Herbal paste for relieving limpness, numbness and swelling pain and preparation method thereof

Abstract

The invention provides herbal ointment for relieving limpness, numbness and swelling pain and a preparation method thereof, and belongs to the technical field of medicines. The traditional Chinese medicine composition is prepared from the following raw materials: codonopsis pilosula, cinnamon, angelica sinensis, corydalis serrate, paeonia lactiflora, peony root bark, ligusticum chuanxiong hort, liquorice, fructus evodiae, caulis spatholobi, leonurus, rhizoma corydalis, garden balsam stem, radix aconiti carmichaeli, rhizoma atractylodis, lycopodium clavatum, cortex dictamni, ramulus mori, radix clematidis, rhizoma arisaematis, semen brassicae and notopterygium root. The herbal ointment for relieving limp, numb and swelling pain has the effects of promoting blood circulation to remove blood stasis, expelling wind and removing cold, relieving pain and clearing damp, expelling toxin and enhancing immunity, is good in transdermal absorption promoting effect, long in contact time with skin and lasting in acting effect, can well improve toothache and arthralgia caused by shoulder pain, cervical vertebra pain, waist soreness and back pain, stiff neck, dizziness, headache and excessive internal heat, and has the effects of relieving pain, relieving swelling pain, relieving pain and relieving swelling pain. , varicosity, sprain, bruise, limpness, numbness and swelling pain of limbs, and the like, and has a wide application prospect.

Description

Technical Field

[0001] The invention relates to the technical field of medicines, and in particular to a herbal ointment for relieving soreness, numbness, swelling and pain and a preparation method thereof. Background Art

[0002] The main causes of soreness, numbness, pain, pain and numbness in the human body are due to deficiency of qi and blood, liver and kidney yin deficiency, which leads to weak heart qi in the human body, and the external evil wind, cold and dampness take advantage of the opportunity to enter, resulting in poor blood circulation in the human body, obstruction of qi and blood, and various diseases. Since both Chinese and Western medicine oral medicines are mainly anti-humidity and collateral-activating drugs, they seriously stimulate gastrointestinal function, and the disease is not cured, resulting in digestive tract ulcers, bleeding and even perforation. Therefore, patients can only abandon oral medicines and endure soreness and pain. Furthermore, due to the development of the times, most young people are head-down tribes, such as working on a computer desk every day, or keeping the same posture for a long time, such as driving, playing mahjong, etc., which causes mental fatigue and meridian fatigue, causing lumbar pain, cervical spondylosis, lumbar disc herniation, soreness and numbness in various parts of the body, etc., which has become a common social disease. Summary of the invention

[0003] The purpose of the present invention is to provide a herbal ointment for relieving soreness, numbness and swelling and a preparation method thereof. The herbal ointment has the effects of promoting blood circulation and removing blood stasis, dispelling wind and cold, relieving pain and removing dampness, detoxifying and enhancing immunity, has a good effect of promoting transdermal absorption, has a long contact time with the skin and a lasting effect, can well improve shoulder pain, cervical vertebra pain, back pain, stiff neck, dizziness and headache, toothache caused by getting angry, joint pain, varicose veins, sprains and bruises, soreness, numbness and swelling of limbs, etc., and has broad application prospects.

[0004] The technical solution of the present invention is achieved in this way:

[0005] The invention provides a traditional Chinese medicine composition for relieving soreness, numbness, swelling and pain. The traditional Chinese medicine composition is prepared from the following raw materials by weight: 3-5 parts of codonopsis pilosula, 5-7 parts of cinnamon bark, 2-4 parts of angelica sinensis, 2-3 parts of corydalis dentata, 1-3 parts of peony flower, 5-7 parts of peony root bark, 5-10 parts of chuanxiong, 2-3 parts of liquorice, 5-10 parts of evodia rutaecarpa fruit, 5-10 parts of millettia reticulata, 3-5 parts of motherwort, 3-5 parts of corydalis yanhusuo, 3-5 parts of radix spatholobi, 2-4 parts of aconite, 1-3 parts of atractylodes, 1-3 parts of schizonepeta tenuifolia, 2-4 parts of dittany, 5-7 parts of mulberry twig, 7-10 parts of clematis, 3-5 parts of arisaema, 2-4 parts of white mustard seeds and 2-4 parts of notopterygium wilfordii.

[0006] The present invention further protects a method for preparing the above-mentioned Chinese medicine composition for relieving soreness, numbness, swelling and pain, comprising the following steps:

[0007] S1. Weigh the raw materials according to the proportion, wash, dry and crush them respectively to obtain a mixed powder of traditional Chinese medicine;

[0008] S2. Add the mixed powder of traditional Chinese medicine into water, treat it under high pressure and high heat, cool it to room temperature, add biological enzyme, and heat for enzymatic hydrolysis.

[0009] As a further improvement of the present invention, the mass ratio of the Chinese medicine mixed powder, biological enzyme and water in step S2 is 1:0.05-0.1:5-7; the pressure of the high pressure and high heat treatment is 1-1.5MPa, the temperature is 120-150°C, and the time is 1-2h; the biological enzymes are cellulase and neutral protease, and the mass ratio is 10:3-5; the temperature of the heating enzymatic hydrolysis is 45-55°C, and the time is 2-3h; the molecular weight retained by the ultrafiltration is 0.5k-2.5kDa.

