Improved fructus aurantii and liquorice soup as well as preparation method and application thereof

Abstract

The invention belongs to the field of traditional Chinese medicine compound preparations, and particularly discloses an improved fructus aurantii and liquorice decoction as well as a preparation method and application thereof. The traditional Chinese medicine composition is prepared from multiple traditional Chinese medicinal materials according to a specific proportion, aims to relieve the lumbocrural pain symptom caused by lumbar disc herniation and comprises the steps of primary smashing, steam heating, extraction, drying and the like, and the medicinal materials are divided into two groups to be treated respectively and then combined; wherein active ingredients in one group are extracted through enzymolysis and supercritical extraction technologies, and the other group is directly crushed and ground. Finally, the two extracts are mixed and subjected to spray granulation, then the granules are mixed with a non-steroidal anti-inflammatory drug (such as celecoxib) to be prepared into capsules, the compound preparation has a clear curative effect and a clear preparation process, and a new choice is provided for relieving / treating symptoms caused by lumbar disc herniation.

Description

Technical Field

[0001] The invention belongs to the field of traditional Chinese medicine compound preparations, and specifically discloses an improved Zhiqiao Gancao decoction and a preparation method and application thereof. Background Art

[0002] The incidence of acute low back and leg pain is high. The main indications for surgical treatment are unbearable pain that cannot be relieved by strict non-surgical treatment; progressively worsening neurological dysfunction, especially patients with symptoms of cauda equina compression. For most patients, radical surgical options are often not the best choice, and non-surgical treatment is also worthy of attention. There are many non-surgical treatment methods at present, which are mainly divided into two categories: non-drug treatment and drug treatment. Non-drug treatments generally include: absolute bed rest, functional exercise, physical therapy, traction, acupuncture and massage, etc.; drugs mainly include Western medicines such as anti-inflammatory, detumescent, analgesic, and nerve nutrition. The use of Western medicine can only temporarily relieve pain, but the recurrence frequency is high, and the side effects of using Western medicine are large. In the prior art, Gong Zhengfeng disclosed the formula of "Zhi Ke Gan Cao Tang" for the treatment of cervical disc herniation and lumbar disc herniation; at the same time, there is also a patent CN201910496548.2 A formula of Zhi Ke Gan Cao Tang and its preparation method, which discloses a formula of Zhi Ke Gan Cao Tang and its preparation method. The raw materials are prepared according to the following weight ratios: Zhi Ke 3-10g, Licorice 1.5-9g, Angelica 6-12g, Salvia miltiorrhiza 9-15g, Trigonosciadium 4.5-9g, Curcuma 6-9g, and processed black and white ugly 3-6g each. This scheme is mainly used to relieve acute low back and leg pain, and solves the problem of high recurrence frequency of low back and leg pain treated with Western medicine. How to develop a better Chinese medicine preparation based on the above-mentioned prior art and traditional Chinese medicine theory is a research direction worthy of effort. Summary of the invention

[0003] In order to solve the above problems, the present invention discloses an improved Zhi Fructus and Licorice Decoction and a preparation method and application thereof.

[0004] The technical solution of the present invention is as follows: An improved Zhi Fructus and Licorice Decoction, the active ingredients of which are composed of the following Chinese medicinal beverage raw materials in parts by weight: 3-10 parts of Citrus aurantium, 1.5-9 parts of Licorice, 6-12 parts of Angelica sinensis, 9-15 parts of Salvia miltiorrhiza, 4.5-9 parts of Trillium, 6-9 parts of Curcuma, 3-6 parts each of processed Black and White Atractylodes, 3-6 parts of Polygala tenuifolia, 6-9 parts of Eucommia ulmoides, 1-3 parts of Achyranthes bidentata, 1-3 parts of Cassia twig, 3-6 parts of Gastrodia elata, 2-4 parts of Ganoderma lucidum, 2-4 parts of Ginkgo biloba, 3-6 parts of Polygonum cuspidatum, 1-3 parts of Jujube, 3-6 parts of Pueraria root, and 1-3 parts of Leonurus japonicus.

[0005] Furthermore, the present invention discloses the use of the improved Zhi Fructus and Licorice Decoction in preparing a medicine for relieving the symptoms of lumbar disc herniation.

[0006] Furthermore, in the above application, the symptom is low back and leg pain.

[0007] Furthermore, the present invention also discloses a compound preparation for relieving the symptoms of low back and leg pain caused by lumbar disc herniation, comprising the above-mentioned improved Zhi Fructus Licorice Decoction.

[0008] Furthermore, in the above-mentioned compound preparation, the preparation includes pills, tablets, and capsules.

