Traditional Chinese medicine composition for treating spinal cervical spondylosis and preparation method thereof

Abstract

The invention relates to the technical field of traditional Chinese medicine compositions, in particular to a traditional Chinese medicine composition for treating spinal cervical spondylosis and a preparation method thereof. The traditional Chinese medicine composition is prepared from the following components in parts by weight: 25-35 parts of rhizoma cibotii, 12-18 parts of prepared rehmannia root, 25-35 parts of radix puerariae, 10-15 parts of cornu cervi slices, 12-18 parts of rhizoma drynariae, 25-35 parts of raw radix astragali, 12-18 parts of radix angelicae sinensis, 10-15 parts of rhizoma chuanxiong, 8-12 parts of radix paeoniae rubra, 2-4 parts of leech, 12-18 parts of radix achyranthis bidentatae, 25-35 parts of fried cortex eucommiae, 20-30 parts of radix dipsaci, 12-18 parts of prepared rhizoma corydalis and 5-8 parts of liquorice root. The traditional Chinese medicine composition can supplement essence and qi in the kidney and warm and nourish governor meridians through accurate compatibility of medicines such as rhizoma cibotii and prepared rehmannia roots, and can strengthen tendons and bones and prevent and treat osteoporosis through optimized compatibility of medicines such as rhizoma drynariae and eucommia ulmoides in the aspect of bone metabolism regulation, thereby having important significance in preventing and treating cervical degeneration.

Description

Technical Field

[0001] The present invention relates to the technical field of Chinese medicine compositions, and in particular to a Chinese medicine composition for treating cervical spondylotic myelopathy and a preparation method thereof. Background Art

[0002] With the change of lifestyle, the incidence of cervical spondylotic myelopathy has increased year by year, and it has become one of the common diseases that seriously affect the health of the people with a younger age. The modern basic concept of cervical spondylotic myelopathy is that the degeneration of the cervical intervertebral disc is the main pathological basis, including secondary changes in the muscles and joints around the neck and the degeneration and hyperplasia of the adjacent vertebral bodies until the compression of nerves and blood vessels and the induction of clinical symptoms and signs related to them. Long-term compression of the spinal cord and surrounding structures causes nerve dysfunction. Since it is difficult to recover after nerve function is damaged, single therapy often cannot achieve a satisfactory treatment effect. How to further improve the efficacy is a problem that needs to be solved clinically.

[0003] The Governor Vessel has a close connection with the spine and spinal cord in terms of anatomical position, physiological function and pathological changes. Therefore, traditional Chinese medicine believes that most diseases in the cervical spine are related to damage to the Governor Vessel. Traditional Chinese medicine does not have the name of cervical spondylotic myelopathy. According to its etiology, pathogenesis and clinical characteristics, it belongs to the categories of "arthralgia" and "weakness" in traditional Chinese medicine. Its pathological evolution is divided into early, middle and late stages. In the early stage, due to damage to the Governor Vessel, blood does not circulate through the meridians, and Qi does not function, the syndrome is classified as Governor Vessel obstruction. In the middle and late stages, based on the pathogenesis of Governor Vessel stasis, the syndrome evolves in the direction of affecting the kidneys and Chong and Ren meridians, resulting in severe damage to Yang Qi. This theory is consistent with the symptoms of the progression of the disease in patients with cervical spondylosis in clinical practice, and also proves that Governor Vessel stasis is the pathogenesis of cervical spondylotic myelopathy. Because the kidney is the foundation of the innate constitution, it receives and stores the essence of the five internal organs and six bowels, and is the center for regulating the functions of other organs. The Du Yang is actually rooted in the true Yang in the kidney, and is the carrier of the fire of the gate of life that covers the back and warms the body. There are many articles reporting effective TCM treatments for cervical spondylotic myelopathy, but most of them are based on clinical experience and lack high-level clinical evidence-based medicine evidence. Moreover, for patients with severe spinal stenosis, symptoms of nerve compression, and Du Meridian stasis, the results are not satisfactory. How to maximize the advantages of traditional Chinese medicine in the treatment of cervical spondylotic myelopathy and spinal cord injury and form high-level clinical evidence-based medicine evidence is a topic worthy of in-depth exploration by the industry.

[0004] Our research group combined the research progress of the treatment of cervical spondylotic myelopathy at home and abroad, especially the one with neurological dysfunction, and our own clinical experience, and innovatively proposed a new concept of treating the disease from the perspective of "Kidney Governor Vessel". We took advantage of the platform advantages of the Cervical Spondylosis Research Center of the National Key Research Laboratory of Famous Doctors and Prescriptions and the Upper Cervical Medical Alliance of the China-Japan Friendship Hospital, combined with the Governor Vessel Stasis Scoring System, to construct a diagnostic and treatment paradigm for this disease with both Chinese and Western medicine. A retrospective study by our research group previously confirmed the superiority of surgical decompression combined with traditional Chinese medicine in the treatment of cervical spondylotic myelopathy. However, due to the poor integrity and homogeneity of the retrospective study data, there has not been a comprehensive review and evaluation of the treatment plan, and patients with cervical spondylotic myelopathy without surgical indications have not yet been included.

[0005] At present, there are many Chinese medicine compound preparations for clinical treatment that are mainly used for simple kidney tonifying, blood circulation and blood stasis removal, or strengthening tendons and bones, but the efficacy is poor. Although there are some Chinese medicine compositions for kidney tonifying and blood circulation in the prior art, they generally have the following shortcomings:

[0006] First, existing kidney-tonifying preparations often focus on a single effect, such as only focusing on tonifying kidney yang or nourishing kidney yin, which makes it difficult to achieve the overall regulatory effect of tonifying both yin and yang. In addition, the bioavailability of tonic drugs is generally low, requiring a larger dose to exert its therapeutic effect, which not only increases the medication burden of patients, but also easily causes side effects such as gastrointestinal discomfort.

[0007] Secondly, although blood-activating and blood-stasis-removing preparations can improve local blood circulation, simple blood-activating preparations often lead to the dissipation of Yang Qi, and blood stasis cannot be removed, which ultimately affects the therapeutic effect. The ratio of kidney-tonifying and blood-activating drugs in existing preparations is not reasonable, making it difficult to achieve the effect of treating both the symptoms and the root cause.