[0010] The present invention further protects a herbal ointment for relieving soreness, numbness, swelling and pain, which is prepared from the following raw materials by weight: 7-12 parts of the above-mentioned traditional Chinese medicine composition for relieving soreness, numbness, swelling and pain, 1-2 parts of vitamin E, 0.5-1 parts of a transdermal absorption accelerator, 70-90 parts of a matrix material, and 0.01-0.02 parts of EDC·HCl.

[0011] As a further improvement of the present invention, the transdermal absorption enhancer is menthol and a permeation enhancer in a mass ratio of 3-5:1. The structural formula of the permeation enhancer is shown in Formula I:

[0012]

[0013] Wherein, R = C12-18 alkyl chain.

[0014] As a further improvement of the present invention, the preparation method of the penetration enhancer is as follows:

[0015] T1. 1,3-dichloropropanol and caprolactam are reacted to obtain an intermediate having the following structure:

[0016]

[0017] T2. The intermediate is reacted with an alkyl chloride to obtain the product.

[0018] As a further improvement of the present invention, the molar ratio of 1,3-dichloropropanol to caprolactam in step T1 is 1:2-2.1, the molar ratio of the intermediate to the alkyl chloride is 1:1-1.1, and the alkyl chloride is at least one of 1-chlorododecane, 1-chlorotetradecane, 1-chlorohexadecane, and 1-chlorooctadecane.

[0019] As a further improvement of the present invention, the preparation method of the matrix material is as follows:

[0020] U1. Dissolve hydroxymethyl chitosan in water, add poloxamer P407 and P188, stir and mix well to obtain a solution;

[0021] U2. Add gelatin into the solution, stir and mix evenly, expand it, and prepare the matrix material.

[0022] As a further improvement of the present invention, the mass ratio of hydroxymethyl chitosan, water, poloxamer P407 and P188 in step U1 is 3-5:150-200:57-65:20-25; the mass ratio of gelatin and solution in step U2 is 3-5:17-25, the expansion temperature is 3-5°C, and the time is 20-24h.

[0023] The present invention further protects a method for preparing the above-mentioned herbal ointment for relieving soreness, numbness, swelling and pain, comprising the following steps:

[0024] The Chinese medicine composition for relieving soreness, numbness, swelling and pain, vitamin E and a transdermal absorption enhancer are added to the matrix material, stirred and mixed evenly, filtered, EDC·HCl is added to the filtrate, stirred and cross-linked for 2-4 hours, and sterilized to obtain a herbal ointment for relieving soreness, numbness, swelling and pain.

[0025] The present invention has the following beneficial effects:

