Knee arthralgia prescription for treating or preventing knee osteoarthritis and preparation method of knee arthralgia prescription

Abstract

The invention discloses a knee arthralgia prescription for preventing or treating knee osteoarthritis as well as a preparation method and application of the knee arthralgia prescription. The traditional Chinese medicine composition is prepared from caulis spatholobi, radix clematidis, radix angelicae pubescentis, radix glycyrrhizae preparata, radix cyathulae, radix dipsaci, radix gentianae macrophyllae, rhizoma atractylodis stir-fried with bran, radix angelicae sinensis, herba taxilli, rhizoma atractylodis macrocephalae, rhizoma corydalis, scorpio, radix aconiti and radix aconiti agrestis, the formula is reasonable, the medicines are compatible, and the traditional Chinese medicine composition has the effects of warming and dredging meridians, nourishing liver and kidney and promoting blood circulation to arrest pain. Animal experiments and clinical research prove that the knee arthralgia prescription has a remarkable curative effect in the aspect of treatment of knee osteoarthritis and is high in safety.

Description

Technical Field

[0001] The invention relates to use of a Xibi prescription in preparing medicines for preventing and treating knee osteoarthritis, and belongs to the field of traditional Chinese medicines. Background Art

[0002] Knee osteoarthritis (KOA), also known as knee osteoarthritis, is a disease caused by cartilage lesions and bone hyperplasia in the knee joint. Its main clinical manifestations are joint stiffness, difficulty in movement and unbearable pain. In the early stage of the disease, the symptoms of knee osteoarthritis are relatively hidden, so patients tend to ignore it. Once the disease occurs, the pain is unbearable.

[0003] In the long-term exploration and treatment of knee osteoarthritis, traditional Chinese medicine has divided knee osteoarthritis into four types: liver and kidney deficiency type, rheumatism and heat type, wind-cold-dampness type, and blood stasis type. Liver and kidney deficiency type is the most common type in knee osteoarthritis, and its medication principle is mainly to warm and tonify the liver and kidney, and to promote blood circulation and activate collaterals. Wind-cold-dampness type knee osteoarthritis belongs to the syndrome of paralysis and arthralgia, and the treatment should follow the medication principle of strengthening the body and expelling evil, and removing wind and dampness. Rheumatism and heat type knee osteoarthritis belongs to the syndrome of deficiency of the body and excess of evil. It is caused by the invasion and blockage of meridians and joints by wind, cold, dampness and heat evil due to insufficient body's positive energy. The treatment should be based on the method of clearing heat, detoxifying, warming yang, and supporting qi. Blood stasis type knee osteoarthritis, also known as blood stasis type, is characterized by spleen deficiency and dampness, blood stasis blocking collaterals, and qi and blood deficiency. The treatment should be based on the method of strengthening the body and expelling evil, and strengthening the spleen and removing dampness.

[0004] In clinical treatment, complex syndromes are often seen. Combined with the age characteristics of the elderly, as the disease progresses, the syndrome characteristics are also prone to change. The most common type of knee osteoarthritis is kidney deficiency and blood stasis. Adhering to the pathogenesis, tonifying the kidney and activating blood circulation is the treatment principle of this disease. Professor Feng Xinsong (Li Zhao. Professor Feng Xinsong's experience in treating osteoarthritis with kidney deficiency and blood stasis [J]. New Chinese Medicine, 2011, 43 (11): 152-153) believes that kidney deficiency is the root of this disease, and blood stasis is the key. He proposed the method of tonifying the kidney and activating blood circulation to treat kidney deficiency and blood stasis type KOA.

[0005] At present, there is no clear and effective treatment for knee osteoarthritis. Western medicine often uses non-steroidal anti-inflammatory drugs, sodium hyaluronate, COX-2 inhibitors or glucosamine for treatment. Although they can improve symptoms in the short term, they have great side effects and are prone to drug resistance, so they cannot be taken for a long time. Traditional Chinese medicine has a profound understanding of knee osteoarthritis. In the clinical treatment of knee osteoarthritis, it is necessary to reasonably choose Chinese medicine for internal use, external application, fumigation, acupuncture and massage according to the patient's pathogenesis and physical condition, which has a good effect on knee osteoarthritis. Summary of the invention

[0006] The invention discloses a knee arthritis prevention or treatment medicine, a preparation method and a use thereof. The knee arthritis treatment medicine has a significant effect on the treatment of knee arthritis, high safety and low recurrence rate, and a simple preparation method.

[0007] The invention provides a knee arthritis prescription for preventing or treating knee osteoarthritis. The knee arthritis prescription is prepared from Millettia reticulata, clematis root, angelica dahurica, roasted liquorice root, cyathula officinalis, dipsaccharum officinale, gentiana macrophylla, bran-fried atractylodes, angelica sinensis, parasitic plant, atractylodes macrocephala, corydalis yanhusuo, scorpion, aconite and kusnezoffii.

[0008] Specifically, the knee arthritis prescription comprises the following raw materials in parts by weight:

[0009] 10-20 parts of Millettia reticulata, 10-20 parts of Clematis, 8-15 parts of Angelica dahurica, 5-12 parts of Radix Glycyrrhizae Preparata, 8-15 parts of Cyathulae obtusifolia, 8-15 parts of Dipsacus asper, 8-15 parts of Gentiana macrophylla, 8-15 parts of stir-fried Atractylodes lancea, 8-15 parts of Angelica sinensis, 8-15 parts of Parasitic loranthus, 8-15 parts of Atractylodes macrocephala, 8-15 parts of Corydalis yanhusuo, 3-9 parts of Scorpio, 3-9 parts of Aconiti kusnezoffii, and 3-9 parts of Aconitum carmichaelii.

[0010] In one embodiment, the knee arthritis prescription comprises the following ingredients by weight:

[0011] 15 parts of Caulis Spatholobi, 15 parts of Radix Clematidis, 12 parts of Radix Angelicae Pubescentis, 9 parts of Radix Glycyrrhizae Preparata, 12 parts of Cyathulae Bidentatae, 12 parts of Dipsacus Asper, 12 parts of Gentiana Macrophyllae, 12 parts of Rhizoma Atractylodis Macrocephalae, 12 parts of Radix Angelicae Sinensis, 12 parts of Herba Taxillae Viridis, 12 parts of Atractylodes Macrocephalae, 12 parts of Rhizoma Corydalis, 6 parts of Scorpio, 6 parts of Radix Aconiti Kusnezoffii, 6 parts of Radix Aconiti Kusnezoffii.

