Powder for treating gouty arthritis and preparation method thereof

Abstract

The invention discloses powder for treating gouty arthritis and a preparation method, and the powder is prepared from the following raw materials in parts by weight: 1-6 parts of guarana extract, 8-15 parts of water-soluble turmeric powder, 0.005-0.2 part of vitamin B1, 0.005-0.2 part of vitamin B2 and 2 * 10 <-5 >-1.5 * 10 <-4 > parts of vitamin D3 as well as 1.5-9 parts of plantain seed extract and 8-15 parts of oat powder as auxiliary materials. The obtained product mainly adopts medicinal and edible raw materials as a formula, can achieve the effect of safely reducing uric acid, and has a good application prospect.

Description

Technical Field

[0001] The invention belongs to the field of medicines, and particularly relates to a powder for treating gouty arthritis and a preparation method thereof. Background Art

[0002] Gouty arthritis is caused by the deposition of urate in the joint capsule, bursa, cartilage and other tissues, which causes lesions and inflammatory reactions. It is more common in men, and is more common in the first metatarsophalangeal joint. The side effects of existing therapeutic drugs such as diclofenac sodium or diclofenac potassium can be manifested as edema, anorexia, rash, electrolyte imbalance, arrhythmia, dizziness, and other symptoms, as well as side effects of the digestive system and systemic organ dysfunction; the side effects and hazards of colchicine include gastrointestinal discomfort, blood system reactions, nervous system reactions, etc., and may also cause kidney damage; the use of glucocorticoids will cause side effects such as obesity, digestive tract reactions, edema, nervous system damage, liver damage, and may also cause increased uric acid, blood pressure or blood lipids. Summary of the invention

[0003] In view of the problems existing in the application of existing drugs, the present invention provides a powder for treating gouty arthritis and a preparation method thereof, which is mainly formulated with raw materials that can be used as both medicine and food, and can achieve the effect of safely lowering uric acid.

[0004] To achieve the above object, the present invention adopts the following technical solution: A powder for treating gouty arthritis is prepared using guarana extract (food raw material), water-soluble turmeric powder (medicinal and edible raw material), vitamin B1, vitamin B2, and vitamin D3 (nutrient supplement) as raw materials, and psyllium extract and oatmeal powder as food-grade auxiliary materials.

[0005] By weight, the amount of each material in the powder is 1-6 parts of guarana extract, 8-15 parts of water-soluble turmeric powder, 0.005-0.2 parts of vitamin B1, 0.005-0.2 parts of vitamin B2, 2×10 -5 -1.5×10 -4 parts of vitamin D3, 1.5-9 parts of psyllium extract, and 8-15 parts of oatmeal powder.

[0006] Preferably, the amount of each material in the powder is 2-5 parts of guarana extract, 10-13 parts of water-soluble turmeric powder, 0.01-0.03 parts of vitamin B1, 0.01-0.03 parts of vitamin B2, 5×10 -5 -1.0×10 -4 parts of vitamin D3, 3-8 parts of psyllium extract, and 10-14 parts of oatmeal powder.

[0007] More preferably, the amount of each material in the powder is 3 parts of guarana extract, 12 parts of water-soluble turmeric powder, 0.02 parts of vitamin B1, 0.02 parts of vitamin B2, 8×10 -5 1 portion of vitamin D3, 5 portions of psyllium extract, and 12 portions of oatmeal powder.

[0008] The preparation method of the powder for treating gouty arthritis comprises the following steps: 1) adding the formulated amount of guarana extract, vitamin B2 and vitamin D3 into a 95 vol% ethanol solution which is 5-10 times the total mass of the three, stirring and dissolving to obtain a mixture alcohol solution; 2) Add drinking water to the reaction kettle, add the formulated amount of psyllium extract and oatmeal powder under stirring to prepare a solution with a total mass concentration of 30%-50%, then slowly add the alcohol solution of the mixture prepared in step 1) under stirring, and continue stirring for 2.5-5.0 hours after the addition; 3) Concentrating the liquid obtained in step 2) to a solid content of 65%-75%; 4) drying the concentrated material in step 3) by hot air circulation at normal pressure until the moisture content is ≤5.0%, then crushing it and passing it through a 60-mesh sieve to obtain a premix; 5) Grind the formulated amount of water-soluble turmeric powder and vitamin B1 separately and pass through a 60-mesh sieve; 6) The premix obtained in step 4), the water-soluble turmeric powder crushed and sieved in step 4), and vitamin B1 are mixed in a three-mixer for 20 minutes, and after the moisture content is detected to be ≤5.0%, they are packaged in an amount of 1.5 g / bag.

