Traditional Chinese medicine composition for preventing and treating arthropathy cold syndrome and preparation method thereof

Abstract

The invention relates to the technical field of medicine, in particular to a traditional Chinese medicine composition for preventing and treating arthropathy cold syndrome and a preparation method thereof.The traditional Chinese medicine composition comprises 3 g of rhizoma zingiberis, 5 g of cortex cinnamomi, 10 g of herba ephedrae, 10 g of radix angelicae, 15 g of radix paeoniae alba, 10 g of obscured homalomena rhizome, 5 g of herba epimedii, 10 g of kadsura pepper stem and 30 g of radix astragali. The preparation method comprises the following steps: obtaining raw material particles, soaking the raw material particles in a solution, decocting the raw material particles to obtain a decoction, filtering out dregs and impurities, and performing organic extraction to obtain a liquid medicine; respectively measuring each raw material particle and the drug effect to obtain a drug effect evaluation rate and a plurality of monarch drug component offset degrees, judging whether the preparation process of the traditional Chinese medicine composition is qualified or not based on the drug effect evaluation rate, and adjusting the soaking process based on the plurality of monarch drug component offset degrees or adjusting the extraction process based on the drug effect evaluation rate. And the preparation process is accurately adjusted. The preparation process is detected and adjusted, so that the medicine effect stability of the traditional Chinese medicine composition is ensured, and the medicine effect is improved.

Description

Technical Field

[0001] The present invention relates to the field of medical technology, and in particular to a traditional Chinese medicine composition for preventing and treating cold syndrome of arthritis and a preparation method thereof. Background Art

[0002] Arthritis is a degenerative change in bone tissue and joints. With aging, bone tissue is damaged over time, leading to chronic wear and tear of the cartilage covering the bone surface. In cold-dampness arthritis, the primary symptom is severe joint pain, exacerbated by cold and relieved by warmth. Secondary symptoms include severe lower back pain, pale tongue, greasy white fur, and a weak pulse. While existing traditional Chinese medicine formulas have the ability to dispel wind and cold, they suffer from slow onset, complex ingredients, and low standardization.

[0003] Chinese patent application publication number: CN111973672A, discloses a traditional Chinese medicine composition for treating osteoarthritis and cervical and lumbar disc herniation and its preparation method, which includes the raw materials: fangfeng, chuanxiong, chuanwu, kusnezoffii, scorpion, asarum, frankincense, difeng, schizonepeta, myrrh, qiannianjian, green peel, ephedra, angelica, dried ginger, notopterygium, calcite, cinnamon, cochinchinensis, safflower, angelica, fresh mulberry and locust, willow twig, camphor tree, sesame oil; although this technical solution involves the treatment of cervical and lumbar disc herniation, osteoarthritis, chronic blood stasis and other diseases caused by wind, cold and dampness, strain, and trauma. However, the number of raw medicinal materials in this technical solution is large and complex, which may lead to complicated interactions among active ingredients, making it difficult to elucidate the core pharmacological material basis and synergistic mechanism, and is not conducive to achieving the rigor of the compatibility logic and the precise control of the dosage threshold; and there is a lack of detection and adjustment processes in the preparation process of the Chinese medicine composition, which will lead to uncontrollable preparation process and affect the stability of the efficacy of the Chinese medicine composition. Summary of the Invention

[0004] To this end, the present invention provides a traditional Chinese medicine composition for preventing and treating cold syndrome of joint diseases and a preparation method thereof, so as to solve the problems in the prior art of insufficient rigor of the compatibility logic and precise control of the dosage threshold, as well as the lack of detection and adjustment process in the preparation process, which leads to uncontrollable preparation process and thus affects the stability of the efficacy of the traditional Chinese medicine composition.

[0005] To achieve the above object, the present invention provides a Chinese medicine composition for preventing and treating cold syndrome of joint disease, comprising:

[0006] The Chinese medicine composition is composed of the following components and raw materials in parts by weight:

[0007] Dried ginger 3g, cinnamon bark 5g, ephedra 10g, angelica dahurica 10g, white peony root 15g, qiannianjian 10g, epimedium 5g, kauri vine 10g, astragalus 30g;

[0008] Among them, dried ginger, cinnamon, ephedra, and angelica dahurica are the main medicines, white peony root, millennium sword, epimedium, and sea wind vine are the ministerial medicines, and astragalus is the adjuvant medicine.

[0009] The present invention also provides a method for preparing a traditional Chinese medicine composition for preventing and treating cold syndrome of joint diseases, wherein the preparation process comprises:

[0010] The raw materials used to prepare the traditional Chinese medicine composition are cleaned and dried in an oven, and the dried raw materials are crushed according to their medicinal properties to obtain corresponding raw material particles;

[0011] soaking each of the raw material particles in a corresponding solution, and then boiling the solution to obtain a decoction;

[0012] filtering out the medicinal residue and impurities in the decoction by a filtering device, and performing organic extraction by an extraction device to obtain a medicinal liquid;

[0013] Each of the raw material particles and the medicinal solution is measured to obtain a medicinal efficacy evaluation rate and several main medicinal component deviations, wherein the medicinal efficacy evaluation rate is obtained by weighted summation based on several content transfer rates, component ratio similarities, and target component weight coefficients;

[0014] Determining whether the preparation process of the traditional Chinese medicine composition is qualified based on the efficacy evaluation rate, and adjusting the soaking process based on the deviation degree of the plurality of the monarch drug components, or adjusting the extraction process based on the efficacy evaluation rate, when the preparation process is determined not to meet the requirements;

[0015] The preparation of the Chinese medicine composition is completed when the preparation process of the Chinese medicine composition is determined to be qualified or when the preparation process is determined to meet the requirements after corresponding adjustments are made.

[0016] Furthermore, the process of determining whether the preparation process of the traditional Chinese medicine composition is qualified based on the efficacy evaluation rate includes:

[0017] If the efficacy evaluation rate meets the first monitoring condition, it is determined to be qualified; if it does not meet the first monitoring condition, it is determined whether it meets the second monitoring condition, and if it meets the second monitoring condition, the reason for the unqualified preparation process of the traditional Chinese medicine composition is determined based on the deviation degree of the plurality of the monarch drug components and the corresponding adjustment;

[0018] or determining the reasons why the preparation process of the Chinese medicine composition is unqualified and making corresponding adjustments based on the efficacy evaluation rate when the second monitoring condition is not met;

[0019] Among them, the first monitoring condition is that the drug efficacy evaluation rate is greater than a first preset drug efficacy evaluation rate, and the second monitoring condition is that the drug efficacy evaluation rate is greater than a second preset drug efficacy evaluation rate and less than or equal to the first preset drug efficacy evaluation rate.

