Traditional Chinese medicine compound paste for treating spinal lesion and preparation method thereof
The Chinese medicine compound ointment prepared through fermentation conversion and ultrafiltration technology solves the problems of low transdermal penetration and poor targeting of Chinese medicine external preparations, and achieves effective drug delivery and improved treatment effects on spinal lesions.
Patent Information
- Application Number
- CN202511138751.4
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-08-14
- Publication Date
- 2025-09-16
AI Technical Summary
Existing topical Chinese medicine preparations have difficulty penetrating the deep skin barrier and fascia tissue, and cannot effectively reach the site of spinal lesions. They lack targeting and have low bioavailability, and cannot simultaneously provide key substances such as small molecule repair peptides, metal coenzyme factors and bioactive selenium, resulting in difficulties in the coordinated delivery of multiple components.
Fermentation conversion and ultrafiltration technology are used to prepare a Chinese medicine compound paste, using herbs such as Drynaria fortunei and Cibotium bark as the main medicines, combined with adjuvants such as Viscum album and Cinnamon bark. Organic selenium and minerals are converted through fermentation, and small molecule peptides are enriched through enzymatic hydrolysis and ultrafiltration to improve transdermal efficiency and targeting. The preparation process breaks through the bottleneck of low transdermal rate and poor targeting of traditional Chinese medicine external application preparations.
The transdermal rate and targeting of the Chinese medicine compound ointment are improved, effective drug delivery to the spinal lesion site is achieved, chondrocyte differentiation and anti-inflammatory and analgesic effects are promoted, and the therapeutic effect of spinal lesions is enhanced.
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Figure CN120643658A_ABST
Abstract
Description
Technical Field
[0001] The invention belongs to the technical field of traditional Chinese medicine preparations, and particularly relates to a traditional Chinese medicine compound ointment for treating spinal lesions and a preparation method thereof. Background Art
[0002] Spinal lesions are common degenerative diseases, and their pathological roots involve multiple mechanisms such as intervertebral disc water loss, cartilage matrix degradation, and inflammatory factor infiltration. Today, the incidence of spinal diseases continues to rise, mainly manifested as intervertebral disc herniation, spinal stenosis, ankylosing spondylitis, etc., and severe cases can lead to nerve compression and motor dysfunction. Current clinical treatment methods mainly include surgical intervention and drug control, which have problems such as large trauma and many complications. Although drug treatment can relieve symptoms, its bioavailability is low due to gastrointestinal degradation and first-pass effect, and it lacks the ability to target and enrich spinal tissue.
[0003] The complexity of spinal lesions requires therapeutic substances to possess multiple functions: they must guide bone tissue regeneration, effectively block the chain reaction of oxidative damage, and simultaneously rely on trace elements to stabilize cellular enzyme systems. Traditional Chinese medicine topical preparations, such as plasters and fumigants, are limited by the large molecular weight or insufficient lipid solubility of their active ingredients, making it difficult to penetrate the deep skin barrier and fascia tissue, let alone effectively reach the core area of the intervertebral disc. For the core links of cartilage matrix regeneration and oxidative stress regulation in spinal lesions, conventional drugs have difficulty simultaneously delivering key substances such as small molecule repair peptides, metal coenzyme factors, and bioactive selenium. This makes the coordinated delivery of multiple components difficult, preventing the formation of effective concentrations at the lesion site, and the mineral elements suffer from low bioavailability and poor transdermal penetration. Therefore, the development of a transdermal Chinese medicine preparation with high activity, multiple therapeutic targets, and rich nutritional ingredients is of great significance for improving the treatment efficiency of spinal lesions. Summary of the Invention
[0004] In response to the above situation, the present invention provides a Chinese medicine compound ointment for treating spinal diseases and a preparation method thereof. A transdermal ointment is prepared based on abundant herbal Chinese medicines to treat spinal diseases. Drynaria fortunei and Cibotium bark are used as the main medicines, supplemented with mistletoe, cinnamon, tripterygium wilfordii and other adjuvants to achieve anti-inflammatory and analgesic effects and improve transdermal efficiency. Fermentation is used to obtain organic selenium and minerals, and enzymatic hydrolysis and ultrafiltration are used to enrich small molecule peptides to improve the therapeutic effect of the spine. The innovative preparation process breaks through the bottlenecks of low transdermal rate and poor targeting of traditional Chinese medicine external application preparations.
[0005] To achieve the above object, the technical solution adopted by the present invention is as follows: The invention provides a traditional Chinese medicine compound ointment for treating spinal diseases. The traditional Chinese medicine compound ointment comprises the following raw materials in parts by weight: 15-25 parts of drynaria rhizome, 12-20 parts of dog spine, 10-15 parts of mistletoe, 8-12 parts of amomum villosum, 8 parts of cinnamon bark, 2 parts of tripterygium wilfordii, 1 part of aconite root, 5 parts of scutellaria baicalensis, 4 parts of poria, 4 parts of polygonatum, 3-6 parts of propolis, 5-8 parts of turpentine and 5-10 parts of traditional Chinese medicine fermentation components.
