CN115105580A - A topical Chinese medicinal composition containing nervonic acid for relieving swelling and pain, and its preparation method - Google Patents

A topical Chinese medicinal composition containing nervonic acid for relieving swelling and pain, and its preparation method Download PDF

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CN115105580A
CN115105580A CN202210852437.2A CN202210852437A CN115105580A CN 115105580 A CN115105580 A CN 115105580A CN 202210852437 A CN202210852437 A CN 202210852437A CN 115105580 A CN115105580 A CN 115105580A
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nervonic acid
pain
traditional chinese
chinese medicine
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王悦
崔晓廷
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Shenyang Yaoda Biotechnology Co ltd
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Shenyang Yaoda Biotechnology Co ltd
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Abstract

The invention relates to the technical field of medicine and health care products, and discloses a traditional Chinese medicine composition containing nervonic acid and application thereof in detumescence and analgesia. It is an external liniment or spray prepared from a nervonic acid composition, a traditional Chinese medicine composition and auxiliary materials. The combined application of the nervonic acid and the traditional Chinese medicine composition to the external product is realized for the first time. The product has clear mechanism and synergistic effect on regulating and controlling pain information transmission system and endogenous pain modulation system. Experiments prove that the traditional Chinese medicine composition is applied to the fields of relieving swelling and pain, relaxing channels and activating collaterals, accelerating microcirculation and improving the activity of peripheral nerves in the scenes of treating diseases such as soft tissue injury, arthritis, rheumatoid bone diseases, cervical spondylosis, sciatica and the like, has quick response, good curative effect, convenient use, difficult relapse, wide application population and novelty, practicability and application prospect.

Description

A topical Chinese medicinal composition containing nervonic acid for relieving swelling and pain, and its preparation method
Technical Field
The invention belongs to the technical field of preparation of medicine health products, and particularly relates to a traditional Chinese medicine composition containing nervonic acid for relieving swelling and pain and a preparation method thereof.
Background
Pain (pain) is usually caused by the noxious stimulation of tissue damage and is a complex psychophysiological activity. The diseases such as soft tissue injury, arthritis, rheumatoid bone diseases, cervical spondylosis, sciatica and the like have the same symptom of pain although the disease types are different. Pain and swelling are often associated with each other. It has been reported that one third of the world population suffers from persistent or recurrent pain, and that progressive pain often results in loss of labor capacity for patients, placing a tremendous burden on individuals, families, and society. According to the international health organization report, only about 15% of painful patients can be treated properly, and more patients are in painful and disabling scenes. China has already stepped into an aging society, and 3 hundred million elderly people have common diseases and frequently encountered diseases such as rheumatism, rheumatoid arthritis, scapulohumeral periarthritis, cervical spondylosis, hyperosteogeny and the like, and patients suffering from various pains account for about 65 percent. Long-term working of industrial workers easily causes body strain and arthralgia. The incidence of cervical vertebra pain and back pain gradually increases due to long-term sitting of computer terminal people, so that the pain group is continuously expanded. Pain and pain relief has been a goal pursued by medical researchers. Over the last 20 years there has been great progress in the mechanism and treatment of pain, however, pain remains a powerful research topic in medicine.
At present, the current treatment status of pain and swelling is that physical therapy such as massage, heat therapy, electrotherapy and the like, acupuncture and moxibustion, electrical stimulation and nerve therapy and the like can relieve pain, but the effect is slow, and the traditional Chinese medicine is not suitable for acute pain. For medication, non-narcotic analgesics (e.g. aspirin), narcotic analgesics (e.g. morphine), non-steroidal anti-inflammatory drugs, etc. are usually used for relieving swelling and pain, but such drugs, especially morphine drugs, have large side effects on patients after long-term administration. Surgical therapy, which is a therapy for permanently destroying or interrupting the pain ascending pathway adopted under the condition that the pain is not available, is not only painful for patients, but also is difficult to achieve the purpose of relieving the pain for a long time. The discovery of 5-hydroxytryptamine, norepinephrine and certain polypeptides involved in the descending inhibition pathway provides application prospects for pain treatment. The medicine is not technically mature enough, is still in experimental exploration, and is really applied to a novel clinical medicine special medicine product for relieving swelling and pain.