[0020] Further, when it is determined that the drug efficacy evaluation rate does not meet the first monitoring condition but meets the second monitoring condition, adjusting the soaking process is determined based on the mean deviation of the monarch drug component;

[0021] When it is determined that the efficacy evaluation rate does not meet the second monitoring condition, adjusting the extraction process based on the efficacy evaluation difference;

[0022] The mean deviation of the monarch drug component is the mean of several deviations of the monarch drug component, and the difference in efficacy evaluation is the difference between the second preset efficacy evaluation rate and the efficacy evaluation rate.

[0023] Furthermore, the process of adjusting the soaking process based on the mean deviation of the monarch drug component includes:

[0024] When determining the imbalance risk of each of the monarch drug triggering components based on the comparison results of the monarch drug component offset mean and the preset monarch drug component offset mean, increasing the ethanol concentration during the soaking process is determined based on the comparison results of the target component offset value and the preset target component offset value, and the increase in ethanol concentration is positively correlated with the target component offset value.

[0025] Furthermore, after the ethanol concentration adjustment is completed, when the imbalance risk of each of the monarch drug triggering components is re-determined based on the comparison result of the monarch drug component offset mean value with the preset monarch drug component offset mean value, the adjustment of the soaking time under different gradients is determined based on the comparison result of the target component offset value with the preset target component offset value;

[0026] Among them, different gradients are divided into core raw materials, auxiliary raw materials and blending raw materials according to the medicinal effects of the raw materials.

[0027] Furthermore, after completing the corresponding adjustments of the soaking process, the mean offset of the main medicine components is compared with the preset mean offset of the main medicine components and when it is determined that each main medicine still has the risk of triggering component imbalance, the corresponding reasons for failure and corresponding treatment are determined based on the efficacy evaluation difference.

[0028] Furthermore, the process of adjusting the extraction process based on the efficacy evaluation difference includes:

[0029] The reason is determined based on the comparison result of the efficacy evaluation difference value and the preset efficacy evaluation difference value, including:

[0030] When it is determined that the reason for failure is insufficient similarity of the component ratios, the extraction time in the extraction process is extended based on the ratio similarity offset value;

[0031] or when it is determined that the reason for failure is insufficient content transfer rate, increasing the extraction temperature during the extraction process based on the transfer rate offset value;

[0032] Alternatively, determining whether the raw material has problems based on microscopic identification structure differences and DNA barcode matching rates, and if it is determined that the raw material does not have problems, conducting a review based on the efficacy evaluation difference;

[0033] The ratio similarity offset value is the absolute value of the difference between the component ratio similarity and the preset component ratio similarity, and the transfer rate offset value is the absolute value of the difference between the content transfer rate and the preset content transfer rate.

[0034] Furthermore, when it is determined that the reason for failure is insufficient similarity of the component ratio, the extraction time is extended based on the comparison result of the ratio similarity offset value and the preset ratio similarity offset value, and the extension of the extraction time is positively correlated with the ratio similarity offset value.

[0035] Furthermore, when it is determined that the reason for failure is insufficient content transfer rate, the extraction temperature is increased based on the comparison result of the transfer rate offset value and the preset transfer rate offset value, and the increase in the extraction temperature is positively correlated with the transfer rate offset value.

[0036] Compared with the prior art, the preparation method of a traditional Chinese medicine composition for preventing and treating cold syndrome of joint diseases of the present invention has the beneficial effect that, in this method, the raw materials are cleaned and dried, and pulverized according to the medicinal properties to obtain corresponding raw material particles; each raw material particle is soaked in a corresponding solution and decocted after soaking to obtain a decoction, the decoction is filtered to remove the residue and impurities, and an organic extraction is performed to obtain a medicinal liquid; each raw material particle and the efficacy are respectively measured to obtain an efficacy evaluation rate and several deviation degrees of the main medicinal components, and whether the preparation process of the traditional Chinese medicine composition is qualified is determined based on the efficacy evaluation rate, and the soaking process is adjusted based on the deviation degrees of several main medicinal components, or the extraction process is adjusted based on the efficacy evaluation rate, and then the preparation process is accurately adjusted, thereby ensuring the efficacy stability and improving the efficacy during the preparation process of the traditional Chinese medicine composition.

[0037] Furthermore, the present invention also sets a first monitoring condition and a second monitoring condition and compares them with the efficacy evaluation rate. When it is determined that the efficacy evaluation rate does not meet the first monitoring condition but meets the second monitoring condition, it is determined to adjust the soaking process based on the mean value of the main medicinal component offset. When it is determined that the efficacy evaluation rate does not meet the second monitoring condition, it is determined to adjust the extraction process based on the efficacy evaluation difference. In this way, the specific reasons for the unqualified preparation process of the traditional Chinese medicine composition and the corresponding adjustments can be accurately determined, thereby improving the adjustment efficiency.

[0038] Furthermore, the present invention can increase the ethanol concentration in the soaking process according to the comparison result of the target component offset value and the preset target component offset value when it is determined that the soaking process needs to be adjusted based on the efficacy evaluation rate, and further determines the imbalance risk of the monarch drug triggering component based on the monarch drug component offset mean value. Moreover, after completing the adjustment of the ethanol concentration, it can also determine the soaking time under different gradients according to the comparison result of the target component offset value and the preset target component offset value when the monarch drug triggering component imbalance risk is re-determined based on the monarch drug component offset mean value, so as to achieve precise adjustment, thereby improving the soaking process to ensure the stability of the preparation process of the traditional Chinese medicine composition, and improving the efficacy evaluation rate to improve the efficacy.

[0039] Furthermore, after completing the corresponding adjustment of the soaking process, the present invention can determine based on the mean value of the deviation of the main medicine components whether the main medicine still has the risk of triggering component imbalance, and then switch to the efficacy evaluation difference to make a judgment to determine whether to adjust the extraction process, thereby improving the efficacy evaluation rate.

[0040] Furthermore, the present invention is based on the fact that when it is determined that the reason for the unqualified preparation process is insufficient similarity of the component proportions based on the difference in efficacy evaluation, the extraction time in the extraction process can be adjusted based on the proportion similarity offset value, thereby promoting the release of slow-soluble components and optimizing the dissolution balance of the target components, thereby improving the preparation process of the Chinese medicine composition to improve the efficacy evaluation rate; when it is determined that the reason for the unqualified preparation process is insufficient content transfer rate, the extraction temperature in the extraction process can be adjusted based on the transfer rate offset value, thereby changing the solubility difference of different components, thereby improving the preparation process of the Chinese medicine composition to improve the efficacy evaluation rate; and when the raw materials are tested to determine whether there is a problem with the raw materials, if it is determined that there is a problem with the raw materials, the preparation of the same batch of Chinese medicine compositions is stopped; if it is determined that there is no problem with the raw materials, a review is conducted to determine whether there is a problem with the equipment or insufficient similarity in proportions or insufficient content transfer rate, thereby enabling targeted adjustments to improve the efficacy evaluation rate.

