Traditional Chinese medicine composition for lowering uric acid and relieving gout and preparation method thereof

Abstract

The present invention provides a uric acid-lowering and gout-relieving Chinese medicine composition and a preparation method thereof, and belongs to the technical field of Chinese medicine, wherein the Chinese medicine composition includes a base material extract and a radix serrulata leaf-lotus leaf extract; the base material extract is prepared by water extraction from a basic mixture, and the basic mixture includes components: cassia seed, honeysuckle, burdock root, codonopsis, kudzu root, peach kernel, angelica, Poria, citron, mulberry, Cistanche deserticola, hawthorn and apple; the radix serrulata leaf-lotus leaf extract is prepared by water extraction from a mixture of radix serrulata leaves and lotus leaves to obtain a crude extract and then fermented with a composite enzyme, and the composite enzyme includes pectate lyase, cellulase and papain. The present invention uses pure herbal Chinese medicinal materials as raw materials, ensures that the prepared medicine has no toxic and side effects, and effectively improves the effect of reducing uric acid.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a uric acid-lowering and gout-relieving traditional Chinese medicine composition and a preparation method thereof. Background Art

[0002] Gout is an inflammatory disease caused by the deposition of urate crystals in the joints. Hyperuricemia can lead to the formation of urate crystals, which can cause joint inflammation and severe pain. Lowering blood uric acid levels can reduce the formation of urate crystals, thereby preventing gout attacks. Maintaining normal uric acid levels over the long term can help reduce the frequency and severity of gout recurrences. In short, there is a direct relationship between lowering uric acid and relieving gout, and controlling uric acid levels is a key measure for preventing and treating gout.

[0003] Methods to lower uric acid include dietary adjustments and drug treatment. In terms of dietary adjustments, it is necessary to reduce the intake of high-purine foods, such as red meat, seafood, and offal, and increase the intake of low-purine foods, such as vegetables, fruits, and whole grains. In terms of drug treatment, commonly used drugs include allopurinol and febuxostat, which can inhibit uric acid production or promote uric acid excretion.

[0004] However, at the same time, the adverse reactions of allopurinol include rash, diarrhea, abdominal pain, low fever, temporary increase in aminotransferase or granulocytopenia, etc.; long-term use of allopurinol may increase certain health risks, such as liver and kidney damage. The adverse reactions of febuxostat include nausea, rash, abnormal liver function and joint pain, etc.; when taking febuxostat, liver function needs to be monitored regularly to prevent potential liver damage; long-term use of febuxostat may increase the risk of cardiovascular disease. Therefore, how to reduce the side effects of uric acid-lowering drugs while improving the treatment effect has always been a research hotspot in the medical field. Summary of the invention

[0005] In order to solve the problems existing in the background technology, the present invention provides a uric acid-lowering and gout-relieving Chinese medicine composition and a preparation method thereof, which ensures that the prepared medicine has no toxic side effects while effectively improving the uric acid-lowering effect.

[0006] In order to achieve the above-mentioned object, in a first aspect, the present invention provides a Chinese medicine composition for lowering uric acid and relieving gout, comprising a base material extract and a leaf-lotus leaf extract of Agave sphenanthera, wherein the mass ratio of the base material extract to the leaf-lotus leaf extract of Agave sphenanthera is 5:(4-5);

[0007] The base material extract is obtained by water extraction of the base mixed material, and the mass of the base material extract is 30-35% of the mass of the base mixed material;

[0008] The basic mixture comprises the following components by weight: 8-11 parts of cassia seed, 5-7 parts of honeysuckle, 4-4.5 parts of burdock root, 1.2-1.7 parts of codonopsis pilosula, 3-3.6 parts of kudzu root, 3-5 parts of peach kernel, 2-2.5 parts of angelica, 3-4 parts of tuckahoe, 1-1.3 parts of citron, 4-6 parts of mulberry, 2-3 parts of cistanche, 3-5 parts of hawthorn and 3-5 parts of apple;

[0009] The extract of Ampelopsis grossularis leaf-lotus leaf is prepared by extracting a mixture of Ampelopsis grossularis leaf and lotus leaf with water to obtain a crude extract, which is then fermented with a composite enzyme. The mass ratio of Ampelopsis grossularis leaf to lotus leaf is 11:(7-9), the mass of the crude extract is 2.3-2.8 times the mass of the mixture of Ampelopsis grossularis leaf and lotus leaf, and the mass of the composite enzyme is 0.4-0.6% of the mass of the crude extract.

[0010] The complex enzyme comprises pectate lyase, cellulase and papain, and the mass ratio of the three is 1: (0.5-0.7): (1.3-1.5).

[0011] Furthermore, the preparation method of the Ampelopsis grossedentata leaf-lotus leaf extract is as follows:

[0012] A1. Using a mixture of Ampelopsis grossedentata leaves and lotus leaves as the initial material, add 70-80°C water 3-5 times the mass of the initial material, soak for 1-2 hours, then add room temperature water 7-8 times the mass of the initial material, distill and reflux for 10-12 hours, and concentrate to obtain a crude extract;

[0013] A2. Adding complex enzyme to the crude extract obtained in A1, fermenting at a warm temperature, heating to inactivate, filtering, and obtaining a filtrate, which is the Ampelopsis grossedentata leaf-lotus leaf extract.

[0014] Furthermore, donkey-hide gelatin is added to A2, and the mass of the donkey-hide gelatin is 5-8% of the mass of the crude extract.

[0015] Furthermore, in A2, the specific operation of heat preservation fermentation is: at a temperature of 52-60°C, stirring at a stirring speed of 100-120 r / min for 65-72 hours.

[0016] Furthermore, in A2, the specific operation of temperature inactivation is: heating to 95-100° C. and keeping warm for 30-40 minutes.

