Biological preparation containing saffron crocus extract for treating gout and preparation method of biological preparation

Abstract

The invention discloses a biological preparation containing saffron crocus extract and used for treating gout and a preparation method of the biological preparation, and belongs to the technical field of medicines. The raw materials adopted by the invention are saffron crocus, radix clematidis, pseudobulbus cremastrae seu pleiones, lumbricus, turmeric, rhodiola rosea, gastrodia elata, calculus bovis, sandalwood, pearl powder, propylene glycol, glycerol, pentanediol and carbomer. The raw materials of the traditional Chinese medicinal materials are compatible with one another to achieve the effects of promoting blood circulation to remove blood stasis, clearing heat, resisting inflammation, reducing acid, relieving pain and ablating and crystallizing, and can effectively degrade urate deposition in an articular cavity, remove inflammatory substances in the articular cavity, repair the environment in the cavity and enable uric acid to lose crystallization conditions. And the auxiliary material part has the functions of promoting penetration, preserving moisture and preventing corrosion. Through cooperation and synergistic interaction of the medicines, the purpose of treating both symptoms and root causes is finally achieved. The traditional Chinese medicine can enable gout patients to return to normal work and life, and has high treatment significance and social value.

Description

Technical Field

[0001] The present invention relates to the technical field of external medicines, and in particular to a biological preparation containing saffron extract for treating gout and a preparation method thereof. Background Art

[0002] Gout is a highly prevalent disease, with an annual incidence of 4.9% and a cumulative incidence of 22% over five years. In Traditional Chinese Medicine, gout is classified as "bi syndrome," primarily due to insufficient vital energy, the invasion of wind, cold, and dampness, which leads to poor circulation of qi and blood, and obstruction of the meridians, causing joint pain and swelling. Western medicine calls this a metabolic rheumatic disease caused by hyperuricemia, also known as gouty arthritis. Excessive uric acid levels are a direct cause, and over 80% of gout cases occur in the first metatarsophalangeal joint of the big toe. The toes are terminal areas of the blood supply, and circulation is weakened, with the temperature at the end of the toes being lower than the core body temperature. Therefore, when high-uric acid blood reaches the end of the toes, blood flow slows and the temperature drops. Uric acid is particularly prone to crystallization, depositing in the joint cavity, especially at night, causing severe redness, swelling, and pain. This is because the sharp crystals of urate can pierce or even sever nerves, leading to inflammation and swelling in the joints. Gout attacks are extremely painful. If the disease is not cured for a long time, it will not only cause joint deformities, functional disorders, and limited movement, but further development will also lead to gouty nephropathy, gradually causing renal failure and terminal events.

[0003] Under the existing technology, gout is treated with two methods: traditional Chinese medicine, which aims to reduce swelling and relieve pain by promoting the flow of qi and blood, and dispelling wind and dampness. Commonly used prescriptions include Si Miao San, Si Wu Tang, Er Chen Tang, etc. Another method is Western medicine, which aims to reduce swelling and relieve pain by anti-inflammatory and analgesic methods, inhibiting uric acid synthesis, and promoting uric acid excretion. Commonly used drugs include colchicine and febuxostat. The therapeutic window of colchicine is very narrow, and its therapeutic dose is very close to the toxic dose. In mild cases, the poisoning reaction may include diarrhea, nausea, vomiting, etc., while in severe cases, bone marrow suppression, aplastic anemia, peripheral neuropathy, etc. may occur. Febuxostat also has very serious hepatotoxicity and nephrotoxicity. Whether it is traditional Chinese medicine or Western medicine, under the current existing technical conditions, it is still still possible to alleviate symptoms and control pain, but it is impossible to achieve clinical cure.

[0004] Traditional Chinese Medicine (TCM) is indeed a natural and safe treatment for gout, but it's also true that the evidence base for gout treatment is insufficient. Western medicine is highly evidence-based, but its toxic side effects are unbearable for patients. Furthermore, neither TCM nor Western medicine currently cures gout, only alleviating symptoms.

[0005] Therefore, it is an urgent problem for those skilled in the art to combine traditional Chinese and Western medicine to provide a biological preparation containing saffron extract for the treatment of gout that is both safe and can completely cure gout. Summary of the Invention

[0006] In view of this, the present invention provides a biological preparation containing saffron extract for treating gout, which can achieve complete cure for patients with a disease course of less than 5 years, partial cure or no progression for patients with a disease course of more than 5 years, and can be discontinued when the expected results are achieved without the need for long-term use.