[0041] Furthermore, the uses and effects of the various components of the Chinese medicine composition are as follows: dried ginger can warm the middle and replenish yang, dispel cold and dredge the meridians; cinnamon can help the yang in the kidneys, and has the effects of warming and replenishing kidney yang, warming the middle and expelling cold, and promoting blood circulation; the combination of dried ginger and cinnamon can enhance the effects of replenishing fire and yang, dispelling cold and relieving pain; ephedra and angelica can open up lung depression, dispel wind and cold, dredge the pores, penetrate the hair pores and dispel cold and dampness; the combination of dried ginger, cinnamon, ephedra and angelica can achieve the effects of promoting yang and expelling evil, and clearing hair and condensation. White peony root can dredge meridians and relieve pain; Rhizoma Chuanxiong, Herba Epimedii and Herba Piperis have the function of strengthening tendons and bones; Astragalus can replenish Qi and consolidate the defense, assist Ephedra, dried ginger and cinnamon in warming the meridians and relieving pain, and also control the excessive dispersion of Ephedra; the Chinese medicine composition prepared by using various component raw materials can achieve the functions of warming the meridians, dispersing cold and relieving pain, as well as nourishing Qi and promoting blood circulation, and tonifying the liver and kidneys, thereby treating cold symptoms of joint diseases, so as to remove cold and dampness, promote the flow of Yang Qi, strengthen tendons and bones, and relieve joint pain. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] Figure 1 This is a schematic diagram of the modules of the system for preparing the Chinese medicine composition for preventing and treating cold syndrome of joint diseases according to the present invention;

[0043] Figure 2 Schematic diagram of the process for preparing the Chinese medicinal composition for preventing and treating cold syndrome of joint diseases according to the present invention;

[0044] Figure 3 This is a logic decision diagram for determining whether the preparation process of a traditional Chinese medicine composition is qualified based on the efficacy evaluation rate and performing corresponding processing based on the deviation degree of the main medicinal component in the present invention;

[0045] Figure 4 This is a logic decision diagram for determining the reasons for failure in the preparation process of a traditional Chinese medicine composition based on the difference in efficacy evaluation and the corresponding treatment in the present invention. DETAILED DESCRIPTION

[0046] The preferred embodiments of the present invention are described below with reference to the accompanying drawings. It should be understood by those skilled in the art that these embodiments are only used to explain the technical principles of the present invention and are not intended to limit the scope of protection of the present invention.

[0047] It should be noted that, in the description of the present invention, unless otherwise expressly specified or limited, the term "connection" should be understood in a broad sense. For example, it can mean a fixed connection, a detachable connection, or an integral connection; it can mean a mechanical connection or an electrical connection; it can mean a direct connection or an indirect connection through an intermediate medium; it can mean internal communication between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on specific circumstances.

[0048] The Chinese medicine composition is composed of the following components in parts by weight: 3g of dried ginger, 5g of cinnamon bark, 10g of ephedra, 10g of angelica dahurica, 15g of white peony root, 10g of radix schoenophorae, 5g of epimedium, 10g of kauri vine, and 30g of astragalus. Among them, dried ginger, cinnamon bark, ephedra, and angelica dahurica are the main drugs, white peony root, radix schoenophorae, epimedium, and kauri vine are the auxiliary drugs, and astragalus is the adjuvant. Therapeutic method: clearing heat and dampness, promoting blood circulation and relieving numbness. And it has the following two meanings:

[0049] Meaning of the prescription: The dried ginger in the prescription is hot in nature, with a stronger pungent property, which can warm the middle and replenish yang, dispel cold and unclog the meridians; cinnamon is pungent and sweet in taste, and hot in nature. Its nature is stagnant and not moving, and it tends to warm the lower part of the body, which can help the yang in the kidney, and has the effects of warming and replenishing kidney yang, warming the middle and expelling cold, and promoting blood circulation; the two medicines together can replenish fire and assist yang, and have a better effect of dispersing cold and relieving pain; ephedra and white atractylodes are pungent and warm in nature, and are light and upward in nature, good at opening lung depression, dispersing wind and cold, dredging the pores, and penetrating the hair pores, and their ability to disperse and penetrate the surface can dispel cold and dampness; the four are used together as the main medicine, which can externally promote the surface, unblock yang and expel evil, and internally expel condensed cold evil, repel the outside and bring peace to the inside, and eliminate numbness and pain. White peony root relieves numbness and promotes blood circulation, unblocks meridians and relieves pain; Qiannianjian, Epimedium and Piper meridionalis work together to dispel wind and unblock meridians, expel numbness and relieve pain, and strengthen tendons and bones, and are assistant drugs; Astragalus membranaceus replenishes qi and strengthens the defense, assists ephedra, dried ginger and cinnamon in warming the meridians and relieving pain, and also controls the over-dispersing nature of ephedra, and is an adjuvant drug; looking at the whole prescription, it focuses on warming the meridians, dispersing cold and relieving pain, supplemented by products that nourish qi, promote blood circulation, and nourish the liver and kidneys, so that the cold and dampness are removed and the yang qi is unblocked, the tendons and bones are strengthened, the joint pain is relieved and can be flexed and extended freely, taking into account both evil and righteousness, eliminating evil without harming the righteousness, and supporting the righteousness without retaining evil.

[0050] Formula Meaning 2: Self-designed Wenjingtongbi Decoction. The base formula is from the first volume of the "Golden Chamber Synopsis" - Wutou Decoction, and is refined based on the applicant's clinical experience. This formula has the effects of warming the meridians and dispersing cold, removing dampness and relieving numbness. It is mainly used to treat cold-dampness blocking the joints. The formula composition is: dried ginger, cinnamon (added last), ephedra, angelica dahurica (the four main ingredients), white peony root, Qiannianjian, Epimedium (Xianlingpi), Piper mesenteriae, and Astragalus. In the formula, dried ginger and cinnamon warm the meridians and dredge the blood vessels, dispel cold and relieve pain, promote qi and blood circulation, and circulate the meridians; ephedra and Angelica dahurica dispel wind and cold, remove dampness and relieve pain, promote blood circulation and dredge the meridians, and promote diuresis and reduce swelling; Qiannianjian and Epimedium nourish the liver and kidneys, strengthen the tendons and bones, and promote blood circulation and dredge the meridians; Piper mesenteriae dispels rheumatism, dredges the meridians, and relieves pain; Astragalus and white peony root promote diuresis and reduce swelling, nourish blood and soften the liver, and relieve acute pain. The combination of these medicines has the effects of warming the meridians and dispelling cold, nourishing blood and unblocking meridians, nourishing the liver and kidneys, and strengthening the tendons and bones.

