Traditional Chinese medicine composition for treating qi stagnation and blood stasis syndromes of knee osteoarthritis and application of traditional Chinese medicine composition

Abstract

The invention relates to a traditional Chinese medicine composition for treating qi stagnation and blood stasis syndromes of knee osteoarthritis. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10-26 parts of safflower, 10-26 parts of peach kernel, 6-18 parts of ligusticum wallichii, 10-26 parts of angelica sinensis, 10-30 parts of centella asiatica, 4-16 parts of pseudo-ginseng, 6-18 parts of trogopterus dung, 6-18 parts of frankincense, 6-18 parts of myrrh, 2-10 parts of rhizoma cyperi, 9-21 parts of lycopodium clavatum, 2-10 parts of notopterygium root, 2-10 parts of gentiana macrophylla, 10-26 parts of radix achyranthis bidentatae, 6-18 parts of earthworm and 6-18 parts of liquorice. The traditional Chinese medicine has the advantages that the monarch drugs promote qi to activate blood, dissipate blood stasis and relieve pain; the ministerial drug has the effects of promoting blood circulation, removing blood stasis, promoting qi and blood circulation, strengthening qi and blood circulation and relieving pain; the adjuvant drug dredges meridians to benefit joints and assists the monarch drug in clearing and activating the channels and collaterals; the conductant drug harmonizes the medicines; the whole formula has the main functions of promoting qi circulation and removing blood stasis, can simultaneously enrich blood, dispel wind, eliminate dampness, stop arthralgia and clear and activate the channels and collaterals, and is remarkable in curative effect and outstanding in treatment effect.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating qi stagnation and blood stasis syndrome of knee osteoarthritis and application thereof. Background Art

[0002] With the aging of the population and the extension of the average human life expectancy, the incidence of osteoarthritis (OA) is not only high, but also has an upward trend; osteoarthritis is common, and knee osteoarthritis (KOA) is the most common clinically, which will directly affect walking function; according to 33 studies, a meta-analysis of 77,957 KOA patients showed that the prevalence of KOA in China was 18%, of which the prevalence in men was 11% and the prevalence in women was 19%; and according to the SF-36 scale survey of OA patients and KOA patients, their scores in each item were significantly lower than those without the disease; the quality of life of OA patients and KOA patients is worse than that of the general population, so the treatment of KOA and OA patients is of great clinical significance.

[0003] The TCM syndrome diagnosis of knee osteoarthritis mainly includes qi stagnation and blood stasis syndrome, cold-dampness and arthralgia syndrome, liver-kidney deficiency syndrome, and kidney yang deficiency syndrome; according to the 2020 TCM Diagnosis and Treatment Guidelines for Knee Osteoarthritis, for patients with knee osteoarthritis with qi stagnation and blood stasis syndrome, the guidelines recommend oral administration of Xuefu Zhuyu Decoction with modifications; for KOA patients with cold-dampness and arthralgia syndrome, it is recommended to take Qunbi Decoction with modifications orally.

[0004] Among them, the classification of Qi stagnation and blood stasis syndrome is more common in the attack period and the remission period; its main symptoms are joint pain such as stabbing or swollen pain, the pain does not decrease when resting, and the joints are difficult to flex and extend; the secondary symptoms are dull complexion; the tongue and pulse are purple and dark tongue, or with ecchymosis, and the pulse is deep and sluggish; the cold-dampness arthralgia syndrome is more common in the attack period and the remission period; the main symptoms are severe joint pain, which is aggravated by cold and relieved by warmth, and the joints are difficult to flex and extend; the secondary symptoms are severe pain in the waist and body; the tongue and pulse are pale tongue, white and greasy tongue coating, and soft and slow pulse.

[0005] However, the syndromes are not separated from each other. Knee osteoarthritis is quite similar to the "arthritis" in traditional Chinese medicine. Shentong Zhuyu Decoction, one of the "Five Zhuyu Decoctions" created by Wang Qingren, together with Xuefu Zhuyu Decoction, treats long-lasting arthritis caused by wind, cold and dampness invading the tendons, veins and joints, which blocks blood and qi for a long time, and causes shoulder pain, arm pain, back pain, leg pain, or body pain.

[0006] In modern clinical research, many people have also studied the therapeutic effect of Shentong Zhuyu Decoction on knee osteoarthritis; for example, Wang Zhengzhen et al. found that the drug-containing serum of Shentong Zhuyu Decoction can weaken the oxidative damage of chondrocytes in KOA rats and reduce cell apoptosis, and its protective effect may be related to the activation of the AMPK / Sirt1 signaling pathway; Li Jichao et al. found that Shentong Zhuyu Decoction is effective in treating phlegm and blood stasis type knee osteoarthritis, and its mechanism may be related to regulating the body's IL-lβ level; Yi Tengda et al. found that the Shentong Zhuyu Patch as an auxiliary treatment for blood stasis type knee osteoarthritis has obvious effects on relieving pain and improving joint movement function; Lu Mei et al. found that Shentong Zhuyu Decoction plus or minus combined with arthroscopic cleaning has a definite clinical efficacy in the treatment of knee osteoarthritis, which can improve patients' postoperative blood rheology indicators, enhance joint function recovery and quality of life; Huang Lei et al. found that Shentong Zhuyu Decoction patch treatment can significantly relieve the pain symptoms of patients with qi stagnation and blood stasis type KOA and improve their daily living ability.