[0017] Furthermore, the preparation method of the base material extract is as follows:

[0018] B1. Mix cassia seed, honeysuckle, burdock root, codonopsis, kudzu root, peach kernel, angelica, tuckahoe, citron, mulberry, cistanche, hawthorn and apple to obtain a basic mixture;

[0019] B2. Add 70-80℃ water (3-5 times the mass of the basic mixture) to the basic mixture obtained in B1, soak for 1-2 hours, then add room temperature water (7-8 times the mass of the basic mixture), distill and reflux for 8-10 hours, filter, and concentrate the filtrate to obtain the base material extract.

[0020] Furthermore, it also includes an antioxidant stabilizer, the mass of which is 1.2-1.5% of the total mass of the base material extract and the Ampelopsis grossedentata leaf-lotus leaf extract.

[0021] Furthermore, the antioxidant stabilizer includes vitamin C and / or vitamin E.

[0022] In a second aspect, the present invention provides a method for preparing the above-mentioned uric acid-lowering and gout-relieving Chinese medicine composition, which is prepared by uniformly mixing the base material extract and the Ampelopsis grossedentata leaf-lotus leaf extract.

[0023] The relevant effects of the Chinese medicinal materials components involved in this application are as follows:

[0024] Cassia seed: clears away heat and improves eyesight, moistens the intestines and promotes bowel movements, helps improve symptoms such as constipation and red and swollen eyes.

[0025] Honeysuckle: clears away heat and detoxifies, dispels wind-heat, and is used to treat sores and swelling caused by excessive heat and toxicity, as well as fever, cough and other symptoms caused by exogenous wind-heat.

[0026] Burdock root: dispels wind-heat, reduces swelling and toxins, and treats wind-toxic facial swelling, dizziness, and hot and swollen throat.

[0027] Codonopsis: tonifies the spleen and lungs, nourishes blood and produces body fluids. It is suitable for symptoms of spleen and lung weakness, and insufficient qi and blood.

[0028] Pueraria root: relieves muscles and reduces fever, promotes the production of body fluids and quenches thirst, promotes the production of rashes, raises yang and stops diarrhea, and helps relieve the symptoms of acute gouty arthritis.

[0029] Peach kernel: promotes blood circulation and removes blood stasis, moistens the intestines and promotes bowel movements, relieves cough and asthma, and is suitable for blood stasis syndrome and constipation.

[0030] Angelica: replenishes blood and promotes blood circulation, regulates menstruation and relieves pain, moistens the intestines and promotes bowel movements, and is suitable for various symptoms caused by blood deficiency.

[0031] Poria: It can promote diuresis and eliminate dampness, strengthen the spleen, and calm the mind. It helps to eliminate edema and strengthen the spleen.

[0032] Citron: Soothes the liver and regulates qi, relieves fullness, and resolves phlegm. It is suitable for chest and flank pain caused by liver qi stagnation.

[0033] Mulberry: nourishes yin and blood, promotes fluid production and moistens dryness, and is used for dizziness, tinnitus, palpitations, insomnia, etc. caused by liver and kidney yin deficiency.

[0034] Cistanche: Nourishes kidney yang, benefits essence and blood, moistens the intestines and promotes bowel movements. It is suitable for symptoms caused by insufficient kidney yang.

[0035] Hawthorn: helps digestion and strengthens the stomach, promotes qi and relieves blood stasis, clears turbidity and reduces fat. It is suitable for meat stagnation and hyperlipidemia.

[0036] Apple: It can quench thirst, moisten the lungs and relieve restlessness, stimulate the appetite and sober up, and is suitable for a variety of symptoms related to dampness and heat.

[0037] Lotus leaf: clears away heat and relieves summer heat, promotes the development of clear yang, cools blood and stops bleeding. It is suitable for summer heat, thirst and various bleeding symptoms.

[0038] Donkey-hide gelatin: replenishes blood and yin, moistens dryness and stops bleeding, suitable for symptoms such as blood deficiency, sallow complexion, dizziness and palpitations.

[0039] This application has the following beneficial effects:

[0040] 1. The uric acid-lowering and gout-relieving Chinese medicine composition of the present invention is prepared by compounding a base material extract, a leaf-lotus leaf extract and an antioxidant stabilizer, wherein the base material extract is prepared by water extraction using a variety of effective Chinese medicinal materials such as Cassia seed, honeysuckle and burdock root as raw materials, and has a balanced efficacy and a relatively slow release rate of efficacy; and the leaf-lotus leaf extract is prepared by combined extraction and fermentation of a leaf-lotus leaf and a lotus leaf, which can improve both the efficacy and the release rate of efficacy; the efficacy and the release rate of efficacy of the two can achieve a complementary effect, thereby synergistically improving the therapeutic effect. At the same time, the antioxidant stabilizer is prepared by using vitamin C and xanthan gum as raw materials, which can form a stable and lasting antioxidant protection for the active ingredients, and can increase the contact time of the active ingredients in the gastrointestinal tract, thereby further improving the therapeutic effect.

[0041] 2. In the preparation of the Agave sphenanthera leaf-lotus leaf extract of the present invention, the water extract of the Agave sphenanthera leaf and lotus leaf mixture is fermented with a composite enzyme prepared by compounding pectate lyase, cellulase and papain, and donkey-hide gelatin is added as a nutrient base to promote and enhance the composite fermentation effect; on the one hand, the secondary metabolites produced during the fermentation process can complement each other with the water extract of the medicinal materials, increase the activity and content of the effective substances, and thus improve the efficacy; on the other hand, the composite enzyme fermentation action converts macromolecules into small molecules, making them easier to be absorbed by the gastrointestinal tract, that is, improving the release and action speed of the efficacy; ultimately, while improving its own therapeutic effect, it can also complement the efficacy and efficacy release speed of the base material extract of the present invention, thereby synergistically improving the therapeutic effect.