[0012] The preparation method of the knee arthritis prescription for preventing or treating knee osteoarthritis of the present invention is as follows: weighing raw materials, adding 8-12 times the weight of purified water, soaking for 40min-70min, putting the soaked medicine and water into a decoction pot, boiling with high heat, simmering with low heat for 50-80min, filtering out medicinal solution A; after filtering out the medicinal solution, re-adding 6-10 times the weight of purified water, boiling with high heat, simmering with low heat for 40-60min, filtering out medicinal solution B; combining medicinal solution A and medicinal solution B, concentrating the filtrate to a relative density of 1.10-1.25, spray drying, and passing the dried fine powder through an 80-100 mesh sieve to obtain the knee arthritis prescription of the present invention.

[0013] Furthermore, the preparation method of the Chinese medicine composition for preventing or treating knee arthritis of the present invention is as follows: weigh the raw materials, add 10 times the weight of purified water, soak for 50 minutes, put the soaked medicine and water into a decoction pot, boil over high heat, simmer over low heat for 60 minutes, and filter out liquid A; after filtering out the liquid medicine, add 8 times the weight of purified water again, boil over high heat, simmer over low heat for 50 minutes, and filter out liquid medicine B; combine liquid medicine A and liquid medicine B, concentrate the filtrate to a relative density of 1.15, spray dry, and pass the dried fine powder through a 100-mesh sieve to obtain the knee arthritis of the present invention.

[0014] Furthermore, the preparation of the knee arthritis prescription is a decoction, pill, gel, tablet, mixture, capsule, granule, powder or paste.

[0015] Furthermore, the preparation of the knee arthralgia prescription is a knee arthralgia capsule.

[0016] The present invention provides use of the knee arthritis prescription in preparing a medicine for preventing or treating knee osteoarthritis.

[0017] Furthermore, the knee osteoarthritis is liver and kidney deficiency type knee osteoarthritis.

[0018] Furthermore, the knee osteoarthritis is kidney deficiency and blood stasis type knee osteoarthritis.

[0019] The TCM diagnosis of knee osteoarthritis is liver and kidney deficiency, cold stagnation in tendons and vessels, and blood stasis. Symptoms include swollen and painful knee joints, cold body and limbs, local tenderness, poor joint movement, pale tongue, thin white fur, and a stringy and fine pulse.

[0020] Bone arthritis is caused by excessive desire, which injures the kidneys. Kidney damage is closely related to the onset of bone arthritis. The kidney governs bones and stores essence. If the kidney is deficient, the bones will be without a master and the essence will not be stored. The knee joint cannot be nourished by the kidney essence, and the flexion and extension will be difficult and the function will be impaired. The liver governs tendons and stores blood. If the liver is deficient, the tendons will contract and the blood will not be stored, resulting in the knee joint losing the nourishment of liver blood and joint strain and functional degradation. As the human body ages, the liver and kidney are prone to deficiency, unable to warm the tendons and bones and flex the joints, resulting in fatigue of the tendons, weak bones and fragile joints, and arthritis will occur. If bone arthritis cannot be relieved, it will aggravate the movement disorder, deformation and pain of the knee joint, and eventually cause knee osteoarthritis.

[0021] Qi is the commander of blood and blood is the mother of Qi. The harmony of Qi and blood can effectively ensure the good functioning of the body and is the basis for strong tendons, strong bones and smooth joints.

[0022] Millettia reticulata is warm in nature, bitter and sweet in taste, and enters the liver and kidney meridians. It has the effects of promoting blood circulation and replenishing blood, regulating menstruation and relieving pain, and relaxing muscles and tendons. It is mainly used to treat uncomfortable symptoms such as irregular menstruation, dysmenorrhea, amenorrhea, blood deficiency and chlorosis, numbness and paralysis, rheumatism and pain.

[0023] Clematis is warm in nature, spicy and salty in taste, and belongs to the bladder meridian. It has the effects of eliminating rheumatism and unblocking meridians. It is often used clinically to treat rheumatic pain, bone stuck in the throat, traumatic injuries, bone stuck in the throat and other diseases.

[0024] Duhuo is slightly warm, bitter and pungent in taste, and enters the kidney meridian and bladder meridian. It has the effects of removing rheumatism, relieving arthralgia and pain, nourishing the liver and kidney, and strengthening the tendons and bones. It is mainly used to treat arthralgia, liver and kidney deficiency, rheumatic arthralgia and other diseases.

[0025] Roasted licorice is warm in nature and sweet in taste. It belongs to the heart meridian, lung meridian, stomach meridian and spleen meridian. It has the effects of invigorating the spleen and replenishing qi, relieving cough and asthma, clearing away heat and detoxifying, relieving pain, and harmonizing medicinal properties.

[0026] Sichuan Achyranthes bidentata is neutral in nature, bitter in taste, and enters the kidney meridian; it dispels wind, promotes dampness, dredges the menstruation, and activates blood circulation; it is mainly used to treat amenorrhea, retained placenta, joint pain, foot paralysis and muscle spasm, hematuria and hematuria, and injuries from falls.

[0027] Dipsacus asper is slightly warm, bitter and pungent in nature, and enters the liver and kidney meridians. It can nourish the liver and kidneys, repair tendons and bones, protect bones, preserve the fetus, and regulate blood circulation.

[0028] Qinjiao is pungent, bitter, and slightly cold in nature, and belongs to the stomach, liver, and gallbladder meridians. It has the effects of eliminating rheumatism, relieving arthralgia, relieving deficiency fever, and clearing damp heat.

[0029] Fried Atractylodes lancea with bran is warm in nature, pungent and bitter in taste, and enters the spleen, stomach, and liver meridians. It has the effects of drying dampness, strengthening the spleen, removing rheumatism, and improving eyesight.

[0030] Angelica sinensis is warm in nature, slightly sweet and spicy in taste, and enters the heart, liver, and spleen meridians. It has the effects of nourishing Qi and blood, promoting blood circulation and removing blood stasis, and moistening the intestines and promoting bowel movements.

