阅读说明：本技术 一种降尿酸的药物组合物及其制备方法 (Pharmaceutical composition for reducing uric acid and preparation method thereof ) 是由 鲁雪梅 于 2020-05-29 设计创作，主要内容包括：本发明属于医药领域,具体涉及一种降尿酸的药物组合物及其制备方法,包括以下重量份的组分：白芷1-50份、葛根10-100份、茯苓1-60份和柠檬酸钾5-30份,所述的制备方法包括以下步骤：S1乙醇提取：将配方量的白芷、葛根和茯苓干燥、切片或破碎,得到混合物A,将得到的混合物A用乙醇提取,经过过滤、合并滤液、减压浓缩得到浸膏A,将得到的浸膏A经过干燥、粉碎,得到醇提取物；S2配方量的柠檬酸钾与步骤S1得到的醇提取物混合,得到所述药物组合物。本发明可以有效降低血清中尿酸和肌酐水平,同时,有效规避了多种中药组分共同使用可能带来肝脏损失的风险,提高了药物的安全性和患者的依从性。(The invention belongs to the field of medicines, and particularly relates to a pharmaceutical composition for reducing uric acid and a preparation method thereof, wherein the pharmaceutical composition comprises the following components in parts by weight: 1-50 parts of angelica dahurica, 10-100 parts of kudzu root, 1-60 parts of tuckahoe and 5-30 parts of potassium citrate, and the preparation method comprises the following steps: s1 ethanol extraction: drying, slicing or crushing the angelica dahurica, the kudzu vine root and the tuckahoe according to the formula ratio to obtain a mixture A, extracting the obtained mixture A with ethanol, filtering, combining filtrates, concentrating under reduced pressure to obtain an extract A, drying and crushing the obtained extract A to obtain an alcohol extract; and mixing the potassium citrate with the formula amount of S2 with the alcohol extract obtained in the step S1 to obtain the pharmaceutical composition. The invention can effectively reduce the levels of uric acid and creatinine in serum, effectively avoids the risk of liver loss caused by the common use of various traditional Chinese medicine components, and improves the safety of the medicine and the compliance of patients.)

1. The pharmaceutical composition for reducing uric acid is characterized by comprising the following components in parts by weight: 1-50 parts of angelica dahurica, 10-100 parts of kudzu root, 1-60 parts of tuckahoe and 5-30 parts of potassium citrate.

2. The pharmaceutical composition according to claim 1, comprising the following components in parts by weight: 2-48 parts of angelica dahurica, 15-95 parts of kudzu root, 5-55 parts of tuckahoe and 5.5-29 parts of potassium citrate.

3. The pharmaceutical composition of claim 1, wherein the weight ratio of radix angelicae, radix puerariae and poria cocos is 1:2: 1.

4. A process for preparing a pharmaceutical composition according to any one of claims 1 to 3, comprising the steps of:

S1, ethanol extraction: drying, slicing or crushing the angelica dahurica, the kudzu vine root and the tuckahoe according to the formula ratio to obtain a mixture A, extracting the obtained mixture A with ethanol, filtering, combining filtrates, concentrating under reduced pressure to obtain an extract A, drying and crushing the obtained extract A to obtain an alcohol extract;

S2, mixing the potassium citrate with the alcohol extract obtained in the step S1 according to the formula amount to obtain the pharmaceutical composition.

5. The production method according to claim 4, wherein the mass ratio of the mixture A to the ethanol in the step S1 is 1: 8-10.

6. The method according to claim 4, wherein the ethanol in step S1 is an aqueous ethanol solution having a volume fraction of 10 to 70%.

7. The method according to claim 4, wherein the temperature of the ethanol extraction in step S1 is 60-80 deg.C, and the extraction is performed for 2-3 times, each time for 1-2 h.

8. Use of a pharmaceutical composition according to any one of claims 1 to 3 for the preparation of a food for special medical use and/or for the preparation of a medicament for the treatment of gout and/or hyperuricemia.

9. A pharmaceutical preparation for reducing uric acid, comprising the pharmaceutical composition of any one of claims 1 to 3 and a pharmaceutically acceptable excipient.

10. The pharmaceutical formulation of claim 9, wherein the pharmaceutical formulation includes, but is not limited to, granules, tablets, pills, and capsules.

Technical Field

The invention belongs to the field of medicines, and particularly relates to a pharmaceutical composition for reducing uric acid and a preparation method thereof.

