Traditional Chinese medicine formula and preparation process for treating knee arthritis

By preparing a traditional Chinese medicine pill containing processed Aconitum kusnezoffii and other drugs, the treatment problem of knee joint arthritis, especially the symptoms of yang deficiency and cold stagnation type, is solved, and effective relief and a convenient way of taking are achieved.

CN118319999BActive Publication Date: 2025-09-05鲁奕辰
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Patent Information

Application Number
CN202410475404.X
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2024-04-19
Publication Date
2025-09-05
Estimated Expiration
2044-04-19

AI Technical Summary

Technical Problem

The existing technology lacks effective traditional Chinese medicine formulas for treating knee arthritis, especially for the symptoms of yang deficiency and cold stagnation type knee arthritis such as limb joint pain, heaviness, and difficulty in flexion and extension, and the medicines are inconvenient to carry and take.

Method used

A traditional Chinese medicine formula, including processed Aconitum kusnezoffii, Piper longum, cloves, nutmeg, jujube, yak heart, agarwood, costus root and white cloud osmanthus, is made into pellets through wet heat sterilization, crushing, mixing and pill making, and is used to treat symptoms such as wind-cold-dampness arthralgia and joint pain.

Benefits of technology

This traditional Chinese medicine formula significantly alleviates the symptoms of yang deficiency and cold stagnation type knee joint arthritis through the effects of warming the meridians and dispersing cold, nourishing the heart and calming the mind, and improves the hygiene and portability of the medicine, making it easier for patients to take.

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Abstract

The invention discloses a traditional Chinese medicine formula for treating knee arthritis and a preparation process, relates to the technical field of knee arthritis, and aims to solve the problem of treating knee arthritis. The raw materials of the traditional Chinese medicine are composed of the following components, calculated by weight: 13.3-16.7 parts of processed aconite root, 7.3-10.7 parts of longan root, 2.8-6.2 parts of cloves, 2.8-6.2 parts of nutmeg, 25.3-28.7 parts of jujube, 2.8-6.2 parts of yak heart, 2.8-6.2 parts of agarwood, 2.8-6.2 parts of costus root, 2.8-6.2 parts of white cloud osmanthus, and 28.3-31.7 parts of terminalia chebula, which are ground and taken with water.
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Description

Technical Field

[0001] The present invention relates to the technical field of knee arthritis, and in particular to a traditional Chinese medicine formula and a preparation process for treating knee arthritis. Background Art

[0002] Yang deficiency and cold stagnation is mainly caused by the deficiency of Yang Qi and the decline of its function, so it is also called "deficiency and cold". Clinically, it manifests as fear of cold and cold limbs, pale complexion, vomiting of clear water, diarrhea, fatigue and preference for lying down, and meridian cramps. Knee joint arthritis is a type of Yang deficiency and cold stagnation, and the main reason is the deficiency of Qi and blood.

[0003] The main symptoms of knee arthritis are pain, heaviness, and difficulty in flexing and extending the limb joints. When the weather changes, that is, on rainy days, the symptoms will worsen, being milder during the day and worse at night. The pain increases when it is cold and decreases when it is hot, and the patient may even have difficulty sleeping all night. The body and limbs are cold, the limbs are not warm, and the patient feels tired and exhausted. The tongue is pale, the tongue coating is white, and the pulse is deep and thready.

[0004] Therefore, it is very necessary to develop a drug formula for treating knee arthritis. Summary of the Invention

[0005] In order to solve the above problem, that is, the problem of treating knee joint arthritis, the present invention provides a traditional Chinese medicine formula for treating knee joint arthritis. The raw materials are composed of the following components, calculated by weight: 13.3-16.7 parts of processed Aconitum kusnezoffii, 7.3-10.7 parts of Piper longum, 2.8-6.2 parts of cloves, 2.8-6.2 parts of nutmeg, 25.3-28.7 parts of Fructus jujubae, 2.8-6.2 parts of yak heart, 2.8-6.2 parts of Aquilaria sinensis, 2.8-6.2 parts of Costus root, 2.8-6.2 parts of Cortex chebulae, and 28.3-31.7 parts of Terminalia chebulae, which are ground into powder and taken orally.

