CN115299602A - Uric acid reducing composition and preparation method thereof - Google Patents

Uric acid reducing composition and preparation method thereof Download PDF

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CN115299602A
CN115299602A CN202210755520.8A CN202210755520A CN115299602A CN 115299602 A CN115299602 A CN 115299602A CN 202210755520 A CN202210755520 A CN 202210755520A CN 115299602 A CN115299602 A CN 115299602A
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uric acid
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谭剑平
尹秀菊
程江红
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Beijing Caiye Health Management Co ltd
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Abstract

The invention discloses a uric acid reducing composition which comprises a sour cherry extract, a sophora flower extract, a celery seed extract and potassium citrate. The composition of the invention can not only inhibit the formation of uric acid, but also promote the excretion of uric acid, can quickly control the uric acid level of patients with hyperuricemia, and reduce the side effect of blood pressure reduction; the composition of the invention has high stability, and can reduce the adverse effect of impurities caused by instability in the storage process.

Description

Uric acid reducing composition and preparation method thereof
Technical Field
The invention relates to the field of food and medicine, in particular to a uric acid reducing composition and a preparation method thereof.
Background
Hyperuricemia is caused by increased uric acid production and/or decreased renal uric acid secretion, which is the most dangerous factor for inducing gout. Gout can be divided into three stages from generation to onset, when a patient is in the first stage, clinical manifestations such as arthritis and kidney stones do not appear immediately, so that the gout is generally not easy to be perceived and is most easily ignored, and the stage is called as asymptomatic hyperuricemia; the second stage is acute hyperuricemia arthritis, which is frequently caused after eating overeat, cold dampness and wound infection; the third stage is gout, the uric acid concentration in blood is in a supersaturated level for a long time, the uric acid is usually free in the body in the form of urate, and because the solubility of the urate is extremely low, urate crystals are formed after the urate is saturated in excess, and inflammation and tissue pathological changes which are usually generated at hungry cartilage, soft tissues, joints and kidneys of gout patients are caused by long-term accumulation of the urate crystals on the tissues.
The excessive production of uric acid in the body and the decrease in uric acid amount discharged from the body are two direct causes of the occurrence of hyperuricemia. Uric acid is a metabolic end product of purine, and the increase of purine substances in vivo directly causes the increase of uric acid level of a human body. The second reason for hyperuricemia is that the amount of uric acid discharged is reduced, most of the uric acid discharged from the human body is excessively discharged through the kidney, and when the excretion function of the kidney on uric acid is weakened, the probability of hyperuricemia is greatly increased.
The use of drugs to reduce blood uric acid concentrations is a common method of preventing gout development. The medicine is mainly uricosuric medicine (such as benzbromarone, probenecid, and bensulazolone) capable of blocking renal tubular cavity membrane from absorbing uric acid, and xanthine oxidase inhibitor (such as allopurinol and febuxostat). However, the above drugs have various degrees of side effects to limit their applications, and therefore, in recent years, the uric acid lowering effect of natural extracts has been receiving more and more attention.
Celery seeds, which are seeds of the plant celery (Apium graveolens) of the family Umbelliferae. Celery seeds are often applied to seasonings and foods, celery seed tea has a remarkable effect of promoting sleep, and extracts of celery seed tea have a contraction effect on pregnant and non-pregnant uteri and can be used for treating dysmenorrhea. The celery seed has the effects of dispersing qi, reducing swelling, promoting urination, activating retardation, reducing blood pressure and the like, and is mainly used for treating diseases such as hypertension, arthritis, rheumatoid arthritis, qi stagnation type metritis, ascites, kidney and the like. At home and abroad, the celery seed extract has pharmacological actions of cardiovascular diseases, cancer resistance, cerebral ischemia resistance, uric acid reduction, inflammation resistance and the like.
Sophora japonica is broadly Sophora japonica (Sophora japonica Linn.) belonging to leguminous plants, also called Sophora japonica, and broadly refers to flowers and buds of leguminous plants. Flos Sophorae Immaturus is bitter in taste, mild in nature, and nontoxic, and has effects of clearing heat, cooling blood, stopping bleeding, and lowering blood pressure. Has remarkable curative effects on hematemesis, hematuria, hemorrhoid hemorrhage, conjunctival congestion due to wind-heat, hypertension, hyperlipidemia, cervical lymphoid tuberculosis, angiosclerosis, hematochezia, diabetes, retinitis, psoriasis, etc.; it also has anthelmintic and pharyngitis treating effects. Flos Sophorae Immaturus has effects of enhancing resistance of capillary vessel, reducing vascular permeability, and restoring elasticity of fragile blood vessel, so as to reduce blood lipid and prevent angiosclerosis.