[0009] Furthermore, the preparation process of the above-mentioned Chinese medicine compound preparation comprises the following steps: 1) Primary crushing: put Fructus Aurantii Immaturus, Radix Glycyrrhizae, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, Rhizoma Curcumae, and Radix Eupatorii Herba into a crusher for crushing, then grind into powder, and pass through a 150-200 mesh sieve to obtain raw material A; 2) Steam heating: Place raw material A into the steam treatment equipment and heat it with 115-120℃ steam at a high pressure of 4-6 atmospheres for 15-35 minutes; 3) Extraction: put the heated material into 5-10 times volume of water, heat and extract at 80-90℃ for 2-4 times, collect the extract when evaporation reaches 15% of the original water volume each time; finally combine the extracts; 4) Drying: Evaporating and drying the combined extracts until the water content is less than 20% to obtain extract A; 5) Secondary crushing: Mix Polygala tenuifolia, Eucommia ulmoides, Achyranthes bidentata, Cinnamon twig, Gastrodia elata, Ganoderma lucidum, Ginkgo biloba, Polygonum cuspidatum, jujube, Pueraria root and Leonurus japonicus, put them into a grinder, grind them into powder, and pass through a 150-200 mesh sieve to obtain raw material B; 6) Enzymolysis: Add raw material B into water at a ratio of 1g:20-30mL, and add 100-200U / mL of cellulase, 150-250U / mL of pectinase, and 100-200U / mL of papain at the same time, and perform enzymolysis at 38-42℃ for 4-8h, stirring at the same time, and the speed is 50-100rpm; 7) Supercritical extraction: Use carbon dioxide as the extraction solvent to perform supercritical extraction of raw material B, the extraction pressure is 25-30MPa, the temperature is 75-80℃, the extraction time is 25-45min, and the extraction solvent flow rate is 5-10kg / h; the analysis process of the extraction effluent is two-stage, the first stage analysis pressure is 15-20MPa, the analysis temperature is 65~75℃, the second stage analysis pressure is 5-10MPa, and the analysis temperature is 55~65℃. Collect the extracted part, which is extract B; 8) Rotary evaporation: Place extract B into a rotary evaporator and heat and rotary evaporate until the solid content is 75-85wt% to obtain extract B; 9) Spray granulation: Combine extract A and extract B, add 50-100 g / L sucrose powder, 50-100 g / L β-cyclodextrin, and 300-600 g / L water, and stir continuously to form a suspension. Then, use a pump to spray the suspension through a high-pressure sprayer in the hot air flow in the drying chamber to rapidly evaporate the water to directly form spherical dry fine particles with an average particle size of 50-100 μm to obtain Chinese medicine particles; 10) Preparation of capsules: The Chinese medicine granules are mixed with the nonsteroidal anti-inflammatory drugs and prepared into capsules according to the general preparation method of capsule preparations.

[0010] Furthermore, in the above preparation process, the capsule contains 250-500 mg of Chinese medicine particles.

[0011] Furthermore, in the above preparation process, the non-steroidal anti-inflammatory drug is celecoxib.

[0012] Furthermore, in the above preparation process, the content of celecoxib is 25-50 mg.

[0013] Compared with the prior art, the present invention has the following beneficial effects: The present invention discloses an improved Zhi Fructus and Licorice Decoction and a preparation method and application thereof, which specifically has the following four advantages: 1. Relieve waist and leg pain caused by lumbar disc herniation: The improved Zhike Gancao decoction and its compound preparation of the present invention can effectively relieve the waist and leg pain symptoms caused by lumbar disc herniation by scientifically combining multiple Chinese medicinal materials. This comprehensive therapy combines the conditioning effect of traditional Chinese medicine and the advantages of modern pharmaceutical technology to improve the treatment effect.

[0014] 2. Improve drug absorption and utilization: Modern technologies such as steam heating, enzymatic hydrolysis and supercritical extraction used in the preparation process help to extract and retain the active ingredients in medicinal materials while removing impurities, thereby improving the purity and bioavailability of drugs.

[0015] 3. Synergistic enhancement and reduction of side effects: Combining Chinese medicine granules with celecoxib to make capsules can not only exert the overall conditioning effect of Chinese medicine, but also quickly relieve pain symptoms, and may reduce the side effects of non-steroidal anti-inflammatory drugs through the regulatory effect of Chinese medicine.

[0016] 4. High safety: All raw materials are from natural Chinese medicinal materials and are strictly screened and processed to ensure the safety and effectiveness of the products.

[0017] In traditional Chinese medicine theory, "monarch, minister, assistant and envoy" is one of the basic principles of prescription composition, which embodies the essence of Chinese medicine compatibility. Specifically, in the Zhike Gancao Decoction of the present invention, it can be roughly analyzed as follows: Monarch medicine: Monarch medicine is the medicine in the prescription that has the main therapeutic effect or main symptom for the main disease. In this prescription, Zhike and Gancao are used as monarch medicines because they have the effects of promoting qi and relieving pain, and harmonizing. All medicines have a direct therapeutic effect on relieving waist and leg pain.

[0018] Minister medicine: Minister medicine is a medicine that assists the monarch medicine to strengthen the treatment of the main disease or main symptom. Angelica, Danshen and other blood-activating and stasis-removing drugs such as Tripterygium wilfordii and Curcuma zedoaria play the role of minister medicine in this prescription. They can enhance the therapeutic efficacy of the monarch medicine and work together on the lesion site. Adjuvant medicine: Adjuvant medicine has three main functions: one is adjuvant medicine, that is, assisting the monarch and minister medicine to strengthen the therapeutic effect; the second is adjuvant medicine, which is used to eliminate or reduce the toxicity and strong and ministerial properties of the monarch medicine; the third is anti-adjuvant medicine, which is used to add medicines with opposite properties but can play a complementary role in treatment due to the rejection of medicine due to the disease. In this prescription, drugs such as Polygala tenuifolia calm the mind and stabilize the mind, Eucommia ulmoides replenishes the liver and kidneys and strengthens the tendons and bones, and Gastrodia elata calms the liver, relieves wind and stops spasms play the role of adjuvant or control. Envoy medicine: Envoy medicine has two meanings: one is the guiding medicine, that is, the medicine that guides the medicines in the prescription directly to the diseased area; the second is the harmonizing medicine, that is, the effect of harmonizing the medicines so that they can work together to eliminate evil and jujube. Drugs such as cinnamon twig play the role of guiding meridians or harmonizing in this prescription. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 The preparation process diagram of the present invention; Figure 2 Clinical score results of lumbar disc herniation treatment (low back pain); Figure 3 Clinical score results of lumbar disc herniation treatment (leg pain); Figure 4 Clinical scoring results of lumbar disc herniation treatment (leg numbness). DETAILED DESCRIPTION

