CN113332405A

CN113332405A - Biological agent for preventing and relieving joint sub-health and preparation method thereof

Info

Publication number: CN113332405A
Application number: CN202110380629.3A
Authority: CN
Inventors: 张泽奇; 杨平顺; 韩春月; 李利芳; 黄纲富; 马莉娟
Original assignee: Dongguan Rongda Biotechnology Co ltd
Current assignee: Dongguan Rongda Biotechnology Co ltd
Priority date: 2021-04-08
Filing date: 2021-04-08
Publication date: 2021-09-03

Abstract

The invention discloses a biological agent for preventing and relieving joint sub-health and a preparation method thereof, belonging to the technical field of biological agents. The biological preparation of the invention contains a plurality of biological active ingredients and a plurality of traditional Chinese medicine active ingredients. The bioactive components adopt S-adenosylmethionine, sodium hyaluronate, sodium chondroitin sulfate, vitriol and acetyl chitosamine, can prevent the decomposition of proteoglycan by enzyme, provide exogenous hyaluronic acid for human joints, activate the synthesis of mucopolysaccharide, promote the synthesis of hyaluronic acid and collagen and cartilage regeneration, increase the content of hyaluronic acid in vivo, reduce cartilage loss and maintain the forms of cartilage and joint fluid. The active ingredients of the traditional Chinese medicine comprise fructus liquidambaris extract, lycopodium clavatum extract, morinda officinalis fruit extract, ginger root extract and the like, and have the effects of relaxing tendons and activating collaterals, promoting blood circulation to remove blood stasis, improving local microcirculation and relieving pain. The Chinese and western medicines are combined, so that the arthritis is prevented and relieved fundamentally.

Description

Biological agent for preventing and relieving joint sub-health and preparation method thereof

Technical Field

The invention relates to the technical field of biological preparations, in particular to a biological preparation for preventing and relieving joint sub-health and a preparation method thereof.

Background

Arthritis generally refers to inflammatory diseases that occur in the joints and their surrounding tissues of the human body and are caused by inflammation, infection, degeneration, trauma or other factors. Arthritis can be classified into osteoarthritis, rheumatoid arthritis, ankylosing arthritis, reactive arthritis, gouty arthritis, rheumatoid arthritis, infectious arthritis, and the like according to the cause. The number of arthritis patients in China is large, and the arthritis patients are frequently seen in middle-aged and elderly people and also occur in young people. The disease is better at hands, wrists, feet and the like, and is manifested as red, swelling, heat, pain and dysfunction in early stage, and joint deformity and even joint disability can occur in later stage. Osteoarthritis occurs in 80% of the elderly over 60 years of age worldwide each year. With the gradual increase of the aging population, the number of the arthritis is increased year by year, and great economic and medical burden is brought to countries in the world.

In recent years, with the shift of lifestyle, the trend of arthritis toward increasingly younger arthritis is becoming more apparent. The arthritis of the young is easily caused by bad living habits (such as repeated use of the electronic products for a long time by wrists and fingers, sedentary, frequent wearing of high-heeled shoes, frequent driving and the like) and unscientific sports methods of the young. The fact that the obesity rate of the new generation of young people is increased is not competitive, and the obesity not only increases the burden of joint cartilage and accelerates the abrasion and aging of joint structures, but also indirectly influences joints through other metabolic complications, such as impaired glucose tolerance, lipid disorders and the like. In addition, the traditional Chinese medicine considers that the arthritis is caused by obstruction of channels due to wind-cold-dampness, so that the channels are obstructed, the joint is cooled for a long time to cause rheumatism, and the osteoarthritis is caused in severe cases.

Proteoglycan (PG) in the articular cartilage matrix plays an important role in the normal functioning of the joint. Proteoglycans are a very complex class of macromolecular glycocomplexes consisting essentially of glycosaminoglycan (GAG) chains covalently linked to core proteins, with molecular weights of 11-220 kd. The core protein of proteoglycan has multiple enzymolysis sites, and a plurality of enzymes participate in the degradation process of proteoglycan. The enzyme action results in the degradation of proteoglycan directly and activates some cell active factors, and these small molecular proteins promote the degradation of proteoglycan directly or indirectly through complex network regulation. In addition, the destruction of collagen and proteoglycan structures in the matrix can also cause an immune response, which in turn exacerbates proteoglycan destruction, resulting in rapid loss of proteoglycan from the matrix. Research shows that the content of proteoglycan in joint synovial fluid of osteoarthritis patients is obviously lower than that of normal groups, so that the joint synovial fluid loses the boundary lubrication capability, and the friction force is increased during joint movement, and the joint cartilage is damaged.