[0007] In order to achieve the above object, the present invention adopts the following technical solutions:

[0008] A biological preparation containing saffron extract for treating gout comprises the following raw materials in parts by weight: 1-5 parts of saffron, 15-25 parts of clematis root, 1-5 parts of trillium, 10-15 parts of earthworm, 3-10 parts of turmeric, 3-9 parts of rhodiola rosea, 10-15 parts of gastrodia elata, 1-5 parts of bezoar, 5-10 parts of sandalwood, 5-10 parts of pearl powder, 1-5 parts of propylene glycol, 5-10 parts of glycerin, 1-5 parts of pentylene glycol, and 0.8-2 parts of carbomer.

[0009] Preferably, the biological preparation containing saffron extract for treating gout includes the following raw materials in parts by weight: 3 parts of saffron, 20 parts of clematis, 2 parts of trillium, 12 parts of earthworm, 5 parts of turmeric, 6 parts of rhodiola, 12 parts of gastrodia, 3 parts of bezoar, 6 parts of sandalwood, 5 parts of pearl powder, 2 parts of propylene glycol, 5 parts of glycerin, 3 parts of pentylene glycol, and 1.2 parts of carbomer.

[0010] To better understand the present invention, the following is a detailed explanation of the functions of each raw material in the present invention, including traditional Chinese medicine explanations and modern pharmacological research.

[0011] Saffron (scientific name: Crocus sativus, also known as crocus sativus) is the dried stigma of the Iridaceae plant. It is sweet and slightly cold in nature, and enters the heart and liver meridians. It has the effects of promoting blood circulation and removing blood stasis, cooling blood and detoxifying, relieving depression and calming the mind. Traditional Chinese medicine often uses it to treat heart, brain, liver, joints, and skin problems. For example, saffron oil, a classic preparation, is often used to treat joint swelling and pain. Modern pharmacological research shows that saffron's core components: crocin and crocetin, can effectively inhibit platelet aggregation, reduce blood viscosity, dilate cardiovascular and cerebrovascular systems, and improve microcirculation. Ketones, polysaccharides, and alkaloids in saffron have significant anti-inflammatory and anti-acid properties. Modeling the environment in which urate crystallizes revealed that saffron has a very strong anti-crystallization ability. Crocin and safranal in saffron have a broad antimicrobial spectrum, demonstrating significant antimicrobial activity against Gram-positive and Gram-negative bacteria, Candida albicans, and dermatophytes. Their mechanism of action is to disrupt the structure and permeability of bacterial cell membranes, leading to leakage of their contents. This inhibits the activity of key bacterial enzymes and interferes with protein synthesis and DNA replication. As a precious medicinal herb, its medicinal value is highly recognized in both traditional medicine and modern research.

[0012] Clematis chinensis is a perennial vine of the genus Clematis in the Ranunculaceae family. Its roots and rhizomes are used medicinally. Its main functions in Traditional Chinese Medicine are to dispel wind and dampness, dredge the meridians and relieve pain, promote qi and blood circulation, and disperse blood stasis and reduce swelling. It is often used in Traditional Chinese Medicine to treat rheumatic pain, joint cramps, and numbness of the limbs, with remarkable effectiveness. Modern pharmacology shows that Clematis chinensis contains triterpenoid saponins, annelidone, and flavonoids, which can significantly inhibit the release of inflammatory factors (such as COX-2 and TNF-α) and pain mediators. It has excellent anti-inflammatory and analgesic properties. It is commonly used to treat osteoarthritis and gouty arthritis, and also has inhibitory effects against Staphylococcus aureus and Shigella dysenteriae.

[0013] Cremanthodium appendiculatum, the dried pseudobulb of the orchid plant Cremanthodium appendiculatum, is primarily used in Traditional Chinese Medicine to clear heat and detoxify, reduce swelling, and resolve stagnation. It is commonly used in traditional Chinese medicine to treat carbuncles, boils, and scrofula caused by stagnant heat and toxicity. Modern pharmacological research has shown that Cremanthodium appendiculatum, containing colchicine and other alkaloids, is effective in treating acute attacks of gout and has inhibitory effects on Staphylococcus aureus and Mycobacterium tuberculosis. Its polysaccharides can enhance macrophage activity and boost immunity.

[0014] Earthworms (Pheretima aspergillum), the dried body of a member of the family Lumbricidae, are also known as earthworms and are an important animal-based medicinal ingredient in traditional Chinese medicine. Their primary functions in TCM are clearing heat and calming convulsions, promoting blood circulation and activating collaterals, calming wind and stopping spasms, and relaxing muscles and relieving pain. Modern pharmacological research has shown that the lumbrokinase in earthworms can effectively degrade fibrin in blood clots, inhibit platelet aggregation, and improve blood circulation. Earthworm extracts can also inhibit inflammatory factors (such as IL-6 and TNF-α), alleviating inflammatory reactions in arthritis, asthma, and other conditions. They are commonly used in the treatment of rheumatoid arthritis and gouty arthritis.