[0026] Codonopsis contains polysaccharides, phenols, vitamins B1 and B2, a variety of essential amino acids, trace alkaloids, trace elements, etc. It has the functions of strengthening the spleen and lungs, replenishing qi, nourishing blood and promoting body fluids. It is mainly used to treat spleen and stomach weakness, poor appetite and loose stools, asthma and cough caused by lung deficiency. It can enhance the body's resistance, lower blood pressure, treat gastric ulcers, and treat diabetes. Cinnamon is very hot in nature, pungent and sweet in taste. "Experienced Prescriptions" records: it can dispel wind and dampness, promote blood circulation and relieve pain. It is mainly used to treat joint and muscle pain caused by rheumatism, impotence, cold uterus, amenorrhea, dysmenorrhea, warming the meridians and unblocking the meridians. Angelica is rich in vitamin A, vitamin B12, vitamin E; 17 kinds of amino acids and more than 20 kinds of inorganic elements such as sodium, potassium, calcium, magnesium, etc. Efficacy: nourishing blood and promoting blood circulation, regulating menstruation and relieving pain, moisturizing and lubricating the intestines, anti-cancer, anti-aging, immunity, antibacterial, anti-atherosclerosis, skin care and beauty, etc. Indications: irregular menstruation, amenorrhea, dysmenorrhea, injuries from falls, constipation due to dry intestines, rheumatic pain. Corydalis dentata, pungent, warm, non-toxic, effects: promoting blood circulation, dispersing blood stasis, regulating qi, relieving pain, and promoting urination. Indications: pain in the heart, abdomen, waist and knees, irregular menstruation, postpartum blood fainting, lochia retention, injuries from falls, and promoting urination. Peony flower, nourishing blood and regulating menstruation, liver qi imbalance, abdominal pain during menstruation, promoting menstruation, gout, and diuresis. Indications: rheumatic arthritis, irregular menstruation, and gynecological inflammation. Peony root bark, treats the hidden fire in the blood of the four meridians of Shaoyin and Jueyin of the hands and feet. Cold in nature, bitter in taste; cool; slightly cold, effects: clearing heat and cooling blood; promoting blood circulation and dispersing blood stasis, Indications: blood stasis amenorrhea, dysmenorrhea, diuresis, injuries from falls, and rheumatic heat arthralgia. Chuanxiong, pungent, dispersing, warming and unblocking, can not only promote blood circulation and remove blood stasis, but also promote qi and relieve pain, and is a "qi medicine in the blood". Efficacy: promoting blood circulation and qi, dispelling wind and relieving pain, mainly used for: abdominal pain, rheumatic arthralgia, blood stasis and amenorrhea, dysmenorrhea, postpartum lochia retention, irregular menstruation, early or late menstruation. Licorice, (root) sweet, flat, non-toxic, efficacy: tonifying spleen and replenishing qi, clearing away heat and detoxifying, expectorant and cough, relieving pain, harmonizing various medicines, anti-cancer, mainly used for: spleen and stomach weakness, cough with sputum, abdominal and limb cramps and pain, expectorant, pain relief, stomachache, gastrointestinal ulcers, etc. Evodia rutaecarpa fruit, pungent, bitter, hot, invigorating spleen and unblocking joints, mainly used for: dysmenorrhea, abdominal pain during menstruation, kidney qi, beriberi, edema, postpartum residual blood, dispelling cold and relieving pain, high blood pressure. Millettia reticulata, bitter, sweet, warm, blood circulation, warm waist and knees, effects: nourishing blood, blood circulation, regulating menstruation and relieving pain, relaxing muscles and activating collaterals, mainly used for: irregular menstruation, rheumatic pain, dysmenorrhea, amenorrhea, abnormal leucorrhea, numbness of hands and feet, pain in waist and shoulders, nourishing liver and kidney, blood circulation and relieving pain. It is most suitable for people with long-term arthralgia. Motherwort, bitter and cool, Activate blood , remove stasis, regulate menstruation, eliminate water, treat women's irregular menstruation, fetal leakage, dystocia, retained placenta, postpartum Blood fainting, abdominal pain due to blood stasis, metrorrhagia and leakage. Yuanhu, warm in nature, bitter in taste, enters the heart, spleen, liver and lungs. It is a wonderful product for promoting blood circulation, removing blood stasis, promoting qi and relieving pain, and is especially famous for its analgesic effect. It has four major effects of "promoting blood circulation, regulating qi, relieving pain, and promoting urination", and Yuanhu is praised for "being able to promote qi stagnation in blood and blood stagnation in qi, so it is specially used to treat all kinds of pain in the body". Perforated bone grass, sweet, pungent, warm; enters the lung and liver meridians. Indications: dispel wind and dampness, this product is pungent and warm, pungent can disperse, and warm can overcome cold and dampness. "Treat all rheumatic pain and contracture of tendons and bones." If the wind, cold and dampness invade the limbs and meridians, it will cause limb pain, numbness, and poor flexion and extension. This product can be used to dispel wind, dissipate cold and overcome dampness, and the disease evil will be removed, then all symptoms will heal themselves. It has the effects of promoting blood circulation, removing blood stasis, diuresis and detoxification, and promoting menstruation. It belongs to the liver meridian and kidney meridian. It has the effects of dispelling wind and dampness, relaxing muscles and activating blood circulation, dispersing blood stasis and reducing swelling, and detoxifying eye pain. Aconite is pungent, sweet and hot in nature, dispelling cold and drying dampness, and it goes to the kidney meridian, warms the kidney and assists yang, goes without staying, reaches the inside and penetrates the outside, and rises and falls to activate the collaterals. The two medicines are used together, and they complement each other. The liver and kidney are treated together, and the qi and blood are all regulated. It can eliminate chronic diseases and treat stubborn arthritis. Atractylodes, one is long in drying dampness, and the other is effective in relieving pain. The two medicines are used together to dispel dampness and relieve pain, and the efficacy is greatly increased. Stretching grass, the two medicines are used together to treat liver and kidney deficiency, muscle and bone malnutrition, flexion and extension difficulties, limb numbness, muscle and bone contracture, and have the effect of stretching and penetrating grass. Dictamni, bitter can dry dampness, purge fire and detoxify, the two medicines are used together to treat eczema and heat sores. It dries the moisture of the skin and relieves the toxins in the muscles, and its effect is remarkable. Mulberry branch, mulberry branch reaches the limbs, runs the meridians, benefits the joints, and helps the efficacy of the medicine. The two herbs are used together to dispel wind and relieve pain, and are the most effective in treating rheumatism. Clematis chinensis, Clematis chinensis can pass through the twelve meridians, and its nature is wandering, dispelling wind and unblocking collaterals. It is good at treating numbness of the limbs. The two herbs are used together. The former warms and unblocks the meridians, and the latter dispels wind and relieves pain. It is used to treat rheumatism caused by wind, cold, and dampness, and it works wonders. Arisaema, belongs to the lung meridian, liver meridian, and spleen meridian. It dries dampness and resolves phlegm, dispels wind and relieves spasms; it can be used externally to reduce swelling and relieve pain, and has anti-tumor effects. White mustard seeds, belong to the lung meridian, liver meridian, spleen and stomach meridian, and pericardium meridian. It can dispel stagnation and reduce swelling, unblock collaterals and relieve pain, and warm the stomach to treat breast pain. Notopterygium incisum, belongs to the bladder meridian and kidney meridian. It dispels cold and dampness, treats colds, headaches, rheumatism caused by wind, cold, and dampness, and strengthens tendons and bones.

[0027] The Chinese medicine composition for relieving soreness, numbness and swelling of the present invention combines Chinese medicine with modern enzymatic extraction technology, and the prescription is a prescription medicine for warming and dispelling cold, promoting blood circulation and removing blood stasis, softening tendons and dissolving knots and relieving pain. It has the effects of promoting blood circulation and removing blood stasis, dispelling wind and cold, relieving pain and removing dampness, detoxifying, and enhancing immunity. It can improve shoulder pain, cervical vertebra pain, back pain, stiff neck, dizziness and headache, toothache caused by getting angry, joint pain, varicose veins, sprains and bruises, and soreness, numbness and swelling of limbs.