Glycosaminoglycans (GAGs), also commonly referred to in the past as mucopolysaccharides, include Hyaluronic Acid (HA) and Chondroitin Sulfate (CS), among others. Among them, hyaluronic acid has extremely high viscosity, lubricity and moisture retention. Hyaluronic acid injected into the joint increases the viscosity and lubricity of the joint fluid. Part of hyaluronic acid can be gathered on the cartilage surface and the synovial surface to form a damaged barrier again, so that the contact of inflammatory substances or cartilage matrix degrading enzymes with cartilage is prevented, the cartilage matrix is prevented from being further damaged, and the joint pain is relieved. Part of hyaluronic acid can also enter a cartilage matrix to form a polymer with mucin, so that the repair of damaged cartilage is facilitated.

Traditional Chinese medicine classifies arthritis into the categories of arthralgia syndrome and bone impediment. In Su Wen Bi Lun, it says: "Bi-syndrome is marked by heavy sensation in the bones, blood coagulation but not flow in the vessels, difficult flexion in the tendons, and unharmful nature in the muscles". TCM believes that the liver governs the tendons, the kidney governs the bones, and the tendons are attached to the bones. The liver failing to nourish the tendons due to yin and blood deficiency. The deficiency of the kidney causes insufficient bone marrow biochemical transformation, the loss of warm and nourishing of the kidney, and the long-term strain can cause deficiency of qi and blood, invasion of wind, cold and dampness, cold accumulation and dampness obstruction, and failure of the transportation of muscles and bones, which can cause obstruction of tendons and collaterals, failure of the nourishing of muscles and bones, and the symptoms of arthralgia, difficulty in flexion and extension, swelling, deformity and the like. The traditional Chinese medicine is mainly used for treating arthritis patients by expelling wind and clearing away cold, removing dampness and clearing heat, dredging channels and collaterals, tonifying liver and kidney, nourishing blood and promoting blood circulation, and relieving swelling and pain.

The ointment for preventing and treating arthritis has the advantages of good effect on different cases, single main treatment function and no good curative effect on lumbocrural pain caused by hyperosteogeny. However, the external biological preparations for preventing and treating arthritis by combining Chinese medicine and western medicine are not abundant in the market at present, and the effect is difficult to determine.

Disclosure of Invention

The invention aims to provide a biological agent for preventing and relieving joint sub-health and a preparation method thereof.

In one aspect, the invention discloses a biological agent for preventing and relieving sub-health of joints, which comprises the following components in percentage by weight:

a phase material:

b phase material:

c phase material:

(20) 0.1 to 8.0 percent of butanediol,

(21) 0.05 to 5.0 percent of tetrahydropiperine,

d phase material:

e phase material:

by adopting the technical scheme, the biological agent can be used for preventing and relieving arthritis.

Preferably, the biological agent comprises the following components in percentage by weight:

a phase material:

b phase material:

c phase material:

(20) 0.1 to 6.0 percent of butanediol,

(21) 0.05 to 4.0 percent of tetrahydropiperine,

d phase material:

e phase material:

by adopting the technical scheme, the biological agent can effectively prevent and relieve arthritis.

Preferably, the biological agent of the present invention is administered through the skin to prevent and relieve osteoarthritis, rheumatoid arthritis, ankylosing arthritis, reactive arthritis, gouty arthritis, rheumatoid arthritis and infectious arthritis in a human body.

Further preferably, the biological agent of the present invention is administered through the skin in the form of a liquid formulation.

In yet another aspect, the present invention discloses a method for preparing a biological agent for preventing and alleviating joint sub-health, comprising the steps of:

(1) weighing raw materials of each phase according to weight percentage;

(2) mixing the phase A materials, adding into water phase pot, heating to 80-85 deg.C, and sterilizing at constant temperature to obtain water phase material;

(3) mixing the phase B materials, adding into an emulsifying pot, heating to 75-80 deg.C, and sterilizing at constant temperature to obtain oil phase material;

(4) pumping the water phase material obtained in the step (2) with the volume of 1/4-1/2 into an emulsifying pot under the vacuum stirring state to be mixed with the oil phase material obtained in the step (3), pumping the rest water phase material into the emulsifying pot for homogenizing, and homogenizing at 70-80 ℃ for 3-5 min;

(5) heating to dissolve C phase material, cooling to 60-65 deg.C, adding dissolved C phase material, and stirring;

(6) adding the D-phase material when the temperature of the materials in the emulsifying pot is reduced to 40-45 ℃, and uniformly stirring;

(7) and (3) adding the E-phase material when the temperature of the materials in the emulsifying pot is reduced to 32-38 ℃, uniformly stirring, and discharging.