Sour cherries (Ceraus Valgaris Mill), originally produced in Europe, were grown on a large scale since the 50 s of the last century since countries around the world. In compendium of materia medica, it is mentioned that the combination of cherries and wine has the functions of invigorating spleen and replenishing qi, promoting the production of body fluid to quench thirst, dispelling wind-damp, dredging the channels and collaterals and treating arthralgia.
Potassium citrate, used in the food industry as buffering agents, chelating agents, stabilizers, antioxidants, emulsifiers, flavoring agents, and the like. Can be used for milk and dairy products, jelly, jam, meat, canned hydrogel snack, cheese emulsification, orange fresh-keeping, etc.; in the pharmaceutical industry, it is used for hypokalemia and potassium deficiency and for alkalinizing urine.
The invention develops a double-effect uric acid reducing composition, which can inhibit the formation of uric acid, promote the excretion of uric acid, quickly control the uric acid level of a patient with hyperuricemia and reduce the side effect of blood pressure reduction; the composition of the invention has high stability, and can reduce the adverse effect of impurities caused by instability in the storage process.
Disclosure of Invention
The invention provides a uric acid reducing composition which comprises a sour cherry extract, a sophora flower extract, a celery seed extract and potassium citrate.
In some embodiments, the sour cherry extract is 15-30 parts by weight, the sophora flower extract is 8-15 parts by weight, the celery seed extract is 10-25 parts by weight, and the potassium citrate is 5-15 parts by weight.
The inventor finds that the combination of the potassium citrate, the sour cherry extract, the celery seed extract and the sophora flower extract not only obviously improves the stability of the composition, but also obviously produces synergistic effect of the four components in the aspect of reducing uric acid, and can obviously reduce side effects such as hypotension and the like. On the basis, the inventor further researches and obtains the optimal mixture ratio of the four active ingredients.
In some embodiments of the invention, the tart cherry extract is present in 15, 16, 18, 20, 25, or 30 parts by weight;
in some embodiments of the present invention, the parts by weight of the sophora flower extract are 8, 10, 12, 14, 14.47, 15 parts;
in some embodiments of the invention, the celery seed extract is present in 10, 12, 13, 14, 20, 25 parts by weight;
in some embodiments of the invention, the weight parts of the potassium citrate are 5, 8, 10, 15 parts.
In a preferred embodiment of the invention, the sour cherry extract is 16-25 parts by weight, the sophora flower extract is 10-14 parts by weight, the celery seed extract is 10-20 parts by weight, and the potassium citrate is 8-10 parts by weight.
In a preferred embodiment of the invention, the sour cherry extract is 18-20 parts by weight, the sophora flower extract is 10-12 parts by weight, the celery seed extract is 12-14 parts by weight, and the potassium citrate is 8-10 parts by weight.
In a preferred embodiment of the invention, the sour cherry extract is 18, 19 or 20 parts by weight, the sophora flower extract is 10-12 parts by weight, the celery seed extract is 12-14 parts by weight, and the potassium citrate is 8-10 parts by weight.
In a preferred embodiment of the invention, the sour cherry extract is 18-20 parts by weight, the sophora flower extract is 10, 11 or 12 parts by weight, the celery seed extract is 12-14 parts by weight, and the potassium citrate is 8-10 parts by weight.
In a preferred embodiment of the invention, the sour cherry extract is 18-20 parts by weight, the sophora flower extract is 10-12 parts by weight, the celery seed extract is 12, 13 or 14 parts by weight, and the potassium citrate is 8-10 parts by weight.
In a preferred embodiment of the invention, the sour cherry extract is 18-20 parts by weight, the sophora flower extract is 10-12 parts by weight, the celery seed extract is 12-14 parts by weight, and the potassium citrate is 8, 9 or 10 parts by weight.
In a preferred embodiment of the invention, the parts by weight of the sour cherry extract are 20 parts, the parts by weight of the sophora flower extract are 12 parts, the parts by weight of the celery seed extract are 14 parts, and the parts by weight of the potassium citrate is 10 parts.
In a preferred embodiment of the invention, the sour cherry extract is 18 parts by weight, the sophora flower extract is 10 parts by weight, the celery seed extract is 12 parts by weight, and the potassium citrate is 8 parts by weight.
In some embodiments of the invention, the composition is in the form of a solid formulation or a liquid formulation.
In some embodiments of the invention, the solid formulation is a tablet, capsule or granule; the liquid preparation is oral liquid, oral suspension or syrup.