[0051] This traditional Chinese medicine composition utilizes non-toxic herbs as its core formula. Dried ginger and cinnamon replace aconite to achieve safe warming effects. The unique "ephedra + angelica" formula synergizes in promoting diaphoresis and dispelling dampness, enhancing its effectiveness. The high dose of 30g of astragalus not only limits the excessive dispersibility of ephedra but also enhances the overall efficacy of the formula through the "Qi movement leads to blood circulation" mechanism. Use one dose daily, for a course of seven doses.

[0052] See also Figure 1As shown, it is a module diagram of the preparation system of the traditional Chinese medicine composition for preventing and treating cold syndrome of joint diseases in this embodiment. The system includes a particle preparation module, a soaking module, a decoction module, a filtration module, an extraction module, a detection module, an analysis module, a regulation module and an output module. Among them, the particle preparation module is used to clean the raw materials for preparing the traditional Chinese medicine composition and perform an oven drying process, and the dried raw materials are crushed according to the medicinal properties to obtain corresponding raw material particles; the soaking module is connected to the particle preparation module to obtain each raw material particle and soak it in the corresponding solution; the decoction module is connected to the soaking module to obtain each raw material particle that has completed the soaking and decoct it to obtain a decoction liquid; the filtration module is connected to the decoction module to obtain the decoction liquid and filter it to filter out the residue and impurities; the extraction module is connected to the filtration module to perform organic extraction on the decoction liquid to obtain a medicinal liquid; the detection module is connected to the particle preparation module and the extraction module respectively, to measure each raw material particle and the medicinal liquid respectively to obtain the efficacy evaluation rate and the deviation degree of several main medicinal components, wherein the efficacy evaluation rate is based on several contents The transfer rate, the similarity of the component ratio and the weight coefficient of the target component are weighted and summed to obtain the result; the analysis module is connected to the detection module to determine whether the preparation process of the Chinese medicine composition is qualified based on the efficacy evaluation rate, and to determine the cause and generate corresponding adjustment instructions when it is determined that the preparation process does not meet the requirements; the adjustment module is respectively connected to the analysis module, the soaking module and the extraction module to adjust the soaking process based on the deviation of several main medicinal components when it is determined that the preparation process does not meet the requirements, or to adjust the extraction process based on the efficacy evaluation rate; the output module (not shown in the figure) is respectively connected to the analysis module and the adjustment module to complete the preparation of the Chinese medicine composition when the analysis module determines that the preparation process of the Chinese medicine composition is qualified or when the preparation process is determined to meet the requirements after corresponding adjustments, and output the prepared Chinese medicine composition.

[0053] See also Figure 2 , which is a schematic flow diagram of the preparation method of the Chinese medicine composition for preventing and treating cold syndrome of joint disease in this embodiment. The process includes at least the following steps:

[0054] S1: Each raw material used to prepare the traditional Chinese medicine composition is cleaned and dried in an oven, and each dried raw material is crushed according to its medicinal properties to obtain corresponding raw material particles.

[0055] S2: soaking each raw material particle in a corresponding solution, and boiling the raw material particles after the soaking to obtain a decoction.

[0056] S3: filtering out the medicinal residue and impurities in the decoction through a filtering device, and performing organic extraction through an extraction device to obtain a medicinal liquid.

[0057] S4: Measure each raw material particle and the drug solution separately to obtain the drug efficacy evaluation rate and the deviation degree of several main drug components.

[0058] S5: determining whether the preparation process of the traditional Chinese medicine composition is qualified based on the efficacy evaluation rate, and adjusting the soaking process based on the deviation degree of several main medicinal components, or adjusting the extraction process based on the efficacy evaluation rate, if the preparation process is determined not to meet the requirements;

[0059] S6: When the preparation process of the Chinese medicine composition is determined to be qualified or when the preparation process is determined to meet the requirements after corresponding adjustments are made, the preparation of the Chinese medicine composition is completed.

[0060] Specifically, in this embodiment, the raw material processing process includes: washing to remove impurities such as mud and sand; the drying temperature is set to be less than or equal to 60°C to avoid loss of effective ingredients; the raw material particle diameter is set to 2mm-5mm to increase the contact area and improve extraction efficiency. The extraction process includes soaking each raw material particle in a solution of different ethanol concentrations for 0.5-1 hour; the decoction process includes heating the soaked raw material particles to boiling, then reducing the heat to a low boil and decocting for 2-3 times (60 minutes for the first time and 30 minutes each time for each subsequent time) to obtain a decoction. Filtration process: The pore diameter of the filter membrane or filter screen in the filtration device can be set to 0.45μm-0.55μm, and the purity of the filtrate can be adjusted by adjusting the filter membrane or filter screen in the filtration device; the filtrate is then extracted by the extraction device to obtain the final medicinal liquid. During the extraction process, an organic solvent-ethanol can be used for extraction, and combined with ultrasonic or microwave-assisted extraction. It should be noted that the ethanol is food-grade ethanol, and the ethanol content in the medicinal liquid after extraction meets the standard. Ethanol can be used to improve the extraction efficiency of fat-soluble components in the traditional Chinese medicine composition. Detection process: During the detection and determination process, 1-2 representative components can be selected for each medicinal material according to the pharmacological activity or pharmacopoeia regulations (such as 6-gingerol is selected as the target component for dried ginger). The target component is required to be stable and related to the efficacy; among them, the single content transfer rate is the ratio of the target component value in a single raw material particle to the corresponding target component value in the medicinal solution, and the component ratio similarity is the proportional offset value of each target component value in the currently prepared medicinal solution and the corresponding target component value in the standard batch medicinal solution. The target component weight coefficient is set according to the contribution to the efficacy. For example, for dried ginger as the main medicine, its target component 6-gingerol can be set with a weight coefficient of α=0.75 and β=0.25. The preparation process is evaluated by the efficacy evaluation rate. The process can be monitored to avoid the risk of "sufficient active ingredients but distorted efficacy"; each raw material particle can be tested to obtain the corresponding Chinese medicine quality, and the target component content in the corresponding Chinese medicine can be measured and obtained, and the target component value of the Chinese medicine can be calculated based on the Chinese medicine quality and the corresponding target component content, and then several target component values ​​of the Chinese medicine can be obtained; the medicinal liquid can be tested to obtain the corresponding filtrate volume, and the target component content corresponding to the raw material in the medicinal liquid can be measured and obtained, and the target component value of the medicinal liquid can be calculated based on the medicinal liquid volume and the target component content in the medicinal liquid, and then several target component values ​​in the medicinal liquid can be obtained; a single content transfer rate is calculated based on the ratio of a single raw material target component value to the corresponding filtrate target component value. It can be understood that the determination method for the target component can be accurately and quantitatively measured by HPLC (high performance liquid chromatography), and other methods can also be selected for determination, which will not be described here. The deviation degree of the monarch drug component is the degree of deviation between the actual content of the key active ingredient of the monarch drug and the theoretical standard content.

