CN107669991A - A kind of pharmaceutical composition for reducing serum uric acid level and preparation method thereof - Google Patents

Abstract

The invention provides a pharmaceutical composition for reducing blood uric acid level, which is prepared from raw materials comprising the following weight proportions: 17-23 parts of cassia twig, 17-23 parts of turmeric, 17-23 parts of Fangji, 17‑23 parts of psyllium, 7‑13 parts of Arrowhead mushroom, 12‑18 parts of Evodia rutaecarpa. The invention also provides the preparation method and application of the composition. The composition provided by the invention has reasonable compatibility and significant effect on lowering the blood uric acid level, can be used for treating hyperuricemia and gouty arthritis, and provides a new drug option for clinical use.

Description

A pharmaceutical composition for reducing blood uric acid level and preparation method thereof

technical field

The invention relates to a pharmaceutical composition for reducing blood uric acid level, its preparation method and application.

Background technique

Uric acid is the final product of purine metabolism in the body, which is mainly excreted by the kidneys. When the concentration of uric acid in the blood exceeds the normal value, the uric acid is easy to deposit in soft tissues or joints, causing acute inflammatory reactions, leading to hyperuricemia, gout, etc. .

With the improvement of people's living standards and changes in dietary structure, the excessive intake of high-purine foods will cause purine metabolism to become disordered, and uric acid in the blood will increase, leading to an increasing trend in the incidence of gout and hyperuricemia worldwide. The data shows that the incidence of gout and hyperuricemia in my country has risen sharply at a rate of 7.5% per year, and the number of gout and hyperuricemia in China has reached 13.5 million. The harm of cured uremia cannot be underestimated.

The pathogenesis of gout and hyperuricemia has not yet been fully clarified. In terms of treatment, Western medicine currently only stops at using drugs to improve symptoms and control uric acid levels, such as colchicine, non-steroidal anti-inflammatory drugs, glucocorticoids and other drugs However, it has not been able to cure hyperuricemia and gout, and it is easy to cause adverse events such as severe gastrointestinal reactions, which will affect the treatment.

In recent years, traditional Chinese medicine therapy has gradually become a development trend in the treatment of gout due to its diverse treatment methods, remarkable curative effect, and few adverse reactions. Using the basic theory of traditional Chinese medicine to actively develop and introduce effective, safe and reliable anti-gout products is the direction of many medical workers.

Contents of the invention

The object of the present invention is to provide a pharmaceutical composition for reducing blood uric acid level and its preparation method and application.

The invention provides a pharmaceutical composition for reducing blood uric acid level, which is prepared from raw materials comprising the following weight ratios:

17-23 parts of Guizhi, 17-23 parts of Turmeric, 17-23 parts of Fangji, 17-23 parts of Plantago, 7-13 parts of Arrowhead Mushroom, 12-18 parts of Evodia.

Wherein, it is prepared from the raw materials of following weight ratio:

20 parts of Guizhi, 20 parts of Turmeric, 20 parts of Fangji, 20 parts of Plantago Seed, 10 parts of Arrowhead Mushroom, 15 parts of Evodia rutaecarpa.

Among them, it is prepared from raw powder or water or organic solvent extracts of cassia twigs, turmeric, fangji, psyllium, shiitake mushrooms, and evodia as active ingredients, and is prepared by adding pharmaceutically acceptable excipients or auxiliary ingredients. preparation.

Wherein, the preparation is an oral preparation.

Wherein, the oral preparation is decoction, ointment, oral liquid, granule, capsule, pill, tablet, powder.

The present invention also provides the preparation method of above-mentioned composition, and it comprises the steps:

a, take the raw materials of each weight ratio;

b. It is prepared by directly powdering the raw materials, or extracting them with water or an organic solvent, and then adding pharmaceutically acceptable auxiliary materials or auxiliary components.

The present invention also provides the use of the above composition in the preparation of medicine for lowering blood uric acid level.