[0015] Turmeric (Curcuma longa) is the dried rhizome of the ginger family. In Traditional Chinese Medicine, it promotes blood circulation and qi, relieves pain through menstruation, and dispels wind and dampness. It is commonly used in traditional Chinese medicine to treat rheumatic pain and joint swelling. Modern pharmacology shows that curcumin can inhibit the NF-κB pathway, reducing the release of inflammatory factors such as IL-6 and TNF-α. It is commonly used to treat rheumatoid arthritis, osteoarthritis, and ulcerative colitis.

[0016] Rhodiola rosea (Rhodiola rosea) is a plant of the Crassulaceae family, primarily grown in high-altitude, cold, and hypoxic regions (such as the Qinghai-Tibet Plateau). In Traditional Chinese Medicine, it boasts benefits such as invigorating Qi and promoting blood circulation, combating fatigue, combating hypoxia, and modulating the immune system. Modern pharmacological research has shown that its core ingredients, including salidroside and tyrosol, activate the HIF-1α (hypoxia-inducible factor) pathway, promoting erythropoiesis and improving oxygen utilization. They also regulate serotonin (5-HT) and dopamine (DA) levels, enhance NK cell activity, and balance the Th1 / Th2 immune response, demonstrating significant benefits for immunosuppression and autoimmune diseases.

[0017] Gastrodia elata (Gastrodia elata) is a dried tuber of the orchid family, known in Traditional Chinese Medicine as "Dingfengcao." It boasts properties such as calming the liver and extinguishing wind, dispelling wind and unblocking the meridians, and relieving spasms. It is commonly used in Traditional Chinese Medicine to treat post-stroke symptoms and rheumatic pain. Modern pharmacological research has shown that gastrodin, a polysaccharide from Gastrodia elata, can inhibit glutamate excitotoxicity and reduce neuronal damage. It also regulates the GABA system, reduces abnormal neuronal discharge, inhibits the NF-κB pathway, and alleviates inflammatory responses in conditions such as rheumatoid arthritis and enteritis. Furthermore, Gastrodia elata polysaccharides can enhance the phagocytic capacity of macrophages, protecting cells from oxidative damage and delaying aging.

[0018] Calculus bovis is a stone found in the gallbladder or bile duct of bovines. Traditional Chinese medicine includes natural, artificial, and in vitro-cultured bezoar. In TCM, it boasts benefits such as clearing heat and detoxifying, calming wind and relieving spasms, and resolving phlegm and invigorating the mind. Modern pharmacology shows that bezoar extracts primarily contain bilirubin, bile acids (such as cholic acid and deoxycholic acid), taurine, cholesterol, and trace elements. Deoxycholic acid and taurine can inhibit inflammatory factors (such as TNF-α and IL-6) and have potent inhibitory effects against Staphylococcus aureus and influenza virus. By regulating γ-aminobutyric acid receptors, it reduces neuronal excitation, thereby achieving neuroprotection and repair. It also enhances macrophage phagocytosis and balances the Th1 / Th2 immune response.

[0019] Sandalwood (Santalum album), also known as white sandalwood, is the dried heartwood of the Santalaceae family. In Traditional Chinese Medicine, it promotes qi circulation and relieves pain, dispels cold and regulates the middle, and calms the mind and stimulates the mind. Modern pharmacological research shows that sandalwood's core components, including volatile oils such as α-santalol and β-santalol, have significant inhibitory effects on Staphylococcus aureus and Candida albicans. By regulating GABA (gamma-aminobutyric acid) receptors, it reduces cortisol levels, alleviates anxiety, and improves sleep quality, achieving both sedative and anti-anxiety effects.

[0020] Pearl powder is made from ground pearls (mineral crystals formed from shellfish secretions). In Traditional Chinese Medicine, it has been shown to calm the nerves, improve eyesight, and promote tissue regeneration. It's commonly used in traditional Chinese medicine to treat insomnia, dreaminess, red and swollen eyes, skin ulcers, moisturize the skin, and reduce dark spots. Modern pharmacological research shows that the core ingredients of pearl powder—calcium carbonate and pearl protein—can effectively promote tissue repair, accelerate epidermal cell proliferation, enhance macrophage activity, and inhibit inflammatory factors (such as IL-6 and TNF-α). It's commonly used to treat chronic inflammatory diseases and improve skin texture.