[0007] Therefore, the present invention uses Shentong Zhuyu Decoction as the basic formula, adds Centella asiatica to promote blood circulation and remove blood stasis, adds Stretch Marks Herb and Frankincense to enhance the ventilation, blood circulation and pain relieving effects; adopts the wet heat compress method with the characteristic operation process of the internal power massage school to treat knee osteoarthritis. Summary of the invention

[0008] The first purpose of the present invention is to provide a Chinese medicine composition for treating knee osteoarthritis caused by wind, cold and dampness invading tendons, veins and joints, which blocks blood and qi for a long time and blocks meridians due to blood stasis, in view of the deficiencies in the prior art.

[0009] To achieve the above first purpose, the technical solution adopted by the present invention is:

[0010] A traditional Chinese medicine composition for treating knee osteoarthritis is prepared from the following raw materials in proportion by weight: 10-26 parts of safflower, 10-26 parts of peach kernel, 6-18 parts of chuanxiong, 10-26 parts of angelica, 10-30 parts of centella asiatica, 4-16 parts of panax notoginseng, 6-18 parts of quinquefolius, 6-18 parts of frankincense, 6-18 parts of myrrh, 2-10 parts of cyperus rotundus, 9-21 parts of lycopodii herba, 2-10 parts of notopterygium wilfordii, 2-10 parts of gentiana macrophylla, 10-26 parts of achyranthes bidentata, 6-18 parts of earthworm, and 6-18 parts of liquorice.

[0011] As a preferred example, the Chinese medicine composition is made of the following raw materials in the following weight proportions: 15-21 parts of safflower, 15-21 parts of peach kernel, 9-15 parts of chuanxiong, 15-21 parts of angelica, 15-25 parts of Centella asiatica, 7-13 parts of Panax notoginseng, 9-15 parts of aconiti lobata, 9-15 parts of frankincense, 9-15 parts of myrrh, 4-8 parts of cyperus rotundus, 12-18 parts of lycopodii herb, 4-8 parts of notopterygium wilfordii, 4-8 parts of gentiana macrophylla, 15-21 parts of Achyranthes bidentata, 9-15 parts of earthworm, and 9-15 parts of licorice.

[0012] More preferably, the Chinese medicine composition is made of the following raw materials in the following weight ratio: 18 parts of safflower, 18 parts of peach kernel, 12 parts of chuanxiong, 18 parts of angelica, 20 parts of Centella asiatica, 10 parts of Panax notoginseng, 12 parts of aconite, 12 parts of frankincense, 12 parts of myrrh, 6 parts of Cyperus rotundus, 15 parts of Lycopodiella ciliata, 6 parts of Notopterygium wilfordii, 6 parts of Gentiana macrophylla, 18 parts of Achyranthes bidentata, 12 parts of Pheretima, and 12 parts of Licorice.

[0013] As another preferred example, the Chinese medicine composition is further prepared into an external dosage form.

[0014] More preferably, the external dosage form is an external liquid medicament, ointment, gel, paste or transdermal patch.

[0015] To achieve the above second purpose, the technical solution adopted by the present invention is:

[0016] Use of any of the above-mentioned traditional Chinese medicine compositions in the preparation of medicines for treating knee osteoarthritis.

[0017] More preferably, the knee osteoarthritis is of Qi stagnation and blood stasis syndrome.

[0018] The effects of each Chinese medicine in the formula of the present invention are:

[0019]

[0020]

[0021] the term

[0022] As used herein, the term "parts by weight" can be any fixed weight expressed in milligrams, grams or kilograms (such as 1 mg, 1 g, 2 g, 5 g or 1 kg, etc.). For example, a composition consisting of 1 part by weight of component a and 9 parts by weight of component b can be a composition consisting of 1 gram of component a + 9 grams of component b, or 10 grams of component a + 90 grams of component b, etc. In the composition, the percentage content of a component = (the weight parts of the component / the sum of the weight parts of all components) × 100%. Therefore, in a composition consisting of 1 part by weight of component a and 9 parts by weight of component b, the content of component a is 10%, and the content of component b is 90%.

[0023] The compatibility principle of the present invention is:

[0024] Among the main drugs, peach kernel tastes bitter and has a laxative effect. It enters the heart and liver blood, is good at relieving blood stasis, and has a strong ability to remove blood stasis. It is an important drug for treating various blood stasis diseases. Safflower enters the heart and liver blood, has a pungent, dispersing, warming and unblocking nature, and has a strong ability to promote blood circulation, remove blood stasis, promote menstruation and relieve pain. When used together, peach kernel breaks blood stasis and moisturizes dryness, while safflower promotes blood circulation, removes blood stasis and relieves pain.

[0025] Chuanxiong is pungent and fragrant, and can warm and circulate blood. It can not only invigorate blood circulation and remove blood stasis, but also invigorate qi and relieve stagnation. It is a "blood qi medicine" (Compendium of Materia Medica), and is good at relieving pain. It is an essential medicine for treating various pain syndromes caused by qi stagnation and blood stasis. Angelica sinensis is sweet and pungent, and is pungent and warm. It is good at nourishing blood and invigorating blood circulation. It is "truly a blood qi medicine and a holy medicine". Chuanxiong and Angelica sinensis are used together to nourish blood and invigorate blood circulation.

[0026] The four medicines are used together: safflower and peach kernel promote blood circulation and disperse blood stasis, while chuanxiong and angelica replenish blood and promote blood circulation. Together, they regulate the symptoms of qi stagnation and blood stasis in the knee joint, and they are the main medicines.

[0027] Among the auxiliary drugs, Centella asiatica clears away heat and dampness, detoxifies and reduces swelling. Ophiopogon japonicus is bitter, warms and unblocks the meridians, and specifically enters the blood of the liver meridian. It is good at promoting blood circulation, removing blood stasis and relieving pain, and is an essential drug for treating pain caused by blood stasis. The two can be used together to promote blood circulation and remove blood stasis.

