Traditional Chinese medicine composition for treating hyperuricemia and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating hyperuricemia and a preparation method thereof. The traditional Chinese medicine composition is prepared from the following medicines: 25-35 parts of rhizoma smilacis glabrae, 12-18 parts of radix paeoniae rubra, 12-18 parts of radix cyathulae, 12-18 parts of herba lysimachiae, 6-14 parts of rhizoma atractylodis, 8-10 parts of cortex phellodendri, 6-14 parts of radix clematidis, 4-6 parts of rhizoma polygoni cuspidati and 5-7 parts of flos carthami. Through scientific compatibility, the synergistic effect of all the medicines is exerted, and the purposes of reducing the blood uric acid level and improving the illness state are achieved. Meanwhile, the traditional Chinese medicine composition has better safety and tolerance, is good in curative effect, and is suitable for patients with different types and different degrees of hyperuricemia.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine composition technology, specifically to a traditional Chinese medicine composition for treating hyperuricemia and its preparation method. Background Technology

[0002] Hyperuricemia is a common metabolic disease caused by abnormal purine metabolism or impaired renal excretion. High blood uric acid levels directly or indirectly lead to gouty arthritis, uric acid nephropathy, and other kidney diseases. Hyperuricemia is also a risk factor for coronary heart disease and diabetes. Increasing research indicates a close relationship between hyperuricemia and hypertension, hyperlipidemia, and other diseases, increasing the risk of all-cause mortality, all-cause cardiovascular disease mortality, and cardiovascular events in hypertensive patients. Hyperuricemia can further exacerbate atherosclerosis, promote the development of cardiovascular and cerebrovascular diseases, and induce and worsen kidney damage.

[0003] With the improvement of people's living standards and changes in dietary habits, the incidence of hyperuricemia is increasing year by year. Currently, Western medicine mainly uses uric acid-lowering drugs for treatment, but these drugs often have significant side effects, require long treatment cycles, and are difficult to treat accompanying physical symptoms. Therefore, finding a safe and effective traditional Chinese medicine combination to treat hyperuricemia is of great significance.

[0004] Traditional Chinese medicine (TCM) considers hyperuricemia to fall under the category of "Bi syndrome," with its pathogenesis primarily related to damp-heat, phlegm, and blood stasis. Treatment should focus on clearing heat and dampness, resolving phlegm and dissipating nodules, and promoting blood circulation and removing blood stasis. In recent years, many scholars have researched TCM treatment for hyperuricemia, discovering many herbs with uric acid-lowering effects, such as Fraxinus chinensis bark, Plantago asiatica, and Alisma plantago-aquatica. However, most of these studies remain at the stage of researching single herbs or extracts, lacking systematic research on TCM combinations.

[0005] In recent years, the treatment of hyperuricemia with traditional Chinese medicine (TCM) has become a research hotspot. Many institutions are engaged in research on TCM for treating hyperuricemia. For example, CN202411026578.4 discloses a TCM composition for the prevention or treatment of hyperuricemia, comprising the following ingredients: Cirsium japonicum, Gardenia jasminoides, Lophatherum gracile, Angelica sinensis, Lilium brownii, Corn silk, Broccoli seed extract, and Eucommia ulmoides leaves. This TCM composition has the effects of inhibiting uric acid synthesis, promoting uric acid excretion, improving kidney damage, and protecting the liver. Although various formulations have been disclosed in the prior art, further research into new TCM compositions that can treat hyperuricemia remains of great significance. Summary of the Invention

[0006] The purpose of this invention is to provide a traditional Chinese medicine composition for treating hyperuricemia and its preparation method. Through scientific formulation, the synergistic effect of each drug is utilized to achieve the goal of lowering blood uric acid levels and improving the condition. At the same time, this traditional Chinese medicine composition has good safety and efficacy, and is suitable for patients with different types and degrees of hyperuricemia.