[0031] Mulberry parasite is flat in nature, bitter and sweet in taste, and enters the liver and kidney meridians. It has the effects of removing rheumatism, nourishing the liver and kidney, strengthening the bones and tendons, and calming the fetus. It is mainly used to treat rheumatic pain, soreness of the waist and knees, weakness of the bones and tendons, metrorrhagia, bleeding during pregnancy, and restless fetuses.

[0032] Atractylodes is warm in nature, sweet and bitter in taste, and enters the spleen and stomach meridians. It has the effects and functions of tonifying Qi and strengthening the spleen, drying dampness and promoting diuresis, stopping sweat and stagnating the fetus, strengthening the spleen and appetizing, drying dampness and promoting diuresis. It is mainly used to treat spleen deficiency, spleen deficiency and stagnation, spleen deficiency and fluid stagnation, phlegm and fluid, edema and other symptoms.

[0033] Corydalis yanhusuo is warm in nature, pungent and bitter in taste, and enters the liver and spleen meridians. It has the effects of promoting blood circulation, promoting qi movement, and relieving pain. It is mainly used for symptoms such as qi stagnation and blood stasis, such as headache, heart, abdomen, chest, and flank pain, dysmenorrhea, postpartum abdominal pain due to blood stasis, rheumatic pain, and injuries from falls.

[0034] The whole scorpion is mild in nature, pungent in taste, and belongs to the liver meridian. It has the effects of calming wind and stopping convulsions, detoxifying and dispersing nodules, and unblocking meridians and relieving pain. It is mainly used to treat rheumatism, stroke, hemiplegia, spasm and convulsions, tetanus, acute and chronic convulsions in children and other diseases.

[0035] Chuanwu is hot in nature and pungent in taste. It enters the heart meridian, liver meridian, kidney meridian and spleen meridian. It has the effects of dispelling wind and cold, warming the meridians and relieving pain. It can treat wind-cold and dampness, cold pain in the heart and abdomen, cold hernia pain and other diseases.

[0036] Aconitum is hot in nature, pungent and bitter in taste, and enters the heart, liver, kidney and spleen meridians. It has the effects of dispelling wind and dampness, warming the meridians and relieving pain. It is mainly used to treat joint pain caused by wind, cold and dampness, cold pain in the heart and abdomen, and abdominal pain caused by cold hernia.

[0037] According to the characteristics of liver and kidney deficiency type knee osteoarthritis and kidney deficiency and blood stasis type knee osteoarthritis, the present invention uses the medication principle of "warming and tonifying the liver and kidney, unblocking the meridians and activating the collaterals" as the theoretical basis to form a traditional Chinese medicine composition for preventing and treating knee osteoarthritis, the prescription has reasonable components, various medicines are combined, warming and unblocking the meridians, nourishing the liver and kidneys, activating blood circulation and relieving pain. Animal experiments and clinical studies have verified that the knee bi prescription of the present invention has significant efficacy in the treatment of knee osteoarthritis and high safety.

[0038] The knee arthritis prescription of the present invention significantly reduces the behavioral score of knee osteoarthritis, reduces the levels of serum inflammatory factors IL-1β, IL-6, and TNF-α, reduces Mankin's score, improves knee joint function and articular cartilage morphology, and achieves the effect of treating knee osteoarthritis.

[0039] Compared with the prior art, the present invention has the following advantages:

[0040] (1) Based on the medication principle of "warming and tonifying the liver and kidney, unblocking the meridians and activating the collaterals", the various medicinal ingredients of the knee arthritis prescription of the present invention work synergistically to warm and tonify the meridians, nourish the liver and kidney, and activate blood circulation and relieve pain, thereby significantly improving the symptoms of knee osteoarthritis and improving the efficacy.

[0041] (2) The knee arthritis prescription of the present invention uses natural herbal ingredients, which, compared with Western medicine, has lower side effects, high safety, and is suitable for long-term use. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] Figure 1 Comparison of behavioral scores among groups

[0043] Compared with the model control group, * P<0.05, ** P<0.01; compared with the Example 1 group, # P<0.05, ## P<0.01.

[0044] Figure 2 Comparison of Mankin's scores among groups

[0045] Compared with the model control group, * P<0.05, ** P<0.01; compared with the Example 1 group, # P<0.05, ## P<0.01. DETAILED DESCRIPTION

[0046] The technical solution of the present invention will be described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0047] Example 1

[0048] A Chinese medicine composition for preventing or treating knee osteoarthritis, comprising the following raw materials in parts by weight:

[0049] 15 parts of Caulis Spatholobi, 15 parts of Radix Clematidis, 12 parts of Radix Angelicae Pubescentis, 9 parts of Radix Glycyrrhizae Preparata, 12 parts of Cyathulae Bidentatae, 12 parts of Dipsacus Asper, 12 parts of Gentiana Macrophyllae, 12 parts of Rhizoma Atractylodis Macrocephalae, 12 parts of Radix Angelicae Sinensis, 12 parts of Herba Taxillae Viridis, 12 parts of Atractylodes Macrocephalae, 12 parts of Rhizoma Corydalis, 6 parts of Scorpio, 6 parts of Radix Aconiti Kusnezoffii, 6 parts of Radix Aconiti Kusnezoffii.

[0050] The preparation method is as follows: weigh the raw materials, add 10 times the weight of purified water, soak for 50 minutes, put the soaked medicine and water into a decoction pot, boil over high heat, simmer over low heat for 60 minutes, and filter out liquid A; after filtering out the liquid medicine, add 8 times the weight of purified water again, boil over high heat, simmer over low heat for 50 minutes, and filter out liquid medicine B; combine liquid medicine A and liquid medicine B, concentrate the filtrate to a relative density of 1.15, spray dry, pass the dried fine powder through a 100-mesh sieve, and add pharmaceutically acceptable excipients through conventional procedures to prepare the knee arthritis capsule of the present invention.