[0020] An improved Zhi Fructus and Licorice Decoction, the active ingredients of which are composed of the following Chinese medicinal beverage raw materials in parts by weight: 3-10 parts of Citrus aurantium, 1.5-9 parts of Licorice, 6-12 parts of Angelica sinensis, 9-15 parts of Salvia miltiorrhiza, 4.5-9 parts of Trillium, 6-9 parts of Curcuma, 3-6 parts each of processed Black and White Atractylodes, 3-6 parts of Polygala tenuifolia, 6-9 parts of Eucommia ulmoides, 1-3 parts of Achyranthes bidentata, 1-3 parts of Cassia twig, 3-6 parts of Gastrodia elata, 2-4 parts of Ganoderma lucidum, 2-4 parts of Ginkgo biloba, 3-6 parts of Polygonum cuspidatum, 1-3 parts of Jujube, 3-6 parts of Pueraria root, and 1-3 parts of Leonurus japonicus.

[0021] The preparation process of the Chinese medicine capsule based on the formula of the improved Zhike Gancao decoction is characterized by comprising the following steps: 1) Primary crushing: put Fructus Aurantii Immaturus, Radix Glycyrrhizae, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, Rhizoma Curcumae, and Radix Eupatorii Herba into a crusher for crushing, then grind into powder, and pass through a 150-200 mesh sieve to obtain raw material A; 2) Steam heating: Place raw material A into the steam treatment equipment and heat it with 115-120℃ steam at a high pressure of 4-6 atmospheres for 15-35 minutes; 3) Extraction: put the heated material into 5-10 times volume of water, heat and extract at 80-90℃ for 2-4 times, collect the extract when evaporation reaches 15% of the original water volume each time; finally combine the extracts; 4) Drying: Evaporating and drying the combined extracts until the water content is less than 20% to obtain extract A; 5) Secondary crushing: Mix Polygala tenuifolia, Eucommia ulmoides, Achyranthes bidentata, Cinnamon twig, Gastrodia elata, Ganoderma lucidum, Ginkgo biloba, Polygonum cuspidatum, jujube, Pueraria root and Leonurus japonicus, put them into a grinder, grind them into powder, and pass through a 150-200 mesh sieve to obtain raw material B; 6) Enzymolysis: Add raw material B into water at a ratio of 1g:20-30mL, and add 100-200U / mL of cellulase, 150-250U / mL of pectinase, and 100-200U / mL of papain at the same time, and perform enzymolysis at 38-42℃ for 4-8h, stirring at the same time, and the speed is 50-100rpm; 7) Supercritical extraction: Use carbon dioxide as the extraction solvent to perform supercritical extraction of raw material B, the extraction pressure is 25-30MPa, the temperature is 75-80℃, the extraction time is 25-45min, and the extraction solvent flow rate is 5-10kg / h; the analysis process of the extraction effluent is two-stage, the first stage analysis pressure is 15-20MPa, the analysis temperature is 65~75℃, the second stage analysis pressure is 5-10MPa, and the analysis temperature is 55~65℃. Collect the extracted part, which is extract B; 8) Rotary evaporation: Place extract B into a rotary evaporator and heat and rotary evaporate until the solid content is 75-85wt% to obtain extract B; 9) Spray granulation: Combine extract A and extract B, add 50-100 g / L sucrose powder, 50-100 g / L β-cyclodextrin, and 300-600 g / L water, and stir continuously to form a suspension. Then, use a pump to spray the suspension through a high-pressure sprayer in the hot air flow in the drying chamber to rapidly evaporate the water to directly form spherical dry fine particles with an average particle size of 50-100 μm to obtain Chinese medicine particles; 10) Preparation of capsules: The Chinese medicine granules are mixed with the nonsteroidal anti-inflammatory drugs and prepared into capsules according to the general preparation method of capsule preparations.

[0022] The capsule contains 250 mg of traditional Chinese medicine granules and 25 mg of celecoxib.

[0023] The technical solutions in the embodiments of the present invention are described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0024] Example 1 An improved Zhi Fructus and Licorice Decoction, the active ingredients of which are composed of the following Chinese medicinal beverage raw materials in parts by weight: 3 parts of Citrus aurantium, 1.5 parts of Licorice, 6 parts of Angelica sinensis, 9 parts of Salvia miltiorrhiza, 4.5 parts of Trigonosciadium japonicum, 6 parts of Curcuma zedoaria, 3 parts each of processed Black and White Rhizoma, 3 parts of Polygala tenuifolia, 6 parts of Eucommia ulmoides, 1 part of Achyranthes bidentata, 1 part of Cinnamomum cassia, 3 parts of Gastrodia elata, 2 parts of Ganoderma lucidum, 2 parts of Ginkgo biloba, 3 parts of Polygonum cuspidatum, 1 part of Jujube, 3 parts of Pueraria root, and 1 part of Leonurus japonicus.