[0007] The technical solution of this invention is:

[0008] A traditional Chinese medicine composition for treating hyperuricemia, comprising the following herbs: 25-35 parts of Smilax glabra, 12-18 parts of Paeonia lactiflora, 12-18 parts of Achyranthes bidentata, 12-18 parts of Lysimachia christinae, 6-14 parts of Atractylodes lancea, 8-10 parts of Phellodendron chinense, 6-14 parts of Clematis chinensis, 4-6 parts of Polygonum cuspidatum, and 5-7 parts of Carthamus tinctorius.

[0009] Another preferred formulation in this embodiment of the invention is: 25 parts of Smilax glabra, 15 parts of Paeonia lactiflora, 15 parts of Achyranthes bidentata, 15 parts of Lysimachia christinae, 9 parts of Atractylodes lancea, 8 parts of Phellodendron chinense, 9 parts of Clematis chinensis, 4 parts of Polygonum cuspidatum, and 5 parts of Carthamus tinctor

[0010] A preferred formulation in this embodiment of the invention is: 30 parts of Smilax glabra, 20 parts of Paeonia lactiflora, 20 parts of Achyranthes bidentata, 20 parts of Lysimachia christinae, 10 parts of Atractylodes lancea, 9 parts of Phellodendron chinense, 10 parts of Clematis chinensis, 5 parts of Polygonum cuspidatum, and 6 parts of Carthamus

[0011] As another objective of this invention, this invention also provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps: weighing nine kinds of traditional Chinese medicine components, adding water and decocting 2-3 times, adding 10-12 times the amount of water each time, and decocting for 1-2 hours; combining the filtrates, concentrating the filtrate under reduced pressure to a clear extract with a relative density of 1.05-1.10, centrifuging, and further concentrating the centrifuged liquid under reduced pressure to a clear extract with a relative density of 1.20-1.30, and vacuum drying to obtain the traditional Chinese medicine composition.

[0012] Hyperuricemia is often caused by congenital deficiency, dietary imbalance, or pathogenic factors such as wind, cold, dampness, and heat, leading to the accumulation of dampness and internal toxins in the body. Damp-heat, phlegm-stasis, and turbid toxins are the basic pathological features. The basic pathogenesis is damp-heat stagnation, heat-toxin accumulation, internal accumulation of phlegm-dampness, and the combination of stasis and heat. Traditional Chinese medicine treatment should follow the principle of "treating the symptoms in acute cases and addressing the root cause in chronic cases," differentiating syndromes and treating accordingly, combining tonification and purgation. The main treatment principles are clearing heat and detoxifying, eliminating dampness and turbidity, and resolving stasis and unblocking the meridians, supplemented by tonifying qi and strengthening the spleen.

[0013] The principal herb in this formula is Smilax glabra, which is sweet and bland in taste and neutral in nature. It enters the liver and stomach meridians; it eliminates dampness and detoxifies, and promotes joint mobility. It is a key herb for treating damp-heat toxins. The *Ben Cao Zheng Yi* states that Smilax glabra "eliminates dampness and clears heat, can enter the collaterals, and eliminates the accumulated toxins of damp-heat." Smilax glabra is a key herb for treating damp-heat toxins. The *Ben Cao Zai Xin* states that it "eliminates damp-heat and benefits tendons and bones," and the *Neijing* states that "dampness harms the skin, flesh, tendons, and bones." Furthermore, Smilax glabra "detoxifies and eliminates evil without harming vital energy" (*Ben Cao Mi Lu*). The *Jiu Huang Ben Cao* states that it can be used as a substitute for grain, and that appropriate dosage has no obvious toxic side effects. Therefore, Smilax glabra is used in large quantities as the principal herb. Astragalus membranaceus tonifies qi and strengthens the exterior, enhances the constitution, assists the body's vital energy in expelling evil, and can also promote diuresis and reduce swelling. Together, they serve as the principal herbs, ensuring that damp-heat and turbid toxins are eliminated without harming the body's vital energy.