[0009] Furthermore, in step 2), the stirring speed is 80 r / min-100 r / min.

[0010] Furthermore, in step 2), the addition of the mixed alcohol solution is controlled within 10 minutes.

[0011] Furthermore, the concentration temperature in step 3) is 70±3° C., and the vacuum degree is maintained at 0.01-0.06Mpa.

[0012] Furthermore, the drying temperature in step 4) is 70±3°C.

[0013] The mechanism of the raw materials and auxiliary materials used is as follows: Guarana, also known as Brazilian cocoa, contains theobromine and theophylline, which have anti-inflammatory and anti-aging effects. Theobromine is slightly soluble in water.

[0014] Vitamin B2 can participate in many important functions and metabolic processes in the body, maintain the body's normal metabolism, and has anti-inflammatory effects. Vitamin B2 is almost insoluble in water, ethanol, chloroform or ether.

[0015] Vitamin D3 is an important vitamin that helps maintain healthy bones and teeth, improves immune function, and has anti-inflammatory and antibacterial properties. Vitamin D3 is insoluble in water.

[0016] As a diuretic and dampness-removing Chinese medicine, Plantago is one of the commonly used Chinese medicines for the clinical treatment of hyperuricemia and gout. Modern pharmacological studies have confirmed that its main chemical components can reduce uric acid by inhibiting xanthine oxidase activity and uric acid transporter. At the same time, the psyllium gum in the plantago extract and the oat β-glucan in the oatmeal powder have a solubilizing effect on poorly soluble drugs.

[0017] Curcumin in turmeric can significantly reduce the uric acid level in hyperuricemia mice and has the effect of protecting the liver and kidneys.

[0018] The significant advantages of the present invention are: (1) The present invention enhances the solubility of guarana extract, vitamin B2 and vitamin D3 by premixing with psyllium extract and oatmeal powder, and then mixes the obtained premix with water-soluble turmeric powder and vitamin B1 to effectively enhance the effect of the product in preventing and treating rheumatoid arthritis.

[0019] (2) The product obtained by the present invention is formulated with raw materials that can be used as both medicine and food, and can achieve the effect of safely lowering uric acid. DETAILED DESCRIPTION

[0020] A powder for treating gouty arthritis, which comprises, by weight, 1-6 parts of guarana extract, 8-15 parts of water-soluble turmeric powder, 0.005-0.2 parts of vitamin B1, 0.005-0.2 parts of vitamin B2, 2×10 -5 -1.5×10 -4 The method comprises the following steps: 1) adding the formulated amount of guarana extract, vitamin B2 and vitamin D3 into a 95 vol% ethanol solution which is 5-10 times the total mass of the three, stirring and dissolving to obtain a mixture alcohol solution; 2) Add drinking water to the reactor, add the formulated amount of psyllium extract and oatmeal powder under stirring at 80 r / min-100 r / min to prepare a solution with a total mass concentration of 30%-50%, then slowly add the mixed alcohol solution prepared in step 1) from the feed port under stirring (addition takes 10 minutes), and continue stirring for 2.5-5.0 hours after addition; 3) Pump the liquid obtained in step 2) into a vacuum concentrator, control the concentration temperature to 70±3°C, maintain the vacuum degree at 0.01-0.06Mpa, and concentrate until the solid content is 65%-75%, and refrigerate for later use; 4) drying the concentrated material in step 3) at 70±3°C by hot air circulation at normal pressure until the moisture content is ≤5.0%, and then crushing the dried lumps by a crusher and passing through a 60-mesh sieve to obtain a premix; 5) Grind the formulated amount of water-soluble turmeric powder and vitamin B1 separately and pass through a 60-mesh sieve; 6) The premix obtained in step 4), the water-soluble turmeric powder crushed and sieved in step 4), and vitamin B1 are mixed in a three-mixer for 20 minutes, and after the moisture content is detected to be ≤5.0%, they are packaged in an amount of 1.5 g / bag.