[0025] The preparation process of the Chinese medicine capsule based on the formula of the improved Zhike Gancao decoction is characterized by comprising the following steps: 1) Primary crushing: put Fructus Aurantii Immaturus, Radix Glycyrrhizae, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, Rhizoma Curcumae, and Radix Eupatorii Herba into a crusher for crushing, then grind into powder, and pass through a 150-200 mesh sieve to obtain raw material A; 2) Steam heating: Place raw material A into the steam treatment equipment and heat it with 115-120℃ steam at a high pressure of 4-6 atmospheres for 15-35 minutes; 3) Extraction: put the heated material into 5-10 times volume of water, heat and extract at 80-90℃ for 2-4 times, collect the extract when evaporation reaches 15% of the original water volume each time; finally combine the extracts; 4) Drying: Evaporating and drying the combined extracts until the water content is less than 20% to obtain extract A; 5) Secondary crushing: Mix Polygala tenuifolia, Eucommia ulmoides, Achyranthes bidentata, Cinnamon twig, Gastrodia elata, Ganoderma lucidum, Ginkgo biloba, Polygonum cuspidatum, jujube, Pueraria root and Leonurus japonicus, put them into a grinder, grind them into powder, and pass through a 150-200 mesh sieve to obtain raw material B; 6) Enzymolysis: Add raw material B into water at a ratio of 1g:20-30mL, and add 100-200U / mL of cellulase, 150-250U / mL of pectinase, and 100-200U / mL of papain at the same time, and perform enzymolysis at 38-42℃ for 4-8h, stirring at the same time, and the speed is 50-100rpm; 7) Supercritical extraction: Use carbon dioxide as the extraction solvent to perform supercritical extraction of raw material B, the extraction pressure is 25-30MPa, the temperature is 75-80℃, the extraction time is 25-45min, and the extraction solvent flow rate is 5-10kg / h; the analysis process of the extraction effluent is two-stage, the first stage analysis pressure is 15-20MPa, the analysis temperature is 65~75℃, the second stage analysis pressure is 5-10MPa, and the analysis temperature is 55~65℃. Collect the extracted part, which is extract B; 8) Rotary evaporation: Place extract B into a rotary evaporator and heat and rotary evaporate until the solid content is 75-85wt% to obtain extract B; 9) Spray granulation: Combine extract A and extract B, add 50-100 g / L sucrose powder, 50-100 g / L β-cyclodextrin, and 300-600 g / L water, and stir continuously to form a suspension. Then, use a pump to spray the suspension through a high-pressure sprayer in the hot air flow in the drying chamber to rapidly evaporate the water to directly form spherical dry fine particles with an average particle size of 50-100 μm to obtain Chinese medicine particles; 10) Preparation of capsules: The Chinese medicine granules are mixed with the nonsteroidal anti-inflammatory drugs and prepared into capsules according to the general preparation method of capsule preparations.

[0026] The capsule contains 250 mg of traditional Chinese medicine granules and 25 mg of celecoxib.

[0027] Example 2 An improved Zhi Fructus and Licorice Decoction, the active ingredients of which are composed of the following Chinese medicinal beverage raw materials in parts by weight: Fructus Aurantii Immaturus 5 parts, Radix Glycyrrhizae 5 parts, Radix Angelicae Sinensis 9 parts, Radix Salviae Miltiorrhizae 12 parts, Rhizoma Trigonosciae 6 parts, Rhizoma Curcumae 7.5 parts, 4.5 parts each of processed Rhizoma Atractylodis Macrocephalae, 4.5 parts of Radix Polygoni Multiflori, 7.5 parts of Eucommia ulmoides, 2 parts of Achyranthes Bidentatae, 2 parts of Cinnamomum cassia twig, 4.5 parts of Gastrodia elatae, 3 parts of Ganoderma lucidum, 3 parts of Ginkgo biloba, 4.5 parts of Polygonum cuspidatum, 2 parts of Jujube, 4.5 parts of Radix Puerariae, and 2 parts of Leonurus japonicus.

[0028] The preparation process of the Chinese medicine capsule based on the formula of the improved Zhike Gancao decoction is characterized by comprising the following steps: 1) Primary crushing: put Fructus Aurantii Immaturus, Radix Glycyrrhizae, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, Rhizoma Curcumae, and Radix Eupatorii Herba into a crusher for crushing, then grind into powder, and pass through a 150-200 mesh sieve to obtain raw material A; 2) Steam heating: Place raw material A into the steam treatment equipment and heat it with 115-120℃ steam at a high pressure of 4-6 atmospheres for 15-35 minutes; 3) Extraction: put the heated material into 5-10 times volume of water, heat and extract at 80-90℃ for 2-4 times, collect the extract when evaporation reaches 15% of the original water volume each time; finally combine the extracts; 4) Drying: Evaporating and drying the combined extracts until the water content is less than 20% to obtain extract A; 5) Secondary crushing: Mix Polygala tenuifolia, Eucommia ulmoides, Achyranthes bidentata, Cinnamon twig, Gastrodia elata, Ganoderma lucidum, Ginkgo biloba, Polygonum cuspidatum, jujube, Pueraria root and Leonurus japonicus, put them into a grinder, grind them into powder, and pass through a 150-200 mesh sieve to obtain raw material B; 6) Enzymolysis: Add raw material B into water at a ratio of 1g:20-30mL, and add 100-200U / mL of cellulase, 150-250U / mL of pectinase, and 100-200U / mL of papain at the same time, and perform enzymolysis at 38-42℃ for 4-8h, stirring at the same time, and the speed is 50-100rpm; 7) Supercritical extraction: Use carbon dioxide as the extraction solvent to perform supercritical extraction of raw material B, the extraction pressure is 25-30MPa, the temperature is 75-80℃, the extraction time is 25-45min, and the extraction solvent flow rate is 5-10kg / h; the analysis process of the extraction effluent is two-stage, the first stage analysis pressure is 15-20MPa, the analysis temperature is 65~75℃, the second stage analysis pressure is 5-10MPa, and the analysis temperature is 55~65℃. Collect the extracted part, which is extract B; 8) Rotary evaporation: Place extract B into a rotary evaporator and heat and rotary evaporate until the solid content is 75-85wt% to obtain extract B; 9) Spray granulation: Combine extract A and extract B, add 50-100 g / L sucrose powder, 50-100 g / L β-cyclodextrin, and 300-600 g / L water, and stir continuously to form a suspension. Then, use a pump to spray the suspension through a high-pressure sprayer in the hot air flow in the drying chamber to rapidly evaporate the water to directly form spherical dry fine particles with an average particle size of 50-100 μm to obtain Chinese medicine particles; 10) Preparation of capsules: The Chinese medicine granules are mixed with the nonsteroidal anti-inflammatory drugs and prepared into capsules according to the general preparation method of capsule preparations.