[0028] Frankincense is pungent, dispersing, bitter and purging. It enters both the blood and qi, can relieve qi stagnation in the blood, promote the flow of qi and blood in the viscera, penetrate the meridians, and is good at relieving pain. It can be used for various pain syndromes caused by blood stasis and qi stagnation. Myrrh is flat in nature, pungent and bitter in taste, and enters the heart, liver, and spleen meridians. It has the effects of promoting blood circulation and relieving pain, reducing swelling and promoting tissue regeneration. Herba Lycopodii is slightly bitter, pungent, and warm, and enters the liver, spleen, and kidney meridians. It has the effects of promoting blood circulation and relieving pain, reducing swelling and promoting tissue regeneration. Cyperus rotundus is pungent and fragrant, dispersing, bitter and purging, and mainly enters the liver meridian. It is good at regulating the stagnation of liver qi and relieving pain. It is an important medicine for relieving liver qi and relieving depression. It is suitable for various pain syndromes caused by liver qi stagnation and qi stagnation, and is known as the "important medicine for promoting qi and relieving pain". The four can be used together to strengthen the power of ventilation and blood circulation and the effect of relieving pain.

[0029] Qianghuo is pungent and dispersing, bitter and drying, warm and cold-dispersing, and has strong anti-rheumatic and analgesic effects. It is often used in combination with other anti-rheumatic and analgesic drugs to treat wind-cold-dampness arthralgia and joint pain. Qinjiao is pungent and dispersing, bitter and purging, moist but not dry, good at removing rheumatism, relaxing tendons and collaterals, and relieving arthralgia and pain. It is the "moisturizing agent among wind-clearing drugs" and can "open joints and circulate blood vessels." Qianghuo and Qinjiao are used together to dispel wind, dampness and relieve arthralgia and pain.

[0030] Centella asiatica and Aconiti Lateralis Preparata can invigorate blood circulation and remove blood stasis; frankincense, myrrh, cyperus rotundus and herba striataes can promote the circulation of qi and blood, enhance the ventilation and blood circulation effects as well as the analgesic effects; Notopterygium wilfordii and Gentiana macrophylla can dispel wind, remove dampness and relieve arthralgia and together they help the main medicine to invigorate qi, invigorate blood circulation, disperse blood stasis and relieve pain, and serve as the assistant medicine.

[0031] Among the adjuvant drugs, Achyranthes bidentata tastes bitter and laxative, tastes sweet and slow-tonifying, has a mild nature, and mainly enters the liver and kidney meridians. It can not only promote blood circulation and remove blood stasis, but also nourish the liver and kidneys, strengthen tendons and bones, and is good at treating liver and kidney deficiency. It helps the main drug to promote blood circulation and activate collaterals, and is an adjuvant drug.

[0032] Licorice harmonizes the medicinal properties of the other medicines in the Shentong Zhuyu Decoction and serves as a guiding drug.

[0033] The advantages of the present invention are:

[0034] 1. In the present invention, safflower, peach seed, chuanxiong and angelica are used as monarch drugs, respectively, and their effects of promoting qi and blood circulation, dispersing blood stasis and relieving pain are taken; Centella asiatica, Panax notoginseng, Atractylodes macrocephala, frankincense, myrrh, cyperus, herba schizonepetae, notopterygium wilfordii and gentiana macrophylla are used as ministerial drugs, and Centella asiatica, Panax notoginseng and Atractylodes macrocephala promote blood circulation and remove blood stasis; frankincense, myrrh, cyperus and herba schizonepetae promote qi and blood circulation, strengthen the power of ventilating and promoting blood circulation and the analgesic effect; notopterygium wilfordii and gentiana macrophylla dispel wind and dampness to stop pain; Achyranthes bidentata and earthworm are used as adjuvant drugs to dredge meridians to benefit joints and help the monarch drug to promote blood circulation and activate collaterals; Licorice is used as a messenger to coordinate various drugs; the whole prescription takes promoting qi and blood circulation and removing blood stasis as the main function, and can also take into account blood tonifying, dispelling wind and dampness to stop pain, and promoting blood circulation and activating collaterals.

[0035] 2. The Chinese medicine composition of the present invention is formulated according to the principles of prescription based on dialectical analysis of the cause and the establishment of treatment methods. It has also been verified by a large number of clinical experiments and has significant therapeutic effects and outstanding treatment effects.

[0036] 3. The Chinese medicine composition of the present invention is made of common medicinal materials, which are low in price and easy to obtain, and is suitable for popularization and application. DETAILED DESCRIPTION

[0037] The present invention will be further described below in conjunction with specific embodiments. It should be understood that these embodiments are only used to illustrate the present invention and are not intended to limit the scope of the present invention. In addition, it should be understood that after reading the content of the present invention, those skilled in the art can make various changes or modifications to the present invention, and these equivalent forms fall within the scope limited by the appended claims of the application equally.

[0038] Example 1 Preparation of the Chinese medicine composition for treating knee osteoarthritis of the present invention (I)

[0039] 18 parts of safflower, 18 parts of peach kernel, 12 parts of chuanxiong, 18 parts of angelica, 20 parts of centella asiatica, 10 parts of notoginseng, 12 parts of quinquefolius, 12 parts of frankincense, 12 parts of myrrh, 6 parts of cyperus, 15 parts of lycopodii herba, 6 parts of notopterygium, 6 parts of gentiana macrophylla, 18 parts of achyranthes bidentata, 12 parts of earthworms, and 12 parts of liquorice.