[0021] Propylene glycol is a common organic compound with properties such as penetration enhancement, moisturizing, and preservative properties. It is widely used in the pharmaceutical, cosmetic, food, and industrial sectors. It is highly safe and, in the pharmaceutical field, facilitates drug absorption through the skin or mucous membranes (e.g., topical gels and patches).

[0022] Glycerin, also known as propanetriol, is a colorless, odorless, sweet, viscous, non-toxic organic compound. Its antibacterial and antiviral properties make it widely used in wound and burn treatments. It is also a humectant in pharmaceutical formulations.

[0023] Pentylene glycol is a natural preservative extracted from corn cobs. It can enter the cell membrane of microorganisms, destroy the integrity of the cell membrane, allow the cell fluid to seep out, and ultimately lead to the death of the microorganisms.

[0024] Carbomer is a high molecular weight polymer widely used in medicine, cosmetics, and daily chemical products. It is an indispensable thickener and stabilizer in gel products.

[0025] The present invention also provides a method for preparing the above-mentioned biological preparation containing saffron extract for treating gout, comprising the following steps:

[0026] (1) Weigh the raw materials according to the above weight parts and set aside;

[0027] (2) Slice the clematis root, trillium, earthworm, turmeric, rhodiola rosea, gastrodia elata, and sandalwood and set aside;

[0028] (3) Crush the bezoar and pearls into powder, sieve and set aside;

[0029] (4) Mix saffron with Clematis chinensis, Trillium gracile, earthworm, turmeric, rhodiola rosea, Gastrodia elata, and sandalwood, soak in water, then decoct, filter, and collect the filtrate;

[0030] (5) Add water to the filter residue after filtering in step (4) and boil it again, filter it, and collect the secondary filtrate;

[0031] (6) Combine the primary filtrate and the secondary filtrate, add bezoar powder and pearl powder, and stir evenly to form a Chinese medicine liquid preparation;

[0032] (7) Adding carbomer to liquid preparations of traditional Chinese medicine to form gel bodies;

[0033] (8) Propylene glycol, glycerol, and pentanediol are sequentially added to the gelatin body and encapsulated to obtain a biological preparation containing saffron extract for treating gout.

[0034] Furthermore, the solid-liquid ratio of the Chinese medicinal raw materials to water in step (1) and step (2) is 1:10-15, and the solid-liquid ratio of the filter residue to water in step (5) is 1:6-10.

[0035] The thickness of the slices in step (2) is 1-2 mm.

[0036] Furthermore, the bezoar and pearls in step (3) are ground into a particle size of 200-400 mesh.

[0037] Furthermore, the soaking time of the Chinese medicinal raw materials in step (4) is 30 minutes, the decoction time is 1-3 hours, and the decoction time of the Chinese medicinal raw materials in step (5) is 1-2 hours.

[0038] Furthermore, in step (7), the temperature of the Chinese medicine liquid preparation is adjusted to 22-36° C. before adding carbomer. After adding carbomer, stirring is prohibited, and the liquid preparation is allowed to swell for 24 hours, and then stirred at a constant speed of 100-500 rpm for 5 minutes.

[0039] Furthermore, in step (8), the propylene glycol, glycerol and pentanediol are added while stirring, and the stirring speed is <500 rpm.

[0040] The beneficial effects of the present invention are:

[0041] The present invention provides a biological preparation for treating gout containing saffron extract, with saffron and clematis as monarch medicine, and exert its effect of promoting blood circulation and removing blood stasis, dispelling wind and dampness, reducing swelling and relieving pain. Psoralea corylifolia, earthworm, turmeric, rhodiola rosea are ministerial medicines, and exert its effect of promoting blood circulation and promoting qi, relieving menstruation and relieving pain, resisting fatigue, resisting hypoxia, regulating immunity, etc., Gastrodia elata, bezoar, sandalwood are adjuvants, and exert its effect of clearing away heat and detoxifying, stopping wind and relieving spasm, repairing nerves and joint cavity, pearl powder is a making medicine, and exerts its effect of detoxification and promoting granulation, accelerates epidermal cell proliferation, and promotes tissue repair. The above-mentioned various medicines work together, synergize and enhance efficiency, and ultimately achieve the purpose of treating both the symptoms and the root cause at the same time. In the present invention, saffron cannot be extracted at low temperature alone, although the current common practice is low-temperature water extraction or ethanol extraction, in order that the heat-sensitive components such as crocin are not degraded by high temperature. However, in the present invention, saffron must be mixed with other ingredients, and then water must be added and heated to above 90°C for decoction and extraction to ensure efficacy. In the present invention, saffron is used as the main medicine in the combination, and its role is comprehensive. The active ingredient is also an extract product mixed with other compatible raw materials, rather than a certain extract known in saffron.