[0006] The present invention is further configured as follows: the raw materials are composed of the following components, calculated by weight: 15 parts of processed aconite, 9 parts of long pipe, 4.5 parts of cloves, 4.5 parts of nutmeg, 27 parts of jujube, 4.5 parts of yak heart, 4.5 parts of agarwood, 4.5 parts of costus root, 4.5 parts of white cloud osmanthus, and 30 parts of terminalia chebula, which are ground and taken orally.

[0007] The preparation process of the traditional Chinese medicine formula for treating knee arthritis according to any one of the above-mentioned methods comprises the following preparation steps:

[0008] S1: Weighing: Weigh the medicinal materials in the raw materials according to the production instructions and then check the name and quantity; S2: Moist heat sterilization: Sterilize the raw materials weighed in step S1 with moist heat, set the sterilization temperature to 100-120°C, the sterilization time to 20 minutes, and dry them after the moist heat sterilization is completed;

[0009] S3: Powder screening: Finely grind the dried API, using a 100 mesh screen.

[0010] S4: Total mixing: The crushed APIs are mixed for 30 minutes;

[0011] S5: Mixing: Add cross-linked polyvinylpyrrolidone to the mixed API and mix evenly for 30 minutes;

[0012] S6: Mixing the drugs: Add the mixed APIs into a mixer, add water into the mixer, and stir for 20-30 minutes.

[0013] S7: Pellet making: The API stirred into a soft material is fed into a plodder, the API of the soft material is pressed into strips, and the strips are then conveyed onto a strip feeding wheel into a pellet making wheel for pellet making, and the prepared pill molds are placed on a stainless steel plate;

[0014] S8: Pill making: Pour the pill mold into a rotating pot and sprinkle a small amount of water into it. After the pill mold is soaked in water, sprinkle the raw material powder and water into the rotating pot to make the raw material powder adhere to the surface of the pill mold.

[0015] S9: Drying: Place the pellets in a 60°C environment for drying;

[0016] S10: Pill selection: The dried long pills are put into a centrifugal automatic pill selection machine to remove the pills that are not round, damaged, or stuck together;

[0017] S11: Packaging: Use pharmaceutical composite film to pack the selected qualified pellets, and each bag contains 6.32g; S12: Warehousing: Put the packaged finished products into the finished product warehouse.

[0018] The present invention is further configured such that steps S2-S11 need to be performed in a Class D clean area.

[0019] The present invention is further configured as follows: in step S2, the sterilization temperature is set to 115°C.

[0020] The present invention is further configured as follows: the raw material powder is sprinkled on the stainless steel plate in step S7.

[0021] The beneficial effects of the present invention are:

[0022] 1. In the traditional Chinese medicine formula disclosed in the present invention, processed Radix Aconiti Kusnezoffii dispels wind and dampness, warms the meridians and relieves pain. It is used for wind-cold-dampness arthralgia, joint pain, cold pain in the heart and abdomen, pain caused by cold hernia, and anesthesia and pain relief. Processed Radix Aconiti Kusnezoffii is pungent and warm, and is good at dispelling cold and dampness, and is known for warming the meridians and relieving pain. It is the monarch ingredient in the formula. Clove warms the middle and reduces adverse reactions, tonifies the kidney and supports yang; Piper longum warms the middle and dispels cold, promotes qi descent and relieves pain; Nutmeg warms the middle and promotes qi circulation, astringes the intestines and stops diarrhea, and Piper longum and cardamom support spleen yang. These three herbs assist the monarch ingredient in warming the meridians and dispelling cold, warming yang and relieving pain. Choerospondias axillaris is a traditional Mongolian medicine that promotes qi and blood circulation, nourishes the heart, and calms the mind. Yak heart, also known as "Heyi," is sedative, cardiotonic, and relieves pain. The two herbs used together have the function of supporting heart yang, while also warming the middle and replenishing qi, nourishing the heart and calming the mind. All of the above herbs serve as ministers. Agarwood promotes qi and relieves pain, warms the middle and stops vomiting, and promotes qi and relieves asthma. Costus root promotes qi and relieves pain, strengthens the spleen and aids digestion. Scutellaria baicalensis promotes blood circulation and relieves pain, detoxifies, promotes tissue regeneration, and cools the blood. These three herbs warm the middle and promote qi and relieve pain. Terminalia chebula astringes the intestines and relieves diarrhea, astringes the lungs and relieves cough, and reduces internal heat and relieves sore throat. In this formula, the Terminalia chebula fruit warms and astringes qi, preventing the other herbs from being too pungent and dispersing, which could deplete vital energy. These four herbs serve as adjuvants. The combined effects of all ten herbs in this formula dispel cold and relieve pain, warm the middle and invigorate qi, and nourish the heart and calm the mind. They are highly effective for knee arthritis characterized by yang deficiency and cold stagnation.

