Preparation method of traditional Chinese medicine preparation for treating cervical spondylotic radiculopathy caused by blood stasis and qi stagnation

Abstract

The invention discloses a preparation method of a traditional Chinese medicine preparation for treating cervical spondylotic radiculopathy caused by blood stasis and qi stagnation. The preparation method comprises the following steps: S1, crushing pseudo-ginseng into fine powder; s2, volatile oil of notopterygium root and radix clematidis is extracted, a DCS is adopted for volatile oil extraction, the amount of volatile oil among batches is stabilized within the range of + / -5% by controlling the water adding amount, steam pressure and extraction time, the volatile oil is included into an inclusion compound with beta-cyclodextrin, then the inclusion compound is filtered, and the qualified inclusion compound is collected for standby application; the invention provides a preparation method of a traditional Chinese medicine preparation which is prepared from pseudo-ginseng, corydalis tuber, notopterygium root, white paeony root, clematis root and kudzuvine root and is used for treating cervical spondylotic radiculopathy caused by blood stasis, qi stagnation and obstruction of veins, the control level of the preparation process is high, systematicness is achieved, the requirements of uniformity and stability of the product can be met, uniformity and stability of the traditional Chinese medicine preparation product are guaranteed, and the traditional Chinese medicine preparation is suitable for being used for treating cervical spondylotic radiculopathy caused by blood stasis, qi stagnation and obstruction of veins. By combining a traditional Chinese medicine intelligent manufacturing process control method, the stability and uniformity of the traditional Chinese medicine preparation are improved.

Description

Technical Field

[0001] The invention relates to the technical field of Chinese medicine preparation, and in particular to a method for preparing a Chinese medicine preparation for treating radiculopathy-type cervical spondylosis and blood stasis and qi stagnation. Background Art

[0002] Cervical spondylosis of radiculopathy is a disease of blood stasis, qi stagnation, and vascular obstruction. This is a type of cervical spondylosis caused by stimulation or pressure on one or both spinal nerve roots. Definition: Cervical spondylosis of radiculopathy is caused by stimulation or pressure on one or both spinal nerve roots, resulting in sensory, motor, and reflex disorders consistent with the distribution area of ​​the spinal nerve roots. Causes: It may be related to factors such as the protrusion or extrusion of the nucleus pulposus, bone hyperplasia or traumatic arthritis of the posterior facet joints, the formation of bone spurs in the uncovertebral joints, and the loosening and displacement of adjacent joints. Neck symptoms: The severity of neck symptoms varies depending on the cause of radicular compression. The main manifestations are neck pain, paraspinal muscle tenderness, and upright neck posture. Radicular pain: The most common, and its range is consistent with the distribution area of ​​the spinal nerve roots of the affected vertebrae. Finger numbness, fingertip hyperesthesia, and skin hypoesthesia are common manifestations. Radicular muscle dysfunction: It is obvious in those who are compressed by the front root first, with increased muscle tension in the early stage, but it quickly weakens and muscle atrophy occurs. The most obvious changes are in the thenar and hypothenar muscles and interosseous muscles of the hands. Changes in tendon reflexes: The reflex arcs involved in the affected spinal nerve roots are abnormal, active in the early stage, but weakened or disappeared in the middle and late stages. Diagnosis: Mainly based on typical radicular symptoms, such as numbness and pain, and their range is consistent with the area innervated by the cervical spinal nerves. The neck compression test and upper limb traction test are mostly positive, and imaging examinations such as X-rays and MRI examinations can show abnormal findings in the cervical spine. Treatment: Non-surgical therapy: including continuous (or intermittent) traction of the head and neck, neck circumference immobilization and correction of improper posture, all show obvious therapeutic effects. Drug therapy: such as cervical pain granules, which can promote blood circulation and remove blood stasis, promote qi and relieve pain, and are suitable for radiculopathy of cervical spondylosis, which belongs to blood stasis, qi stagnation, and vascular occlusion. Surgical therapy: When non-surgical therapy is not effective or the condition is extremely serious, surgical therapy can be considered.

[0003] At present, there is a lack of systematic control methods in the preparation process of traditional Chinese medicine preparations for the treatment of radiculopathy-type cervical spondylosis, which is a type of blood stasis, qi stagnation, and vascular obstruction. It is difficult to meet the requirements of product uniformity and stability, resulting in uneven quality of traditional Chinese medicine preparations, affecting the efficacy, safety and stability of traditional Chinese medicine preparations.

[0004] Therefore, a method for preparing a Chinese medicine preparation for treating radiculopathy-type cervical spondylosis and blood stasis and qi stagnation is proposed. Summary of the invention

[0005] The present invention aims to solve the problems raised in the background technology and provides a method for preparing a Chinese medicine preparation for treating radiculopathy-type cervical spondylosis and blood stasis and qi stagnation.