[0028] The herbal ointment for relieving soreness, numbness, swelling and pain of the present invention has a Chinese medicine composition for relieving soreness, numbness, swelling and pain as the main active ingredient, and vitamin E is added, which is an important fat-soluble vitamin and a powerful antioxidant. It can protect cells from oxidative stress damage, and can delay the process of cell aging, thereby delaying aging. In addition, it can also reduce the generation of wrinkles and keep the skin young. In addition, a transdermal absorption promoter is added, including menthol and a penetration promoter, and menthol has significant transdermal absorption of hydrophilic and lipophilic compounds. The penetration promoter uses caprolactam as the main functional structure, contains 2 molecules of caprolactam, and compared with ordinary laurocaprolactam, its penetration promoting effect is significantly improved, and at the same time, its toxic and side effects are reduced, and it has the characteristics of high efficiency, safety and non-toxicity, without any light stimulation, and no allergic reaction or photosensitivity contact reaction. It has the advantages of low cost, smaller addition amount, better effect, gentle preparation method, high yield, biodegradability, etc. And it contains long-chain molecular chains, which can disturb the phospholipid bilayer, thereby promoting the transdermal absorption of drugs.

[0029] The menthol and the penetration enhancer of the present invention act synergistically to promote the ability of the active substance of traditional Chinese medicine to penetrate the skin, and by improving the orderly stacking structure of flat keratinocytes in the stratum corneum of the skin, act on the lipids in the stratum corneum to make it completely fluidized, thereby making the active substance of traditional Chinese medicine easier and faster to be absorbed through the skin and better exerting its efficacy.

[0030] The matrix material of the present invention is a hydrogel matrix material, with chitosan and gelatin as main components, and the gel material can have certain temperature-sensitive properties by adding poloxamer P407 and P188. Under the condition of body temperature, the gel material can be better gelled, thereby being fixed on the skin surface, so that the drug can fully exert its efficacy and prolong the contact time between the ointment and the skin. At the same time, the matrix material of the present invention is in a solution state, and in the process of preparing the ointment, other components are directly added, and after being evenly mixed, a cross-linking agent EDC is added to activate the gelatin molecules, help the carboxyl and amino groups in the gelatin molecules to form amide bonds, and form a preliminary gel state. The EDC itself does not actually become a part of the cross-linking structure, thereby greatly reducing the toxicity of the ointment, and has the characteristics of being non-toxic and having good biocompatibility.

[0031] The herbal ointment for relieving soreness, numbness and swelling prepared by the invention has the effects of promoting blood circulation and removing blood stasis, dispelling wind and cold, relieving pain and removing dampness, detoxifying and enhancing immunity, has good effect of promoting transdermal absorption, rapid penetration, dispersing knots and relieving pain, has a long contact time with the skin and a lasting effect, can well improve shoulder pain, cervical vertebra pain, back pain, stiff neck, dizziness and headache, toothache caused by getting angry, joint pain, varicose veins, sprains and bruises, soreness, numbness and swelling of limbs, etc., has obvious effect, can replenish deficiency and relieve excess, and has broad application prospects. DETAILED DESCRIPTION

[0032] 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.

[0033] Cellulase, 5000U / g, neutral protease, 10,000U / g, commercially available.

[0034] Preparation Example 1 Preparation of penetration enhancer

[0035] Synthesis route:

[0036]

[0037] Here’s how:

[0038] T1. Add 0.1 mol 1,3-dichloropropanol and 0.2 mol caprolactam into 500 mL dichloromethane, add 1 mol NaOH, heat to reflux and stir to react for 3 h, cool to room temperature, filter, recrystallize from toluene-acetone, wash with deionized water, and dry to obtain an intermediate; ESI-MS calculated value: C 15 H 27 N 2 O 3 (M+H)+283.19, found: 283.2, yield: 91%.

[0039] NMR results: 1 H NMR (300 MHz, CDCl 3 )δ4.47 (m, 1H), 3.35 (d, 4H), 3.20 (t, 4H), 2.18 (t, 4H), 2.0 (br, 1H), 1.55-1.57 (m, 8H), 1.29 (m, 4H).

[0040] T2. Add 0.1 mol of the intermediate, 0.1 mol of 1-chlorododecane and 0.5 mol of KOH into 500 mL of dichloromethane, heat under reflux and stir to react for 2 h, cool to room temperature, filter, wash, recrystallize from acetone, filter, wash and dry to obtain the product. ESI-MS calculated value: C 27 H 51 N 2 O 3 (M+H)+451.38, found: 451.4, yield: 89%.

[0041] NMR results: 1 H NMR (300 MHz, CDCl 3)δ4.09(m, 1H), 3.37(t, 2H), 3.32(d, 4H), 3.22(t, 4H), 2.16(t, 4H), 1.54 -1.57(m, 8H), 1.45(m, 2H), 1.33(m, 2H), 1.27-1.29(m, 20H), 0.97(t, 3H).

[0042] Preparation Example 2 Preparation of penetration enhancer

[0043] Here’s how:

[0044] T1. Add 0.1 mol 1,3-dichloropropanol and 0.21 mol caprolactam into 500 mL dichloromethane, add 1 mol NaOH, heat to reflux and stir to react for 3 h, cool to room temperature, filter, recrystallize from toluene-acetone, wash with deionized water, and dry to obtain an intermediate;

[0045] T2. Add 0.1 mol of the intermediate, 0.11 mol of 1-chlorohexadecane and 0.5 mol of KOH into 500 mL of dichloromethane, heat under reflux and stir to react for 2 h, cool to room temperature, filter, wash, recrystallize from acetone, filter, wash and dry to obtain the product. ESI-MS calculated value: C 31 H 59 N 2 O 3 (M+H)+507.44, found: 507.4, yield: 87%.

