A zhuang-yao medicine diet composition for assisting treatment of gout and a preparation method thereof

Abstract

The application discloses a kind of auxiliary treatment gout's Zhuang Yao medicine medicinal composition and preparation method thereof, belong to medicinal composition technical field, the weight ratio of each raw material component is Ficus pumila L.: Gualoupi: Shanyao: Yiyiren: Lianzi: Fuling = 5: 5: 6: 10: 5: 5;The composition is based on Zhuang Yao medical theory, and spleen and kidney are considered with dampness and turbidity, suitable for gout intermittent period and long-term diet therapy conditioning of hyperuricemia population, the composition takes Ficus pumila L. as monarch drug to invigorate the spleen and tonify qi, and adjust dragon road and fire road;With Shanyao, Lianzi, Gualoupi as minister drug to protect valley, and cultivate and nourish the root of spleen and kidney;With Fuling, Yiyiren as auxiliary drug to pass through dampness and turbidity, and seep wet and turbidity;A kind of method for preparing the above-mentioned Zhuang Yao medicine medicinal composition, comprising the following steps: (1) pretreatment;It is suitable for gout intermittent period and long-term diet therapy conditioning of hyperuricemia population, effectively overcome the defect that Zhuang Yao medical theory is missing, simple water is kept for a long time and spleen is hurt, and local characteristic medicine of Guangxi is lacked.

Description

Technical Field

[0001] This invention belongs to the field of medicinal diet composition technology, specifically relating to a Zhuang and Yao medicinal diet composition for the adjunctive treatment of gout and its preparation method. Background Technology

[0002] The prevalence of hyperuricemia and gout in my country is on the rise and is affecting younger people, with a particularly high incidence in the hot and humid regions of Lingnan and Guangxi. In Zhuang and Yao medicine theory, the core pathogenesis of gout is obstruction of the digestive tract and water passages, accumulation of dampness, turbidity, and toxins, and blockage of the blood and fire pathways, belonging to a condition of deficiency in the root and excess in the branch. Currently, the existing techniques for dietary therapy for gout remission and hyperuricemia mainly employ the following methods: Common traditional Chinese medicine dietary therapy for gout, mainly consisting of ingredients such as Job's tears, poria cocos, and corn silk, or commercially available uric acid-lowering teas, while having some diuretic and dampness-removing effects, still suffer from the following technical limitations: First, there is a lack of theoretical guidance. Existing treatment plans are all based on traditional Chinese medicine diagnosis and treatment, without fully incorporating the core theories of "three paths and two routes, and disease caused by toxicity and deficiency" characteristic of Zhuang and Yao medicine in Guangxi. The lack of ethnic medicine characteristics results in relatively singular treatment targets and a failure to formulate prescriptions from the holistic perspective of ethnic medicine.

[0003] Secondly, the formulation approach is flawed. Most prescriptions overemphasize diuresis and turbidity elimination, neglecting the key pathogenesis of "spleen deficiency as the root cause," and lacking the combination of herbs to strengthen the spleen and consolidate the foundation. Long-term consumption of such purely diuretic dietary therapy can easily deplete the spleen and stomach's vital energy, making it unsuitable for the long-term dietary conditioning needed by people in the intercritical period of gout.

[0004] Third, the selection of raw materials is limited. Existing solutions mostly use common food and medicine ingredients, without selecting local Zhuang and Yao medicinal materials unique to Guangxi, such as five-finger peach, thus failing to give full play to the unique effects of local food and medicine, and showing obvious deficiencies in terms of targeted medicinal effects and regional characteristics.

[0005] Therefore, in view of the above-mentioned technical problems, it is necessary to provide a Zhuang-Yao medicinal diet composition for the adjunctive treatment of gout and its preparation method. Summary of the Invention

[0006] The purpose of this invention is to provide a Zhuang-Yao medicinal diet composition for the adjunctive treatment of gout and its preparation method, aiming to solve the problems of lack of theoretical guidance, imperfect compatibility and limited raw material selection in the prior art.

[0007] To achieve the above objectives, a specific embodiment of the present invention provides the following technical solution: A Zhuang-Yao medicinal diet composition for the adjunctive treatment of gout, wherein the weight ratio of each ingredient component is 5:5:6:10:5:5; the composition is based on Zhuang medicine theory and takes into account both strengthening the spleen and consolidating the foundation and promoting diuresis and eliminating turbidity, and is suitable for long-term dietary conditioning in the intercritical period of gout and in people with hyperuricemia.