[0006] The specific technical solutions are as follows:

[0007] A method for preparing a Chinese medicine preparation for treating radiculopathy-type cervical spondylosis caused by blood stasis and qi stagnation, comprising the following steps:

[0008] S1: First, crush Panax notoginseng into fine powder;

[0009] S2: Extracting volatile oil from Notopterygium wilfordii and Clematis chinensis. The volatile oil extraction adopts a DCS control system. By controlling the amount of water added, steam pressure, and extraction time, the amount of volatile oil between batches is stabilized within the range of ±5%. The volatile oil is included into inclusion compounds with beta-cyclodextrin, and then the inclusion compounds are filtered, and qualified inclusion compounds are collected for standby use.

[0010] S3: DCS control system is used to control the amount of solvent added, steam pressure, extraction time, and process parameters include relative density, temperature, and solution volume. The above parameters are exported and the data processing system is used to summarize and analyze the data to guide the later product production.

[0011] As a preferred solution of the present invention, step S3 specifically includes the following steps:

[0012] S31: The distilled aqueous solution is collected in another container, the residue is boiled in water for 1 hour, then filtered, and the filtrate is reserved;

[0013] S32: decocting Pueraria root and white peony root with water twice, the first time for 1-2 hours and the second time for 0.5-1.5 hours, combining the decoctions and filtering, combining with the above filtrate and the distilled aqueous solution, concentrating to a clear paste with a relative density of 1.10-1.15 and a temperature of 45-55° C., adding ethanol to make the alcohol content reach 55%-65%, stirring, refrigerating, filtering, washing the residue once with 55%-65% ethanol, filtering the washing solution, combining with the above filtrate, recovering ethanol, and concentrating to a concentrated paste with a relative density of 1.15-1.20 and a temperature of 45-55° C.;

[0014] S33: Extract Chuanxiong and Yanhusuo twice with ethanol under reflux heating, the first time for 1.5-2.5 hours and the second time for 0.5-1.5 hours, combine the extracts, let stand, filter, recover ethanol from the filtrate, and concentrate to a concentrated paste with a relative density of 1.15-1.20 and a temperature of 45-55°C.

[0015] As a preferred embodiment of the present invention, step S4 is also included, and the step S4 specifically includes: granulation, using Panax notoginseng powder and dextrin as base materials, combining the inclusion material with the above-mentioned concentrated paste to make granules, drying, using a near-infrared spectrometer to monitor the production process online, establishing a quantitative analysis model of moisture in the fluidized bed granulation process for determining the moisture content of the particles, and stabilizing the operating parameters of the inlet temperature, material temperature, and inlet pressure during the operation.

[0016] As a preferred embodiment of the present invention, the fine powder of Panax notoginseng is 70-90 mesh.

[0017] As a preferred embodiment of the present invention, the steam pressure is 0.02-0.20 MPa.

[0018] As a preferred embodiment of the present invention, the filtration in steps S2-S3 is performed using a filter material with a pore size of less than 0.45 μm.

[0019] As a preferred solution of the present invention, step S32 is specifically as follows:

[0020] The kudzu root and white peony root are decocted twice with water by using a DCS control system, the first time the amount of water is 8-10 times the amount of the medicinal materials, and the second time the amount of water is 6-8 times the amount of the medicinal materials, and the decoctions are combined, filtered through a 70-90 mesh sieve, combined with the above filtrate and the distilled aqueous solution, concentrated to a clear paste with a relative density of 1.125 and a temperature of 50°C by using a double-effect concentrator, alcohol precipitation is performed by using an alcohol precipitation tank, ethanol is added to make the alcohol content reach 60%, stirred evenly, refrigerated at 0-10°C for more than 12 hours, filtered through a filter material with a pore size of less than 0.45 μm, the filter residue is washed once with 55%-65% ethanol, the washing liquid is filtered through a filter material with a pore size of less than 0.45 μm, combined with the above filtrate, ethanol is recovered, and concentrated to a concentrated paste with a relative density of 1.175 and a temperature of 45-55°C by using a single-effect concentrator.

[0021] As a preferred solution of the present invention, step S33 is specifically as follows:

[0022] Chuanxiong and Corydalis yanhusuo were heated with ethanol twice using a DCS control system. The first time, 5 times the amount of ethanol was used for reflux extraction for 2 hours, and the second time, 3 times the amount of ethanol was used for reflux extraction for 1 hour. The extracts were combined, allowed to stand, filtered through an 80-mesh sieve, and ethanol was recovered from the filtrate. A single-effect concentrator was used to concentrate the extract to a concentrated paste with a relative density of 1.15 and an temperature of 50°C. The reflux extraction steam pressure was 0.01-0.10MPa; the concentration temperature was 40-85°C; the steam pressure was 0.01-0.20MPa; and the vacuum degree was -0.02--0.09MPa.

[0023] As a preferred embodiment of the present invention, the concentration parameters of the double-effect concentrator are as follows:

[0024] First effect temperature: 50~98℃; First effect vacuum degree: -0.02~-0.09MPa;

[0025] Second effect temperature: 50~98℃; Second effect vacuum: -0.05~-0.10MPa;

[0026] Steam pressure: 0.03~0.25MPa.

