CN113813248A

CN113813248A - Traditional Chinese medicine plaster special for treating lumbar disc herniation and preparation process thereof

Info

Publication number: CN113813248A
Application number: CN202111278332.2A
Authority: CN
Inventors: 吕向东
Original assignee: Zhejiang Yanghe Health Management Technology Co ltd
Current assignee: Zhejiang Yanghe Health Management Technology Co ltd
Priority date: 2021-10-30
Filing date: 2021-10-30
Publication date: 2021-12-21

Abstract

The invention provides a traditional Chinese medicine plaster specially used for treating lumbar disc herniation and a manufacturing process thereof, and relates to the technical field of plaster plasters. The preparation process of the traditional Chinese medicine plaster specially used for treating lumbar disc herniation is simple to operate, the physical and chemical properties of the gel matrix are improved, the gel matrix is used as a carrier of the medicine components, the slow release of the medicine is facilitated, the administration time is prolonged, the maximum effect of the medicine is played, and the curative effect is enhanced. The invention also relates to a traditional Chinese medicine plaster specially used for treating lumbar disc herniation, which has the advantages of accurate dosage, good skin affinity, biocompatibility, sweat resistance, air permeability, repeated tearing property, no allergy and the like. The traditional Chinese medicine patch is used for transdermal administration, is simple to operate, safe and convenient, and can improve the compliance of patients.

Description

Traditional Chinese medicine plaster special for treating lumbar disc herniation and preparation process thereof

Technical Field

The invention relates to the technical field of plaster, in particular to a traditional Chinese medicine plaster specially used for treating lumbar disc herniation and a manufacturing process thereof.

Background

Prolapse of lumbar intervertebral disc refers to the condition of rupture of the annulus fibrosus, prolapse of nucleus pulposus, and lumbago and lower limb radiation pain caused by compression or stimulation of nerve root or dural sac. In recent years, the incidence of diseases is increasing and the diseases are younger, which negatively affects the life and work of patients. In clinic, about 80-90% of first-diagnosis patients do not have surgical indications, and the recurrence rate of the lumbar intervertebral disc herniation is 5-18% according to epidemiological statistics, and the recurrence rate gradually increases with time, so that non-surgical conservative treatment is the preferred treatment method for the disease. The non-operative treatment method for the disease is various, and according to a large number of clinical observation reports, various non-operative treatment methods which are singly or jointly applied obtain more satisfactory clinical treatment effects. The external application of the traditional Chinese medicine plays a vital role in treating the lumbar intervertebral disc protrusion, not only is supported by the theory of percutaneous absorption of the traditional Chinese medicine, but also has the verification of a large amount of clinical curative effect observation and experimental research, and in addition to the progress and the perfection of the traditional Chinese medicine therapeutic apparatus, the curative effect of the traditional Chinese medicine therapeutic apparatus is favored and confirmed by patients.

The Chinese medicine transdermal plaster is prepared through crushing Chinese medicine into fine powder, reasonable extraction, purification and other technological steps, mixing the effective part, effective component, extract, etc. with proper supplementary material or matrix, and applying medicine to the skin surface to make the Chinese medicine components pass through the skin layers at constant speed and enter body circulation to reach the systemic or local treating effect. However, the existing medicinal emplastrum has poor transdermal absorbability, air permeability and skin compatibility, so that the medicinal components can not directly reach the focus of a patient and can not be completely absorbed and utilized, and the experience of the patient using the medicinal emplastrum is poor.

Disclosure of Invention

The invention aims to provide a manufacturing process of a traditional Chinese medicine plaster specially used for treating lumbar disc herniation, which is simple to operate, improves the physical and chemical properties of a gel matrix, is favorable for slowly releasing medicines by taking the gel matrix as a carrier of medicine components, prolongs the administration time, exerts the maximum effect of the medicines and enhances the curative effect.

The invention also aims to provide the traditional Chinese medicine plaster specially used for treating lumbar disc herniation, which has the advantages of accurate dosage, good skin affinity, biocompatibility, sweat resistance, air permeability and repeated tearing property, no allergy and the like, and the traditional Chinese medicine plaster is transdermal administration, is simple to operate, safe and convenient, and can improve the compliance of patients.

The technical problem to be solved by the invention is realized by adopting the following technical scheme.