[0042] The biological preparation containing saffron extract for treating gout of the present invention is mainly composed of traditional Chinese medicine raw materials, and is supplemented with propylene glycol as a penetration enhancer to promote the above-mentioned effective ingredients of traditional Chinese medicine to penetrate the skin into the joint cavity to exert their effects. Glycerin is used as a moisturizer to make the above-mentioned effective ingredients of traditional Chinese medicine more lasting. Pentylene glycol is a natural preservative extracted from corn cobs, which ensures that the biological preparation of the present invention can be stored for a long time.

[0043] The biological preparation for treating gout containing saffron extract provided by the present invention can be applied directly to the affected area, achieving immediate results. This product offers advantages over oral medications in that it maximizes the concentration of the drug's efficacy on the affected area while bypassing internal organ metabolism and producing no toxic side effects. Gout often occurs in joints, particularly the first metatarsophalangeal joint of the big toe, where there is less tissue and a thin cortex, making it ideal for topical preparations to penetrate. DETAILED DESCRIPTION

[0044] The following is a clear and complete description of the technical solutions in the embodiments of the present invention. Obviously, the embodiments described are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making any creative efforts are within the scope of protection of the present invention.

[0045] Example 1

[0046] A biological preparation containing saffron extract for treating gout

[0047] (1) Weigh 1 part of saffron, 15 parts of clematis root, 1 part of trillium root, 10 parts of earthworm, 3 parts of turmeric, 3 parts of rhodiola rosea, 10 parts of gastrodia elata, 1 part of bezoar, 5 parts of sandalwood, and 5 parts of pearl powder. 1 part of propylene glycol, 5 parts of glycerin, 1 part of pentylene glycol, and 0.8 part of carbomer.

[0048] (2) Slice the clematis root, trillium, earthworm, turmeric, rhodiola rosea, gastrodia elata and sandalwood and set aside.

[0049] (3) Crush the bezoar and pearl into powder, pass through a 300-mesh sieve, and set aside;

[0050] (4) Saffron was mixed with Clematis chinensis, Trillium gracile, earthworm, turmeric, Rhodiola rosea, Gastrodia elata, and sandalwood, and soaked in water for 30 minutes. The mixture was then decocted for 1.5 hours, filtered, and the filtrate was collected. The solid-liquid ratio of the Chinese medicinal materials to water was 1:12.

[0051] (5) Add water to the filter residue after filtering in step (4) and boil it again for 1 hour, filter it, and collect the secondary filtrate; the solid-liquid ratio of the above filter residue to water is 1:6;

[0052] (6) Combine the primary filtrate and the secondary filtrate, add bezoar powder and pearl powder, and stir evenly to form a Chinese medicine liquid preparation;

[0053] (7) Add carbomer to the liquid preparation of traditional Chinese medicine to form a gel body; the temperature of the liquid before adding carbomer is 22-36 ° C. After adding carbomer, do not stir and let it stand for 24 hours to swell. After 24 hours, stir it at a constant speed of 300 rpm for 5 minutes.

[0054] (8) Propylene glycol, glycerol, and pentanediol are sequentially added to the gelatin body during stirring, and the gelatin body is encapsulated to obtain a biological preparation containing saffron extract for treating gout.

[0055] Example 2

[0056] A biological preparation containing saffron extract for treating gout

[0057] (1) Weigh 5 parts of saffron, 25 parts of clematis root, 5 parts of trillium, 15 parts of earthworm, 10 parts of turmeric, 9 parts of rhodiola rosea, 15 parts of gastrodia elata, 5 parts of bezoar, 10 parts of sandalwood, and 10 parts of pearl powder. Add 5 parts of propylene glycol, 10 parts of glycerin, 5 parts of pentylene glycol, and 1.2 parts of carbomer.

[0058] (2) Slice the clematis root, trillium, earthworm, turmeric, rhodiola rosea, gastrodia elata and sandalwood and set aside.

[0059] (3) Crush the bezoar and pearl into powder, pass through a 300-mesh sieve, and set aside;

[0060] (4) Saffron was mixed with Clematis chinensis, Trillium gracile, earthworm, turmeric, Rhodiola rosea, Gastrodia elata, and sandalwood, and soaked in water for 30 minutes. The mixture was then decocted for 1.5 hours, filtered, and the filtrate was collected. The solid-liquid ratio of the Chinese medicinal materials to water was 1:12.