[0006] Furthermore, the Chinese medicine fermentation components include the following raw materials: black sesame, deer antler slices, earthworm, salvia miltiorrhiza, Panax notoginseng and Achyranthes bidentata, and the mass ratio of black sesame, deer antler slices, earthworm, salvia miltiorrhiza, Panax notoginseng and Achyranthes bidentata is 4-10:2-6:1.5:1.5:0.5:0.5.
[0007] The preparation method of the traditional Chinese medicine fermentation component is as follows: S1: Weigh black sesame seeds and soak them in purified water until they germinate to promote selenium biotransformation. Weigh deer antler slices, earthworm, salvia miltiorrhiza, Panax notoginseng, and Achyranthes bidentata, add them to the water and grind them to obtain a mixed solution. S2: Sucrose and yeast extract powder are added to the mixed solution as carbon and nitrogen sources, respectively, and then activated Lactobacillus plantarum is inoculated and naturally fermented for 48 hours at 37°C, with stirring once every 12 hours, to secrete organic acids to dissolve and extract beneficial ions, promote the conversion of inorganic selenium into organic selenium, and hydrolyze large molecular proteases into small molecular active peptides, to obtain a fermentation mixture; S3: After the fermentation mixture is coarsely filtered through filter cloth to remove solid materials and flocculants, the coarse filtrate is collected, i.e., the Chinese medicine fermentation component.
[0008] The present invention also provides a method for preparing a Chinese medicine compound ointment for treating spinal lesions, which specifically comprises the following steps: Step 1: Weigh 15-25 parts of Drynaria fortunei, 12-20 parts of Cibotium barometz, 4 parts of Poria cocos, and 4 parts of Polygonatum sibiricum, mix them, grind them, pass them through a 60-mesh sieve, add cellulase and purified water, extract and enzymatically hydrolyze them at 4°C for 48 hours to destroy the cell walls to release the active substances while retaining the heat-sensitive components, and filter them through filter cloth to obtain the filter residue and primary filtrate respectively; Step 2: Squeeze and squeeze the filter residue to obtain a residue and a squeezed juice, respectively. Weigh 2-6 parts of the Chinese medicinal fermentation component, mix them with the squeezed juice and the primary filtrate, and filter them through a 1 μm filter membrane to obtain a filtrate. Ultrafilter the filtrate through a 2-10 kDa ultrafiltration membrane to remove macromolecular substances, heat and concentrate to obtain a concentrate. The mass ratio of the filtrate to the concentrate is 5:1. Step 3: Weigh 2 parts of Tripterygium wilfordii, 1 part of Aconite root, and 5 parts of Herba speranskiae speranskiae, mix them, spread them flat on a steaming plate, and steam them under high pressure and high temperature for 30 minutes to reduce the toxicity, thereby obtaining a reduced-toxic Chinese medicinal component. Weigh 10-15 parts of Herba Moriphyllume, 8-12 parts of Fructus Amomi, 8 parts of Cinnamomum cassiae, the reduced-toxic Chinese medicinal component, and the residue obtained in step 2, mix them, and grind them to obtain a component to be decocted. Step 4: Add olive oil and 50% ethanol by volume to the components to be decocted, decoct at 70°C for 4 h, filter to obtain an extract, weigh 3-6 parts of propolis, 5-8 parts of turpentine, and 0.5 parts of lecithin, mix with the extract and concentrate, and homogenize to obtain a traditional Chinese medicine compound ointment for treating spinal lesions.
[0009] The beneficial effects achieved by the present invention are as follows: The traditional Chinese medicine compound paste for treating spinal lesions prepared by the present invention activates the cysteine synthase system through the germination process of black sesame, converts inorganic selenium into organic selenium, forms selenoprotein, and after being mixed and crushed with deer antler slices, earthworm, salvia miltiorrhiza, Panax notoginseng and Achyranthes bidentata, releases beneficial mineral elements such as zinc, copper, manganese, magnesium, potassium and sodium. Under the fermentation and enzymatic hydrolysis of Lactobacillus plantarum, metal ion-organic acid chelation occurs, thereby increasing the content of beneficial metal elements in the compound. At the same time, selenoprotein is converted into small molecular active peptides and selenoamino acids to activate GSH-Px (glutathione peroxidase), thereby increasing the skin penetration rate and the therapeutic effect of spinal lesions. Medicinal materials such as Drynaria fortunei and Cibotium barometz have been Low-temperature enzymatic hydrolysis of the cell wall releases active ingredients such as flavonoid glycosides, pteridin, and polysaccharides, and their activity is retained. Among them, flavonoids can promote chondrocyte differentiation and collagen synthesis, pteridin can be used for anti-inflammatory and analgesic effects to promote drug penetration, and polysaccharides can reduce drug allergic reactions and serve as nutrients for the body to absorb. After the cold-soaked residues are extracted with oil and water in two phases with medicinal materials such as Tripterygium wilfordii and Aconitum carmichaelii that have been detoxified by high-pressure steaming, on the one hand, the utilization rate of the medicinal materials is improved, and on the other hand, the extracted volatile oils, cinnamaldehyde and other fat-soluble components and alkaloids and other water-soluble components have higher compatibility and emulsification effects, which are also beneficial to the dissolution and absorption of amphiphilic substances such as protein peptides.