The invention provides a process for preparing a traditional Chinese medicine plaster special for treating lumbar disc herniation, which comprises the following steps: stirring the combined medicinal powder for treating lumbar disc herniation and the transdermal enhancer to obtain a first mixture; preparing gel matrix solution with solid content of 2-5%; adding the first mixture into gel matrix solution to prepare a mixture with a total solid content of 20-30%, stirring to obtain a second mixture, drying the second mixture at 60-70 ℃ until the water content is 35-40% to obtain an ointment, and coating the ointment on a patch base cloth to obtain the traditional Chinese medicine patch specially used for treating lumbar disc herniation, wherein solid raw materials in the gel matrix solution comprise gelatin, sodium alginate, gellan gum and glycerol.

The invention relates to a traditional Chinese medicine plaster for specially treating lumbar disc herniation, which is prepared by utilizing the manufacturing process of the traditional Chinese medicine plaster for specially treating lumbar disc herniation.

The traditional Chinese medicine plaster specially used for treating lumbar disc herniation and the preparation process thereof provided by the embodiment of the invention have the following beneficial effects:

on one hand, the invention provides a process for preparing a traditional Chinese medicine plaster specially used for treating lumbar disc herniation, wherein a first mixture is obtained by stirring combined medicinal powder for treating lumbar disc herniation and a penetration enhancer, the penetration enhancer in the first mixture is tightly combined with the combined medicament, and the first mixture can carry medicinal components to directly reach a focus through a skin surface layer after contacting with the skin, so that the absorption and utilization of the medicinal components by a human body are improved, the curative effect of the medicament is improved, and the dosage of the medicament is reduced. The gel matrix has synergistic effect, improves the thermal stability, water resistance, mechanical property and the like of the gel matrix, provides a good drug-loading substrate for drugs, and the gel matrix solution with the solid content of 2-5% has good fluidity, can be well mixed with raw materials added in the later period, and ensures the stability of the curative effect of the ointment. The first mixture is added into the gel matrix solution and stirred, so that the agglomeration and bonding of the combined medicinal powder can be avoided, the dispersibility of the combined medicinal powder in the gel matrix solution is improved, the stability of the quality of the ointment is ensured, and the curative effect of the ointment is prevented from being influenced. The first mixing step is added into the gel matrix solution to prepare a mixture with the total solid content of 20-30%, and the mixture is stirred to obtain a second mixture, wherein the dosage of the medicine contained in the final product under the solid content is proper, the maximum effect of the medicine can be exerted, and the curative effect is obvious. Drying the mixture II at 60-70 deg.C can avoid cracking of the outer layer of gel matrix due to too fast drying rate, and influence on its application. Drying to water content of 35-40% to obtain ointment with good moisture keeping, adhesion and fluidity, which is not only beneficial to slowly releasing the medicine and prolonging the administration time, but also beneficial to smearing the ointment on a plaster base cloth to obtain a traditional Chinese medicine plaster specially used for treating lumbar disc herniation with good spreadability. Finally, the ointment is coated on a plaster base cloth to obtain the traditional Chinese medicine plaster specially used for treating lumbar disc herniation.

On the other hand, the invention also provides a traditional Chinese medicine plaster specially used for treating lumbar disc herniation, which is prepared by utilizing the preparation process of the traditional Chinese medicine plaster specially used for treating lumbar disc herniation. The Chinese medicinal patch has the advantages of accurate dosage, good skin affinity, biocompatibility, sweat resistance, air permeability, repeated tearing property, and no allergy. The patch contains transdermal enhancer, and can promote the penetration of medicinal components into dermis via horny layer and epidermis, diffuse into capillary vessel, and transfer to systemic circulation for treatment. In addition, the ointment in the traditional Chinese medicine plaster takes the gel as a medicine carrier, the gel can control the release rate of the medicine, the action time of the medicine is prolonged by continuously releasing the medicine at a constant rate, the administration frequency is reduced, the first pass effect of the liver can be avoided, the bioavailability of the medicine is improved, and the stimulation of the medicine to the intestines and the stomach is reduced. Moreover, the traditional Chinese medicine patch is used for transdermal administration, so that the operation is simple, safe and convenient, and the compliance of patients can be improved.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. The examples, in which specific conditions are not specified, were conducted under conventional conditions or conditions recommended by the manufacturer. The reagents or instruments used are not indicated by the manufacturer, and are all conventional products available commercially.

It should be noted that the embodiments and features of the embodiments in the present application may be combined with each other without conflict. The present invention will be described in detail below with reference to specific examples.