[0061] (5) Add water to the filter residue after filtering in step (4) and boil it again for 1 hour, filter it, and collect the secondary filtrate; the solid-liquid ratio of the above filter residue to water is 1:6;

[0062] (6) Combine the primary filtrate and the secondary filtrate, add bezoar powder and pearl powder, and stir evenly to form a Chinese medicine liquid preparation;

[0063] (7) Add carbomer to the liquid preparation of traditional Chinese medicine to form a gel body; the temperature of the liquid should be 22-36°C before adding carbomer. After adding carbomer, do not stir it and let it stand for 24 hours to swell. After 24 hours, stir it at a constant speed of 100 rpm for 5 minutes.

[0064] (8) Propylene glycol, glycerol, and pentanediol are sequentially added to the gelatin body during stirring, and the gelatin body is encapsulated to obtain a biological preparation containing saffron extract for treating gout.

[0065] Example 3

[0066] A biological preparation containing saffron extract for treating gout

[0067] (1) Weigh 3 parts of saffron, 20 parts of clematis root, 2 parts of trillium, 12 parts of earthworm, 5 parts of turmeric, 6 parts of rhodiola rosea, 12 parts of gastrodia elata, 3 parts of bezoar, 6 parts of sandalwood, 5 parts of pearl powder. 2 parts of propylene glycol, 5 parts of glycerin, 3 parts of pentylene glycol, and 1.2 parts of carbomer.

[0068] (2) Slice the clematis root, trillium, earthworm, turmeric, rhodiola rosea, gastrodia elata and sandalwood and set aside.

[0069] (3) Crush the bezoar and pearl into powder, pass through a 300-mesh sieve, and set aside;

[0070] (4) Saffron was mixed with Clematis chinensis, Trillium gracile, earthworm, turmeric, Rhodiola rosea, Gastrodia elata, and sandalwood, and soaked in water for 30 minutes. The mixture was then decocted for 1.5 hours, filtered, and the filtrate was collected. The solid-liquid ratio of the Chinese medicinal materials to water was 1:12.

[0071] (5) The filter residue after filtering in step (4) was boiled again with water for 1 hour, filtered, and the secondary filtrate was collected; the solid-liquid ratio of the filter residue to water was 1:6;

[0072] (6) Combine the primary filtrate and the secondary filtrate, add bezoar powder and pearl powder, and stir evenly to form a Chinese medicine liquid preparation;

[0073] (7) Add carbomer to the liquid preparation of traditional Chinese medicine to form a gel body; the temperature of the liquid should be 22-36°C before adding carbomer. After adding carbomer, do not stir it and let it stand for 24 hours to swell. After 24 hours, stir it at a constant speed of 500 rpm for 5 minutes.

[0074] (8) Propylene glycol, glycerol, and pentanediol are sequentially added to the gelatin body during stirring, and the gelatin body is encapsulated to obtain a biological preparation containing saffron extract for treating gout.

[0075] Comparative Example 1

[0076] Compared with Example 3, saffron is not contained, and other aspects are the same as Example 3.

[0077] Comparative Example 2

[0078] Compared with Example 3, the invention does not contain Clematis chinensis, and other aspects are the same as those of Example 3.

[0079] Comparative Example 3

[0080] Compared with Example 3, saffron and clematis are not contained, and other contents are the same as those in Example 3.

[0081] Test Example 1

[0082] 1.1 Animal toxicity test

[0083] The biological preparation for treating gout containing saffron extract prepared in Example 1-3 was given to rats under continuous skin exposure for 200 days at a standard of 25 μg / g rat body weight. The daily activities, including body hair and feces of the rats after the drug administration were observed to be normal; the indicators of liver function and kidney function were basically the same as before administration, and the levels of serum total protein and albumin were not significantly different from those of the control group; the physical structure and volume coefficient of the organs such as the heart, liver, spleen, lungs, and kidneys were not significantly different from those of the control group; no abnormalities were found in the histopathological examination, and no obvious toxic and side effects were found within the dose range tested. The results show that the biological preparation for treating gout containing saffron extract of the present invention has extremely high safety.