The inventor finds that nervonic acid (cis-15-tetracosenoic acid) derived from acer truncatum seed oil has a remarkable analgesic effect through long-term research, and a product prepared by matching nervonic acid with traditional Chinese medicine components is experienced by volunteers, and has an unexpected effect of relieving swelling and pain. The possible pharmacological mechanisms of the product are repairing or regenerating myelin biological membranes, weakening thin fiber afferent and strengthening thick fiber afferent, and increasing the release of endogenous enkephalin and neurotransmitter, thereby rapidly achieving the aim of treating pain. On the premise of fully researching experiments, the patent formula and the preparation process are formed, relevant documents are checked, and reports which are the same as or similar to the technical characteristics of the patent are not found.
Disclosure of Invention
Solves the technical problem
Aiming at the defects of the prior art of detumescence and analgesia, the invention aims to provide a formula, a preparation method and application of a nervonic acid-containing traditional Chinese medicine composition with the effect of external use of detumescence and analgesia. To solve the problems set forth in the background art.
Technical scheme
In order to achieve the purpose, the invention provides the following technical scheme:
a topical Chinese medicinal composition containing nervonic acid for detumescence and analgesia and its preparation method, it is a topical preparation made of nervonic acid composition, Chinese medicinal composition and adjuvants, include the raw materials adjuvants weight shares saffron 18-72, Clematis chinensis 18-72, corydalis tuber 30-120, dipsacus root 18-72, radix Aconiti 18-72, Lycopodium clavatum 15-60, speranskia herb 15-60, radix Salviae Miltiorrhizae 23-90, radix Et rhizoma Rhei 10-38, 10-40 parts of dried ginger, 10-24 parts of lithospermum, 3-10 parts of nervonic acid, 5-20 parts of methyl salicylate, 1-10 parts of vanillyl butyl ether, 20-120 parts of dimethyl sulfoxide, 807-30 parts of tween-807, 25-100 parts of glycerol, 25-100 parts of propylene glycol, 5-20 parts of menthol and a proper amount of purified water.
Preferably, the external traditional Chinese medicine composition containing nervonic acid for detumescence and analgesia comprises the raw materials and auxiliary materials of 36 parts by weight of saffron, 36 parts by weight of clematis root, 60 parts by weight of corydalis tuber, 36 parts by weight of teasel root, 36 parts by weight of unprocessed radix aconiti, 30 parts by weight of lycopodium clavatum, 30 parts by weight of garden balsam stem, 45 parts by weight of salvia miltiorrhiza, 19 parts by weight of rhubarb, 20 parts by weight of dried ginger, 12 parts by weight of lithospermum, 5 parts by weight of nervonic acid, 10 parts by weight of methyl salicylate, 5 parts by weight of vanillyl butyl ether, 60 parts by weight of dimethyl sulfoxide, 5 parts by weight of tween-8015, 50 parts by weight of glycerol, 50 parts by weight of propylene glycol, 10 parts by weight of menthol and a proper amount of purified water.
The traditional Chinese medicine composition comprises saffron, clematis root, corydalis tuber, teasel root, unprocessed radix aconiti, lycopodium clavatum, garden balsam stem, salvia miltiorrhiza, rhubarb, dried ginger and lithospermum, and each traditional Chinese medicine material accords with the requirements of Chinese pharmacopoeia (one part).
The nervonic acid combination comprises nervonic acid and vanillyl butyl ether.
Nervonic acid, chinese name: Cis-15-Tetracosenoic Acid, English name Cis-15-Tetracosenoic Acid, mass fraction of which is more than or equal to 85%, and structural formula: CH 3- (CH2) 7-CH = CH- (CH2) 11-COOH. The molecular formula is as follows: C24H46O2, molecular weight: 366.6, it should meet the No. 7 announcement requirement of Weijian Commission in 2017 of China. Nervonic acid is available from manufacturers.