Background

the biochemical marker of gout is hyperuricemia, which means that urate of extracellular fluid is in a supersaturated state, and hyperuricemia is generally considered to be achieved when the blood uric acid is 416 mu mol/L, about 5-12% of patients with hyperuricemia can develop into gout.

At present, gout and/or hyperuricemia are mostly treated by oral medicines, and western medicine treatment medicines are mainly classified into three types according to disease conditions: 1. treatment of the acute phase: colchicine, non-steroidal anti-inflammatory drugs, glucocorticoids; 2. treatment in the intermittent period: drugs for inhibiting uric acid production and promoting uric acid excretion, such as allopurinol, probenecid, and sulpirenone. 3. Treatment of the chronic phase: diet therapy and the above drugs. However, the drugs have the side effects of gastrointestinal tract reaction, skin anaphylactic reaction, kidney damage, liver damage, leucopenia and the like, and the compliance of patients is poor.

Modern clinical and pharmacological studies show that the traditional Chinese medicine has a certain curative effect on gout and/or hyperuricemia. For example, CN103330926A discloses a toxin-expelling gout-treating medicine, which comprises the following components: 15-30 parts of cassia twig, 20-40 parts of white paeony root, 20-30 parts of ginger, 10-20 parts of Chinese date, 15-30 parts of liquorice, 20-40 parts of kudzu root, 15-30 parts of mangnolia officinalis, 15-20 parts of immature bitter orange, 10-30 parts of rhubarb, 20-30 parts of betel nut, 30-60 parts of glabrous greenbrier rhizome and 20-30 parts of clematis root.

CN108186932A discloses a traditional Chinese medicine for treating gout, which is composed of the following traditional Chinese medicine raw materials in parts by weight: 8-12 parts of wheatgrass, 10-12 parts of rhizoma panacis majoris, 20-25 parts of Chinese yam, 15-18 parts of lycopodium clavatum, 10-12 parts of sappan wood, 15-18 parts of mulberry twig, 5-7 parts of peach kernel and 3-5 parts of borneol.

Epidemiological investigation shows that along with the improvement of living standard and the acceleration of life rhythm of people, the prevalence rate of gout is increasing day by day, and along with the continuous increase of the prevalence rate of gout, the demand of medicines for treating gout and/or hyperuricemia is increasing, but the traditional medicine composition for treating gout and/or hyperuricemia is only simple matching of a plurality of traditional Chinese medicinal materials which are beneficial to reducing uric acid, and the synergistic promotion effect among the traditional Chinese medicinal materials is not considered from the traditional Chinese medicine pharmacology, so that the prepared medicine composition has low treatment response rate and limited treatment effect.

Disclosure of Invention

In order to solve the technical problems, the invention provides a pharmaceutical composition for reducing uric acid and a preparation method thereof.

In order to achieve the purpose, the invention adopts the following technical scheme:

The invention provides a pharmaceutical composition for reducing uric acid, which comprises the following components: radix Angelicae Dahuricae, radix Puerariae, Poria and potassium citrate.

In the pharmaceutical composition, the using amount of the angelica dahurica is 1 to 50 parts by weight; preferably 2 to 48 parts.

In the pharmaceutical composition, the using amount of the kudzuvine root is 10 to 100 parts by weight; preferably 15 to 95 parts.

In the pharmaceutical composition, the dosage of the tuckahoe is 1 to 60 parts by weight; preferably 5 to 55 parts.

In the pharmaceutical composition, the amount of the potassium citrate is 5-30 parts by weight; preferably 5.5 to 29 parts.

The technical effects of the invention can be realized by the above technical solutions, but in some preferred embodiments, the achieved technical effects are superior to other solutions.

For example:

The ratio of the angelica dahurica, the radix puerariae and the tuckahoe is 1: 2: 1, wherein a preferred pharmaceutical composition comprises the following specific components in parts by weight: 40 parts of angelica dahurica, 80 parts of kudzu root, 40 parts of tuckahoe and 24 parts of potassium citrate.

The pharmaceutical composition also comprises 10-60 parts by weight of cordyceps militaris.

Radix angelicae: has pungent and warm nature, and has effects of relieving exterior syndrome, dispelling cold, dispelling pathogenic wind, relieving pain, dredging nasal orifice, eliminating dampness, relieving leukorrhagia, relieving swelling, expelling pus, dispelling pathogenic wind and relieving itching.