[0023] 2. The preparation process of the traditional Chinese medicine formula for treating knee arthritis disclosed in the present invention can further improve the hygiene of the formula medicine, and make the formula components into pellets, which are more convenient for patients to carry and take. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 Shown is a process flow chart of the present invention. DETAILED DESCRIPTION

[0025] Those skilled in the art can refer to the content of this article and appropriately improve the process parameters. It is particularly important to point out that all similar substitutions and modifications are obvious to those skilled in the art and are considered to be included in the present invention. The methods and applications of the present invention have been described through preferred embodiments. Relevant persons can modify or appropriately change and combine the methods and applications described herein without departing from the content, spirit and scope of the present invention to implement and apply the technology of the present invention.

[0026] Example 1

[0027] The invention provides a traditional Chinese medicine formula for treating knee arthritis. The raw materials are composed of the following components by weight: 13.3-16.7 parts of processed aconite root, 7.3-10.7 parts of longan root, 2.8-6.2 parts of cloves, 2.8-6.2 parts of nutmeg, 25.3-28.7 parts of jujube tree, 2.8-6.2 parts of yak heart, 2.8-6.2 parts of agarwood, 2.8-6.2 parts of costus root, 2.8-6.2 parts of white cloud osmanthus, and 28.3-31.7 parts of terminalia chebula.

[0028] Preferably, calculated by weight, the raw material consists of the following components: 15 parts of processed Aconitum, 9 parts of Piper longum, 4.5 parts of cloves, 4.5 parts of nutmeg, 27 parts of Strawberry, 4.5 parts of yak heart, 4.5 parts of Aquilaria, 4.5 parts of Costus root, 4.5 parts of Baiyunxiang, and 30 parts of Terminalia chebula.

[0029] The monarch drug in the above-mentioned raw material drug components,

[0030] Processed Aconitum: pungent, bitter, and hot in nature; has the effects of dispelling wind and dampness, warming the meridians and relieving pain; mainly used for wind-cold-dampness arthralgia, joint pain, cold pain in the heart and abdomen, and pain relief due to cold hernia.

[0031] The above raw material drug components include the auxiliary drug,

[0032] Piper longum: spicy in taste, hot in nature; warms the middle and dispels cold, relieves gas and relieves pain; mainly used for cold pain in the abdomen, vomiting, diarrhea, cold stagnation and qi stagnation, chest pain, heart pain, headache and toothache.

[0033] Clove: spicy, warm in nature; warms the middle and reduces adverse reactions, nourishes the kidney and aids yang; mainly used to treat spleen and stomach deficiency and cold, hiccups and vomiting, loss of appetite, vomiting and diarrhea, cold pain in the heart and abdomen, and kidney deficiency and impotence.

[0034] Nutmeg: pungent, bitter and warm in nature; warms the middle and astringes the intestines, promotes qi and aids digestion; mainly used to treat diarrhea, cold dysentery, abdominal distension and pain, loss of appetite and vomiting, and indigestion.

[0035] Guangzao: sweet and sour in taste, neutral in nature; it has the effects of promoting qi and blood circulation, nourishing the heart, calming the mind, resisting myocardial ischemia, and protecting heart function. It is mainly used for qi stagnation and blood stasis, chest pain, palpitations and shortness of breath, and restlessness.