Vanillyl butyl ether is also known as: vanillyl butyl ether, english name: vanillyl Butyl Ether, content 99%, CAS: 82654-98-6.
The adjuvants include methyl salicylate, dimethyl sulfoxide, tween-80, glycerol, propylene glycol, Mentholum, purified water, and optionally carbomer and hydroxyethyl cellulose. All the auxiliary materials should meet the requirements of the relevant quality standards of medicines, foods or reagents.
The external preparation is characterized by comprising a liniment, a spray and a gel.
The formula basis of the technical scheme
Efficacy of decoction pieces of Chinese herbs
Saffron: promoting blood circulation, removing blood stasis, cooling blood, removing toxic substance, resolving stagnation, and tranquilizing mind;
red sage root: promoting blood circulation, removing blood stasis, dredging channels, relieving pain, clearing heart fire, relieving restlessness, cooling blood, and eliminating carbuncle;
dried ginger: warming the middle-jiao to dispel cold, restoring yang to activate collaterals, warming the lung to resolve fluid retention, and cooling the limbs and slightly thready pulse;
the 3 medicines are used together, and have synergistic effect on promoting blood circulation, dissipating blood stasis, improving microcirculation, dredging channels and collaterals, and relieving swelling and pain;
rhizoma corydalis: the traditional analgesics can relieve pain, activate blood and treat pain of waist and knees and traumatic injury;
clematis root: has effects in dispelling pathogenic wind, removing dampness, and dredging channels and collaterals;
rhubarb: cooling blood, removing toxic substances, removing blood stasis, dredging channels, promoting diuresis, eliminating jaundice, and resisting bacteria and virus;
teasel root: nourishing liver and kidney, strengthening tendons and bones, treating fracture and traumatic injury;
raw radix aconiti: dispel wind and dampness, warm meridians and alleviate pain. Can be used for treating arthralgia due to wind-cold-dampness and arthralgia;
b, common clubmoss herb: dispelling pathogenic wind and removing dampness, relieving rigidity of muscles and activating collaterals, and can be used for treating joint pain and difficulty in flexion and extension;
garden balsam stem: dispelling pathogenic wind and removing dampness, relieving pain of limbs, relaxing muscles and tendons, activating collaterals, promoting blood circulation, relieving pain, removing toxic substance, and eliminating rash;
lithospermum: anti-inflammatory, anti-pathogenic microorganism, and analgesic effects;
8 components such as corydalis tuber and the like are used together to promote blood circulation, relieve pain, expel wind, remove dampness, resist inflammation and bacteria, relax muscles and tendons and activate collaterals.
Nervonic acid
Nervonic acid is the core component of the neuro-biomembrane, improves the composition, the structure and the function of the biomembrane mainly by synthesizing glycosphingolipid and sphingomyelin in vivo, and has unique functions of nutrition, repair, regeneration and remodeling on neurons and neural networks. Nervonic acid has remarkable effect on central nerve and peripheral neuropathy.
The cause of pain can be caused by in vitro noxious stimulation, or by potassium ion, 5-hydroxytryptamine, acetylcholine, bradykinin, histamine, etc. in vivo extracellular fluid. Prostaglandins potentiate the pain-causing effects of these chemicals. In the nervous system, not only a pain signal transmission system but also an endogenous pain modulation system exists, which can produce a strong self-analgesic effect. Free nerve endings, nerve fibers, nerve myelin sheaths, spinal cords, thalamus and chemicals such as 5-hydroxytryptamine, endorphin and the like are involved in pain transmission and pain modulation systems. The pain control is greatly affected by the poor conduction of information or the decrease of neurotransmitters in any of the links. Therefore, the product formula is far from sufficient only by traditional Chinese medicines. Nervonic acid must be introduced. Nervonic acid can nourish nerve cells in time, enhance nerve cell energy, improve peripheral nerve activity, induce self growth and division of nerve fibers, promote recovery of damaged nerve fibers, dissolve necrotic tissues blocking nerve conduction channels, regenerate damaged and fallen protective sheaths, enable instructions sent by a central center and information fed back from the outside to be smoothly transmitted through nerve fibers, activate diseased and dormant nerve cells, enable the nerve center to freely command a pain sensation transmission system and a pain sensation modulation system, achieve the purposes of weakening fine fiber afferent and strengthening crude fiber afferent, control pain 'gates', increase release of endogenous neurotransmitters such as enkephalin, 5-hydroxytryptamine and the like, combine with receptors in brain, and rapidly and continuously realize swelling and pain relief. The method is a great progress of the theoretical mechanism research of the pain, and brings new strategies and measures to the practice of preventing and treating the pain.
