CN107669991B - Pharmaceutical composition for reducing blood uric acid level and preparation method thereof - Google Patents
Pharmaceutical composition for reducing blood uric acid level and preparation method thereof Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/54—Lauraceae (Laurel family), e.g. cinnamon or sassafras
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/59—Menispermaceae (Moonseed family), e.g. hyperbaena or coralbead
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/68—Plantaginaceae (Plantain Family)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/75—Rutaceae (Rue family)
- A61K36/754—Evodia
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/898—Orchidaceae (Orchid family)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/906—Zingiberaceae (Ginger family)
- A61K36/9066—Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
Abstract
The invention provides a pharmaceutical composition for reducing blood uric acid level, which is prepared from the following raw material medicines in parts by weight: 17-23 parts of cassia twig, 17-23 parts of turmeric, 17-23 parts of radix stephaniae tetrandrae, 17-23 parts of semen plantaginis, 7-13 parts of Indian iphigenia bulb and 12-18 parts of fructus evodiae. The invention also provides a preparation method and application of the composition. The composition provided by the invention is reasonable in compatibility, has a remarkable effect of reducing the blood uric acid level, can be used for treating hyperuricemia and gouty arthritis, and provides a new medicine choice for clinic.
Description
Technical Field
The invention relates to a pharmaceutical composition for reducing blood uric acid level and a preparation method and application thereof.
Background
Uric acid is a final product of purine metabolism in vivo, is mainly discharged by the kidney, and when the concentration of uric acid in blood exceeds a normal value, the uric acid is easily deposited on soft tissues or joints to cause acute inflammatory reaction, so that hyperuricemia, gout and the like are caused.
With the improvement of living standard and the change of dietary structure of people, the excessive intake of high purine food leads purine metabolism to be disordered, uric acid in blood is increased, and the incidence rate of gout and hyperuricemia in the world shows a trend. Data show that the disease rate of gout and hyperuricemia in China is greatly increased at a speed of 7.5% every year, the number of gout and hyperuricemia in China reaches 1350 thousands of people, the disease course of patients exceeds 10 years, most of uremia which is difficult to cure occurs, and the harm is invisible.
The pathogenesis of gout and hyperuricemia is not completely clear up to now, and in treatment, the western medicine only uses medicines such as colchicine, non-steroidal anti-inflammatory drugs, glucocorticoid and the like to improve symptoms and control uric acid level, but cannot radically cure hyperuricemia and gout, and is easy to cause serious adverse events such as gastrointestinal tract reaction and the like, so that the treatment development is influenced.
In recent years, Chinese medicine therapy has gradually become a development trend for treating gout due to the characteristics of various treatment methods, remarkable curative effect, few adverse reactions and the like. By applying the basic theory of traditional Chinese medicine, gout-resisting products with obvious curative effect, safety and reliability are actively developed and introduced, and the direction of efforts of a plurality of medical workers is oriented.
Disclosure of Invention
The invention aims to provide a pharmaceutical composition for reducing the level of hematuria acid, a preparation method and application thereof.
The invention provides a pharmaceutical composition for reducing blood uric acid level, which is prepared from the following raw material medicines in parts by weight:
17-23 parts of cassia twig, 17-23 parts of turmeric, 17-23 parts of radix stephaniae tetrandrae, 17-23 parts of semen plantaginis, 7-13 parts of Indian iphigenia bulb and 12-18 parts of fructus evodiae.
The composite material is prepared from the following raw materials in parts by weight:
20 parts of cassia twig, 20 parts of turmeric, 20 parts of radix stephaniae tetrandrae, 20 parts of semen plantaginis, 10 parts of Indian iphigenia bulb and 15 parts of fructus evodiae.
Wherein, the preparation is prepared by taking raw powder or water or organic solvent extract of cassia twig, turmeric, tetrandra root, plantain seed, edible tulip and evodia rutaecarpa as active ingredients and adding pharmaceutically acceptable auxiliary materials or auxiliary ingredients.
Wherein the formulation is an oral formulation.
Wherein the oral preparation is decoction, paste, oral liquid, granule, capsule, pill, tablet, or powder.
The invention also provides a preparation method of the composition, which comprises the following steps:
a. weighing raw materials in each weight ratio;
b. pulverizing the raw materials directly, or extracting with water or organic solvent, and adding pharmaceutically acceptable adjuvants or auxiliary components.
