45:1.79:0.01:0.08.

[0017] Preferably, the extraction method of the berberine comprises the steps of: pulverizing Coptis chinensis, mixing it with an ethanol solution, extracting 1 - 3 times, filtering, recrystallizing, and drying to obtain berberine.

[0018] Further preferably, the method for extracting berberine is specifically as follows: Take Coptis chinensis, pulverize it, mix it with an ethanol solution, and perform reflux extraction twice. The first extraction time is 1 - 1.5 h, and the second extraction time is 0.5 - 1 h. Then filter, combine the filtrates, perform recrystallization, and dry to obtain berberine.

[0019] Even further preferably, the method for extracting berberine is specifically as follows: Take Coptis chinensis, pulverize it, mix it with an ethanol solution, and perform reflux extraction twice. The first extraction time is 50 min, and the second extraction time is 30 min. Then filter, combine the filtrates, perform recrystallization, and dry to obtain berberine.

[0020] Further preferably, the particle size of the pulverized Coptis chinensis is 100 - 150 mesh.

[0021] Further preferably, the concentration of the ethanol is 75 - 90%, v / v.

[0022] Even further preferably, the concentration of the ethanol is 80 - 88%, v / v.

[0023] Further preferably, the solid - liquid ratio of Coptis chinensis to ethanol is 1:6 - 11, g / mL.

[0024] Even further preferably, the solid - liquid ratio of Coptis chinensis to ethanol is 1:7 - 8, g / mL.

[0025] Further preferably, the recrystallization is specifically as follows: Heat - concentrate the filtrate into a thick paste, add an acetic acid solution, dissolve it, then drop - add concentrated hydrochloric acid, cool and dry, and wash with distilled water to obtain berberine.

[0026] Even further preferably, the recrystallization is specifically as follows: Heat - concentrate the filtrate into a thick paste, add 3 - 5 times the amount of 20 - 80% acetic acid solution, dissolve it, then drop - add concentrated hydrochloric acid with a concentration of 35 - 55% (v / v) until turbidity appears, cool, dry, and wash with distilled water to obtain berberine.

[0027] In the present invention, the drying is conventional drying, and the drying method has no significant influence on the technical effect, and it can be any one of freeze - drying, vacuum drying, spray drying, fluidized - bed drying, and microwave drying.

[0028] Preferably, the dosage form of the electrolyte composition is any liquid dosage form, and it can be oral liquid, decoction, or syrup.

[0029] Then, the present invention provides a method for preparing the above - mentioned electrolyte composition, including the steps:

[0030] (1) Take water, heat it to 60 - 75 °C, mix it evenly with sodium citrate, sodium chloride, potassium chloride, sodium dihydrogen phosphate, and glucose accounting for 50 - 80% by weight, and dissolve to obtain mixture 1;

[0031] (2) The mixture 1 is cooled to room temperature and mixed with the remaining components of the electrolyte composition, namely magnesium chloride, magnesium sulfate, sucralose, berberine, vitamin B1 and the remaining weight portion of glucose, and then dissolved to obtain mixture 2.

[0032] (3) The mixture 2 is filtered through multiple stages to obtain mixture 3.

[0033] (4) The mixture 3 is sterilized at a high temperature. The sterilization temperature is 110 - 135 °C and the sterilization time is 18 - 30 min, thus obtaining the electrolyte composition.

[0034] Preferably, in step (1), the heating temperature is 64 - 70 °C, and the dissolution time is controlled within 30 min.

[0035] More preferably, the heating temperature is 66 °C.

[0036] Preferably, in step (1), the partial glucose is 60 - 75% by weight of the glucose in the composition.

[0037] Preferably, in step (3), the multiple - stage filtration is as follows: the mixture 2 is first pre - filtered and then subjected to secondary filtration, and mixture 3 is obtained after two - stage filtration.

[0038] More preferably, the multiple - stage filtration is specifically: the mixture 2 is first pre - filtered through a filter membrane with a pore size of 0.8 - 1.2 μm, and then subjected to secondary filtration. The pore size of the filter membrane for secondary filtration is 0.18 - 0.24 μm, and mixture 3 is obtained after the mixture 2 has been filtered twice.