[0027] As a preferred embodiment of the present invention, the concentration parameters of the single-effect concentrator are as follows:

[0028] Concentration temperature: 40~85℃; Steam pressure: 0.01~0.20MPa; Vacuum degree: -0.02~-0.09MPa.

[0029] The present invention has the following beneficial effects:

[0030] The present invention provides a method for preparing a Chinese medicine preparation for treating blood stasis, qi stagnation and vascular obstruction of radiculopathy-type cervical spondylosis, which is made of Panax notoginseng, Corydalis yanhusuo, Notopterygium incisum, Paeonia lactiflora, Clematis chinensis and Pueraria lobata. The preparation process has a high control level and is systematic, and can meet the requirements of product uniformity and stability. The preparation product is "uniform and stable", and the Chinese medicine preparation is combined with the intelligent manufacturing process control method of Chinese medicine to improve the stability and uniformity of the Chinese medicine preparation. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 The present invention provides a flowchart of a method for preparing a Chinese medicine preparation for treating cervical spondylotic radiculopathy and blood stasis and qi stagnation. DETAILED DESCRIPTION

[0032] The technical solution of the present invention is further described below with reference to the accompanying drawings and through specific implementation methods.

[0033] Among them, the drawings are only used for illustrative explanations, and they only represent schematic diagrams rather than actual pictures, and should not be understood as limitations on this patent; in order to better illustrate the embodiments of the present invention, some parts of the drawings may be omitted, enlarged or reduced, and do not represent the size of the actual product; for those skilled in the art, it is understandable that some well-known structures and their descriptions in the drawings may be omitted.

[0034] The same or similar numbers in the drawings of the embodiments of the present invention correspond to the same or similar parts; in the description of the present invention, it should be understood that if the terms "upper", "lower", "left", "right", "inner", "outer", etc. appear, the orientation or position relationship indicated is based on the orientation or position relationship shown in the drawings, which is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, the terms describing the position relationship in the drawings are only used for illustrative purposes and cannot be understood as a limitation on this patent. For ordinary technicians in this field, the specific meanings of the above terms can be understood according to specific circumstances.

[0035] In the description of the present invention, unless otherwise clearly specified and limited, if the term "connection" or the like appears to indicate the connection relationship between components, the term should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two components or the interaction relationship between two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0036] like Figure 1 As shown, the present invention provides a method for preparing a Chinese medicine preparation for treating cervical spondylotic radiculopathy, which belongs to blood stasis and qi stagnation, and vascular occlusion. The formula of the Chinese medicine for treating cervical spondylotic radiculopathy, which belongs to blood stasis and qi stagnation, and vascular occlusion is the same as the formula of the Chinese medicine preparation for treating cervical spondylotic radiculopathy, which belongs to blood stasis and qi stagnation. Both are calculated by weight: 1 part of Panax notoginseng, 3 parts of Chuanxiong, 2 parts of Corydalis, 4 parts of Notopterygium, 3 parts of White Peony, 4 parts of Clematidis, and 3 parts of Pueraria. The following three embodiments are provided:

[0037] Implementation case 1:

[0038] 1. First, crush Panax notoginseng into 80-mesh fine powder;

[0039] 2. Use the DCS control system to control the amount of water added to be 4 times the amount of medicinal materials, the steam pressure is 0.1MPa, and the extraction time is 2 hours; the volatile oil is encapsulated into an inclusion compound with beta-cyclodextrin, and filtered with a filter material with a pore size of less than 0.45μm, and the inclusion compound is collected for standby use;

[0040] 3. The DCS control system is used for extraction, concentration and alcohol precipitation. The system can control the amount of solvent added, steam pressure, extraction time, and process parameters such as relative density, temperature, and solution volume. The above parameters can be exported and the data can be summarized and analyzed using a data processing system to guide the production of later products. The application of this technology includes the following steps:

[0041] 3.1 The distilled aqueous solution is collected in another device; the residue is boiled with 4 times the amount of medicinal materials using the DCS control system for 1 hour, filtered through an 80-mesh sieve, and the filtrate is used for later use;

[0042] 3.2. Radix Puerariae and Radix Paeoniae Alba were decocted twice with water using a DCS control system. The first time, 8 times the amount of water was used for decocting for 1 hour, and the second time, 6 times the amount of water was used for decocting for 1 hour. The decoctions were combined, filtered through an 80-mesh sieve, combined with the above filtrate and the distilled aqueous solution, concentrated to a clear paste with a relative density of 1.10 (50°C) using a double-effect concentrator, and precipitated with alcohol using an alcohol precipitation tank. Ethanol was added to make the alcohol content reach 60%, stirred evenly, refrigerated at 0-10°C for more than 12 hours, filtered through a filter material with a pore size of less than 0.45 μm, and the filter residue was washed once with 55%-65% ethanol. The washing liquid was filtered through a filter material with a pore size of less than 0.45 μm, combined with the above filtrate, and the ethanol was recovered. The solution was concentrated to a concentrated paste with a relative density of 1.15 (50°C) using a single-effect concentrator.