The invention provides a process for preparing a traditional Chinese medicine plaster special for treating lumbar disc herniation, which comprises the following steps: stirring the combined medicinal powder for treating lumbar disc herniation and the transdermal enhancer to obtain a first mixture; preparing gel matrix solution with solid content of 2-5%; adding the first mixture into gel matrix solution to prepare a mixture with a total solid content of 20-30%, stirring to obtain a second mixture, drying the second mixture at 60-70 ℃ until the water content is 35-40% to obtain an ointment, and coating the ointment on a patch base cloth to obtain the traditional Chinese medicine patch specially used for treating lumbar disc herniation, wherein solid raw materials in the gel matrix solution comprise gelatin, sodium alginate, gellan gum and glycerol. Wherein, the gelatin is a biopolymer with excellent physicochemical and biological properties, contains a plurality of hydrophilic groups in the molecule, can react with water molecules, and is a hydrophilic colloid solution. The process of gelatin formation is the process of molecular recovery from a random coil state to an ordered triple helix structure, and hydrogen bonds in the formed gel play a leading role. Glycerin is a colorless transparent viscous liquid, has strong hydrophilicity, and has good compatibility with many colloidal materials. The gelatin-based gel is hardened due to rapid drying in the air, so that the stability and durability of the gelatin-based gel as a drug carrier are influenced, and the biocompatibility and safety of the material are not influenced by mixing the gelatin-based gel with glycerol, and the thermal stability and water retention of a gel matrix can be improved. The sodium alginate has good film forming property and compatibility, and is added into the gel matrix, so that the water resistance, stability and mechanical property of the gel matrix can be improved under the synergistic effect of the raw materials, and meanwhile, the inactivation of sensitive medicines can be avoided, and the treatment effect of the medicines is ensured. The gellan gum is a microbial extracellular polysaccharide, and can be added to improve the stability of the gel matrix, and also can be used as a stabilizer to improve the shape retention of the gel matrix and shorten the forming time of the gel matrix. Furthermore, the solid mass ratio of the gelatin to the sodium alginate to the gellan gum to the glycerin is 4 (1-2) to (2-3), and a gel matrix solution formed by the ratio has good fluidity, can improve the dispersibility of the combined medicinal powder in the gel matrix solution, and has good formability, excellent mechanical properties and more medicine-loading capacity. And the raw materials of the gel matrix solution are added into deionized water in batches and stirred to prepare the gel matrix solution with the solid content of 2-5%, and the gel matrix solution with the solid content has good fluidity and can be well mixed with the raw materials added in the later period, so that the stability of the curative effect of the ointment is ensured.

The composite medicinal powder for treating lumbar disc herniation and the penetration enhancer are stirred to obtain a mixture I, the promoter in the mixture I is tightly combined with the composite medicament, and the mixture I can carry medicinal components to directly reach a focus through the surface layer of skin after contacting with the skin, so that the absorption and utilization of the medicinal components by a human body are improved, the curative effect of the medicament is improved, and the dosage of the medicament is reduced. In detail, the penetration enhancer is at least one of isopropyl myristate, cetearyl alcohol and jojoba seed oil. Wherein, isopropyl myristate can be used as penetration promoter in transdermal absorption preparation, can effectively contact with hair follicle in cortex, and brings active components in the combined medicinal powder into deep cortex to give full play to the effect of effective components; simultaneously, the skin care product can also play roles in removing cutin, moisturizing and moistening skin. Cetearyl alcohol is used as an emollient, emulsifier, and thickener, which allows the combined powder to more easily penetrate the skin, while also improving the stability of the combined powder in the gel matrix. Jojoba oil is not easily oxidized, has good touch and ductility, and is easily absorbed by skin. Furthermore, the mass ratio of the combined medicinal powder to the penetration enhancer is 1 (1-1.5), the combined medicinal powder and the penetration enhancer can be uniformly mixed according to the proportion without reducing the dosage, and the absorption of the medicament can be promoted and the medicinal effect can be improved.