[0010] From the perspective of Chinese medicine compatibility, Drynaria fortunei, Cibotium bark and Deer Antler Slices are the main drugs, with bitter, sweet and warm nature, belonging to the liver meridian and kidney essence, and are used to strengthen the waist and spine, strengthen the tendons and bones, eliminate rheumatism, and benefit the essence and blood. Cibotium bark ascends the Du channel, Drynaria fortunei sinks into the bones, and Deer Antler Slices fill the marrow sea; Viscum album, Amomum villosum and cinnamon bark are pungent and warm in nature, breaking up dampness in the middle burner, transforming dampness and promoting qi circulation; Viscum album is neutral in nature, preventing the main and auxiliary drugs from overheating and damaging the yin; Tripterygium wilfordii is cool in nature, controlling the high heat of Aconitum carmichaelii, restoring yang, rescuing adverse conditions, dispersing cold and relieving pain; Radix radix polygonati dispels wind and dampness, and guides the drugs into the tendons; Achyranthes bidentata is an important drug for guiding the meridians, removing blood stasis and promoting menstruation; Poria cocos and Polygonatum sibiricum are sweet and neutral in nature, preventing warm and dryness from damaging the body, and strengthening the spleen and calming the mind. BRIEF DESCRIPTION OF THE DRAWINGS
[0011] Figure 1 This is the appearance of the Chinese medicine compound ointment prepared in Example 5; Figure 2 The size exclusion chromatography test results of the traditional Chinese medicine compound paste prepared in Example 5 are as follows; Figure 3 The molecular weight distribution of the traditional Chinese medicine compound paste prepared in Example 5 is investigated; Figure 4The liquid phase detection results of selenomethionine in the traditional Chinese medicine compound paste prepared in Example 5; Figure 5 The results are as follows: the transdermal penetration rate of the Chinese medicine compound ointment prepared in Example 5 and Comparative Example 1. DETAILED DESCRIPTION
[0012] The technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, rather than all 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.
[0013] Unless otherwise defined, all technical and scientific terms used herein have the same meanings as those familiar to those skilled in the art. Furthermore, any methods and materials similar or equivalent to those described herein can be applied to the present invention. The preferred embodiments and materials described herein are for illustrative purposes only and are not intended to limit the scope of this application.
[0014] In the following embodiments, unless otherwise specified, conventional methods are used; the parts described below are all parts by weight; the materials used in the following embodiments, unless otherwise specified, are all new materials purchased from the market. In the following embodiments, the drynaria used is made from wine, the dog spine and amomum are made from salt, the mistletoe is made from vinegar, the cinnamon is made from oil cinnamon, the aconite is made from ginger, and the poria is stir-fried; the plant lactobacillus is a freeze-dried powder with an active lactic acid bacteria content of ≥150 billion CFU / g; the cellulase activity used is 400 U / mg.
[0015] Example 1: This example provides a Chinese medicine fermentation component, comprising the following raw materials in parts by weight: 8 parts of black sesame, 4 parts of deer antler slices, 3 parts of earthworms, 3 parts of salvia miltiorrhiza, 1 part of Panax notoginseng and 1 part of Achyranthes bidentata; The preparation method of the traditional Chinese medicine fermentation component is as follows: S1: Weigh 8 parts of black sesame seeds and soak them in 5 parts of purified water in the dark, drain and soak until they germinate to promote selenium biotransformation. Weigh 4 parts of pilose antler slices, 3 parts of earthworms, 3 parts of salvia miltiorrhiza, 1 part of Panax notoginseng and 1 part of Achyranthes bidentata, add them to the mixture and grind them. Then add 15 parts of purified water to obtain a mixture. S2: Add 2 parts of sucrose and 0.5 parts of yeast extract powder to the mixed solution as carbon source and nitrogen source, respectively. Then, inoculate activated Lactobacillus plantarum at an inoculum rate of 5% and ferment naturally for 48 hours at 37°C with stirring every 12 hours to secrete organic acid to dissolve and extract beneficial ions, promote the conversion of inorganic selenium into organic selenium, and hydrolyze large molecular proteins into small molecular active peptides to obtain a fermentation mixture. S3: After the fermentation mixture is coarsely filtered through a 200-mesh nylon filter cloth to remove solid materials and flocculants, the coarse filtrate is collected and sterilized by ultraviolet irradiation to obtain the traditional Chinese medicine fermentation component.
[0016] Example 2: This example provides a Chinese medicine fermentation component, comprising the following raw materials in parts by weight: 16 parts of black sesame, 12 parts of deer antler slices, 3 parts of earthworms, 3 parts of salvia miltiorrhiza, 1 part of Panax notoginseng and 1 part of Achyranthes bidentata; The preparation method of the traditional Chinese medicine fermentation component is as follows: S1: Weigh 16 parts of black sesame seeds and soak them in 10 parts of purified water in the dark, drain the water, and soak until they germinate to promote selenium biotransformation. Weigh 12 parts of velvet antler slices, 3 parts of earthworms, 3 parts of salvia miltiorrhiza, 1 part of Panax notoginseng, and 1 part of Achyranthes bidentata, add them to the mixture and grind them. Then, add 26 parts of purified water to obtain a mixed solution. S2: Add 2 parts of sucrose and 0.5 parts of yeast extract powder to the mixed solution as carbon source and nitrogen source, respectively. Then, inoculate activated Lactobacillus plantarum at an inoculum rate of 5% and ferment naturally for 48 hours at 37°C with stirring every 12 hours to secrete organic acid to dissolve and extract beneficial ions, promote the conversion of inorganic selenium into organic selenium, and hydrolyze large molecular proteins into small molecular active peptides to obtain a fermentation mixture. S3: After the fermentation mixture is coarsely filtered through a 200-mesh nylon filter cloth to remove solid materials and flocculants, the coarse filtrate is collected and sterilized by ultraviolet irradiation to obtain the traditional Chinese medicine fermentation component.