[0008] Third, in terms of preparation technology, traditional methods do not adequately protect temperature-sensitive components, and the selection of extraction process parameters lacks scientific basis, resulting in insufficient extraction of active ingredients or easy degradation, affecting product quality stability. In particular, in the alcohol precipitation process, due to improper control of parameters such as temperature and concentration, it is easy to cause co-precipitation loss of active ingredients.

[0009] Fourth, the existing granules often ignore the selection of excipients and the optimization of the ratio when designing the prescription, which makes it difficult to achieve the ideal effect of important indicators such as disintegration and solubility of the preparation, affecting the clinical efficacy. Summary of the invention

[0010] In view of the above problems, the present invention provides a Chinese medicine composition for treating cervical spondylotic myelopathy and a preparation method thereof.

[0011] The object of the present invention is to provide a Chinese medicine composition for treating cervical spondylotic myelopathy, comprising the following components by weight:

[0012] 25-35 parts of Cibotium barometz, 12-18 parts of Rehmannia root, 25-35 parts of Pueraria root, 10-15 parts of antler slices, 12-18 parts of Drynaria fortunei, 25-35 parts of raw Astragalus, 12-18 parts of Angelica sinensis, 10-15 parts of Ligusticum chuanxiong, 8-12 parts of red peony root, 2-4 parts of Hirudo, 12-18 parts of Achyranthes bidentata, 25-35 parts of stir-fried Eucommia ulmoides, 20-30 parts of Dipsacus asper, 12-18 parts of processed Corydalis yanhusuo, and 5-8 parts of Licorice.

[0013] Preferably, the composition is in the form of granules.

[0014] Preferably, the granules further include the following auxiliary materials in weight percentage:

[0015] Microcrystalline cellulose 15-20%, dextrin 10-15%, sodium carboxymethyl starch 3-5%, cross-linked polyvinylpyrrolidone 2-3%, polyvinylpyrrolidone K301-2%, magnesium stearate 0.5-1.0%.

[0016] The method for preparing the Chinese medicine composition for treating cervical spondylotic myelopathy comprises the following steps:

[0017] (1) crushing the components except leeches into 20-40 mesh and mixing;

[0018] (2) performing extraction;

[0019] (3) Concentrating;

[0020] (4) performing alcohol precipitation;

[0021] (5) recovering the solvent and drying to obtain an extract;

[0022] (6) mixing the extract with auxiliary materials and granulating to obtain the composition.

[0023] Preferably, the step (2) comprises:

[0024] First, add 8-10 times the amount of purified water, extract at 95-100℃ for 1.5-2 hours, and filter;

[0025] Secondly, add 6-8 times amount of purified water, extract at 95-100℃ for 1-1.5 hours, and filter;

[0026] Then, the two extracts were combined.

[0027] Preferably, the step (3) comprises:

[0028] The mixture was concentrated under reduced pressure at 60°C to a relative density of 1.10-1.15 (60°C).

[0029] Preferably, the step (4) comprises:

[0030] Add ethanol to an alcohol precipitation concentration of 60-70%, let stand at 20-25°C for 24 hours, and filter.

[0031] Preferably, the step (5) comprises:

[0032] First, ethanol is recovered by vacuum distillation at -0.08 to -0.06 MPa and 50-60°C;

[0033] Secondly, spray drying is adopted, with a feed temperature of 180-200°C, a discharge temperature of 85-95°C, and an atomization pressure of 0.3-0.4MPa.

[0034] Preferably, the step (6) comprises:

[0035] First, the extract and excipients were mixed for 15-20 minutes at a speed of 15-20 r / min;

[0036] Secondly, add the binder solution and granulate using a 20-mesh screen for 15-20 minutes;

[0037] Again, dry at 55-60°C for 2-3 hours until the moisture content is no more than 5%;

[0038] Finally, use a 24-mesh screen to sieve the particles at a speed of 20-25 r / min.

[0039] Preferably, the quality index of the composition is:

[0040] The particle size of 20-40 mesh accounts for more than 90%, the moisture content is not more than 5.0%, the disintegration time is not more than 30 minutes, the filling amount difference is ±5%, the puerarin content is not less than 0.8 mg / g, the ligustrazine content is not less than 0.2 mg / g, and the paeoniflorin content is not less than 0.5 mg / g.

[0041] The present invention has the following beneficial effects:

[0042] The present invention creatively solves the above technical problems through systematic experimental research and clinical practice.

[0043] Specifically:

[0044] The present invention solves the key technical problems in the treatment of cervical spondylotic myelopathy through systematic and in-depth pharmacodynamic research and clinical practice:

[0045] In terms of mechanism of action, the present invention innovatively proposes a new treatment idea of ​​"treating both kidney and governor meridian". Through the precise combination of kidney-tonifying drugs such as Cibotium barometz and Radix Rehmanniae Root, it can not only replenish the kidney essence, but also warm and nourish the governor meridian. Experimental data show that the serum testosterone level of Example 2 group (7.8±0.5ng / mL) is significantly higher than that of the control group (5.1-5.8ng / mL), which confirms the advantage of this combination in tonifying the kidney and strengthening the foundation.

[0046] In terms of neuroprotection, the present invention significantly improves the local microcirculation state through the rational use of angelica sinensis, chuanxiong and other blood stasis-promoting drugs. The experimental results show that the local blood flow of the embodiment group (108-115PU) is significantly better than that of the control group (84-90PU), which is of great significance for relieving nerve compression and promoting nerve function recovery.

[0047] In terms of anti-inflammatory and analgesic effects, this prescription innovatively uses drugs such as leeches and Achyranthes bidentata to effectively reduce the level of inflammatory factors through multi-target synergistic effects. Data show that the IL-6 level in the example group (75-85pg / mL) is significantly lower than that in the control group (115-128pg / mL). This significant anti-inflammatory effect helps to improve the symptoms of nerve root compression.

[0048] In terms of bone metabolism regulation, the optimized combination of Rhizoma Drynariae and Eucommia ulmoides can not only strengthen the tendons and bones, but also prevent and treat osteoporosis. The experimental results show that the bone density (0.235-0.242 g / cm 2 ) and trabecular count (4.25-4.52 / mm 2 ) were close to the normal group level, which is of great significance for the prevention and treatment of cervical degeneration.

[0049] It is particularly noteworthy that the present invention exhibits a significant synergistic effect in protecting neurological function:

[0050] 1. Multi-level neuroprotective mechanism: Kidney-tonifying drugs enhance the antioxidant capacity of nerve cells by increasing the activity of SOD (168-175 U / mg in the example group vs. 125-135 U / mg in the comparative group), while blood-activating and blood-stasis-removing drugs improve local blood supply. The two act synergistically to effectively protect nerve function.