[0051] Example 2

[0052] A Chinese medicine composition for preventing or treating knee osteoarthritis, comprising the following raw materials in parts by weight:

[0053] 20 parts of Millettia Spatholobi, 10 parts of Radix Clematidis, 8 parts of Angelicae Pubescentis, 12 parts of Radix Glycyrrhizae Preparata, 15 parts of Cyathulae Bidentatae, 8 parts of Dipsacus Asper, 8 parts of Gentiana Macrophyllae, 15 parts of Rhizoma Atractylodis Macrocephalae, 8 parts of Radix Angelicae Sinensis, 8 parts of Herba Taxilli, 15 parts of Atractylodes Macrocephalae, 15 parts of Rhizoma Corydalis, 3 parts of Scorpio, 9 parts of Radix Aconiti Kusnezoffii, and 3 parts of Radix Aconiti Kusnezoffii.

[0054] The preparation method is as follows: weigh the raw materials, add 12 times the weight of purified water, soak for 40 minutes, put the soaked medicine and water into a decoction pot, boil over high heat, simmer over low heat for 50 minutes, and filter out liquid A; after filtering out the liquid medicine, add 6 times the weight of purified water again, boil over high heat, simmer over low heat for 60 minutes, and filter out liquid medicine B; combine liquid medicine A and liquid medicine B, concentrate the filtrate to a relative density of 1.25, spray dry, pass the dried fine powder through an 80-mesh sieve, granulate, and dry to obtain the knee arthritis granules of the present invention.

[0055] Example 3

[0056] A Chinese medicine composition for preventing or treating knee osteoarthritis, comprising the following raw materials in parts by weight:

[0057] 10 parts of Millettia Spatholobi, 20 parts of Radix Clematidis, 15 parts of Angelicae Pubescentis, 12 parts of Radix Glycyrrhizae Preparata, 8 parts of Cyathulae Bidentatae, 15 parts of Dipsacus Asper, 15 parts of Gentiana Macrophyllae, 8 parts of Rhizoma Atractylodis Macrocephalae, 15 parts of Radix Angelicae Sinensis, 15 parts of Herba Taxillae Viridis, 8 parts of Atractylodes Macrocephalae, 8 parts of Rhizoma Corydalis, 9 parts of Scorpio, 3 parts of Radix Aconiti Kusnezoffii, and 9 parts of Radix Aconiti Kusnezoffii.

[0058] The preparation method is as follows: weigh the raw materials, add 8 times the weight of purified water, soak for 70 minutes, put the soaked medicine and water into a decoction pot, boil over high heat, simmer over low heat for 80 minutes, and filter out liquid A; after filtering out the liquid medicine, add 10 times the weight of purified water again, boil over high heat, simmer over low heat for 40 minutes, and filter out liquid medicine B; combine liquid medicine A and liquid medicine B, concentrate the filtrate to a relative density of 1.10, spray dry, pass the dried fine powder through a 100-mesh sieve, and add pharmaceutically acceptable excipients through conventional procedures to prepare the knee arthritis tablets of the present invention.

[0059] Example 4

[0060] A Chinese medicine composition for preventing or treating knee osteoarthritis, comprising the following raw materials in parts by weight:

[0061] 20 parts of Millettia Spatholobi, 10 parts of Radix Clematidis, 15 parts of Radix Angelicae Pubescentis, 5 parts of Radix Glycyrrhizae Preparata, 8 parts of Cyathulae Bidentatae, 15 parts of Dipsacus Asper, 15 parts of Radix Gentianae Macrophyllae, 8 parts of Rhizoma Atractylodis Macrocephalae, 15 parts of Radix Angelicae Sinensis, 8 parts of Herba Taxillae Viridis, 15 parts of Atractylodes Macrocephalae, 15 parts of Rhizoma Corydalis, 3 parts of Scorpio, 3 parts of Radix Aconiti Kusnezoffii, 9 parts of Radix Aconiti Kusnezoffii.

[0062] The preparation method is as follows: weigh the raw materials, add 8 times the weight of purified water, soak for 55 minutes, put the soaked medicine and water into a decoction pot, boil with high heat, simmer for 65 minutes with low heat, and filter out the medicinal liquid A; after filtering out the medicinal liquid, add 7 times the weight of purified water again, boil with high heat, simmer for 45 minutes with low heat, and filter out the medicinal liquid B; combine the medicinal liquid A and the medicinal liquid B, concentrate the filtrate to a relative density of 1.20, spray dry, pass the dried fine powder through a 100-mesh sieve, and add pharmaceutically acceptable excipients through conventional procedures to prepare the knee arthralgia pills of the present invention.

[0063] Example 5

[0064] A Chinese medicine composition for preventing or treating knee osteoarthritis, comprising the following raw materials in parts by weight:

[0065] 15 parts of Caulis Spatholobi, 12 parts of Radix Clematidis, 10 parts of Radix Angelicae Pubescentis, 9 parts of Radix Glycyrrhizae Preparata, 10 parts of Cyathulae Bidentatae, 12 parts of Dipsacus Asper, 10 parts of Radix Gentianae Macrophyllae, 9 parts of Rhizoma Atractylodis Macrocephalae, 12 parts of Radix Angelicae Sinensis, 12 parts of Herba Taxilli, 10 parts of Atractylodes Macrocephalae, 15 parts of Rhizoma Corydalis, 6 parts of Scorpio, 3 parts of Radix Aconiti Kusnezoffii, and 9 parts of Radix Aconiti Kusnezoffii.

[0066] The preparation method is as follows: weigh the raw materials, add 10 times the weight of purified water, soak for 50 minutes, put the soaked medicine and water into a decoction pot, boil over high heat, simmer over low heat for 60 minutes, and filter out liquid A; after filtering out the liquid medicine, add 8 times the weight of purified water again, boil over high heat, simmer over low heat for 50 minutes, and filter out liquid medicine B; combine liquid medicine A and liquid medicine B, concentrate the filtrate to a relative density of 1.15, spray dry, pass the dried fine powder through a 100-mesh sieve, and add pharmaceutically acceptable excipients through conventional procedures to prepare the knee arthritis capsule of the present invention.

[0067] Example 6

[0068] A Chinese medicine composition for preventing or treating knee osteoarthritis, comprising the following raw materials in parts by weight:

[0069] 10 parts of Millettia Spatholobi, 15 parts of Radix Clematidis, 15 parts of Radix Angelicae Pubescentis, 10 parts of Radix Glycyrrhizae Preparata, 8 parts of Cyathulae Bidentatae, 15 parts of Dipsacus Asper, 12 parts of Gentiana Macrophyllae, 12 parts of Rhizoma Atractylodis Macrocephalae, 10 parts of Radix Angelicae Sinensis, 10 parts of Herba Taxillae Viridis, 12 parts of Atractylodes Macrocephalae, 12 parts of Rhizoma Corydalis, 7 parts of Scorpio, 5 parts of Radix Aconiti Kusnezoffii, and 6 parts of Radix Aconiti Kusnezoffii.