The invention also provides application of the composition in preparing a medicine for reducing the level of hematuria.
Wherein the drug for reducing the level of the blood uric acid is a drug for treating hyperuricemia and/or gout.
Wherein the medicament for treating gout is a medicament for treating gouty arthritis.
The invention also provides application of the composition in preparing a medicine for treating the damp-heat accumulation syndrome in traditional Chinese medicine.
Traditional Chinese medicine considers that hyperuricemia is mainly caused by endogenous dampness and turbidity due to innate endowment (mostly the body of the food with abundant phlegm and dampness), and is more severe due to drinking and addiction to fatty and sweet and thick-flavored products, so that heat and toxin are removed, stagnation and internal resistance are caused, and the hyperuricemia is confined in the joints of channels and collaterals, so that the joints are red, swollen and painful; for a long time, blood stasis and phlegm are produced, the joints are deformed, the skin phlegm core is broken even, and the grease is leaked. The tetrandra root in the pharmaceutical composition for reducing the level of the hematuria acid is the monarch drug for clearing heat, promoting diuresis and relieving pain; the plantain seed has the effects of clearing heat, promoting diuresis and removing arthralgia, and the evodia has the effects of relieving pain and removing dampness and blood arthralgia as ministers; the turmeric has the functions of promoting blood circulation and relieving pain, the Indian iphigenia bulb has the functions of clearing heat and reducing phlegm, and softening and resolving hard mass, and the cassia twig has the functions of dredging the channels and collaterals and benefiting joints as adjuvant guiding. The whole formula has the effects of clearing heat, promoting turbidity, promoting blood circulation, removing stasis, eliminating arthralgia and relieving pain. Therefore, the symptoms of hyperuricemia and gouty arthritis can be relieved.
The composition provided by the invention is reasonable in compatibility, can obviously reduce the blood uric acid level, can be used for treating hyperuricemia and gouty arthritis, and has obvious curative effects of improving clinical symptoms and relieving pain and good clinical cure rate; the composition has good safety, no toxic or side effect and convenient use, and provides a new medicine selection for clinic.
Obviously, many modifications, substitutions, and variations are possible in light of the above teachings of the invention, without departing from the basic technical spirit of the invention, as defined by the following claims.
The present invention will be described in further detail with reference to the following examples. This should not be understood as limiting the scope of the above-described subject matter of the present invention to the following examples. All the 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 further illustrative, but the present invention is not limited to these examples.
EXAMPLE 1 preparation of a composition according to the invention
Prescription: 20g of cassia twig, 20g of turmeric, 20g of radix stephaniae tetrandrae, 20g of semen plantaginis, 10g of Indian iphigenia bulb and 15g of fructus evodiae.
The preparation process comprises the following steps:
(1) weighing the raw materials according to the prescription;
(2) the first step is as follows: the medicinal materials are put into an earthen pot, 2000ml of water is added, and the medicinal materials are soaked for half an hour. The second step is that: boiling with strong fire, decocting with slow fire to obtain 300ml, and pouring the decoction into a bowl. The third step: the first step (optionally soaking) and the second step can be repeated, and the two steps are mixed for administration.
Example 2 preparation of a composition according to the invention
Prescription: 17g of cassia twig, 17g of turmeric, 23g of radix stephaniae tetrandrae, 23g of semen plantaginis, 13g of Indian iphigenia bulb and 18g of fructus evodiae.
The preparation process comprises the following steps: the preparation process is the same as that of example 1.
EXAMPLE 3 preparation of the composition of the invention
Prescription: 23g of cassia twig, 23g of turmeric, 17g of radix stephaniae tetrandrae, 17g of semen plantaginis, 7g of Indian iphigenia bulb and 12g of fructus evodiae.
The preparation process comprises the following steps: the preparation process is the same as that of example 1.
EXAMPLE 4 preparation of the composition of the invention
Prescription: the same prescription as in example 1.
The preparation process comprises the following steps: weighing the raw materials according to the prescription, pulverizing, sieving, mixing, and packaging.
The beneficial effects of the invention are illustrated by way of test examples as follows:
test example 1 clinical observations of the composition of the invention for reducing the level of uric acid in blood
First, the source of the case
Outpatients of the affiliated hospital of Chinese medicine university in Chengdu were visited from 1 month to 2017 months in 2010 and were randomly grouped according to a random comparison table.