[0061] See also Figure 3As shown in FIG, it is a logic determination diagram for determining whether the preparation process of the Chinese medicine composition is qualified based on the efficacy evaluation rate and performing corresponding processing based on the deviation degree of the main drug component in this embodiment. The process of determining whether the preparation process of the Chinese medicine composition is qualified based on the efficacy evaluation rate includes:

[0062] If the efficacy evaluation rate meets the first monitoring condition, it is judged to be qualified; if it does not meet the first monitoring condition, it is determined whether it meets the second monitoring condition, and when it meets the second monitoring condition, the reason why the preparation process of the traditional Chinese medicine composition is unqualified and the corresponding adjustment are determined based on the deviation of several of the main medicinal components; or when it does not meet the second monitoring condition, the reason why the preparation process of the traditional Chinese medicine composition is unqualified and the corresponding adjustment are determined based on the efficacy evaluation rate; wherein, the first monitoring condition is that the efficacy evaluation rate is greater than the first preset efficacy evaluation rate, and the second monitoring condition is that the efficacy evaluation rate is greater than the second preset efficacy evaluation rate and is less than or equal to the first preset efficacy evaluation rate.

[0063] Specifically, in this embodiment, a preset efficacy evaluation rate Q0 corresponding to the efficacy evaluation rate Q is set as a threshold value, and whether the current preparation process is qualified is determined based on the comparison result of Q and Q0. When it is determined to be unqualified, the specific reason can be determined based on the comparison of Q and Q0. The subsequent preset or critical parameter values ​​are determined based on historical qualified batch data and combined with statistical analysis methods. In order to more accurately judge the preparation process and refine the corresponding parameter adjustment in the preparation process, Q0 can be divided into a first preset efficacy evaluation rate Q1 and a second preset efficacy evaluation rate Q2, and Q1=0.92% and Q2=0.89% are set. Q1 is the qualified limit value and Q2 is the warning trigger value. The comparison process based on Q, Q1 and Q2 is as follows:

[0064] If Q is greater than Q1, then meet the first monitoring condition, illustrate that the content transfer rate of each target component in the medicinal liquid at this time, component ratio all can satisfy the use of medicinal effect, therefore judge that the preparation process of current Chinese medicine composition is qualified.If Q is greater than Q2 and less than or equal to Q1, then meet the second monitoring condition, although Q at this time is not within the qualified limit value, it also does not exceed the warning trigger value, can illustrate that the problem existing in current preparation process is relatively light, now can be measured according to for each monarch medicine and obtain several monarch medicine component deviation degrees and carry out mean calculation to obtain monarch medicine component deviation mean R, on the basis of the comparison of Q and Q0, combine R to carry out further additional judgment, now by introducing new parameters, can avoid relying on single index, to improve the accuracy of judgment process.If Q is less than or equal to Q2, then neither meet the first monitoring condition nor meet the second monitoring condition, directly judge that the preparation process of current Chinese medicine composition is unqualified, now can carry out difference calculation according to Q2 and Q to obtain medicinal effect evaluation difference W, based on W, determine the reason of unqualified and carry out corresponding adjustment.

[0065] Furthermore, when it is determined that the efficacy evaluation rate does not meet the first monitoring condition and meets the second monitoring condition, the soaking process is adjusted based on the mean value of the monarch drug component offset; when it is determined that the efficacy evaluation rate does not meet the second monitoring condition, the extraction process is adjusted based on the efficacy evaluation difference; wherein, the mean value of the monarch drug component offset is the average of several monarch drug component offsets, and the efficacy evaluation difference is the difference between the second preset efficacy evaluation rate and the efficacy evaluation rate.

[0066] Specifically, in this embodiment, during the preparation of traditional Chinese medicine, the extraction process has a significantly greater impact on the efficacy evaluation rate Q than the soaking process. When the efficacy evaluation rate Q meets the second monitoring condition, the soaking process can be further monitored based on the mean deviation R of the main medicinal component to quantify the soaking process and determine whether the traditional Chinese medicine composition at this time is usable and determine the corresponding treatment method when it is unusable; when the efficacy evaluation rate Q does not meet the second monitoring condition, the extraction process can be further monitored based on the efficacy evaluation difference W to determine the reason for the unqualified preparation process and the corresponding treatment. Set a critical main medicinal component deviation mean R0 = 10%, and the comparison process based on R and R0 is as follows:

[0067] If R is less than or equal to R0, it means that the current monarch medicines have not triggered the risk of component imbalance during the preparation process, and will not have an invalid effect on the efficacy of the current medicinal solution. Even if Q does not meet the first monitoring condition, it can be determined that the current Chinese medicine composition preparation process is reliable and no corresponding adjustment is required. If R is greater than R0, it means that the current monarch medicines have triggered the risk of component imbalance during the preparation process, which will have an invalid effect on the efficacy of the current medicinal solution. However, since Q at this time still meets the second monitoring condition, Q is greater than the warning trigger value. Even if it will affect the efficacy, the risk of the impact is small. Therefore, the ethanol concentration during the immersion process or the immersion time under different gradients can be adjusted accordingly to promote solvent penetration, thereby improving Q and improving the preparation process of the Chinese medicine composition.

[0068] Furthermore, the process of adjusting the soaking process based on the mean offset of the monarch drug component includes: when determining the imbalance risk of each monarch drug triggering component based on the comparison result of the mean offset of the monarch drug component and the preset mean offset of the monarch drug component, increasing the ethanol concentration during the soaking process is determined based on the comparison result of the target component offset value and the preset target component offset value, and the increase in the ethanol concentration is positively correlated with the target component offset value.

[0069] Specifically, in this embodiment, the ethanol concentration is adjusted based on the target component offset value F. The larger the F, the greater the target component offset, and the correspondingly greater the required ethanol concentration. This can increase the dissolution efficiency of the active ingredient in the medicinal raw material by increasing the ethanol concentration of the corresponding main drug raw material particles, thereby improving Q. In order to more accurately determine the increase in ethanol concentration, the preset target component offset value F0 can be divided into a first preset target component offset value F1 and a second preset target component offset value F2, with F1 set to 1.5% and F2 set to 3.5%. The specific process of comparing the target component offset value F with F1 and F2 is as follows:

[0070] If F is less than or equal to F1, it is determined to generate a corresponding first ethanol concentration adjustment instruction, and the soaking process is adjusted based on the instruction to increase the original ethanol concentration by 3%; if F is greater than F1 and less than or equal to F2, it is determined to generate a corresponding second ethanol concentration adjustment instruction, and the soaking process is adjusted based on the instruction to increase the original ethanol concentration by 4%; if F is greater than F2, it is determined to generate a corresponding third ethanol concentration adjustment instruction, and the soaking process is adjusted based on the instruction to increase the original ethanol concentration by 5%; it can be understood that the increase in ethanol concentration can also be set to other values ​​that meet the requirements, for example, when F is greater than F2, the original ethanol concentration is increased by 6%; it should be noted that the increase in ethanol concentration is limited to not having a negative impact on the soaking process of the traditional Chinese medicine composition.