[0029] The capsule contains 250 mg of traditional Chinese medicine granules and 25 mg of celecoxib.

[0030] Example 3 An improved Zhi Fructus and Licorice Decoction, the active ingredients of which are composed of the following Chinese medicinal beverage raw materials in parts by weight: Fructus Aurantii Immaturus 10 parts, Radix Glycyrrhizae 9 parts, Radix Angelicae Sinensis 12 parts, Radix Salviae Miltiorrhizae 15 parts, Rhizoma Trigonosciae 9 parts, Rhizoma Curcumae 9 parts, 6 parts each of processed Rhizoma Atractylodis Macrocephalae, 6 parts of Polygala Tenuifolia, 9 parts of Eucommia ulmoides, 3 parts of Achyranthes Bidentatae, 3 parts of Cinnamomum Cassiae, 6 parts of Gastrodiae, 4 parts of Ganoderma Lucidum, 4 parts of Ginkgo Biloba, 6 parts of Polygonum Cuspidati, 3 parts of Jujube, 6 parts of Radix Puerariae, and 3 parts of Leonurus Herba.

[0031] The preparation process of the Chinese medicine capsule based on the formula of the improved Zhike Gancao decoction is characterized by comprising the following steps: 1) Primary crushing: put Fructus Aurantii Immaturus, Radix Glycyrrhizae, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, Rhizoma Curcumae, and Radix Eupatorii Herba into a crusher for crushing, then grind into powder, and pass through a 150-200 mesh sieve to obtain raw material A; 2) Steam heating: Place raw material A into the steam treatment equipment and heat it with 115-120℃ steam at a high pressure of 4-6 atmospheres for 15-35 minutes; 3) Extraction: put the heated material into 5-10 times volume of water, heat and extract at 80-90℃ for 2-4 times, collect the extract when evaporation reaches 15% of the original water volume each time; finally combine the extracts; 4) Drying: Evaporating and drying the combined extracts until the water content is less than 20% to obtain extract A; 5) Secondary crushing: Mix Polygala tenuifolia, Eucommia ulmoides, Achyranthes bidentata, Cinnamon twig, Gastrodia elata, Ganoderma lucidum, Ginkgo biloba, Polygonum cuspidatum, jujube, Pueraria root and Leonurus japonicus, put them into a grinder, grind them into powder, and pass through a 150-200 mesh sieve to obtain raw material B; 6) Enzymolysis: Add raw material B into water at a ratio of 1g:20-30mL, and add 100-200U / mL of cellulase, 150-250U / mL of pectinase, and 100-200U / mL of papain at the same time, and perform enzymolysis at 38-42℃ for 4-8h, stirring at the same time, and the speed is 50-100rpm; 7) Supercritical extraction: Use carbon dioxide as the extraction solvent to perform supercritical extraction of raw material B, the extraction pressure is 25-30MPa, the temperature is 75-80℃, the extraction time is 25-45min, and the extraction solvent flow rate is 5-10kg / h; the analysis process of the extraction effluent is two-stage, the first stage analysis pressure is 15-20MPa, the analysis temperature is 65~75℃, the second stage analysis pressure is 5-10MPa, and the analysis temperature is 55~65℃. Collect the extracted part, which is extract B; 8) Rotary evaporation: Place extract B into a rotary evaporator and heat and rotary evaporate until the solid content is 75-85wt% to obtain extract B; 9) Spray granulation: Combine extract A and extract B, add 50-100 g / L sucrose powder, 50-100 g / L β-cyclodextrin, and 300-600 g / L water, and stir continuously to form a suspension. Then, use a pump to spray the suspension through a high-pressure sprayer in the hot air flow in the drying chamber to rapidly evaporate the water to directly form spherical dry fine particles with an average particle size of 50-100 μm to obtain Chinese medicine particles; 10) Preparation of capsules: The Chinese medicine granules are mixed with the nonsteroidal anti-inflammatory drugs and prepared into capsules according to the general preparation method of capsule preparations.

[0032] The capsule contains 250 mg of traditional Chinese medicine granules and 25 mg of celecoxib.

[0033] Comparative Example 1 An improved Zhi Fructus and Licorice Decoction, the active ingredients of which are composed of the following Chinese medicinal beverage raw materials in parts by weight: Fructus Aurantii Immaturus 5 parts, Radix Glycyrrhizae 5 parts, Radix Angelicae Sinensis 9 parts, Radix Salviae Miltiorrhizae 12 parts, Rhizoma Trigonosciae 6 parts, Rhizoma Curcumae 7.5 parts, 4.5 parts each of processed Rhizoma Atractylodis Macrocephalae, 4.5 parts of Radix Polygoni Multiflori, 7.5 parts of Eucommia ulmoides, 2 parts of Achyranthes Bidentatae, 2 parts of Cinnamomum cassia twig, 4.5 parts of Gastrodia elatae, 3 parts of Ganoderma lucidum, 3 parts of Ginkgo biloba, 4.5 parts of Polygonum cuspidatum, 2 parts of Jujube, 4.5 parts of Radix Puerariae, and 2 parts of Leonurus japonicus.