Wherein, the drug for reducing blood uric acid level is a drug for treating hyperuricemia and/or gout.

Wherein, the medicine for treating gout is a medicine for treating gouty arthritis.

The present invention also provides the use of the above composition in preparing a medicine for treating damp-heat accumulation syndrome in traditional Chinese medicine.

Traditional Chinese medicine believes that hyperuricemia is mostly due to innate endowment (mostly plump and phlegm-damp body), which leads to endogenous dampness and turbidity. In addition, drinking alcohol and eating fatty, sweet and thick-flavored products will cause dampness and turbidity even more, and heat and poison , stasis and internal resistance, occluded in the meridians and joints, the joints are red, swollen and painful; for a long time, blood stasis and phlegm are produced, joint deformities, phlegm nuclei of the skin, and even ulceration, oozing fat ointment. In the medicinal composition for lowering blood uric acid level, Han Fangji clears away heat and promotes dampness and relieves pain as king; Plantago Rens clears heat and promotes dampness and eliminates numbness; Evodia rutaecarpa relieves pain and removes dampness and blood numbness as subject; Knot, cassia twig unblocks the meridians and sharpens the joints as assistant envoy. All parties play the merits of clearing heat and promoting turbidity, promoting blood circulation and dispelling stagnation, eliminating numbness and relieving pain. Therefore, all diseases of hyperuricemia and gouty arthritis can be solved.

The composition provided by the present invention has reasonable compatibility, can significantly reduce blood uric acid levels, can be used to treat hyperuricemia and gouty arthritis, has significant curative effect on improving clinical symptoms and relieving pain, and has a good clinical cure rate; and the composition of the present invention It is safe, has no toxic and side effects, and is convenient to use, providing a new drug option for clinical practice.

Apparently, according to the above content of the present invention, according to common technical knowledge and conventional means in this field, without departing from the above basic technical idea of the present invention, other various forms of modification, replacement or change can also be made.

The above-mentioned content of the present invention will be further described in detail below through specific implementation in the form of examples. However, this should not be construed as limiting the scope of the above-mentioned subject matter of the present invention to the following examples. All technologies realized based on the above contents of the present invention belong to the scope of the present invention.

detailed description

The following examples are used for further description, but the present invention is not limited to these examples.

The preparation of embodiment 1 composition of the present invention

Prescription: Guizhi 20g, Turmeric 20g, Fangji 20g, Plantago Seed 20g, Arrowhead Mushroom 10g, Evodia 15g.

Preparation Process:

(1) Weigh each bulk drug according to the prescription;

(2) The first step: first put the medicinal materials into the casserole, add 2000ml of water, and soak for half an hour. Step 2: After boiling with strong fire (high fire), boil with slow fire (low fire) until 300ml is left, and pour the boiled medicinal liquid into a bowl. Step 3: Repeat Step 1 (without soaking) and Step 2, and take it twice before and after.

The preparation of embodiment 2 compositions of the present invention

Prescription: Guizhi 17g, Turmeric 17g, Fangji 23g, Plantago 23g, Arrowhead Mushroom 13g, Evodia 18g.

Preparation process: with the preparation process of embodiment 1.

The preparation of embodiment 3 compositions of the present invention

Prescription: Guizhi 23g, Turmeric 23g, Fangji 17g, Plantago 17g, Arrowhead Mushroom 7g, Evodia 12g.

Preparation process: with the preparation process of embodiment 1.

The preparation of embodiment 4 compositions of the present invention

Prescription: with the prescription of embodiment 1.

Preparation process: Weigh each raw material according to the prescription, pulverize, sieve, mix evenly, pack separately, and obtain.

The beneficial effect of the present invention is illustrated below in the mode of test example:

Test example 1 The clinical observation that composition of the present invention reduces blood uric acid level

1. Case source

From January 2010 to August 2017, outpatients in the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine were randomly grouped according to the random control table.