Vanillyl butyl ether
Vanillyl butyl ether is locally acted on skin or mucosa, can quickly generate mild and lasting pyrogen effect, including accelerating microcirculation, promoting capillary blood circulation and the like, can quickly activate vanilloid receptor (a channel complex protein), opens a calcium channel, depolarizes a membrane at the periphery of a primary sensory neuron, can quickly generate strong heat within about 2 minutes, and lasts for about 2 hours; vanillyl butyl ether produces a sensation of heat by direct stimulation of nerve endings, a thermal effect that is perceived by triggering neurotransmitters, and can produce a strong sensation of heat at very low doses. Vanillyl butyl ether is a stable and safe material.
Application of nervonic acid and vanillyl butyl ether as composition in formula
The application of nervonic acid and vanillyl butyl ether as a fixed composition in a formula is a great technical characteristic of the patent. The two show various advantages of combined application in the aspects of stimulating the activity of nerve endings, triggering the release of neurotransmitter and the like, and the results of comparative experiments prove that the combination of the formula and the formula without using nervonic acid has the effects of reducing swelling and easing pain of patients by at least more than 10 percent and has the effects of isoqu and isogong.
The preparation method of the external traditional Chinese medicine composition containing nervonic acid for detumescence and analgesia comprises the following steps:
the method comprises the following steps: weighing 11 traditional Chinese medicines such as saffron and the like according to a ratio, removing impurities, crushing into 20 meshes, placing into a container, adding 75% ethanol with the weight 8-10 times of the weight of the medicinal materials, soaking for 30 days, heating and refluxing for extraction once for 1 hour at the extraction temperature of 80 ℃, and recovering the ethanol under reduced pressure to ensure that the ethanol content in the extracting solution is 38%. Obtaining traditional Chinese medicine extract mother liquor;
step two: dissolving nervonic acid with appropriate amount of ethanol, adding into the mother liquor under stirring, and stirring at a speed of 30 rpm;
step three: weighing methyl salicylate, vanillyl butyl ether, dimethyl sulfoxide, tween-80, glycerol, propylene glycol and menthol at one time, adding into the mother liquor, adding purified water to the total amount, stirring for 30 minutes at the stirring speed of 30 revolutions per minute. Adjusting the pH value of the mixed solution to 6-7.5;
step four: if the gel is prepared, 1% carbomer is soaked in purified water for 10 hours, and is combined with the traditional Chinese medicine extract, and other steps are the same;
step five: making into liniment, spray, or gel by conventional method.
The application method of the traditional Chinese medicine composition external preparation containing the nervonic acid comprises the step of applying the liquid medicine on or spraying the liquid medicine on affected parts with skin mucosa diseases, wherein the liquid medicine is applied once every 8 hours for mild pain, the liquid medicine is applied once every 4 hours for moderate pain, and the liquid medicine is applied once every 3 hours for severe pain. After each administration, massage is carried out for 15 minutes.
The external preparation of the traditional Chinese medicine composition containing nervonic acid is applied to the preparation of products for relieving swelling and pain of human bodies.
In particular to a Chinese medicinal composition external preparation containing nervonic acid, which is used for detumescence and analgesia treatment in the preparation of products of soft tissue injury, osteoarthritis, rheumatism, rheumatoid arthritis, cervical spondylosis, sciatica and the like.