[0040] Example 2 Preparation of the Chinese medicine composition for treating knee osteoarthritis of the present invention (II)

[0041] 18 parts of safflower, 15 parts of peach kernel, 15 parts of chuanxiong, 10 parts of angelica, 30 parts of centella asiatica, 10 parts of notoginseng, 9 parts of quinquefolius, 15 parts of frankincense, 6 parts of myrrh, 10 parts of cyperus, 15 parts of lycopodii herba, 4 parts of notopterygium, 8 parts of gentiana macrophylla, 10 parts of achyranthes bidentata, 18 parts of earthworms, and 12 parts of liquorice.

[0042] Example 3 Preparation of the Chinese medicine composition for treating knee osteoarthritis of the present invention (III)

[0043] 15 parts of safflower, 21 parts of peach kernel, 6 parts of ligusticum chuanxiong, 26 parts of angelica, 20 parts of centella asiatica, 7 parts of notoginseng, 15 parts of quinquefolius, 6 parts of frankincense, 18 parts of myrrh, 6 parts of cyperus, 12 parts of lycopodii herba, 8 parts of notopterygium, 2 parts of gentiana macrophylla, 26 parts of achyranthes bidentata, 12 parts of earthworms, and 9 parts of liquorice.

[0044] Example 4 Preparation of the Chinese medicine composition for treating knee osteoarthritis of the present invention (IV)

[0045] 21 parts of safflower, 10 parts of peach kernel, 18 parts of chuanxiong, 18 parts of angelica, 15 parts of centella asiatica, 13 parts of panax notoginseng, 6 parts of quinquefolius, 18 parts of frankincense, 12 parts of myrrh, 4 parts of cyperus, 18 parts of lycopodii, 2 parts of notopterygium, 10 parts of gentiana macrophylla, 18 parts of achyranthes bidentata, 9 parts of earthworms, and 15 parts of liquorice.

[0046] Example 5 Preparation of the Chinese medicine composition for treating knee osteoarthritis of the present invention (V)

[0047] 10 parts of safflower, 26 parts of peach kernel, 12 parts of chuanxiong, 15 parts of angelica, 25 parts of centella asiatica, 4 parts of panax notoginseng, 18 parts of quinquefolius, 12 parts of frankincense, 9 parts of myrrh, 8 parts of cyperus, 9 parts of lycopodii herba, 10 parts of notopterygium, 6 parts of gentiana macrophylla, 15 parts of achyranthes bidentata, 15 parts of earthworms, and 6 parts of liquorice.

[0048] Example 6 Preparation of the Chinese medicine composition for treating knee osteoarthritis of the present invention (VI)

[0049] 26 parts of safflower, 18 parts of peach kernel, 9 parts of ligusticum chuanxiong, 21 parts of angelica, 10 parts of centella asiatica, 16 parts of notoginseng, 12 parts of quinquefolius, 9 parts of frankincense, 15 parts of myrrh, 2 parts of cyperus, 21 parts of lycopodii herba, 6 parts of notopterygium, 4 parts of gentiana macrophylla, 21 parts of achyranthes bidentata, 6 parts of earthworm, and 18 parts of liquorice.

[0050] Example 7 Preparation of the Chinese medicine composition for treating knee osteoarthritis of the present invention (VII)

[0051] 18 parts of safflower, 21 parts of peach kernel, 6 parts of ligusticum chuanxiong, 26 parts of angelica, 20 parts of centella asiatica, 7 parts of notoginseng, 15 parts of quinquefolius, 6 parts of frankincense, 18 parts of myrrh, 6 parts of cyperus, 12 parts of lycopodii herba, 8 parts of notopterygium, 2 parts of gentiana macrophylla, 26 parts of achyranthes bidentata, 12 parts of earthworms, and 9 parts of liquorice.

[0052] Example 8 Preparation of the Chinese medicine composition for treating knee osteoarthritis of the present invention (VIII)

[0053] 15 parts of safflower, 10 parts of peach kernel, 18 parts of chuanxiong, 18 parts of angelica, 15 parts of centella asiatica, 13 parts of notoginseng, 6 parts of quinquefolius, 18 parts of frankincense, 12 parts of myrrh, 4 parts of cyperus, 18 parts of lycopodii, 2 parts of notopterygium, 10 parts of gentiana macrophylla, 18 parts of achyranthes bidentata, 9 parts of earthworms, and 15 parts of liquorice.

[0054] Example 9 Preparation of the Chinese medicine composition for treating knee osteoarthritis of the present invention (IX)

[0055] 21 parts of safflower, 26 parts of peach kernel, 12 parts of ligusticum chuanxiong, 15 parts of angelica, 25 parts of centella asiatica, 4 parts of notoginseng, 18 parts of quinquefolium, 12 parts of frankincense, 9 parts of myrrh, 8 parts of cyperus, 9 parts of lycopodii herba, 10 parts of notopterygium, 6 parts of gentiana macrophylla, 15 parts of achyranthes bidentata, 15 parts of earthworms, 6 parts of liquorice.

[0056] Example 10 Preparation of the Chinese medicine composition for treating knee osteoarthritis of the present invention (X)

[0057] 10 parts of safflower, 18 parts of peach kernel, 9 parts of ligusticum chuanxiong, 21 parts of angelica, 10 parts of centella asiatica, 16 parts of notoginseng, 12 parts of quinquefolius, 9 parts of frankincense, 15 parts of myrrh, 2 parts of cyperus rotundus, 21 parts of lycopodii herba, 6 parts of notopterygium, 4 parts of gentiana macrophylla, 21 parts of achyranthes bidentata, 6 parts of earthworms, and 18 parts of liquorice.