2. Diagnostic criteria

①The diagnostic criteria of western medicine adopt the diagnostic criteria of the primary gout diagnosis and treatment guidelines formulated by the rheumatology branch of the Chinese medical association in 2010 (the rheumatology branch of the Chinese medical association. Guidelines for the diagnosis and treatment of primary gout [J], Chinese rheumatology Journal of Pathology, 2011, 15(6):410-413);

② The diagnostic criteria of TCM syndromes adopt the diagnostic criteria of gout (damp-heat accumulation) in the 2012 edition of "Standards of Curative Effects of TCM Diseases and Syndromes" (State Administration of Traditional Chinese Medicine. Criteria for Diagnosis and Efficacy of TCM Diseases and Syndromes [S], Beijing: China Medical Science and Technology Press , 2012:50-51).

3. Case selection criteria

1. Inclusion criteria: ① meet the diagnostic criteria of Western medicine for gout; ② meet the diagnostic criteria for damp-heat accumulation syndrome in traditional Chinese medicine.

2. Exclusion criteria: ①Patients have been treated with glucocorticoids within one week; ②Patients who have contraindications to non-steroidal drugs such as peptic ulcer and severe heart disease; ③Patients who are pregnant or breastfeeding women;④ Patients who are planning to give birth in the near future; ⑤mentally ill patients.

4. Treatment

According to random grouping, they were divided into control group and treatment group, and the treatments were as follows:

Control group: colchicine 0.5mg, orally, 3 times a day.

Treatment group: Guizhi 20g turmeric 20g Fangji 20g Plantago 20g Arrowhead mushroom 10g Evodia rutaecarpa 15g, decoct in water (ie: according to the preparation process of Example 1 of the present invention), one dose per day.

The course of treatment was 2 months.

5. Efficacy indicators

1. Serum uric acid is collected and fasting venous blood is sent for examination to check blood uric acid.

2. Clinical curative effect: clinical control: symptoms such as joint redness, swelling and pain disappeared, the joints could move normally, and the score reduction was greater than or equal to 95%. Significantly effective: symptoms such as joint swelling and pain basically disappeared, joint activities were not restricted, and the points were reduced by 70% to 94%. Effective: Symptoms such as joint redness, swelling and pain are improved, joint activities are slightly restricted, and points are reduced by 30% to 69%. Invalid: Symptoms such as joint redness and pain and joint activity did not improve, and the score decreased by less than 30%.

3. Pain observation indicators Among them, joint pain was assessed by visual analogue scale (Visual Analogue Scale/Score, referred to as VAS): 0-10 points. 0 points: no pain; 3 points or less: slight pain, which can be tolerated by the patient; 4-6 points: the patient has pain and affects sleep, which is still tolerable; 7-10 points: the patient has severe pain, which is unbearable.

6. Data analysis

SPSS 13.0 was used to analyze the counting data, the chi-square test was used for the count data, and the t test was used for the measurement data. P<0.05 was considered statistically significant in the difference.

Seven, treatment results

1 Comparison of blood uric acid levels before and after treatment

See Table 1.

Table 1: Comparison of blood uric acid levels in patients (mmol/L)

group Number of cases Before treatment After treatment therapy group 40 523.9±34.2 412.7±29.9*# control group 38 529±39.5 435.4±30.8*

Note: Compared with before treatment, *P<0.05; compared with the control group after treatment, #P<0.05

As can be seen from Table 1, compared with before treatment, the uric acid levels of 2 groups of patients significantly decreased after treatment, and the difference was statistically significant (P<0.05), indicating that both the pharmaceutical composition of the present invention and the positive drug can reduce blood uric acid levels;

Compared with the control group after treatment, the uric acid level of the treatment group significantly decreased after treatment, and the difference was statistically significant (P<0.05), indicating that the effect of the pharmaceutical composition of the present invention on reducing blood uric acid level is significantly better than that of the positive control colchicine.

2 Comparison of clinical curative effect between the two groups

See Table 2.