[0046] NMR results: 1 H NMR (300 MHz, CDCl 3 )δ4.10(m, 1H), 3.35(t, 2H), 3.34(d, 4H), 3.22(t, 4H), 2.19(t, 4H), 1.55 -1.57(m, 8H), 1.43(m, 2H), 1.33(m, 2H), 1.27-1.32(m, 28H), 0.97(t, 3H).

[0047] Preparation Example 3 Preparation of Matrix Material

[0048] Here’s how:

[0049] U1. 3 g of hydroxymethyl chitosan was dissolved in 150 g of water, 57 g of poloxamer P407 and 20 g of P188 were added, and the mixture was stirred for 20 min to obtain a solution;

[0050] U2. Add 3 g of gelatin to 17 g of solution, stir and mix for 15 min, and swell at 3°C ​​for 20 h to obtain the matrix material.

[0051] Preparation Example 4 Preparation of Matrix Material

[0052] Here’s how:

[0053] U1. Dissolve 5 g of hydroxymethyl chitosan in 200 g of water, add 65 g of poloxamer P407 and 25 g of P188, and stir for 20 min to obtain a solution;

[0054] U2. Add 5 g of gelatin to 25 g of solution, stir and mix for 15 min, and swell at 5°C for 24 h to obtain the matrix material.

[0055] Preparation Example 5 Preparation of Matrix Material

[0056] Here’s how:

[0057] U1. 4 g of hydroxymethyl chitosan was dissolved in 170 g of water, 60 g of poloxamer P407 and 22 g of P188 were added, and the mixture was stirred for 20 min to obtain a solution;

[0058] U2. Add 4 g of gelatin to 20 g of solution, stir and mix for 15 min, and swell at 4°C for 22 h to obtain the matrix material.

[0059] Comparative Preparation Example 1

[0060] The difference compared with Preparation Example 5 is that no gelatin was added.

[0061] The details are as follows:

[0062] Here’s how:

[0063] 4 g of hydroxymethyl chitosan was dissolved in 170 g of water, and 60 g of poloxamer P407 and 22 g of P188 were added, and the mixture was stirred for 20 min to obtain a solution, and then expanded at 4° C. for 22 h to obtain a matrix material.

[0064] Example 1

[0065] This embodiment provides a Chinese medicine composition for relieving soreness, numbness, swelling and pain.

[0066] The preparation method is as follows:

[0067] S1. Weigh the raw materials according to the proportion, wash, dry and crush them respectively to obtain a mixed powder of traditional Chinese medicine;

[0068] The proportion of Chinese medicinal components (by weight): 3 parts of Codonopsis pilosula, 5 parts of cinnamon bark, 2 parts of Angelica sinensis, 2 parts of Corydalis dentata, 1 part of Peony Flos, 5 parts of Peony Root Bark, 5 parts of Chuanxiong, 2 parts of Licorice, 5 parts of Evodia rutaecarpa Fruit, 5 parts of Millettia Spatholobi, 3 parts of Leonurus japonicus, 3 parts of Corydalis yanhusuo, 3 parts of Radix schizonepetae, 2 parts of Aconite, 1 part of Atractylodes macrocephala, 1 part of Lycopodiella ciliata, 2 parts of Dictamni Cortex, 5 parts of Morus alba, 7 parts of Clematidis, 3 parts of Arisaema consanguineum, 2 parts of Sinapis alba, and 2 parts of Notopterygium wilfordii.

[0069] S2. Add 10g of Chinese medicine mixed powder into 50mL of water, with a pressure of 1MPa and a temperature of 120℃, treat for 1h, cool to room temperature, add 0.5g of biological enzyme, heat to 45℃, stir for enzymolysis for 2h, inactivate the enzyme, filter, ultrafilter the filtrate, and retain a molecular weight of 0.5k-2.5kDa. Freeze-dry to obtain a Chinese medicine composition for relieving soreness, numbness, swelling and pain.

[0070] The biological enzymes are cellulase and neutral protease, with a mass ratio of 10:3.

[0071] Example 2

[0072] This embodiment provides a Chinese medicine composition for relieving soreness, numbness, swelling and pain.

[0073] The preparation method is as follows:

[0074] S1. Weigh the raw materials according to the proportion, wash, dry and crush them respectively to obtain a mixed powder of traditional Chinese medicine;

[0075] The proportion of Chinese medicinal components (by weight): 5 parts of Codonopsis pilosula, 7 parts of cinnamon bark, 4 parts of Angelica sinensis, 3 parts of Corydalis dentata, 3 parts of Peony flower, 7 parts of Paeonia lactiflora root bark, 10 parts of Chuanxiong, 3 parts of Licorice, 10 parts of Evodia rutaecarpa fruit, 10 parts of Millettia reticulata, 5 parts of Leonurus japonicus, 5 parts of Corydalis yanhusuo, 5 parts of Radix spatholobi, 4 parts of Aconite, 3 parts of Atractylodes macrocephala, 3 parts of Lycopodiella cuneata, 4 parts of Dictamni cortex, 7 parts of Morus twig, 10 parts of Clematidis, 5 parts of Arisaema consanguineum, 4 parts of Sinapis alba, and 4 parts of Notopterygium wilfordii.