In some embodiments of the invention, the solid dosage form may further comprise a diluent; the diluent may be a diluent conventionally usable on food or pharmaceutical preparations; preferably, the diluent is selected from any one or more of microcrystalline cellulose, mannitol, sorbitol, lactose; preferably, the diluent is present in an amount of from 35 to 50 parts by weight, more preferably from 40 to 45 parts by weight.
In some embodiments of the invention, the solid dosage form may further comprise a lubricant; the lubricant is a lubricant usable on food or pharmaceutical preparations; preferably, the lubricant is selected from any one or more of stearic acid, magnesium stearate, sodium stearyl fumarate; preferably, the lubricant is present in an amount of 0 to 1.5 parts by weight, more preferably 0.5 to 1 part by weight.
In some embodiments of the invention, the liquid dosage form may further comprise a bacteriostatic agent; the bacteriostatic agent can be a lubricant which can be used conventionally on food or pharmaceutical preparations; preferably, the bacteriostatic agent is selected from any one or more of sorbic acid, sorbate and paraben; preferably, the bacteriostatic agent is 0-1.5 parts by weight, preferably 0.5-1.0 part by weight.
In some embodiments of the invention, the liquid dosage form may further comprise a mucilage; the mucilage can be a mucilage which can be used conventionally on food or medicine preparations; preferably, the mucilage is selected from any one or more of sodium alginate, sodium carboxymethyl cellulose and sucrose; preferably, the weight portion of the mucilage is 20-55 portions, more preferably 30-52 portions, and further preferably 29.45-51.25 portions.
Optionally, the composition of the present invention may further comprise a flavoring agent and/or a fragrance; the flavoring agent and/or essence can be a flavoring agent and/or essence which can be used conventionally on food or pharmaceutical preparations; preferably, the flavoring agent is selected from one or more of sucralose, acesulfame potassium, stevioside and saccharin sodium, and the essence is one or more of strawberry essence, vanilla essence and orange essence; preferably, the parts by weight of the flavoring agent and/or essence are 0-0.05 part.
The invention also provides application of the composition in preparing functional food capable of reducing uric acid.
The invention also provides the application of the composition in preparing a medicament for treating diseases and/or alleviating disease symptoms, preferably hyperuricemia or gout.
The present invention also provides a method for preparing the above composition, comprising the steps of: the preparation method comprises the steps of premixing the four active components of the acerola cherry extract, the sophora flower extract, the celery seed extract and the potassium citrate, uniformly mixing, and then carrying out the subsequent steps, wherein the subsequent steps are preferably granulating or dissolving and mixing according to the preparation types.
In some embodiments, the process steps for extracting the acerola extract, the sophora flower extract, or the celery seed extract comprise: (1) Pre-treating, extracting with ethanol or water, concentrating, centrifuging,
(2) Concentrating for the second time, filtering, homogenizing, and spray drying; obtaining sour cherry extract, flos Sophorae Immaturus extract or semen Apii Graveolentis extract.
In a specific embodiment, in the extraction process of the sour cherry extract, the step (1) is extraction by pure water; preferably, the weight ratio of the pure water to the tart cherry is 20.
In a specific embodiment, in the extraction process of the sophora flower extract, the extraction in the step (1) is extraction by 50% ethanol; preferably, the weight ratio of the ethanol to the sophora flower is 20.
In a specific embodiment, in the extraction process of the celery seed extract, the ethanol extraction in the step (1) is 70% ethanol; preferably, the weight ratio of the ethanol to the celery seeds is 20.
The uric acid reducing composition provided by the invention has the following effects and advantages:
(1) The composition takes the potassium citrate, the sour cherry extract, the celery seed extract and the sophora flower extract as active ingredients, and can generate a synergistic interaction effect after the four ingredients are combined, so that the composition not only can inhibit the formation of uric acid, but also can promote the excretion of uric acid, and the uric acid level of a hyperuricemia patient can be quickly controlled;
(2) The composition takes the potassium citrate, the sour cherry extract, the celery seed extract and the sophora flower extract as active ingredients, and can play a synergistic interaction role after being used in combination, so that the occurrence of hypotension caused by side effects is remarkably reduced.
(3) The potassium citrate in the composition can improve the stability of the brass and the vitamin C in the extract, and reduce the adverse effect caused by impurities in the storage process, and the three extracts of the sour cherry extract, the sophora flower extract and the celery seed extract are mixed with the potassium citrate in advance in the preparation process, so that the three extracts are in full contact with the potassium citrate, and the potassium citrate can play a role in improving the stability of the composition.
Drawings
FIG. 1 DPPH radical scavenging curves at different concentrations for each formulation and comparative example
Detailed Description
The advantages and features of the present invention will become more apparent from the following description of the embodiments of the invention given by way of example. These examples are illustrative only and do not limit the scope of the present invention in any way. It will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention, and that such changes and modifications may be made without departing from the spirit and scope of the invention.