The invention has the beneficial effects that:
1. the combined application of the nervonic acid and the vanillyl butyl ether in the external product for the first time can quickly relieve pain, accelerate microcirculation, promote capillary blood circulation, improve the activity of peripheral nerves and have comfortable thermal effect. Experiments prove that the traditional Chinese medicine composition has quick response, good curative effect and difficult relapse on dredging channels and activating collaterals and treating stubborn pain. The product is creative and novel;
2. pure Chinese herbal medicines are adopted as raw materials, the compatibility of all components is proper, the mechanism is clear, the synergy is realized, and the traditional Chinese medicine composition and the nervonic acid composition are compounded to realize the improvement of the efficacy quality, so that the traditional Chinese medicine composition becomes a refined product for relieving swelling and pain without any toxic or side effect;
3. adopts liniment, spray and other external preparations, is convenient to use, has easy absorption of the effective components of the medicine, and shortens the treatment period. The possible body injury caused by oral administration of the medicine is avoided;
4. the raw materials are easy to obtain, the cost is low, the application crowd is wide, and the practicability and the social benefit are realized.
Detailed Description
The technical solution of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. It is to be understood that the described embodiments are merely exemplary of the invention, and not restrictive of the full scope of the invention. Based on the embodiments of the present invention, those skilled in the art can obtain all other embodiments without creative efforts, which belong to the protection scope of the present invention.
Example one
A topical Chinese medicinal composition containing nervonic acid for detumescence and analgesia comprises 18-72 parts of stigma croci Sativi, 18-72 parts of radix Clematidis, 30-120 parts of rhizoma corydalis, 18-72 parts of radix Dipsaci, 18-72 parts of radix Aconiti, 15-60 parts of herba Lycopodii, 15-60 parts of herba Speranskiae Tuberculatae, 23-90 parts of Saviae Miltiorrhizae radix, 10-38 parts of radix et rhizoma Rhei, 10-40 parts of Zingiberis rhizoma, 10-24 parts of radix Arnebiae, 3-10 parts of nervonic acid, 5-20 parts of methyl salicylate, 1-10 parts of vanillyl butyl ether, 20-120 parts of dimethyl sulfoxide, Tween-807-30 parts of glycerol 25-100 parts, 25-100 parts of propylene glycol, 5-20 parts of Mentholum, and a suitable amount of purified water.
The preparation method of the external traditional Chinese medicine composition containing nervonic acid for detumescence and analgesia comprises the following steps:
the method comprises the following steps: weighing 11 traditional Chinese medicines such as saffron and the like according to a ratio, removing impurities, crushing into 20 meshes, placing into a container, adding 75% ethanol with the weight 8-10 times of the weight of the medicinal materials, soaking for 30 days, heating and refluxing for extraction once for 1 hour at the extraction temperature of 80 ℃, and recovering the ethanol under reduced pressure to ensure that the ethanol content in the extracting solution is 38%. Obtaining traditional Chinese medicine extract mother liquor;
step two: dissolving nervonic acid with appropriate amount of ethanol, adding into the mother liquor under stirring, and stirring at a speed of 30 rpm;
step three: sequentially weighing methyl salicylate, vanillyl butyl ether, dimethyl sulfoxide, tween-80, glycerol, propylene glycol and menthol, adding into the mother liquor, adding purified water to the total amount, stirring for 30 minutes at a stirring speed of 30 revolutions per minute, and adjusting the pH value of the mixed liquor to 6-7.5;
step four: if the gel is prepared, 1% carbomer is soaked in purified water for 10 hours, and is combined with the traditional Chinese medicine extract, and other steps are the same;
step five: making into liniment, spray, or gel by conventional method.
The external preparation is liniment, spray or gel.
Example two
1000ml externally used Chinese medicinal composition liniment containing nervonic acid for detumescence and analgesia
The formula is as follows:
36g of saffron, 36g of clematis root, 60g of corydalis tuber, 36g of teasel root, 36g of unprocessed radix aconiti, 30g of lycopodium clavatum, 30g of garden balsam stem, 45g of salvia miltiorrhiza, 19g of rhubarb, 20g of dried ginger, 12g of lithospermum, 5g of nervonic acid, 5g of vanillyl butyl ether, 10g of methyl salicylate, 60g of dimethyl sulfoxide, 60g of tween-8015 g, 50g of glycerol, 50g of propylene glycol, 10g of menthol and purified water for constant volume. Made into 1000 ml.