[0076] S2. Add 10g of Chinese medicine mixed powder into 70mL of water, with a pressure of 1.5MPa and a temperature of 150℃, treat for 2h, cool to room temperature, add 1g of biological enzyme, heat to 55℃, stir for enzymolysis for 3h, inactivate the enzyme, filter, ultrafilter the filtrate, and retain a molecular weight of 0.5k-2.5kDa. Freeze-dry to obtain a Chinese medicine composition for relieving soreness, numbness, swelling and pain.

[0077] The biological enzymes are cellulase and neutral protease, with a mass ratio of 10:5.

[0078] Example 3

[0079] This embodiment provides a Chinese medicine composition for relieving soreness, numbness, swelling and pain.

[0080] The preparation method is as follows:

[0081] S1. Weigh the raw materials according to the proportion, wash, dry and crush them respectively to obtain a mixed powder of traditional Chinese medicine;

[0082] The proportion of Chinese medicine components (by weight): 4 parts of Codonopsis pilosula, 6 parts of cinnamon bark, 3 parts of Angelica sinensis, 2.5 parts of Corydalis dentata, 2 parts of Peony Flos, 6 parts of Peony Root Bark, 7 parts of Chuanxiong, 2.5 parts of Licorice, 7 parts of Evodia rutaecarpa Fruit, 7 parts of Millettia Spatholobi, 4 parts of Leonurus japonicus, 4 parts of Corydalis yanhusuo, 4 parts of Radix schizonepetae, 3 parts of Aconite, 2 parts of Atractylodes macrocephala, 2 parts of Lycopodiella cuneata, 3 parts of Dictamni Cortex, 6 parts of Morus alba, 8 parts of Clematidis, 4 parts of Arisaema consanguineum, 3 parts of Sinapis alba, and 3 parts of Notopterygium wilfordii.

[0083] S2. Add 10g of Chinese medicine mixed powder into 60mL of water at a pressure of 1.2MPa and a temperature of 135℃ for 1.5h, cool to room temperature, add 0.7g of biological enzyme, heat to 50℃, stir for enzymolysis for 2.5h, inactivate the enzyme, filter, ultrafilter the filtrate, and retain a molecular weight of 0.5k-2.5kDa. Freeze-dry to obtain a Chinese medicine composition for relieving soreness, numbness, swelling and pain.

[0084] The biological enzymes are cellulase and neutral protease, with a mass ratio of 10:4.

[0085] Example 4

[0086] This embodiment provides a herbal ointment for relieving soreness, numbness, swelling and pain, and the preparation method comprises the following steps:

[0087] 7 g of the Chinese medicine composition for relieving soreness, numbness, swelling and pain prepared in Example 1, 1 g of vitamin E and 0.5 g of a transdermal absorption enhancer were added to 70 g of the matrix material prepared in Preparation Example 3, and the mixture was stirred and mixed evenly. The mixture was filtered, and 0.01 g of EDC·HCl was added to the filtrate. The mixture was stirred and cross-linked for 2 h, and sterilized to prepare a herbal ointment for relieving soreness, numbness, swelling and pain.

[0088] The transdermal absorption enhancer is menthol and the permeation enhancer prepared in Preparation Example 1, and the mass ratio is 3:1.

[0089] Example 5

[0090] This embodiment provides a herbal ointment for relieving soreness, numbness, swelling and pain, and the preparation method comprises the following steps:

[0091] 12 g of the Chinese medicine composition for relieving soreness, numbness, swelling and pain prepared in Example 2, 2 g of vitamin E and 1 g of a transdermal absorption enhancer were added to 90 g of the matrix material prepared in Preparation Example 4, stirred and mixed evenly, filtered, 0.02 g of EDC·HCl was added to the filtrate, stirred and cross-linked for 4 h, and sterilized to prepare a herbal ointment for relieving soreness, numbness, swelling and pain.

[0092] The transdermal absorption enhancer is menthol and the permeation enhancer prepared in Preparation Example 2, with a mass ratio of 5:1.

[0093] Example 6

[0094] This embodiment provides a herbal ointment for relieving soreness, numbness, swelling and pain, and the preparation method comprises the following steps:

[0095] 10 g of the Chinese medicine composition for relieving soreness, numbness, swelling and pain prepared in Example 3, 1.5 g of vitamin E and 0.7 g of a transdermal absorption enhancer were added to 80 g of the matrix material prepared in Preparation Example 5, and the mixture was stirred and mixed evenly. The mixture was filtered, and 0.015 g of EDC·HCl was added to the filtrate. The mixture was stirred and cross-linked for 3 h, and sterilized to prepare a herbal ointment for relieving soreness, numbness, swelling and pain.

[0096] The transdermal absorption enhancer is menthol and the permeation enhancer prepared in Preparation Example 2, with a mass ratio of 4:1.

[0097] Example 7

[0098] Compared with Example 6, the difference is that the transdermal absorption enhancer is a single menthol.

[0099] Example 8

[0100] Compared with Example 6, the difference is that the transdermal absorption enhancer is a single permeation enhancer prepared in Preparation Example 2.

[0101] Comparative Example 1

[0102] Compared with Example 6, the difference is that no transdermal absorption enhancer is added.