[0051] 2. Balance between anti-inflammation and repair: This prescription can not only alleviate acute symptoms through anti-inflammatory effects, but also promote nerve repair by improving microcirculation, achieving a therapeutic effect that takes into account both the symptoms and the root cause.

[0052] 3. Long-term and stable therapeutic effect: Through optimized formulation technology, the bioavailability of the drug is significantly improved, so that the blood drug concentration is maintained at an effective level, providing continuous and stable drug support for the recovery of neurological function.

[0053] In addition, in clinical applications, the present invention also exhibits the following advantages:

[0054] 1. Wide scope of application: It has significant therapeutic effects on patients with cervical spondylotic myelopathy of different disease courses, especially suitable for patients in the conservative treatment period and the recovery period after surgery.

[0055] 2. Good safety: Through the reasonable combination of monarch, minister, assistant and guiding ingredients, it not only ensures the therapeutic effect but also avoids adverse reactions, and is particularly suitable for long-term use.

[0056] 3. High compliance: Granules prepared using modern formulation technology are easy to take, have good patient compliance, and are conducive to the continued implementation of the treatment plan.

[0057] In summary, the present invention provides a safe and effective new option for the treatment of cervical spondylotic myelopathy through the innovative concept of "treating both the kidney and the governor vessel" combined with the optimized design of a modern drug delivery system, which has important clinical application value and promotion significance. DETAILED DESCRIPTION

[0058] In order to make the purpose, technical solution and advantages of the present invention clearer, the technical solution of the present invention will be clearly and completely described below in conjunction with the specific embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0059] The Tongdu Bushen Shuji prescription of the present invention is composed of 15 Chinese medicines, and the specific compatibility is as follows:

[0060] King medicine:

[0061] Cibotium barometz: bitter, sweet, warm in nature, and enters the liver and kidney meridians. It has the effects of removing rheumatism, nourishing the liver and kidneys, and strengthening the waist and knees.

[0062] Rehmannia root: sweet in nature, slightly warm in flavor, enters the liver and kidney meridians, has the effects of nourishing blood and yin, replenishing essence and filling marrow.

[0063] Minister medicine:

[0064] Raw Astragalus: sweet in nature, slightly warm, enters the lung and spleen meridians, and has the effect of replenishing qi and raising yang;

[0065] Deer antler slices: salty in nature and flavor, warm, enter the kidney and liver meridians, warm kidney yang, and strengthen tendons and bones;

[0066] Drynaria: bitter in nature and flavor, warm, enters the liver and kidney meridians, nourishes the kidneys and strengthens bones;

[0067] Stir-fried Eucommia ulmoides: sweet in nature and warm in flavor, enters the liver and kidney meridians, nourishes the liver and kidneys, and strengthens the tendons and bones;

[0068] Chuanxiongduan: bitter, pungent, slightly warm in nature, enters the liver and kidney meridians, nourishes the liver and kidneys, and strengthens the tendons and bones;

[0069] Adjuvant:

[0070] Pueraria root: sweet, spicy, cool in nature, enters the spleen, stomach, and lung meridians, and activates blood circulation;

[0071] Angelica: sweet, spicy, warm in nature, enters the liver, heart, and spleen meridians, replenishes blood and activates blood circulation;

[0072] Chuanxiong: pungent in nature and flavor, warm, enters the liver, gallbladder, and pericardium meridians, promotes blood circulation and qi movement;

[0073] Red Peony Root: bitter in nature and flavor, slightly cold, enters the liver meridian, dissipates blood stasis and relieves pain;

[0074] Leech: salty, bitter, neutral, slightly toxic, enters the liver meridian, breaks blood and dredges the menstrual channels;

[0075] Achyranthes bidentata: bitter, sweet, sour, neutral in nature, enters the liver and kidney meridians, guides blood downward;

[0076] Processed Corydalis: pungent, bitter, warm, enters the liver and spleen meridians, activates blood circulation and promotes qi movement;

[0077] Drug:

[0078] Licorice: sweet in nature and flavor, neutral, enters the heart, lung, spleen, and stomach meridians, and harmonizes various medicines;

[0079] Analysis of compatibility characteristics:

[0080] Tonic effect:

[0081] With Cibotium barometz and Rehmanniae glutinosae as the main ingredients, they mainly nourish the liver and kidneys;

[0082] Combined with tonic drugs such as raw astragalus, antler slices, and bone-setting herb, it can enhance the kidney-tonifying and bone-strengthening effects;

[0083] Stir-fried Eucommia ulmoides and Dipsacus asper can enhance the effect of strengthening the kidney and bones;

[0084] Effect of promoting blood circulation and removing blood stasis:

[0085] Angelica sinensis, Chuanxiong and red peony root form a blood-activating and blood-stasis-removing combination;

[0086] Combining leeches and Achyranthes bidentata to enhance the effect of promoting blood circulation and unblocking meridians;

[0087] Processed Yuanhu helps to promote qi circulation and relieve pain;

[0088] Analgesic effect:

[0089] Pueraria root promotes blood circulation and activates collaterals;

[0090] Red peony root and processed Corydalis have analgesic effect;

[0091] Licorice harmonizes all medicines, relieves pain;

[0092] Medication characteristics:

[0093] Dosage form and usage: The drug is Tongdu Bushen Shuji Recipe, which is provided by the China-Japan Friendship Hospital with unified quality standards for experimental Chinese medicine in accordance with the requirements, and the quality is guaranteed. At the same time, the placebo is guaranteed to be similar to the prescription in terms of smell and appearance. Usage: Chinese medicine formula granules; Usage: Dissolve the granules in 150ml of hot water, stir evenly, and take it after the water temperature is suitable, 1 dose each time, once in the morning and evening, after meals, and 4 consecutive weeks as a course of treatment. The placebo is simulated with equal doses of dextrin, starch, bitter element, etc. to be consistent with the appearance and taste of Bushen Qiangdu Recipe, and the method of taking is the same as the treatment group.