[0084] 1.2 Efficacy Verification

[0085] The products prepared in Example 1-3 and Comparative Example 1-3 were subjected to efficacy tests. The specific method was to select 60 male and female patients with gouty arthritis aged 40-75 years, for a total of 120 people. They were randomly divided into 6 groups, 20 people in each group, 3 groups of Examples, and 3 groups of Comparative Examples. Instructions for use: Apply 3-5g to the affected area twice a day, knead appropriately, and observe and count the improvement of symptoms in each group of patients after two months. The specific results are shown in Table 1. Among them, the efficacy evaluation criteria are (with reference to the "Multidisciplinary Expert Consensus on Diagnosis and Treatment of Hyperuricemia-Related Diseases in China" issued by the National Health and Health Commission). Joint pain disappears, redness and swelling are eliminated, and laboratory tests are normal for marked effect; joint pain is relieved, redness and swelling are reduced, and laboratory tests are improved for effectiveness; failure to meet the above-mentioned effective standards is invalid.

[0086] Table 1

[0087] Group Significantly effective (example) Valid (example) Invalid (example) Total effective rate (%) Example 1 11 3 6 70% Example 2 12 3 5 75% Example 3 16 2 2 90% Comparative Example 1 6 2 12 40% Comparative Example 2 5 1 14 30% Comparative Example 3 2 2 16 20%

[0088] From the data comparison of Example 3 and Comparative Example 1, it can be concluded that the biological preparation containing saffron extract for treating gout of the present invention, Example 3 containing saffron is more effective than Comparative Example 1 without saffron, and the difference is statistically significant. The therapeutic effect is significant. From the comparison of Example 3 and Comparative Example 2, it can be concluded that after containing the main drug of Clematidis, the therapeutic effect of Example 3 is also substantially improved. From the comparison of Example 3 and Comparative Example 3, it can be concluded that after containing the two main drugs of saffron and Clematidis, the therapeutic effect of the present invention is more stable than that of Comparative Examples 1-3, and the difference is significant.

[0089] 1.3 Typical Cases

[0090] (1) Zheng Moujun, male, 56 years old, has a history of gout for 5 years. The pain occurs every 3 months or so. The pain is located in the first metatarsophalangeal joint of the right foot. Each attack lasts for about a week, during which time walking is difficult. The blood uric acid level is 600-650umol / L. When the pain recurred in May 2023, he applied the biological preparation containing saffron extract prepared by the present invention for treating gout externally. After 2 days, the joint swelling and pain disappeared, and he resumed normal work and life. The application was continued for 20 days and then discontinued. He has been followed up for two years and no recurrence has been observed.

[0091] (2) Xue, male, 42 years old, suffered from gouty arthritis for 6 years, with the attack site being the right ankle joint. Before treatment, the pain and swelling recurred, but there was an interval. Until the use of the product of the present invention, the redness, swelling and pain in the ankle joint had no interval, and the redness, swelling and pain continued, making it difficult to walk. The blood uric acid level has been hovering between 680-710 μmol / L. After 6 days of using the biological preparation containing saffron extract prepared by the present invention to treat gout, the redness and swelling improved, and after 10 days, the redness, swelling and pain disappeared completely. After 30 days of use, it was discontinued, and there has been no recurrence for one year.

[0092] (3) Liu Mouyun, female, 61 years old, was diagnosed with gouty arthritis in 2016. The gout site was the first metatarsophalangeal joint of the left toe. When she was re-examined in 2023, the joint had deformed, urate crystals protruded, and the pain persisted. The pain was more severe at night than during the day. After 15 days of using the biological preparation containing saffron extract to treat gout of the present invention, the pain disappeared. After 45 days, the protrusion of the joint caused by urate crystals began to degrade and shrink. After 60 days, the joint returned to smoothness. She has been followed up for more than 2 years since she stopped using the biological preparation, and no recurrence has been observed.

[0093] Comparative Example 4

[0094] The raw materials were weighed according to the amounts in Example 3, and saffron was extracted separately with 12 times the amount of water at 50°C for 15 minutes. The obtained extract was mixed with 90°C extracts of other raw materials such as Clematis chinensis at room temperature, and then bezoar powder and pearl powder were added to obtain a liquid Chinese medicine preparation. Carbomer was then added after standing for 24 hours. Glycerin, propylene glycol, and pentylene glycol were then added in sequence with low-speed stirring. After the gel was obtained, the efficacy of the gel was observed in 9 patients with gout. One patient showed significant efficacy, one patient was effective, and seven patients were ineffective, with an overall efficacy of 22%.

[0095] Comparative Example 5

[0096] According to the consumption of embodiment 3, raw material is weighed, by other decocted medicinal materials such as Clematidis, with 12 times of water, 90 DEG C of water temperature decocts 1.5h, after collecting filtrate, medicinal residues are twice decocted, with 6 times of water, decoction time 1h, merge secondary filtrate, filtrate temperature is controlled at 50-60 DEG C interval, add Stigma Croci, after low temperature soaking extraction 15min, collect filtrate, then add bezoar powder and pearl powder, obtain Chinese medicine liquid preparation, then add carbomer, after standing 24h, glycerol, propylene glycol and pentanediol are added sequentially in low speed stirring. After obtaining gel, observe the use effect of 15 gout patients, significantly effective 1 case, effective 2 cases, invalid 12 cases, total effective rate 20%.