[0103] The details are as follows:

[0104] 10 g of the Chinese medicine composition for relieving soreness, numbness, swelling and pain prepared in Example 3 and 1.5 g of vitamin E were added to 80 g of the matrix material prepared in Preparation Example 5, stirred and mixed evenly, filtered, 0.015 g of EDC·HCl was added to the filtrate, stirred and cross-linked for 3 h, and sterilized to prepare a herbal ointment for relieving soreness, numbness, swelling and pain.

[0105] Comparative Example 2

[0106] Compared with Example 6, the difference is that the matrix material is prepared by Comparative Preparation Example 1.

[0107] Comparative Example 3

[0108] The difference compared with Example 6 is that EDC·HCl was not added.

[0109] The details are as follows:

[0110] 10 g of the Chinese medicine composition for relieving soreness, numbness, swelling and pain prepared in Example 3, 1.5 g of vitamin E and 0.7 g of a transdermal absorption enhancer were added to 80 g of the matrix material prepared in Preparation Example 5, and the mixture was stirred and mixed evenly, filtered and sterilized to prepare a herbal liquid for relieving soreness, numbness, swelling and pain.

[0111] Test Example 1

[0112] Healthy Kunming mice weighing 18-22g were taken, half male and half female, and randomly divided into 10 groups: Example 4-8 group, Comparative Example 1-3 group, blank control group, and aspirin group, with 10 mice in each group. The blank control group and the mice in Example 4-8 and Comparative Example 1-3 groups were shaved on the back and then smeared with drugs (2mL / kg). The blank control group was given an equal amount of water, once every 48 hours, and continuously applied for 8 days. The aspirin group was gavaged, and the dosage was 0.2g / kg, once a day, and continuously gavaged for 8 days. 30 minutes after the last administration, the mice were intraperitoneally injected with 0.01mL / g of 6g / L glacial acetic acid. After observing for 5 minutes, the number of times the mouse twisting reaction occurred within 10 minutes was recorded. The results are shown in Table 1.

[0113] Table 1

[0114] Group Number of mouse writhings (times) Blank control group 23.5±4.9 Aspirin group 8.9±2.7* Example 4 9.5±3.2* Example 5 9.7±2.9* Example 6 9.3±2.4* Example 7 12.1±5.5 Example 8 11.9±4.8 Comparative Example 1 18.6±6.2 Comparative Example 2 16.9±5.9 Comparative Example 3 17.4±6.8

[0115] Note: * Compared with the blank control group, P < 0.05.

[0116] It can be seen from the above table that the herbal ointment for relieving soreness, numbness, swelling and pain prepared in Examples 4-6 of the present invention has an obvious analgesic effect.

[0117] Test Example 2

[0118] Take healthy Wistar male rats weighing 180g-220g. Before the test, use the rat tail light pain meter to screen. Select animals that cause tail flicking for about 5s for the test, and do not use those that are less than 3s or greater than 10s. Select qualified rats and randomly divide them into 10 groups: Example 4-8 group, comparative example 1-3 group, blank control group, aspirin group, 10 rats in each group, the blank control group and the mice in Example 4-8 and comparative example 1-3 groups are shaved on the back and smeared with drugs (2mL / kg), and the blank control group is given an equal amount of water, once every 48h, and continuously applied for 8d. The aspirin group is gavaged, and the dosage is 0.2g / kg, once a day, and continuously gavaged for 8d. 30min after the last administration, the rats are tested with the rat tail light pain meter, and the time required for the rat to flick its tail from the beginning of irradiation is the pain threshold, and each rat is measured twice. Take the average value. The results are shown in Table 2.

[0119] Table 2

[0120] Group Pain threshold(s) Blank control group 5.09±0.94 Aspirin group 9.10±2.14* Example 4 9.78±1.89* Example 5 9.72±1.75* Example 6 9.91±1.94* Example 7 8.02±2.41 Example 8 7.89±2.27 Comparative Example 1 6.17±3.05 Comparative Example 2 6.82±3.24 Comparative Example 3 7.22±2.98

[0121] Note: * Compared with the blank control group, P < 0.05.

[0122] It can be seen from the above table that the herbal ointment for relieving soreness, numbness, swelling and pain prepared in Examples 4-6 of the present invention has an obvious analgesic effect.

[0123] Test Example 3

[0124] Take healthy female Kunming mice weighing 18g-22g, and screen them with a hot plate analgesic before the test. Mice with a pain threshold between 5s-30s are selected for the test, and those below 5s or above 30s are discarded. Select qualified mice and randomly divide them into 10 groups, 10 in each group, embodiment 4-8 group, comparative example 1-3 group, blank control group, aspirin group, blank control group and embodiment 4-8 and comparative example 1-3 group mice shave their backs and apply medicine (2mL / kg), the blank control group is given an equal amount of water, 48h administration once, and a total of 1 administration. The aspirin group is gavaged, and the dosage is 0.2g / kg, 1 administration per day, and continuous gavage for 2d. Before administration, each group of mice and 30min after the last administration, the mice are measured by the hot plate analgesic for the time required for the pain response to thermal stimulation, that is, the pain threshold. Calculate the percentage increase of pain threshold. Take the average value. The results are shown in Table 3.

[0125] Pain threshold increase percentage = (pain threshold after medication - pain threshold before medication) / pain threshold before medication × 100%.