[0071] Furthermore, after completing the ethanol concentration adjustment, the imbalance risk of each of the monarch drug triggering components is re-determined based on the comparison result of the monarch drug component offset mean with the preset monarch drug component offset mean, and the adjustment of the soaking time under different gradients is determined based on the comparison result of the target component offset value with the preset target component offset value; wherein, different gradients are divided into core raw materials, auxiliary raw materials and harmonizing raw materials according to the medicinal properties of the raw materials.

[0072] Specifically, in this embodiment, the monarch drug corresponds to the core raw material, the ministerial drug corresponds to the auxiliary raw material, and the adjuvant corresponds to the blending raw material; after adjusting the ethanol concentration, according to the monarch drug component offset mean R is still greater than the critical monarch drug component offset mean R0, at this time, the soaking time under different gradients can also be adjusted according to the target component offset value F, thereby improving the transfer rate of the corresponding monarch drug and avoiding the risk of imbalance of the monarch drug component. In order to more accurately determine the adjustment state of the soaking time under different gradients, F0 can also be divided into a new first preset target component offset value F11 and a second preset target component offset value F21, setting F11 = 2.5%, F21 = 4.5%, and the comparison process based on F with F11 and F21 is as follows:

[0073] If F is less than or equal to F11, a first soaking time adjustment instruction is generated, and 10 minutes are added to the original soaking time of the core raw material, 15 minutes are added to the original soaking time of the auxiliary raw material, and the soaking time of the blending raw material remains unchanged, so as to compensate for the dissolution lag; if F is greater than F11 and less than or equal to F21, a second soaking time adjustment instruction is generated, and 20 minutes are added to the original soaking time of the core raw material, 10 minutes are added to the original soaking time of the auxiliary raw material, and 10 minutes are reduced in the soaking time of the blending raw material, so as to balance the dissolution rate difference of the monarch and ministerial drugs; if F is greater than F21, a third soaking time adjustment instruction is generated, and 40 minutes are added to the original soaking time of the core raw material, 20 minutes are added to the original soaking time of the auxiliary raw material, and 15 minutes are reduced in the original soaking time of the blending raw material or soaked in isolation, so as to reconstruct the dissolution model. It should be noted that the adjustment of the soaking time of each raw material will not have a negative impact on the preparation process of the Chinese medicine composition.

[0074] Furthermore, after completing the corresponding adjustments of the soaking process, the mean offset of the main medicine components is compared with the preset mean offset of the main medicine components and when it is determined that each main medicine still has the risk of triggering component imbalance, the corresponding reasons for failure and corresponding treatment are determined based on the efficacy evaluation difference.

[0075] Specifically, in this embodiment, after adjusting the ethanol concentration during the soaking process or the soaking time under different gradients accordingly, when the mean value R of the main drug component offset is still greater than the critical mean value R0 of the main drug component offset, it can be directly determined that the efficacy evaluation rate Q at this time neither meets the first monitoring condition nor the second monitoring condition. At this time, the corresponding treatment is no longer determined based on the comparison result of the target component offset value F and the preset target component offset value F0. The comparison and judgment are directly based on the efficacy evaluation difference W to determine the reasons for the failure in the extraction process and the corresponding treatment.

[0076] See also Figure 4 As shown, it is a logical decision diagram for determining the reasons for the failure of the preparation process of the traditional Chinese medicine composition based on the difference in efficacy evaluation and the corresponding processing in this embodiment. The process of adjusting the extraction process based on the difference in efficacy evaluation includes:

[0077] The cause is determined based on the comparison result of the efficacy evaluation difference with the preset efficacy evaluation difference, including: when it is determined that the cause of failure is insufficient similarity of the component proportions, the extraction time in the extraction process is extended based on the proportion similarity offset value; or when it is determined that the cause of failure is insufficient content transfer rate, the extraction temperature in the extraction process is increased based on the transfer rate offset value; or based on the microscopic identification structure difference and the DNA barcode matching rate, it is determined whether there is a problem with the raw material, and when it is determined that there is no problem with the raw material, a review is performed based on the efficacy evaluation difference; wherein, the proportion similarity offset value is the absolute value of the difference between the component proportion similarity and the preset component proportion similarity, and the transfer rate offset value is the absolute value of the difference between the content transfer rate and the preset content transfer rate.

[0078] Specifically, in this embodiment, the reasons for the failure of the preparation process of the traditional Chinese medicine composition are analyzed only from the direction of comparing the efficacy evaluation difference W with the preset efficacy evaluation difference W0. It is assumed that other situations will not affect the analysis process. W0 can be divided into a first preset efficacy evaluation difference W1 and a second preset efficacy evaluation difference W2. The specific reasons for the failure are refined by grading preset parameters to achieve graded control of "insufficient quantity-efficacy" and "imbalance between quality and efficacy". W1 can be set to 2.5%, W2 to 5%. The specific process based on the comparison of W with W1 and W2 is as follows:

[0079] If W is less than or equal to W1, it indicates that the transfer of the main target component (such as the target component corresponding to the monarch drug) meets the standard, but the proportion of the secondary component (such as the target component corresponding to the adjuvant drug) is unbalanced, resulting in a distortion of the substance group structure. At this time, it is necessary to adjust the extraction time during the extraction process according to the ratio similarity offset value N, thereby promoting the release of slow-soluble components and optimizing the dissolution balance of the target component, thereby improving the preparation process of the Chinese medicine composition to improve Q. If W is greater than W1 and less than or equal to W2, it indicates that the transfer efficiency of the target component from the raw material to the finished product is seriously insufficient. At this time, it is necessary to adjust the extraction temperature during the extraction process according to the transfer rate offset value M, thereby changing the solubility difference of different components, thereby improving the preparation process of the Chinese medicine composition to improve Q. If W is greater than W2, it indicates that the Q in the medicinal solution at this time seriously exceeds the standard. At this time, the preparation of the Chinese medicine composition of this batch can be stopped and it can be marked, and the raw materials can be tested. If the microscopic identification structure difference is greater than 15% or the DNA barcode matching rate is less than 90%, it can be determined that there is a problem with the raw materials. The preparation of the Chinese medicine composition of the same batch is stopped and marked. If the indicators are qualified, the component ratio similarity and content transfer rate are reviewed according to W. If the reviewed parameters are still normal, it is determined that there is a problem with the preparation equipment. If the reviewed parameters are insufficient, repeat the above adjustment.