[0014] The assistant herbs are: *Polygonum cuspidatum* (Japanese knotweed), bitter and cold in nature; it enters the liver, gallbladder, and lung meridians. It dispels wind and dampness, disperses blood stasis, and relieves pain. *Compendium of Materia Medica* states that it "treats wind in the joints and blood stasis." *Lysimachia christinae* (Golden Coin Grass), sweet and salty, slightly cold in nature; it enters the liver, gallbladder, kidney, and bladder meridians. It promotes diuresis and relieves jaundice, promotes urination and relieves strangury, and detoxifies and reduces swelling. *Atractylodes lancea* (Atractylodes lancea) dries dampness and strengthens the spleen, enhancing spleen and stomach function and promoting the expulsion of dampness. *Phellodendron chinense* (Phellodendron amurense) clears heat and dries dampness; when combined with *Atractylodes lancea*, it enhances the effect of clearing damp-heat in the lower burner. *Clematis chinensis* (Clematis armandii) relaxes muscles and tendons, and is used for rheumatic pain, numbness of limbs, muscle contractures, and difficulty in flexion and extension. These five herbs together serve as assistant herbs, clearing heat, promoting diuresis, and relieving pain to supplement the principal herbs.

[0015] Adjuvant herbs: Achyranthes bidentata dispels wind and dampness, promotes joint mobility, invigorates blood circulation, and removes blood stasis, thus strengthening the removal of dampness and unblocking the meridians. Dampness accumulates into phlegm, and the accumulation of phlegm and dampness leads to qi stagnation and blood stasis; therefore, safflower and red peony root are used to invigorate blood circulation, remove blood stasis, and relieve pain. All of the above are

[0016] The above-mentioned herbs are combined in a way that tonifies and purges simultaneously, regulates ascending and descending properties, and warms and clears simultaneously. This ensures that tonifying qi does not cause excessive heat, eliminating pathogens does not damage body fluids, supporting the body's resistance does not retain pathogens, and detoxifying does not harm the body's vital energy. It achieves the effects of clearing heat and detoxifying, promoting diuresis and eliminating turbidity, resolving blood stasis and unblocking the meridians, and tonifying qi and strengthening the spleen. Overall, the formula is meticulously composed and appropriately combined, and its clinical application is sure to yield good results.

[0017] Compared with the prior art, the advantages of the present invention are:

[0018] 1. Currently available uric acid-lowering drugs have significant side effects, such as allergies and kidney damage, and are mostly targeted at gout patients. There are no effective and safe drugs to prevent and treat asymptomatic hyperuricemia. Pharmacokinetic studies have demonstrated that, by replicating a rat model of hyperuricemia, the herbal composition of this invention has a significant therapeutic effect on hyperuricemia.

[0019] 2. A single-dose toxicity test of the traditional Chinese medicine composition of the present invention administered orally to rats showed that the traditional Chinese medicine composition of the present invention has high safety and no toxic side effects.

[0020] 3. The preparation method of the traditional Chinese medicine composition of the present invention is simple and has a high efficacy rate in clinical trials.

[0021] 4. Compared with the comparative formulation, the synergistic effect between the drugs in the traditional Chinese medicine composition of the present invention is stronger and the therapeutic effect is better. Detailed Implementation

[0022] The following examples are for illustrative purposes only and are not intended to limit the scope of the invention. Where specific techniques or conditions are not specified in the examples, they are performed in accordance with the techniques or conditions described in the literature in this field, or according to the product instructions. Raw materials whose manufacturers are not specified are all conventional products that can be purchased through legitimate channels.

[0023] Example 1

[0024] This embodiment provides a traditional Chinese medicine composition for treating hyperuricemia, which consists of the following components: 30 parts of Smilax glabra, 20 parts of Paeonia lactiflora, 20 parts of Achyranthes bidentata, 20 parts of Lysimachia christinae, 10 parts of Atractylodes lancea, 9 parts of Phellodendron chinense, 10 parts of Clematis chinensis, 5 parts of Polygonum cuspidatum, and 6 parts of Carthamus tinctorius.