[0021] In order to make the contents of the present invention easier to understand, the technical solution of the present invention is further described below in conjunction with specific implementation methods, but the present invention is not limited thereto.

[0022] The guarana extract used is: National Food Safety Standard Food Additives Usage Standard (GB 2760) The water-soluble turmeric powder used is: Fujian Mofan Nutrition Food Co., Ltd. Enterprise Standard Water-soluble Turmeric Powder (Q / FJMF 0003S-2024) The vitamin B1 used is: Food Safety National Standard Food Additive Vitamin B1 (Thiamine Hydrochloride) (GB 14751) The vitamin B2 used is: National Food Safety Standard Food Additive Vitamin B2 (Riboflavin) (GB 14752); The vitamin D3 used is: Food Safety National Standard Food Nutrition Fortifier Cholecalciferol (Vitamin D3) (GB1903.50) The psyllium seed extract used is a water extract of the dried mature seeds of Plantago asiatica L. or Plantago depressa Willd. of the Plantaginaceae family, and mainly contains psyllium seed gum.

[0023] The oatmeal powder used is: Green food oats and oatmeal powder (NY / T 892) (Ministry of Agriculture and Rural Affairs standard) Example 1 Step 1. Weighing: According to weight, weigh 3 parts of guarana extract, 12 parts of water-soluble turmeric powder, 0.02 parts of vitamin B1, 0.02 parts of vitamin B2, and 8×10 -5 1 portion, 5 portions of psyllium extract, and 12 portions of oatmeal powder.

[0024] Step 2, preparation of premix: 1) Add the formulated amount of guarana extract, vitamin B2 and vitamin D3 into a 95 vol% ethanol solution which is 8 times the total mass of the three, stir and dissolve to obtain a mixture alcohol solution.

[0025] 2) Add drinking water to the reactor, add the formulated amount of psyllium extract and oatmeal powder under stirring at 90 r / min to prepare a solution with a total mass concentration of 40%, and then slowly add the mixed alcohol solution prepared in step 1) from the feed port under stirring (add in 10 minutes), and continue stirring for 3.0 hours after the addition; 3) Pump the liquid obtained in step 2) into a vacuum concentrator, control the concentration temperature to 70±3°C, maintain the vacuum degree at 0.02-0.05Mpa, and concentrate until the solid content is 68%, and refrigerate for later use; 4) The concentrated material in step 3) is dried at 70±3°C with hot air circulation at normal pressure to a moisture content of 4.3%, and then the dried lumps are crushed with a pulverizer and passed through a 60-mesh sieve to obtain a premix.

[0026] Step 3: Material crushing and screening Grind the formulated amount of water-soluble turmeric powder and vitamin B1 separately and pass through a 60-mesh sieve.

[0027] Step 4: Total Mixing The crushed and sieved water-soluble turmeric powder, vitamin B1 and premix were placed in a three-mixer and mixed for 20 minutes. The moisture content was detected to be 4.5%, and the products were packaged into composite bags of 1.5 g / bag.

[0028] Step 5: Submit for inspection Take samples for inspection in a timely manner, and fill out the inspection form for the products to be inspected, stating the product name, batch number, specifications, quantity, production date and other information.

[0029] Example 2 Step 1. Weighing: According to weight, weigh 2 parts of guarana extract, 13 parts of water-soluble turmeric powder, 0.03 parts of vitamin B1, 0.03 parts of vitamin B2, and 35×10 -5 1 portion, 8 portions of psyllium extract, and 10 portions of oatmeal powder.

[0030] Step 2, preparation of premix: 1) Add the formulated amount of guarana extract, vitamin B2 and vitamin D3 into a 95 vol% ethanol solution which is 5 times the total mass of the three, stir and dissolve to obtain a mixture alcohol solution.