[0094] Prescription compatibility principles:

[0095] Tonifying: The main treatment direction is to nourish the liver and kidneys and strengthen the tendons and bones;

[0096] Activating blood circulation and removing blood stasis: Combined with blood circulation and blood stasis-removing drugs to enhance the efficacy;

[0097] Tongluo analgesic: Add tongluo analgesic drugs to improve symptoms;

[0098] Harmonizing the properties of medicines: Use licorice to harmonize various medicines;

[0099] The invention selects 15 kinds of Chinese medicines with reasonable dosage ratio; adopts granules to improve the compliance of taking; unifies the quality standards to ensure the curative effect; has proper compatibility and moderate dosage of toxic drugs; this prescription can not only nourish the liver and kidney, strengthen the tendons and bones, but also activate blood circulation, remove blood stasis, dredge the meridians and relieve pain through reasonable compatibility of monarch, minister, assistant and envoy, which embodies the overall concept of traditional Chinese medicine and the characteristics of syndrome differentiation and treatment. At the same time, modern preparation technology is adopted to improve the feasibility and safety of clinical application.

[0100] Example 1

[0101] Preparation of Chinese medicine composition for treating cervical spondylotic myelopathy

[0102] Raw material components: by weight, take 25 parts of dog spine, 12 parts of Rehmannia root, 25 parts of Pueraria root, 10 parts of antler slices, 12 parts of Drynaria, 25 parts of raw Astragalus, 12 parts of Angelica, 10 parts of Chuanxiong, 8 parts of red peony root, 2 parts of leech, 12 parts of Achyranthes, 25 parts of stir-fried Eucommia, 20 parts of Dipsacus asper, 12 parts of processed Corydalis, and 5 parts of Licorice. Among them, dog spine is the main medicine, which nourishes the kidney and strengthens the tendons, and is combined with Rehmannia root to nourish yin and blood, together forming the basis of the prescription. Raw Astragalus and antler slices are combined, one to nourish qi and the other to warm yang, and they have a tonic effect.

[0103] Auxiliary materials: microcrystalline cellulose 15%, dextrin 10%, sodium carboxymethyl starch 3%, cross-linked polyvinylpyrrolidone 2%, polyvinylpyrrolidone K301%, and magnesium stearate 0.5%.

[0104] The preparation method comprises the following steps:

[0105] (1) Grinding and sieving: Grind the above medicinal materials (except leeches) to 40 mesh and mix them evenly. In this step, the control of the grinding degree has an important impact on the subsequent extraction efficiency. The grinding degree of 40 mesh can ensure sufficient extraction without causing the medicinal material powder to be too fine to affect the filtration.

[0106] (2) Extraction: First, add 10 times the amount of purified water, extract at 100°C for 2 hours, and filter; then add 8 times the amount of purified water, extract at 95°C for 1.5 hours, and filter; then combine the two extracts. This step uses a secondary extraction method, which can extract the active ingredients to the greatest extent, especially the polysaccharides in Cibotium barometz and the rehmannia glutinosa in Rehmannia glutinosa.

[0107] (3) Concentration: The combined extracts are concentrated under reduced pressure at 60°C to a relative density of 1.15 (60°C). The selection of such temperature and pressure conditions can avoid the destruction of heat-sensitive components.

[0108] (4) Alcohol precipitation: Add ethanol to 70% alcohol content, let stand at 25°C for 24 hours and then filter. The alcohol precipitation process can effectively remove large molecular impurities and improve product purity.

[0109] (5) Drying: First, ethanol was recovered by vacuum distillation at -0.08 MPa and 50°C. Second, spray drying was performed with a feed temperature of 200°C, a discharge temperature of 95°C, and an atomization pressure of 0.4 MPa.

[0110] (6) Granulation: First, the extract and the excipients were mixed for 20 minutes at a rotation speed of 20 r / min; secondly, granulation was performed using a 20-mesh screen for 20 minutes; then, the mixture was dried at 60° C. for 3 hours until the moisture content reached 4.5%; finally, granulation was performed using a 24-mesh screen at a rotation speed of 25 r / min.

[0111] Example 2

[0112] Preparation of Chinese medicine composition for treating cervical spondylotic myelopathy

[0113] Raw material components: by weight, take 35 parts of Cibotium barometz, 18 parts of Radix Rehmanniae Preparata, 35 parts of Radix Puerariae, 15 parts of Antler Slices, 18 parts of Drynariae Rhizoma, 35 parts of Radix Astragali, 18 parts of Radix Angelicae Sinensis, 15 parts of Rhizoma Chuanxiong, 12 parts of Radix Paeoniae Rubrae, 4 parts of Hirudo, 18 parts of Radix Achyranthis Bidentatae, 35 parts of Stir-fried Eucommia, 30 parts of Radix Dipsaci, 18 parts of Radix Corydalis Processed, and 8 parts of Radix Glycyrrhizae. In the present embodiment, the dosage of tonic medicinal materials is appropriately increased to enhance the effect of invigorating the kidney and strengthening the tendons, and the dosage of blood circulation and stasis-removing drugs is correspondingly increased to maintain the overall balance of the prescription. Among them, the increase in the dosage of Radix Dipsaci and stir-fried Eucommia is conducive to the performance of the effect of strengthening the tendons and bones, while the increase in the dosage of Radix Angelicae Sinensis and Rhizoma Chuanxiong can enhance the effect of blood circulation and stasis-removing.

[0114] Auxiliary materials: 20% microcrystalline cellulose, 15% dextrin, 5% sodium carboxymethyl starch, 3% cross-linked polyvinylpyrrolidone K302%, and 1.0% magnesium stearate.

[0115] The preparation method comprises the following steps:

[0116] (1) Grinding and sieving: Grind the above medicinal materials (except leeches) to 20 mesh and mix them evenly. Selecting 20 mesh can increase the contact area between the medicinal materials and the extraction solvent and improve the extraction efficiency.

[0117] (2) Extraction: First, add 8 times the amount of purified water, extract at 95°C for 1.5 hours, and filter; then add 6 times the amount of purified water, extract at 95°C for 1 hour, and filter; then combine the two extracts. This extraction condition optimizes the extraction temperature and time, which can both ensure extraction efficiency and reduce energy consumption.

[0118] (3) Concentration: The combined extracts are concentrated under reduced pressure at 60°C to a relative density of 1.10 (60°C). A relatively low concentration density is beneficial to the subsequent alcohol precipitation process.

[0119] (4) Alcohol precipitation: Add ethanol to 60% alcohol content, let stand at 20°C for 24 hours, then filter. Lowering the alcohol precipitation temperature is beneficial to improving the precipitation effect.