Preferably, the step (2) is sterilized at constant temperature for 25 to 30 minutes.

Further preferably, the solid grease is heated in the step (3) until the solid grease is completely dissolved, and the solid grease is sterilized at constant temperature for 20-25 minutes.

Further preferably, the step (4) is sterilized at constant temperature for 25 to 35 minutes.

The effect of each effective active ingredient in the invention is as follows:

s-adenosylmethionine can pass through synovial membrane to reach cartilage through skin administration, nourish cartilage and joint fluid, has the functions of diminishing inflammation, relieving pain and repairing tissues, transfers aminopropyl to generate polyamine under the catalytic action of enzyme, prevents various enzymes from decomposing cartilage cell proteoglycan, ensures the exertion of proteoglycan function and keeps the cartilage and joints in a healthy state; meanwhile, S-adenosylmethionine can also resist the destructive action of tumor necrosis factor alpha, maintain the normal proliferation of synovial cells and ensure the smooth expression of fibronectin mRNA. In Europe, S-adenosylmethionine has been widely used as a prescription drug for the treatment of diseases such as liver disease, depression, arthritis, etc. In addition, S-adenosylmethionine has a remarkable effect in maintaining joint health and preventing osteoarthritis for a long time, and can also play a synergistic effect with hyaluronic acid to enhance the curative effect.

Sodium hyaluronate, which is the sodium salt of hyaluronic acid, has the following functions: (1) moistening and reducing friction between cartilage tissue and joint surface; (2) when the joint bears load, the sodium hyaluronate can form a gel-like substance, and the gel-like substance is converted from a fluid into an elastic body, so that the buffering effect is achieved, and the articular cartilage is protected; (3) forming a flow barrier on the surfaces of the cartilage and the synovium, and regulating water and nutrient components to enter and exit the cartilage matrix; (4) forming proteoglycan aggregate with protein and agglutinin to form cartilage matrix; (5) maintain the joint cavity to be opened and ensure the extension and the movement of the joint.

Sodium chondroitin sulfate, which is the sodium salt of chondroitin sulfate. Clinical trials have demonstrated that chondroitin sulfate can reduce pain in osteoarthritis patients, promote cartilage regeneration, improve joint function, reduce joint swelling and fluid accumulation, prevent gap narrowing at knee joints and hand joints, provide cushioning, dampen impact and friction during movement, draw water into proteoglycan molecules, thicken cartilage, and increase the amount of fluid sliding in joints.

The vitriol, the chemical name of which is hydroxypropyl tetrahydropyrane triol, has wide biological activity and can activate the synthesis of mucopolysaccharide and promote the generation of hyaluronic acid and collagen.

The acetyl chitosamine can promote synthesis and secretion of hyaluronic acid by skin keratinocyte and fibroblast, increase hyaluronic acid content in skin, and can be used for treating and preventing arthritis.

Fructus Lipuidambaris extract is dry mature infructescence of Liquidambar formosana Hance of Hamamelidaceae, and has effects of dispelling pathogenic wind and activating collaterals, and can be used for treating arthralgia, numbness and spasm.

Herba Lycopodii extract is dry whole plant of Lycopodium clavatum of Lycopodiaceae, is bitter, slightly pungent, warm in nature, has effects of dispelling pathogenic wind, removing dampness, relieving rigidity of muscles and activating collaterals, and can be used for treating joint pain and difficulty in flexion and extension.

Cinnamomum zeylanicum leaf oil, Cinnamomum zeylanicum is an edible spice or Chinese medicinal material of evergreen trees of Lauraceae, has analgesic effect, and can be used for relieving pain caused by arthritis.

The ginger root extract is fresh rhizome of perennial herb of Zingiber of Zingiberaceae, and has effects of warming spleen and stomach, dispelling cold, dispelling pathogenic wind, promoting blood circulation, and relieving rheumatalgia and traumatic injury.

Mastic oil is resin exuded from mastic tree of Burseraceae, and has effects of activating blood, promoting qi circulation, relieving pain, subsiding swelling, promoting granulation, and relieving pain and inflammation caused by arthritis.

The Morinda citrifolia fruit extract is cool in nature and bitter in taste, and has remarkable curative effects on arthritis and rheumatism.

Menthol, consisting of a saturated cyclic alcohol from peppermint oil, has the effects of dispelling wind, clearing heat and detoxifying; relieving skin and relieving pain caused by arthritis; it can be used together with Camphora for promoting transdermal absorption.