[0039] Even more preferably, the multiple - stage filtration is specifically: the mixture 2 is first pre - filtered through a 1.0 - μm filter membrane, and then subjected to secondary filtration. The pore size of the filter membrane for secondary filtration is 0.22 μm, and mixture 3 is obtained after the mixture 2 has been filtered twice.

[0040] Preferably, in step (4), for the high - temperature sterilization, the sterilization temperature is 113 - 120 °C and the sterilization time is 20 - 26 min.

[0041] More preferably, for the high - temperature sterilization, the sterilization temperature is 116 °C and the sterilization time is 23 min.

[0042] Furthermore, the present invention provides the application of the above - mentioned electrolyte composition in the preparation of drugs for treating diarrhea and / or electrolyte water.

[0043] Finally, the present invention provides the application of the above - mentioned electrolyte composition in the preparation of drugs for treating dehydration and electrolyte imbalance and / or aqueous solutions.

[0044] Compared with the prior art, the present invention has the following beneficial effects:

[0045] 1. The electrolyte composition of the present invention has clear components and precise dosages, and can efficiently supplement the water and electrolytes of patients during and / or after diarrhea, balance the osmotic pressure in the body, and improve the healing ability of diarrhea patients.

[0046] 2. The electrolyte composition of the present invention has uniform and reasonable components. The sodium, potassium, magnesium, phosphorus and other ions supplemented by the composition can reasonably balance the electrolytes in the body; at the same time, the components are reasonably matched, and sodium citrate, berberine and vitamin B1 act synergistically to improve the ability to balance the blood and intestinal osmotic pressure of diarrhea patients and promote the cure of diarrhea.

[0047] 3. In the electrolyte composition of the present invention, glucose and sucralose are not degraded and have stable quality; through specific dissolution, filtration and sterilization methods, the stability and safety are improved.

[0048] 4. The electrolyte composition of the present invention can not only supplement electrolytes, relieve diarrhea symptoms, but also improve thirst, balance the viscosity of mucosal secretions, and improve the intestinal environment, regulate the intestinal absorption and blood sugar of diarrhea patients, promote the cure of diarrhea and improve the treatment efficiency; it can also be used for drinking by diabetic patients during and / or after diarrhea. Detailed implementation manners

[0049] The following non-limiting examples can enable those of ordinary skill in the art to more comprehensively understand the present invention, but do not limit the present invention in any way. The following content is only an exemplary description of the scope claimed in the present application. Those skilled in the art can make various changes and modifications to the invention of the present application based on the disclosed content, and it should also fall within the scope claimed in the present application.

[0050] When the examples give numerical ranges, it should be understood that unless otherwise specified in the present invention, any value between the two endpoints of each numerical range and any value between the two endpoints can be selected. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the technical field to which the present invention belongs.

[0051] The present invention will be further described below by way of specific examples. All chemical reagents used in the examples of the present invention are obtained through conventional commercial channels unless otherwise specified. For the components of the composition in the present invention, products from different manufacturers do not have a significant impact on the effect.

[0052] Examples 1 - 5

[0053] An electrolyte composition suitable for use during and / or after diarrhea, by weight parts, includes the components as shown in Table 1:

[0054] Table 1

[0055] parts by weight Example 1 Example 2 Example 3 Example 4 Example 5 glucose 20.45 20 21 19 21.8 sodium citrate 1.79 1.6 1.82 1.55 1.9 sodium chloride 1.63 1.55 1.71 1.78 1.5 potassium chloride 1.50 1.35 1.6 1.65 1.33 magnesium chloride 0.20 0.16 0.23 0.14 0.26 magnesium sulfate 0.04 0.03 0.046 0.025 0.051 sodium dihydrogen phosphate 0.22 0.16 0.25 0.28 0.17 sucralose 0.08 0.06 0.09 0.098 0.05 berberine 0.01 0.009 0.11 0.007 0.013 vitamin B1 0.08 0.07 0.09 0.066 0.1 water 1000 985 1015 960 1035

[0056] In the electrolyte compositions of Examples 1 - 5, the extraction method of berberine includes the steps of: taking traditional Chinese medicine Coptis chinensis, pulverizing it, passing through a 120 - mesh sieve to obtain Coptis chinensis powder, mixing the Coptis chinensis powder with an 86% (v / v) ethanol solution, with a solid - liquid ratio of 1:7, g / mL, heating under reflux for extraction twice, with the first extraction time being 50 min and the second extraction time being 30 min, filtering, and combining the filtrates; heating and concentrating the filtrates into a thick paste, adding 3 times the amount of 30% acetic acid solution, dissolving, then dropping concentrated hydrochloric acid with a concentration of 35 - 55% (v / v) until turbidity appears, cooling to room temperature, freeze - drying, and washing with distilled water 3 - 4 times to obtain berberine.