[0042] 3. In the preparation of the antioxidant stabilizer of the present invention, vitamin C, as a powerful antioxidant, can effectively prevent the active ingredients from being damaged by oxidation, thereby maintaining and improving the therapeutic effects of the active ingredients; xanthan gum, as a protective carrier, can maintain the stability of vitamin C, delay the release of vitamin C to prolong its beneficial effects, and at the same time improve the adhesion of vitamin C and active ingredients in the gastrointestinal tract, increase the contact time, thereby improving the absorption rate and improving the therapeutic effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] Figure 1 , a comparative trend chart of the test data of the uric acid-lowering effect of the traditional Chinese medicine composition prepared in Examples 1 to 7 of the present invention and Comparative Examples 1 to 8. DETAILED DESCRIPTION

[0044] The present application is further described in detail below with reference to the embodiments.

[0045] Unless otherwise specified, the raw materials used in the examples and comparative examples of the present application are all commercially available.

[0046] Example 1: (1) Prepare a base material extract, the preparation method of which is as follows:

[0047] B1. Mix 9 parts of Cassia Seed, 6 parts of Honeysuckle, 4.2 parts of Burdock Root, 1.5 parts of Codonopsis Pilosula, 3.2 parts of Pueraria lobata, 4 parts of Peach Kernel, 2.3 parts of Angelica Sinensis, 3.4 parts of Poria, 1.1 parts of Citron, 5 parts of Mulberry, 2.5 parts of Cistanche, 4 parts of Hawthorn and 4 parts of Apple, chop and mix well to obtain a basic mixture.

[0048] B2. Add 75℃ water (4 times the mass of the basic mixture) to the basic mixture obtained in B1, soak for 1.5 hours, then add room temperature water (7.5 times the mass of the basic mixture), distill and reflux for 9 hours, filter to obtain filtrate, place the filtrate in a vacuum concentration tank, reduce the pressure in the tank by a vacuum pump, evaporate and concentrate the filtrate at 55±5℃, and obtain the base material extract. The mass of the base material extract is 32% of the mass of the basic mixture.

[0049] (2) Preparation of the Ampelopsis grossedentata leaf-lotus leaf extract, the preparation method thereof is as follows:

[0050] A1. Mix the leaves of Ampelopsis gracile and lotus leaves in a mass ratio of 11:8, chop and mix well to obtain the initial material. Add 75℃ water 4 times the mass of the initial material to it, soak for 1.5 hours, then add room temperature water 7.5 times the mass of the initial material, distill and reflux for 11 hours, and vacuum concentrate at 60±5℃ to obtain a crude extract. The mass of the crude extract is 2.5 times the mass of the initial material.

[0051] A2. Add donkey-hide gelatin and compound enzyme to the crude extract obtained in A1. The mass of donkey-hide gelatin is 7% of the mass of the crude extract; the mass of compound enzyme is 0.5% of the mass of the crude extract. The compound enzyme includes pectate lyase, cellulase and papain, and the mass ratio of the three is 1:0.6:1.4. Then keep warm and ferment. The specific operation is: stir at a constant speed of 110r / min at a temperature of 55℃ for 68h. Then heat and inactivate. The specific operation is: heat to 97℃ and keep warm for 35min. Then filter to obtain the filtrate, which is the extract of Ampelopsis serrulata leaf-lotus leaf.

[0052] Among them, pectate lyase M1 (MGZ-E-PCLYAN) was purchased from Shanghai Yubo Biotechnology Co., Ltd. Cellulase (YT2466) was purchased from Beijing Yita Biotechnology Co., Ltd. Papain (60373ES25) was purchased from Yisheng Biotechnology (Shanghai) Co., Ltd.

[0053] (3) A Chinese medicinal composition for lowering uric acid and relieving gout was prepared. The preparation method was as follows: a base material extract and a Grapevine leaf-lotus leaf extract were mixed in a mass ratio of 5:4.5, and an antioxidant stabilizer was added, the mass of which was 1.3% of the total mass of the base material extract and the Grapevine leaf-lotus leaf extract. The mixture was stirred at a constant speed of 220 r / min for 15 min to mix well, thereby obtaining the Chinese medicinal composition for lowering uric acid and relieving gout.

[0054] The preparation method of the antioxidant stabilizer is as follows: add 8g of vitamin C to 90mL of freshly boiled distilled water cooled to room temperature, shake well to dissolve, add 2g of xanthan gum, keep warm in a 40°C water bath for 30 minutes, and cool naturally to room temperature to obtain the antioxidant stabilizer.

[0055] Food grade vitamin C powder (water soluble) was purchased from Hunan Tairen Pharmaceutical Co., Ltd. Food grade xanthan gum (effective content 99%) was purchased from Tianxin (Qingdao) Food Co., Ltd.

[0056] Example 2: The difference between this example and Example 1 is that: (1) a base material extract is prepared, and the preparation method thereof is as follows:

[0057] B1. Mix 8 parts of Cassia Seed, 5 parts of Honeysuckle, 4 parts of Burdock Root, 1.2 parts of Codonopsis Pilosula, 3 parts of Pueraria lobata, 3 parts of Peach Kernel, 2 parts of Angelica Sinensis, 3 parts of Poria, 1 part of Citron, 4 parts of Mulberry, 2 parts of Cistanche, 3 parts of Hawthorn and 3 parts of Apple by weight, chop and mix well to obtain a basic mixture.

[0058] B2. Add 70℃ water (3 times the mass of the basic mixture) to the basic mixture obtained in B1, soak for 2 hours, then add room temperature water (7 times the mass of the basic mixture), distill and reflux for 10 hours, filter, and concentrate the filtrate to obtain the base material extract. The mass of the base material extract is 30% of the mass of the basic mixture.