[0017] Example 3: This example provides a Chinese medicine fermentation component, comprising the following raw materials in parts by weight: 20 parts of black sesame, 8 parts of deer antler slices, 3 parts of earthworms, 3 parts of salvia miltiorrhiza, 1 part of Panax notoginseng and 1 part of Achyranthes bidentata; The preparation method of the traditional Chinese medicine fermentation component is as follows: S1: Weigh 20 parts of black sesame seeds and soak them in 16 parts of purified water in the dark, drain the water, and soak until they germinate to promote selenium biotransformation. Weigh 8 parts of pilose antler slices, 3 parts of earthworms, 3 parts of salvia miltiorrhiza, 1 part of Panax notoginseng, and 1 part of Achyranthes bidentata, add them to the mixture and grind them. Then, add 20 parts of purified water to obtain a mixed solution. S2: Add 2 parts of sucrose and 0.5 parts of yeast extract powder to the mixed solution as carbon source and nitrogen source, respectively. Then, inoculate activated Lactobacillus plantarum at an inoculum rate of 5% and ferment naturally for 48 hours at 37°C with stirring every 12 hours to secrete organic acid to dissolve and extract beneficial ions, promote the conversion of inorganic selenium into organic selenium, and hydrolyze large molecular proteins into small molecular active peptides to obtain a fermentation mixture. S3: After the fermentation mixture is coarsely filtered through a 200-mesh nylon filter cloth to remove solid materials and flocculants, the coarse filtrate is collected and sterilized by ultraviolet irradiation to obtain the traditional Chinese medicine fermentation component.
[0018] Example 4: This example provides a Chinese medicine compound ointment for treating spinal lesions, comprising the following raw materials in parts by weight: 15 parts of Drynaria Rhizoma, 12 parts of Cibotium barometz, 12 parts of Morus alba, 8 parts of Amomum villosum, 8 parts of Cinnamon bark, 2 parts of Tripterygium wilfordii, 1 part of Aconite root, 5 parts of Herba schizonepetae, 4 parts of Poria cocos, 4 parts of Polygonatum sibiricum, 3 parts of propolis, 8 parts of turpentine, and 5 parts of Chinese medicine fermentation components; The preparation method of the Chinese medicine fermentation component is shown in Example 1; This embodiment also provides a method for preparing a Chinese medicine compound ointment for treating spinal lesions, comprising the following steps: Step 1: Weigh 15 parts of Drynaria fortunei, 12 parts of Cibotium barometz, 4 parts of Poria cocos, and 4 parts of Polygonatum sibiricum, mix them, grind them, pass them through a 60-mesh sieve, add 0.3 parts of cellulase and 70 parts of purified water, extract and enzymatically hydrolyze them at 4°C for 48 hours to destroy the cell walls to release the active substances while retaining the heat-sensitive components, and filter them through filter cloth to obtain the filter residue and primary filtrate respectively; Step 2: The filter residue is squeezed to obtain a residue and a squeezed juice, respectively. 5 parts of the traditional Chinese medicine fermentation component prepared in Example 1 are weighed, mixed with the squeezed juice and the primary filtrate, and then filtered through a 1 μm filter membrane to obtain a filtrate. The filtrate is ultrafiltered through a 2 kDa ultrafiltration membrane to remove macromolecular substances, and heated and concentrated to 1 / 5 of the mass of the filtrate to obtain a concentrate; Step 3: Weigh 2 parts of Tripterygium wilfordii, 1 part of Aconite root, and 5 parts of Herba speranskiae speranskiae, mix them, spread them flat on a steaming plate, and steam them at 121°C and 0.15 MPa for 30 min to reduce the toxicity, thereby obtaining a reduced-toxic Chinese medicinal component. Then, weigh 12 parts of Herba Moriphyllume, 8 parts of Fructus Amomi, 8 parts of Cinnamomum cassiae, the reduced-toxic Chinese medicinal component, and the residue obtained in step 2, mix and grind them to obtain a component to be decocted; Step 4: Add 15 parts of olive oil and 30 parts of 50% ethanol by volume to the components to be decocted, decoct at 70°C for 4 h, filter to obtain an extract, weigh 3 parts of propolis, 8 parts of turpentine, and 0.5 parts of lecithin, mix with the extract and concentrate, and homogenize to obtain a traditional Chinese medicine compound ointment for treating spinal lesions.