[0034] The preparation process of the Chinese medicine capsule based on the formula of the improved Zhike Gancao decoction is characterized by comprising the following steps: 1) Primary crushing: put Fructus Aurantii Immaturus, Radix Glycyrrhizae, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, Rhizoma Curcumae, and Radix Eupatorii Herba into a crusher for crushing, then grind into powder, and pass through a 150-200 mesh sieve to obtain raw material A; 2) Steam heating: Place raw material A into the steam treatment equipment and heat it with 115-120℃ steam at a high pressure of 4-6 atmospheres for 15-35 minutes; 3) Extraction: put the heated material into 5-10 times volume of water, heat and extract at 80-90℃ for 2-4 times, collect the extract when evaporation reaches 15% of the original water volume each time; finally combine the extracts; 4) Drying: Evaporating and drying the combined extracts until the water content is less than 20% to obtain extract A; 5) Secondary crushing: Mix Polygala tenuifolia, Eucommia ulmoides, Achyranthes bidentata, Cinnamon twig, Gastrodia elata, Ganoderma lucidum, Ginkgo biloba, Polygonum cuspidatum, jujube, Pueraria root and Leonurus japonicus, put them into a grinder, grind them into powder, and pass through a 150-200 mesh sieve to obtain raw material B; 6) Enzymolysis: Add raw material B into water at a ratio of 1g:20-30mL, and add 100-200U / mL of cellulase, 150-250U / mL of pectinase, and 100-200U / mL of papain at the same time, and perform enzymolysis at 38-42℃ for 4-8h, stirring at the same time, and the speed is 50-100rpm; 7) Supercritical extraction: Use carbon dioxide as the extraction solvent to perform supercritical extraction of raw material B, the extraction pressure is 25-30MPa, the temperature is 75-80℃, the extraction time is 25-45min, and the extraction solvent flow rate is 5-10kg / h; the analysis process of the extraction effluent is two-stage, the first stage analysis pressure is 15-20MPa, the analysis temperature is 65~75℃, the second stage analysis pressure is 5-10MPa, and the analysis temperature is 55~65℃. Collect the extracted part, which is extract B; 8) Rotary evaporation: Place extract B into a rotary evaporator and heat and rotary evaporate until the solid content is 75-85wt% to obtain extract B; 9) Spray granulation: Combine extract A and extract B, add 50-100 g / L sucrose powder, 50-100 g / L β-cyclodextrin, and 300-600 g / L water, and stir continuously to form a suspension. Then, use a pump to spray the suspension through a high-pressure sprayer in the hot air flow in the drying chamber to rapidly evaporate the water to directly form spherical dry fine particles with an average particle size of 50-100 μm to obtain Chinese medicine particles; 10) Preparation of capsules: The Chinese medicine granules are mixed with the nonsteroidal anti-inflammatory drugs and prepared into capsules according to the general preparation method of capsule preparations.

[0035] The capsule contains 250 mg of traditional Chinese medicine granules.

[0036] Comparative Example 1 does not contain celecoxib, and the rest is the same as Example 2.

[0037] Comparative Example 2 An improved Zhi Fructus and Licorice Decoction, the active ingredients of which are composed of the following Chinese medicinal beverage raw materials in parts by weight: 5 parts of Citrus aurantium, 5 parts of Licorice, 9 parts of Angelica sinensis, 12 parts of Salvia miltiorrhiza, 6 parts of Trigonosciadium japonicum, 7.5 parts of Curcuma zedoaria, and 4.5 parts each of processed Heibaichou.

[0038] The preparation process of the Chinese medicine capsule based on the formula of the improved Zhike Gancao decoction is characterized by comprising the following steps: 1) Primary crushing: put Fructus Aurantii Immaturus, Radix Glycyrrhizae, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, Rhizoma Curcumae, and Radix Eupatorii Herba into a crusher for crushing, then grind into powder, and pass through a 150-200 mesh sieve to obtain raw material A; 2) Steam heating: Place raw material A into the steam treatment equipment and heat it with 115-120℃ steam at a high pressure of 4-6 atmospheres for 15-35 minutes; 3) Extraction: put the heated material into 5-10 times volume of water, heat and extract at 80-90℃ for 2-4 times, collect the extract when evaporation reaches 15% of the original water volume each time; finally combine the extracts; 4) Drying: Evaporating and drying the combined extracts until the water content is less than 20% to obtain extract A; 5) Spray granulation: Add 50-100g / L sucrose powder, 50-100g / L β-cyclodextrin, and 300-600g / L water to the extract A, stir continuously to form a suspension, and then use a pump to spray it into the hot air flow in the drying chamber through a high-pressure sprayer to evaporate the water quickly to directly form spherical dry fine particles with an average particle size of 50-100μm to obtain Chinese medicine granules; 6) Preparation of capsules: Mix the Chinese medicine granules with the nonsteroidal anti-inflammatory drug and prepare capsules according to the general preparation method of capsule preparations.

[0039] The capsule contains 250 mg of traditional Chinese medicine granules and 25 mg of celecoxib.

[0040] Comparative Example 2 does not contain 4.5 parts of Polygala tenuifolia, 7.5 parts of Eucommia ulmoides, 2 parts of Achyranthes bidentata, 2 parts of Cinnamon twig, 4.5 parts of Gastrodia elata, 3 parts of Ganoderma lucidum, 3 parts of Ginkgo biloba, 4.5 parts of Polygonum cuspidatum, 2 parts of Jujube, 4.5 parts of Pueraria root, and 2 parts of Leonurus japonicus; the rest is the same as Example 2.