[0031] 2) Add drinking water to the reactor, add the formulated amount of psyllium extract and oatmeal powder under stirring at 100 r / min to prepare a solution with a total mass concentration of 35%, and then slowly add the mixed alcohol solution prepared in step 1) from the feed port under stirring (add in 10 minutes), and continue stirring for 2.5 hours after the addition; 3) Pump the liquid obtained in step 2) into a vacuum concentrator, control the concentration temperature to 70±3°C, maintain the vacuum degree at 0.01-0.05Mpa, and concentrate until the solid content is 65%, and refrigerate for later use; 4) The concentrated material in step 3) is dried at 70±3°C under normal pressure hot air circulation to a moisture content of 3.6%, and then the dried lumps are crushed by a pulverizer and passed through a 60-mesh sieve to obtain a premix.

[0032] Step 3: Material crushing and screening Grind the formulated amount of water-soluble turmeric powder and vitamin B1 separately and pass through a 60-mesh sieve.

[0033] Step 4: Total Mixing The crushed and sieved water-soluble turmeric powder, vitamin B1 and premix were placed in a three-mixer and mixed for 20 minutes. The moisture content was detected to be 4.0%, and the products were packaged into composite bags of 1.5 g / bag.

[0034] Step 5: Submit for inspection Take samples for inspection in a timely manner, and fill out the inspection form for the products to be inspected, stating the product name, batch number, specifications, quantity, production date and other information.

[0035] Example 3 Step 1. Weighing: According to weight, weigh 5 parts of guarana extract, 10 parts of water-soluble turmeric powder, 0.01 parts of vitamin B1, 0.01 parts of vitamin B2, and 8×10 -5 3 parts, 3 parts of psyllium extract, and 14 parts of oatmeal powder.

[0036] Step 2, preparation of premix: 1) Add the formulated amount of guarana extract, vitamin B2 and vitamin D3 into a 95 vol% ethanol solution which is 10 times the total mass of the three, stir and dissolve to obtain a mixture alcohol solution.

[0037] 2) Add drinking water to the reactor, add the formulated amount of psyllium extract and oatmeal powder under stirring at 80 r / min to prepare a solution with a total mass concentration of 50%, and then slowly add the mixed alcohol solution prepared in step 1) from the feed port under stirring (add in 10 minutes), and continue stirring for 5.0 hours after the addition; 3) Pump the liquid obtained in step 2) into a vacuum concentrator, control the concentration temperature to 70±3°C, maintain the vacuum degree at 0.02-0.06Mpa, and concentrate until the solid content is 73%, and refrigerate for later use; 4) The concentrated material in step 3) is dried at 70±3°C under normal pressure hot air circulation to a moisture content of 4.7%, and then the dried lumps are crushed by a pulverizer and passed through a 60-mesh sieve to obtain a premix.

[0038] Step 3: Material crushing and screening Grind the formulated amount of water-soluble turmeric powder and vitamin B1 separately and pass through a 60-mesh sieve.

[0039] Step 4: Total Mixing The crushed and sieved water-soluble turmeric powder, vitamin B1 and premix were placed in a three-mixer and mixed for 20 minutes. The moisture content was detected to be 4.0%, and the products were packaged into composite bags of 1.5 g / bag.

[0040] Step 5: Submit for inspection Take samples for inspection in a timely manner, and fill out the inspection form for the products to be inspected, stating the product name, batch number, specifications, quantity, production date and other information.

[0041] Comparative Example Step 1. Weighing: According to weight, weigh 3 parts of guarana extract, 12 parts of water-soluble turmeric powder, 0.02 parts of vitamin B1, 0.02 parts of vitamin B2, and 8×10 -5 1 portion, 5 portions of psyllium extract, and 12 portions of oatmeal powder.

[0042] Step 2: Total Mixing The formulated amounts of guarana extract, vitamin B2, vitamin D3, water-soluble turmeric powder, vitamin B1, psyllium extract, and oatmeal powder were crushed separately and passed through a 60-mesh sieve, mixed in a three-mixer for 20 minutes, and packaged into 1.5 g / bag products in compound bags.