[0019] Example 5: This example provides a Chinese medicine compound ointment for treating spinal lesions, comprising the following raw materials in parts by weight: 20 parts of Drynaria fortunei, 15 parts of Cibotium barometz, 10 parts of Morus alba, 10 parts of Amomum villosum, 8 parts of Cinnamon bark, 2 parts of Tripterygium wilfordii, 1 part of Aconite root, 5 parts of Herba schizonepetae, 4 parts of Poria cocos, 4 parts of Polygonatum sibiricum, 4 parts of Propolis, 7 parts of turpentine, and 8 parts of Chinese medicine fermentation components; The preparation method of the Chinese medicine fermentation component is shown in Example 2; This embodiment also provides a method for preparing a Chinese medicine compound ointment for treating spinal lesions, comprising the following steps: Step 1: Weigh 20 parts of Drynaria fortunei, 15 parts of Cibotium barometz, 4 parts of Poria cocos, and 4 parts of Polygonatum sibiricum, mix them, grind them, pass them through a 60-mesh sieve, add 0.5 parts of cellulase and 86 parts of purified water, extract and enzymatically hydrolyze them at 4°C for 48 hours to destroy the cell walls to release the active substances while retaining the heat-sensitive components, and filter them through filter cloth to obtain the filter residue and primary filtrate respectively; Step 2: The filter residue is squeezed to obtain a residue and a squeezed juice, respectively. 8 parts of the traditional Chinese medicine fermentation component prepared in Example 2 are weighed, mixed with the squeezed juice and the primary filtrate, and then filtered through a 1 μm filter membrane to obtain a filtrate. The filtrate is ultrafiltered through a 5 kDa ultrafiltration membrane to remove macromolecular substances, and heated and concentrated to 1 / 5 of the mass of the filtrate to obtain a concentrate; Step 3: Weigh 2 parts of Tripterygium wilfordii, 1 part of Aconite root, and 5 parts of Herba speranskiae speranskiae, mix them, spread them flat on a steaming plate, and steam them at 121°C and 0.15 MPa for 30 min to reduce the toxicity, thereby obtaining a reduced-toxic Chinese medicinal component. Then, weigh 10 parts of Herba Moriphyllume, 10 parts of Fructus Amomi, 8 parts of Cinnamomum cassiae, the reduced-toxic Chinese medicinal component, and the residue obtained in step 2, mix and grind them to obtain a component to be decocted; Step 4: Add 18 parts of olive oil and 36 parts of 50% ethanol by volume to the components to be decocted, decoct at 70°C for 4 h, filter to obtain an extract, weigh 4 parts of propolis, 7 parts of turpentine, and 0.5 parts of lecithin, mix with the extract and concentrate, and homogenize to obtain a traditional Chinese medicine compound ointment for treating spinal lesions.
[0020] Example 6: This example provides a Chinese medicine compound ointment for treating spinal lesions, comprising the following raw materials in parts by weight: 25 parts of Drynaria fortunei, 20 parts of Cibotium barometz, 15 parts of Morus alba, 12 parts of Amomum villosum, 8 parts of Cinnamon bark, 2 parts of Tripterygium wilfordii, 1 part of Aconite root, 5 parts of Herba schizonepetae, 4 parts of Poria cocos, 4 parts of Polygonatum sibiricum, 6 parts of Propolis, 5 parts of turpentine, and 10 parts of Chinese medicine fermentation components; The preparation method of the Chinese medicine fermentation component is shown in Example 3; This embodiment also provides a method for preparing a Chinese medicine compound ointment for treating spinal lesions, comprising the following steps: Step 1: Weigh 25 parts of Drynaria fortunei, 20 parts of Cibotium barometz, 4 parts of Poria cocos, and 4 parts of Polygonatum sibiricum, mix them, grind them, pass them through a 60-mesh sieve, add 0.8 parts of cellulase and 106 parts of purified water, extract and enzymatically hydrolyze them at 4°C for 48 hours to destroy the cell walls to release the active substances while retaining the heat-sensitive components, and filter them through filter cloth to obtain the filter residue and primary filtrate respectively; Step 2: The filter residue is squeezed to obtain a residue and a squeezed juice, respectively. 10 parts of the traditional Chinese medicine fermentation component prepared in Example 3 are weighed, mixed with the squeezed juice and the primary filtrate, and then filtered through a 1 μm filter membrane to obtain a filtrate. The filtrate is ultrafiltered through a 5 kDa ultrafiltration membrane to remove macromolecular substances, and heated and concentrated to 1 / 5 of the mass of the filtrate to obtain a concentrate; Step 3: Weigh 2 parts of Tripterygium wilfordii, 1 part of Aconite root, and 5 parts of Herba speranskiae speranskiae, mix them, spread them flat on a steaming plate, and steam them at 121°C and 0.15 MPa for 30 min to reduce the toxicity, thereby obtaining a reduced-toxic Chinese medicinal component. Weigh 15 parts of Herba Moriphyllume, 12 parts of Fructus Amomi, 8 parts of Cinnamomum cassiae, the reduced-toxic Chinese medicinal component, and the residue obtained in step 2, mix and grind them to obtain a component to be decocted; Step 4: Add 24 parts of olive oil and 48 parts of 50% ethanol by volume to the components to be decocted, decoct at 70°C for 4 h, filter to obtain an extract, weigh 6 parts of propolis, 5 parts of turpentine, and 0.7 parts of lecithin, mix with the extract and concentrate, and homogenize to obtain a traditional Chinese medicine compound ointment for treating spinal lesions.