[0097] Summary: There are significant differences in efficacy between the products prepared by the above two low-temperature extraction methods and the product prepared by the extraction method in Example 3. Saffron extracted by low temperature cannot achieve the expected effect of the present invention.

[0098] Although the embodiments of the present invention have been shown and described above, it will be understood that the above embodiments are illustrative and are not to be construed as limitations on the present invention. A person skilled in the art may change, modify, replace and modify the above embodiments within the scope of the present invention.

Claims

1. A biological preparation containing saffron extract for treating gout, characterized in that: The invention comprises the following raw materials in parts by weight: 1-5 parts of saffron, 15-25 parts of clematis root, 1-5 parts of trillium, 10-15 parts of earthworm, 3-10 parts of turmeric, 3-9 parts of rhodiola rosea, 10-15 parts of gastrodia elata, 1-5 parts of bezoar, 5-10 parts of sandalwood, 5-10 parts of pearl powder, 1-5 parts of propylene glycol, 5-10 parts of glycerin, 1-5 parts of pentylene glycol and 0.8-2 parts of carbomer.

2. A biological preparation for treating gout containing saffron extract according to claim 1, characterized in that: The invention comprises the following raw materials in parts by weight: 3 parts of saffron, 20 parts of clematis root, 2 parts of trillium, 12 parts of earthworm, 5 parts of turmeric, 6 parts of rhodiola rosea, 12 parts of gastrodia elata, 3 parts of bezoar, 6 parts of sandalwood, 5 parts of pearl powder, 2 parts of propylene glycol, 5 parts of glycerin, 3 parts of pentylene glycol and 1.2 parts of carbomer.

3. A method for preparing a biological preparation containing saffron extract for treating gout, characterized in that: The following steps are involved: (1) Weigh the raw materials according to the weight ratios specified in claim 1 or 2 and set aside; (2) Slice the clematis root, trillium, earthworm, turmeric, rhodiola rosea, gastrodia elata, and sandalwood and set aside; (3) Crush the bezoar and pearls into powder, sieve and set aside; (4) Mix saffron with Clematis chinensis, Trillium gracile, earthworm, turmeric, rhodiola rosea, Gastrodia elata, and sandalwood, soak in water, then decoct, filter, and collect the filtrate; (5) Add water to the filter residue after filtering in step (4) and boil it again, filter it, and collect the secondary filtrate; (6) Combine the primary filtrate and the secondary filtrate, add bezoar powder and pearl powder, and stir evenly to form a Chinese medicine liquid preparation; (7) Adding carbomer to liquid preparations of traditional Chinese medicine to form gel bodies; (8) Propylene glycol, glycerol, and pentanediol are sequentially added to the gelatin body and encapsulated to obtain a biological preparation containing saffron extract for treating gout.

4. The method for preparing a biological preparation containing saffron extract for treating gout according to claim 3, characterized in that: The solid-liquid ratio of the Chinese medicinal raw materials to water in steps (1) and (4) is 1:10-15, and the solid-liquid ratio of the filter residue to water in step (5) is 1:6-10.

5. The method for preparing a biological preparation containing saffron extract for treating gout according to claim 3, characterized in that: The slice thickness in step (2) is 1-2 mm.

6. The method for preparing a biological preparation containing saffron extract for treating gout according to claim 3, characterized in that: The bezoar and pearls in step (3) are ground into a particle size of 200-400 mesh.

7. The method for preparing a biological preparation containing saffron extract for treating gout according to claim 4, characterized in that: The soaking time of the Chinese medicinal raw materials in step (4) is 30 minutes, and the decoction time is 1-3 hours. The decoction time of the Chinese medicinal raw materials in step (5) is 1-2 hours.

8. The method for preparing a biological preparation containing saffron extract for treating gout according to claim 3, characterized in that: In step (7), the temperature of the Chinese medicine liquid preparation is adjusted to 22-36° C. before adding carbomer. After adding carbomer, stirring is prohibited, and the preparation is allowed to swell for 24 hours, and then stirred at a constant speed of 100-500 rpm for 5 minutes.

9. The method for preparing a biological preparation containing saffron extract for treating gout according to claim 3, characterized in that: When adding propylene glycol, glycerol and pentanediol in step (8), the mixture is added while stirring, and the stirring speed is <500 rpm.