II, diagnosis standard
The western medicine diagnosis standard adopts a diagnosis standard of a primary gout diagnosis and treatment guide established by the Chinese medical society rheumatology division 2010 (Chinese medical society rheumatology division, primary gout diagnosis and treatment guide [ J ], Chinese rheumatology journal, 2011, 15(6): 410-;
secondly, the diagnosis standard of the syndrome of traditional Chinese medicine adopts the diagnosis standard of gout (damp-heat accumulation) in 2012 edition of the curative effect standard of the syndrome of traditional Chinese medicine (national institute of traditional Chinese medicine, the standard of curative effect of the diagnosis of the syndrome of traditional Chinese medicine [ S ], Beijing: Chinese medicine science and technology publishing agency, 2012: 50-51).
Third, case selection criteria
1. The inclusion standard is that the first step accords with the western medicine diagnosis standard of gout; ② the Chinese medicine composition accords with the diagnosis standard of the damp-heat accumulation syndrome in the traditional Chinese medicine.
2. The exclusion standard is that firstly, the patient is treated by glucocorticoid within one week; ② patients suffering from contraindications of nonsteroidal drugs such as peptic ulcer and severe heart disease; ③ pregnant women or women in lactation; preparing a patient for childbearing recently; patients with psychosis.
Fourth, the therapeutic method
Randomly divided into a control group and a treatment group, and respectively treated as follows:
control group: colchicine 0.5mg, is administered orally 3 times daily.
Treatment groups: 20g of cassia twig, 20g of turmeric, 20g of radix stephaniae tetrandrae, 20g of semen plantaginis, 10g of Indian iphigenia bulb and 15g of fructus evodiae are decocted with water (namely, according to the preparation process of the embodiment 1 of the invention), and one dose is taken every day.
The treatment course is 2 months.
Five therapeutic index
1. Collecting serum uric acid and inspecting the blood uric acid by fasting venous blood.
2. Clinical control of clinical efficacy: the symptoms such as joint redness and swelling, pain and the like disappear, the joint can normally move, and the score is reduced by more than or equal to 95 percent. The effect is shown: the symptoms such as joint red swelling and pain basically disappear, joint movement is not limited, and the integral is reduced by 70-94%. The method has the following advantages: the symptoms such as joint red swelling and pain are improved, the joint movement is slightly limited, and the integral is reduced by 30-69%. And (4) invalidation: the symptoms such as joint redness and swelling and pain and joint movement are not improved, and the integral is reduced by less than 30%.
3. Pain observation indexes of joint pain are Visual analog Scale/Score (VAS): the division is 0-10 minutes. 0 minute: no pain; 3 points are as follows: slight pain, patient can tolerate; 4-6 points: patients are painful and influence sleep, and can tolerate the pain; 7-10 min: the patient has strong pain and hard to endure.
Sixthly, data analysis
The analysis is carried out by SPSS 13.0 meter software, the counting data is tested by chi-square, the metering data is tested by t, and the difference is statistically significant when P is less than 0.05.
Seventh, therapeutic results
1 comparison of serum uric acid levels before and after treatment of patients
See table 1.
Table 1: patient blood uric acid level comparison (mmol/L)
Group of | Number of examples | Before treatment | After treatment |
Treatment group | 40 | 523.9±34.2 | 412.7±29.9*# |
Control group | 38 | 529±39.5 | 435.4±30.8* |
Note: p <0.05 compared to pre-treatment; after treatment with control, # P <0.05
As can be seen from Table 1, compared with the pre-treatment, the uric acid level of the patients in the group 2 is significantly reduced after the treatment, and the difference has statistical significance (P <0.05), which indicates that the pharmaceutical composition and the positive drug can reduce the blood uric acid level;
compared with the control group after treatment, the uric acid level of the treatment group is obviously reduced, and the difference has statistical significance (P <0.05), so that the effect of reducing the uric acid level of the pharmaceutical composition is obviously better than that of the positive control colchicine.
2 comparison of clinical effects of two groups
See table 2.
Table 2: comparison of the two therapeutic effects (%)
Group of | Number of examples | Show effect | Is effective | Invalidation |
Treatment group | 40 | 23 | 17 | 0 |
Control group | 38 | 17 | 19 | 2 |
Note: p is less than 0.05 compared with the control group
As shown in Table 2, the total effective rate of the treatment group is 100%, the treatment effect is significant, and the difference is statistically significant (P is less than 0.05) compared with the control group.