[0043] Among them, the concentration parameters of the double-effect concentrator are as follows:

[0044] First effect temperature: 50~98℃; First effect vacuum degree: -0.02~-0.09MPa;

[0045] Second effect temperature: 50~98℃; Second effect vacuum: -0.05~-0.10MPa;

[0046] Steam pressure: 0.03~0.25MPa

[0047] Among them, the concentration parameters of the single-effect concentrator are as follows:

[0048] Concentration temperature: 40~85℃; Steam pressure: 0.01~0.20MPa; Vacuum degree: -0.02~-0.09MPa;

[0049] 3.3. Rhizoma Chuanxiong and Rhizoma Corydalis were heated twice with ethanol using a DCS control system. The first time, 5 times the amount of the medicinal materials were used for ethanol reflux extraction for 2 hours. The second time, 3 times the amount of the medicinal materials were used for ethanol reflux extraction for 1 hour. The extracts were combined, allowed to stand, filtered through an 80-mesh sieve, and the filtrate was used to recover ethanol. The filtrate was concentrated to a concentrated paste with a relative density of 1.15 (50°C) using a single-effect concentrator.

[0050] The reflux extraction steam pressure is 0.01~0.10MPa;

[0051] Concentration temperature: 40~85℃; Steam pressure: 0.01~0.20MPa; Vacuum degree: -0.02~-0.09MPa;

[0052] 4. Granulation: Using Panax notoginseng powder and dextrin as base materials, combine the inclusion material with the above-mentioned concentrated paste and grind it into a slurry through a colloid mill. Adjust the fan frequency to mix them evenly. After spraying into the slurry, use a near-infrared spectrometer to monitor the production process online, establish a quantitative analysis model of moisture in the fluidized bed granulation process to determine the moisture content of the particles, stabilize the operating parameters such as atomization pressure, fan frequency, granulation and drying temperature during operation, make granules, dry them, cool them down and serve.

[0053] Granulation and drying temperature 65℃~80℃; atomization pressure 0.05Mpa~0.5Mpa

[0054] Fan frequency 26HZ~50HZ

[0055]

[0056] Implementation Case 2

[0057] 1. First, crush Panax notoginseng into 80-mesh fine powder;

[0058] 2. Use the DCS control system to control the amount of water added to be 5 times the amount of the medicinal material, the steam pressure is 0.02-0.20 MPa, and the extraction time is 2 hours; the volatile oil is encapsulated into an inclusion compound with beta-cyclodextrin, and filtered with a filter material with a pore size of less than 0.45 μm, and the inclusion compound is collected for later use;

[0059] 3. The DCS control system is used for extraction, concentration and alcohol precipitation. The system can control the amount of solvent added, steam pressure, extraction time, and process parameters such as relative density, temperature, and solution volume. The above parameters can be exported and the data can be summarized and analyzed using a data processing system to guide the production of later products. The application of this technology includes the following steps:

[0060] 3.1 The distilled aqueous solution is collected in another device; the residue is boiled with 5 times the amount of medicinal materials using the DCS control system for 1.5 hours, filtered through an 80-mesh sieve, and the filtrate is used for later use;

[0061] 3.2. Radix Puerariae and Radix Paeoniae Alba are decocted twice with water using a DCS control system. The first time, 8-10 times the amount of the medicinal materials are decocted with water for 1-2 hours, and the second time, 6-8 times the amount of the medicinal materials are decocted with water for 1-2 hours. The decoctions are combined, filtered through a 70-90 mesh sieve, combined with the above filtrate and the distilled aqueous solution, and concentrated to a clear paste with a relative density of 1.125 (50°C) using a double-effect concentrator. Alcohol precipitation is performed using an alcohol precipitation tank, and ethanol is added to make the alcohol content reach 60%. The mixture is stirred evenly, refrigerated at 0-10°C for more than 12 hours, filtered through a filter material with a pore size of less than 0.45 μm, and the filter residue is washed once with 55%-65% ethanol. The washing liquid is filtered through a filter material with a pore size of less than 0.45 μm, combined with the above filtrate, and the ethanol is recovered. The mixture is concentrated to a concentrated paste with a relative density of 1.175 (50°C) using a single-effect concentrator.

[0062] Among them, the concentration parameters of the double-effect concentrator are as follows:

[0063] First effect temperature: 50~98℃; First effect vacuum degree: -0.02~-0.09MPa;

[0064] Second effect temperature: 50~98℃; Second effect vacuum: -0.05~-0.10MPa;

[0065] Steam pressure: 0.03~0.25MPa.

[0066] Among them, the concentration parameters of the single-effect concentrator are as follows:

[0067] Concentration temperature: 40~85℃; Steam pressure: 0.01~0.20MPa; Vacuum degree: -0.02~-0.09MPa;

[0068] 3.3. Rhizoma Chuanxiong and Rhizoma Corydalis were heated twice with ethanol using a DCS control system. The first time, 6 times the amount of the medicinal materials were used for ethanol reflux extraction for 2 hours. The second time, 4 times the amount of the medicinal materials were used for ethanol reflux extraction for 1 hour. The extracts were combined, allowed to stand, filtered through an 80-mesh sieve, and the filtrate was used to recover ethanol. The filtrate was concentrated to a concentrated paste with a relative density of 1.125 (50°C) using a single-effect concentrator.