[0025] The above nine Chinese herbs are decocted 2-3 times with water, each time adding 10-12 times the amount of water, and decocted for 1-2 hours. The filtrates are combined and concentrated under reduced pressure to a clear extract with a relative density of 1.05-1.10. The extract is centrifuged, and the centrifuged liquid is further concentrated under reduced pressure to a clear extract with a relative density of 1.20-1.30. The extract is then vacuum dried to obtain the Chinese herbal composition.

[0026] The traditional Chinese medicine composition is prepared into a decoction paste.

[0027] Comparative Example 1

[0028] This comparative example provides a traditional Chinese medicine composition consisting of the following components: 30 parts of Smilax glabra, 20 parts of Paeonia lactiflora, 20 parts of Achyranthes bidentata, 20 parts of Lysimachia christinae, 10 parts of Atractylodes lancea, 9 parts of Phellodendron chinense, and 10 parts of Clematis chinensis. The specific preparation process is the same as in Example 1.

[0029] Comparative Example 2

[0030] This comparative example provides a traditional Chinese medicine composition consisting of the following components: 30 parts of Smilax glabra, 20 parts of Lysimachia christinae, 10 parts of Atractylodes lancea, 9 parts of Phellodendron chinense, 10 parts of Clematis chinensis, 5 parts of Polygonum cuspidatum, and 6 parts of Carthamus tinctorius. The specific preparation process is the same as in Example 1.

[0031] Example 2

[0032] Toxicity test of the traditional Chinese medicine composition prepared in Example 1 via oral administration to rats after a single consecutive dose.

[0033] The toxicity of the traditional Chinese medicine combination solution prepared in Example 1 was observed by oral administration of different doses to SD rats in a single-dose continuous administration test. The toxicity of the traditional Chinese medicine combination prepared in Example 1 to SD rats after repeated administration was evaluated, and reference data was provided for the clinical use of the traditional Chinese medicine combination prepared in Example 1.

[0034] Forty male SD rats, weighing 180-220g, were acclimatized to their environment for 7 days.

[0035] The animals were randomly divided into two groups: a blank control group and a group containing the traditional Chinese medicine composition prepared in Example 1 (g crude drug / kg), with 20 animals in each group.

[0036] The animals were administered 20 mL / kg orally with pure water and the traditional Chinese medicine composition prepared in Example 1, twice a day. The animals were closely observed and recorded for 0-4 hours after each administration, noting the characteristics of poisoning, the onset and recovery time of toxic reactions, and mortality. Observations were then conducted twice daily, once in the morning and once in the afternoon, for 14 consecutive days. The animals were weighed on days 0, 7, and 14 after administration, and their weight changes were recorded.

[0037] Experimental Results: Effects on general activity, poisoning symptoms, and mortality in experimental animals: From 1 hour 56 minutes to 3 hours 29 minutes after the first administration, 7 / 20 rats in the group using the herbal composition prepared in Example 1 developed loose stools. All rats exhibiting loose stools did not recover within the 4-hour observation period. From 30 minutes to 57 minutes after the second administration, an additional 1 / 4 of the rats in the group using the herbal composition prepared in Example 1 developed loose stools. From 2 hours 18 minutes to 3 hours 30 minutes after the second administration, 13 / 20 rats in the group using the herbal composition prepared in Example 1 developed yellow-brown watery stools. Loose stools persisted into the morning of the second day but recovered by the afternoon. The remaining rats exhibiting watery stools recovered by the morning of the second day. No other toxic reactions or animal deaths were observed. After 14 days of continuous observation following administration, no significant abnormalities were observed in the behavior, mental state, or diet of rats in the blank control group and the group using the herbal composition prepared in Example 1. No related toxic reactions or animal deaths were observed.