[0036] Yak heart: sweet in taste, sweet after digestion, mild and moist in nature; suppresses "Long", calms the mind; mainly treats heart pain, arrhythmia, and angina pectoris.

[0037] Adjuvants in the above-mentioned raw material components,

[0038] Agarwood: It tastes spicy and bitter, and is slightly warm in nature; it promotes qi circulation and relieves pain, warms the middle and stops vomiting, and relieves asthma; it is mainly used for chest and abdominal distension and pain, vomiting and hiccups due to stomach cold, and shortness of breath due to kidney deficiency.

[0039] Costus root: pungent and bitter in taste, warm in nature; promotes qi circulation, relieves pain, strengthens the spleen, and helps digestion; mainly used to promote qi circulation, relieve pain, regulate the middle and relieve stagnation.

[0040] Baiyunxiang: spicy, slightly bitter, neutral in nature; has the effects of promoting blood circulation, detoxifying, stopping bleeding, promoting tissue regeneration, and relieving pain;

[0041] Terminalia chebula: bitter, sour, astringent in taste, neutral in nature, mainly used to astringe the lungs, astringe the intestines, and relieve gas.

[0042] The above raw materials are ground and taken orally.

[0043] It should be noted that when prescribing the Chinese medicine formula disclosed in the present invention for a patient, the patient's blood pressure needs to be tested in advance. If the patient's blood pressure is level 2 or above, or is still level 2 or above after taking antihypertensive drugs, the patient cannot take this Chinese medicine formula. Only when the blood pressure is lower than the level 2 blood pressure standard can the patient take this Chinese medicine formula.

[0044] The present invention is further described below with reference to specific examples, but the present invention is not limited to these specific examples.

[0045] Example 2

[0046] Raw material ingredients: processed Aconitum kusnezoffii 15g, Piper longum 9g, cloves 4.5g, nutmeg 4.5g, jujube 27g, yak heart 4.5g, agarwood 4.5g, costus root 4.5g, white cloud osmanthus 4.5g, terminalia chebula 30g.

[0047] This embodiment is a dose of medicine, and a dose of medicine is divided into 18 portions for taking. When taking, the patient takes 1 portion each time, twice a day, morning and evening, and grinds and takes it.

[0048] Example 3

[0049] Raw material ingredients: processed Aconitum kusnezoffii 13.3g, Piper longum 7.3g, Clove 2.8g, Nutmeg 2.8g, Ziziphus jujuba 25.3g, Yak heart 2.8g, Aquilaria sinensis 2.8g, Costus root 2.8g, Scutellaria baicalensis 2.8g, Terminalia chebula 28.3g.

[0050] This embodiment is a dose of medicine, and a dose of medicine is divided into 18 portions for taking. When taking, the patient takes 1 portion each time, twice a day, morning and evening, and grinds and takes it.

[0051] Example 4

[0052] The raw material components are: 16.7g of Radix Aconiti Kusnezoffii, 10.7g of Piper Longum, 6.2g of Cloves, 6.2g of Myristica Fragrance, 28.7g of Fructus Choerospondiatis, 6.2g of Psoralea Corylifolia, 6.2g of Aquilaria Sinensis, 6.2g of Aucklandia Rhizoma, 6.2g of Rhizoma Cibotii, and 31.7g of Terminalia Terminalia. This embodiment is a dose of 18 portions. When taking the dose, the patient takes 1 portion each time, twice a day, morning and evening, grind and drink with water.

[0053] Comparative Case 1

[0054] Ms. Li, 52 years old,

[0055] Chief complaint: Knee joint pain for more than 2 months, diagnosed as arthritis at another hospital, used Zhengtong patch for 2 consecutive weeks without good effect.

[0056] Current medical history: Knee joint pain, pain aggravated by movement, worse when exposed to cold, poor sleep, and morning stiffness of the knee joint.

[0057] Physical examination: BP: 130 / 85 mmHg, pale complexion, pale tongue, white fur, deep and thready pulse.