The first mixture is added into the gel matrix solution and stirred, so that the agglomeration and bonding of the combined medicinal powder can be avoided, the dispersibility of the combined medicinal powder in the gel matrix solution is improved, the stability of the quality of the ointment is ensured, and the curative effect of the ointment is prevented from being influenced. In detail, the combined medicinal powder for treating lumbar disc herniation in the embodiment of the invention comprises the following raw materials in parts by weight: 5-10 parts of black monkshood, 2-3 parts of prepared monkshood, 5-8 parts of radix angelicae pubescentis, 3-5 parts of erythrina bark, 6-8 parts of radix clematidis, 5-8 parts of rhizoma corydalis, 5-10 parts of safflower, 5-10 parts of cassia twig and 3-6 parts of liquorice. Wherein, the black aconite root is pungent and sweet in flavor and large in nature and heat in nature, enters heart, kidney and spleen channels, has the effects of restoring yang and rescuing from collapse, tonifying fire and supporting yang, and dispelling cold and relieving pain, and is commonly used for treating cold-dampness arthralgia, kidney yang deficiency, yang deficiency and external infection and other symptoms. The prepared radix aconiti has pungent, bitter and hot taste, is in the heart, liver, kidney and spleen channels, has the effects of dispelling wind and removing dampness, warming channels and relieving pain, is commonly used for treating diseases such as anemofrigid-damp arthralgia, cold hernia and pain, and can also be used as an anesthetic and analgesic medicament. Radix Angelicae Pubescentis is pungent and bitter in flavor and slightly warm in nature, enters kidney and bladder channels, has effects of dispelling pathogenic wind, removing dampness, dredging arthralgia and relieving pain, and is used for treating arthralgia due to wind-cold-dampness, and pain in waist and knees. Erythrina bark, bitter and pungent in flavor and neutral in nature, enters liver and spleen channels, has the effects of dispelling wind-damp, dredging meridians and killing parasites, and is commonly used for treating rheumatism. Clematis root, radix Clematidis, being pungent, salty and warm in nature, enters bladder meridian, has the effects of expelling wind-damp and dredging meridian, and is commonly used for treating rheumatism, numbness of limbs, spasm of tendons and vessels, difficulty in flexion and extension and other diseases. Corydalis tuber is pungent and bitter in flavor and warm in nature, enters liver and spleen channels, has the effects of activating blood, promoting qi circulation and relieving pain, and is commonly used for treating chest stuffiness and pains, amenorrhea and dysmenorrhea, traumatic injury and swelling pain and other diseases. Safflower is pungent in flavor and warm in nature, enters heart and liver meridians, has the functions of promoting blood circulation and dredging meridian, and removing blood stasis and relieving pain, and is commonly used for treating chest stuffiness and pain, stabbing pain in chest and hypochondrium, traumatic injury and other diseases. Cassia twig, pungent and sweet in flavor and warm in nature, entering heart, lung and bladder meridians, has the effects of inducing sweat, expelling pathogenic factors from muscles, warming and activating meridians, supporting yang, regulating qi, and calming the adverse-rising energy, and is commonly used for treating abdominal cold pain, amenorrhea due to blood cold, arthralgia and other diseases. The liquorice has sweet taste and mild nature, enters heart, lung, spleen and stomach channels, has the effects of tonifying spleen and qi, clearing heat and detoxicating, eliminating phlegm and stopping cough, relieving spasm and pain and harmonizing various medicaments, is commonly used for treating diseases such as weakness of spleen and stomach, lassitude and hypodynamia, palpitation and shortness of breath, abdominal and limb spasm and pain and the like, and can also relieve the toxicity and the pungency of medicaments.

The medicines have reasonable compatibility, and have the effects of expelling wind and removing dampness, warming channels and expelling cold, promoting blood circulation and removing blood stasis, clearing and activating the channels and collaterals, tonifying kidney and strengthening waist, so that the powder for treating wind and cold and dampness and arthralgia can be removed, the treatment effect is good, and the pain is relieved, thereby reducing the influence of the waist pain on the daily life of a patient. Wherein, the black aconite root has the effects of warming and dispelling cold; the prepared radix aconiti and the erythrina bark have the effects of dispelling wind, eliminating dampness, dispelling cold and relieving pain, and have the advantages of quick and smooth property, opening closure striae and quick cold and dampness expelling capability, and the prepared radix aconiti has the effects of anesthesia and pain relieving; radix Angelicae Pubescentis, being pungent and bitter with the action of dispersing and drying, fragrant and warm in nature, excels in dispelling wind-damp and stopping arthralgia, governs kidney meridian, and especially excels in treating wind-cold-dampness arthralgia of lower half body; clematis chinensis is the essential herb for treating rheumatic arthralgia of the whole body, because it excels in dredging meridians; rhizoma corydalis and Carthami flos have effects of promoting blood circulation, dredging channels, removing blood stasis, and relieving pain; ramulus Cinnamomi warms and unblocks meridians; licorice root, radix Glycyrrhizae coordinates the effects of the other drugs in the recipe. When 8 parts of black monkshood, 2.5 parts of prepared monkshood, 6 parts of radix angelicae pubescentis, 4 parts of erythrina bark, 6.5 parts of radix clematidis, 7 parts of rhizoma corydalis, 8 parts of safflower, 8 parts of cassia twig and 5 parts of liquorice are used, the combined medicinal powder of the embodiment has a remarkable curative effect on lumbar intervertebral disc protrusion, has small side effect and can quickly relieve pain in the waist of a human body.