[0069] The reflux extraction steam pressure is 0.01~0.10MPa;

[0070] Concentration temperature: 40~85℃; Steam pressure: 0.01~0.20MPa; Vacuum degree: -0.02~-0.09MPa;

[0071] 5. Granulation: Using Panax notoginseng powder and dextrin as base materials, combine the inclusion material with the above-mentioned concentrated paste and grind it into a slurry through a colloid mill. Adjust the fan frequency to mix them evenly. After spraying into the slurry, use a near-infrared spectrometer to monitor the production process online, establish a quantitative analysis model of moisture in the fluidized bed granulation process to determine the moisture content of the particles, stabilize the operating parameters such as atomization pressure, fan frequency, granulation and drying temperature during operation, make granules, dry them, cool them down and serve.

[0072] Among them, the granulation and drying temperatures are 65°C to 80°C; the atomization pressure is 0.05Mpa to 0.5Mpa.

[0073] Among them, the fan frequency is 26HZ~50HZ.

[0074]

[0075] Implementation Case 3

[0076] 1. First, crush Panax notoginseng into 80-mesh fine powder;

[0077] 2. Use the DCS control system to control the amount of water added to be 6 times the amount of medicinal materials, the steam pressure is 0.02-0.20 MPa, and the extraction time is 2 hours; the volatile oil is encapsulated into inclusion compounds with beta-cyclodextrin, and filtered with filter materials with a pore size of less than 0.45 μm, and the inclusion compounds are collected for later use;

[0078] 3. The DCS control system is used for extraction, concentration and alcohol precipitation. The system can control the amount of solvent added, steam pressure, extraction time, and process parameters such as relative density, temperature, and solution volume. The above parameters can be exported and the data can be summarized and analyzed using a data processing system to guide the production of later products. The application of this technology includes the following steps:

[0079] 3.1 The distilled aqueous solution is collected in another device; the residue is boiled with 6 times the amount of medicinal materials using the DCS control system for 2 hours, filtered through an 80-mesh sieve, and the filtrate is used for later use;

[0080] 3.2. Radix Puerariae and Radix Paeoniae Alba were decocted twice with water using a DCS control system. The first time, 10 times the amount of the medicinal materials was used for decocting for 2 hours, and the second time, 8 times the amount of the medicinal materials was used for decocting for 2 hours. The decoctions were combined, filtered through an 80-mesh sieve, combined with the above filtrate and the distilled aqueous solution, concentrated to a clear paste with a relative density of 1.15 (50°C) using a double-effect concentrator, and precipitated with alcohol using an alcohol precipitation tank. Ethanol was added to make the alcohol content reach 60%, stirred evenly, refrigerated at 0-10°C for more than 12 hours, filtered through a filter material with a pore size of less than 0.45 μm, and the filter residue was washed once with 55%-65% ethanol. The washing liquid was filtered through a filter material with a pore size of less than 0.45 μm, combined with the above filtrate, and the ethanol was recovered. The single-effect concentrator was concentrated to a concentrated paste with a relative density of 1.20 (50°C).

[0081] Among them, the concentration parameters of the double-effect concentrator are as follows:

[0082] First effect temperature: 50~98℃; First effect vacuum degree: -0.02~-0.09MPa;

[0083] Second effect temperature: 50~98℃; Second effect vacuum: -0.05~-0.10MPa;

[0084] Steam pressure: 0.03~0.25MPa

[0085] Among them, the concentration parameters of the single-effect concentrator are as follows:

[0086] Concentration temperature: 40~85℃; Steam pressure: 0.01~0.20MPa; Vacuum degree: -0.02~-0.09MPa;

[0087] 3.3. Rhizoma Chuanxiong and Rhizoma Corydalis were heated twice with ethanol using a DCS control system. The first time, 7 times the amount of the medicinal materials were used for ethanol reflux extraction for 2 hours. The second time, 5 times the amount of the medicinal materials were used for ethanol reflux extraction for 1 hour. The extracts were combined, allowed to stand, filtered through an 80-mesh sieve, and the filtrate was used to recover ethanol. The filtrate was concentrated to a concentrated paste with a relative density of 1.20 (50°C) using a single-effect concentrator.

[0088] The reflux extraction steam pressure is 0.01~0.10MPa;

[0089] Concentration temperature: 40~85℃; Steam pressure: 0.01~0.20MPa; Vacuum degree: -0.02~-0.09MPa;

[0090] 6. Granulation: Using Panax notoginseng powder and dextrin as base materials, combine the inclusion material with the above-mentioned concentrated paste and grind it into a slurry through a colloid mill. Adjust the fan frequency to mix them evenly. After spraying into the slurry, use a near-infrared spectrometer to monitor the production process online, establish a quantitative analysis model of moisture in the fluidized bed granulation process to determine the moisture content of the particles, stabilize the operating parameters such as atomization pressure, fan frequency, granulation and drying temperature during operation, make granules, dry them, cool them down and serve.