The preparation method comprises the following steps:
1. weighing 11 traditional Chinese medicines such as saffron and the like according to a ratio, and preparing a traditional Chinese medicine extracting solution, namely a mother solution according to the extraction method of the embodiment I;
2. dissolving nervonic acid with appropriate amount of ethanol, adding into the mother liquor under stirring, and stirring at a speed of 30 rpm;
3. sequentially weighing methyl salicylate, vanillyl butyl ether, dimethyl sulfoxide, tween-80, glycerol, propylene glycol and menthol, adding into the mother liquor, adding purified water to the total amount, stirring for 30 minutes at a stirring speed of 30 revolutions per minute. Adjusting the pH value of the mixed solution to 6-7.5;
4. introducing the mixed solution into a liquid filling machine, and making into liniment by conventional process.
EXAMPLE III
1000ml externally used traditional Chinese medicine composition spray containing nervonic acid for detumescence and analgesia and preparation method thereof
The formula is as follows:
18g of saffron, 18g of clematis root, 30g of corydalis tuber, 18g of teasel root, 18g of unprocessed radix aconiti, 15g of lycopodium clavatum, 15g of garden balsam stem, 23g of salvia miltiorrhiza, 10g of rhubarb, 10g of dried ginger, 10g of lithospermum, 3g of nervonic acid, 1g of vanillyl butyl ether, 5g of methyl salicylate, 20g of dimethyl sulfoxide, 807 g of tween-807, 25g of glycerol, 25g of propylene glycol and 5g of menthol, and purified water is added for constant volume to prepare 1000 ml.
The preparation method comprises the following steps:
1. weighing 11 traditional Chinese medicines such as saffron and the like according to a ratio, and preparing a traditional Chinese medicine extracting solution, namely a mother solution according to the extraction method of the embodiment I;
2. dissolving nervonic acid with appropriate amount of ethanol, adding into the mother liquor under stirring, and stirring at a speed of 30 rpm;
3. sequentially weighing methyl salicylate, vanillyl butyl ether, dimethyl sulfoxide, tween-80, glycerol, propylene glycol and menthol, adding into the mother liquor, adding purified water to the total amount, stirring for 30 minutes at a stirring speed of 30 revolutions per minute. Adjusting the pH value of the mixed solution to 6-7.5;
4. introducing the mixed solution into a liquid filling machine, and preparing into spray according to a conventional process.
Example four
1000ml preparation of externally used traditional Chinese medicine composition gel containing nervonic acid for detumescence and analgesia
The formula is as follows:
72g of saffron, 72g of clematis root, 120g of corydalis tuber, 72g of teasel root, 72g of unprocessed radix aconiti, 60g of lycopodium clavatum, 60g of garden balsam stem, 90g of salvia miltiorrhiza, 38g of rhubarb, 40g of dried ginger, 24 g of lithospermum, 10g of nervonic acid, 5g of vanillyl butyl ether, 20g of methyl salicylate, 120g of dimethyl sulfoxide, 8030 g of tween-8030, 100g of glycerol, 100g of propylene glycol, 20g of menthol, 10g of carbomer and purified water for fixing the volume, and the volume is prepared into 1000 ml.
The preparation method comprises the following steps:
1. weighing 11 traditional Chinese medicines such as saffron and the like in the formula, and preparing a traditional Chinese medicine extracting solution according to the extraction method in the embodiment I;
2. soaking carbomer in purified water for 10 hr, mixing the extractive solution with carbomer solution, and stirring;
3. dissolving nervonic acid with ethanol, adding into the liquid obtained in step 2 under stirring, and stirring at a speed of 30 rpm;
4. sequentially weighing methyl salicylate, vanillyl butyl ether, dimethyl sulfoxide, tween-80, glycerol, propylene glycol and menthol, adding into the mother liquor, adding purified water to the total amount, stirring for 30 minutes at a stirring speed of 30 revolutions per minute. Adjusting the pH value of the mixed solution to 6-7.5;
5. introducing the mixed solution into a gel filling machine, and preparing into gel according to a conventional process.