[0058] Diagnosis and prescription: Knee joint arthritis of yang deficiency and cold stagnation type / knee osteoarthritis.

[0059] Treatment principle: prescribe one dose of the raw material drug component in Example 2 for the patient, divide one dose into 18 portions, take one portion each time, grind and take twice a day, morning and evening, and return for a follow-up visit after 9 days.

[0060] Second visit: After taking the medicine, the knee pain was significantly relieved, the morning stiffness was basically gone, and the sleep improved. The effect was not changed. The patient was prescribed 2 sets of the raw material components of Example 2 again. Each set was divided into 18 portions. One portion was taken twice a day, morning and evening, grind and drink. The patient returned for a follow-up visit 18 days later.

[0061] Third diagnosis: After taking the medicine continuously, the patient's pain disappeared, the original symptoms no longer existed, and the prescription was not changed. Two pairs of the total raw material components of Example 2 were prescribed for the patient again. Each pair was divided into 18 portions, one portion each time, and taken twice a day, morning and evening, for grinding and taking to consolidate the therapeutic effect.

[0062] Comparative Case 2

[0063] Ms. Feng, 41 years old,

[0064] Chief complaint: Bilateral knee pain for more than two months. Diagnosed with knee osteoarthritis at another hospital, the treatment with western medicine was not satisfactory.

[0065] Current medical history: The patient has bilateral knee pain with a noticeable heaviness. The pain worsens with activity, the affected area has difficulty flexing and extending, and the pain worsens with weather changes. The pain is milder during the day and worse at night. The pain increases with cold and decreases with warmth, and the patient has poor sleep.

[0066] Physical examination: BP: 125 / 85 mmHg, pale complexion, pale tongue, white fur, deep and thready pulse.

[0067] Diagnosis: Knee joint arthritis of Yang deficiency and cold stagnation type / knee osteoarthritis (accompanied by bone hyperplasia).

[0068] Prescription: Prescribe one dose of the raw material drug component in Example 2 for the patient, divide one dose into 18 portions, take one portion each time, grind and take twice a day, morning and evening, and return for a follow-up visit after 9 days.

[0069] Second visit: After taking the medicine, the pain in bilateral knee joints was significantly relieved, the heaviness disappeared, the flexion and extension difficulty symptoms improved, and the sleep was slightly improved. The effect was not changed. The patient was prescribed 2 sets of the raw material components in Example 2 again. Each set was divided into 18 portions, one portion each time, twice a day, morning and evening, grind and take. The patient came back for a follow-up visit after 18 days.

[0070] Third diagnosis: After continuous medication, the pain basically disappeared, the joints were flexible, and the sleep improved. The effect was not changed. Two pairs of the total raw material components of Example 2 were prescribed for the patient again. Each pair was divided into 18 portions, one portion each time, and taken twice a day, morning and evening, for grinding and drinking to consolidate the therapeutic effect.

[0071] Comparative Case 3

[0072] Ms. Zhao, 32 years old,

[0073] Chief complaint: Left knee pain for more than 2 months. After external examination, it was confirmed to be knee osteoarthritis. Joint pain relief ointment was applied for 2 weeks, but the effect was not satisfactory.

[0074] Current medical history: The patient has pain in the left knee joint, which worsens during activity. Affected by weather changes, the pain increases when it is cold and decreases when it is warm, accompanied by insomnia.

[0075] Physical examination: BP: 120 / 80 mmHg, pale complexion, pale tongue, white fur, deep and thready pulse.

[0076] Diagnosis: Knee joint arthritis of Yang deficiency and cold stagnation type / knee osteoarthritis (accompanied by bone hyperplasia).

[0077] Prescription: Prescribe one dose of the raw material drug component in Example 2 for the patient, divide one dose into 18 portions, take one portion each time, grind and take twice a day, morning and evening, and return for a follow-up visit after 9 days.

[0078] Second visit: After taking the medicine for 3 days, the patient felt that the pain was significantly relieved, the heaviness disappeared, and the sleep was slightly improved. The effect was not changed, so the patient was prescribed 2 sets of the raw material components in Example 2 again. Each set was divided into 18 portions, one portion each time, and the medicine was ground and taken twice a day, morning and evening. The patient was reviewed again after 18 days.