[0057] The preparation method of the electrolyte compositions of Examples 1 - 5 includes the steps:

[0058] (1) Heating the water in the electrolyte composition to 66 °C, mixing it evenly with sodium citrate, sodium chloride, potassium chloride, sodium dihydrogen phosphate, and glucose accounting for 65% of the total weight of glucose, and keeping warm and stirring for dissolution for 10 - 15 min to obtain Mixture 1;

[0059] (2) Cooling Mixture 1 to room temperature, mixing it with the remaining components of the electrolyte composition, magnesium chloride, magnesium sulfate, sucralose, berberine, vitamin B1, and the remaining weight portion of glucose, and stirring for dissolution to obtain Mixture 2;

[0060] (3) First pre - filtering Mixture 2 through a 1.0 - μm filter membrane, and then performing secondary filtration. The pore size of the filter membrane for secondary filtration is 0.22 μm. After Mixture 2 passes through two - stage filtration, Mixture 3 is obtained;

[0061] (4) Performing high - temperature sterilization on Mixture 3 at a sterilization temperature of 116 °C and a sterilization time of 23 min to obtain the electrolyte composition; after the electrolyte mixture passes the lamp inspection and is qualified, it is packaged.

[0062] Example 6

[0063] The difference from Example 1 is that the extraction method of berberine is different. Specifically, it includes the steps of: taking traditional Chinese medicine Coptis chinensis, pulverizing it, passing through a 150 - mesh sieve to obtain Coptis chinensis powder, mixing the Coptis chinensis powder with an 80% ethanol solution, with a solid - liquid ratio of 1:7, g / mL, heating under reflux for extraction twice, with the first extraction time being 90 min and the second extraction time being 30 min, filtering, and combining the filtrates; heating and concentrating the filtrates into a thick paste, adding 3 times the amount of 30% (v / v) acetic acid solution, dissolving, then dropping concentrated hydrochloric acid with a concentration of 35 - 55% (v / v) until turbidity appears, cooling to room temperature, freeze - drying, and washing with distilled water 3 - 4 times to obtain berberine.

[0064] The preparation of the electrolyte composition was carried out according to the preparation method of the electrolyte composition described in Example 1.

[0065] Example 7

[0066] Different from Example 1, the preparation method of the electrolyte composition was different, including the steps:

[0067] (1) Heat the water in the electrolyte composition to 60 °C, mix it evenly with sodium citrate, sodium chloride, potassium chloride, and sodium dihydrogen phosphate, and glucose accounting for 65% of the total weight of glucose, and keep stirring and dissolving for 10 - 15 min to obtain Mixture 1;

[0068] Steps (2) and (3) were the same as those in Example 1;

[0069] (4) Subject Mixture 3 to high-temperature sterilization at a sterilization temperature of 110 °C and a sterilization time of 25 min to obtain the electrolyte composition; after the electrolyte mixture passed the lamp inspection, it was packaged.

[0070] Comparative Example 1

[0071] An electrolyte composition, by weight, includes the components: 20.45 parts of glucose, 1.79 parts of sodium citrate, 1.63 parts of sodium chloride, 1.50 parts of potassium chloride, 0.20 parts of magnesium chloride, 0.04 parts of magnesium sulfate, 0.1 part of sodium dihydrogen phosphate, 0.08 parts of sucralose, 0.01 parts of berberine, 0.04 parts of vitamin B1, and 1000 parts of water.

[0072] The preparation method of the above composition was the same as that in Example 1.

[0073] That is, the difference from Example 1 was that the weight ratio of the composition was different.