[0091] Among them, the granulation and drying temperatures are 65°C to 80°C; the atomization pressure is 0.05Mpa to 0.5Mpa.

[0092] Among them, the fan frequency is 26HZ~50HZ.

[0093] The test results are shown in the following table:

[0094]

[0095] It can be seen from the above table that the present invention meets the requirements of product uniformity and stability, thereby solving the problem of uneven quality of traditional Chinese medicine preparations and affecting the efficacy, safety and stability of traditional Chinese medicine preparations to a certain extent.

[0096] Among them, the Chinese medicine preparation for treating radiculopathy type cervical spondylosis, which is blood stasis and qi stagnation, prepared in this embodiment is made of Panax notoginseng, Corydalis yanhusuo, Notopterygium incisum, White Peony Root, Clematis chinensis, and Pueraria lobata, and is mainly used to treat radiculopathy type cervical spondylosis, which is blood stasis and qi stagnation, and vascular occlusion, wherein:

[0097] Effects and functions of Panax notoginseng:

[0098] Hemostasis: Rapidly make the blood coagulate and the blood vessels contract to achieve the purpose of hemostasis.

[0099] Blood tonic: Increases white blood cells in the human body, protects hematopoietic cells and platelets, and has a blood tonic effect.

[0100] Activate blood circulation: accelerate blood circulation and relieve bruises.

[0101] Note:

[0102] Women should not take it during menstruation unless they have irregular menstruation or light menstrual flow.

[0103] It is forbidden for pregnant women, but it can be taken appropriately after childbirth to replenish blood and promote blood circulation.

[0104] Medicinal effects of Corydalis yanhusuo:

[0105] Promote blood circulation: relieve pain and local blood stasis caused by trauma.

[0106] Regulating Qi: Improves symptoms such as liver and stomach pain, chest pain and heart pain caused by Qi stagnation.

[0107] Pain relief: Effectively improve abdominal pain caused by cold hernia, abdominal pain caused by postpartum congestion, dysmenorrhea and other pain symptoms.

[0108] The effects of Qianghuo:

[0109] Relieve exterior symptoms and dispel cold: Treat symptoms such as exogenous wind-cold, headache and no sweating.

[0110] Dispel wind and dampness: treat wind-cold-dampness arthralgia, rheumatic pain in the upper limbs, etc.

[0111] Pain relief: It can relieve stiff neck, sore joints, etc.

[0112] Effects and functions of white peony root:

[0113] Nourishing blood and regulating menstruation: Replenishing the Yin blood of the liver, regulating symptoms such as sallow complexion and irregular menstruation caused by blood deficiency.

[0114] Nourishes yin and stops sweating: Treats symptoms such as spontaneous sweating caused by exogenous wind-cold, yin deficiency and fatigue.

[0115] Softens the liver and relieves pain: Relieves symptoms such as chest and rib pain caused by blood deficiency and liver depression.

[0116] Calming down liver yang: It can relieve symptoms such as headache and dizziness caused by hyperactivity of liver yang.

[0117] The efficacy and function of Clematis chinensis:

[0118] Anti-rheumatic: Remove wind, cold and dampness from the body and treat rheumatic pain.

[0119] Open up the meridians: relieve symptoms such as limb numbness, difficulty in flexion and extension caused by poor blood circulation.

[0120] Pain relief: It can reduce swelling and relieve pain, helping to relieve pain, swelling and other uncomfortable symptoms.

[0121] Eliminate bone stagnation: Soften hard objects and eliminate bone stagnation (but not suitable for bone spurs).

[0122] The effects and functions of Pueraria root:

[0123] Relieving muscles and reducing fever: Treating symptoms such as fever, headache, stiff neck and back pain caused by exogenous factors.

[0124] Rash-clearing: Helps measles to break out.

[0125] Producing fluid and quenching thirst: Relieve symptoms such as thirst and diabetes.

[0126] Raise yang and stop diarrhea: treat symptoms such as diarrhea, dizziness and headache.

[0127] Promote blood circulation and activate collaterals: relieve symptoms such as hemiplegia, chest pain and heart pain caused by stroke.

[0128] Detoxification: Relieve the damage caused by alcohol.

[0129] Scientific combination of Panax notoginseng, Corydalis yanhusuo, Notopterygium incisum, White Peony Root, Clematis chinensis and Pueraria lobata can be used to treat radiculopathy of cervical spondylosis, which is caused by blood stasis, qi stagnation and vascular obstruction, and has a good therapeutic effect.

[0130] Among them, the DCS control system, full name Distributed Control System, is a computer system used for industrial automation control. The system controls the industrial process by assigning control tasks to multiple controllers, thereby improving production efficiency, reducing costs, and improving product quality. The following is a detailed explanation of the DCS control system:

[0131] 1. Definition and Background

[0132] Definition: DCS control system is a distributed control system, distributed control system or distributed computer control system, which combines control technology, computer technology, image display technology and communication technology to achieve control and management of production.