[0079] Third diagnosis: After taking the medicine, the pain symptoms basically disappeared, sleep improved significantly, and the energy was abundant. The effect was not changed. Two pairs of the total raw material components of Example 2 were prescribed for the patient again. Each pair was divided into 18 portions, one portion each time, and taken twice a day, morning and evening, for grinding and drinking to consolidate the therapeutic effect.

[0080] Comparative Case 4

[0081] Mr. Zhou, 54 years old,

[0082] Chief complaint: Bilateral knee pain for several months, diagnosed as knee osteoarthritis in another hospital, but not diagnosed.

[0083] Current medical history: Bilateral knee pain with obvious heaviness, difficulty in flexion and extension of the affected area, pain increased with cold and reduced with heat, and poor sleep.

[0084] Physical examination: BP: 125 / 90 mmHg, pale tongue, white fur, deep and fine pulse.

[0085] Diagnosis: Knee joint arthritis of Yang deficiency and cold stagnation type / knee osteoarthritis.

[0086] Prescription: Prescribe one dose of the raw material drug component in Example 2 for the patient, divide one dose into 18 portions, take one portion each time, grind and take twice a day, morning and evening, and return for a follow-up visit after 9 days.

[0087] Second visit: After taking the medicine, the pain in bilateral knee joints was relieved, the heaviness basically disappeared, and the sleep was improved. The effect was not changed. The patient was prescribed 2 sets of the raw material components in Example 2 again. Each set was divided into 18 portions, one portion each time, twice a day, morning and evening, grind and take. The patient was reviewed again after 18 days.

[0088] Third diagnosis: After taking the medicine, the pain disappeared, the heaviness disappeared, the joints were flexible, and the sleep was good. The effect was not changed. Two pairs of the total raw material components of Example 2 were prescribed for the patient again. Each pair was divided into 18 portions, one portion each time, and taken twice a day, morning and evening, for grinding and drinking to consolidate the therapeutic effect.

[0089] Comparative Case 5

[0090] Mr. Zhou, 43 years old,

[0091] Chief complaint: right knee pain for more than one month. Treatment at an external hospital was confirmed with knee osteoarthritis.

[0092] Current medical history: pain in the right joints, which worsens with weather changes, stiffness in the morning, better during the day and worse at night, and poor sleep.

[0093] Physical examination: BP: 130 / 90 mmHg, pale tongue, white fur, deep and fine pulse.

[0094] Diagnosis: Knee joint arthritis of Yang deficiency and cold stagnation type / knee osteoarthritis (accompanied by bone hyperplasia).

[0095] Prescription: Prescribe one dose of the raw material drug component in Example 2 for the patient, divide one dose into 18 portions, take one portion each time, grind and take twice a day, morning and evening, and return for a follow-up visit after 9 days.

[0096] Second visit: After taking the medicine, the pain basically disappeared, the stiffness in the morning disappeared, and the sleep improved. The effect was not changed. The patient was prescribed 2 sets of the raw material components in Example 2 again, each set was divided into 18 portions, one portion each time, twice a day, morning and evening, grind and take. The patient came back for a follow-up visit after 18 days.

[0097] Third diagnosis: After taking the medicine, the pain disappeared, the patient slept well, and was full of energy. The effect was not changed. Two pairs of the total raw material components of Example 2 were prescribed for the patient again. Each pair was divided into 18 portions, one portion each time, and taken twice a day, morning and evening, for grinding and drinking to consolidate the therapeutic effect.

[0098] Example 4

[0099] The present invention also discloses a preparation process of a traditional Chinese medicine formula for treating knee arthritis as described in Example 1, comprising the following preparation steps:

[0100] S1: Weighing: Weigh the medicinal materials in the raw materials according to the production instructions and then check the name and quantity; S2: Moist heat sterilization: Sterilize the raw materials weighed in step S1 with moist heat, set the sterilization temperature to 100-120°C, the sterilization time to 20 minutes, and dry them after the moist heat sterilization is completed;

[0101] S3: Powder screening: Finely grind the dried API, using a 100 mesh screen.