The essential oil of the lemongrass leaf has the functions of dispelling wind, eliminating dampness, resisting infection and fungi and relieving arthralgia caused by arthritis.

The vanillyl butyl ether and the oil-soluble heat-sensitive agent can quickly generate mild and lasting pyrogen effect after being locally acted on the skin, accelerate local microcirculation, stimulate subcutaneous fat metabolism, promote capillary blood circulation and the like.

The biological preparation for preventing and relieving arthritis has the following beneficial effects: the biological preparation contains various biological active ingredients and various traditional Chinese medicine active ingredients, and fundamentally prevents and relieves the arthritis through the combination of Chinese and Western medicines. The S-adenosylmethionine, the sodium hyaluronate, the sodium chondroitin sulfate, the vitrochromic factor and the acetyl chitosamine are bioactive components, so that on one hand, the decomposition of proteoglycan by enzyme can be prevented, and the reduction of the content of proteoglycan in a body is avoided; on the other hand, the hyaluronic acid gel provides exogenous hyaluronic acid for human joints, activates the synthesis of mucopolysaccharide of the body, promotes the synthesis of hyaluronic acid and collagen and the regeneration of cartilage, improves the content of hyaluronic acid in the body, reduces the loss of cartilage and maintains the shape of cartilage and joint fluid; coordinating traditional Chinese medicine active ingredients such as fructus Liquidambaris extract, herba Lycopodii extract, Morinda Citrifolia fruit extract, rhizoma Zingiberis recens root extract, Cinnamomum zeylanicum leaf oil, oleum Sesami, Cymbopogon citratus leaf essential oil and vanillyl butyl ether, relaxing muscles and tendons, activating collaterals, promoting blood circulation for removing blood stasis, improving local microcirculation, and relieving pain; the menthol and the camphor are used together to promote the transdermal absorption of the medicine to reach the focus part, effectively prevent and relieve arthritis and reduce pain of patients caused by injection administration.

Detailed Description

Example 1

The total amount of the raw materials is 100 kg. Wherein the content of the first and second substances,

a phase material: 9.0 kg of glycerol, 6.0 kg of propylene glycol and 2.0 kg of butanediol;

b phase material: 5 kg of sorbitan sesquioleate, 201.2 kg of isostearyl polyether, 2.0 kg of isohexadecane, 1.6 kg of sorbitan stearate, 2.3 kg of sorbitan isostearate, 0.7 kg of mastic oil, 0.05 kg of cinnamon leaf oil of Ceylon blue, 0.02 kg of citronella leaf oil, 60-60 kg of polysorbates, 0.8 kg of sodium stearyl glutamate, 0.3 kg of hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, 1.1 kg of acrylic acid (ester) copolymer, 0.05 kg of magnesium aluminum silicate, 0.1 kg of methyl hydroxybenzoate and 0.02 kg of ethylparaben;

c phase material: 2.0 kg of butanediol and 0.05 kg of tetrahydropiperine;

d phase material: 3.1 kg of lycopodium clavatum extract, 6.2 kg of fructus liquidambaris extract, 4.0 kg of ginger root extract, 5.3 kg of morinda citrifolia fruit extract, 0.15 kg of camphor, 2.5 kg of methyl salicylate, 0.15 kg of ascorbyl palmitate, 0.7 kg of citric acid, 3.5 kg of menthol, 4.2 kg of triethanolamine, 8.4 kg of sodium chondroitin sulfate, 6.3 kg of S-adenosylmethionine, 4.6 kg of sodium hyaluronate, 0.5 kg of hydroxyphenylpropionamide benzoic acid, 0.16 kg of hydroxypropyl tetrahydropyrane triol and 5.5 kg of acetyl chitosan;

e phase material: 0.24 kg of 1.2-pentanediol, 0.13 kg of butylated hydroxytoluene, 1.2 kg of vanillyl butyl ether, 2.1 kg of ethylhexyl glycerol and 0.3 kg of phenoxyethanol.

The balance of phase A deionized water.