[0059] Example 3: The difference between this example and Example 1 is that: (1) a base material extract is prepared, and the preparation method thereof is as follows:

[0060] B1. Mix 11 parts of Cassia Seed, 7 parts of Honeysuckle, 4.5 parts of Burdock Root, 1.7 parts of Codonopsis Pilosula, 3.6 parts of Pueraria lobata, 5 parts of Peach Kernel, 2.5 parts of Angelica Sinensis, 4 parts of Poria, 1.3 parts of Citron, 6 parts of Mulberry, 3 parts of Cistanche, 5 parts of Hawthorn and 5 parts of Apple by weight, chop and mix well to obtain a basic mixture.

[0061] B2. Add 80℃ water (5 times the mass of the basic mixture) to the basic mixture obtained in B1, soak for 1 hour, then add room temperature water (8 times the mass of the basic mixture), distill and reflux for 8 hours, filter, and concentrate the filtrate to obtain the base material extract. The mass of the base material extract is 35% of the mass of the basic mixture.

[0062] Example 4: The difference between this example and Example 1 is that: (2) preparing the Ampelopsis grossedentata leaf-lotus leaf extract, the preparation method thereof is as follows:

[0063] A1. Mix the leaves of Ampelopsis grossedentata and lotus leaves in a mass ratio of 11:7, chop them, and mix them well to obtain the initial material. Add 70℃ water 3 times the mass of the initial material to it, soak it for 2 hours, then add room temperature water 7 times the mass of the initial material, distill and reflux for 12 hours, and vacuum concentrate at 60±5℃ to obtain a crude extract. The mass of the crude extract is 2.3 times the mass of the initial material.

[0064] A2. Add donkey-hide gelatin and compound enzyme to the crude extract obtained in A1. The mass of donkey-hide gelatin is 5% of the mass of the crude extract; the mass of compound enzyme is 0.4% of the mass of the crude extract. The compound enzyme includes pectate lyase, cellulase and papain, and the mass ratio of the three is 1:0.5:1.3. Then keep warm and ferment. The specific operation is: stir at a constant speed of 100r / min at a temperature of 52℃ for 72h. Then heat and inactivate. The specific operation is: heat to 95℃ and keep warm for 40min. Then filter to obtain the filtrate, which is the extract of Ampelopsis serrulata leaf-lotus leaf.

[0065] Example 5: The difference between this example and Example 1 is that: (2) preparing the Ampelopsis grossedentata leaf-lotus leaf extract, the preparation method thereof is as follows:

[0066] A1. Mix the leaves of Ampelopsis grossularis and lotus leaves in a mass ratio of 11:9, chop them, and mix them well to obtain the initial material. Add 80℃ water 5 times the mass of the initial material to it, soak it for 1 hour, then add room temperature water 8 times the mass of the initial material, distill and reflux for 10 hours, and vacuum concentrate at 60±5℃ to obtain a crude extract. The mass of the crude extract is 2.8 times the mass of the initial material.

[0067] A2. Add donkey-hide gelatin and compound enzyme to the crude extract obtained in A1. The mass of donkey-hide gelatin is 8% of the mass of the crude extract; the mass of compound enzyme is 0.6% of the mass of the crude extract. The compound enzyme includes pectate lyase, cellulase and papain, and the mass ratio of the three is 1:0.7:1.5. Then keep warm and ferment. The specific operation is: stir at a constant speed of 120r / min at a temperature of 60℃ for 65h. Then heat and inactivate. The specific operation is: heat to 100℃ and keep warm for 30min. Then filter to obtain the filtrate, which is the Agave sphenanthera leaf-lotus leaf extract.

[0068] Example 6: The difference between this example and Example 1 is that: (3) A Chinese medicinal composition for lowering uric acid and relieving gout is prepared, and its preparation method is as follows: the base material extract and the Agave ulmoides leaf-lotus leaf extract are mixed in a mass ratio of 5:4, and then an antioxidant stabilizer is added, the mass of which is 1.2% of the total mass of the base material extract and the Agave ulmoides leaf-lotus leaf extract, and the mixture is mixed to obtain the Chinese medicinal composition for lowering uric acid and relieving gout.

[0069] Example 7: The difference between this example and Example 1 is that: (3) A Chinese medicinal composition for lowering uric acid and relieving gout is prepared, and its preparation method is as follows: the base material extract and the Agave ulmoides leaf-lotus leaf extract are mixed in a mass ratio of 1:1, and then an antioxidant stabilizer is added, the mass of which is 1.5% of the total mass of the base material extract and the Agave ulmoides leaf-lotus leaf extract, and the mixture is mixed to obtain the Chinese medicinal composition for lowering uric acid and relieving gout.

[0070] Comparative Example 1: The difference between this comparative example and Example 1 is that in the preparation of the Ampelopsis grossedentata leaf-lotus leaf extract, the fermentation process step is deleted, that is, the donkey-hide gelatin and the complex enzyme are deleted.

[0071] Specifically, the Ampelopsis grossedentata leaf-lotus leaf extract is prepared, and the preparation method thereof is as follows:

[0072] A1. Mix the leaves of Ampelopsis gracile and lotus leaves in a mass ratio of 11:8, chop and mix well to obtain the initial material. Add 75℃ water 4 times the mass of the initial material to it, soak for 1.5 hours, then add room temperature water 7.5 times the mass of the initial material, distill and reflux for 11 hours, and vacuum concentrate at 60±5℃ to obtain a crude extract. The mass of the crude extract is 2.5 times the mass of the initial material.

[0073] A2. Filter the crude extract obtained in A1 to obtain a filtrate, which is the Ampelopsis grossedentata leaf-lotus leaf extract.

[0074] Comparative Example 2: The difference between this comparative example and Example 1 is that the Ampelopsis grossedentata leaf-lotus leaf extract is replaced by a mixture of Ampelopsis grossedentata leaf extract and lotus leaf extract, wherein no donkey-hide gelatin is added in the preparation of Ampelopsis grossedentata leaf extract and lotus leaf extract, and no fermentation is performed.