[0074] Comparative Example 2

[0075] An electrolyte composition, by weight, includes the components: 10 parts of glucose, 2.1 parts of sodium citrate, 1.63 parts of sodium chloride, 1.50 parts of potassium chloride, 0.20 parts of magnesium chloride, 0.04 parts of magnesium sulfate, 0.22 parts of sodium dihydrogen phosphate, 0.08 parts of sucralose, 0.003 parts of berberine, 0.08 parts of vitamin B1, and 1000 parts of water.

[0076] The preparation method of the above composition was the same as that in Example 1.

[0077] That is, the difference from Example 1 was that the weight ratios of glucose, sodium citrate, berberine, and vitamin B1 in the composition were different.

[0078] Comparative Example 3

[0079] Different from Example 1, the components of the composition were changed, and sodium citrate was replaced with sodium acetate.

[0080] The preparation methods of the remaining components and the composition are the same as those in Example 1.

[0081] Comparative Example 4

[0082] Different from Example 1, the components of the composition were changed, and sodium citrate was replaced with sodium chloride.

[0083] The preparation methods of the remaining components and the composition are the same as those in Example 1.

[0084] Comparative Example 5

[0085] Different from Example 1, the components of the composition were changed, and sucralose was replaced with fructose.

[0086] The preparation methods of the remaining components and the composition are the same as those in Example 1.

[0087] Comparative Example 6

[0088] Different from Example 1, the components of the composition were changed, and vitamin B1 was replaced with folic acid.

[0089] The preparation methods of the remaining components and the composition are the same as those in Example 1.

[0090] Comparative Example 7

[0091] Different from Example 1, the extraction method of berberine was different. The number of times of reflux extraction was 1 time. Specifically, it included the steps of: taking traditional Chinese medicine Coptis chinensis, pulverizing it, passing through a 120-mesh sieve to obtain Coptis chinensis powder, mixing the Coptis chinensis powder with an 86% ethanol solution, with a solid-liquid ratio of 1:7, g / mL, heating under reflux for 90 min, and filtering; concentrating the filtrate by heating into a thick paste, adding 3 times the amount of 30% (v / v) acetic acid solution, dissolving and then dropping concentrated hydrochloric acid with a concentration of 35 - 55% (v / v) until turbidity appears, cooling to room temperature, freeze-drying, and washing with distilled water 3 - 4 times to obtain berberine.

[0092] The preparation methods of the remaining components and the composition are the same as those in Example 1.

[0093] Comparative Example 8

[0094] Different from Example 1, the preparation method of the electrolyte composition was different. Specifically, it included the steps of:

[0095] (1) Mixing all components in the electrolyte composition of Example 1, stirring and dissolving at room temperature to obtain a mixture;

[0096] (2) The mixture is first pre-filtered through a 1.0 μm filter membrane and then subjected to secondary filtration. The pore size of the filter membrane for secondary filtration is 0.22 μm; (4) High-temperature sterilization is carried out at a sterilization temperature of 116 °C for 23 min to obtain the electrolyte composition; after the electrolyte mixture passes the lamp inspection, it is packaged.

[0097] Comparative Example 9

[0098] Differing from Example 1, the preparation method of the electrolyte composition is different. Specifically, it includes the steps:

[0099] (1) Heat the water in the electrolyte composition to 66 °C, mix it evenly with sodium citrate, sodium chloride, potassium chloride, sodium dihydrogen phosphate, and glucose accounting for 65% of the total weight of glucose, and keep stirring and dissolving for 10 - 15 min to obtain Mixture 1;

[0100] (2) Cool Mixture 1 to room temperature, mix it with the remaining components of the electrolyte composition, namely magnesium chloride, magnesium sulfate, sucralose, berberine, vitamin B1, and the remaining weight portion of glucose, and stir to dissolve to obtain Mixture 2;

[0101] (3) Mixture 2 is first pre-filtered through a 1.0 μm filter membrane and then subjected to secondary filtration. The pore size of the filter membrane for secondary filtration is 0.22 μm. After Mixture 2 is filtered twice, Mixture 3 is obtained;

[0102] (4) Mixture 3 is subjected to high-temperature and high-pressure sterilization at a sterilization temperature of 121 °C for 5 min to obtain the electrolyte composition; after the electrolyte mixture passes the lamp inspection, it is packaged.