[0058] Example 11 Preparation of the Chinese medicine composition for treating knee osteoarthritis of the present invention (XI)

[0059] 26 parts of safflower, 15 parts of peach kernel, 15 parts of chuanxiong, 10 parts of angelica, 30 parts of centella asiatica, 10 parts of notoginseng, 9 parts of quinquefolius, 15 parts of frankincense, 6 parts of myrrh, 10 parts of cyperus, 15 parts of lycopodii herba, 4 parts of notopterygium, 8 parts of gentiana macrophylla, 10 parts of achyranthes bidentata, 18 parts of earthworms, and 12 parts of liquorice.

[0060] Example 12 Preparation of an ointment for treating knee osteoarthritis of the present invention

[0061] Take each raw material medicine according to the weight proportion described in any one of Examples 1-11, add water to soak the medicine surface, decoct twice, each time for 1 hour, combine the decoctions, filter, concentrate the filtrate, add 1 / 5 volume of beeswax and yellow vaseline to the filtrate, decoct over low heat and stir, and cool to obtain a paste.

[0062] Example 13 Preparation of a gel for treating knee osteoarthritis of the present invention

[0063] Take each raw material medicine according to the weight ratio described in any one of Examples 1-11, add water to soak the medicine surface, decoct twice, each time for 1 hour, combine the decoction, filter, and concentrate the filtrate. Add carbomer to glycerol and grind it to moisten it, then add a small amount of distilled water to grind it, move it to a measuring cup, take triethanolamine, ethyl hydroxybenzoate, and distilled water in appropriate amounts to dissolve them, stir them into a gel, add an appropriate amount of distilled water to stir evenly, add the above-mentioned medicinal material filtrate concentrate, and grind it evenly to obtain it.

[0064] Example 14 Preparation of a transdermal patch for treating knee osteoarthritis of the present invention

[0065] Take each raw material drug according to the weight ratio described in any one of Examples 1-11, add water to soak the drug surface, decoct for 3 times, each time for 1 hour, combine the decoction, filter, and concentrate the filtrate. Add kaolin, glycerin and other conventional patch matrix to the filtrate, stir well, apply to the backing layer, and add a protective layer to obtain the patch.

[0066] Example 15: The optimal treatment method for knee osteoarthritis of the present invention is a method of treating with hot and wet compresses

[0067] Take each raw material medicine according to the weight ratio described in any one of Examples 1-11 and put it into a cloth bag, pack it with a cloth bag and tie it up tightly, put it into a casserole, and add 6 times the total mass of Chinese medicine raw materials. Heat and boil, and start timing after boiling. The boiling time is 10 minutes. Soak the towel while hot and wring it out, fold it into a square, and apply it to the affected part. When the towel is not too hot, change another towel to operate, and share three towels in rotation. Each hot compress time is 30 minutes. This method is used after the rubbing method, and the patting method is applied to increase heat penetration. When the patient feels that the heat is slightly reduced, the pressing method can be applied to make the central hot medicine juice penetrate with heat and extend the single hot compress time.

[0068] Example 16 Clinical efficacy experiment

[0069] 1.1 Case source

[0070] The cases observed in this study were all from 120 patients with knee osteoarthritis who visited the Massage Department of Shanghai Traditional Chinese Medicine Hospital from September 2023 to September 2024. They were randomly divided into a control group and a treatment group of 60 cases in each group using a random number table method.

[0071] 1. Clinical diagnosis

[0072] The diagnostic criteria refer to the diagnostic basis of the "Guidelines for the Diagnosis and Treatment of Knee Osteoarthritis in Traditional Chinese Medicine" (2020 edition):

[0073] ①Recurrent knee pain in the past month;

[0074] ② Those aged between 30 and 70;

[0075] ③Morning stiffness ≤30min;

[0076] ④ Bone friction sound (feeling) during activities;

[0077] ⑤X-ray films (standing or weight-bearing position) show narrowing of the joint space, subchondral bone sclerosis and / or cystic changes, and formation of osteophytes at the joint margins.

[0078] The diagnosis can be made if any two of ①, ②③④⑤ are met.

[0079] (II) Imaging grading

[0080] X-ray grading refers to the Kellgren-Lawrence imaging grading method

[0081] ①Level 0: No change (normal);

[0082] ② Grade I suspected osteophytes, normal joint space;

[0083] ③ Grade II: definite osteophytes and suspected narrowing of the joint space;

[0084] ④ Grade III: moderate amount of osteophytes, obvious narrowing of the joint space, and sclerotic changes;

[0085] ⑤Grade IV: There are a large number of osteophytes, the joint space is significantly narrowed, there are severe sclerotic changes and obvious deformities.