[0075] Specifically, a mixture of an Ampelopsis grossedentata leaf extract and a lotus leaf extract is prepared, and the preparation method thereof is as follows:

[0076] A1. Weigh and mix the leaves of Ampelopsis grossedentata and lotus leaves in a mass ratio of 11:8, and chop them separately to obtain Ampelopsis grossedentata leaf fragments and lotus leaf fragments.

[0077] Add 75°C water in an amount of 4 times the mass of the Agave leaf fragments to the Agave leaf fragments, soak for 1.5 hours, then add room temperature water in an amount of 7.5 times the mass of the Agave leaf fragments, distill and reflux for 11 hours, and concentrate in vacuo at 60±5°C to obtain a crude extract of the Agave leaf, the mass of which is 2.5 times the mass of the Agave leaf fragments.

[0078] Add 75°C water in an amount of 4 times the mass of the lotus leaf fragments to the lotus leaf fragments, soak for 1.5 hours, then add room temperature water in an amount of 7.5 times the mass of the lotus leaf fragments, distill and reflux for 11 hours, and vacuum concentrate at 60±5°C to obtain a crude lotus leaf extract, the mass of which is 2.5 times the mass of the lotus leaf fragments.

[0079] A2. Filter the crude extract of Ampelopsis grossedentata leaves obtained in A1 to obtain a filtrate, which is the Ampelopsis grossedentata leaf extract.

[0080] The crude lotus leaf extract obtained in A1 is filtered to obtain a filtrate, which is the lotus leaf extract.

[0081] The Ampelopsis grossedentata leaf extract and the lotus leaf extract are mixed evenly to obtain a mixture of the Ampelopsis grossedentata leaf extract and the lotus leaf extract.

[0082] Comparative Example 3: The difference between this comparative example and Example 1 is that in the preparation of the Ampelopsis grossedentata leaf-lotus leaf extract, donkey-hide gelatin is deleted.

[0083] Specifically, the Ampelopsis grossedentata leaf-lotus leaf extract is prepared, and the preparation method thereof is as follows:

[0084] A1. Mix the leaves of Ampelopsis gracile and lotus leaves in a mass ratio of 11:8, chop and mix well to obtain the initial material. Add 75℃ water 4 times the mass of the initial material to it, soak for 1.5 hours, then add room temperature water 7.5 times the mass of the initial material, distill and reflux for 11 hours, and vacuum concentrate at 60±5℃ to obtain a crude extract. The mass of the crude extract is 2.5 times the mass of the initial material.

[0085] A2. Add compound enzyme to the crude extract obtained in A1. The mass of compound enzyme is 0.5% of the mass of crude extract. The compound enzyme includes pectate lyase, cellulase and papain, and the mass ratio of the three is 1:0.6:1.4. Then keep warm and ferment. The specific operation is: stir at a constant speed of 110r / min for 68h under the temperature of 55℃. Then heat and inactivate. The specific operation is: heat to 97℃ and keep warm for 35min. Then filter to obtain the filtrate, which is the extract of Ampelopsis serrulata leaf-lotus leaf.

[0086] Comparative Example 4: This comparative example is different from Example 1 in that the Ampelopsis grossedentata leaf-lotus leaf extract is replaced by a mixture of Ampelopsis grossedentata leaf extract and lotus leaf extract, wherein no donkey-hide gelatin is added in the preparation of Ampelopsis grossedentata leaf extract and lotus leaf extract.

[0087] Specifically, a mixture of an Ampelopsis grossedentata leaf extract and a lotus leaf extract is prepared, and the preparation method thereof is as follows:

[0088] A1. Weigh the leaves of Ampelopsis grossedentata and lotus leaves in a mass ratio of 11:8, chop them separately to obtain Ampelopsis grossedentata leaf fragments and lotus leaf fragments.

[0089] Add 75°C water in an amount of 4 times the mass of the Agave leaf fragments to the Agave leaf fragments, soak for 1.5 hours, then add room temperature water in an amount of 7.5 times the mass of the Agave leaf fragments, distill and reflux for 11 hours, and concentrate in vacuo at 60±5°C to obtain a crude extract of the Agave leaf, the mass of which is 2.5 times the mass of the Agave leaf fragments.

[0090] Add 75°C water in an amount of 4 times the mass of the lotus leaf fragments to the lotus leaf fragments, soak for 1.5 hours, then add room temperature water in an amount of 7.5 times the mass of the lotus leaf fragments, distill and reflux for 11 hours, and vacuum concentrate at 60±5°C to obtain a crude lotus leaf extract, the mass of which is 2.5 times the mass of the lotus leaf fragments.

[0091] A2. Add compound enzyme to the crude extract of Agave sphenodontica leaves obtained in A1. The mass of compound enzyme is 0.5% of the mass of the crude extract of Agave sphenodontica leaves. Compound enzyme includes pectate lyase, cellulase and papain, and the mass ratio of the three is 1:0.6:1.4. Then keep warm and ferment. The specific operation is: stir at a constant speed of 110r / min for 68h under the temperature of 55℃. Then heat and inactivate. The specific operation is: heat to 97℃ and keep warm for 35min. Then filter to obtain the filtrate, which is the Agave sphenodontica leaf extract.

[0092] Add compound enzyme to the crude lotus leaf extract obtained in A1. The mass of compound enzyme is 0.5% of the mass of crude lotus leaf extract. The compound enzyme includes pectate lyase, cellulase and papain, and the mass ratio of the three is 1:0.6:1.4. Then keep warm and ferment. The specific operation is: stir at a constant speed of 110r / min for 68h under the temperature condition of 55℃. Then heat and inactivate. The specific operation is: heat to 97℃ and keep warm for 35min. Then filter to obtain the filtrate, which is the lotus leaf extract.