[0133] Development background: The DCS control system was developed in the mid-1970s. It solved the problem of excessive centralization of information, management, and control in traditional control systems, making the control system more flexible and efficient.

[0134] 2. System composition

[0135] Core components: DCS system mainly consists of computer control system, sensors, controllers, actuators, displays, input / output (I / O), data network and process network.

[0136] Functional division: The system adopts a hierarchical structure, each level consists of several subsystems, and each subsystem achieves several specific limited goals.

[0137] 3. Working Principle

[0138] Collecting data: Sensors in the system continuously collect various parameter data of the industrial process, such as temperature, pressure, liquid level, flow, etc.

[0139] Processing data: The controller processes the data collected from the sensor and generates corresponding control instructions.

[0140] Execution and feedback: The actuator executes the control instructions and feeds back the execution results to the controller so that the controller can adjust the control strategy based on the feedback data.

[0141] 4. Application areas

[0142] Petrochemical industry: widely used in crude oil processing, chemical reactions, storage tank control, etc.

[0143] Power industry: used for generator set control, transmission line monitoring, substation control, etc.

[0144] Water treatment industry: such as sewage treatment, tap water treatment, industrial wastewater treatment, etc.

[0145] Manufacturing industry: It plays an important role in the control of automated production lines, robots, warehousing and logistics, etc.

[0146] Food industry: In the production process of brewing, baking, processing, packaging, etc., to achieve fine control of the production process.

[0147] 5. Advantages:

[0148] Supports medium and large-scale projects with large capacity and high speed.

[0149] The system network is reliable, secure and scalable.

[0150] The operator station has the function of an engineer station and supports online downloading of new control logic programs.

[0151] Distributed slave modules support hot-swap and random replacement.

[0152] 6. Development Trends

[0153] Integrated real-time control system: DCS system is developing towards the direction of integrated real-time control system, paying more attention to information sharing and interconnection, and realizing intelligent collaboration and intelligent optimization control between devices.

[0154] Artificial intelligence application: With the development of artificial intelligence technology, DCS systems will be more integrated with artificial intelligence technology to achieve automated decision-making and intelligent optimization control, and improve the system's adaptability and production efficiency.

[0155] In summary, the method for preparing a Chinese medicine preparation for treating cervical spondylotic radiculopathy and blood stasis and qi stagnation provided in this embodiment has the following advantages:

[0156] 1. The product quality is stable. Each bag contains ginsenoside Rg1(C 42 H 72 O 14 )、ginsenoside Rb1(C 54 H 92 O 23 ) and notoginsenoside R1(C 47 H 80 O 18 ) is not less than 50 mg. The RSD between batches can reach about 5%.

[0157] 2. When analyzing the product based on the chemical group chemistry standard, there is no obvious difference in the identifiable components in the chemical group between batches.

[0158] 3. Taking the dry extract yield as an indicator, the dry extract yield between batches can be within 10%.

[0159] The present invention provides a method for preparing a Chinese medicine preparation for treating blood stasis, qi stagnation and vascular obstruction of radiculopathy-type cervical spondylosis, which is made of Panax notoginseng, Corydalis yanhusuo, Notopterygium incisum, Paeonia lactiflora, Clematis chinensis and Pueraria lobata. The preparation process has a high control level and is systematic, and can meet the requirements of product uniformity and stability. The preparation product is "uniform and stable", and the Chinese medicine preparation is combined with the intelligent manufacturing process control method of Chinese medicine to improve the stability and uniformity of the Chinese medicine preparation.

[0160] The above are only preferred embodiments of the present invention, and are not intended to limit the implementation methods and protection scope of the present invention. Those skilled in the art should be aware that all solutions obtained by equivalent substitutions and obvious changes made using the description and illustrations of the present invention should be included in the protection scope of the present invention.

Claims

1. A method for preparing a Chinese medicine preparation for treating cervical spondylotic radiculopathy with blood stasis and qi stagnation, characterized in that: The following steps are involved: S1: First, crush Panax notoginseng into fine powder; S2: Extracting volatile oil from Notopterygium wilfordii and Clematis chinensis. The volatile oil extraction adopts a DCS control system. By controlling the amount of water added, steam pressure, and extraction time, the amount of volatile oil between batches is stabilized within the range of ±5%. The volatile oil is included into inclusion compounds with beta-cyclodextrin, and then the inclusion compounds are filtered, and qualified inclusion compounds are collected for standby use. S3: A DCS control system is used to control the amount of solvent added, steam pressure, extraction time, and process parameters such as relative density, temperature, and solution volume. The above parameters are exported and the data is summarized and analyzed using a data processing system to guide subsequent product production.