[0120] (5) Drying: First, ethanol was recovered by vacuum distillation at -0.06 MPa and 60°C; second, spray drying was performed with a feed temperature of 180°C, a discharge temperature of 85°C, and an atomization pressure of 0.3 MPa. This embodiment uses a lower atomization pressure, which is conducive to obtaining a product with uniform particle size.

[0121] (6) Granulation: First, the extract and the excipients were mixed for 15 minutes at a rotation speed of 15 r / min; secondly, granulation was performed using a 20-mesh screen for 15 minutes; then, the mixture was dried at 55° C. for 2 hours until the moisture content reached 5%; finally, granulation was performed using a 24-mesh screen at a rotation speed of 20 r / min.

[0122] Example 3

[0123] Preparation of Chinese medicine composition for treating cervical spondylotic myelopathy

[0124] Raw material components: by weight, take 30 parts of Cibotium barometz, 15 parts of Radix Rehmanniae Preparata, 30 parts of Radix Puerariae, 12 parts of Antler Slices, 15 parts of Drynariae Rhizoma, 30 parts of Raw Astragalus, 15 parts of Radix Angelicae Sinensis, 12 parts of Rhizoma Chuanxiong, 10 parts of Red Peony Root, 3 parts of Hirudo, 15 parts of Radix Achyranthis Bidentatae, 30 parts of Stir-fried Eucommia, 25 parts of Radix Dipsaci, 15 parts of Processed Rhizoma Corydalis, and 6 parts of Radix Glycyrrhizae. This embodiment selects the intermediate dose of each medicinal material, which embodies the principle of balanced compatibility of monarch, minister, assistant and envoy. Among them, the dosage ratio of Cibotium barometz and Radix Rehmanniae Preparata highlights the medication characteristics of tonifying the kidney as the main and promoting blood circulation and removing blood stasis as the auxiliary.

[0125] Auxiliary materials: microcrystalline cellulose 18%, dextrin 12%, sodium carboxymethyl starch 4%, cross-linked polyvinylpyrrolidone 2.5%, polyvinylpyrrolidone K301.5%, magnesium stearate 0.8%.

[0126] The preparation method comprises the following steps:

[0127] (1) Grinding and sieving: Grind the above medicinal materials (except leeches) to 30 mesh and mix them evenly. The 30 mesh grinding degree is a balanced choice between extraction efficiency and filtration difficulty.

[0128] (2) Extraction: First, add 9 times the amount of purified water, extract at 98°C for 1.8 hours, and filter; then add 7 times the amount of purified water, extract at 98°C for 1.2 hours, and filter; then combine the two extracts. The solvent ratio and time arrangement of the two extractions are more conducive to the complete extraction of the active ingredients.

[0129] (3) Concentration: The combined extracts were concentrated under reduced pressure at 60°C to a relative density of 1.12 (60°C). This concentration is beneficial for the separation of the active ingredients in the subsequent alcohol precipitation process.

[0130] (4) Alcohol precipitation: Add ethanol to an alcohol content of 65%, let stand at 22°C for 24 hours, and then filter. Moderate alcohol content and temperature conditions are conducive to the separation of polysaccharides.

[0131] (5) Drying: First, ethanol was recovered by vacuum distillation at -0.07 MPa and 55°C. Second, spray drying was performed with a feed temperature of 190°C, a discharge temperature of 90°C, and an atomization pressure of 0.35 MPa.

[0132] (6) Granulation: First, the extract and the excipients were mixed for 18 minutes at a rotation speed of 18 r / min; secondly, granulation was performed using a 20-mesh screen for 18 minutes; thirdly, the granulation was performed using a 58°C dry screen for 2.5 hours until the moisture content reached 4.8%; finally, the granulation was performed using a 24-mesh screen at a rotation speed of 22 r / min.

[0133] Example 4

[0134] Preparation of Chinese medicine composition for treating cervical spondylotic myelopathy

[0135] Raw material components: by weight, take 28 parts of dog spine, 14 parts of Rehmannia root, 28 parts of Pueraria root, 11 parts of antler slices, 14 parts of drynaria, 28 parts of raw astragalus, 14 parts of angelica, 11 parts of Chuanxiong, 9 parts of red peony root, 2.5 parts of leech, 14 parts of Achyranthes bidentata, 28 parts of stir-fried Eucommia, 22 parts of Dipsacus asper, 14 parts of processed Corydalis, and 5.5 parts of Licorice. This embodiment appropriately adjusts the dosage of each medicinal material on the basis of maintaining the overall ratio of the prescription, and pays special attention to the dose-effect relationship between kidney-tonifying and tendon-strengthening drugs and blood-activating and blood-stasis-removing drugs.

[0136] Excipients: microcrystalline cellulose 17%, dextrin 11%, sodium carboxymethyl starch 3.5%, cross-linked polyvinylpyrrolidone 2.2%, polyvinylpyrrolidone K301.2%, magnesium stearate 0.6%.

[0137] The preparation method comprises the following steps:

[0138] (1) Grinding and sieving: Grind the above medicinal materials (except leeches) to 25 mesh and mix them evenly. This degree of pulverization not only ensures the extraction efficiency, but also facilitates the subsequent filtration operation.

[0139] (2) Extraction: First, add 8.5 times the amount of purified water, extract at 96°C for 1.6 hours, and filter; secondly, add 6.5 times the amount of purified water, extract at 96°C for 1.1 hours, and filter; then combine the two extracts.

[0140] (3) Concentration: The combined extracts were concentrated under reduced pressure at 60°C to a relative density of 1.13 (60°C). This concentration facilitates the subsequent alcohol precipitation and drying process.

[0141] (4) Alcohol precipitation: add ethanol to an alcohol content of 68%, let stand at 23°C for 24 hours, and then filter. This alcohol content condition can ensure the precipitation of polysaccharides while avoiding the co-precipitation of excessive impurities.

[0142] (5) Drying: First, ethanol was recovered by vacuum distillation at -0.075 MPa and 58°C; second, spray drying was performed with a feed temperature of 185°C, a discharge temperature of 88°C, and an atomization pressure of 0.38 MPa. The drying parameters selected in this embodiment not only ensured product quality, but also improved production efficiency.

[0143] (6) Granulation: First, the extract and the excipients were mixed for 16 minutes at a rotation speed of 16 r / min; secondly, granulation was performed using a 20-mesh screen for 16 minutes; thirdly, the granulation was performed using a 56° C. dryer for 2.2 hours to a moisture content of 4.6%; finally, the granulation was performed using a 24-mesh screen at a rotation speed of 23 r / min.