[0043] 1. Dissolution test of the active ingredient theobromine 1.1 Detection method Agricultural Industry Standard of the People's Republic of China Determination of theobromine and theophylline content in tea by high performance liquid chromatography (NY / T 3631-2020) 1.2 Sample processing Weigh 0.5 g (accurate to 0.0001 g) of each product obtained in Example 1 and the comparative example in a 50 mL centrifuge tube, add 1.0 g of heavy magnesium oxide (MgO) and 15 mL of 70°C water, place in a 70°C water bath, extract for 10 min (oscillate from time to time during the period to ensure full contact between the feed and the liquid), cool to room temperature, centrifuge at 4000 r / min for 10 min, and transfer the supernatant to a 25 mL volumetric flask. Add 10 mL of 70°C water to the residue and repeat the extraction operation once. Combine the supernatants of the two extractions, dilute to 25 mL with water, filter through a 0.45 μm water filter membrane, and provide high performance liquid chromatography detection. Repeat the test three times and take the average.

[0044] 1.3 Test results Table 1 Comparison of theobromine solubility of Example 1 and the comparative example product (mg / g)

[0045] As can be seen from Table 1, the theobromine solubility of the product obtained in the example is 7.2 times that of the comparative example.

[0046] 2. Uric acid lowering efficacy test 2.1 Materials and methods 2.1.1 Sample The product of Example 1 has a specification of 1.5 g / bag. The recommended oral dosage for humans is 1 bag per person (adult) once a day.

[0047] 2.1.2 Blank reference Corn starch, specification: 1.5g / bag, once a day, 1 bag each time.

[0048] 2.1.3 Subjects 2.1.3.1 Subject inclusion criteria a) serum uric acid level ≥360 μmol / L (6 mg / dL); b) Rapid onset of severe pain and redness and swelling in the first metatarsophalangeal joint (usually at night), the appearance of tophi, and severe pain, redness, or swelling in other joints such as the midfoot, ankle, knee, hand, wrist, and elbow.

[0049] 2.1.3.2 Subject Exclusion Criteria (1) People under 18 years old or over 65 years old, pregnant or lactating women, or those who are allergic to the test samples.

[0050] (2) Patients with serious diseases of the heart, liver, kidney and hematopoietic system, and mental illness.

[0051] (3) Taking items related to the function being tested in the short term may affect the judgement of the results.

[0052] (4) Those who do not meet the inclusion criteria, fail to take the test samples as required, or have incomplete data that affects the observation results.

[0053] 2.1.3.3 Experimental design and grouping 120 volunteers were selected and randomly divided into a control group and a trial group according to their blood uric acid levels using a self-control design and an inter-group control design. When grouping, the main factors affecting the results, such as age, gender, and course of disease, were considered as much as possible, and balanced adjustments were made to ensure comparability between groups.

[0054] 2.1.3.4 Dosage and time of administration The trial group took the sample. The control group took the blank control. The continuous taking time was 60 days. During the trial, the two groups of people maintained their original living and eating habits.

[0055] 2.1.3.5 Requirements for main instruments, reagents and testing environment Biochemical analyzer, etc.

[0056] 2.1.3.6 Efficacy indicators Clinical symptoms, fasting uric acid 2.1.3.7 Efficacy determination criteria 2.1.3.7.1 Symptom Observation The scores were calculated based on the severity of the symptoms (see Table 2 for scoring criteria) before and after the trial, and the improvement rates of clinical symptoms were observed and compared based on the improvement of the main symptoms (improvement of 1 point was considered effective).

[0057] Symptom 1: Pain and redness and swelling of the first metatarsophalangeal joint occur rapidly (usually at night), and tophi appear; Symptom 2: The main clinical symptoms include severe pain, redness or swelling in other joints, low back pain, fatigue, etc.

[0058] Table 2 Clinical symptom scoring table

[0059] 2.1.3.7.2 Fasting uric acid: After the test, the fasting uric acid reduction efficiency of the trial group was higher than that of the control group, and the difference was significant. It can be judged that the fasting uric acid index result of the test sample is positive.

[0060] Effective rate of fasting uric acid reduction (%) = number of effective fasting uric acid cases / reciprocal of fasting uric acid observation × 100%.