Comparison of VAS scores before and after treatment of patients
See table 3.
Table 3: patient VAS score comparison
Group of | Number of examples | Before treatment | After treatment |
Treatment group | 40 | 7.8±0.3 | 2.5±0.1*# |
Control group | 38 | 8.0±0.4 | 3.1±0.2* |
Note: p <0.05 compared to pre-treatment; after treatment with control, # P <0.05
As can be seen in table 3, the difference in the significant reduction in VAS scores after treatment was statistically significant (P <0.05) for the 2 groups of patients compared to pre-treatment, indicating that both groups had therapeutic efficacy;
compared with the control group after treatment, the VAS score of the treatment group after treatment is obviously reduced, and the difference has statistical significance (P <0.05), which shows that the pharmaceutical composition has better effect on relieving the pain of the patient compared with the control group.
Therefore, the composition can obviously reduce the blood uric acid level, improve the clinical symptoms of patients and relieve the joint pain of the patients, which shows that the pharmaceutical composition can effectively treat gout and hyperuricemia, and particularly has obvious effect on acute attack stage of gout, and the effect of reducing the blood uric acid level of the pharmaceutical composition is better than that of a contrast medicament colchicine.
In conclusion, the composition disclosed by the invention is reasonable in compatibility, can obviously reduce the blood uric acid level, can be used for treating hyperuricemia and gouty arthritis, and has obvious curative effects of improving clinical symptoms and relieving pain and good clinical effective rate; the composition has good safety, no toxic or side effect and convenient use, and provides a new medicine selection for clinic.
Claims (9)
1. A pharmaceutical composition for lowering blood uric acid levels, comprising: the traditional Chinese medicine is prepared from the following raw materials in parts by weight:
20 parts of cassia twig, 20 parts of turmeric, 20 parts of radix stephaniae tetrandrae, 20 parts of semen plantaginis, 10 parts of Indian iphigenia bulb and 15 parts of fructus evodiae.
2. The composition of claim 1, wherein: the preparation is prepared by taking raw powder or water or organic solvent extract of cassia twig, turmeric, radix stephaniae tetrandrae, plantain seed, Indian iphigenia bulb and fructus evodiae as active ingredients and adding pharmaceutically acceptable auxiliary materials or auxiliary ingredients.
3. The composition of claim 2, wherein: the preparation is an oral preparation.
4. The composition of claim 3, wherein: the oral preparation is decoction, paste, oral liquid, granule, capsule, pill, tablet, or powder.
5. A process for preparing a composition according to any one of claims 1 to 4, characterized in that: it comprises the following steps:
a. weighing raw materials in each weight ratio;
b. pulverizing the raw materials directly, or extracting with water or organic solvent, and adding pharmaceutically acceptable adjuvants or auxiliary components.
6. Use of a composition according to any one of claims 1 to 4 in the manufacture of a medicament for reducing the level of uric acid in blood.
7. Use according to claim 6, characterized in that: the drug for reducing the level of the blood uric acid is a drug for treating hyperuricemia and/or gout.
8. Use according to claim 7, characterized in that: the medicament for treating gout is a medicament for treating gouty arthritis.
9. Use of the composition of any one of claims 1-4 for the manufacture of a medicament for the treatment of damp-heat accumulation in traditional Chinese medicine.
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CN111773352A (en) * | 2019-09-20 | 2020-10-16 | 厦门医学院 | Application of turmeric and plantain seed composition in preparation of pharmaceutical composition for reducing blood sugar and blood pressure |
CN113144095B (en) * | 2020-01-07 | 2022-08-02 | 成都医学院 | Pharmaceutical composition for treating gouty arthritis and preparation method and application thereof |
CN112843178A (en) * | 2021-03-04 | 2021-05-28 | 刘树民 | Compatible combination for treating hyperuricemia and preparation method thereof |
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CN101264205A (en) * | 2008-04-25 | 2008-09-17 | 北京中泰天和科技有限公司 | Chinese medicinal composition for treating gout and preparation thereof |
CN103721125A (en) * | 2014-01-21 | 2014-04-16 | 李朝成 | Medicament for treating gout and preparation method thereof |
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CN103721125A (en) * | 2014-01-21 | 2014-04-16 | 李朝成 | Medicament for treating gout and preparation method thereof |
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加减木防己汤治疗痛风性关节炎40例报告;黄德军;《中医正骨》;20060430;第18卷(第04期);第63页 * |
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