[0093] The Ampelopsis grossedentata leaf extract and the lotus leaf extract are mixed evenly to obtain a mixture of the Ampelopsis grossedentata leaf extract and the lotus leaf extract.

[0094] Comparative Example 5: This comparative example is different from Example 1 in that the Ampelopsis grossedentata leaf-lotus leaf extract is replaced by a mixture of Ampelopsis grossedentata leaf extract and lotus leaf extract.

[0095] Specifically, a mixture of an Ampelopsis grossedentata leaf extract and a lotus leaf extract is prepared, and the preparation method thereof is as follows:

[0096] A1. Weigh the leaves of Ampelopsis grossedentata and lotus leaves in a mass ratio of 11:8, chop them separately to obtain Ampelopsis grossedentata leaf fragments and lotus leaf fragments.

[0097] Add 75°C water in an amount of 4 times the mass of the Agave leaf fragments to the Agave leaf fragments, soak for 1.5 hours, then add room temperature water in an amount of 7.5 times the mass of the Agave leaf fragments, distill and reflux for 11 hours, and concentrate in vacuo at 60±5°C to obtain a crude extract of the Agave leaf, the mass of which is 2.5 times the mass of the Agave leaf fragments.

[0098] Add 75°C water in an amount of 4 times the mass of the lotus leaf fragments to the lotus leaf fragments, soak for 1.5 hours, then add room temperature water in an amount of 7.5 times the mass of the lotus leaf fragments, distill and reflux for 11 hours, and vacuum concentrate at 60±5°C to obtain a crude lotus leaf extract, the mass of which is 2.5 times the mass of the lotus leaf fragments.

[0099] A2. Add donkey-hide gelatin and complex enzyme to the crude extract of Ampelopsis serrulata leaves obtained in A1. The mass of donkey-hide gelatin is 7% of the mass of the crude extract of Ampelopsis serrulata leaves; the mass of the complex enzyme is 0.5% of the mass of the crude extract of Ampelopsis serrulata leaves. The complex enzyme includes pectate lyase, cellulase and papain, and the mass ratio of the three is 1:0.6:1.4. Then keep warm and ferment. The specific operation is: stir at a constant speed of 110r / min for 68h at a temperature of 55℃. Then heat and inactivate. The specific operation is: heat to 97℃ and keep warm for 35min. Then filter to obtain the filtrate, which is the Ampelopsis serrulata leaf extract.

[0100] Add donkey-hide gelatin and compound enzyme to the crude lotus leaf extract obtained in A1. The mass of donkey-hide gelatin is 7% of the mass of the crude lotus leaf extract; the mass of the compound enzyme is 0.5% of the mass of the crude lotus leaf extract. The compound enzyme includes pectate lyase, cellulase and papain, and the mass ratio of the three is 1:0.6:1.4. Then keep warm and ferment. The specific operation is: stir at a constant speed of 110r / min at a temperature of 55℃ for 68h. Then heat up and inactivate. The specific operation is: heat up to 97℃ and keep warm for 35min. Then filter to obtain the filtrate, which is the lotus leaf extract.

[0101] The Ampelopsis grossedentata leaf extract and the lotus leaf extract are mixed evenly to obtain a mixture of the Ampelopsis grossedentata leaf extract and the lotus leaf extract.

[0102] Comparative Example 6: The difference between this comparative example and Example 1 is that the antioxidant stabilizer is deleted in the preparation of the Chinese medicine composition for lowering uric acid and relieving gout.

[0103] Specifically, a Chinese medicinal composition for lowering uric acid and relieving gout is prepared, and the preparation method is as follows: the base material extract and the Agave ulmoides leaf-lotus leaf extract are mixed in a mass ratio of 5:4.5, and stirred at a constant speed of 220r / min for 15min to mix well, so as to obtain the Chinese medicinal composition for lowering uric acid and relieving gout.

[0104] Comparative Example 7: The difference between this comparative example and Example 1 is that xanthan gum is deleted in the preparation of the antioxidant stabilizer.

[0105] Specifically, the preparation method of the antioxidant stabilizer is as follows: add 8g of vitamin C to 90mL of freshly boiled distilled water cooled to room temperature, shake well to dissolve, keep warm in a 40°C water bath for 30min, and cool naturally to room temperature to obtain the antioxidant stabilizer.

[0106] Comparative Example 8: The difference between this comparative example and Example 1 is that vitamin C is deleted in the preparation of the antioxidant stabilizer.

[0107] Specifically, the preparation method of the antioxidant stabilizer is as follows: add 2 g of xanthan gum to 90 mL of freshly boiled distilled water cooled to room temperature, keep warm in a 40° C. water bath for 30 minutes, and naturally cool to room temperature to obtain the antioxidant stabilizer.

[0108] Test example: Test item: uric acid lowering therapeutic effect.

[0109] Test objects: Example 1-Example 7 and Comparative Example 1-Comparative Example 8.

[0110] Experimental content: ① Animals (90 in total): Kunming mice (SPF level, male, 20±2g), the mice were adaptively raised for one week before the experiment.

[0111] ② Grouping (18 groups in total): blank group, model group, positive control group, Example 1 group to Example 7 group and Comparative Example 1 group to Comparative Example 8 group; 5 mice in each group.

[0112] ③ Modeling: Potassium oxonate solution was prepared at 10 mg / mL with normal saline, and the model group, positive control group, Example 1 group to Example 7 group and Comparative Example 1 group to Comparative Example 8 group of mice were gavaged at 10 mL / kg every day; the blank group was given normal saline at 10 mL / kg, and the administration cycle was 7 days.

