CN112843178A - Compatible combination for treating hyperuricemia and preparation method thereof - Google Patents
Compatible combination for treating hyperuricemia 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)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/894—Dioscoreaceae (Yam family)
- A61K36/8945—Dioscorea, e.g. yam, Chinese yam or water yam
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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)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/898—Orchidaceae (Orchid family)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/06—Antigout agents, e.g. antihyperuricemic or uricosuric agents
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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
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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
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
Abstract
The invention discloses a compatible combination for treating hyperuricemia and a preparation method thereof, belonging to the technical field of traditional Chinese medicine preparations. The invention is prepared from the following traditional Chinese medicine raw materials: ningpo Yam rhizome, Pseudobulbus Cremastrae Seu pleiones, and semen plantaginis; the preparation process comprises the following steps: the decocting time, the decocting times and the water quantity are the same; the following traditional Chinese medicine raw materials in parts by weight are preferably selected: 10-15 g of yam rhizome, 3-10 g of edible tulip and 10-15 g of plantain seed; the following preparation process ranges are preferred: the decoction time is 1-3 hours, the decoction times are 1-3 times, and the water volume is 8-12 times. The product can be prepared into various clinical commonly used oral preparations through the compatibility combination obtained by screening and the preparation method thereof, wherein the oral preparations comprise granules, capsules, tablets, powder, pills, mixtures, dripping pills and the like.
Description
Technical Field
The invention relates to the technical field of traditional Chinese medicine preparations, in particular to a compatible combination for treating hyperuricemia and a preparation method thereof.
Background
Hyperuricemia (HUA) is a metabolic disease characterized by hyperuricemia due to abnormal purine metabolism. Many hyperuricemia is caused by increased uric acid production or normal uric acid production due to increased xanthine oxidase activity in the body, but hyperuricemia is caused by increased uric acid production or decreased uric acid excretion due to abnormal renal uric acid-related transporters. Gout (gout) is a metabolic disease in which, on the basis of hyperuricemia, elevated blood uric acid levels form monosodium urate crystals that are deposited in joints and surrounding tissues and kidneys, causing autoinflammatory reactions and changes in joint morphology. It is often manifested as red swelling and pain in joints and tissues around the joints, or damage to synovial membranes and fluids in joints.
With the change of living environment and dietary structure, hyperuricemia is one of the diseases affecting the quality of life of human beings, and the incidence rate is increased year by year and the recurrence rate is high in the whole world in recent years. The occurrence of hyperuricemia is closely related to physical activity, purine-containing and protein-containing dietary intake, alcohol consumption, obesity, and the like. Recent studies have shown that hyperuricemia can induce gout by forming urate crystals, and is often accompanied by various metabolic diseases such as hypertension, diabetes, lipid metabolism disorders, cardiovascular diseases, and metabolic syndrome. Therefore, the method has important significance for finding and treating the hyperuricemia in time and reducing the uric acid level and improving the life quality.
The clinically common drugs for treating hyperuricemia and inhibiting uric acid generation comprise allopurinol and febuxostat, and the drug for promoting uric acid excretion, benzbromarone. However, the western medicines have more side effects, such as gastrointestinal reaction, urticaria, headache, interstitial nephritis, liver necrosis and the like, which are seen in clinical use of allopurinol, and about 2% of patients can cause anaphylactic syndrome. Therefore, we have noticed that these drugs, although having significant efficacy, have significant side effects and are apparently not suitable for long-term administration.
The traditional Chinese medicine theory considers that the pathogenesis of hyperuricemia generally comes down to spleen and kidney deficiency, turbid phlegm, damp and heat, blood stasis and blood vessel blockage, and the main treatment principle is to control diet, strengthen spleen and tonify kidney, discharge turbidity, expel toxin and clear and activate channels and collaterals. Therefore, on the premise of no adverse reaction or less toxic and side effects, the development of a natural Chinese herbal medicine formula with good effects of reducing uric acid, preventing urate deposition, resisting inflammation and the like is particularly important. The new medicine for treating hyperuricemia is a traditional Chinese medicine prescription which is formed by combining a turbid toxicity theory and clinical experience under the guidance of a basic theory of traditional Chinese medicine. The formula is prepared by combining dioscorea nipponica, edible tulip and plantain seed, wherein the dioscorea nipponica is good at dredging collaterals and relieving pain, can keep energy away and can tonify energy and dredge, and is a monarch drug; che Qian Zi excels in promoting diuresis and descending turbid urine; the Indian iphigenia bulb has the effects of detoxifying, reducing phlegm, relieving swelling, resolving masses and strengthening the power and is used as a ministerial drug. Therefore, the formula starts with the efficacies of clearing away heat and toxic material, promoting diuresis and discharging turbidity, dredging collaterals and relieving pain and the like, can be taken for a long time, and has small side effect and stable drug effect.