[0070] The preparation method is as follows: weigh the raw materials, add 10 times the weight of purified water, soak for 50 minutes, put the soaked medicine and water into a decoction pot, boil over high heat, simmer over low heat for 60 minutes, and filter out liquid A; after filtering out the liquid medicine, add 8 times the weight of purified water again, boil over high heat, simmer over low heat for 50 minutes, and filter out liquid medicine B; combine liquid medicine A and liquid medicine B, concentrate the filtrate to a relative density of 1.15, spray dry, pass the dried fine powder through a 100-mesh sieve, and add pharmaceutically acceptable excipients through conventional procedures to prepare the knee arthritis capsule of the present invention.

[0071] Example 7

[0072] A Chinese medicine composition for preventing or treating knee osteoarthritis, comprising the following raw materials in parts by weight:

[0073] 15 parts of Millettia Spatholobi, 20 parts of Radix Clematidis, 15 parts of Radix Angelicae Pubescentis, 5 parts of Radix Glycyrrhizae Preparata, 8 parts of Cyathulae Bidentatae, 15 parts of Dipsacus Asper, 10 parts of Radix Gentianae Macrophyllae, 10 parts of Rhizoma Atractylodis Macrocephalae, 8 parts of Radix Angelicae Sinensis, 15 parts of Herba Taxillae Viridis, 15 parts of Atractylodes Macrocephalae, 8 parts of Rhizoma Corydalis, 5 parts of Scorpio, 7 parts of Radix Aconiti Kusnezoffii, and 6 parts of Radix Aconiti Kusnezoffii.

[0074] The preparation method is as follows: weigh the raw materials, add 10 times the weight of purified water, soak for 50 minutes, put the soaked medicine and water into a decoction pot, boil over high heat, simmer over low heat for 60 minutes, and filter out liquid A; after filtering out the liquid medicine, add 8 times the weight of purified water again, boil over high heat, simmer over low heat for 50 minutes, and filter out liquid medicine B; combine liquid medicine A and liquid medicine B, concentrate the filtrate to a relative density of 1.15, spray dry, pass the dried fine powder through a 100-mesh sieve, and add pharmaceutically acceptable excipients through conventional procedures to prepare the knee arthritis capsule of the present invention.

[0075] Comparative Example 1

[0076] A Chinese medicine composition for preventing or treating knee osteoarthritis, comprising the following raw materials in parts by weight:

[0077] 15 parts of Sargentodoxae, 15 parts of Angelica dahurica, 12 parts of Notopterygium wilfordii, 9 parts of Radix Glycyrrhizae Preparata, 12 parts of Cyathulae obtusifolia, 12 parts of Dipsacus asper, 12 parts of Gentiana macrophylla, 12 parts of stir-fried Atractylodes lancea with bran, 12 parts of Angelica sinensis, 12 parts of Parasitic Herb, 12 parts of Atractylodes macrocephala, 12 parts of Corydalis yanhusuo, 6 parts of Scorpio, 6 parts of Aconiti kusnezoffii, and 6 parts of Aconitum carmichaelii.

[0078] The preparation method is as follows: weigh the raw materials, add 10 times the weight of purified water, soak for 50 minutes, put the soaked medicine and water into a decoction pot, boil over high heat, simmer over low heat for 60 minutes, and filter out liquid A; after filtering out the liquid medicine, add 8 times the weight of purified water again, boil over high heat, simmer over low heat for 50 minutes, and filter out liquid medicine B; combine liquid medicine A and liquid medicine B, concentrate the filtrate to a relative density of 1.15, spray dry, pass the dried fine powder through a 100-mesh sieve, and add pharmaceutically acceptable excipients through conventional procedures to prepare capsules of comparative example 1.

[0079] Comparative Example 2

[0080] A Chinese medicine composition for preventing or treating knee osteoarthritis, comprising the following raw materials in parts by weight:

[0081] 9 parts of roasted liquorice root, 12 parts of cyathula, 12 parts of dipsaccharides, 12 parts of gentiana macrophylla, 12 parts of stir-fried atractylodes, 12 parts of angelica, 12 parts of parasitic loranthus, 12 parts of atractylodes macrocephala, 12 parts of corydalis, 6 parts of scorpion, 6 parts of aconite, and 6 parts of aconite.

[0082] The preparation method is as follows: weigh the raw materials, add 10 times the weight of purified water, soak for 50 minutes, put the soaked medicine and water into a decoction pot, boil over high heat, simmer over low heat for 60 minutes, and filter out liquid A; after filtering out the liquid medicine, add 8 times the weight of purified water again, boil over high heat, simmer over low heat for 50 minutes, and filter out liquid medicine B; combine liquid medicine A and liquid medicine B, concentrate the filtrate to a relative density of 1.15, spray dry, pass the dried fine powder through a 100-mesh sieve, and add pharmaceutically acceptable excipients through conventional procedures to prepare capsules of comparative example 2.

[0083] Comparative Example 3

[0084] A Chinese medicine composition for preventing or treating knee osteoarthritis, comprising the following raw materials in parts by weight:

[0085] 15 parts of Caulis Spatholobi, 15 parts of Radix Clematis, 12 parts of Radix Angelicae Pubescentis, 9 parts of Radix Glycyrrhizae, 12 parts of Rhizoma Chuanxiongs, 12 parts of Eucommia Bark, 12 parts of Saposhnikoviae Saposhnikoviae, 12 parts of Semen Coix Lachryma-jobi stir-fried with bran, 12 parts of Radix Angelicae Sinensis, 12 parts of Herba Mori Parasitici, 12 parts of Atractylodes Macrocephalae, 12 parts of Rhizoma Corydalis, 6 parts of Scorpio, 6 parts of Radix Aconiti Kusnezoffii, and 6 parts of Radix Aconiti Kusnezoffii.