[0086] 1.2 Inclusion criteria

[0087] ① Meet the above diagnostic criteria and the disease duration is more than 2 months

[0088] ② Those who have not received any other treatment or taken any other medication in the past month

[0089] ③Patients with Kellgren-Lawrence radiological grade 1 to 3;

[0090] ④ Volunteer to participate in the study, sign the informed consent form, and can cooperate with the treatment

[0091] 1.3 Exclusion criteria

[0092] ①Complications affecting joints;

[0093] ② Patients with combined knee joint infection and immune diseases;

[0094] ③ Those who have had severe knee joint trauma;

[0095] ④ Those with skin infection or skin disease around the knee

[0096] ⑤ Those with allergic constitution and allergic to multiple drugs;

[0097] ⑥ Patients with severe primary diseases such as cardiovascular, cerebrovascular, liver, kidney, hematopoietic system, endocrine system, and mental illness;

[0098] 7. Those with a large amount of fluid accumulation in the joints;

[0099] 1.4 Elimination criteria

[0100] The reasons and time for the subjects to terminate the clinical trial shall be recorded in detail. Subjects who meet any one of the following six criteria shall be excluded:

[0101] ① Leading to serious adverse events;

[0102] ② During medication, the subject's original condition progresses seriously, or is combined with other serious diseases or has serious adverse reactions;

[0103] ③ The subjects have low compliance and fail to follow the doctor's advice;

[0104] ④ Subjects who voluntarily withdraw due to personal reasons;

[0105] ⑤ Those who take other drugs on their own during treatment and interfere with the research results;

[0106] ⑥ Those who were lost to follow-up or unable to be followed up.

[0107] 2. Research Methods

[0108] 2.1 Grouping method

[0109] The patients were randomly divided into a treatment group and a control group, with 60 patients in each group;

[0110] Control group: 32 males and 28 females; aged 46 to 68 years, with an average age of 56.9 years; the shortest course of disease was 3 months, the longest was 12 years, and the average course of disease was 4.2 years; among them, 24 cases involved left knee joints, 25 cases involved right knee joints, and 11 cases involved both knee joints.

[0111] Treatment group: 30 males and 30 females; aged 45-69 years old, with an average age of 57.0 years; the shortest course of disease was 4 months, the longest was 11 years, and the average course of disease was 4.0 years; among them, 23 cases were left knee joints, 27 cases were right knee joints, and 10 cases were bilateral knee joints.

[0112] 1.2 Diagnostic criteria

[0113] 2.2 Treatment methods

[0114] (1) Treatment group: the formula of above-mentioned embodiment 1: 15g of safflower, 18g of peach kernel, 12g of chuanxiong, 15g of angelica, 18g of centella asiatica, 12g of olibanum, 6g of frankincense, 6g of myrrh, 12g of cyperus, 18g of lycopodiella ciliata, 6g of notopterygium wilfordii, 6g of gentiana macrophylla, 18g of achyranthes bidentata, 12g of liquorice, which are heated and boiled, and the boiling time is counted, and the boiling time is 10 minutes. While hot, the towel is soaked and wrung out, folded into a square, and applied to the affected part. When the towel is not too hot, another towel is changed to operate, and three towels are used in rotation. The hot compress time is 30 minutes each time. This method is used after the rubbing method, and the patting method is applied to increase the heat penetration. When the patient feels that the heat is slightly reduced, the pressing method can be applied to make the central hot medicine juice penetrate out with heat, and the single hot compress time is extended.

[0115] (2) Control group: The patients were treated with hot water of the same temperature (without adding any Chinese medicine) combined with massage techniques, which were the same as those in the treatment group.

[0116] 2.3 Treatment options

[0117] The experimental group was treated with the formula of Example 15, hot compress and massage, and the control group was treated with hot water of the same temperature and the same massage. Each treatment lasted 30 minutes, 3 times a week, and the course of treatment was 3 weeks.

[0118] 2.4 Evaluation Method

[0119] The efficacy was evaluated by WOMAC scoring scale after each weekly treatment. The evaluation of knee joint function efficacy referred to the evaluation criteria for disease efficacy and syndrome efficacy in the Guiding Principles for Clinical Research of New Traditional Chinese Medicines.

[0120] 2.5 Clinical observation indicators

[0121] 2.5.1 Observation of therapeutic efficacy

[0122] The efficacy was evaluated after each weekly treatment using the Western Ontario and Mc-Master Osteoarthritis Index (WOMAC) scoring scale, with a total score of 0 to 96 points, including 24 items divided into three dimensions: pain (0 to 20 points), stiffness (0 to 8 points), and physiological function (0 to 68 points). The higher the score, the worse the knee joint function.

[0123] 2.5.2 Evaluation of knee joint function efficacy

[0124] The evaluation of knee joint function efficacy refers to the evaluation criteria for disease efficacy and syndrome efficacy in the "Guiding Principles for Clinical Research of New Chinese Medicines":

[0125] ①Clinical control: symptoms disappear, joint movement is normal, and WOMAC score decreases by ≥95%;

[0126] ② Significantly effective: symptoms disappear, joint movement is not restricted, and WOMAC score decreases by ≥70% and <95%;

[0127] ③Effective: symptoms are basically eliminated, joint movement is slightly limited, and WOMAC score is reduced by ≥30% and <70%;

[0128] ④ Ineffective: No significant improvement in symptoms and joint movement, and WOMAC score decreased by <30%.

[0129] 2.6 Observation time and follow-up methods

[0130] Treatment was given 3 times a week, each treatment lasted 30 minutes, and the course of treatment was 3 weeks.

[0131] 2.7 Statistical methods

[0132] SPSS 26.0 statistical software was used for data analysis. The data were expressed as percentages (%) and compared between groups using t-test. The enumeration data were expressed as rates (%) and compared between groups using χ2 test. P<0.05 indicated statistically significant differences.

[0133] 3. Research Results

[0134] After three weeks of treatment, the performance of the two groups of patients on the WOMAC score scale was as follows (Table 1):

[0135] Table 1 Improvement of WOMAC score (mean ± SD)

[0136] Group Before treatment After treatment P-value Experimental Group 63.80±6.30 27.00±4.80* <0.01 Control group 63.20±5.50 42.00±5.00 <0.05

[0137] *Comparison of WOMAC scores between the two groups after treatment, P<0.05, the difference was statistically significant.