[0038] Experimental Results: Effect on Body Weight: The experimental animals were weighed on days 0, 7, and 14 after administration. Compared with the control group, there was no statistically significant difference in body weight between the animals in the group receiving the herbal composition prepared in Example 1, and the weight gain was within the normal range. These results indicate that under the experimental conditions, oral administration of the herbal composition prepared in Example 1 twice to rats had no significant effect on their body weight. See Table 1 for details.

[0039] Table 1. Effects of the traditional Chinese medicine composition prepared in Example 1 on rat body weight (n=20, )

[0040]

[0041] Weights are expressed as mean ± standard deviation. P < 0.05 is considered statistically significant.

[0042] Conclusion: Under the conditions of this experiment, the Chinese medicine composition liquid prepared in Example 1 was orally administered to rats by gavage, with a dosing volume of 20 mL / kg, administered 2 times a day, and the cumulative dose was 143.6 g of crude drug / kg, which was 95 times the equivalent clinical dosing amount per kilogram of body weight for adults (the daily dose for adults is 1.514 g of crude drug / kg). No obvious toxic reactions or deaths were observed in the experimental animals.

[0043] Pharmacodynamic Study of the Chinese Medicine Composition Prepared in Example 1

[0044] Experimental Materials: 50 SPF-grade Kunming mice, 4 - 5 weeks old, weighing 180 - 220 g, male, purchased from Beijing Vital River Laboratory Animal Technology Co., Ltd. (License No.: SCXK(Jing)2021 - 0006), environmental temperature: 20 - 25 °C, humidity 50 - 70%, free access to food and water. Oxonic acid potassium (Aladdin reagent), hypoxanthine (Aladdin reagent).

[0045] Animal Grouping: 50 male SD rats were randomly divided into 5 groups: blank group, model group, low-dose group, medium-dose group, and high-dose group, with 10 rats in each group. The mice in the model group, low-dose group, medium-dose group, and high-dose group were model animals. The specific modeling process is as follows: A high-uric acid model of mice was established by intraperitoneal injection of 300 mg / kg of oxonic acid potassium and intragastric administration of 300 mg / kg of hypoxanthine daily.

[0046] Drug Administration: One hour after drug administration for mouse modeling, intragastric administration began. The blank group and the model group were given the same volume of solvent, the low-dose group was administered 5 mg / kg, the medium-dose group was administered 250 mg / kg, and the high-dose group was administered 500 mg / kg. Intragastric administration was carried out once a day for 28 consecutive days. The changes in body weight, hair color, diet, and drinking water of each group of mice during the 28-day drug administration period were observed and recorded.

[0047] After 28 days of drug administration, blood was taken to measure the serum uric acid, creatinine, and urea levels of each group of mice using a biochemical analyzer.

[0048] Experimental Results and Discussion

[0049] General Condition and Body Weight of Mice: Compared with the control group, the body weight of the animals in each modeling group increased significantly more slowly with the increase in modeling time, and there was a significant difference in body weight between the modeling group and the normal group of mice after 10 days. Compared with the model group, the body weight of the animals in each treatment group showed an upward trend compared to the model group, and there were no obvious differences in appearance signs, behavioral activities, fecal characteristics, etc. As can be seen from Table 2, compared with the model group, the body weight of the animals in the drug administration group increased but there was no statistical difference (P > 0.05).

[0050] Table 2 Effects of the Chinese Medicine Composition Prepared in Example 1 on the Body Weight of Rats (g, n = 10, x ± s)

[0051]

[0052] Serum uric acid and creatinine levels in mice: As shown in Table 3, the serum uric acid and creatinine levels in the model group mice were significantly increased compared with the normal group (P < 0.01), indicating successful model establishment. After 28 days of treatment with the traditional Chinese medicine compound, the serum uric acid levels in mice in each treatment group were significantly reduced.

[0053] Table 3 Effects of serum uric acid and serum creatinine on rats in each group (g, n=10, x±s)

[0054]

[0055] Note: * indicates that compared with the blank control group, P < 0.01; △△ and △ indicate that compared with the model control group, P < 0.01 and P < 0.05; # indicates that compared with the low-dose group, P < 0.01.