[0144] Comparative Example 1

[0145] This comparative example is used to verify the effect of the compatibility ratio of the main drug Cibotium barometz and the auxiliary drug Radix Rehmanniae glutinosae on the product effect. The components and preparation method of Example 1 are adopted, but Cibotium barometz is changed to 20 parts (lower than the minimum limit of 25 parts), Radix Rehmanniae glutinosae is changed to 10 parts (lower than the minimum limit of 12 parts), and the other components remain unchanged. Due to the insufficient dosage of the main drug, although the appearance of the obtained product is similar to that of Example 1, it is found through animal experiments that its kidney-tonifying and tendon-strengthening effect is significantly lower than that of Example 1. This shows that the dosage of Cibotium barometz and Radix Rehmanniae glutinosae must reach a certain ratio to give full play to its synergistic effect of tonifying the kidney and replenishing essence.

[0146] Comparative Example 2

[0147] This comparative example is used to verify the necessity of the blood-activating and stasis-removing drug combination. The components and preparation method of Example 2 are adopted, but the three herbs of Angelica sinensis, Chuanxiong and Red Peony Root are deleted, and the other components remain unchanged. The experimental results show that although the product has a certain kidney-tonifying effect, it lacks the compatibility of blood-activating and stasis-removing drugs, resulting in insufficient drug efficacy. This verifies the importance of blood-activating and stasis-removing drugs for dredging collaterals and relieving pain in the present invention.

[0148] Preferably, the preparation method is the same as that in Example 2 and will not be described in detail here.

[0149] Comparative Example 3

[0150] This comparative example is aimed at the influence of water extraction process parameters. The components of Example 3 were used for comparison, but the temperature of the first extraction was reduced to 90°C and the time was shortened to 1 hour. The results showed that the effective ingredients were not fully extracted, especially the effective ingredients with poor heat solubility were significantly affected, and the content determination results of the final product were lower than the quality standard requirements. This shows that the selection of the extraction process parameters of the present invention is scientific and necessary.

[0151] Comparative Example 4

[0152] This comparative example verifies the importance of the alcohol precipitation process. The components of Example 3 were used, but the alcohol precipitation step was omitted and drying was performed directly. It was found that the impurity content in the product was high and the disintegration time exceeded the standard requirements. This confirms the important role of the alcohol precipitation process in improving product purity and improving formulation performance.

[0153] Comparative Example 5

[0154] This comparative example investigates the influence of the auxiliary material ratio. The components of Example 4 are used, but the microcrystalline cellulose content is reduced to 10%, and the dextrin content is increased to 20%. The results show that the fluidity and stability of the product are lower than those of Example 4, and there is agglomeration. This verifies the rationality of the auxiliary material ratio of the present invention.

[0155] Comparative Example 6

[0156] This comparative example studies the criticality of the overall preparation process. The components of Example 4 were used, but the following process parameters were changed:

[0157] (1) Grind to 50 mesh (finer than standard requirements);

[0158] (2) The extraction temperature was increased to 105°C;

[0159] (3) The alcohol precipitation concentration is increased to 80%;

[0160] (4) The spray drying feed temperature was increased to 210°C.

[0161] The results show that too fine a degree of pulverization leads to difficulty in filtration, high temperature extraction causes destruction of some heat-sensitive components, and too high alcohol precipitation concentration and drying temperature affect product quality. This fully demonstrates that the selection of the preparation process parameters of the present invention is scientific and necessary.

[0162] Through the above six comparative examples, the innovation and necessity of the present invention in terms of component ratio, process parameter selection, etc. are verified from different angles. In particular, the controllability and stability of product quality are ensured by the reasonable compatibility of the monarch, minister, assistant and guiding drugs, the optimization of the extraction process and the improvement of the preparation process. These research results provide sufficient experimental basis for the creativity of the present invention.

[0163] In order to comprehensively evaluate the efficacy of the Chinese medicine composition for the treatment of cervical spondylotic myelopathy in terms of dredging the Du meridian and tonifying the kidney, relaxing the meridians and activating the collaterals, and strengthening the tendons and bones, the following systematic evaluation experiment was designed:

[0164] 1. Evaluation of the efficacy of tonifying the kidney and strengthening the tendons

[0165] 1. Experimental methods:

[0166] A rat model of kidney yang deficiency was used and randomly divided into a negative control group, a positive control group (Jinkui Shenqi Pills), Example 1-4 groups and Comparative Example 1-6 groups according to body weight, with 12 rats in each group. The dosage was calculated according to the clinical dosage of humans and the drug was administered continuously for 4 weeks.

[0167] 2. Detection indicators:

[0168] (1) Serum levels of testosterone (T), luteinizing hormone (LH), and follicle-stimulating hormone (FSH);

[0169] (2) superoxide dismutase (SOD) and glutathione peroxidase (GSH-Px) activities in renal tissue;

[0170] (3) Time to exhaustion.

[0171] The results are shown in Table 1:

[0172] Table 1 Evaluation results of kidney-tonifying and tendon-strengthening effects

[0173] Group T(ng / mL) SOD(U / mg) Swimming time (min) Normal group 8.5±0.6 185±12 25.8±2.3 Model Group 3.2±0.4 95±8 12.4±1.8 Example 1 7.2±0.5 168±11 22.5±2.1 Example 2 7.8±0.5 175±13 24.2±2.0 Example 3 7.5±0.6 170±12 23.4±2.2 Example 4 7.4±0.5 172±11 23.1±2.1 Comparative Example 1 5.1±0.4 125±10 16.5±1.9 Comparative Example 2 5.8±0.5 135±11 18.2±2.0 Comparative Example 3 5.5±0.4 130±10 17.5±1.8 Comparative Example 4 5.3±0.5 128±11 17.0±1.9 Comparative Example 5 5.4±0.4 132±10 17.8±1.8 Comparative Example 6 5.2±0.5 127±11 16.8±1.9

[0174] 2. Evaluation of the efficacy of unblocking the Du channel and activating the collaterals

[0175] 1. Experimental methods:

[0176] Cervical spondylosis model rats were used, and the grouping and medication scheme were the same as above. The following indicators were used to evaluate the effect of unblocking the Du channel and activating the collaterals:

[0177] 2. Detection indicators:

[0178] (1) Serum levels of inflammatory factors IL-1β, TNF-α, and IL-6;

[0179] (2) Changes in local tissue blood flow;

[0180] (3) Motor function score.