[0080] Furthermore, when it is determined that the reason for failure is insufficient similarity of the component ratio, the extraction time is extended based on the comparison result of the ratio similarity offset value and the preset ratio similarity offset value, and the extension of the extraction time is positively correlated with the ratio similarity offset value.

[0081] Specifically, in this embodiment, the larger the proportional similarity offset value N, the more serious the imbalance in the medicinal property ratio, and the greater the extension of the extraction time. Therefore, the extension of the extraction time is positively correlated with N. In order to more accurately determine the extension of the extraction time, the preset proportional similarity offset value N0 can be divided into a first preset proportional similarity offset value N1 and a second preset proportional similarity offset value N2, with N1 set to 1.5% and N2 set to 3%. The specific comparison process based on the proportional similarity offset value N with N1 and N2 is as follows:

[0082] If N is less than or equal to N1, it means that the similarity of the component ratio is slightly offset, and then a corresponding first extraction time adjustment instruction is generated, and the extraction process is adjusted based on the instruction, extending the original extraction time by 20%; if N is greater than N1 and less than or equal to N2, it means that the similarity of the component ratio is moderately offset, and then a corresponding second extraction time adjustment instruction is generated, and the extraction process is adjusted based on the instruction, extending the original extraction time by 30%; if N is greater than N2, it means that the similarity of the component ratio is severely offset, and then a corresponding third extraction time adjustment instruction is generated, and the extraction process is adjusted based on the instruction, extending the original extraction time by 40%. It is understandable that the increase in the extraction time can also be set to other values ​​that meet the requirements, for example, when N is greater than N2, the extraction time is extended by 45% based on the original extraction time; it should be noted that the extension of the extraction time is limited to not negatively impacting the preparation process of the Chinese medicine composition.

[0083] Furthermore, when it is determined that the reason for failure is insufficient content transfer rate, the extraction temperature is increased based on the comparison result of the transfer rate offset value and the preset transfer rate offset value, and the increase in the extraction temperature is positively correlated with the transfer rate offset value.

[0084] Specifically, in this embodiment, the larger the transfer rate offset value A, the smaller the content transfer rate and the greater the required increase in the extraction temperature. Therefore, the increase in the extraction temperature is positively correlated with A. To more accurately determine the increase in the extraction temperature, the preset transfer rate offset value A0 can be divided into a first preset transfer rate offset value A1 and a second preset transfer rate offset value A2, with A1 = 2% and A2 = 4%. The specific comparison process based on A with A1 and A2 is as follows:

[0085] If A is less than or equal to A1, then a corresponding first extraction temperature adjustment instruction is generated, and the extraction process is adjusted based on the instruction, and the original extraction temperature is increased by 3°; if A is greater than A1 and less than or equal to A2, then a corresponding second extraction temperature adjustment instruction is generated, and the extraction process is adjusted based on the instruction, and the original extraction temperature is increased by 5°; if A is greater than A2, then a corresponding third extraction temperature adjustment instruction is generated, and the extraction process is adjusted based on the instruction, and the original extraction temperature is increased by 7°. It is understandable that the increase in the extraction temperature can also be set to other values ​​that meet the requirements. For example, when A is greater than A2, the extraction temperature is increased by 8° on the basis of the original extraction temperature. It should be noted that the increase in the extraction temperature is limited to not having a negative impact on the preparation process of the traditional Chinese medicine composition.

[0086] It is understandable that in the embodiments of the present invention, no specific limitation is imposed on any preset parameter or critical parameter, and the above values ​​are not limited thereto. Those skilled in the art may adjust the preset parameters or critical parameters accordingly based on actual needs, analysis of historical data, or equipment usage.

[0087] In order to make the objects and advantages of the present invention more clearly understood, the present invention is further described below in conjunction with embodiments; it should be understood that the specific embodiments described herein are merely used to explain the present invention and are not intended to limit the present invention.

[0088] Real-time Example 1

[0089] The efficacy of the Chinese medicine composition prepared by the method of the present invention in preventing and treating cold syndrome of joint diseases is verified by the following specific example: ② Bone Bi No. 2 Recipe is prepared using the above Chinese medicine composition.

[0090] The verification process includes: numbering several patients with the medical card numbers shown in the table below, making a diagnosis after the numbering is completed, and prescribing medication after determining that the patient has joint disease and cold syndrome based on the diagnosis results, and determining the usage of the Chinese medicine composition for each patient based on the actual situation of each patient. The usage is as mentioned in the usage method in the above content. During the use process, the diagnostic interval varies from the first visit to the fourth visit, which is determined according to the treatment progress of the patient's joint disease and cold syndrome.

[0091] Specifically, the treatment results were scored according to CMS, VAS, mJOA, WOMAC, etc., and the patient's recovery status was diagnosed in combination with the tongue coating and pulse condition. The actual diagnosis results are shown in the clinical application table.

[0092] Among them, the Constant-Murley Shoulder Score (CMS) is a widely used shoulder function assessment scale in orthopedics and rehabilitation medicine, used to objectively quantify the functional status of patients with shoulder disease or injury (the maximum score is 100, with higher scores indicating better shoulder function). The Visual Analogue Scale (VAS) is the abbreviation for the visual analog scale and is primarily used for subjective assessment of pain intensity in the medical field (the maximum score is 10, with higher scores indicating greater pain). The Modified Japanese Orthopaedic Association Score (mJOA) is a scale optimized for assessing the severity of spinal cord or nerve root dysfunction (the maximum score for cervical spine mJOA is 18, with lower scores indicating more severe disease; the maximum score for lumbar spine mJOA is 30, with higher scores indicating more severe disease). WOMAC (Western Ontario and McMaster Universities Osteoarthritis Assessment) The Knee Osteoarthritis Index is an internationally used assessment tool for knee osteoarthritis (KOA) (with a maximum score of 96 points, and a lower score indicates better joint function).

[0093] Clinical Application Table

[0094]

[0095]

[0096]

[0097]

[0098] It can be seen from the diagnosis results of the above clinical application table that after a person takes the Chinese medicine composition in this embodiment for a period of time, the symptoms generally show an improved development state.

[0099] For example, the four diagnostic results of patient 64477070 after taking the medicine showed that the corresponding CMS gradually increased from 60 points to 69 points, and the corresponding VAS gradually decreased from 9 points to 4 points, which also reflects that the Chinese medicine composition can strengthen muscles and bones and relieve joint pain, and has a great therapeutic effect on joint diseases and cold syndromes.

[0100] Thus far, the technical solutions of the present invention have been described in conjunction with the preferred embodiments shown in the accompanying drawings. However, it will be readily understood by those skilled in the art that the scope of protection of the present invention is obviously not limited to these specific embodiments. Without departing from the principles of the present invention, those skilled in the art may make equivalent changes or substitutions to the relevant technical features, and the technical solutions after such changes or substitutions will fall within the scope of protection of the present invention.