[0061] 2.2 Statistics For self-control data, paired t-test can be used, and for comparison of two groups of means, group t-test is used. The latter requires variance homogeneity test. For data with non-normal distribution or uneven variance, appropriate variable transformation is performed. After the normal variance homogeneity is met, the transformed data is used for t-test; if the transformed data still cannot meet the normal variance homogeneity requirement, t' test or rank sum test is used instead; for data with homogeneous variance but too large coefficient of variation (such as CV>50%), rank sum test is used. The χ2 test is used for efficiency. 2 Test for comparison.

[0062] 2.3 Results 2.3.1 Effects of samples on symptomatic indicators of gout patients Table 3 Symptom improvement of the population before and after the trial

[0063] Table 4 Comparison of clinical symptom scores between the two groups before and after the trial ( )

[0064] 2.3.2 Effect of samples on uric acid index in gout patients Table 5 Comparison of uric acid and fasting uric acid effectiveness between the two groups of people ( )

[0065] As shown in Tables 3 to 5, after the trial, the clinical symptoms of the trial group were improved to a certain extent, with a total improvement rate of 73.2%, which was significantly higher than the 22.2% of the control group (P<0.01). The fasting uric acid effective rate of the trial group was 48.1%, significantly higher than the effective rate of the control group (P<0.01).

[0066] The above description is only a preferred embodiment of the present invention. All equivalent changes and modifications made according to the scope of the patent application of the present invention should fall within the scope of the present invention.

Claims

1. A powder for treating gouty arthritis, characterized in that: The powder is composed of 1-6 parts of guarana extract, 8-15 parts of water-soluble turmeric powder, 0.005-0.2 parts of vitamin B1, 0.005-0.2 parts of vitamin B2, 2×10 -5 -1.5×10 -4 The invention discloses a novel ...

2. A powder for treating gouty arthritis according to claim 1, characterized in that: The powder is composed of 2-5 parts of guarana extract, 10-13 parts of water-soluble turmeric powder, 0.01-0.03 parts of vitamin B1, 0.01-0.03 parts of vitamin B2, 5×10 -5 -1.0×10 -4 The invention discloses a novel ...

3. A powder for treating gouty arthritis according to claim 1, characterized in that: By weight, the powder is composed of 3 parts of guarana extract, 12 parts of water-soluble turmeric powder, 0.02 parts of vitamin B1, 0.02 parts of vitamin B2, 8×10 -5 It is made from 12 parts of oatmeal powder and 5 parts of psyllium extract as raw materials.

4. A method for preparing a powder for treating gouty arthritis as claimed in claim 1, characterized in that: The following steps are involved: 1) adding the formulated amount of guarana extract, vitamin B2 and vitamin D3 into a 95 vol% ethanol solution which is 5-10 times the total mass of the three, stirring and dissolving to obtain a mixture alcohol solution; 2) Add drinking water to the reaction kettle, add the formulated amount of psyllium extract and oatmeal powder under stirring to prepare a solution with a total mass concentration of 30%-50%, then slowly add the alcohol solution of the mixture prepared in step 1) under stirring, and continue stirring for 2.5-5.0 hours after the addition; 3) Concentrating the liquid obtained in step 2) to a solid content of 65%-75%; 4) drying the concentrated material in step 3) by hot air circulation at normal pressure until the moisture content is ≤5.0%, then crushing it and passing it through a 60-mesh sieve to obtain a premix; 5) Grind the formulated amount of water-soluble turmeric powder and vitamin B1 separately and pass through a 60-mesh sieve; 6) The premix obtained in step 4) and the water-soluble turmeric powder and vitamin B1 after crushing and sieving in step 4) are mixed in a three-mixer for 20 minutes, and after the water content is detected to be ≤5.0%, they are packaged in an amount of 1.5 g / bag.

5. The method for preparing a powder for treating gouty arthritis according to claim 4, characterized in that: Step 2) The stirring speed is 80r / min-100r / min.

6. The method for preparing a powder for treating gouty arthritis according to claim 4, characterized in that: In step 2), the addition of the mixed alcohol solution is controlled within 10 minutes.

7. The method for preparing a powder for treating gouty arthritis according to claim 4, characterized in that: The concentration temperature in step 3) is 70±3°C, and the vacuum degree is maintained at 0.01-0.06Mpa.

8. The method for preparing a powder for treating gouty arthritis according to claim 4, characterized in that: The drying temperature in step 4) is 70±3°C.

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