[0181] The results are shown in Table 2:

[0182] Table 2 Evaluation results of the efficacy of unblocking the Du channel and activating the collaterals

[0183]

[0184]

[0185] 3. Evaluation of the impact on bone metabolism

[0186] 1. Experimental methods:

[0187] Ovarian osteoporosis model rats were used to evaluate the regulatory effect of this prescription on bone metabolism.

[0188] 2. Detection indicators:

[0189] (1) serum calcium and phosphorus levels;

[0190] (2) Bone density measurement;

[0191] (3) Bone morphometric analysis.

[0192] The results are shown in Table 3:

[0193] Table 3 Results of bone metabolism index determination

[0194] Group <![CDATA[Bone density (g / cm 2 )]]> <![CDATA[Bone trabecular number (per mm 2 )]]> Normal group 0.256±0.015 4.85±0.32 Model Group 0.185±0.012 2.65±0.25 Example 1 0.235±0.014 4.25±0.30 Example 2 0.242±0.015 4.52±0.31 Example 3 0.238±0.014 4.35±0.30 Example 4 0.236±0.015 4.32±0.31 Comparative Example 1 0.205±0.013 3.25±0.28 Comparative Example 2 0.215±0.014 3.45±0.29 Comparative Example 3 0.208±0.013 3.32±0.28 Comparative Example 4 0.206±0.014 3.28±0.29 Comparative Example 5 0.210±0.013 3.38±0.28 Comparative Example 6 0.203±0.014 3.22±0.29

[0195] Experimental results analysis:

[0196] 1. Analysis of the effect of tonifying the kidney and strengthening the tendons: Examples 1-4 groups were significantly better than the control group in terms of increasing testosterone levels, enhancing antioxidant capacity and improving exercise endurance (P<0.01). Among them, Example 2 had the best effect, close to the level of the normal control group, which was closely related to the reasonable compatibility of kidney-tonifying drugs such as Cibotium barometz and Rehmanniae glutinosae in the prescription.

[0197] 2. Analysis of the effect of promoting blood circulation and activating collaterals: The Example group can significantly reduce the level of inflammatory factors, improve local blood flow status, and improve motor function scores. In particular, the effect of Example 2 group is the most significant, which is closely related to the compatibility of angelica, Chuanxiong and other blood circulation promoting and blood stasis removing drugs in the prescription.

[0198] 3. Bone metabolism regulation effect: The Example group showed significant effects in improving bone density and trabecular microstructure, which was better than the Comparative Example groups. This is related to the synergistic effect of bone strengthening drugs such as Drynariae Rhizoma and Eucommia ulmoides in the formula.

[0199] Unexpected technical effects:

[0200] 1. Synergistic effect: Experimental data show that the therapeutic effect of the complete regimen is significantly better than the effect of each component used alone or in partial combination, suggesting that there is a significant synergistic effect between the components in the prescription.

[0201] 2. Multi-target regulation: This prescription can not only improve renal function, but also regulate bone metabolism and improve local blood circulation at the same time. This multi-target synergistic effect is difficult to achieve with a single medicine.

[0202] 3. Improved bioavailability: Through optimized preparation process, the bioavailability of each active ingredient in this prescription has been significantly improved, which may be one of the important reasons why the efficacy is better than traditional dosage forms.

[0203] Based on the experimental results, Example 2 shows the best comprehensive effect, and its component ratio and process parameters can be used as the best implementation scheme of the present invention. It shows significant advantages in tonifying the kidney and strengthening the tendons, dredging the Governor Vessel and activating the collaterals, and regulating bone metabolism, and has good safety and stability.

[0204] Based on experimental data and TCM theory, the mechanism of action of the TCM composition for treating cervical spondylotic myelopathy is analyzed as follows:

[0205] 1. The mechanism of action of tonifying kidney and strengthening tendons:

[0206] As can be seen from the data in Table 1, the testosterone level (7.8±0.5ng / mL) and SOD activity (175±13U / mg) in Example 2 are closest to the normal group (8.5±0.6ng / mL and 185±12U / mg, respectively), and are significantly higher than Comparative Example 1 (5.1±0.4ng / mL and 125±10U / mg, respectively). This significant difference can be explained from the following aspects:

[0207] (1) Optimization of the compatibility of the main drugs: The optimal ratio of Cibotium barometz (35 parts) and Radix Rehmanniae Preparata (18 parts) is shown in Example 2. According to the theory of traditional Chinese medicine, Cibotium barometz is bitter, sweet, warm, enters the liver and kidney meridians, and is good at tonifying the kidney and strengthening the tendons; Radix Rehmanniae Preparata is sweet, slightly warm, enters the liver and kidney meridians, and has the effect of nourishing yin and replenishing blood. The two drugs are combined, one warms and the other replenishes, and yin and yang complement each other, forming a combination of "hardness and softness". Experimental data show that this ratio can maximize the increase in testosterone levels, indicating that this ratio is most conducive to the generation of kidney qi.

[0208] (2) Synergistic effect of the ministerial drugs: The dosage ratio of raw astragalus (35 parts) and antler tablets (15 parts) reached the best in Example 2. Raw astragalus replenishes qi and raises yang, and antler tablets warm the kidney yang. The two drugs are matched, one replenishes qi and the other warms yang, which can significantly enhance SOD activity (175±13U / mg), which is consistent with the traditional Chinese medicine theory of "Yang Qi biochemical".

[0209] 2. The mechanism of action of the effect of unblocking Du channel and activating collaterals:

[0210] Table 2 shows that Example 2 has the best effect in reducing IL-6 level (75±7 pg / mL) and improving local blood flow (115±8 PU), which is close to the level of the normal group (42±5 pg / mL and 125±8 PU, respectively). The reasons are as follows:

[0211] (1) Optimized ratio of blood-activating and stasis-removing combination: The ratio of the three drugs, angelica (18 parts), Chuanxiong (15 parts), and red peony root (12 parts), is optimal in Example 2. From the perspective of TCM theory, angelica nourishes blood and activates blood circulation, Chuanxiong promotes qi and activates blood circulation, and red peony root clears heat and cools blood. The combination of the three drugs forms a combination of "tonifying without stagnation, activating without dryness", which can not only improve hemodynamic indicators, but also regulate the expression of inflammatory factors.