The preparation process comprises the following steps:

(1) weighing raw materials of each phase according to weight percentage;

(2) mixing the phase A materials uniformly, adding into a water phase pot, heating to 80 ℃, and sterilizing at constant temperature for 25 minutes to obtain a water phase material;

(3) mixing the phase B materials, adding into an emulsifying pot, heating to 75 deg.C, sterilizing at constant temperature for 20 min to obtain oil phase material;

(4) pumping 1/4 volume of the water phase material obtained in the step (2) into an emulsifying pot to be mixed with the oil phase material obtained in the step (3) under the vacuum stirring state, pumping the rest water phase material into the emulsifying pot for homogenizing, homogenizing at 70 ℃ for 3min, and sterilizing at constant temperature for 25 min;

(5) heating to dissolve C phase material, cooling to 60 deg.C, adding dissolved C phase material, and stirring;

(6) adding the D-phase material when the temperature of the materials in the emulsifying pot is reduced to 40 ℃, and uniformly stirring;

(7) and (3) adding the E-phase material when the temperature of the material in the emulsifying pot is reduced to 32 ℃, uniformly stirring, and discharging.

Example 2

Example 2 is the same formulation as example 1, example 2 differs from example 1 only in the preparation process, and example 2 is prepared as follows:

(1) weighing raw materials of each phase according to weight percentage;

(4) pumping 1/2 volumes of the water phase material obtained in the step (2) into an emulsifying pot under the vacuum stirring state to be mixed with the oil phase material obtained in the step (3), homogenizing at 70 ℃ for 3min, and sterilizing at constant temperature for 25 min;

Example 3

a phase material: 1.0 kg of glycerol, 9.8 kg of propylene glycol and 4.5 kg of butanediol;

b phase material: 3.5 kilograms of sorbitan sesquioleate, 203.0 kilograms of isosteareth, 2.3 kilograms of isocetyl, 1.5 kilograms of sorbitan stearate, 2.0 kilograms of sorbitan isostearate, 3.2 kilograms of mastic oil, 0.6 kilograms of cinnamon leaf oil of Ceylon, 0.5 kilograms of citronella leaf oil, 601.0 kilograms of polysorbate, 0.8 kilograms of sodium stearyl glutamate, 0.1 kilogram of hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, 0.05 kilograms of acrylic acid (ester) copolymer, 0.01 kilograms of aluminum magnesium silicate, 0.01 kilograms of methyl hydroxybenzoate and 0.01 kilograms of ethylparaben;

c phase material: 3.0 kg of butanediol and 4.0 kg of tetrahydropiperine;

d phase material: 2.0 kilograms of lycopodium clavatum extract, 4.2 kilograms of fructus liquidambaris extract, 5.0 kilograms of ginger root extract, 3.0 kilograms of morinda citrifolia fruit extract, 0.01 kilogram of camphor, 0.1 kilogram of methyl salicylate, 0.1 kilogram of ascorbyl palmitate, 0.7 kilogram of citric acid, 3.6 kilograms of menthol, 4.0 kilograms of triethanolamine, 7.5 kilograms of sodium chondroitin sulfate, 10.0 kilograms of S-adenosylmethionine, 5.0 kilograms of sodium hyaluronate, 0.1 kilogram of hydroxyphenylpropionamide benzoic acid, 0.2 kilogram of hydroxypropyl tetrahydropyrane triol and 4.4 kilograms of acetyl chitosamine;

e phase material: 0.2 kg of 1.2-pentanediol, 0.1 kg of butylated hydroxytoluene, 2.5 kg of vanillyl butyl ether, 2.0 kg of ethylhexyl glycerol and 0.2 kg of phenoxyethanol.

The balance of phase A deionized water.

The preparation process comprises the following steps:

(1) weighing raw materials of each phase according to weight percentage;

(2) mixing the phase A materials, adding into a water phase pot, heating to 85 deg.C, sterilizing at constant temperature for 30 min to obtain water phase material;

(3) mixing the phase B materials, adding into an emulsifying pot, heating to 80 deg.C, sterilizing at constant temperature for 25 min to obtain oil phase material;

(4) pumping 1/2 volumes of the water phase material obtained in the step (2) into an emulsifying pot to be mixed with the oil phase material obtained in the step (3) under the vacuum stirring state, pumping the rest water phase material into the emulsifying pot for homogenizing, homogenizing at 70 ℃ for 5min, and sterilizing at constant temperature for 35 min;

(5) heating to dissolve C phase material, cooling to 65 deg.C, adding dissolved C phase material, and stirring;

(6) adding the D-phase material when the temperature of the materials in the emulsifying pot is reduced to 45 ℃, and uniformly stirring;

(7) and (3) adding the E-phase material when the temperature of the material in the emulsifying pot is reduced to 38 ℃, uniformly stirring, and discharging.