[0126] Table 3

[0127] Group Pain threshold increase percentage (%) Blank control group 16.9 Aspirin group 92.7 Example 4 96.2 Example 5 95.6 Example 6 97.8 Example 7 90.2 Example 8 88.5 Comparative Example 1 72.4 Comparative Example 2 82.5 Comparative Example 3 79.6

[0128] It can be seen from the above table that the herbal ointment for relieving soreness, numbness, swelling and pain prepared in Examples 4-6 of the present invention has an obvious analgesic effect.

[0129] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A Chinese medicine composition for relieving soreness, numbness, swelling and pain, characterized in that: The invention is prepared from the following raw materials by weight: 3-5 parts of Codonopsis pilosula, 5-7 parts of cinnamon bark, 2-4 parts of Angelica sinensis, 2-3 parts of Corydalis dentata, 1-3 parts of Peony flower, 5-7 parts of Paeonia suffruticosa root bark, 5-10 parts of Chuanxiong, 2-3 parts of Licorice root, 5-10 parts of Evodia rutaecarpa fruit, 5-10 parts of Millettia reticulata, 3-5 parts of Leonurus japonicus, 3-5 parts of Corydalis yanhusuo, 3-5 parts of Radix spatholobi, 2-4 parts of Aconitum, 1-3 parts of Atractylodes macrocephala, 1-3 parts of Lycopodiella ciliata, 2-4 parts of Dictamni cortex, 5-7 parts of Morus alba, 7-10 parts of Clematis chinensis, 3-5 parts of Arisaema confusa, 2-4 parts of Sinapis alba and 2-4 parts of Notopterygium wilfordii.

2. A method for preparing a Chinese medicine composition for relieving soreness, numbness, swelling and pain as claimed in claim 1, characterized in that: The following steps are involved: S1. Weigh the raw materials according to the proportion, wash, dry and crush them respectively to obtain a mixed powder of traditional Chinese medicine; S2. Add the mixed Chinese medicine powder into water, treat it under high pressure and high heat, cool it to room temperature, add biological enzyme, heat it for enzymolysis, inactivate the enzyme, filter it, ultrafilter the filtrate, and freeze-dry it to obtain a Chinese medicine composition for relieving soreness, numbness, swelling and pain.

3. The preparation method according to claim 2, characterized in that: The mass ratio of the Chinese medicine mixed powder, biological enzyme and water in step S2 is 1:0.05-0.1:5-7; the pressure of the high pressure and high heat treatment is 1-1.5MPa, the temperature is 120-150°C, the time is 1-2h, the biological enzymes are cellulase and neutral protease, and the mass ratio is 10:3-5; the temperature of the heating enzymolysis is 45-55°C, and the time is 2-3h; the molecular weight retained by the ultrafiltration is 0.5k-2.5kDa.

4. A herbal ointment for relieving soreness, numbness, swelling and pain, characterized in that: The invention is prepared from the following raw materials in parts by weight: 7-12 parts of the Chinese medicinal composition for relieving soreness, numbness, swelling and pain according to claim 1, 1-2 parts of vitamin E, 0.5-1 parts of a transdermal absorption enhancer, 70-90 parts of a matrix material and 0.01-0.02 parts of EDC·HCl.

5. The herbal ointment for relieving numbness, swelling and pain according to claim 4, characterized in that: The transdermal absorption enhancer is menthol and a permeation enhancer, and the mass ratio is 3-5:

1. The structural formula of the permeation enhancer is shown in Formula I: Wherein, R = C12-18 alkyl chain.

6. The herbal ointment for relieving numbness, swelling and pain according to claim 5, characterized in that: The preparation method of the penetration enhancer is as follows: T1. 1,3-dichloropropanol and caprolactam are reacted to obtain an intermediate having the following structure: T2. The intermediate is reacted with an alkyl chloride to obtain the product.

7. The herbal ointment for relieving soreness, numbness, swelling and pain according to claim 6, characterized in that: In step T1, the molar ratio of 1,3-dichloropropanol to caprolactam is 1:2-2.1, the molar ratio of the intermediate to the alkyl chloride is 1:1-1.1, and the alkyl chloride is at least one of 1-chlorododecane, 1-chlorotetradecane, 1-chlorohexadecane, and 1-chlorooctadecane.

8. The herbal ointment for relieving numbness, swelling and pain according to claim 4, characterized in that: The preparation method of the matrix material is as follows: U1. Dissolve hydroxymethyl chitosan in water, add poloxamer P407 and P188, stir and mix well to obtain a solution; U2. Add gelatin into the solution, stir and mix evenly, expand it, and prepare the matrix material.

9. The herbal ointment for relieving numbness, swelling and pain according to claim 8, characterized in that: The mass ratio of hydroxymethyl chitosan, water, poloxamer P407 and P188 in step U1 is 3-5:150-200:57-65:20-25; the mass ratio of gelatin and solution in step U2 is 3-5:17-25, the expansion temperature is 3-5°C, and the time is 20-24h.

10. A method for preparing a herbal ointment for relieving numbness, swelling and pain as claimed in any one of claims 4 to 9, characterized in that: The following steps are involved: The Chinese medicine composition for relieving soreness, numbness, swelling and pain, vitamin E and a transdermal absorption enhancer are added to the matrix material, stirred and mixed evenly, filtered, EDC·HCl is added to the filtrate, stirred and cross-linked for 2-4 hours, and sterilized to obtain a herbal ointment for relieving soreness, numbness, swelling and pain.

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