[0008] In one or more embodiments of the present invention, the composition uses five-finger peach as the principal ingredient to invigorate the spleen and replenish qi, and regulate the blood and fire pathways; uses yam, lotus seed, and fox nut as assistant ingredients to protect the digestive tract and nourish the spleen and kidneys; and uses poria and coix seed as adjuvant ingredients to promote urination and eliminate dampness and turbidity.

[0009] A method for preparing the Zhuang-Yao medicinal diet composition described above includes the following steps: (1) Pretreatment: Five-finger peach, gorgon fruit, yam, coix seed, lotus seed and poria are selected, washed and dried respectively, sliced ​​or crushed into 20-60 mesh coarse powder, and mixed according to the above weight ratio; (2) Segmented low-temperature extraction: Add 8-12 times the amount of purified water to the mixed crude powder obtained in step (1), and extract at 60-80℃ for 1-2 hours. Filter to obtain the first filtrate; add 6-8 times the amount of purified water to the filter residue, and extract by boiling at 90-100℃ for 1-1.5 hours. Filter to obtain the second filtrate; combine the first and second filtrates and concentrate under reduced pressure to an extract with a relative density of 1.10-1.20. (3) Forming: The extract obtained in step (2) is prepared into a standardized product by adding excipients according to the target dosage form requirements.

[0010] In one or more embodiments of the present invention, the segmented low-temperature extraction process described in step (2) is used to simultaneously retain the heat-sensitive flavonoid active ingredients in *Ficus hirta* and the polysaccharide components in *Coix lacryma-jobi*, and the retention rates of astilbene and total flavonoids in the resulting extract are higher than those of the conventional one-time decoction method.

[0011] In one or more embodiments of the present invention, the standardized product is selected from any one of medicinal milk tea, medicinal dry ingredients package, tea bag substitute or medicinal concentrated paste; wherein, the preparation method of the medicinal milk tea is as follows: the extract obtained in step (2) is mixed evenly with instant tea powder, vegetable fat powder and fructooligosaccharide in a mass ratio of 1:2:3:1, and then spray-dried or freeze-dried to make powder, and packaged and sealed in 10g-15g bags.

[0012] In one or more embodiments of the present invention, the preparation method of the medicinal food dry powder package is as follows: the 20-60 mesh coarse powder obtained in step (1) is directly mixed according to the prescription ratio, and put into a food-grade non-woven filter bag with a filling amount of 10g-20g per bag. After microwave sterilization or irradiation sterilization, it is sealed and packaged. When used, it is brewed with boiling water or stewed, and the release rate of effective ingredients reaches more than 80%.

[0013] In one or more embodiments of the present invention, the method for preparing the tea bag substitute is as follows: the extract obtained in step (2) is mixed with soluble starch and dextrin in a mass ratio of 1:1:1 to form a soft material, which is then granulated through a 12-16 mesh sieve, dried at 50-70℃ until the moisture content is ≤5%, granulated, and packaged in tea bag filter paper in portions of 2g-5g per bag, and then heat-sealed.

[0014] In one or more embodiments of the present invention, the preparation method of the concentrated medicinal paste is as follows: the extract obtained in step (2) is further concentrated under reduced pressure to a relative density of 1.30-1.35 (60°C), 10%-20% of honey or rock sugar by weight of the extract is added for flavoring, stirred evenly, heated to 100°C for sterilization for 30 minutes, and filled into sterile containers while hot and sealed; the paste has a shelf life of not less than 12 months at room temperature.

[0015] In one or more embodiments of the present invention, the drying in step (1) is to dry the medicinal material in a ventilated manner at 60-70°C until the moisture content of the medicinal material is ≤6%; the vacuum concentration in step (2) is carried out in a vacuum concentration tank, the concentration temperature is 50°C-60°C, the vacuum degree is 0.08MPa-0.09MPa, and the resulting extract remains uniform and without stratification after three freeze-thaw cycles at -20°C.

[0016] In one or more embodiments of the present invention, the molding in step (3) includes: sterilizing the extract obtained in step (2) through a microfiltration membrane with a pore size of 0.2μm-0.5μm, collecting the filtrate, dispensing it into containers in a quantitative manner under sterile conditions, and filling it with nitrogen gas to seal it, so that the product has a shelf life of not less than 18 months under normal temperature conditions.