The examples, which do not specify specific conditions or methods, were carried out according to conventional conditions or methods. The reagents or instruments used are not indicated by the manufacturer, and are all conventional products commercially available.
Example 1: preparation of uric acid-reducing composition prescription preparation
1. Preparation of the extract
Sour cherry extract: the sour cherry producing area used in the examples is the United states, and the extraction process comprises pretreatment (cleaning, impurity removing and drying), 3 times of pure water extraction (the weight ratio of pure water to sour cherry is 20.
And (3) flos sophorae extract: the production place of the sophora japonica used in the examples is Shaanxi Qinling, and the extraction process comprises pretreatment (cleaning, impurity removal and drying), 3 times of 50% ethanol extraction (the weight ratio of ethanol to sophora japonica is 20, the extraction temperature is 50-60 ℃), negative pressure concentration, centrifugation, secondary concentration, filtration and homogenization, and spray drying.
The celery seed extract: the celery seed used in the embodiment is produced in Qinling mountains of Shaanxi, and the extraction process comprises pretreatment (cleaning, impurity removing and drying), 3 times of 70% ethanol extraction (the weight ratio of ethanol to celery seed is 20, the extraction temperature is 50-60 ℃), negative pressure concentration, centrifugation, secondary concentration, filtration, homogenization and spray drying.
2. Preparation of tablets of formula 1
(1) Premixing: weighing the sour cherry extract, the sophora flower extract, the celery seed extract and the potassium citrate according to the prescription in the table 1, and premixing for 5min by using a three-dimensional mixer at the rotating speed of 12 rpm.
(2) And (3) granulating: adding diluent into a granulator, adding the mixture obtained in the step (1), adding 70% ethanol, stirring at 120rpm, shearing at 1500rpm and 10min. And (4) finishing the granules by using a 18-mesh sieve after drying by using a fluidized bed.
(3) Total mixing: adding correctant and/or essence (if necessary) and lubricant, and mixing with three-dimensional mixer at 12rpm for 10min.
(4) Tabletting: the dosage form is tabletted by a high-speed tabletting machine.
2. Preparation of granules of formula 2
The prescription 2 is granules, except that the step (4) of tabletting is not carried out, the other steps are the same as the prescription 1, and granules are prepared by a granule subpackaging machine.
3. Preparation of formula 3 capsules
(1) Pre-mixing: weighing the sour cherry extract, the sophora flower extract, the celery seed extract and the potassium citrate according to the prescription in the table 1, and premixing for 10min by a three-dimensional mixer at the rotating speed of 10 rpm.
(2) And (3) granulating: adding a diluent into a granulator, adding the mixture obtained in the step (1), adding 70% ethanol, and stirring at a speed of 120rpm and a shear speed of 1500rpm for 15min. And (4) finishing the granules by using a 18-mesh sieve after drying by using a fluidized bed.
(3) Total mixing: adding correctant and/or essence (if necessary) and lubricant, and mixing with three-dimensional mixer at 10rpm for 15min.
(4) Filling: capsules were prepared using a capsule filling machine.
4. Preparation of oral liquid of formula 4
(1) Premixing: weighing the sour cherry extract, the sophora flower extract, the celery seed extract and the potassium citrate according to the prescription in the table 1, and premixing for 10min by a three-dimensional mixer at the rotating speed of 10 rpm.
(2) Dissolution 1: and (3) taking a proper amount of purified water to dissolve the mixture in the step (1).
(3) Dissolution 2: heating appropriate amount of purified water to 75 deg.C, dissolving bacteriostatic agent, excipient, and other adjuvants.
(4) Mixing: and (3) mixing the solutions obtained in the step (2) and the step (3) to prepare the oral liquid.
5. Prescription 5 is prepared by the same method as prescription 4, and can be made into oral liquid.
6. Prescription 6 is prepared by the same method as prescription 4, and the oral suspension is prepared from purified water.
Table 1, recipe Components and addition amounts
Figure BDA0003719473290000081
Example 2 preparation of a formulation of the comparative example
The formulation of comparative example was prepared according to table 2, the formulation of comparative example 1 was granules, and the preparation method was the same as formulation 2. Comparative examples 2-7 the compositions were oral liquids prepared according to the same method as described in formula 4.