Furthermore, the combined medicinal powder for treating lumbar disc herniation also comprises 3-5 parts of frankincense, 10-15 parts of poria cocos and 6-10 parts of white paeony root in parts by weight in addition to the medicines. The frankincense is pungent and bitter in taste and warm in nature, enters heart and liver meridians, has the effects of promoting blood circulation, relieving pain, reducing swelling and promoting granulation, and is beneficial to repair of intervertebral disc fibrous rings. The tuckahoe has sweet and light taste and neutral nature, has the effects of benefiting heart, lung, spleen and kidney channels, promoting diuresis, eliminating dampness, strengthening spleen and calming heart, contains medicinal components for inhibiting the expression of inflammatory factors, and can relieve inflammatory reaction and pain. White peony root, radix paeoniae alba is bitter and sour in taste and slightly cold in nature, enters liver and spleen channels, has the effects of nourishing blood, regulating menstruation, astringing yin, arresting sweating, softening liver, relieving pain and calming liver yang, and white peony root total glycosides in white peony root can inhibit the release of inflammatory factors, has an anti-inflammatory effect, and can enhance the pain relieving effect when used together with poria cocos. The addition of the medicinal components can relieve pain caused by the protrusion of the lumbar intervertebral disc and promote the recovery of the function of the lumbar vertebra. In detail, the particle size of the combined medicinal powder is 60-80 meshes, the components in the combined medicinal powder with the particle size are mixed more uniformly, the uniformity of the quality of the combined medicinal powder is ensured, the prepared ointment is fine and smooth due to small particle size, the flowability is good for manufacturing the traditional Chinese medicine plaster, and the traditional Chinese medicine plaster is comfortable when being contacted with the skin.

The first mixing step is added into the gel matrix solution to prepare a mixture with the total solid content of 20-30%, and the mixture is stirred to obtain a second mixture, wherein the dosage of the medicine contained in the final product under the solid content is proper, the maximum effect of the medicine can be exerted, and the curative effect is obvious. Drying the mixture II at 60-70 deg.C can avoid cracking of the outer layer of gel matrix due to too fast drying rate, and influence on its application. Drying to water content of 35-40% to obtain ointment with good moisture keeping, adhesion and fluidity, which is not only beneficial to slowly releasing the medicine and prolonging the administration time, but also beneficial to smearing the ointment on a plaster base cloth to obtain a traditional Chinese medicine plaster specially used for treating lumbar disc herniation with good spreadability.

Finally, the ointment is coated on a plaster base cloth to obtain the traditional Chinese medicine plaster specially used for treating lumbar disc herniation. In detail, the plaster base cloth in the embodiment of the invention is calcium alginate non-woven cloth or plaster cloth. Compared with common cotton gauze cloth, the calcium alginate has excellent liquid blocking performance, good air permeability and hygroscopicity, can be used as a good coating carrier of ointment, can improve the comfort of the ointment, and avoids skin rot caused by long-term application. The plaster cloth is composed of non-woven fabrics, hot melt adhesive and release paper, has good self-adhesion and air permeability, good waterproof property, no damage to skin and high practicability.

The invention also provides a traditional Chinese medicine plaster specially used for treating lumbar disc herniation, which is prepared by utilizing the preparation process of the traditional Chinese medicine plaster specially used for treating lumbar disc herniation. The Chinese medicinal patch has the advantages of accurate dosage, good skin affinity, biocompatibility, sweat resistance, air permeability, repeated tearing property, and no allergy. The patch contains transdermal enhancer, and can promote the penetration of medicinal components into dermis via horny layer and epidermis, diffuse into capillary vessel, and transfer to systemic circulation for treatment. In addition, the ointment in the traditional Chinese medicine plaster takes the gel as a medicine carrier, the gel can control the release rate of the medicine, the action time of the medicine is prolonged by continuously releasing the medicine at a constant rate, the administration frequency is reduced, the first pass effect of the liver can be avoided, the bioavailability of the medicine is improved, and the stimulation of the medicine to the intestines and the stomach is reduced. Moreover, the traditional Chinese medicine patch is used for transdermal administration, so that the operation is simple, safe and convenient, and the compliance of patients can be improved.

The features and properties of the present invention are described in further detail below with reference to examples.