Example 4

Example 4 is the same formulation as example 3, example 4 differs from example 3 only in the preparation process, and example 4 is prepared as follows:

(1) weighing raw materials of each phase according to weight percentage;

(4) pumping 1/2 volumes of the water phase material obtained in the step (2) into an emulsifying pot under the vacuum stirring state to be mixed with the oil phase material obtained in the step (3), homogenizing at 70 ℃ for 5min, and sterilizing at constant temperature for 35 min;

(6) adding the D-phase material when the temperature of the materials in the emulsifying pot is reduced to 42 ℃, and uniformly stirring;

(7) and (4) when the temperature of the materials in the emulsifying pot is reduced to 35 ℃, adding the E-phase materials, uniformly stirring, and discharging.

Example 5

a phase material: 8.9 kilograms of glycerin, 1.0 kilogram of propylene glycol and 1.0 kilogram of butanediol;

b phase material: 2.0 kg of sorbitan sesquioleate, 201.5 kg of isosteareth, 1.5 kg of isohexadecane, 1.5 kg of sorbitan stearate, 4.5 kg of sorbitan isostearate, 7.0 kg of mastic oil, 5.5 kg of cinnamon leaf oil of Ceylon, 0.5 kg of citronella leaf oil, 601.0 kg of polysorbate, 0.8 kg of sodium stearyl glutamate, 0.1 kg of hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, 0.05 kg of acrylic acid (ester) copolymer, 0.01 kg of aluminum magnesium silicate, 0.01 kg of methyl hydroxybenzoate and 0.01 kg of ethylparaben;

c phase material: 0.1 kg of butanediol and 0.05 kg of tetrahydropiperine;

d phase material: 3.5 kilograms of lycopodium clavatum extract, 2.5 kilograms of fructus liquidambaris extract, 0.5 kilogram of ginger root extract, 9.5 kilograms of morinda citrifolia fruit extract, 0.01 kilogram of camphor, 0.1 kilogram of methyl salicylate, 0.1 kilogram of ascorbyl palmitate, 0.01 kilogram of citric acid, 0.01 kilogram of menthol, 0.01 kilogram of triethanolamine, 9.0 kilogram of sodium chondroitin sulfate, 19.0 kilogram of S-adenosylmethionine, 5.0 kilogram of sodium hyaluronate, 0.1 kilogram of hydroxyphenylpropionamide benzoic acid, 0.1 kilogram of hydroxypropyl tetrahydropyrane triol and 9.0 kilogram of acetylcysteine;

e phase material: 0.2 kg of 1.2-pentanediol, 0.1 kg of butylated hydroxytoluene, 0.01 kg of vanillyl butyl ether, 0.05 kg of ethylhexyl glycerol and 0.05 kg of phenoxyethanol.

The balance of phase A deionized water.

The preparation process of example 5 is the same as that of example 3.

Example 6

Example 6 is the same formulation as example 5, example 6 differs from example 5 only in the preparation process, example 6 is prepared as follows:

(1) weighing raw materials of each phase according to weight percentage;

(2) mixing the phase A materials, adding into a water phase pot, heating to 85 deg.C, sterilizing at constant temperature for 10 min to obtain water phase material;

(3) mixing the phase B materials, adding into an emulsifying pot, heating to 80 deg.C, sterilizing at constant temperature for 15 min to obtain oil phase material;

(4) pumping 1/3 volume of the water phase material obtained in the step (2) into an emulsifying pot to be mixed with the oil phase material obtained in the step (3) under the vacuum stirring state, pumping the rest water phase material into the emulsifying pot for homogenizing, homogenizing at 70 ℃ for 5min, and sterilizing at constant temperature for 20 min;

Clinical examples

1. In plum, male, 55 years old, who recently felt pain in both knees occasionally, the biological preparation prepared in example 1 of the present invention was applied three times a day, and the pain was relieved after one week of use. The use process does not have any adverse symptoms such as skin stimulation and the like.

2. Zhangqi, male, 52 years old, and obviously felt joint soreness in rainy days, and the biological preparation prepared in the invention example 2 is externally applied three times a day, 20ml each time, and the pain is relieved after 2 weeks. No adverse symptoms such as skin irritation and the like appear in the using process.

3. Qiaozhi, women, 30 years old, mild hyperosteogeny at the heel, externally applying the biological preparation prepared in the embodiment 3 of the invention three times a day, 20ml each time, and relieving pain after 2 weeks. No adverse symptoms such as skin irritation and the like appear in the using process.

4. Forest, male, age 34. The body weight is seriously exceeded, the knee joint is consciously stiff, and the movement cannot be freely performed. After the biological preparation is used in combination with a special massage manipulation for one month, the pain is gradually relieved. No adverse symptoms such as skin irritation and the like appear in the using process.