[0056] Mouse serum urea levels: As shown in Table 4, the serum urea levels in the model group mice were significantly increased, showing a significant difference compared to the control group, indicating that the model was successful and that the model group mice developed renal function damage. However, after administration of the traditional Chinese medicine compound, the serum urea levels in the mice were significantly decreased, showing a statistically significant difference compared to the model group, indicating that the renal function of the mice recovered after administration, and that the traditional Chinese medicine compound can repair renal function damage in mice.

[0057] Table 4. Effects of serum urea levels in rats of different groups (g, n = 10, x ± s)

[0058]

[0059] Note: * indicates that compared with the blank control group, P < 0.01; △△ and △ indicate that compared with the model control group, P < 0.01 and P < 0.05; # indicates that compared with the low-dose group, P < 0.01.

[0060] In summary, the experimental results show that in the experiment of potassium oxonate and hypoxanthine-induced hyperuricemia in mice, the traditional Chinese medicine compound significantly reduced serum uric acid levels, suggesting that the traditional Chinese medicine compound has a synergistic effect in improving hyperuricemia in mice. The traditional Chinese medicine compound treatment group reduced serum creatinine and urea levels, significantly reduced plasma urea nitrogen levels, and alleviated renal tubular and glomerular damage. This demonstrates that the traditional Chinese medicine compound has a synergistic effect in improving renal function in hyperuricemic mice.

[0061] Example 3

[0062] This embodiment provides a traditional Chinese medicine composition for treating hyperuricemia, consisting of the following herbs: 25 parts Smilax glabra, 15 parts Paeonia lactiflora, 15 parts Achyranthes bidentata, 15 parts Lysimachia christinae, 9 parts Atractylodes lancea, 8 parts Phellodendron chinense, 9 parts Clematis chinensis, 4 parts Polygonum cuspidatum, and 5 parts Carthamus tinctorius. The preparation method is the same as in Example 1.

[0063] The product in Example 3 has also been verified to have no toxic side effects, and its efficacy is similar to that in Example 1.

[0064] The above description is a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and concept of the present invention, should be covered within the scope of protection of the claims of the present invention.

Claims

1. A traditional Chinese medicine composition for treating hyperuricemia, characterized in that, It is composed of the following herbs: Smilax glabra 25-35 parts, Paeonia lactiflora 12-18 parts, Achyranthes bidentata 12-18 parts, Lysimachia christinae 12-18 parts, Atractylodes lancea 6-14 parts, Phellodendron chinense 8-10 parts, Clematis chinensis 6-14 parts, Polygonum cuspidatum 4-6 parts, and Carthamus tinctorius 5-7 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The formula consists of the following herbs: Smilax glabra 25 parts, Paeonia lactiflora 15 parts, Achyranthes bidentata 15 parts, Lysimachia christinae 15 parts, Atractylodes lancea 9 parts, Phellodendron chinense 8 parts, Clematis chinensis 9 parts, Polygonum cuspidatum 4 parts, and Carthamus tinctorius 5 parts.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The formula consists of the following herbs: 30 parts Smilax glabra, 20 parts Paeonia lactiflora, 20 parts Achyranthes bidentata, 20 parts Lysimachia christinae, 10 parts Atractylodes lancea, 9 parts Phellodendron chinense, 10 parts Clematis chinensis, 5 parts Polygonum cuspidatum, and 6 parts Carthamus tinctorius.

4. The method for preparing the traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, Includes the following steps: The weighed nine Chinese herbal components are decocted 2-3 times with water, each time adding 10-12 times the amount of water, for 1-2 hours. The filtrates are combined and concentrated under reduced pressure to a clear extract with a relative density of 1.05-1.

10. The extract is centrifuged and further concentrated under reduced pressure to a clear extract with a relative density of 1.20-1.

30. The extract is then vacuum dried to obtain the Chinese herbal composition.

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