[0086] The preparation method is as follows: weigh the raw materials, add 10 times the weight of purified water, soak for 50 minutes, put the soaked medicine and water into a decoction pot, boil over high heat, simmer over low heat for 60 minutes, and filter out liquid A; after filtering out the liquid medicine, add 8 times the weight of purified water again, boil over high heat, simmer over low heat for 50 minutes, and filter out liquid medicine B; combine liquid medicine A and liquid medicine B, concentrate the filtrate to a relative density of 1.15, spray dry, pass the dried fine powder through a 100-mesh sieve, and add pharmaceutically acceptable excipients through conventional procedures to prepare comparative example 3 capsules.

[0087] Comparative Example 4

[0088] A Chinese medicine composition for preventing or treating knee osteoarthritis, comprising the following raw materials in parts by weight:

[0089] 25 parts of Millettia Spatholobi, 20 parts of Radix Clematidis, 6 parts of Radix Angelicae Pubescentis, 15 parts of Radix Glycyrrhizae Preparata, 12 parts of Cyathulae, 18 parts of Dipsacus asper, 7 parts of Gentiana Macrophyllae, 7 parts of Rhizoma Atractylodis Macrocephalae, 16 parts of Radix Angelicae Sinensis, 18 parts of Herba Taxilli, 10 parts of Atractylodes macrocephalae, 7 parts of Rhizoma Corydalis, 10 parts of Scorpio, 2 parts of Radix Aconiti, and 6 parts of Radix Aconiti Kusnezoffii.

[0090] The preparation method is as follows: weigh the raw materials, add 10 times the weight of purified water, soak for 50 minutes, put the soaked medicine and water into a decoction pot, boil over high heat, simmer over low heat for 60 minutes, and filter out liquid A; after filtering out the liquid medicine, add 8 times the weight of purified water again, boil over high heat, simmer over low heat for 50 minutes, and filter out liquid medicine B; combine liquid medicine A and liquid medicine B, concentrate the filtrate to a relative density of 1.15, spray dry, pass the dried fine powder through a 100-mesh sieve, and add pharmaceutically acceptable excipients through conventional procedures to prepare capsules of comparative example 1.

[0091] Efficacy Example 1 Study on the treatment of knee osteoarthritis of kidney deficiency and blood stasis type by the Xibi prescription of the present invention

[0092] 1. Establishment of a rat model of knee osteoarthritis

[0093] 72 SD rats, SPF grade, female, weighing (200±20)g, free access to water and diet, and the room temperature was maintained at 20-25℃. After one week of adaptive feeding, 8 rats were selected as the blank control group, and the remaining rats were modeled. The knee osteoarthritis (kidney deficiency and blood stasis syndrome) model was constructed by ovariectomy, adrenocortical hormone and epinephrine method, and classic Hulth surgery modeling method. First, the ovariectomy was performed, and the adrenocortical hormone and epinephrine method and classic Hulth surgery modeling were performed at the same time after 8 weeks. After the modeling rats were anesthetized, the fallopian tubes and surrounding blood vessels were ligated aseptically, and the bilateral ovaries were removed. 10mg / kg hydrocortisone was injected intramuscularly once a day, and 0.36mg / kg epinephrine was injected subcutaneously once after 13 days. After the rats were anesthetized, the medial side of the knee joints was cut aseptically to expose the knee joints, cut the medial collateral ligaments and the anterior and posterior cruciate ligaments, and remove the medial meniscus. The cartilage was avoided during the operation. The operated limbs were not fixed after surgery, and attention was paid to preventing infection and allowing free movement. One week after surgery, rats were driven twice a day, each time for 30 minutes.

[0094] The modeled rats were randomly divided into 8 groups according to body weight, with 8 rats in each group, namely, model control group, celecoxib group, Example 1 group, Example 2 group, Comparative Example 1 group, Comparative Example 2 group, Comparative Example 3 group, and Comparative Example 4 group.

[0095] The medications for each group are as follows:

[0096] The celecoxib group was intragastrically administered with 0.021 g / kg celecoxib every day.

[0097] The Example 1 group was intragastrically administered with 0.8 g / kg Example 1 capsules every day.

[0098] The Example 2 group was intragastrically administered with 0.8 g / kg of the Example 2 granules every day.

[0099] The comparative example 1 group was intragastrically administered with 0.8 g / kg comparative example 1 capsules every day.

[0100] The comparative example 2 group was intragastrically administered with 0.8 g / kg comparative example 2 capsules every day.

[0101] The comparative example 3 group was intragastrically administered with 0.8 g / kg comparative example 3 capsules every day.

[0102] The comparative example 4 group was intragastrically administered with 0.8 g / kg comparative example 4 capsules every day.

[0103] Rats in the blank control group and the model control group were gavaged with an equal volume of saline at a dose of 10 mL / kg, once a day for 30 consecutive days.

[0104] 2. Model observation and indicator detection

[0105] 2.1 Behavioral evaluation

[0106] 24 hours after administration, behavioral evaluation was performed on each group using the modified Lequese MG knee joint assessment method. Observation indicators included gait changes, pain stimulus response, joint swelling and range of motion.

[0107] Table 1 Behavioral evaluation of the Lequese MG knee joint

[0108]

[0109] 2.2 Detection of serum inflammatory factors IL-1β, IL-6, and TNF-α

[0110] 24 hours after the last administration, 5 mL of abdominal aorta blood was collected from each group of rats, and the blood was separated and placed at room temperature for 30 minutes to obtain serum. The ELISA method was used to detect the levels of serum IL-1β, IL-6, and TNF-α in each group of rats. After IL-1β in the samples and standards was bound to the solid phase monoclonal antibody, horseradish peroxidase-labeled anti-rat IL-1β antibody was added, and the absorbance at 450 nm was measured after color reaction; the IL-6 and TNF-α contents were detected by the same method.

[0111] 2.3 Mankin score for knee cartilage degeneration

[0112] 24 hours after the last administration, the right knee cartilage tissue of rats in each group was obtained, fixed with paraformaldehyde, decalcified with ethylenediaminetetraacetic acid, dehydrated, and routinely embedded in paraffin to make paraffin tissue blocks and 3um sections. Dewaxing, hematoxylin staining at room temperature for 8 minutes, differentiation, washing; saturated lithium carbonate anti-blue, washing; eosin staining for 1 minute, differentiation; gum sealing cover. Optical microscopy was used to observe the pathological conditions of the knee cartilage of rats in each group. The degree of cartilage tissue degeneration was evaluated using the modified Mankin's scoring standard (see Table 2), and the scoring indicators included cartilage structure, chondrocytes, matrix staining, and tide line integrity.