[0113] ④ Medication: The blank group was given physiological saline at 10 mL / kg; the allopurinol solution (5 mg / mL) was prepared with physiological saline, and the positive control group was gavaged with the allopurinol solution at 10 mL / kg; the Chinese medicine compositions prepared from Example 1 to Example 7 and Comparative Example 1 to Comparative Example 8 were diluted 25 times with physiological saline to obtain diluted medicaments of each Chinese medicine composition, and the corresponding diluted medicaments of the Chinese medicine composition were gavaged at 10 mL / kg from Example 1 to Example 7 and Comparative Example 1 to Comparative Example 8 respectively; continued for 7 days.

[0114] ⑤Test: The mice were fed a normal diet during the experiment. After 7 days of medication, the various indicators of the mice were measured. After the last administration, the eyeballs of the mice were removed to collect blood, which was centrifuged at 3600r / min at room temperature for 10 minutes to obtain serum, measure the uric acid data in the serum, and calculate and record the average value of each group of data.

[0115] Test results: See Table 1.

[0116] Table 1. Test example data

[0117] Grouping / Group Serum uric acid level (μmol / L) blank 54.22±1.35 Model 95.45±4.03 Positive Control 57.48±1.04 Example 1 61.21±1.67 Example 2 60.37±2.11 Example 3 60.95±1.85 Example 4 60.58±1.52 Example 5 61.07±2.03 Example 6 59.93±1.58 Example 7 61.42±1.95 Comparative Example 1 76.25±3.17 Comparative Example 2 73.16±2.82 Comparative Example 3 67.98±2.34 Comparative Example 4 67.02±2.47 Comparative Example 5 63.27±2.01 Comparative Example 6 65.86±1.91 Comparative Example 7 62.95±1.62 Comparative Example 8 67.54±1.98

[0118] Result analysis: Comparing the experimental data of the blank group, model group and positive control group, analyzing Examples 1 to 7 and combining the data in Table 1 and Figure 1 It can be seen that after using the Chinese medicine composition prepared by the present invention, the test data of the blood uric acid value of mice was as low as below 61.42 μmol / L, indicating that the Chinese medicine composition prepared by the present invention has an excellent effect on lowering uric acid.

[0119] Analyze Example 1 and Comparative Examples 1-8 and combine the data in Table 1 and Figure 1 From the comparison between Comparative Example 1 and Comparative Example 2, it can be seen that the blood uric acid value of the test mice corresponding to the mixed water extraction of Agave sphenodontica leaves and lotus leaves (Comparative Example 1) is 76.25 μmol / L, which is significantly higher than the blood uric acid value of the test mice corresponding to the separate water extraction of Agave sphenodontica leaves and lotus leaves (Comparative Example 2) of 73.16 μmol / L, indicating that compared with the separate water extraction of Agave sphenodontica leaves and lotus leaves, the mixed water extraction of the two will cause the uric acid-lowering effect of the final prepared traditional Chinese medicine composition to decrease instead of increase.

[0120] From the comparison of comparative examples 1 and 3, it can be seen that the blood uric acid value of mice corresponding to the mixed water extraction of the Agave sphenodontica and the lotus leaf and the composite enzyme fermentation treatment of the present invention (Comparative Example 3) is 67.98 μmol / L, which is significantly lower than the blood uric acid value of the test mice corresponding to the comparative example 1 of 76.25 μmol / L; from the comparison of comparative examples 2 and 4, it can be seen that the blood uric acid value of mice corresponding to the mixed water extraction of the Agave sphenodontica and the lotus leaf and the composite enzyme fermentation treatment of the present invention (Comparative Example 4) is 67.02 μmol / L, which is significantly lower than the blood uric acid value of the test mice corresponding to the comparative example 2 of 73.16 μmol / L; it shows that whether the Agave sphenodontica and the lotus leaf are mixed or separately treated, the composite enzyme fermentation process of the present invention can improve the uric acid lowering effect of the final prepared traditional Chinese medicine composition on the original basis. Moreover, by further comparison, it can be seen that when the Agave sphenodontica and the lotus leaf are mixed, the composite enzyme fermentation process has a significantly greater improvement in the uric acid lowering effect of the final prepared traditional Chinese medicine composition.

[0121] From the comparison of comparative example 3 and example 1, it can be seen that when the leaves of Agave glabra and lotus leaves are mixed and extracted with water and then fermented with the composite enzyme of the present invention, donkey-hide gelatin (Example 1) is added, the corresponding blood uric acid value of mice is 61.21 μmol / L, which is significantly lower than the blood uric acid value of mice tested in comparative example 3, which is 67.98 μmol / L; from the comparison of comparative example 5 and comparative example 4, it can be seen that when the leaves of Agave glabra and lotus leaves are separately extracted with water and fermented with the composite enzyme of the present invention, donkey-hide gelatin is added (Comparative Example 5), the corresponding blood uric acid value of mice is 63.27 μmol / L, which is significantly lower than the blood uric acid value of mice tested in comparative example 4, which is 67.02 μmol / L; This shows that whether the leaves of Agave glabra and lotus leaves are mixed or separately treated, donkey-hide gelatin is added during the composite enzyme fermentation of the present invention, which can improve the uric acid lowering effect of the finally prepared traditional Chinese medicine composition on the original basis. Moreover, through further comparison, it can be seen that when donkey-hide gelatin is added to the mixture of Ampelopsis grossedentata leaves and lotus leaves after water extraction and complex enzyme fermentation, the uric acid-lowering effect of the final Chinese medicine composition is significantly improved.

[0122] From the comparison between Comparative Example 6 and Comparative Example 7, it can be seen that the test data of the blood uric acid value of mice corresponding to the introduction of vitamin C alone (Comparative Example 7) is 62.95 μmol / L, which is significantly lower than the blood uric acid value of the test mice corresponding to Comparative Example 6 (65.86 μmol / L), indicating that the addition of vitamin C alone can improve the uric acid-lowering effect of the final traditional Chinese medicine composition.