Disclosure of Invention
Aiming at the defects of the prior art, the invention provides a compatible combination for treating hyperuricemia and a preparation method thereof, the compatible combination has the effects of reducing uric acid and resisting inflammation, no adverse reaction exists after the compatible combination is taken, and the toxic and side effects are small after long-term taking, so that the uric acid level of a patient can be reduced, the clinical symptoms of gout and chronic gouty arthritis can be relieved, and the occurrence of gouty diseases can be delayed.
The technical scheme adopted by the invention for solving the technical problems is as follows: the compatible combination for treating hyperuricemia and the development of the preparation method thereof are prepared from the following traditional Chinese medicine raw materials: ningpo Yam rhizome, Pseudobulbus Cremastrae Seu pleiones, and semen plantaginis; the preparation process comprises the following steps: the decocting time, the decocting times and the water quantity are the same; the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in parts by weight: 10-15 g of yam rhizome, 3-10 g of edible tulip and 10-15 g of plantain seed; the preparation process range is as follows: the decoction time is 1-3 hours, the decoction times are 1-3 times, and the water volume is 8-12 times.
The traditional Chinese medicine composition is preferably prepared from the following traditional Chinese medicine raw materials in parts by weight: 1, Ningpo Yam rhizome: and (3) edible tulip: plantain seed ═ 3: 2: 2; the preparation process comprises the following steps: decocting in 10 times of distilled water for 3 times, each for 3 hr.
A compatible combination for treating hyperuricemia and a preparation method thereof comprise the following steps:
adding 8-12 times of distilled water into the traditional Chinese medicine raw materials, soaking for 0.5h, then decocting for 1-3 times, decocting for 1-3 hours each time, filtering to obtain liquid medicine, merging, concentrating, drying, weighing the obtained dry paste and calculating the paste yield; the compatible combination for treating hyperuricemia and the development of the preparation method can also be granules, capsules, tablets, powder, pills, mixtures, dripping pills and the like.
Preferably prepared by the following process: adding 10 times of distilled water into the raw materials, soaking for 0.5h, decocting for 3 times, each time for 3 hours, filtering to obtain medicinal liquid, mixing, concentrating, drying, weighing dry extract, and calculating the extract rate.
Adding 10-15 g of yam rhizome, 3-10 g of edible tulip and 10-15 g of plantain seed into 10 parts of distilled water, soaking for 0.5h, decocting for 3 times, decocting for 3 hours each time, mixing decoctions, filtering while hot, concentrating to a gavage volume of 0.5g of crude drug/mL, and gavage the model animal of hyperuricemia combined gouty arthritis for pharmacodynamics investigation. The traditional Chinese medicine composition is preferably prepared from the following traditional Chinese medicine raw materials in parts by weight: 1, Ningpo Yam rhizome: and (3) edible tulip: plantain seed ═ 3: 2: 2
The traditional Chinese medicine composition is prepared from common clinical traditional Chinese medicines (yam rhizome, Indian iphigenia bulb and plantain seed) in a compatible manner.
Chuanlong Yam has the effects of dispelling pathogenic wind, removing dampness, relaxing muscles and tendons, dredging collaterals, promoting blood circulation, and relieving pain, and can enter liver, kidney and lung meridians. Intensive experimental research is carried out on the dioscorea nipponica and saponin components contained in the dioscorea nipponica by scholars at home and abroad, and the dioscorea nipponica is found to have a plurality of pharmacological effects of reducing uric acid, resisting inflammation, easing pain and the like; the dioscorea nipponica total saponins can interfere in the structural composition characteristics and differences of intestinal flora of a hyperuricemia model, and play a role in improving hyperuricemia; meanwhile, the research also finds that the yam rhizome can treat gouty arthritis by inhibiting inflammatory factors, regulating lysosome, NLRP3 inflammatory bodies and the like.