[0103] Experiment 1 Stability Investigation

[0104] Take the packaged electrolyte compositions of each example and comparative example, place them statically at 40 °C for 6 weeks, then observe the morphology and investigate their storage stability. The specific test results are shown in Table 2 below.

[0105] Table 2

[0106]

[0107]

[0108] As can be seen from the above table, the components in the electrolyte composition have a certain influence on the stability of the final product; the dissolution and addition method of the components have a significant influence on the final stability of the electrolyte composition. When all components are mixed and added at one time, especially the one-time addition of glucose, it causes obvious turbidity in the composition; while the sterilization method of Comparative Example 9 makes the composition solution prone to deterioration, breed bacteria, and is difficult to preserve, resulting in turbidity.

[0109] Experiment 2 Animal Experiment

[0110] 1. Experimental animals: Kunming mice were selected, with a body weight of 15 - 18 g, male, and a fasting blood glucose value of 4.8 - 6.5 mmol / L.

[0111] 2. Diarrhea model: Pathogenic Escherichia coli O 111 was intraperitoneally injected into mice to induce a diarrhea model. Mice with diarrhea and dehydration symptoms were selected and randomly divided into 17 groups, with 8 mice in each group.

[0112] The normal group of mice was not induced with diarrhea, and there were 8 mice in the normal group.

[0113] 3. Blood glucose detection and electrolyte ion detection

[0114] Before the experiment, the blood glucose, sodium ion, chloride ion, and potassium ion contents in the blood were measured. Then, the electrolyte compositions of the examples and comparative examples were respectively administered by gavage, 2 times a day, 10 mL / kg each time. The results were statistically analyzed 4 days after the experiment. The specific test results are shown in Table 3. Among them, the model group was only gavaged with drinking water.

[0115] Table 3

[0116]

[0117]

[0118] 4. Diarrhea treatment effect

[0119] The treatment records of the mice in the above experiment were made, and the treatment effects 4 days later are shown in Table 4.

[0120] Table 4

[0121]

[0122] In Table 4, "completely cured" means that the diarrhea symptoms completely disappear, and dehydration and vomiting symptoms no longer appear; "certain improvement" means that the spirit improves or the diarrhea or vomiting symptoms are alleviated; "ineffective" means death, or the diarrhea worsens, or the vomiting worsens, or the symptoms are the same as the initial state.

[0123] As can be seen from the above table, the electrolyte composition of the present invention has good performance in assisting the treatment of diarrhea, is suitable for drinking during and / or after diarrhea, and can improve the survival rate of mice.

[0124] Experiment 3 Evaluation Subjects: 80 healthy subjects, with a body weight of 65 - 80 kg, an age of 25 - 40 years, no stress diseases, good work and rest, and no smoking or alcohol addiction. No other drugs were taken during the test period.

[0125] Randomly divided into 18 groups, with 5 people in each group. Standard diet was given in the first 48 hours, then fasting for 8 hours. Between 6 - 8 am, each subject in each group drank 200 mL of the electrolyte composition in Table 5. Additionally, a control group 1 that did not drink water at all and a control group 2 that only drank pure water were set up. The taste of the subjects was surveyed and filled in 0.5 hours after drinking, and the viscosity of oral mucosal secretions and the degree of dry mouth were recorded and evaluated 6 hours later.

[0126] The results are shown in Table 5: Among them, the viscosity of mucosal secretions is divided into 5 levels (1, 2, 3, 4, 5), 1 is dry, 2 is relatively dry, 3 is normal, 4 is relatively viscous, and 5 is viscous. The degree of dry mouth is divided into 5 levels (1, 2, 3, 4, 5), 1 is the driest, 5 is the most moist, and the degree of dry mouth decreases from 1 to 5 in turn. The overall comfort represents the taste, and is comprehensively evaluated by palatability, sweetness, saltiness, and smoothness, divided into 5 levels (1, 2, 3, 4, 5), 5 is the best, 1 is the worst taste, and the taste comfort gets worse from 1 to 5.