[0041] Comparative Example 3 An improved Zhi Fructus and Licorice Decoction, the active ingredients of which are composed of the following Chinese medicinal beverage raw materials in parts by weight: 5 parts of Citrus aurantium, 5 parts of Licorice, 9 parts of Angelica sinensis, 12 parts of Salvia miltiorrhiza, 6 parts of Trigonosciadium japonicum, 7.5 parts of Curcuma zedoaria, and 4.5 parts each of processed Heibaichou.

[0042] The preparation process of the Chinese medicine capsule based on the formula of the improved Zhike Gancao decoction is characterized by comprising the following steps: 1) Primary crushing: put Fructus Aurantii Immaturus, Radix Glycyrrhizae, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, Rhizoma Curcumae, and Radix Eupatorii Herba into a crusher for crushing, then grind into powder, and pass through a 150-200 mesh sieve to obtain raw material A; 2) Steam heating: Place raw material A into the steam treatment equipment and heat it with 115-120℃ steam at a high pressure of 4-6 atmospheres for 15-35 minutes; 3) Extraction: put the heated material into 5-10 times volume of water, heat and extract at 80-90℃ for 2-4 times, collect the extract when evaporation reaches 15% of the original water volume each time; finally combine the extracts; 4) Drying: Evaporating and drying the combined extracts until the water content is less than 20% to obtain extract A; 5) Spray granulation: Add 50-100g / L sucrose powder, 50-100g / L β-cyclodextrin, and 300-600g / L water to the extract A, stir continuously to form a suspension, and then use a pump to spray it into the hot air flow in the drying chamber through a high-pressure sprayer to evaporate the water quickly to directly form spherical dry fine particles with an average particle size of 50-100μm to obtain Chinese medicine granules; 6) Preparation of capsules: Mix the Chinese medicine granules with the nonsteroidal anti-inflammatory drug and prepare capsules according to the general preparation method of capsule preparations.

[0043] The capsule contains 250 mg of traditional Chinese medicine granules.

[0044] Comparative Example 2 does not contain 4.5 parts of Polygala tenuifolia, 7.5 parts of Eucommia ulmoides, 2 parts of Achyranthes bidentata, 2 parts of Cinnamon twig, 4.5 parts of Gastrodia elata, 3 parts of Ganoderma lucidum, 3 parts of Ginkgo biloba, 4.5 parts of Polygonum cuspidatum, 2 parts of Jujube, 4.5 parts of Pueraria root, and 2 parts of Leonurus japonicus; the rest is the same as Example 2.

[0045] Comparative Example 2 does not contain 4.5 parts of Polygala tenuifolia, 7.5 parts of Eucommia ulmoides, 2 parts of Achyranthes bidentata, 2 parts of Cinnamon twig, 4.5 parts of Gastrodia elata, 3 parts of Ganoderma lucidum, 3 parts of Ginkgo biloba, 4.5 parts of Polygonum cuspidatum, 2 parts of Jujube, 4.5 parts of Pueraria root, and 2 parts of Leonurus japonicus; it also does not contain celecoxib, and the rest is the same as Example 2.

[0046] Comparative Example 4 Celecoxib 25mg.

[0047] Comparative Example 5 Celecoxib 50mg.

[0048] Comparative Example 6 Celecoxib 100mg.

[0049] Comparative Example 7 Celecoxib 200mg.

[0050] Test Case The therapeutic effect of the improved Zhi Ke Gan Cao decoction described in the present invention was tested.

[0051] 330 patients diagnosed with intervertebral disc herniation in our hospital were divided into 10 groups, each with 30 people, namely: a group taking the capsules of Examples 1-3, a group taking the capsules of Comparative Examples 1-7, and a control group (taking a placebo, starch granule capsules) Take the above medicine for 15 days, 2 times a day, morning and evening, 1 pill each time, and fill in the evaluation form shown in Table 1 before and after taking the medicine. The scores (accumulated for each person) are shown in Table 2-4 and Figure 2-4 shown.

[0052] Table 1 Intervertebral disc herniation symptom evaluation table Symptom Index 1 point 2 points 3 points 5 points low back pain none Mild pain Moderate pain Severe pain Leg pain none Mild pain Moderate pain Severe pain Leg numbness none Slight numbness Moderate numbness Electric shock Table 2 Clinical scoring results of lumbar disc herniation treatment (low back pain) Pre-treatment index Post-treatment index (after 15 days) Example 1 114 52 Example 2 111 51 Example 3 107 55 Comparative Example 1 109 92 Comparative Example 2 113 85 Comparative Example 3 115 98 Comparative Example 4 116 94 Comparative Example 5 114 75 Comparative Example 6 112 68 Comparative Example 7 110 52 Control group 116 102 Table 3 Clinical score results of lumbar disc herniation treatment (leg pain) Pre-treatment index Post-treatment index (after 15 days) Example 1 121 43 Example 2 118 45 Example 3 120 42 Comparative Example 1 124 86 Comparative Example 2 118 75 Comparative Example 3 117 101 Comparative Example 4 121 105 Comparative Example 5 120 94 Comparative Example 6 115 71 Comparative Example 7 122 47 Control group 121 103 Table 4 Clinical scoring results of lumbar disc herniation treatment (leg numbness) Pre-treatment index Post-treatment index (after 15 days) Example 1 97 62 Example 2 99 57 Example 3 95 58 Comparative Example 1 103 85 Comparative Example 2 101 72 Comparative Example 3 98 90 Comparative Example 4 96 92 Comparative Example 5 102 74 Comparative Example 6 94 63 Comparative Example 7 103 51 Control group 102 94 As can be seen from Tables 2-4 above, the improved Zhi Fructus Licorice Decoction of the present invention is used in combination with a small dose of celecoxib (25 mg), which has a synergistic effect, and can greatly improve the therapeutic effect of a small dose of celecoxib for intervertebral disc symptoms, such as low back pain, leg pain, and leg numbness, similar to a normal dose of 200 mg. Therefore, the Chinese medicine granules of the present invention are combined with celecoxib to form capsules, which can not only play the overall conditioning effect of Chinese medicine, but also quickly relieve pain symptoms, and may reduce the side effects of non-steroidal anti-inflammatory drugs through the regulatory effect of Chinese medicine. The above are only limited to several preferred embodiments of the present invention, and the description is more specific and detailed, but it cannot be understood as a limitation on the scope of the patent of the present invention. It should be pointed out that for those of ordinary skill in the art, without departing from the concept of the present invention, several deformations and improvements can also be made, and these all belong to the protection scope of the present invention.