[0123] From the comparison between Comparative Example 6 and Comparative Example 8, it can be seen that the test data of the blood uric acid value of mice corresponding to the introduction of xanthan gum (Comparative Example 8) alone is 67.54 μmol / L, which is significantly greater than the blood uric acid value of the test mice corresponding to Comparative Example 6, which is 65.86 μmol / L, indicating that the addition of xanthan gum alone will cause the uric acid-lowering effect of the final Chinese medicine composition to decrease instead of increase. This is because the efficacy of the Agave sphenanthera leaf-lotus leaf extract of the present invention is designed to be released quickly, and when xanthan gum exists alone, it will slow down the dissolution rate of the drug, that is, slow down the release rate of the drug efficacy, thereby affecting the speed of its efficacy, affecting the synergistic effect of the efficacy between it and the base material extract of the present invention, resulting in a decrease in the uric acid-lowering effect.

[0124] By comparison with Example 1, it can be seen that the antioxidant stabilizer prepared by introducing vitamin C and xanthan gum (Example 1) corresponds to the test data of mouse blood uric acid value of 61.21 μmol / L, indicating that vitamin C and xanthan gum produce a synergistic effect, and the two can work synergistically to synergistically improve the uric acid-lowering effect of the final Chinese medicine composition.

[0125] It should also be noted that the various specific technical features described in the above specific embodiments can be combined in any suitable manner without contradiction. In order to avoid unnecessary repetition, the present invention will not further describe various possible combinations.

[0126] In addition, various embodiments of the present invention may be arbitrarily combined, and as long as they do not violate the concept of the present invention, they should also be regarded as the contents disclosed by the present invention.

Claims

1. A Chinese medicine composition for lowering uric acid and relieving gout, characterized in that: It is composed of a base material extract and an Ampelopsis grossedentata leaf-lotus leaf extract, wherein the mass ratio of the base material extract to the Ampelopsis grossedentata leaf-lotus leaf extract is 5:(4-5); The base material extract is obtained by water extraction of the base mixed material, and the mass of the base material extract is 30-35% of the mass of the base mixed material; The basic mixture is composed of the following components by weight: 8-11 parts of cassia seeds, 5-7 parts of honeysuckle, 4-4.5 parts of burdock roots, 1.2-1.7 parts of codonopsis, 3-3.6 parts of kudzu root, 3-5 parts of peach kernel, 2-2.5 parts of angelica, 3-4 parts of tuckahoe, 1-1.3 parts of citron, 4-6 parts of mulberry, 2-3 parts of cistanche, 3-5 parts of hawthorn and 3-5 parts of apple; The extract of Ampelopsis grossularis leaf-lotus leaf is prepared by extracting a mixture of Ampelopsis grossularis leaf and lotus leaf with water to obtain a crude extract, which is then fermented with a composite enzyme. The mass ratio of Ampelopsis grossularis leaf to lotus leaf is 11:(7-9), the mass of the crude extract is 2.3-2.8 times the mass of the mixture of Ampelopsis grossularis leaf and lotus leaf, and the mass of the composite enzyme is 0.4-0.6% of the mass of the crude extract. The complex enzyme comprises pectate lyase, cellulase and papain, and the mass ratio of the three is 1: (0.5-0.7): (1.3-1.5); The preparation method of the Ampelopsis grossedentata leaf-lotus leaf extract is as follows: A1. Using a mixture of Ampelopsis grossedentata leaves and lotus leaves as the initial material, add 70-80°C water 3-5 times the mass of the initial material, soak for 1-2 hours, then add room temperature water 7-8 times the mass of the initial material, distill and reflux for 10-12 hours, and concentrate to obtain a crude extract; A2, adding complex enzyme to the crude extract obtained in A1, keeping warm for fermentation, heating up for inactivation, filtering, and obtaining a filtrate, which is the Ampelopsis grossedentata leaf-lotus leaf extract; In A2, donkey hide gelatin is also added, and the mass of the donkey hide gelatin is 5-8% of the mass of the crude extract; The preparation method of the base material extract is as follows: B1. Mix cassia seed, honeysuckle, burdock root, codonopsis, kudzu root, peach kernel, angelica, tuckahoe, citron, mulberry, cistanche, hawthorn and apple to obtain a basic mixture; B2. Add 70-80℃ water (3-5 times the mass of the basic mixture) to the basic mixture obtained in B1, soak for 1-2 hours, then add room temperature water (7-8 times the mass of the basic mixture), distill and reflux for 8-10 hours, filter, and concentrate the filtrate to obtain the base material extract.

2. The Chinese medicinal composition for lowering uric acid and relieving gout according to claim 1, characterized in that: In A2, the specific operation of heat preservation fermentation is: at a temperature of 52-60°C, stirring at a stirring speed of 100-120 r / min for 65-72 hours.

3. The Chinese medicinal composition for lowering uric acid and relieving gout according to claim 1, characterized in that: In A2, the specific operation of temperature inactivation is: heating to 95-100°C and keeping warm for 30-40 minutes.

4. The Chinese medicinal composition for lowering uric acid and relieving gout according to claim 1, characterized in that: It also includes an antioxidant stabilizer, the mass of which is 1.2-1.5% of the total mass of the base material extract and the Ampelopsis grossedentata leaf-lotus leaf extract.

5. The Chinese medicinal composition for lowering uric acid and relieving gout according to claim 4, characterized in that: The antioxidant stabilizer includes vitamin C and / or vitamin E.

6. The method for preparing the uric acid-lowering and gout-relieving Chinese medicinal composition according to any one of claims 1 to 5, characterized in that: The base material extract and the Ampelopsis grossedentata leaf-lotus leaf extract are mixed evenly to obtain the uric acid-lowering and gout-relieving Chinese medicinal composition.

Images