TABLE 2 comparative example Components and amounts added
Figure BDA0003719473290000082
Figure BDA0003719473290000091
Example 3: study of formulation stability
The stability of each composition preparation is inspected by measuring the contents of total flavone and vitamin C when each prescription and comparative preparation is placed at 40 ℃ for 0 day, 5 days and 10 days, and the measuring method is as follows:
the method for measuring the total flavonoids comprises the following steps: accurately weighing 10mg rutin standard substance, placing in 50ml brown volumetric flask, and diluting to constant volume with 70% ethanol to obtain reference substance stock solution. Taking 6 25ml brown volumetric flasks, adding 0.00ml, 1.00ml, 2.00 ml, 3.00 ml, 4.00 ml and 5.00ml of the above reference substance stock solutions, adding 70% ethanol solution to 10ml, and mixing well. Adding 1.00ml of 5% sodium nitrite solution, uniformly mixing and standing for 6min, adding 1.00mL of aluminum nitrate solution, uniformly mixing and standing for 6min, adding 10.00mL of sodium hydroxide solution, finally using purified water to fix the volume, uniformly mixing and standing for 15min, measuring the light absorption value of the reaction solution at 510nm by using an ultraviolet spectrophotometer, and drawing a linear standard curve by using the concentration of a reference substance and the light absorption value. The light absorption value of the test sample is prepared by the same method, and the total flavone content is calculated by substituting the light absorption value into a standard curve formula.
The vitamin C determination method comprises the following steps: taking about 0.2g of the product, precisely weighing, adding 100ml of newly boiled cold water and 10ml of dilute acetic acid to dissolve, adding 1ml of starch indicator, immediately titrating with iodometric solution (0.05 mol/L) until the solution becomes blue and does not fade within 30 seconds. Each 1ml of iodometric solution (0.05 mol/L) corresponded to 8.806mg of vitamin C.
The results of the stability test are shown in tables 3 and 4, in which the results of the measurement on day 0 are 100%, and the results are converted into the results of the contents on days 5 and 10:
table 3, composition stability evaluation-Total Flavonoids content (%)
Figure BDA0003719473290000101
As can be seen from Table 3 above, under high temperature conditions, the total flavone contents of formulas 1 to 6 and comparative examples 3 to 7 were not significantly different in 5 days and 10 days from 0 day, while the total flavone contents of comparative examples 1 to 2 in 5 days and 10 days were significantly reduced from 0 day. The results show that potassium citrate can significantly increase the stability of the total flavonoids of the active substance.
TABLE 4 stability of the compositions-Total vitamin C content (%)
Grouping 5D 10D 10D vs. 0D variation
Prescription 1 99.3 99.5 -0.5
Prescription 2 98.1 100.3 +0.3
Prescription 3 98.9 100.0 0
Prescription 4 101.0 101.6 +1.6
Prescription 5 101.8 102.6 +2.6
Prescription 6 99.4 100.5 +0.5
Comparative example 1 91.8 75.0 -25.0
Comparative example 2 92.1 75.3 -24.7
Comparative example 3 98.3 100.5 +0.5
Comparative example 4 100.1 100.8 +0.8
Comparative example 5 97.9 98.6 -1.4
Comparative example 6 101.5 102.0 +2.0
As can be seen from Table 4, under high temperature conditions, the total vitamin C contents of formulas 1 to 6 and comparative examples 3 to 7 were not significantly different from day 0 in the 5-day and 10-day period, while the total vitamin C contents of comparative examples 1 to 2 were significantly reduced from day 0 in the 5-day and 10-day period. The above results show that potassium citrate can increase the stability of total vitamin C in the composition.
Example 4: determination of antioxidant Activity of formulations and comparative examples
1. Test method
The antioxidant activity of the composition of the invention is reflected by detecting 1,1-diphenyl-2-trinitrophenylhydrazine (DPPH) free radical clearance. Dissolving the composition in distilled water, and diluting to total content of active ingredients (i.e. the sum of the contents of sour cherry extract, celery seed extract, flos Sophorae Immaturus extract, and potassium citrate) of 10mg/ml, 8mg/ml,6mg/ml,4mg/ml, and 2mg/ml. Adding 3ml of sample solution into the test tube, adding 3ml of DPPH absolute ethanol solution (0.2 mmol/L), mixing the reaction solution, keeping away from light, and standing for 30min, wherein distilled water is used as blank control. And finally, measuring the absorbance of the reaction solution at 517nm, repeating the experiment for 3 times, substituting the absorbance value into the following formula, and calculating the removal rate of the DPPH free radicals of each sample.
Clearance = (a) 0 -A)/A*100％
In the formula: a. The 0 : absorbance of blank solution
A: absorbance of test group solution
2. Test results
The DPPH free radical clearance at different concentrations for each formulation is shown in fig. 1. As can be seen from FIG. 1, each formulation and comparative formulation can scavenge DPPH free radicals, and the clearance rate and the concentration are in positive correlation within a certain range, which indicates that each formulation and comparative formulation has antioxidant activity.