Table 2: Comparison of curative effect between the two groups (%)

group Number of cases markedly effective efficient invalid therapy group 40 twenty three 17 0 control group 38 17 19 2

Note: Compared with the control group, P<0.05

It can be seen from Table 2 that the total effective rate of the treatment group is 100%, and the treatment effect is remarkable. Compared with the control group, the difference is statistically significant (P<0.05).

3 Comparison of VAS scores before and after treatment

See Table 3.

Table 3: Comparison of VAS scores of patients

group Number of cases Before treatment After treatment therapy group 40 7.8±0.3 2.5±0.1*# control group 38 8.0±0.4 3.1±0.2*

Note: Compared with before treatment, *P<0.05; compared with the control group after treatment, #P<0.05

It can be seen from Table 3 that compared with before treatment, the VAS scores of patients in the two groups decreased significantly after treatment, and the difference was statistically significant (P<0.05), indicating that both groups had therapeutic effects;

Compared with the control group after treatment, the VAS score of the treatment group significantly decreased after treatment, and the difference was statistically significant (P<0.05), indicating that the pharmaceutical composition of the present invention is better than the control group in alleviating pain in patients.

Therefore, the composition of the present invention can significantly reduce the level of blood uric acid, improve the patient's clinical symptoms, and relieve the joint pain of the patient, indicating that the pharmaceutical composition of the present invention can effectively treat gout and hyperuricemia, especially for the acute attack of gout. The medicine of the present invention is better than the contrast medicine colchicine in reducing blood uric acid level.

In summary, the composition of the present invention has reasonable compatibility, can significantly reduce blood uric acid levels, can be used to treat hyperuricemia and gouty arthritis, has significant curative effect on improving clinical symptoms and relieving pain, and has a good clinical effective rate; and the composition of the present invention It is safe, has no toxic and side effects, and is convenient to use, providing a new drug option for clinical practice.

Claims (10)

1. A kind of 1. pharmaceutical composition for reducing serum uric acid level, it is characterised in that：It is the raw material by being matched comprising following weight Medicine is prepared：

   Cassia twig 17-23 parts, turmeric 17-23 parts, root of fangji 17-23 parts, plantain seed 17-23 parts, edible tulip 7-13 parts, evodia rutaecarpa 12- 18 parts.
2. 2. pharmaceutical composition according to claim 1, it is characterised in that：It is by following weight proportioning raw material prepare and Into：

   20 parts of cassia twig, 20 parts of turmeric, 20 parts of the root of fangji, 20 parts of plantain seed, 10 parts of edible tulip, 15 parts of evodia rutaecarpa.
3. 3. composition according to claim 1 or 2, it is characterised in that：It is by cassia twig, turmeric, the root of fangji, plantain seed, mountain Arrowhead, the primary powder or water or extractive with organic solvent of evodia rutaecarpa are active component, add pharmaceutically acceptable auxiliary material or auxiliary The preparation that helping property composition is prepared.
4. 4. composition according to claim 3, it is characterised in that：The preparation is oral formulations.
5. 5. composition according to claim 4, it is characterised in that：The oral formulations be decoction, paste, oral liquid, Granula, capsule, pill, tablet, powder.
6. 6. the preparation method of the composition described in claim 1-5 any one, it is characterised in that：It comprises the following steps：

   A, the raw material of each weight proportion is weighed；

   Raw material directly beaten to powder, or after adding water or organic solvent extraction b, add pharmaceutically acceptable auxiliary material or it is complementary into Divide and be prepared.
7. 7. purposes of the composition in the medicine for reducing serum uric acid level is prepared described in claim 1-5 any one.
8. 8. purposes according to claim 7, it is characterised in that：The medicine for reducing serum uric acid level is treatment high lithemia The medicine of mass formed by blood stasis and/or gout.
9. 9. purposes according to claim 8, it is characterised in that：The medicine of the treatment gout is treatment urarthritis Medicine.
10. 10. purposes of the composition in the medicine for preparing treatment traditional Chinese medical science syndrome of accumulated dampness-heat described in claim 1-5 any one.