[0021] Example 7: This example provides a Chinese medicine compound ointment for treating spinal lesions, comprising the following raw materials in parts by weight: 20 parts of Drynaria fortunei, 15 parts of Cibotium barometz, 10 parts of Morus alba, 10 parts of Amomum villosum, 8 parts of Cinnamon bark, 2 parts of Tripterygium wilfordii, 1 part of Aconite root, 5 parts of Herba schizonepetae, 4 parts of Poria cocos, 4 parts of Polygonatum sibiricum, 4 parts of Propolis, 7 parts of turpentine, and 8 parts of Chinese medicine fermentation components; The preparation method of the Chinese medicine fermentation component is shown in Example 1; This embodiment also provides a method for preparing a Chinese medicine compound ointment for treating spinal lesions, comprising the following steps: Step 1: Weigh 20 parts of Drynaria fortunei, 15 parts of Cibotium barometz, 4 parts of Poria cocos, and 4 parts of Polygonatum sibiricum, mix them, grind them, pass them through a 60-mesh sieve, add 0.5 parts of cellulase and 86 parts of purified water, extract and enzymatically hydrolyze them at 4°C for 48 hours to destroy the cell walls to release the active substances while retaining the heat-sensitive components, and filter them through filter cloth to obtain the filter residue and primary filtrate respectively; Step 2: The filter residue is squeezed to obtain a residue and a squeezed juice, respectively. 8 parts of the traditional Chinese medicine fermentation component prepared in Example 1 are weighed, mixed with the squeezed juice and the primary filtrate, and then filtered through a 1 μm filter membrane to obtain a filtrate. The filtrate is ultrafiltered through a 2 kDa ultrafiltration membrane to remove macromolecular substances, and heated and concentrated to 1 / 5 of the mass of the filtrate to obtain a concentrate; Step 3: Weigh 2 parts of Tripterygium wilfordii, 1 part of Aconite root, and 5 parts of Herba speranskiae speranskiae, mix them, spread them flat on a steaming plate, and steam them at 121°C and 0.15 MPa for 30 min to reduce the toxicity, thereby obtaining a reduced-toxic Chinese medicinal component. Then, weigh 10 parts of Herba Moriphyllume, 10 parts of Fructus Amomi, 8 parts of Cinnamomum cassiae, the reduced-toxic Chinese medicinal component, and the residue obtained in step 2, mix and grind them to obtain a component to be decocted; Step 4: Add 18 parts of olive oil and 36 parts of 50% ethanol by volume to the components to be decocted, decoct at 70°C for 4 h, filter to obtain an extract, weigh 4 parts of propolis, 7 parts of turpentine, and 0.5 parts of lecithin, mix with the extract and concentrate, and homogenize to obtain a traditional Chinese medicine compound ointment for treating spinal lesions.
[0022] Example 8: This example provides a Chinese medicine compound ointment for treating spinal lesions, comprising the following raw materials in parts by weight: 20 parts of Drynaria fortunei, 15 parts of Cibotium barometz, 10 parts of Morus alba, 10 parts of Amomum villosum, 8 parts of Cinnamon bark, 2 parts of Tripterygium wilfordii, 1 part of Aconite root, 5 parts of Herba schizonepetae, 4 parts of Poria cocos, 4 parts of Polygonatum sibiricum, 4 parts of Propolis, 7 parts of turpentine, and 8 parts of Chinese medicine fermentation components; The preparation method of the Chinese medicine fermentation component is shown in Example 3; This embodiment also provides a method for preparing a Chinese medicine compound ointment for treating spinal lesions, comprising the following steps: Step 1: Weigh 20 parts of Drynaria fortunei, 15 parts of Cibotium barometz, 4 parts of Poria cocos, and 4 parts of Polygonatum sibiricum, mix them, grind them, pass them through a 60-mesh sieve, add 0.5 parts of cellulase and 86 parts of purified water, extract and enzymatically hydrolyze them at 4°C for 48 hours to destroy the cell walls to release the active substances while retaining the heat-sensitive components, and filter them through filter cloth to obtain the filter residue and primary filtrate respectively; Step 2: The filter residue is squeezed to obtain a residue and a squeezed juice, respectively. 8 parts of the traditional Chinese medicine fermentation component prepared in Example 3 are weighed, mixed with the squeezed juice and the primary filtrate, and then filtered through a 1 μm filter membrane to obtain a filtrate. The filtrate is ultrafiltered through a 10 kDa ultrafiltration membrane to remove macromolecular substances, and heated and concentrated to 1 / 5 of the mass of the filtrate to obtain a concentrate; Step 3: Weigh 2 parts of Tripterygium wilfordii, 1 part of Aconite root, and 5 parts of Herba speranskiae speranskiae, mix them, spread them flat on a steaming plate, and steam them at 121°C and 0.15 MPa for 30 min to reduce the toxicity, thereby obtaining a reduced-toxic Chinese medicinal component. Then, weigh 10 parts of Herba Moriphyllume, 10 parts of Fructus Amomi, 8 parts of Cinnamomum cassiae, the reduced-toxic Chinese medicinal component, and the residue obtained in step 2, mix and grind them to obtain a component to be decocted; Step 4: Add 18 parts of olive oil and 36 parts of 50% ethanol by volume to the components to be decocted, decoct at 70°C for 4 h, filter to obtain an extract, weigh 4 parts of propolis, 7 parts of turpentine, and 0.5 parts of lecithin, mix with the extract and concentrate, and homogenize to obtain a traditional Chinese medicine compound ointment for treating spinal lesions.