The edible tulip is a clinically common traditional Chinese medicine for clearing heat and removing toxicity, reducing phlegm and resolving masses and entering liver and spleen meridians. Experimental research proves that active ingredients such as colchicine contained in the edible tulip can effectively play an anti-inflammatory role and is used for treating gouty arthritis.
Semen plantaginis has effects of clearing heat, promoting diuresis, eliminating dampness, treating stranguria, improving eyesight, and eliminating phlegm, and enters liver, kidney, and small intestine channels. The traditional Chinese medicine semen plantaginis has the effects of resisting oxidation and improving the immunity of the organism; relevant experimental research proves that the plantain seed alcohol extract can reduce the blood uric acid of a hyperuricemia model mouse and improve the kidney function of the hyperuricemia model mouse. In addition, the Plantago asiatica L extract is found to be capable of reducing IL-12 level and delaying the arthritic reaction of animals with gouty arthritis.
The three traditional Chinese medicines are combined together, and the basic treatment method of removing pathogenic factors and dredging collaterals, detoxifying and discharging turbidity is considered, so that the effects of dredging collaterals, lowering turbidity, clearing heat and detoxifying are achieved.
The invention has the beneficial effects that: a compatible combination for treating hyperuricemia and a preparation method thereof are characterized in that the traditional Chinese medicines 'monarch, minister, assistant and guide' are mutually compatible, and the toxic and side effects are small after long-term administration, so that the uric acid level of a patient can be reduced, the clinical symptoms of gout and chronic gouty arthritis can be relieved, and the occurrence of gout diseases can be delayed; the yam, the edible tulip and the plantain seed are scientifically combined to reduce uric acid, resist inflammation and ease pain. The formula contains a plurality of active ingredients which can inhibit the generation of uric acid and reduce the uric acid level; the traditional Chinese medicine composition can promote uric acid excretion, play an anti-inflammatory role, prevent in-vivo urate deposition, prevent and delay the occurrence of gout diseases, and perform combined action from multiple aspects to reduce uric acid level and reduce the release of inflammatory mediators.
Detailed Description
The present invention will be further described with reference to the following examples.
Example one
The following traditional Chinese medicine raw materials of yam in parts by weight are commonly used in clinic: and (3) edible tulip: plantain seed ═ 3: 1: 2; first, byThe preparation process range is determined by taking the cream yield as an investigation index in a single-factor experiment, 6-14 times of distilled water is added into the traditional Chinese medicine raw materials, the raw materials are soaked for 0.5 hour and decocted for 1-5 times, each time of decoction is 1-5 hours, liquid medicines are filtered and combined, concentrated and dried, the dry cream yield is weighed, and the cream yield is calculated. Second, using orthogonal experiment L9(34) Determining the optimal preparation process of the formula.
TABLE 1 test results of the Single-factor preparation Process
The comparison shows that the preparation process has a good ointment yield of 1-3 hours of decoction time, 1-3 times of decoction times and 8-12 times of water, and the preparation process range is determined.
Table 2 formula preparation process factor horizontal table
Table 3 recipe preparation process test results
Table 4 visual analysis results of formulation preparation process
TABLE 5 recipe preparation Process paste yield quantitative recipe differential analysis results
The test result can be obtained through visual analysis, when the paste yield (%) is taken as an observation index, the factor B has obvious influence on the preparation process, and the influence of each factor through comparison and investigation is respectively as follows: b is>C>D>A, number of instant decocts>Time of decoction>The amount of water is the same as the total amount of water. Comprehensively considering the contribution rate of each factor to extraction, energy consumption, process time consumption and other factors, and the optimal preparation process combination is A2B3C3D2，Namely, the extraction is carried out 3 times by 10 times of water, and each time for 3 hours.
The preparation process verifies that 3 batches of clinical commonly used medicinal materials are accurately weighed, are soaked in distilled water in an amount which is 10 times that of the clinical commonly used medicinal materials for 0.5 hour, are extracted for 3 times, are 3 hours each time, are filtered to obtain liquid medicine, are combined, are concentrated and dried, are weighed to obtain dry paste, are calculated to obtain the paste yield, and prove that the selected process is stable and reliable, wherein the average paste yield is 20.38 percent and the RSD is 0.83 percent.