Example 1

The invention provides a process for preparing a traditional Chinese medicine plaster special for treating lumbar disc herniation, which comprises the following steps:

preparation of a liquid medicine: mixing and grinding 8g of black monkshood, 2.5g of prepared monkshood, 6g of radix angelicae pubescentis, 4g of erythrina bark, 6.5g of radix clematidis, 7g of rhizoma corydalis, 8g of safflower, 7g of cassia twig, 4g of frankincense, 13g of poria cocos, 7g of radix paeoniae alba and 5g of liquorice, grinding and sieving to obtain 70-mesh combined medicinal powder for treating lumbar disc herniation, and then stirring the combined medicinal powder and isopropyl myristate at a mass ratio of 1.0:1.3 to obtain a mixture I;

preparing the ointment: adding gelatin, sodium alginate, gellan gum and glycerol with the mass ratio of 4.0:1.5:2.5:2.5 into water to prepare gel matrix solution with the solid content of 3%; adding the first mixture into gel matrix solution to prepare a mixture with a total solid content of 25%, stirring to obtain a second mixture, and drying the second mixture at 65 ℃ until the water content is 38% to obtain an ointment;

preparation of the patch: the ointment is coated on calcium alginate non-woven fabric to obtain traditional Chinese medicine plaster for treating lumbar disc herniation.

Example 2

preparation of a liquid medicine: mixing and grinding 10g of black monkshood, 3g of prepared monkshood, 8g of radix angelicae pubescentis, 5g of erythrina bark, 8g of radix clematidis, 8g of rhizoma corydalis, 10g of safflower, 10g of cassia twig, 5g of frankincense, 15g of poria cocos, 10g of radix paeoniae alba and 6g of liquorice, grinding and sieving to obtain combined medicinal powder with the particle size of 80 meshes for treating lumbar disc herniation, and then stirring the combined medicinal powder and cetostearyl alcohol in a mass ratio of 1:1 to obtain a mixture I;

preparing the ointment: adding gelatin, sodium alginate, gellan gum and glycerol in a mass ratio of 4:1:2:2 into water to prepare a gel matrix solution with a solid content of 2%; adding the mixture I into a gel matrix solution to prepare a mixture with a total solid content of 30%, and stirring to obtain a mixture II; drying the mixture II at 60 ℃ until the water content is 35% to obtain an ointment;

preparation of the patch: the ointment is coated on plaster cloth to obtain the traditional Chinese medicine plaster for treating lumbar disc herniation.

Example 3

preparation of a liquid medicine: mixing and grinding 5g of black monkshood, 2g of prepared monkshood, 5g of radix angelicae pubescentis, 3g of erythrina bark, 6g of radix clematidis, 5g of rhizoma corydalis, 5g of safflower, 5g of cassia twig, 3g of frankincense, 10g of poria cocos, 6g of radix paeoniae alba and 3g of liquorice, grinding and sieving to obtain 60-mesh combined medicinal powder for treating lumbar disc herniation, and then stirring the combined medicinal powder and the jojoba seed oil in a mass ratio of 1.0:1.5 to obtain a mixture I;

preparing the ointment: adding gelatin, sodium alginate, gellan gum and glycerol in a mass ratio of 4:2:3:3 into water to prepare a gel matrix solution with a solid content of 5%; adding the mixture I into a gel matrix solution to prepare a mixture with a total solid content of 20%, and stirring to obtain a mixture II; drying the mixture II at 70 ℃ until the water content is 40% to obtain an ointment;

preparation of the patch: the ointment is coated on a plaster base cloth to obtain the traditional Chinese medicine plaster specially used for treating lumbar disc herniation.

Example 4

preparation of a liquid medicine: mixing and grinding 9g of black monkshood, 2.5g of prepared monkshood, 6g of radix angelicae pubescentis, 4.5g of erythrina bark, 7g of radix clematidis, 6g of rhizoma corydalis, 6g of safflower, 6g of cassia twig and 4g of liquorice, grinding and sieving to obtain combined medicinal powder with the particle size of 75 meshes for treating lumbar disc herniation, and then stirring the combined medicinal powder and a penetration enhancer to obtain a mixture I;

preparing the ointment: adding gelatin, sodium alginate, gellan gum and glycerol into water to prepare a gel matrix solution with a solid content of 4%; adding the first mixture into a gel matrix solution to prepare a mixture with a total solid content of 28%, stirring to obtain a second mixture, and drying the second mixture at 63 ℃ until the water content is 36% to obtain an ointment;

preparation of the patch: the ointment is coated on calcium alginate non-woven fabric to obtain the traditional Chinese medicine plaster for treating lumbar disc herniation.

Example 5

stirring the combined medicinal powder for treating lumbar disc herniation and the transdermal enhancer to obtain a first mixture; adding gelatin, sodium alginate, gellan gum and glycerol into water to obtain gel matrix solution with solid content of 3.5%; adding the first mixture into gel matrix solution to prepare a mixture with a total solid content of 22%, stirring to obtain a second mixture, and drying the second mixture at 66 ℃ until the water content is 37% to obtain ointment; the ointment is coated on a plaster base cloth to obtain the traditional Chinese medicine plaster specially used for treating lumbar disc herniation.