[0102] S4: Total mixing: The crushed APIs are mixed for 30 minutes;

[0103] S5: Mixing: Add cross-linked polyvinylpyrrolidone to the mixed API and mix evenly for 30 minutes;

[0104] S6: Mixing the drugs: Add the mixed APIs into a mixer, add water into the mixer, and stir for 20-30 minutes.

[0105] S7: Pellet making: The API stirred into a soft material is fed into a plodder, the API of the soft material is pressed into strips, and the strips are then conveyed onto a strip feeding wheel into a pellet making wheel for pellet making, and the prepared pill molds are placed on a stainless steel plate;

[0106] S8: Pill making: Pour the pill mold into a rotating pot and sprinkle a small amount of water into it. After the pill mold is soaked in water, sprinkle the raw material powder and water into the rotating pot to make the raw material powder adhere to the surface of the pill mold.

[0107] S9: Drying: Place the pellets in a 60°C environment for drying;

[0108] S10: Pill selection: The dried long pills are put into a centrifugal automatic pill selection machine to remove the pills that are not round, damaged, or stuck together;

[0109] S11: Packaging: The qualified pellets are packaged using a pharmaceutical composite film, with each bag containing 6.32 g;

[0110] S12: Warehousing: Put the packaged finished products into the finished product warehouse.

[0111] Steps S2-S11 must be performed in a Class D cleanroom to ensure hygienic standards during production. The equipment sterilization temperature in step 2 is set to 115°C. The ratio of API to crospovidone in step S5 is 19:1. The mixing time in step S6 is set to 25 minutes. The API powder is sprinkled onto the stainless steel plate in step S7.

[0112] In summary, the traditional Chinese medicine formula disclosed in the present invention uses processed Radix Aconiti Kusnezoffii to dispel wind and dampness, warm the meridians and relieve pain. It is used for wind-cold-dampness arthralgia, joint pain, cold pain in the heart and abdomen, pain caused by cold hernia, and anesthesia to relieve pain. Processed Radix Aconiti Kusnezoffii is pungent and warm, and is good at dispelling cold and dampness, and is known for its warming the meridians and relieving pain. It is the monarch ingredient in the formula. Clove warms the middle and reduces adverse reactions, tonifies the kidney and supports yang; Piper longum warms the middle and dispels cold, promotes qi descent and relieves pain; Nutmeg warms the middle and promotes qi circulation, astringes the intestines and stops diarrhea, and Piper longum and cardamom support spleen yang. These three herbs assist the monarch ingredient in warming the meridians and dispelling cold, warming yang and relieving pain. Choerospondias axillaris is a traditional Mongolian medicine that promotes qi and blood circulation, nourishes the heart, and calms the mind. Yak heart, also known as "Heyi," is sedative, cardiotonic, and relieves pain. The two herbs used together can promote heart yang, while also warming the middle and replenishing qi, nourishing the heart and calming the mind. All of the above herbs serve as ministers. Agarwood promotes qi and relieves pain, warms the middle and stops vomiting, and promotes qi and relieves asthma. Costus root promotes qi circulation and relieves pain, strengthens the spleen and aids digestion. White cloud osmanthus promotes blood circulation and relieves pain, detoxifies, promotes tissue regeneration and cools the blood. The three herbs warm the middle and promote qi circulation and relieve pain. Terminalia chebula astringes the intestines and relieves diarrhea, astringes the lungs and relieves cough, reduces internal heat and relieves sore throat. In the prescription, Terminalia chebula flesh warms and astringes qi, which can prevent the other herbs in the prescription from being too pungent and dispersing, and damaging the vital energy. The above four herbs serve as adjuvants. The ten herbs in the prescription work together to dispel cold and relieve pain, warm the middle and invigorate qi, nourish the heart and soothe the mind, and have a good effect on knee arthritis of yang deficiency and cold stagnation type. The preparation process of the traditional Chinese medicine formula for treating knee arthritis disclosed in the present invention can further improve the sanitation of the formula medicine, and make the formula components into pills, which are more convenient for patients to carry and take.