[0127] Table 5

[0128]

[0129]

[0130] As can be seen from the above table, for the electrolyte composition of the present invention, the components are reasonably matched, with the best effects on taste and mucosal viscosity, and the sweetness and saltiness in the mouth are comfortable; the components in the composition are overall synergistically matched, reducing bitterness and irritation, and the taste is smooth. Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, rather than limiting the protection scope of the present invention. Simple modifications or equivalent replacements made by those of ordinary skill in the art to the technical solution of the present invention do not depart from the essence and scope of the technical solution of the present invention.

Claims

1. An electrolyte composition, characterized in that, By weight, it consists of the following components: 19 - 21.8 parts of glucose, 1.55 - 1.9 parts of sodium citrate, 1.5 - 1.78 parts of sodium chloride, 1.33 - 1.65 parts of potassium chloride, 0.14 - 0.26 parts of magnesium chloride, 0.025 - 0.051 parts of magnesium sulfate, 0.17 - 0.28 parts of sodium dihydrogen phosphate, 0.05 - 0.098 parts of sucralose, 0.007 - 0.013 parts of berberine, 0.066 - 0.1 parts of vitamin B1, and 960 - 1035 parts of water.

2. The electrolyte composition according to claim 1, wherein By weight, it consists of the following components: 20 - 21 parts of glucose, 1.6 - 1.82 parts of sodium citrate, 1.55 - 1.71 parts of sodium chloride, 1.35 - 1.6 parts of potassium chloride, 0.16 - 0.23 parts of magnesium chloride, 0.03 - 0.046 parts of magnesium sulfate, 0.19 - 0.25 parts of sodium dihydrogen phosphate, 0.06 - 0.09 parts of sucralose, 0.009 - 0.011 parts of berberine, 0.07 - 0.09 parts of vitamin B1, and 985 - 1015 parts of water.

3. The electrolyte composition according to claim 2, wherein By weight, it consists of the following components: 20.45 parts of glucose, 1.79 parts of sodium citrate, 1.63 parts of sodium chloride, 1.50 parts of potassium chloride, 0.20 parts of magnesium chloride, 0.04 parts of magnesium sulfate, 0.22 parts of sodium dihydrogen phosphate, 0.08 parts of sucralose, 0.01 parts of berberine, 0.08 parts of vitamin B1, and 1000 parts of water.

4. The electrolyte composition according to any one of claims 1 to 3, characterized in that, The extraction method of the berberine is as follows: Grind Coptis chinensis to 100 - 150 meshes, mix it with an ethanol solution with a volume fraction of 75 - 90%, the solid - liquid ratio of Coptis chinensis to ethanol is 1:6 - 11 g / mL, extract by refluxing twice, the first extraction time is 1 - 1.5 h, the second extraction time is 0.5 - 1 h, filter, combine the filtrates, recrystallize, and dry to obtain berberine.

5. A method for preparing the electrolyte composition according to any one of claims 1 to 4, characterized in that, It includes the steps: (1) Heat water to 60 - 75 °C, mix it evenly with sodium citrate, sodium chloride, potassium chloride, sodium dihydrogen phosphate, and 50 - 80% by weight of glucose, dissolve to obtain mixture 1; (2) Cool mixture 1 to room temperature, mix it with the remaining components of the electrolyte composition, namely magnesium chloride, magnesium sulfate, sucralose, berberine, vitamin B1, and the remaining weight of glucose, dissolve to obtain mixture 2; (3) Filter mixture 2 through multiple - stage filtration to obtain mixture 3; (4) Sterilize mixture 3 at a high temperature, the sterilization temperature is 110 - 116 °C, and the sterilization time is 18 - 30 min to obtain the electrolyte composition.

6. The preparation method according to claim 5, characterized in that, In step (1), the heating temperature is 64 - 70 °C; in step (3), the multiple - stage filtration is as follows: mixture 2 is first pre - filtered and then subjected to secondary filtration, and mixture 3 is obtained after two filtrations; in step (4), the sterilization time is 20 - 26 min.

7. Use of the electrolyte composition according to any one of claims 1 - 4 in the preparation of a drug for treating diarrhea and / or electrolyte water.

8. Use of the electrolyte composition according to any one of claims 1 - 4 in the preparation of a drug for treating dehydration, electrolyte imbalance and / or an aqueous solution.

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