[0138] After three weeks of treatment, the clinical efficacy of the two groups of patients was as follows (Table 2):

[0139] Table 2 Comparison of clinical efficacy between the two groups

[0140] Group Total number of people Number of recovered people Number of significant effects (people) Effective number (person) Invalid number (person) Total effective rate (%) Experimental Group 60 19 23 17 1 98.30* Control group 60 7 22 22 9 85.00

[0141] Note: Total effective rate = (number of cured patients + number of markedly effective patients + number of effective patients) / total number of patients × 100%. *Comparison of total effective rates between the two groups, P < 0.05, the difference is statistically significant.

[0142] The research results show that the Chinese medicine composition provided by the present invention has the effect of improving knee osteoarthritis, and the effect is better than that of the control group, with a significant difference compared with the control group.

[0143] 4 Typical Cases

[0144] 4.1 Case 1

[0145] The patient, Ms. Li, 62 years old, had left knee pain and limited activity for 3 years, which worsened for 1 month. When she came to the hospital, she had obvious pain in her left knee, especially when walking and going up and down stairs, accompanied by morning stiffness for about 20 minutes, and X-ray showed Kellgren-Lawrence grade III. She was diagnosed with knee osteoarthritis and included in the experimental group. After three weeks of treatment, the patient reported that the pain was significantly reduced, the range of motion increased, and the morning stiffness disappeared. The WOMAC score was 68 points before treatment and 14 points after treatment, and the efficacy was judged to be remarkable.

[0146] 4.2 Case 2

[0147] The patient, Mr. Wang, 58 years old, had recurrent pain in both knees for 2 years, with more severe symptoms in the right knee. At the time of consultation, both knees were tender and limited in activity, and X-ray showed Kellgren-Lawrence grade II. He was also included in the experimental group for treatment. After three weeks of treatment, the patient's knee pain was significantly relieved, and his activity ability basically returned to normal. The WOMAC score before treatment was 59 points, and after treatment it was 18 points. The efficacy was judged to be effective.

[0148] 5 Conclusion

[0149] The results of this study show that the use of the Chinese medicine composition provided by the present invention for hot and wet compress combined with massage manipulation to treat knee osteoarthritis can significantly reduce the pain of patients and improve knee joint function, and the total effective rate is as high as 98.3%, which is significantly better than 85.0% of the control group, and the difference is statistically significant (P<0.05). The Chinese medicine prescription is safe and effective, and is worthy of promotion and application in clinical practice.

[0150] Example 15 Animal Experiment

[0151] 1 Experimental Materials

[0152] 1.1 Animals

[0153] 65 male rats, weighing (140±20)g, were housed individually in cages and given regular diet and water. The circadian rhythm was maintained, the room temperature was controlled at 20-26℃, and the humidity was controlled at 45%-50%.

[0154] 1.2 Reagents and drugs

[0155] DMEM culture medium, ELISA detection kits for interleukin-1β (IL-1β), interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α), etc.

[0156] 1.3 Instruments

[0157] XTL250 stereo microscope, protein electrophoresis instrument, membrane transfer instrument, intelligent fumigation machine, etc.

[0158] 1.4 Modeling and grouping

[0159] The rats were divided into group 1 of the present invention, group 2 of the present invention, Shentong Zhuyu Decoction group, model group, and blank group; except for the blank group, all other rats were modeled;

[0160] The rat model of Qi stagnation and blood stasis syndrome of knee osteoarthritis was established by fixation of rat lower limbs. The specific modeling method was as follows: the rat hind limbs were fixed in the extended position by a tube-type plaster. The hair of the left hind limb of the rat was shaved first (from the ankle to the hip joint), and the left lower limb of the rat was wrapped with medical gauze (from the ankle to the hip joint). Then, 6 to 7 layers of medical plaster bandages were used to fix the left knee joint in the extended 180° position. Because too tight fixation will affect the blood circulation of the lower limbs, and too loose plaster will easily fall off and the fixation will fail, the fixation of the rat limbs and the end blood circulation should be observed regularly. When swelling of the rat lower limbs or damage and fall of the plaster are found, timely adjustment should be made.

[0161] The evaluation of the rat knee osteoarthritis model was carried out 3 weeks after modeling. Two model rats were randomly selected to evaluate the modeling situation. The specific method was to observe the stiffness of the knee joint and the walking ability, and take X-rays to evaluate the condition of the knee joint. Then the rats were killed by cervical dislocation, and the knee joints of the model rats were surgically opened to observe whether there was effusion and synovial swelling in the knee joint.

[0162] 1.5 Administration

[0163] Group 1 of the present invention: Take each raw material medicine according to the weight ratio described in Example 1 of the present invention, put it into a cloth bag, put it into a casserole, and add clean water 6 times the total weight of the Chinese medicine raw materials. Heat and boil, and start timing after boiling. The boiling time is 10 minutes to obtain the medicine juice, which is placed in the intelligent fumigation machine with a preset temperature of 40°C. Aim the steam outlet at the rat joint and spray it at a distance of 30 to 50 cm from the affected skin, three times a week for three weeks.

[0164] Group 2 of the present invention: Take each raw material medicine according to the weight ratio described in Example 9 of the present invention, put it into a cloth bag, put it into a casserole, and add 6 times the total weight of the Chinese medicine raw materials. Heat and boil, and start timing after boiling. The boiling time is 10 minutes to obtain the medicine juice, which is placed in the intelligent fumigation machine with a preset temperature of 40°C. Aim the steam outlet at the rat joint and spray it at a distance of 30 to 50 cm from the affected skin, three times a week for three weeks.