[0023] Comparative Example 1: This comparative example provides a Chinese medicine compound ointment for treating spinal diseases, comprising the following raw materials in parts by weight: 20 parts of Drynaria Rhizoma, 15 parts of Cibotium barometz, 10 parts of Morus alba, 10 parts of Amomum villosum, 8 parts of Cinnamon bark, 2 parts of Tripterygium wilfordii, 1 part of Aconite root, 5 parts of Herba schizonepetae, 4 parts of Poria cocos, 4 parts of Polygonatum sibiricum, 4 parts of Propolis, 7 parts of turpentine, and 8 parts of Chinese medicine fermentation components. The Chinese medicinal fermentation component comprises the following raw materials in parts by weight: 16 parts of black sesame, 12 parts of deer antler slices, 3 parts of earthworms, 3 parts of salvia miltiorrhiza, 1 part of Panax notoginseng and 1 part of Achyranthes bidentata, and the preparation method is as follows: S1: Weigh 16 parts of black sesame seeds and soak them in 10 parts of purified water in the dark, drain the water, and soak until they germinate to promote selenium biotransformation. Weigh 12 parts of velvet antler slices, 3 parts of earthworms, 3 parts of salvia miltiorrhiza, 1 part of Panax notoginseng, and 1 part of Achyranthes bidentata, add them to the mixture and grind them. Then, add 26 parts of purified water to obtain a mixed solution. S2: Continue soaking for 48 h to obtain a mixed solution; S3: After the mixed solution is coarsely filtered through a 200-mesh nylon filter cloth to remove solid materials and flocculent substances, the coarse filtrate is collected and sterilized by ultraviolet irradiation to obtain the traditional Chinese medicine fermentation component; This comparative example also provides a method for preparing a Chinese medicine compound ointment for treating spinal lesions, comprising the following steps: Step 1: Weigh 20 parts of Drynaria Rhizoma, 15 parts of Cibotium Cibotium, 4 parts of Poria, and 4 parts of Polygonatum sibiricum, mix them, grind them, pass through a 60-mesh sieve, add 86 parts of purified water, extract at 4°C for 48 hours, and filter with filter cloth to obtain the filter residue and primary filtrate respectively; Step 2: The filter residue is squeezed and pressed to obtain a residue and a squeezed juice, respectively. 8 parts of the Chinese medicinal fermentation component are weighed, mixed with the squeezed juice and the primary filtrate, and then filtered through a 1 μm filter membrane to obtain a filtrate. The filtrate is ultrafiltered through a 5 kDa ultrafiltration membrane to remove macromolecular substances, and heated and concentrated to 1 / 5 of the mass of the filtrate to obtain a concentrate; Step 3: Weigh 2 parts of Tripterygium wilfordii, 1 part of Aconite root, and 5 parts of Herba speranskiae speranskiae, mix them, spread them flat on a steaming plate, and steam them at 121°C and 0.15 MPa for 30 min to reduce the toxicity, thereby obtaining a reduced-toxic Chinese medicinal component. Then, weigh 10 parts of Herba Moriphyllume, 10 parts of Fructus Amomi, 8 parts of Cinnamomum cassiae, the reduced-toxic Chinese medicinal component, and the residue obtained in step 2, mix and grind them to obtain a component to be decocted; Step 4: Add 54 parts of purified water to the components to be decocted, boil at 70°C for 4 hours, filter, and concentrate to 5 parts by weight to obtain an extract. Weigh 4 parts of propolis and 7 parts of turpentine, mix the extract and the concentrate, and homogenize to obtain a traditional Chinese medicine compound ointment for treating spinal lesions.
[0024] Appearance inspection Take the Chinese medicine compound paste prepared in Example 5 and pack it into bottles for taking pictures. The appearance results are shown in Figure 1 .
[0025] Investigation of protein and peptide molecular weight The traditional Chinese medicine compound ointment prepared in Example 5 was tested by entrusting the separation of small molecule active polypeptides using size exclusion chromatography. The results are shown in Figure 2 At the same time, the molecular weight distribution was tested and the results were shown in Figure 3 , the content of selenomethionine in the traditional Chinese medicine compound ointment was detected by high performance liquid chromatography, and the results were shown in Figure 4 .
[0026] Ingredient content detection The commissioned testing agency tested the content of the Chinese medicine compound ointment prepared in Example 5. The mineral element results are shown in Table 1, and the amino acid results are shown in Table 2.
[0027] Investigation of transdermal efficiency The transdermal efficiency of the Chinese medicine compound ointment prepared in Example 5 and Comparative Example 1 was investigated by the Franz diffusion cell method. The Chinese medicine compound ointment was labeled with 0.1% sodium fluorescein and evenly applied to the surface of fresh pig skin. The ointment was fixed in the diffusion cell and the fluorescence intensity of the receiving solution was measured at 0.5, 2, 4, 8, 12, 24 and 48 hours. The results are shown in FIG. Figure 5 .