Kudzu root: sweet and pungent in flavor, cool in nature, entering lung and stomach meridians, and has the effects of expelling pathogenic factors from muscles and skin, allaying fever, promoting eruption, promoting the production of body fluid, quenching thirst, invigorating yang and relieving diarrhea.

Tuckahoe, poria cocos: sweet and light taste, neutral in nature, and has the effects of promoting diuresis, eliminating dampness, invigorating spleen, and calming heart.

Potassium citrate: potassium citrate and tripotassium citrate, which are citrate with molecular formula of C ₆H₅K₃O₇White, slightly hygroscopic crystalline powder, odorless, tasteless, readily soluble in water, slowly soluble in glycerol, insoluble in alcohol, salty and cool in taste, with the taste of physiological saline. Can be used as stabilizer and pH buffer in food; in medical treatment, it can be used for controlling uric acid or cystine from kidney stone, and preventing and treating hypokalemia and alkalized urine.

The invention also provides a preparation method of the pharmaceutical composition, which comprises the following steps:

S1, ethanol extraction: drying, slicing or crushing the angelica dahurica, the kudzu vine root, the tuckahoe and the cordyceps militaris according to the formula ratio to obtain a mixture A, extracting the obtained mixture A with ethanol, filtering, combining the filtrates, concentrating under reduced pressure to obtain an extract A, drying and crushing the obtained extract A to obtain an alcohol extract;

S2, mixing the potassium citrate with the alcohol extract obtained in the step S1 according to the formula amount to obtain the pharmaceutical composition.

Preferably, the mass ratio of the mixture A to the ethanol in the step S1 is 1: 8-10.

Preferably, the ethanol in step S1 is 10-70% ethanol water solution, and the temperature of ethanol extraction is 60-80 ℃, and the extraction is performed for 2-3 times, each time for 1-2 h.

The invention also provides application of the pharmaceutical composition in preparing formula food for special medical application and/or preparing drugs for reducing uric acid.

The invention also provides a pharmaceutical preparation for reducing uric acid, which comprises the pharmaceutical composition for reducing uric acid and medically acceptable auxiliary materials.

Preferably, the pharmaceutical formulation includes, but is not limited to, granules, tablets, pills, capsules, and the like.

Compared with the prior art:

According to the invention, the radix angelicae, the radix puerariae, the poria cocos and the potassium citrate are compounded synergistically, so that the levels of uric acid and creatinine in blood serum can be effectively reduced, and gout and/or hyperuricemia can be effectively treated; meanwhile, the risk that the liver loss is possibly caused by the common use of various traditional Chinese medicine components is effectively avoided, and the safety of the medicine and the compliance of patients are improved.

Meanwhile, the pharmaceutical composition disclosed by the invention contains cordyceps militaris, so that the compounding effect can be enhanced, and the levels of uric acid and creatinine in mouse serum can be obviously reduced.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions of the present invention are further described below.

When numerical ranges are given in the examples, it is understood that both endpoints of each of the numerical ranges and any value therebetween can be selected unless the invention otherwise indicated. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

The raw materials used in the present invention are all common commercial products unless otherwise specified.

Basic embodiment

A pharmaceutical composition for reducing uric acid comprises the following components in parts by weight: 1-50 parts of angelica dahurica, 10-100 parts of kudzu root, 1-50 parts of tuckahoe and 5-30 parts of potassium citrate;

In some preferred embodiments, the weight ratio of the radix angelicae, the radix puerariae and the poria cocos in the pharmaceutical composition is 1:2: 1.

In other preferable embodiments, the pharmaceutical composition further comprises 10-60 parts by weight of cordyceps militaris.

The preparation method of the pharmaceutical composition comprises the following steps:

S1, ethanol extraction: drying, slicing or crushing the angelica dahurica, the kudzu vine root, the tuckahoe and the cordyceps militaris according to the formula ratio to obtain a mixture A, extracting the obtained mixture A with ethanol, filtering, combining the filtrates, concentrating under reduced pressure to obtain an extract A, drying and crushing the obtained extract A to obtain an alcohol extract;

In the step S1, the mass ratio of the mixture A to the ethanol is 1: 8-10; in the step S1, the ethanol is 10-70% ethanol water solution by volume fraction, the temperature of the ethanol extraction is 60-80 ℃, the extraction is carried out for 2-3 times, and the extraction is carried out for 1-2h each time;

S3, mixing the potassium citrate with the alcohol extract obtained in the step S1 according to the formula amount to obtain the pharmaceutical composition.