[0113] Table 2 Mankin scoring table for cartilage degeneration

[0114]

[0115] 3. Statistical methods

[0116] Graphpad Prism 9.0 software was used for data processing, and the measured data were expressed as mean ± standard deviation. One-way analysis of variance was used for comparison among multiple groups, and SNK-q was used for pairwise comparison among groups. The difference was considered statistically significant when P < 0.05.

[0117] 4. Experimental Results

[0118] 4.1 Comparison of behavioral scores

[0119] Compared with the blank control group, the behavioral scores of the rats in the model control group increased significantly. Compared with the model control group, the behavioral scores of the celecoxib group and the Example 1 group and the Example 2 group were significantly reduced. Compared with the Example 1 group, the behavioral scores of the Comparative Example 1 group, the Comparative Example 2 group, the Comparative Example 3 group and the Comparative Example 4 group were higher. Figure 1 .

[0120] 4.2 Comparison of serum inflammatory factors IL-1β, IL-6, and TNF-α

[0121] Compared with the blank control group, the serum inflammatory factors IL-1β, IL-6, and TNF-α content of the model control group rats increased significantly. After administration, compared with the model control group, the celecoxib group and the embodiment 1 group, the embodiment 2 group IL-1β, IL-6, and TNF-α content were significantly reduced. Compared with the embodiment 1 group, the comparative example 1 group, the comparative example 2 group, the comparative example 3 group, and the comparative example 4 group IL-1β, IL-6, and TNF-α content were higher. See Table 3.

[0122] Table 3 Comparison of the levels of inflammatory factors IL-1β, IL-6 and TNF-α in the serum of rats in each group ( n=8)

[0123]

[0124] Compared with the model control group, * P<0.05, ** P<0.01; compared with Example 1 group, # P<0.05, ## P<0.01.

[0125] 4.3 Comparison of Mankin's score for knee cartilage degeneration

[0126] Compared with the blank control group, the Mankin's score of the model control group increased significantly. Compared with the model control group, the Mankin's score of the celecoxib group and the Example 1 group and the Example 2 group decreased significantly. Compared with the Example 1 group, the Mankin's score of the Comparative Example 1 group, the Comparative Example 2 group, the Comparative Example 3 group and the Comparative Example 4 group was higher. Figure 2 .

[0127] The knee arthritis prescription of the present invention inhibits the secretion of inflammatory factors IL-1β, IL-6 and TNF-α, reduces the contents of IL-1β, IL-6 and TNF-α in the serum and synovium of rats with knee osteoarthritis, and inhibits the inflammatory reaction of knee osteoarthritis.

[0128] The knee arthritis prescription of the present invention significantly reduces the behavioral score of knee osteoarthritis, reduces the levels of serum inflammatory factors IL-1β, IL-6, and TNF-α, reduces Mankin's score, improves knee joint function and articular cartilage morphology, and achieves the effect of treating knee osteoarthritis.

[0129] Clinical example: Observation on the therapeutic effect of the present invention's Xibi prescription on liver-kidney deficiency type knee osteoarthritis

[0130] 1. Materials and Methods

[0131] 1. Clinical data

[0132] 70 patients with knee osteoarthritis who visited the orthopedics department were selected and divided into two groups by random number grouping method, the knee arthralgia prescription group of the present invention and the control group, with 35 cases in each group. In the knee arthralgia prescription group of the present invention, there were 19 males and 16 females, aged 51.34±12.7 years old, with a course of disease of 4.5±1.05 years, and 9 patients with Kellgren-Lawrence grade I, 17 patients with grade II, and 8 patients with grade III; in the control group, there were 20 males and 15 females, aged 53.71±11.3 years old, with a course of disease of 4.9±1.23 years, and 10 patients with grade I, 16 patients with grade II, and 9 patients with grade III according to Kellgren-Lawrence grade. There was no statistically significant difference in gender, age and course of disease between the two groups of patients.

[0133] 2. Case selection criteria

[0134] Western medicine diagnostic criteria

[0135] The criteria are described in the Guidelines for the Diagnosis and Treatment of Osteoarthritis (2007 Edition). Morning stiffness duration ≤ 30 minutes; recurrent knee pain within the past month; bone friction sound during movement; X-rays showing narrowing of the joint space, subchondral bone sclerosis or cystic changes, and osteophyte formation at the joint edge.

[0136] TCM Syndrome Differentiation Standards

[0137] According to the "Guidelines for Clinical Research of New Chinese Medicines (Trial)" for the differentiation of liver and kidney deficiency type knee osteoarthritis. Main symptoms: knee pain, stiffness, swelling and pain. Secondary symptoms: insomnia, fatigue, dizziness, tinnitus, soreness of waist and knees.

[0138] 3. Inclusion criteria

[0139] Meet the criteria for Western medicine diagnosis and TCM syndrome differentiation; Patients have not received other medication or surgical treatment within the past month; ③ Age 2-80 years old; Kellgren-Lawrence imaging diagnostic grading standard is grade I-III; ⑤ Single knee lesion.

[0140] 4. Exclusion criteria

[0141] Patients with bone tumors; patients with knee sprains or other trauma; patients with other inflammatory knee diseases; patients with cognitive or mental disorders; patients with skin damage around the knee joint; patients with severe liver and kidney dysfunction; patients who have recently undergone other clinical trials; patients who have severe adverse reactions during treatment and cannot continue to participate; patients with poor compliance; patients who voluntarily request to withdraw.

[0142] 5. Treatment Methods

[0143] The Xibi prescription group of the present invention orally took 100 mg / kg of the capsule of Example 1, once a day.

[0144] The control group orally took 100 mg / kg comparative example 4 capsules, once a day.

[0145] The efficacy of the two groups was determined after taking the medicine for 12 consecutive weeks.