[0028] Table 1 Mineral element test results
[0029] Table 2 Amino acid test results
[0030] Figure 1 The appearance of the Chinese herbal compound ointment is paste-like and viscous.
[0031] Figure 2 The results of size exclusion chromatography showed that the traditional Chinese medicine compound paste prepared in Example 5 had peaks at 17.814 min and 18.831 min, indicating the presence of active peptides in two molecular weight ranges.
[0032] Figure 3 The molecular weight distribution results showed that the traditional Chinese medicine compound ointment prepared in Example 5 contained peptides with molecular weights of 248 Da and 931 Da, which were characteristic small molecule active peptides for the treatment of spinal lesions. Figure 2 The results correspond.
[0033] Figure 4 The results showed that the traditional Chinese medicine compound paste prepared in Example 5 contained selenomethionine at a content of 3.26 mg / kg, and the fermentation treatment was beneficial to the conversion and production of selenomethionine.
[0034] Figure 5 The results of transdermal rate showed that the Chinese medicine compound ointment prepared in Comparative Example 1 without fermentation and two-phase extraction showed a sudden release phenomenon, and the release rate was less than 50%, the transdermal effect was poor, and the utilization rate of the effective ingredients was insufficient. The Chinese medicine compound ointment prepared in Example 5 showed the characteristics of sustained release and long-term effect, and could continuously provide drug stimulation to the spinal lesion site, which was beneficial to the treatment of the disease.
[0035] While embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions, and variations may be made to these embodiments without departing from the principles and spirit of the invention, and that the scope of the invention is defined by the appended claims and their equivalents.
[0036] The present invention and its embodiments are described above. Such description is not restrictive. The drawings show only one embodiment of the present invention, and actual applications are not limited thereto. In short, if a person skilled in the art is inspired by the above, and does not deviate from the purpose of the present invention, any method and embodiment similar to the technical solution without creative design shall fall within the scope of protection of the present invention.
Claims
1. A Chinese medicinal compound ointment for treating spinal lesions, characterized in that: The Chinese medicine compound ointment comprises the following raw materials in parts by weight: 15-25 parts of drynaria rhizome, 12-20 parts of dog spine, 10-15 parts of mistletoe, 8-12 parts of amomum villosum, 8 parts of cinnamon bark, 2 parts of tripterygium wilfordii, 1 part of aconite root, 5 parts of scutellaria baicalensis, 4 parts of poria cocos, 4 parts of polygonatum, 3-6 parts of propolis, 5-8 parts of turpentine and 5-10 parts of Chinese medicine fermentation components; The Chinese medicine fermentation component includes the following raw materials: black sesame, deer antler slices, earthworm, salvia miltiorrhiza, Panax notoginseng and Achyranthes bidentata; The preparation method of the traditional Chinese medicine fermentation component is as follows: S1: Weigh and soak black sesame seeds, mix with deer antler slices, earthworm, salvia miltiorrhiza, Panax notoginseng and Achyranthes bidentata, and grind them to obtain a mixed solution; S2: fermenting the mixed liquid to obtain a fermentation mixed liquid; S3: Filter the fermentation mixture to collect the crude filtrate, i.e., the Chinese medicine fermentation component.
2. A Chinese medicinal compound ointment for treating spinal lesions according to claim 1, characterized in that: In step S1, the black sesame seeds are soaked until they germinate; In step S2, before the mixed solution is fermented, sucrose and yeast extract powder are added to the mixed solution, and the strain used in the fermentation process is Lactobacillus plantarum.
3. A Chinese medicinal compound ointment for treating spinal lesions according to claim 2, characterized in that, The mass ratio of the black sesame, deer antler slices, earthworm, salvia miltiorrhiza, Panax notoginseng and Achyranthes bidentata is 4-10:2-6:1.5:1.5:0.5:0.
5.
4. A method for preparing a Chinese medicinal compound ointment for treating spinal lesions according to any one of claims 1 to 3, characterized in that: The specific steps include: Step 1: Weigh drynaria root, dog spine, poria cocos and polygonatum, mix, crush, sieve, add enzyme and purified water for extraction, filter, and obtain filter residue and primary filtrate respectively; Step 2: Squeeze the filter residue to obtain residue and juice respectively, take the Chinese medicinal fermentation components, mix them with the juice and the primary filtrate, and then pass them through a membrane, ultrafilter, and concentrate to obtain a concentrate; Step 3: Weighing tripterygium wilfordii, aconite root and radix polygoni lobatae and steaming them to obtain a toxin-reducing Chinese medicinal component, and then mixing and crushing them with mistletoe, amomum villosum, cinnamon bark and the residue obtained in step 2 to obtain a component to be decocted; Step 4: The components to be decocted are decocted and filtered to obtain an extract, and propolis, turpentine, lecithin, the extract, and the concentrated solution obtained in step 2 are weighed, mixed, and homogenized to obtain a traditional Chinese medicine compound ointment for treating spinal lesions.
5. The method for preparing a Chinese medicinal compound ointment for treating spinal lesions according to claim 4, wherein: In step 2, the ultrafiltration process uses a 2-10 kDa ultrafiltration membrane; In step 4, the decocting process is to add olive oil and 50% by volume ethanol to the components to be decocted, and decoct at 70° C. for 4 hours.