[0165] Shentong Zhuyu Decoction Group: Take each raw material medicine according to the weight ratio of Shentong Zhuyu Decoction, put it into a cloth bag, put it into a casserole, and add 6 times the total weight of the Chinese medicine raw materials. Heat and boil, and start timing after boiling. The boiling time is 10 minutes. Get the medicine juice and put it into the intelligent fumigation machine with the preset temperature of 40℃. Aim the steam outlet at the rat joints and spray it at a distance of 30-50cm from the affected skin, three times a week for three weeks.

[0166] Model group: Model rats were raised normally.

[0167] Blank group: rats without modeling were raised normally.

[0168] 1.6 Detection indicators

[0169] ELISA method was used to determine the expression levels of IL-1β, IL-6 and TNF-α in joint fluid. According to the determination requirements of the ELISA method, the supernatant of synovial cells of the left knee joint was used as the research object, and the microplate reader absorbance method was used for detection, and then the mass concentration of the target factor was calculated using software.

[0170] 1.7 Statistical analysis

[0171] SPSS 21.0 statistical software was used for analysis and processing. The data were expressed as (x±s), and the t-test was used for comparison among the groups.

[0172] 2 Results

[0173] Compared with the blank group, the expression levels of IL-1β, IL-6 and TNF-α in the synovial fluid of the knee joint cavity of the rats in the model group were significantly increased, and the difference was statistically significant, indicating that the inflammatory factors in the knee joint cavity of the rats in the model group were significantly higher than those in the blank group; compared with the model group, the expression levels of IL-1β, IL-6 and TNF-α in the synovial fluid of the knee joint cavity of the rats in the first group of the present invention were significantly decreased, and the difference was statistically significant; as shown in Table 2.

[0174] Table 2 Comparison of the expression levels of IL-1β, IL-6 and TNF-α in the synovial fluid of the knee joint cavity of rats in each group (x±s, n=10)

[0175]

[0176] In summary, compared with the blank group, the expression levels of inflammatory factors IL-1β, IL-6 and TNF-α in the synovial fluid of the knee joint cavity of rats in the model group were significantly increased, indicating that there was an obvious inflammatory reaction in the knee joint cavity of rats in the model group. Compared with the model group, the expression levels of inflammatory factors in the synovial fluid of the knee joint cavity of rats in group one of the present invention, group two of the present invention, and the body pain stasis soup group were all decreased, but the degree of decrease was different. Among them, the improvement effect of group one of the present invention was the most significant, and its inflammatory factor expression level was closest to the blank group, indicating that group one of the present invention can significantly relieve the pain of the early and middle stages of the knee joint and improve the range of motion and function of the knee joint. Although the body pain stasis soup group also has a certain improvement effect, its therapeutic effect is relatively weak compared with group one of the present invention. In summary, group one of the present invention has a definite therapeutic effect in the treatment of knee arthritis, and has a certain reference significance for clinical treatment.

[0177] The above is only a preferred embodiment of the present invention. It should be pointed out that ordinary technicians in this technical field can make several improvements and supplements without departing from the method of the present invention. These improvements and supplements should also be regarded as the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for treating knee osteoarthritis, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in proportions by weight: 10-26 parts of safflower, 10-26 parts of peach kernel, 6-18 parts of chuanxiong, 10-26 parts of angelica, 10-30 parts of centella asiatica, 4-16 parts of panax notoginseng, 6-18 parts of quinquefolius, 6-18 parts of frankincense, 6-18 parts of myrrh, 2-10 parts of cyperus rotundus, 9-21 parts of lycopodii herba, 2-10 parts of notopterygium wilfordii, 2-10 parts of gentiana macrophylla, 10-26 parts of achyranthes bidentata, 6-18 parts of earthworm, and 6-18 parts of liquorice.

2. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in proportions by weight: 15-21 parts of safflower, 15-21 parts of peach kernel, 9-15 parts of chuanxiong, 15-21 parts of angelica, 15-25 parts of centella asiatica, 7-13 parts of panax notoginseng, 9-15 parts of quinquefolius, 9-15 parts of frankincense, 9-15 parts of myrrh, 4-8 parts of cyperus rotundus, 12-18 parts of lycopodii herba, 4-8 parts of notopterygium wilfordii, 4-8 parts of gentiana macrophylla, 15-21 parts of achyranthes bidentata, 9-15 parts of earthworm, and 9-15 parts of liquorice.

3. The Chinese medicine composition according to claim 1, characterized in that The Chinese medicine composition is prepared from the following raw materials in proportion by weight: 18 parts of safflower, 18 parts of peach kernel, 12 parts of chuanxiong, 18 parts of angelica, 20 parts of centella asiatica, 10 parts of panax notoginseng, 12 parts of aconiti lobata, 12 parts of frankincense, 12 parts of myrrh, 6 parts of cyperus rotundus, 15 parts of lycopodii herba, 6 parts of notopterygium wilfordii, 6 parts of gentiana macrophylla, 18 parts of achyranthes bidentata, 12 parts of earthworm, and 12 parts of liquorice.

4. The Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The Chinese medicine composition is further prepared into an external dosage form.

5. The Chinese medicine composition according to claim 4, characterized in that: The external dosage form is an external liquid medicine, ointment, gel, paste or transdermal patch.

6. Use of the Chinese medicine composition according to any one of claims 1 to 5 in the preparation of a drug for treating knee osteoarthritis.

7. The use according to claim 4, characterized in that: The knee osteoarthritis is of Qi stagnation and blood stasis syndrome.

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