Example two
1. Experimental animals:
SD male rats 176
2. The experimental period is as follows:
22 days
3. Instruments and reagents:
biochemical instrument, TNF-alpha kit
4. Experimental drugs:
adding 10 times of distilled water into the traditional Chinese medicine raw materials, soaking for 0.5h, decocting for 3 times, decocting for 3 hours each time, mixing decoctions, filtering while hot, removing filter residue, concentrating the filtrate to obtain a medicinal solution containing 0.5g/mL of crude drug, and making into intragastric volume.
5. The molding method comprises the following steps:
after shaking 3% urate oxidase inhibitor potassium oxonate uniformly by using a No. 4 injection needle, injecting into an abdominal cavity at a rate of 1mL/100g for 2 times/d, after continuously injecting for 1 week, inserting into a joint cavity at the rear side of the right ankle joint of a rat along the inner side of the achilles tendon at an angle of 30-40 degrees by using a No. 6 injection needle, injecting 0.2mL of sodium urate solution (concentration: 25mg/mL) into the joint cavity, and taking the opposite bulge of a joint capsule as an injection standard. Feeding with 10% yeast feed during the feeding process.
6. Detection indexes are as follows:
BUN (Urea Nitrogen), BUA (blood uric acid), TNF-alpha (tumor necrosis factor alpha)
7. Star point design test:
on the basis of the preparation process test, the dosage of the dioscorea nipponica makino, the bulb of pleione bulbocodioides and the plantain seeds is taken as an investigation factor (represented by A, B, C), the 2-factor and 5-level star point design is carried out by taking the total 'normalization value' of BUN, BUA and TNF-alpha as an effect (the factor level design is shown in the table), the detection index is converted into the 'normalization value' between 0 and 1 by adopting a Hassan method, and dmax＝(xi-xmin)/(xmax-xmin)，dmin＝(xmax-xi)/(xmax-xmin) And calculating the total evaluation normalization value OD of the geometric mean value by normalizing each index, wherein OD is (d)1×d2……×dk)1/kAnd k is the total number of the investigation indexes.
Table 6 star point design factor level table
8. The experimental method comprises the following steps:
the method comprises the following steps of dividing 8 SD rats in each group into a blank group and a modeling group, feeding normal feed into the blank group, feeding 10% yeast feed into the modeling group, modeling according to the modeling method, randomly grouping the rats after modeling, namely, the model group, designing 1-20 administration groups according to star points, feeding drug solutions with different compatibility combinations into the administration groups every day, feeding equal amounts of physiological saline into the blank group and the model group every day for 14 days, taking blood from abdominal aorta after administration, centrifuging at 4000r, 4 ℃ and 15min to obtain serum, and measuring the levels of BUN, BUA and TNF-alpha in the serum.
Table 7 pharmacodynamic indices table (n-8,
)
note: denotes p <0.05, p <0.01, compared to the blank control group
TABLE 8 Experimental design and index measurements
TABLE 9 analysis of variance and regression model coefficient significance test
Statistical analysis is carried out on the data in the table 9 by adopting Design-expert7.0.0 software, multiple nonlinear regression fitting is carried out by taking the total evaluation OD value as an index, the test of a mismatching item of the table 9 model can be used for knowing that a binomial polynomial model is a model recommended to be adopted by the software, the model item P is less than 0.05, and a regression equation is obtained:
Y＝0.38+0.031A+0.029B-0.011C-0.021AB+0.021AC-0.024BC+0.086A2+0.038B2+0.07C2，(R20.9228), indicating that the regression model fits well. The relationship among the factors and the response surface and contour map of the total evaluation OD value are shown in the figure (figure 1). The software recommends the compatibility and combination of the components as yam: and (3) edible tulip: plantain seed ═ 3: 2: 2.