[0017] Compared with existing technologies, the Zhuang and Yao medicinal diet composition and its preparation method for adjuvant treatment of gout of the present invention are based on the Zhuang and Yao medical theory of "three pathways and two routes, and disease caused by toxicity and deficiency". It adopts a specific ratio of five-finger peach, gorgon fruit, yam, coix seed, lotus seed and poria in 5:5:6:10:5:5 to organically combine "strengthening the spleen and consolidating the foundation" with "dampness and turbidity". Five-finger peach is used as the chief ingredient to regulate the two pathways and nourish the digestive tract. Yam, lotus seed and gorgon fruit are used to strengthen the spleen and kidneys to treat the root cause. Poria and coix seed are used to drain dampness and turbidity to treat the symptoms. It regulates the spleen and stomach from the source and reduces the internal generation of dampness and turbidity, thereby blocking the pathological basis of recurrent gout attacks. The medicine is mild and non-toxic, and is suitable for long-term dietary conditioning in the intercritical period of gout and for people with hyperuricemia. It effectively overcomes the defects of Zhuang medicine theory deficiency, damage to the spleen by long-term use of simple diuretic medicine, and lack of local Guangxi medicinal materials. Attached Figure Description

[0018] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0019] Figure 1 This is a flowchart of the pretreatment process for the raw materials of the composition described in this invention.

[0020] Figure 2 This is a flowchart of the segmented low-temperature extraction process of the composition described in this invention. Detailed Implementation

[0021] To enable those skilled in the art to better understand the technical solutions in this disclosure, the technical solutions in the embodiments of this disclosure will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this disclosure, and not all embodiments. Based on the embodiments in this disclosure, all other embodiments obtained by those skilled in the art without creative effort should fall within the scope of protection of this disclosure.

[0022] This embodiment is a Zhuang-Yao medicinal diet composition for the adjunctive treatment of gout; take 500g of five-finger peach, 500g of foxnut, 600g of yam, 1000g of coix seed, 500g of lotus seed, and 500g of poria cocos, for a total of 3000g; the weight ratio of each ingredient is 5:5:6:10:5:5.

[0023] The above-mentioned medicinal materials were cleaned and washed separately, dried in a ventilated environment at 65℃ until the moisture content was ≤6%, and pulverized into a coarse powder of 40 mesh. They were then mixed in a specific ratio. Ten times the volume of purified water was added to the mixed coarse powder, and the mixture was extracted at 70℃ for 1.5 hours. The mixture was filtered to obtain the first filtrate. Eight times the volume of purified water was added to the residue, and the mixture was decocted at 95℃ for 1 hour. The residue was then filtered to obtain the second filtrate. The filtrates were combined and concentrated in a vacuum concentrator to an extract with a relative density of 1.15. After three freeze-thaw cycles at -20℃, the resulting extract remained homogeneous and without stratification.

[0024] This embodiment describes the preparation method of a Zhuang-Yao medicinal food composition. Take 100g of the extract obtained in the above embodiment, mix it evenly with 200g of instant black tea powder, 300g of non-dairy creamer, and 100g of fructooligosaccharides, spray dry to form a powder, and package it into 12g packets in aluminum foil bags, then seal. The finished product has a mild taste after preparation and possesses the unique aroma of Zhuang-Yao medicine.

[0025] The 40-mesh coarse powder obtained in the above examples was directly mixed according to the prescription ratio, packed into food-grade non-woven filter bags, each bag containing 15g, and then sealed after microwave sterilization. When used, it is steeped in boiling water for 10 minutes or stewed, resulting in an effective ingredient release rate of over 85%.

[0026] The extract obtained in the above examples is mixed with soluble starch and dextrin in a mass ratio of 1:1:1 to form a soft material. The material is then granulated through a 14-mesh sieve, dried at 60°C until the moisture content is ≤5%, granulated, and packaged in tea bag filter paper in 3g portions. The package is then heat-sealed to obtain the final product.

[0027] The combined filtrate from the above examples was concentrated under reduced pressure to a relative density of 1.32. Honey was added at 15% of the extract weight, stirred evenly, and sterilized at 100°C for 30 minutes. While still hot, it was filled into 100ml glass bottles, sealed, and inverted to cool. This product is a dark brown thick paste, with each bottle containing approximately 120g of raw medicinal material. 10-15g is taken each time, dissolved in warm water. This product, stored at room temperature for 12 months, showed no mold growth or sedimentation after testing.