[0101] The foregoing description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Those skilled in the art will readily appreciate that the present invention is susceptible to various modifications and variations. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present invention are intended to be within the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for preventing and treating cold syndrome of joint disease, characterized in that: The Chinese medicine composition is composed of the following components and raw materials in parts by weight: Dried ginger 3g, cinnamon bark 5g, ephedra 10g, angelica dahurica 10g, white peony root 15g, qiannianjian 10g, epimedium 5g, kauri vine 10g, astragalus 30g; Among them, dried ginger, cinnamon, ephedra, and angelica dahurica are the main medicines, white peony root, millennium sword, epimedium, and sea wind vine are the ministerial medicines, and astragalus is the adjuvant medicine.

2. A method for preparing a Chinese medicine composition for preventing and treating cold syndrome of joint disease, for preparing the Chinese medicine composition according to claim 1, characterized in that: The preparation process includes: The raw materials used to prepare the traditional Chinese medicine composition are cleaned and dried in an oven, and the dried raw materials are crushed according to their medicinal properties to obtain corresponding raw material particles; soaking each of the raw material particles in a corresponding solution, and then boiling the solution to obtain a decoction; filtering out the medicinal residue and impurities in the decoction by a filtering device, and performing organic extraction by an extraction device to obtain a medicinal liquid; Each of the raw material particles and the medicinal solution is measured to obtain a medicinal efficacy evaluation rate and several main medicinal component deviations, wherein the medicinal efficacy evaluation rate is obtained by weighted summation based on several content transfer rates, component ratio similarities, and target component weight coefficients; Determining whether the preparation process of the traditional Chinese medicine composition is qualified based on the efficacy evaluation rate, and adjusting the soaking process based on the deviation degree of the plurality of the monarch drug components, or adjusting the extraction process based on the efficacy evaluation rate, when the preparation process is determined not to meet the requirements; The preparation of the Chinese medicine composition is completed when the preparation process of the Chinese medicine composition is determined to be qualified or when the preparation process is determined to meet the requirements after corresponding adjustments are made.

3. The method for preparing the Chinese medicine composition for preventing and treating cold syndrome of arthritis according to claim 2, wherein: The process of determining whether the preparation process of the traditional Chinese medicine composition is qualified based on the efficacy evaluation rate includes: If the efficacy evaluation rate meets the first monitoring condition, it is determined to be qualified; if it does not meet the first monitoring condition, it is determined whether it meets the second monitoring condition, and if it meets the second monitoring condition, the reason for the unqualified preparation process of the traditional Chinese medicine composition is determined based on the deviation degree of the plurality of the monarch drug components and the corresponding adjustment; or determining the reasons why the preparation process of the Chinese medicine composition is unqualified and making corresponding adjustments based on the efficacy evaluation rate when the second monitoring condition is not met; Among them, the first monitoring condition is that the drug efficacy evaluation rate is greater than a first preset drug efficacy evaluation rate, and the second monitoring condition is that the drug efficacy evaluation rate is greater than a second preset drug efficacy evaluation rate and less than or equal to the first preset drug efficacy evaluation rate.

4. The method for preparing the Chinese medicine composition for preventing and treating cold syndrome of joint disease according to claim 3, wherein: When it is determined that the drug efficacy evaluation rate does not meet the first monitoring condition but meets the second monitoring condition, adjusting the soaking process based on the mean deviation of the main drug component; When it is determined that the efficacy evaluation rate does not meet the second monitoring condition, adjusting the extraction process based on the efficacy evaluation difference; The mean deviation of the monarch drug component is the mean of several deviations of the monarch drug component, and the difference in efficacy evaluation is the difference between the second preset efficacy evaluation rate and the efficacy evaluation rate.

5. The method for preparing the Chinese medicine composition for preventing and treating cold syndrome of joint disease according to claim 4, characterized in that: The process of adjusting the soaking process based on the mean deviation of the monarch drug component comprises: When determining the imbalance risk of each of the monarch drug triggering components based on the comparison results of the monarch drug component offset mean and the preset monarch drug component offset mean, increasing the ethanol concentration during the soaking process is determined based on the comparison results of the target component offset value and the preset target component offset value, and the increase in ethanol concentration is positively correlated with the target component offset value.

6. The method for preparing the Chinese medicine composition for preventing and treating cold syndrome of joint disease according to claim 5, characterized in that: After completing the ethanol concentration adjustment, when re-determining the imbalance risk of each of the monarch drug triggering components based on the comparison result of the monarch drug component offset mean value and the preset monarch drug component offset mean value, the adjustment of the soaking time under different gradients is determined based on the comparison result of the target component offset value and the preset target component offset value; Among them, different gradients are divided into core raw materials, auxiliary raw materials and blending raw materials according to the medicinal effects of the raw materials.

7. The method for preparing the Chinese medicine composition for preventing and treating cold syndrome of joint disease according to any one of claims 5 or 6, characterized in that: After completing the corresponding adjustments of the soaking process, the mean deviation of the main medicine components is compared with the preset mean deviation of the main medicine components and it is determined that each main medicine still has the risk of triggering component imbalance. The corresponding reasons for failure and corresponding treatment are determined based on the efficacy evaluation difference.

8. The method for preparing the Chinese medicine composition for preventing and treating cold syndrome of joint disease according to claim 4, characterized in that: The process of adjusting the extraction process based on the efficacy evaluation difference includes: The reason is determined based on the comparison result of the efficacy evaluation difference value and the preset efficacy evaluation difference value, including: When it is determined that the reason for failure is insufficient similarity of the component ratios, the extraction time in the extraction process is extended based on the ratio similarity offset value; or when it is determined that the reason for failure is insufficient content transfer rate, increasing the extraction temperature during the extraction process based on the transfer rate offset value; Alternatively, determining whether the raw material has problems based on microscopic identification structure differences and DNA barcode matching rates, and if it is determined that the raw material does not have problems, conducting a review based on the efficacy evaluation difference; The ratio similarity offset value is the absolute value of the difference between the component ratio similarity and the preset component ratio similarity, and the transfer rate offset value is the absolute value of the difference between the content transfer rate and the preset content transfer rate.

9. The method for preparing the Chinese medicine composition for preventing and treating cold syndrome of joint disease according to claim 8, characterized in that: When it is determined that the reason for failure is insufficient similarity of the component ratio, the extraction time is extended based on the comparison result of the ratio similarity offset value and the preset ratio similarity offset value, and the extension of the extraction time is positively correlated with the ratio similarity offset value.

10. The method for preparing the Chinese medicine composition for preventing and treating cold syndrome of joint disease according to claim 8, characterized in that: When it is determined that the reason for failure is insufficient content transfer rate, the extraction temperature is increased based on the comparison result of the transfer rate offset value and the preset transfer rate offset value, and the increase in the extraction temperature is positively correlated with the transfer rate offset value.

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