[0212] (2) Synergistic effect of adjuvant drugs: The dosage ratio of leech (4 parts) and Achyranthes bidentata (18 parts) is the most reasonable in Example 2. Leech breaks blood and dredges the meridians, while Achyranthes bidentata draws blood downward. The combination of the two drugs can significantly improve the local blood flow state, which is consistent with the significant increase in blood flow in the experiment (115±8PU).

[0213] 3. Mechanism of action for bone metabolism regulation:

[0214] As shown in Table 3, Example 2 improved bone density (0.242±0.015 g / cm 2 ) and trabecular number (4.52±0.31 / mm 2 ) had the most significant effect, almost returning to the level of the normal group (0.256±0.015g / cm 2 and 4.85±0.32 / mm 2 ). This advantage comes from:

[0215] (1) Optimal ratio of bone-strengthening drugs:

[0216] The proportion of Drynariae Rhizoma (18 parts), Fried Eucommia ulmoides (35 parts), and Dipsacus chuanxiong (30 parts) in Example 2 is the most reasonable. According to the theory of traditional Chinese medicine, Drynariae Rhizoma nourishes the kidney and strengthens bones, Fried Eucommia ulmoides nourishes the liver and kidney, strengthens tendons and bones, and Dipsacus chuanxiong nourishes the liver and kidney, and heals fractures. The three medicines are matched to form a combination of "tonifying the kidney and strengthening bones, activating blood circulation and healing injuries", which is mutually confirmed by the experimental data of bone density and trabecular improvement.

[0217] Unexpected synergies:

[0218] 1. Multi-level kidney-tonifying mechanism: Experimental data show that this prescription can not only increase testosterone levels, but also significantly enhance SOD activity, indicating that it can both tonify kidney yang and enhance antioxidant capacity. This two-way regulatory effect is difficult to achieve with simple kidney-tonifying drugs.

[0219] 2. Mutually reinforcing effects of promoting blood circulation and tonifying the kidney: The application of blood-activating drugs such as Angelica sinensis and Chuanxiong not only improves the local blood flow state, but also enhances the bioavailability of kidney-tonifying drugs by promoting drug absorption, which can be verified by the significant reduction of IL-6 levels (75±7pg / mL).

[0220] 3. Overall regulation of bone metabolism: Experimental data show that this prescription can not only increase bone density, but also improve bone microstructure. This systematic improvement effect is closely related to the organic combination of kidney-tonifying, blood-activating, and bone-strengthening drugs in the prescription.

[0221] In summary, through the in-depth analysis of experimental data, combined with the theory of traditional Chinese medicine, the scientificity and rationality of the present invention in the formulation ratio are fully confirmed. The components are not simply added together, but through precise ratio optimization, a synergistic and mutually reinforcing whole is formed, thereby producing a therapeutic effect beyond expectations. The excellent performance of Example 2 provides a reliable experimental basis for clinical application.

[0222] The above description is only an embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent substitution, improvement, etc. made within the spirit and principle of the present invention should be included in the scope of the claims of the present invention.

Claims

1. A Chinese medicine composition for treating cervical spondylotic myelopathy, characterized in that: The components include the following by weight: 25-35 parts of Cibotium barometz, 12-18 parts of Rehmannia root, 25-35 parts of Pueraria root, 10-15 parts of antler slices, 12-18 parts of Drynaria fortunei, 25-35 parts of raw Astragalus, 12-18 parts of Angelica sinensis, 10-15 parts of Ligusticum chuanxiong, 8-12 parts of red peony root, 2-4 parts of Hirudo, 12-18 parts of Achyranthes bidentata, 25-35 parts of stir-fried Eucommia ulmoides, 20-30 parts of Dipsacus asper, 12-18 parts of processed Corydalis yanhusuo, and 5-8 parts of Licorice.

2. The Chinese medicine composition for treating cervical spondylotic myelopathy according to claim 1, characterized in that: The composition is in the form of granules.

3. The Chinese medicine composition for treating cervical spondylotic myelopathy according to claim 2, characterized in that: The granules also include the following auxiliary materials in weight percentage: Microcrystalline cellulose 15-20%, dextrin 10-15%, sodium carboxymethyl starch 3-5%, cross-linked polyvinylpyrrolidone 2-3%, polyvinylpyrrolidone K301-2%, magnesium stearate 0.5-1.0%.

4. A method for preparing the Chinese medicine composition for treating cervical spondylotic myelopathy according to any one of claims 1 to 3, characterized in that: The following steps are involved: (1) crushing the components except leeches into 20-40 mesh and mixing; (2) performing extraction; (3) Concentrating; (4) performing alcohol precipitation; (5) recovering the solvent and drying to obtain an extract; (6) mixing the extract with auxiliary materials and granulating to obtain the composition.

5. The method according to claim 4, characterized in that The step (2) comprises: First, add 8-10 times the amount of purified water, extract at 95-100℃ for 1.5-2 hours, and filter; Secondly, add 6-8 times amount of purified water, extract at 95-100℃ for 1-1.5 hours, and filter; Then, the two extracts were combined.

6. The method according to claim 4, characterized in that The step (3) comprises: The mixture was concentrated under reduced pressure at 60°C to a relative density of 1.10-1.15 (60°C).

7. The method according to claim 4, characterized in that The step (4) comprises: Add ethanol to an alcohol precipitation concentration of 60-70%, let stand at 20-25°C for 24 hours, and filter.

8. The method according to claim 4, characterized in that The step (5) comprises: First, ethanol is recovered by vacuum distillation at -0.08 to -0.06 MPa and 50-60°C; Secondly, spray drying is adopted, with a feed temperature of 180-200°C, a discharge temperature of 85-95°C, and an atomization pressure of 0.3-0.4MPa.

9. The method according to claim 4, characterized in that The step (6) comprises: First, the extract and excipients were mixed for 15-20 minutes at a speed of 15-20 r / min; Secondly, add the binder solution and granulate using a 20-mesh screen for 15-20 minutes; Again, dry at 55-60°C for 2-3 hours until the moisture content is no more than 5%; Finally, use a 24-mesh screen to sieve the particles at a speed of 20-25 r / min.

10. The method according to any one of claims 4 to 9, characterized in that: The quality index of the composition is: The particle size of 20-40 mesh accounts for more than 90%, the moisture content is not more than 5.0%, the disintegration time is not more than 30 minutes, the filling amount difference is ±5%, the puerarin content is not less than 0.8 mg / g, the ligustrazine content is not less than 0.2 mg / g, and the paeoniflorin content is not less than 0.5 mg / g.

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