Comparative example 1
Comparative example one compared to example two, nervonic acid, vanillyl butyl ether, were removed from the formulation, and the rest was the same as in example two.
The formula is as follows:
36g of saffron, 36g of clematis root, 60g of corydalis tuber, 36g of teasel root, 36g of unprocessed radix aconiti, 30g of lycopodium clavatum, 30g of garden balsam stem, 45g of salvia miltiorrhiza, 19g of rhubarb, 20g of dried ginger, 12g of lithospermum, 10g of methyl salicylate, 60g of dimethyl sulfoxide, 8015 g of tween-glycerin, 50g of propylene glycol, 10g of menthol and purified water for constant volume. Made into 1000 ml.
The preparation method comprises the following steps:
1. weighing 11 traditional Chinese medicines such as saffron and the like in the formula, and preparing a traditional Chinese medicine extracting solution, namely a mother solution according to the extraction method in the embodiment I;
2. sequentially weighing methyl salicylate, dimethyl sulfoxide, tween-80, glycerol, propylene glycol and menthol, adding into the mother liquor, adding purified water to the total amount, stirring for 30 minutes at a stirring speed of 30 revolutions per minute. Adjusting the pH value of the mixed solution to 6-7.5;
3. introducing the mixed solution into a liquid filling machine, and making into liniment by conventional process.
Experimental example 1
The traditional Chinese medicine composition containing nervonic acid provided by the invention is an external preparation for relieving swelling and pain, in order to verify the curative effect of the prescription on patients, 260 cases are collected for treatment tracking record, and the experimental result is as follows:
tracking the object: the total number of people is 260, the age is 40-70 years, the sex is 185 men and 75 women, and the average course of disease is 5.5 years;
and (3) pain typing: according to the classification standard of the World Health Organization (WHO) pain, the pain is divided into 3 types, namely mild pain (I degree), moderate pain (II degree) and severe pain (III degree);
grouping patients: 100 mild pain (i), 80 moderate pain (ii), and 80 severe pain (iii);
the medication method comprises the following steps: the liniments of example two were used uniformly: mild pain (degree I) is treated 2-3 times a day with 8 hours intervals; moderate pain (II degree) 3-4 times per day with 4 hours intervals; severe pain (degree iii) is 5-6 times a day, each time with 3 hour intervals;
and (4) judging the standard:
the method has the following advantages: the symptom and physical sign are relieved and relieved compared with the symptom and physical sign before treatment;
the effect is shown: the symptom signs disappear completely;
and (4) invalidation: there was no change before and after the treatment of symptoms and signs.
The experimental results are as follows: the specific experimental effects are shown in table 1:
TABLE 1260 person treatment pain detumescence tracking follow-up visit experiment result
Figure 221813DEST_PATH_IMAGE001
As can be seen from Table 1, the treatment period for patients with mild pain (degree I) is 1-4 weeks, the effective rate reaches 100%, and the cure rate reaches 99%; for patients with moderate pain (degree II), the treatment period is 4-15 weeks, the effective rate reaches 98%, and the cure rate reaches 95%; for severe pain (III degree) patients, the treatment period is 15-35 weeks, the effective rate reaches 96%, and the cure rate reaches 91%. No adverse reactions were found in the follow-up visits.
Experimental example II typical cases
Case 1
"Wangzhi" in the Jilin city of Ying and maiden, age 68
Gonarthritis, with a disease course of 4 years, pain intermittently in the first place and lasting for nearly 1 year. The product is used for 4 times a day, the interval is 4 hours each time, the pain is relieved after 10 days, the pain of the knees is not relieved after one month, and the pain of the knee joints disappears after three months, so that the knee joint can move freely.
Case 2
Some certain benzyl herb, male, 72 years old, home in Shenbei Xin district of Shenyang city
Because of serious contusion of left leg and edema of leg in construction site accidents, the left leg is hard to endure and cannot fall asleep at night, the product of the invention is used for 5 times every day, and the swelling and pain are relieved twenty days later, and the work is done again after a half month.