[0146] 6.Indicator observation

[0147] The TCM syndrome scores of the two groups of patients were evaluated before and after treatment. The evaluation criteria are as follows. Main symptoms: knee pain, stiffness, swelling and pain. According to the symptoms of no, mild, moderate, and severe, the scores are 0, 3, 6, and 9, respectively. Secondary symptoms: insomnia, fatigue, dizziness, tinnitus, and soreness of the waist and knees. According to the symptoms of no, mild, moderate, and severe, the scores are 0, 1, 2, and 3, respectively. The sum of each item is the TCM syndrome score.

[0148] During the treatment, adverse reactions such as nausea and vomiting, abnormal liver and kidney function, and anorexia were recorded in the two groups of patients.

[0149] According to the reference document "Guidelines for Clinical Research of New Chinese Medicines (Trial)", cured: clinical symptoms disappear or basically disappear, and the reduction rate of TCM syndrome score is >95%. Significantly effective: clinical symptoms are significantly alleviated, 70%< TCM syndrome score reduction rate ≤95%. Effective: clinical symptoms are improved, 30%≤ TCM syndrome score reduction rate ≤70%. Ineffective: clinical symptoms are not improved or aggravated, and the reduction rate of TCM syndrome score is <30%.

[0150] 7. Statistical methods

[0151] SPSS 22.0 software was used for data processing, and the data were expressed as mean ± standard deviation. The data of each group were subjected to normal distribution test and variance homogeneity test, and the inter-group comparison was performed with one-way analysis of variance, with P < 0.05 as the difference being statistically significant.

[0152] 2. Results

[0153] 1. Comparison of clinical efficacy

[0154] The marked effectiveness and total effectiveness of the Xibi prescription group of the present invention are better than those of the control group, as shown in Table 4.

[0155] Table 4 Comparison of clinical efficacy between the two groups

[0156]

[0157] 2. Adverse reactions

[0158] During the treatment, no adverse reactions such as nausea and vomiting, abnormal liver and kidney function, and anorexia occurred in both groups.

[0159] The above embodiments are merely examples for clear explanation and are not intended to limit the implementation methods. For those skilled in the art, other different forms of changes or modifications can be made based on the above description, and the obvious changes or modifications derived therefrom are still within the scope of protection of the present invention.

Claims

1. A knee arthritis prescription for preventing or treating knee osteoarthritis, characterized in that: The knee arthritis prescription is prepared from Millettia spatholobi, clematis root, Angelica dahurica, roasted licorice, Cyathula capitata, Dipsacus asper, Gentiana macrophylla, stir-fried Atractylodes lancea with bran, Angelica sinensis, Viscum album, Atractylodes macrocephala, Corydalis spp., Scorpio, Aconiti chuanxiong and Aconiti kusnezoffii; the knee arthritis prescription is prepared from the following raw materials in parts by weight: 10-20 parts of Millettia spatholobi, 10-20 parts of Clematidis root, 8-15 parts of Angelica dahurica, 8-15 parts of Dipsacus asper, 8-15 parts of Gentiana macrophylla, 8-15 parts of stir-fried Atractylodes lancea with bran, 8-15 parts of Angelica sinensis, 8-15 parts of Viscum album, 8-15 parts of Atractylodes macrocephala, 8-15 parts of Corydalis spp., 3-9 parts of Scorpio, 3-9 parts of Aconiti chuanxiong and 3-9 parts of Aconiti kusnezoffii.

2. The knee arthralgia prescription according to claim 1, characterized in that: The knee arthritis prescription comprises the following raw materials in parts by weight: 15 parts of Caulis Spatholobi, 15 parts of Radix Clematidis, 12 parts of Radix Angelicae Pubescentis, 9 parts of Radix Glycyrrhizae Preparata, 12 parts of Cyathulae Bidentatae, 12 parts of Dipsacus Asper, 12 parts of Gentiana Macrophyllae, 12 parts of Rhizoma Atractylodis Macrocephalae, 12 parts of Radix Angelicae Sinensis, 12 parts of Herba Taxillae Viridis, 12 parts of Atractylodes Macrocephalae, 12 parts of Rhizoma Corydalis, 6 parts of Scorpio, 6 parts of Radix Aconiti Kusnezoffii, 6 parts of Radix Aconiti Kusnezoffii.

3. The knee arthralgia prescription according to any one of claims 1 or 2, characterized in that: The preparation method of the knee arthralgia prescription is as follows: weigh the raw materials, add 8-12 times the weight of purified water, soak for 40min-70min, put the soaked medicine and water into a decoction pot, boil with high heat, simmer with low heat for 50-80min, and filter out the medicinal solution A; after filtering out the medicinal solution, add 6-10 times the weight of purified water again, boil with high heat, simmer with low heat for 40-60min, and filter out the medicinal solution B; combine the medicinal solution A and the medicinal solution B, concentrate the filtrate to a relative density of 1.10-1.25, spray dry, and pass the dried fine powder through an 80-100 mesh sieve to obtain the knee arthralgia prescription of the present invention.

4. The knee arthralgia prescription according to any one of claims 1 or 2, characterized in that: The preparation method of the knee arthralgia prescription is as follows: weigh the raw materials, add 10 times the weight of purified water, soak for 50 minutes, put the soaked medicine and water into a decoction pot, boil over high heat, simmer over low heat for 60 minutes, and filter out liquid A; after filtering out the liquid medicine, add 8 times the weight of purified water again, boil over high heat, simmer over low heat for 50 minutes, and filter out liquid medicine B; combine liquid medicine A and liquid medicine B, concentrate the filtrate to a relative density of 1.15, spray dry, and pass the dried fine powder through a 100-mesh sieve to obtain the knee arthralgia prescription of the present invention.

5. The knee arthralgia prescription according to any one of claims 1 or 2, characterized in that: The preparation of the knee arthralgia prescription is decoction, pill, gel, tablet, mixture, capsule, granule, powder or paste.

6. The knee arthralgia prescription according to claim 5, characterized in that: The preparation of the Xibi prescription is Xibi capsule.

7. Use of the Xibi prescription according to any one of claims 1 or 2 in the preparation of a drug for preventing or treating knee osteoarthritis.

8. The use according to claim 7, characterized in that The knee osteoarthritis is liver and kidney deficiency type knee osteoarthritis.

9. The use according to claim 7, characterized in that: The knee osteoarthritis is kidney deficiency and blood stasis type knee osteoarthritis.

Images