Effect example 1

50 patients were randomly selected according to the diagnosis criteria in the "standard of curative effect for diagnosis of disease of traditional Chinese medicine", divided into 5 groups and treated with the traditional Chinese medicine patches for treating lumbar disc herniation obtained in examples 1-5, respectively, and the curative effect was evaluated 20 days after treatment, with the evaluation criteria referring to the "guidelines on clinical research of new drugs of traditional Chinese medicine". And (3) curing: clinical symptoms disappear, and the straight leg elevation test is negative; the effect is shown: clinical symptoms improved with greater than 70 ° elevation of the straight leg; the method has the following advantages: the clinical symptoms are reduced, and the straight leg elevation test is improved; and (4) invalidation: the "effective" criterion was not met. The results of the therapeutic effects of the TCM patches obtained in examples 1-5, which were specifically used for treating lumbar disc herniation, are shown in Table 1.

TABLE 1 therapeutic results

	Number of test persons	The curative effect after 20 days
			Example 1	10 persons	10 persons with obvious effect
Example 2	10 persons	9 effective people and 1 effective person
			Example 3	10 persons	9 effective people and 1 effective person
Example 4	10 persons	Show 8 effective 2 effective
			Example 5	10 persons	Show 6 effective people and 4 effective people

As can be seen from the data in table 1, the Chinese medicinal patches for treating lumbar disc herniation in examples 1-3 have significant efficacy, which indicates that isopropyl myristate, cetostearyl alcohol and jojoba seed oil can effectively contact hair follicles in the cortex as skin penetration enhancers, and bring active ingredients in the combined medicinal powder into the deep part of the cortex, thereby fully exerting the effects of the active ingredients. Meanwhile, the medicine components are slowly released under the action of the gel matrix, and the treatment time of the medicine is prolonged, so that the curative effect is more remarkable. Example 5 has a lower therapeutic effect than those of examples 1 to 4, which demonstrates that the pharmaceutical ingredients of black monkshood, radix aconiti lateralis preparata, radix angelicae pubescentis and the like in the examples of the present invention have a good therapeutic effect on lumbar disc herniation and promote recovery of lumbar function.

Effect example 2

The ointments for treating lumbar disc herniation in examples 1-4 were subjected to comprehensive evaluation, and four indexes of comprehensive sense, initial adhesion, permanent adhesion and peel strength of the ointments were subjected to quality evaluation and comprehensive scoring. The higher the score is, the better the performance of the ointment for treating the bromhidrosis is, the total comprehensive score is 100, namely 40 comprehensive sense organs, 20 initial viscosity, 20 holding viscosity and 20 peeling strength, and the specific comprehensive evaluation result is shown in table 2.

Wherein, the comprehensive sense organ: the full point is 40 points, the spreadability of the paste (10 points), the integrity of the appearance of the paste (smoothness, fineness, roughness) (10 points), the elasticity (5 points), the softness (5 points), the color uniformity (5 points), and the spreadability with the skin (5 points).

Initial adhesion: referring to the 2020 edition Chinese pharmacopoeia, taking the gel plaster sample, removing the external package, standing at room temperature for 30min without squeezing. Then fixing the steel ball in the center of an inclined plane rolling ball device with the length of 23cm and the inclination angle of 15 degrees, keeping 8cm of paste surface except the center of the inclined plane, completely covering the rest parts with a film, freely sliding the prepared steel ball from the upper end of the inclined plane, recording the sliding distance of the steel ball when the steel ball is adhered by the paste, wherein the distance is minimum 20 minutes, and comparing the rest parts with the paste, and scoring is carried out by increasing the distance and deducting the points.

Holding and adhering force: taking the gel plaster sample, removing the external package, and standing at room temperature for 30 min. After the test plate is scrubbed, the test piece is adhered to the test plate and is vertically placed for 20min, then a 100g weight is hung along the length direction of the test piece, after 2min, the weight is increased to 200g and 500g if the test piece does not fall off, and the falling time of the test piece from the test plate is recorded. The maximum number of recorded time and weight is 20 points, and the rest is compared with the maximum number of recorded time and weight, and the points with less weight and time are given as deductive points.

Peel strength: taking the gel plaster sample, removing the external package, and standing at room temperature for 30 min. After scrubbing the test board, longitudinally adhering the test article on the test board, vertically placing for 20min, then hanging a weight of 100g along the length direction of the test article in a reverse 180-degree manner, increasing the weight to 200g and 500g after 2min, and recording the falling time of the test article. The maximum weight and time (peel strength maximum) was measured as 20 points, and the remaining points were given a point score less than the maximum weight and time.