9. and (3) verification experiment:
weighing the following traditional Chinese medicine raw materials in parts by weight: and (3) edible tulip: plantain seed ═ 3: 2: 2, extracting 3 batches of drug solution according to the optimal preparation process, and performing pharmacodynamic observation on the gastric lavage of the model rat, wherein the normalized values of all indexes are respectively as follows: 0.59, 0.63 and 0.62, the fitting predicted value is 0.62, and the deviation between the experimental measured value and the predicted value is 4.8%, -1.6% and 0%, which indicates that the method is reasonable and feasible.
FIG. 1 is a response surface diagram and contour diagram of the prescription combination to the total evaluation OD value.
Claims (5)
1. A compatible combination for treating hyperuricemia and a preparation method thereof are characterized in that: is prepared from the following Chinese medicinal raw materials: ningpo Yam rhizome, Pseudobulbus Cremastrae Seu pleiones, and semen plantaginis; the preparation process comprises the following steps: the decoction time, the decoction times and the water times.
2. The compatible combination for treating hyperuricemia according to claim 1, wherein the compatible combination comprises: the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in parts by weight: 10-15 g of yam rhizome, 3-10 g of edible tulip and 10-15 g of plantain seed; the preparation process comprises the following steps: the decoction time is 1-3 hours, the decoction times are 1-3 times, and the water volume is 8-12 times.
3. The compatible combination for treating hyperuricemia according to claim 1, wherein the compatible combination comprises: the traditional Chinese medicine comprises the following raw materials in parts by weight: 1, Ningpo Yam rhizome: and (3) edible tulip: plantain seed ═ 3: 2: 2; the preparation process comprises the following steps: decocting with 10 times of water for 3 times, each time for 3 hr.
4. The compatible combination for treating hyperuricemia according to any one of claims 1 to 3, wherein the compatible combination comprises: the method comprises the following steps:
firstly, a single-factor screening preparation process is used for screening the preparation range by using the time, the times and the amount of water for decoction; test L with orthogonal design9(34) Adding 8-12 times of distilled water into the traditional Chinese medicine raw materials, soaking for 0.5h, then decocting for 1-3 times, decocting for 1-3 hours each time, filtering to obtain liquid medicine, combining, concentrating, drying, weighing the dry paste and calculating the paste yield.
Secondly, screening the compatibility of the traditional Chinese medicines by using a star point design-effect surface method, extracting the traditional Chinese medicine raw materials according to a preparation process, concentrating the traditional Chinese medicine raw materials to the intragastric perfusion volume, observing pharmacodynamic indexes, and determining the optimal compatibility of the traditional Chinese medicines.
5. The compatible combination for treating hyperuricemia according to claim 4, wherein the compatible combination comprises: the compatible combination for treating hyperuricemia and the preparation method thereof can also be prepared into granules, capsules, tablets, powder, pills, mixtures, dripping pills and the like.
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102293928A (en) * | 2010-06-22 | 2011-12-28 | 天津市石天药业有限责任公司 | Chinese medicinal composition for treating hyperuricemia and urarthritis, and preparation method and application thereof |
| CN107669991A (en) * | 2017-11-24 | 2018-02-09 | 成都中医药大学附属医院 | A kind of pharmaceutical composition for reducing serum uric acid level and preparation method thereof |
| US20190099465A1 (en) * | 2016-04-08 | 2019-04-04 | Korea Institute Of Oriental Medicine | Composition for preventing, ameliorating, or treating hyperuricemia or metabolic disorders related with hyperuricemia comprising extract of alpinia oxyphylla as effective ingredient |
-
2021
- 2021-03-04 CN CN202110238844.XA patent/CN112843178A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102293928A (en) * | 2010-06-22 | 2011-12-28 | 天津市石天药业有限责任公司 | Chinese medicinal composition for treating hyperuricemia and urarthritis, and preparation method and application thereof |
| US20190099465A1 (en) * | 2016-04-08 | 2019-04-04 | Korea Institute Of Oriental Medicine | Composition for preventing, ameliorating, or treating hyperuricemia or metabolic disorders related with hyperuricemia comprising extract of alpinia oxyphylla as effective ingredient |
| CN107669991A (en) * | 2017-11-24 | 2018-02-09 | 成都中医药大学附属医院 | A kind of pharmaceutical composition for reducing serum uric acid level and preparation method thereof |
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| Title |
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| 袁忠勰: "《药食验方》", 31 October 2019, 上海科学技术出版社 * |
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