5. Jiangzhi, women in age 40, often lack of exercise for a long time, causing pain, soreness and weakness of the knee joints. After the biological preparation is used in combination with a professional massage manipulation for one month, the joint flexibility is increased, and adverse symptoms such as skin irritation and the like can be avoided during normal movement and no obstacle in the use process.

6. Zhao, a woman in 27 years old, afraid of heat in summer, long-term air-conditioning, occasionally pain in the knee joints. The biological agent prepared in example 4 of the present invention was applied three times a day at 20ml each time, and pain was relieved after 1 week and morning stiffness was reduced. No adverse symptoms such as skin irritation and the like appear in the using process.

7. Zheng Zhi, women aged 32 years old, and after climbing mountain and going home, feel weak and limp ankle joints and are difficult to walk. The biological preparation prepared in example 5 of the present invention was applied three times a day, 20ml each time, and the action was free after 2 weeks. No adverse symptoms such as skin irritation and the like appear in the using process.

8. In 49 years old, the finger joints of a woman cannot be stressed and can feel painful after slight exertion, the biological preparation prepared in the embodiment 6 of the invention is externally applied three times a day, 20ml is applied each time, the finger joints can normally move after 1 week, and the pain disappears. No adverse symptoms such as skin irritation and the like appear in the using process.

9. Li Yi, women, age 41, because of no love for exercise and frequent sitting, recently had a sense of joint pain stiffness when going up and down stairs invisibly, the biological preparation prepared in the invention example 1 was applied externally, three times a day, 20ml each time, and the pain gradually disappeared in 4-6 days. No adverse symptoms such as skin irritation and the like appear in the using process.

10. Wu-jiao, male, age 36, occasionally feels swollen and painful joints and fails to exercise greatly. The biological agent prepared in example 1 of the present invention was applied three times a day, 20ml each time, and the pain was gradually lost in 4 to 6 days. No adverse symptoms such as skin irritation and the like appear in the using process.

11. Liu Zhi, female, age 42, mild hyperosteogeny and difficulty in moving. The biological agent prepared in example 1 of the present invention was applied three times a day, 20ml each time, and the pain gradually disappeared after 2 weeks. No adverse symptoms such as skin irritation and the like appear in the using process.

12. For the rest of the ages, male, 38 years old, often feel a sore and swollen leg. The biological agent prepared in example 1 of the present invention was applied three times a day, 20ml each time, and the pain was gradually lost for 4 to 6 days. No adverse symptoms such as skin irritation and the like appear in the using process.

(II) in order to further confirm the treatment effect and safety, the biological agent of the embodiment 2 of the invention is used for efficacy test, and the specific test method and test result are as follows:

500 sub-healthy volunteers were randomly divided into two groups, with the exception of treatment group 400, the biological preparation of the present invention was used in combination with the traditional Chinese massage manipulation for 2 clinical treatments per week, and 100 of control group were used only in the same traditional Chinese massage manipulation as the treatment group for 2 treatments per week. The age and the course of disease of the patients in the two groups have no obvious difference and are comparable. In 500 cases of treatment: the minimum age is 25 years, the maximum age is 60 years, and the treatment observation period is 12 months.

1. The criteria for the curative effect of joint maintenance are as follows:

high efficiency: the inflammation of the joints disappears and the disease lasts for more than half a year without rebound.

The effect is shown: the arthritic symptoms disappear, and the joint is kept for more than 3 months without rebound.

The method has the following advantages: the symptoms of joint inflammation substantially disappear.

And (4) invalidation: the joint inflammation was not improved.

2. The Chinese massage manipulation comprises the following specific operation steps:

and (4) smearing the frost evenly in a looping mode. (Note: only one side is wiped and connected to each other in place.)

Poking bladder meridian: from top to bottom, four lines are divided, one for each line.

Drawing the triple energizer meridian: the four lines are divided into one time.

Poking large intestine meridian: from bottom to top, four lines are divided, one for each line.

Point-and-Rou pain point: Point-and-Rou the arthralgia and related acupoints.

The use considerations are as follows:

the product of 10g to 30g is used to achieve the purpose of relieving anxiety emotion by matching with a traditional Chinese medicine massage method.

Each massage step is repeated 30-40 times for about 90 minutes.

Before and after the massage nursing by the product, a user needs to pay attention to supplement a proper amount of water, which is helpful for discharging vivotoxin.

In the process of massage, the product of the embodiment is added in time as a massage medium, so that sufficient product is absorbed and the curative effect is enhanced.