[0028] Twenty patients (12 males and 8 females) aged 30-60 years, who were in the intercritical period of gout and were treated at the Department of Preventive Medicine and the Department of Acupuncture and Moxibustion of our hospital, were selected. They were given the concentrated medicinal paste of Example 5 of this invention, 10g twice daily (morning and evening), dissolved in warm water, for 7 consecutive days. Results: Before treatment, the average serum uric acid was (485±32) μmol / L, and after treatment, the average serum uric acid was (398±28) μmol / L, a decrease of approximately 18%, which was statistically significant (P<0.05). Patients reported significant relief from joint heaviness and limb fatigue. No adverse reactions such as gastrointestinal discomfort, diarrhea, or stomach chills occurred in any of the subjects.

[0029] To verify the superiority of the segmented low-temperature extraction process, two comparative groups were set up using the representative active ingredients "astilbene" and "total flavonoids" from *Ficus hirta* as indicators: Experimental group: processed according to the segmented low-temperature extraction process in the above examples; soaked at 70℃ for 1.5h + decocted at 95℃ for 1h, and the filtrates were combined and concentrated into an extract.

[0030] Control group: The same batch of crude powder was added to 10 times the amount of purified water, decocted directly at 100℃ for 2 hours, filtered and concentrated into an equal amount of extract.

[0031] The contents of astilbin and total flavonoids in the extracts of the two groups were determined. Results: The astilbin retention rate in the experimental group was 94.2%, and the total flavonoid retention rate was 91.5%; while the astilbin retention rate in the control group was 72.8%, and the total flavonoid retention rate was 68.3%. The experimental group was significantly higher than the control group (P<0.01), proving that the segmented low-temperature extraction process of the present invention effectively preserves the heat-sensitive active ingredients.

[0032] The extract obtained in the above examples was sterilized and filtered through a 0.3 μm microfiltration membrane in a sterile clean room, and the filtrate was collected. The filtrate was dispensed in 100g portions into sterilized glass bottles, which were immediately filled with high-purity nitrogen and sealed. Microbial limit testing showed no sterile growth in the finished product. The product was then placed in a 40°C accelerated stability test chamber for 6 months. Testing showed that the product had a uniform appearance, no sedimentation, and no mold growth, equivalent to a shelf life of at least 18 months under normal temperature conditions.

[0033] The drying temperatures in step (1) were set to 60℃, 65℃, and 70℃, respectively, and the resulting moisture contents of the medicinal materials were 5.2%, 5.8%, and 6.0%, respectively, all of which met the requirement of ≤6%. The vacuum concentration temperatures in step (2) were set to 50℃, 55℃, and 60℃, and the vacuum degrees were set to 0.08MPa, 0.085MPa, and 0.09MPa, respectively. After the resulting extracts were subjected to three freeze-thaw cycles at -20℃, all samples remained uniform and without stratification.

[0034] It will be apparent to those skilled in the art that this disclosure is not limited to the details of the exemplary embodiments described above, and that this disclosure can be implemented in other specific forms without departing from its spirit or essential characteristics. Therefore, the embodiments should be considered in all respects as exemplary and non-limiting, and the scope of this disclosure is defined by the appended claims rather than the foregoing description. Thus, all variations falling within the meaning and scope of equivalents of the claims are intended to be included within this disclosure. No reference numerals in the claims should be construed as limiting the scope of the claims.

[0035] Furthermore, it should be understood that although this specification describes embodiments, not every embodiment contains only one independent technical solution. This narrative style is merely for clarity. Those skilled in the art should consider the specification as a whole, and the technical solutions in each embodiment can also be appropriately combined to form other embodiments that can be understood by those skilled in the art.

Claims

1. A Zhuang-Yao medicinal diet composition for adjuvant treatment of gout, characterized in that, The weight ratio of each ingredient component is 5:5:6:10:5:

5. The composition is based on the theory of Zhuang and Yao medicine, which takes into account both strengthening the spleen and consolidating the foundation and promoting diuresis and eliminating turbidity. It is suitable for long-term dietary conditioning for people with gout during the intercritical period and hyperuricemia.