Example 5: inhibitory Activity on Xanthine Oxidase (XO) in vitro
1. Test method
The formulation of the formulation and comparative example were dissolved in distilled water and diluted in a gradient to a total active ingredient content of 10. Mu.g/ml, 8. Mu.g/ml, 6. Mu.g/ml, 4. Mu.g/ml, 2. Mu.g/ml. Allopurinol was used as a positive control, and purified water was used as a negative control. Mu.l of the sample solution, 175. Mu.l of a buffer solution (pH 7.5) and 200. Mu.l of a Xanthine Oxidase (XO) solution (0.1U/ml) were sequentially added to a 1.5ml centrifuge tube, mixed well, allowed to stand at 25 ℃ for 15min, 250. Mu.l of a xanthine solution (1.5 mM) was added thereto, and after reaction at 37 ℃ for 30min, 125. Mu.l of HCl (1 mol/L) was added thereto to terminate the reaction.
Detecting uric acid level by HPLC to reflect XO activity, calculating inhibition rate of each group of preparations on XO, and inhibiting by negative control uric acid content of 100% and 1- (sample uric acid content/negative control uric acid content)The rate, the IC was calculated by linear regression from the enzyme inhibition rate and the sample concentration 50 。
2. Test results
Formulations of each formulation and comparative example inhibit IC of XO in vitro 50 See table 5:
TABLE 5 IC50 measurement results for XO inhibition in vitro for each of the formulations
Sample set IC50(μg/ml) Sample set IC50(μg/ml)
Prescription 1 8.4 Comparative example 1 15.3
Prescription 2 5.3 Comparative example 2 13.6
Prescription 3 9 Comparative example 3 19.8
Prescription 4 8.1 Comparative example 4 21.2
Prescription 5 7.9 Comparative example 5 18.6
Prescription 6 4.8 Comparative example 6 14.5
/ / Comparative example 7 15.7
As can be seen from Table 5, formulas 1-6 inhibit XO IC in vitro 50 Are all significantly smaller than comparative examples 1-7, which shows that the formula samples have stronger in vitro inhibition capacity on the activity of XO compared with the comparative examples; in particular IC of recipes 2 and 6 50 Lower, has better in vitro XO inhibition effect.
Example 6: uric acid lowering activity in mice
1. Test method
Model animals: male Kunming mice, randomly grouped, 8 mice per group. 300mg/kg/d of oteracil potassium is injected into the abdominal cavity, 250mg/kg/d of hypoxanthine and 250mg/kg/d of ethanol butylamine are used for intragastric administration. The blank control group was treated with 0.9% physiological saline. The molding time is 30 days, and the gastric lavage is continued in the administration period according to the mode.
Animal administration: after the molding is successful, the prescription 2, the prescription 4 and the comparative examples 1 to 7 are used for gastric lavage administration at 50mg/kg/d based on the total content of the four components. The following items were tested on days 0, 7, 14, and 21, respectively: serum uric acid content, blood liver XO activity, uric acid amount in 24h urine, and blood pressure.
The method for measuring the content of uric acid in serum comprises the following steps: preparing a uric acid standard solution with the concentration of 100 mu mol/L. Taking 0.2ml of uric acid standard solution, adding a protein precipitator (10% trichloroacetic acid), standing for 10min after the reaction liquid is fully mixed, centrifuging for 5min at 3000rpm, taking 1.6ml of supernate, adding 0.5ml of buffer solution and 0.5ml of color development liquid, standing for 10min after the reaction liquid is fully mixed, measuring the light absorption value of the reaction liquid at the wavelength of 690nm, and repeating the test for 3 times, wherein a blank group is distilled water. Samples were prepared in the same manner, and absorbance was measured to calculate the uric acid level in mouse serum.
Assay of serum XO activity: after the mice die at the neck, the liver is taken, ice physiological saline is used for cleaning, then 0.5g of the liver is weighed, ice physiological saline is used for preparing 10% liver tissue homogenate, 5000r/min is carried out, and the centrifugation is carried out for 10min. The supernatant was collected and XO activity was measured according to test example 5.
2. Results of the experiment
(1) Serum uric acid content results
Serum uric acid content at each molding and administration stage is shown in table 6:
TABLE 6 serum uric acid levels (μmol/L) during molding and dosing
Figure BDA0003719473290000131
* : the result shows that P is more than 0.01 and less than 0.05 when compared with 30 days of molding; # denotes that P is < 0.01, compared with 30 days for molding.