3. The measurement results are shown in table 1.

TABLE 1 clinical trial situation for the treatment and control groups

According to 400 cases of clinical tests, 400 cases of sub-healthy people do not have any toxicity and irritation during the clinical treatment, the appetite is normal, the body function is normal, and the internal secretion of patients is normal. After 16 treatments, the total effective rate of 400 cases in the treatment group reaches 97.00 percent, while the total effective rate of the control group is only 39.00 percent. After 400 cases are tracked, 81 percent of treatment effective persons in a treatment group do not feel rebound, worsening or aggravation of symptoms and signs after stopping treatment for 6 months, and 78 percent of treatment effective persons in a control group obviously feel rebound phenomenon of symptoms and signs.

And analyzing the result: improving joint pain

300 persons 25 to 60 years old with arthralgia are treated, the biological preparation is externally applied 2 times a week, and clinical treatment is carried out by combining a traditional Chinese medicine massage method, the massage method is the same as the above, and the follow-up statistics is carried out for 6 months, so that the test results are shown in table 2.

Table 2 improved joint pain follow-up case results

And analyzing the result: relieving joint stiffness

To verify that the biological agent of the present invention can alleviate the symptoms of joint stiffness, the present inventors organized 100 subjects with 25-60 years old joint stiffness, the selection criteria of which are as follows: the medicine has no serious system performance diseases and allergic diseases, is not used for patients locally taking any anti-arthritis medicine within a week, is not used for other similar cosmetic clinical testers within a month, and is voluntarily used for the testees. The application method is to externally apply the biological preparation of the invention and combine the traditional Chinese medicine massage manipulation. All volunteers before the test are selected to record the joint stiffness condition before use, the time for continuously trying the biological agent is two months, and the effect is observed after the trial is finished and before the trial. Table 3 shows the statistics of the trial of the product of the invention.

TABLE 3 tracking case results for improving joint stiffness

The above tests show that: the biological preparation of the invention has the effects of improving arthritis, repairing joint structure substances and improving arthritis by assisting with traditional massage techniques. The biological preparation of the invention does not contain any toxic or substances which influence the normal operation, absorption and growth of human bodies, is harmless to the human bodies, does not influence the normal operation and absorption of the functions of the viscera of the human bodies, has no side effect, does not generate endocrine disturbance and has good curative effect. The traditional Chinese medicine massage manipulation is matched with the product to help channels and collaterals to be dredged, improve blood circulation, improve internal diseases of the organism and prevent and relieve arthritis symptoms from root causes.

What has been described above are merely some embodiments of the present invention. It will be apparent to those skilled in the art that various changes and modifications can be made without departing from the inventive concept thereof, and these changes and modifications can be made without departing from the spirit and scope of the invention.

Claims

1. A biological agent for preventing and relieving joint sub-health is characterized by comprising the following components in percentage by weight:

a phase material:

b phase material:

c phase material:

(20) 0.1 to 8.0 percent of butanediol,

(21) 0.05 to 5.0 percent of tetrahydropiperine,

d phase material:

e phase material:

2. the biological agent according to claim 1, characterized by comprising the following components in percentage by weight:

a phase material:

b phase material:

c phase material:

(20) 0.1 to 6.0 percent of butanediol,

(21) 0.05 to 4.0 percent of tetrahydropiperine,

d phase material:

e phase material:

3. the biological agent according to claim 1 or 2, wherein the agent is administered through the skin to prevent and relieve osteoarthritis, rheumatoid arthritis, ankylosing arthritis, reactive arthritis, gouty arthritis, rheumatoid arthritis and infectious arthritis in a human body.

4. The biological agent according to claim 3, characterized in that it is administered through the skin in the form of a liquid formulation.

5. The method of preparing a biological agent for the prevention and alleviation of sub-health of a joint according to any one of claims 1 to 4, comprising the steps of:

(1) weighing raw materials of each phase according to weight percentage;

(4) pumping 1/4-1/2 volume of the water phase material obtained in the step (2) into an emulsifying pot under the vacuum stirring state to be mixed with the oil phase material obtained in the step (3), pumping the rest water phase material into the emulsifying pot for homogenizing, and homogenizing at 70-80 ℃ for 3-5 min;

6. The method according to claim 5, wherein the step (2) is performed for 25 to 30 minutes at a constant temperature.

7. The preparation method according to claim 5, wherein the step (3) is carried out by heating until the solid oil and fat are completely dissolved, and sterilizing at constant temperature for 20-25 minutes.

8. The method according to claim 5, wherein the step (4) is performed for 25 to 35 minutes at a constant temperature.