2. The method for preparing a Chinese medicine preparation for treating cervical spondylotic radiculopathy and blood stasis and qi stagnation according to claim 1, characterized in that: The step S3 specifically comprises the following steps: S31: The distilled aqueous solution is collected in another container, the residue is boiled in water for 1 hour, then filtered, and the filtrate is reserved; S32: decocting Pueraria root and white peony root with water twice, the first time for 1-2 hours and the second time for 0.5-1.5 hours, combining the decoctions and filtering, combining with the above filtrate and the distilled aqueous solution, concentrating to a clear paste with a relative density of 1.10-1.15 and a temperature of 45-55° C., adding ethanol to make the alcohol content reach 55%-65%, stirring, refrigerating, filtering, washing the residue once with 55%-65% ethanol, filtering the washing solution, combining with the above filtrate, recovering ethanol, and concentrating to a concentrated paste with a relative density of 1.15-1.20 and a temperature of 45-55° C.; S33: Extract Chuanxiong and Yanhusuo twice with ethanol under reflux heating, the first time for 1.5-2.5 hours and the second time for 0.5-1.5 hours, combine the extracts, let stand, filter, recover ethanol from the filtrate, and concentrate to a concentrated paste with a relative density of 1.15-1.20 and a temperature of 45-55°C.

3. The method for preparing a Chinese medicine preparation for treating cervical spondylotic radiculopathy and blood stasis and qi stagnation according to claim 2, characterized in that: The method further includes step S4, which specifically includes: granulation, using Panax notoginseng powder and dextrin as base materials, combining the inclusion material with the above-mentioned concentrated paste to make granules, drying, using a near-infrared spectrometer to monitor the production process online, establishing a quantitative analysis model for moisture in the fluidized bed granulation process to determine the moisture in the particles, and stabilizing the operating parameters of inlet air temperature, material temperature, and inlet air pressure during operation.

4. The method for preparing a Chinese medicine preparation for treating cervical spondylotic radiculopathy and blood stasis and qi stagnation according to claim 1, characterized in that: The fine powder of Panax notoginseng crushed into powder has a mesh size of 70-90.

5. The method for preparing a Chinese medicine preparation for treating cervical spondylotic radiculopathy and blood stasis and qi stagnation according to claim 1, characterized in that: The steam pressure is 0.02-0.20 MPa.

6. The method for preparing a Chinese medicine preparation for treating cervical spondylotic radiculopathy and blood stasis and qi stagnation according to claim 1, characterized in that: The filtration in the steps S2-S3 is carried out using a filter material with a pore size of less than 0.45 μm.

7. The method for preparing a Chinese medicine preparation for treating cervical spondylotic radiculopathy and blood stasis and qi stagnation according to claim 3, characterized in that: The step S32 is specifically as follows: The kudzu root and white peony root are decocted twice with water by using a DCS control system, the first time the amount of water is 8-10 times the amount of the medicinal materials, and the second time the amount of water is 6-8 times the amount of the medicinal materials, and the decoctions are combined, filtered through a 70-90 mesh sieve, combined with the above filtrate and the distilled aqueous solution, concentrated to a clear paste with a relative density of 1.125 and a temperature of 50°C by using a double-effect concentrator, alcohol precipitation is performed by using an alcohol precipitation tank, ethanol is added to make the alcohol content reach 60%, stirred evenly, refrigerated at 0-10°C for more than 12 hours, filtered through a filter material with a pore size of less than 0.45 μm, the filter residue is washed once with 55%-65% ethanol, the washing liquid is filtered through a filter material with a pore size of less than 0.45 μm, combined with the above filtrate, ethanol is recovered, and concentrated to a concentrated paste with a relative density of 1.175 and a temperature of 45-55°C by using a single-effect concentrator.

8. The method for preparing a Chinese medicine preparation for treating cervical spondylotic radiculopathy and blood stasis and qi stagnation according to claim 4, characterized in that: The step S33 is specifically as follows: The Rhizoma Chuanxiong and Rhizoma Corydalis were heated twice with ethanol using a DCS control system. The first time, 5 times the amount of the medicinal materials were used for ethanol reflux extraction for 2 hours. The second time, 3 times the amount of the medicinal materials were used for ethanol reflux extraction for 1 hour. The extracts were combined, allowed to stand, filtered through an 80-mesh sieve, and the filtrate was used to recover ethanol. The extracts were concentrated to a concentrated paste with a relative density of 1.15 and a temperature of 50°C using a single-effect concentrator. The reflux extraction steam pressure was 0.01-0.10MPa. The concentration temperature was 40-85°C. The steam pressure was 0.01-0.20MPa. Vacuum degree: -0.02~-0.09MPa.

9. The method for preparing a Chinese medicine preparation for treating cervical spondylotic radiculopathy and blood stasis and qi stagnation according to claim 8, characterized in that: The concentration parameters of the double-effect concentrator are as follows: First effect temperature: 50~98℃; First effect vacuum degree: -0.02~-0.09MPa; Second effect temperature: 50~98℃; Second effect vacuum: -0.05~-0.10MPa; Steam pressure: 0.03~0.25MPa.

10. The method for preparing a Chinese medicine preparation for treating cervical spondylotic radiculopathy and blood stasis and qi stagnation according to claim 9, characterized in that: The concentration parameters of the single-effect concentrator are as follows: concentration temperature: 40 to 85° C.; steam pressure: 0.01 to 0.20 MPa; vacuum degree: -0.02 to -0.09 MPa.

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