As can be seen from Table 6, the serum uric acid content of the model group is significantly increased at the 15 th day of the molding, indicating that the molding is successful. Comparative examples 1-7 slightly reduced uric acid levels between 7-14 days of administration, and significantly reduced serum uric acid levels by 21 days of administration, but not to blank levels. And the serum uric acid content of the prescription 2 and the prescription 4 is obviously reduced compared with that of the model group at the beginning of the 7 th day of administration, and the serum uric acid content is reduced to be consistent with that of the blank group and to be obviously better than that of the comparative examples 1-7 by the 21 th day of administration.
The results show that the four active ingredients in the formula have obvious synergistic effect on reducing the content of serum uric acid.
(2) Measurement of serum XO Activity
Serum XO activity at each molding and administration stage is shown in table 7:
TABLE 7 serum XO Activity (U/L) during modeling and dosing
Figure BDA0003719473290000132
Figure BDA0003719473290000141
* : the result shows that P is more than 0.01 and less than 0.05 when compared with 30 days of molding; # denotes that P is < 0.01, compared with 30 days for molding.
As can be seen in table 7, the serum XO activity of the model group increased significantly starting at day 15 of molding, indicating successful molding. Comparative examples 1-7 had a slight decrease in serum XO activity between 7 and 14 days of administration, with a significant decrease in serum uric acid levels by 21 days of administration, but not to blank levels. However, formulations 2 and 4 had significantly reduced serum XO activity compared to the model group starting on day 7 of administration, and by day 21 of administration, serum uric acid levels had been reduced to be consistent with the blank group, significantly better than comparative examples 1-7.
The above results indicate that the four active ingredients of the formula of the present invention produce significant synergy in reducing serum XO activity.
(3) Urine pH measurement results
The urine pH at each molding and dosing stage is shown in table 8:
TABLE 8 urine pH during molding and administration
Figure BDA0003719473290000142
* : compared with 30 days of molding, P is more than 0.01 and less than 0.05; # denotes P < 0.01, as compared to 30 days of molding.
As can be seen from Table 8, (1) the pH value of urine in the model group is significantly reduced at the 15 th day of molding, which indicates that molding is successful; (2) Prescription 2 and prescription 4 began on day 7 of administration, with a significant increase in urine pH compared to the model group, and by day 21 of administration, urine pH had increased to be consistent with the blank group; (3) Comparative examples 1, 2, 6, 7, urine pH was not significantly different during the administration period compared to the molded 30D; (4) Comparative examples 3-5, urine pH was significantly elevated compared to the model group starting on day 7 of administration, and had been elevated to be consistent with the blank group by day 21 of administration.
The results show that the prescription of the invention can maintain the pH value of urine due to the addition of the potassium citrate.
(4) Blood pressure measurement results
Blood pressure of mice at each molding and administration stage is shown in tables 9 and 10:
TABLE 9 blood pressure-high pressure (mm Hg) during molding and administration
Figure BDA0003719473290000151
* : it shows that 0.01 < P < 0.05 compared with 30 days of molding.
As can be seen from table 9, (1) the blood pressure (high pressure) of the mice was relatively stable and did not change significantly during the molding and administration period for the model group and the blank group and for the formula 2 and the formula 4; (2) Comparative examples 1-7 mice showed significant reductions in blood pressure (hypertension) between days 14 and 21 of administration.
TABLE 10 blood pressure-Low pressure (mm Hg) during molding and administration
Figure BDA0003719473290000152
* : compared with 30 days of molding, P is more than 0.01 and less than 0.05; # denotes that P is < 0.01, compared with 30 days for molding.
As can be seen from table 10, (1) the blood pressure (low pressure) of the mice was relatively stable and did not change significantly during the molding and administration period for the model group and the blank group and for the formula 2 and the formula 4; (2) Comparative examples 1-6 mice exhibited significant reductions in blood pressure (low pressure) between days 7 and 21 of administration.
As can be seen by combining the results of high pressure (normal physiological range: 95-125) and low pressure (normal physiological range: 67-90) in mice, the blood pressure of the mice in the comparative example group decreased to different degrees during the administration period, whereas the mice in the experimental group of the present invention did not change significantly. The above results indicate that in the formula of the present invention, each active ingredient also exerts a synergistic effect in reducing the occurrence of hypotensive side effects, and can significantly reduce the incidence of adverse reactions.

Claims (12)

1. A uric acid reducing composition is characterized by comprising a sour cherry extract, a sophora flower extract, a celery seed extract and potassium citrate.
2. The composition according to claim 1, wherein the sour cherry extract is 15-30 parts by weight, the sophora flower extract is 8-15 parts by weight, the celery seed extract is 10-25 parts by weight, and the potassium citrate is 5-15 parts by weight.
3. The composition according to claim 2, wherein the weight parts of the sour cherry extract are 16-18 parts, the weight parts of the sophora flower extract are 10-12 parts, the weight parts of the celery seed extract are 12-14 parts, and the weight parts of potassium citrate are 8-10 parts.