Claims

1. An improved Zhi Fructus and Licorice Decoction, characterized in that: The active ingredients are composed of the following Chinese herbal medicine beverage raw materials in parts by weight: 3-10 parts of Citrus aurantium, 1.5-9 parts of Licorice, 6-12 parts of Angelica sinensis, 9-15 parts of Salvia miltiorrhiza, 4.5-9 parts of Trillium, 6-9 parts of Curcuma, 3-6 parts each of processed Black and White Atractylodes, 3-6 parts of Polygala tenuifolia, 6-9 parts of Eucommia ulmoides, 1-3 parts of Achyranthes bidentata, 1-3 parts of Cassia twig, 3-6 parts of Gastrodia elata, 2-4 parts of Ganoderma lucidum, 2-4 parts of Ginkgo biloba, 3-6 parts of Polygonum cuspidatum, 1-3 parts of Jujube, 3-6 parts of Pueraria root, and 1-3 parts of Leonurus japonicus.

2. Use of the improved Zhi Fructus and Licorice Decoction as claimed in claim 1 in preparing a medicine for relieving the symptoms of lumbar disc herniation.

3. The use according to claim 2, characterized in that: The symptom is pain in the waist and legs.

4. A compound preparation for relieving the symptoms of low back and leg pain caused by lumbar disc herniation, characterized in that: The invention comprises the improved Zhi Fructus and Licorice Decoction as claimed in claim 1.

5. The compound preparation according to claim 4, characterized in that: The preparations include pills, tablets and capsules.

6. The preparation process of the Chinese medicinal compound preparation according to claim 4, characterized in that: The following steps are involved: 1) Primary crushing: put Fructus Aurantii Immaturus, Radix Glycyrrhizae, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, Rhizoma Curcumae, and Radix Eupatorii Herba into a crusher for crushing, then grind into powder, and pass through a 150-200 mesh sieve to obtain raw material A; 2) Steam heating: Place raw material A into the steam treatment equipment and heat it with 115-120℃ steam at a high pressure of 4-6 atmospheres for 15-35 minutes; 3) Extraction: put the heated material into 5-10 times volume of water, heat and extract at 80-90℃ for 2-4 times, collect the extract when evaporation reaches 15% of the original water volume each time; finally combine the extracts; 4) Drying: Evaporating and drying the combined extracts until the water content is less than 20% to obtain extract A; 5) Secondary crushing: Mix Polygala tenuifolia, Eucommia ulmoides, Achyranthes bidentata, Cinnamon twig, Gastrodia elata, Ganoderma lucidum, Ginkgo biloba, Polygonum cuspidatum, jujube, Pueraria root and Leonurus japonicus, put them into a grinder, grind them into powder, and pass through a 150-200 mesh sieve to obtain raw material B; 6) Enzymolysis: Add raw material B into water at a ratio of 1g:20-30mL, and add 100-200U / mL of cellulase, 150-250U / mL of pectinase, and 100-200U / mL of papain at the same time, and perform enzymolysis at 38-42℃ for 4-8h, stirring at the same time, and the speed is 50-100rpm; 7) Supercritical extraction: Use carbon dioxide as the extraction solvent to perform supercritical extraction of raw material B, the extraction pressure is 25-30MPa, the temperature is 75-80℃, the extraction time is 25-45min, and the extraction solvent flow rate is 5-10kg / h; the analysis process of the extraction effluent is two-stage, the first stage analysis pressure is 15-20MPa, the analysis temperature is 65~75℃, the second stage analysis pressure is 5-10MPa, and the analysis temperature is 55~65℃. Collect the extracted part, which is extract B; 8) Rotary evaporation: Place extract B into a rotary evaporator and heat and rotary evaporate until the solid content is 75-85wt% to obtain extract B; 9) Spray granulation: Combine extract A and extract B, add 50-100 g / L sucrose powder, 50-100 g / L β-cyclodextrin, and 300-600 g / L water, and stir continuously to form a suspension. Then, use a pump to spray the suspension through a high-pressure sprayer in the hot air flow in the drying chamber to rapidly evaporate the water to directly form spherical dry fine particles with an average particle size of 50-100 μm to obtain Chinese medicine particles; 10) Preparation of capsules: The Chinese medicine granules are mixed with the nonsteroidal anti-inflammatory drugs and prepared into capsules according to the general preparation method of capsule preparations.

7. The preparation process of the Chinese medicinal compound preparation according to claim 6, characterized in that: The capsule contains 250-500 mg of traditional Chinese medicine granules.

8. The preparation process of the Chinese medicinal compound preparation according to claim 7, characterized in that: The nonsteroidal anti-inflammatory drug is celecoxib.

9. The preparation process of the Chinese medicinal compound preparation according to claim 7, characterized in that: The content of celecoxib is 25-50 mg.

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