2. The Zhuang and Yao medicinal diet composition according to claim 1, characterized in that, The composition uses five-finger peach as the principal ingredient to invigorate the spleen and replenish qi, and regulate the flow of qi and blood; yam, lotus seed, and fox nut as assistant ingredients to protect the digestive tract and nourish the spleen and kidneys; and poria and coix seed as adjuvant ingredients to promote urination and eliminate dampness and turbidity.

3. A method for preparing the Zhuang-Yao medicinal diet composition according to claim 1, characterized in that, Includes the following steps: (1) Pretreatment: Five-finger peach, gorgon fruit, yam, coix seed, lotus seed and poria are selected, washed and dried respectively, sliced ​​or crushed into 20-60 mesh coarse powder, and mixed according to the above weight ratio; (2) Segmented low-temperature extraction: Add 8-12 times the amount of purified water to the mixed crude powder obtained in step (1), and extract at 60-80℃ for 1-2 hours. Filter to obtain the first filtrate; add 6-8 times the amount of purified water to the filter residue, and extract by boiling at 90-100℃ for 1-1.5 hours. Filter to obtain the second filtrate; combine the first and second filtrates and concentrate under reduced pressure to an extract with a relative density of 1.10-1.

20. (3) Forming: The extract obtained in step (2) is prepared into a standardized product by adding excipients according to the target dosage form requirements.

4. The preparation method according to claim 3, characterized in that, The segmented low-temperature extraction process described in step (2) is used to simultaneously retain the heat-sensitive flavonoid active ingredients in *Ficus hirta* and the polysaccharide components in *Coix lacryma-jobi*. The retention rates of astilbene and total flavonoids in the resulting extract are higher than those of the conventional one-time decoction method.

5. The preparation method according to claim 3, characterized in that, The standardized product is selected from any one of medicinal milk tea, medicinal dry ingredients package, tea bag substitute or medicinal concentrated paste; wherein, the preparation method of the medicinal milk tea is as follows: the extract obtained in step (2) is mixed evenly with instant tea powder, vegetable fat powder and fructooligosaccharide in a mass ratio of 1:2:3:1, and then spray-dried or freeze-dried to make powder, and packaged and sealed in 10g-15g bags.

6. The preparation method according to claim 3, characterized in that, The preparation method of the medicinal food dry powder package is as follows: the 20-60 mesh coarse powder obtained in step (1) is directly mixed according to the prescription ratio, and put into a food-grade non-woven filter bag with a filling amount of 10g-20g per bag. After microwave sterilization or irradiation sterilization, it is sealed and packaged. When used, it is brewed with boiling water or stewed, and the release rate of effective ingredients reaches more than 80%.

7. The preparation method according to claim 3, characterized in that, The preparation method of the tea bag substitute is as follows: the extract obtained in step (2) is mixed with soluble starch and dextrin in a mass ratio of 1:1:1 to form a soft material, which is then granulated through a 12-16 mesh sieve, dried at 50-70℃ until the moisture content is ≤5%, granulated, and packaged in tea bag filter paper in portions of 2g-5g per bag, and then heat-sealed.

8. The preparation method according to claim 3, characterized in that, The preparation method of the concentrated medicinal paste is as follows: the extract obtained in step (2) is further concentrated under reduced pressure to a relative density of 1.30-1.35 (60℃), 10%-20% of honey or rock sugar by weight of the extract is added for flavoring, stirred evenly, heated to 100℃ for sterilization for 30 minutes, and filled into sterile containers while hot and sealed. The paste has a shelf life of not less than 12 months at room temperature.

9. The preparation method according to claim 3, characterized in that, The drying in step (1) is to dry the medicinal material in a ventilated environment at 60-70℃ until the moisture content of the medicinal material is ≤6%; the vacuum concentration in step (2) is carried out in a vacuum concentration tank with a concentration temperature of 50℃-60℃ and a vacuum degree of 0.08MPa-0.09MPa. The resulting extract remains uniform and without stratification after three freeze-thaw cycles at -20℃.

10. The preparation method according to claim 3, characterized in that, The molding process in step (3) includes: sterilizing the extract obtained in step (2) through a microfiltration membrane with a pore size of 0.2μm-0.5μm, collecting the filtrate, dispensing it into containers in a quantitative manner under sterile conditions, filling them with nitrogen and sealing them, so that the product has a shelf life of not less than 18 months under normal temperature conditions.

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