4. The composition according to any one of claims 1 to 3, characterized in that: the dosage form of the composition is a solid preparation or a liquid preparation; preferably, the solid preparation is a tablet, a capsule or a granule; the liquid preparation is oral liquid, oral suspension or syrup.
5. The composition of claim 4, wherein the solid dosage form further comprises a diluent; preferably, the diluent is selected from any one or more of microcrystalline cellulose, mannitol, sorbitol, lactose; preferably, the diluent is present in an amount of 35 to 50 parts by weight, more preferably 40 to 45 parts by weight.
6. The composition according to claim 4 or 5, wherein the solid dosage form further comprises a lubricant; preferably, the lubricant is selected from any one or more of stearic acid, magnesium stearate, sodium stearyl fumarate; preferably, the lubricant is present in an amount of 0 to 1.5 parts by weight, more preferably 0.5 to 1 part by weight.
7. The composition of claim 4, wherein the liquid dosage form further comprises a bacteriostatic agent; preferably, the bacteriostatic agent is selected from any one or more of sorbic acid, sorbate and paraben; preferably, the weight portion of the bacteriostatic agent is 0 to 1.5 parts, preferably 0.5 to 1.0 part.
8. The composition of claim 4 or 7, wherein the liquid dosage form further comprises a mucilage; preferably, the mucilage is selected from any one or more of sodium alginate, sodium carboxymethyl cellulose and sucrose; preferably, the weight portion of the mucilage is 20-55 portions, more preferably 30-52 portions, and further preferably 29.45-51.25 portions.
9. The composition according to any one of claims 1 to 8, wherein the composition further comprises a flavoring agent and/or a fragrance; preferably, the flavoring agent is selected from one or more of sucralose, acesulfame potassium, stevioside and saccharin sodium, and the essence is selected from one or more of strawberry essence, vanilla essence and orange essence; preferably, the parts by weight of the flavoring agent and/or essence are 0-0.05 part.
10. Use of a composition according to any one of claims 1 to 9 for the preparation of a functional food capable of reducing uric acid.
11. Use of a composition according to any one of claims 1 to 9 in the manufacture of a medicament for the treatment of a disease and/or alleviation of a disease condition, preferably the disease is hyperuricemia or gout.
12. A method of preparing the composition of any one of claims 1-9, wherein said steps comprise: premixing the active ingredients of the acerola cherry extract, the sophora flower extract, the celery seed extract and the potassium citrate, uniformly mixing, and then carrying out the subsequent steps, preferably, the subsequent steps are granulation or dissolution and mixing according to the preparation type.
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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090269425A1 (en) * 2008-04-28 2009-10-29 Truscott Kent J Formulation and method for relieving or preventing symptoms associated with uric acid crystals
CN107362194A (en) * 2016-05-12 2017-11-21 北京人福军威医药技术开发有限公司 Compound celery seed Huai Goat and its medical usage
CN109511984A (en) * 2019-01-09 2019-03-26 丁强 A kind of special dietary seafood with the alleviation gout that celery seed, potassium citrate etc. are primary raw material preparation
CN109758571A (en) * 2019-03-27 2019-05-17 长春健康未来医药科技有限公司 A kind of promotion uric acid metabolism improves gout, the composition of Saving cortilage and preparation method thereof
CN110623182A (en) * 2019-10-10 2019-12-31 胡洁 Probiotic plant solid beverage for treating hyperuricemia and gout
CN112369609A (en) * 2020-10-30 2021-02-19 云南奥咖生物技术有限公司 Functional food capable of reducing uric acid and preparation method thereof

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090269425A1 (en) * 2008-04-28 2009-10-29 Truscott Kent J Formulation and method for relieving or preventing symptoms associated with uric acid crystals
CN107362194A (en) * 2016-05-12 2017-11-21 北京人福军威医药技术开发有限公司 Compound celery seed Huai Goat and its medical usage
CN109511984A (en) * 2019-01-09 2019-03-26 丁强 A kind of special dietary seafood with the alleviation gout that celery seed, potassium citrate etc. are primary raw material preparation
CN109758571A (en) * 2019-03-27 2019-05-17 长春健康未来医药科技有限公司 A kind of promotion uric acid metabolism improves gout, the composition of Saving cortilage and preparation method thereof
CN110623182A (en) * 2019-10-10 2019-12-31 胡洁 Probiotic plant solid beverage for treating hyperuricemia and gout
CN112369609A (en) * 2020-10-30 2021-02-19 云南奥咖生物技术有限公司 Functional food capable of reducing uric acid and preparation method thereof

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