[0113] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be within the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for treating knee arthritis, characterized in that: Calculated by weight, the raw material medicine is composed of the following components: 13.3-16.7 parts of processed Aconitum kusnezoffii, 7.3-10.7 parts of Piper longum, 2.8-6.2 parts of cloves, 2.8-6.2 parts of nutmeg, 25.3-28.7 parts of Fructus jujubae, 2.8-6.2 parts of yak heart, 2.8-6.2 parts of Aquilaria sinensis, 2.8-6.2 parts of Costus root, 2.8-6.2 parts of Cortex chebulae, and 28.3-31.7 parts of Terminalia chebulae. They are ground into powder and taken orally.

2. The Chinese medicine composition for treating knee arthritis according to claim 1, wherein: Calculated by weight, the raw material medicine is composed of the following components: 15 parts of processed Aconitum kusnezoffii, 9 parts of Piper longum, 4.5 parts of cloves, 4.5 parts of nutmeg, 27 parts of Strawberry, 4.5 parts of yak heart, 4.5 parts of Aquilaria sinensis, 4.5 parts of Costus root, 4.5 parts of Baiyunxiang, and 30 parts of Terminalia chebula, which are ground and taken orally.

3. A preparation process of a Chinese medicine composition for treating knee arthritis, characterized in that: The raw material drug is composed of the following components by weight: 13.3-16.7 parts of processed Aconitum kusnezoffii, 7.3-10.7 parts of Piper longum, 2.8-6.2 parts of cloves, 2.8-6.2 parts of nutmeg, 25.3-28.7 parts of Fructus Achyranthis Bidentatae, 2.8-6.2 parts of yak heart, 2.8-6.2 parts of Aquilaria sinensis, 2.8-6.2 parts of Costus root, 2.8-6.2 parts of Cortex Phellodendri, and 28.3-31.7 parts of Terminalia chebula. The method comprises the following preparation steps: S1: Weighing: Weigh the medicinal materials in the raw materials after checking the name and quantity according to the production instructions; S2: Moist heat sterilization: The API weighed in step S1 is sterilized by moist heat sterilization at a temperature of 100-120°C for 20 minutes. After moist heat sterilization, the API is dried. S3: Powder screening: Finely grind the dried API, using a 100 mesh screen. S4: Total mixing: The crushed APIs are mixed for 30 minutes; S5: Mixing: Add cross-linked polyvinylpyrrolidone to the mixed API and mix evenly for 30 minutes; S6: Mixing the drugs: Add the mixed APIs into a mixer, add water into the mixer, and stir for 20-30 minutes; S7: Pellet making: The API stirred into a soft material is fed into a plodder, the API of the soft material is pressed into strips, and the strips are then conveyed onto a strip feeding wheel into a pellet making wheel for pellet making, and the prepared pill molds are placed on a stainless steel plate; S8: Pill making: Pour the pill mold into a rotating pot and sprinkle a small amount of water into it. After the pill mold is soaked in water, sprinkle the raw material powder and water into the rotating pot to make the raw material powder adhere to the surface of the pill mold; S9: Drying: Place the pellets in a 60°C environment for drying; S10: Pill selection: The dried long pills are put into a centrifugal automatic pill selection machine to remove the pills that are not round, damaged, or stuck together; S11: Packaging: The qualified pellets are packaged using a pharmaceutical composite film, with each bag containing 6.32 g; S12: Warehousing: Put the packaged finished products into the finished product warehouse.

4. The preparation process of the Chinese medicine composition for treating knee arthritis according to claim 3, characterized in that: Steps S2-S11 need to be performed in a Class D clean area.

5. The preparation process of the Chinese medicine composition for treating knee arthritis according to claim 3, characterized in that: In step S2, the sterilization temperature is set to 115°C.

6. The preparation process of the Chinese medicine composition for treating knee arthritis according to claim 3, characterized in that: The raw material powder is sprinkled on the stainless steel plate in step S7.