TABLE 2 comprehensive evaluation results

As can be seen from the data in Table 2, the comprehensive sense organs of the ointment are all full 40 points, and the comprehensive scores are all more than 90 points, which shows that the preparation method provided by the invention is beneficial to improving the comprehensive sense organs of the gel. The preparation process of the traditional Chinese medicine plaster specially used for treating lumbar disc herniation is beneficial to obtaining the gel matrix with good physical and chemical properties and strong biological adhesion, and the gel matrix can be used as a medicine carrier to obtain the ointment with good skin affinity, biocompatibility, sweat resistance, air permeability and repeated tearing property.

In summary, the traditional Chinese medicine plaster specially used for treating lumbar disc herniation and the preparation process thereof, and the preparation process thereof.

The embodiments described above are some, but not all embodiments of the invention. The detailed description of the embodiments of the present invention is not intended to limit the scope of the invention as claimed, but is merely representative of selected embodiments of the invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

Claims

1. A manufacturing process of a traditional Chinese medicine plaster specially used for treating lumbar disc herniation is characterized by comprising the following steps:

stirring the combined medicinal powder for treating lumbar disc herniation and the transdermal enhancer to obtain a first mixture; preparing gel matrix solution with solid content of 2-5%; adding the first mixture into the gel matrix solution to prepare a mixture with a total solid content of 20-30%, stirring to obtain a second mixture, drying the second mixture at 60-70 ℃ until the water content is 35-40% to obtain an ointment, and coating the ointment on a patch base cloth to obtain the traditional Chinese medicine patch specially used for treating lumbar disc herniation, wherein solid raw materials in the gel matrix solution comprise gelatin, sodium alginate, gellan gum and glycerol.

2. The manufacturing process of the traditional Chinese medicine patch special for treating lumbar disc herniation according to claim 1, wherein the mass ratio of the gelatin, the sodium alginate, the gellan gum and the glycerol is 4 (1-2) to (2-3).

3. The manufacturing process of the traditional Chinese medicine patch special for treating lumbar disc herniation according to claim 1, wherein the combined medicinal powder for treating lumbar disc herniation comprises the following raw materials in parts by weight:

5-10 parts of black monkshood, 2-3 parts of prepared monkshood, 5-8 parts of radix angelicae pubescentis, 3-5 parts of erythrina bark, 6-8 parts of radix clematidis, 5-8 parts of rhizoma corydalis, 5-10 parts of safflower, 5-10 parts of cassia twig and 3-6 parts of liquorice.

4. The manufacturing process of the traditional Chinese medicine patch special for treating lumbar disc herniation according to claim 3, wherein the combined medicinal powder for treating lumbar disc herniation comprises the following raw materials in parts by weight:

8 parts of black monkshood, 2.5 parts of prepared monkshood, 6 parts of radix angelicae pubescentis, 4 parts of erythrina bark, 6.5 parts of radix clematidis, 7 parts of rhizoma corydalis, 8 parts of safflower, 8 parts of cassia twig and 5 parts of liquorice.

5. The manufacturing process of the traditional Chinese medicine patch special for treating lumbar disc herniation according to any one of claims 3 to 4, wherein the combined medicinal powder for treating lumbar disc herniation further comprises 3 to 5 parts by weight of frankincense, 10 to 15 parts by weight of poria cocos and 6 to 10 parts by weight of white peony root.

6. The manufacturing process of the traditional Chinese medicine patch special for treating lumbar disc herniation according to claim 1, wherein the particle size of the combined medicinal powder is 60-80 meshes.

7. The manufacturing process of the traditional Chinese medicine patch special for treating lumbar disc herniation according to claim 1, characterized in that the penetration enhancer is at least one of isopropyl myristate, cetearyl alcohol and jojoba seed oil.

8. The manufacturing process of the traditional Chinese medicine patch special for treating lumbar disc herniation according to claim 1, characterized in that the mass ratio of the combined medicinal powder to the transdermal enhancer is 1 (1-1.5).

9. The manufacturing process of the traditional Chinese medicine plaster special for treating lumbar disc herniation according to claim 1, wherein the plaster base cloth is calcium alginate non-woven fabric or plaster cloth.

10. A traditional Chinese medicine patch special for treating lumbar disc herniation, which is characterized in that the traditional Chinese medicine patch special for treating lumbar disc herniation is prepared by utilizing the manufacturing process of the traditional Chinese medicine patch special for treating lumbar disc herniation as claimed in any one of claims 1 to 9.