Case 3
Congratulating a certain person, male, 49 years old, home in the stream lake region of Benxi City
Intractable knee arthritis, bilateral pain, limited movement, drug resistance generated by sealing, and no pain relieving effect, and doctors recommend knee replacement surgery. The product is used for 5 times a day, the pain of the knee joints on two sides is relieved after 25 days, the pain of the knee joints basically disappears after 60 days, and the patient can be completely recovered to work after four months.
Case 4
Zhang somewhere, woman, 45 years old, Danjiang Binjiang area
The pain of trigeminal nerve is severely painful when the patient is suffered from the pain and is torn, and the patient can not cure the pain after taking a lot of medicines, the product of the invention is introduced to be used 5 times a day, meanwhile, the nervonic acid granules produced by Shenyang medicine DaBiotechnology limited company are orally taken, the pain is relieved in 15 days, and the pain disappears after two months.
Case 5
Guan some time, male, 50 years old, home in the mountain area of Anshan City
After suffering from cervical spondylosis for 3 years, the cervical spondylosis is aggravated recently, arms are numb and dare not to turn back, the cervical spondylosis is relieved after 20 days by using the product of the invention every day, and the pain symptom completely disappears after 2 months.
Comparative example 1
In order to verify the actual effect of combining nervonic acid and vanillyl butyl ether on the detumescence and analgesia, an effect experiment is carried out on a formula product of a comparative example I, and compared with an experimental example I, the difference is that the experimental product does not contain nervonic acid and vanillyl butyl ether.
The traditional Chinese medicine composition without nervonic acid and vanillyl butyl ether is used for verifying an external preparation for relieving swelling and pain, 100 cases are collected for treatment tracking record, and the experimental results are as follows:
tracking the object: the total number of 100 people, the age is 42-75 years, the sex is male, 55 people and 45 people, and the average course of disease is 3.8 years;
and (3) pain typing: according to the classification standard of the World Health Organization (WHO) pain, the pain is divided into 3 types, namely mild pain (I degree), moderate pain (II degree) and severe pain (III degree);
grouping patients: 60 people with mild pain (degree I), 20 people with moderate pain (degree II), and 20 people with severe pain (degree III);
the medication method comprises the following steps: uniformly used comparative example one liniment: mild pain (degree I) is treated 2-3 times a day with 8 hours intervals; moderate pain (II degree) 3-4 times per day with 4 hours intervals; severe pain (IIID) was 5-6 times daily with 3 hour intervals.
And (4) judging the standard:
the method has the following advantages: the symptom sign is reduced and relieved compared with that before treatment;
the effect is shown: the symptom signs disappear completely;
and (4) invalidation: there was no change before and after the treatment of symptoms and signs.
The experimental results are as follows: the experimental effects are shown in table 2:
TABLE 2100 following-up test results for pain and swelling relief treatment
Figure 732429DEST_PATH_IMAGE002
As can be seen from the table 2, compared with the effect of the product containing nervonic acid and vanillyl butyl ether on the detumescence pain, the effective rate of mild pain (I degree) of the experimental product reaches 92% and the cure rate reaches 85% under the premise of the same pain formation and the same treatment period; for moderate pain (II degree) patients, the effective rate reaches 85 percent, and the cure rate reaches 75 percent; for severe pain (III degree) patients, the effective rate reaches 75 percent, and the cure rate reaches 70 percent. Compared with the first experimental example and the second experimental example, the first experimental example and the second experimental example have obvious difference on the effects of relieving swelling and pain, and particularly have larger difference on patients with moderate and severe pain (II degree and III degree). No adverse reactions were found in the follow-up visits.
Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that changes, modifications, substitutions and alterations can be made in these embodiments without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.

Claims (5)

1. A topical Chinese medicinal composition containing nervonic acid for detumescence and analgesia, which is characterized in that the composition is a topical preparation prepared from the nervonic acid composition, the Chinese medicinal composition and auxiliary materials, and comprises 18-72 parts of saffron, 18-72 parts of clematis root, 30-120 parts of corydalis tuber, 18-72 parts of teasel root, 18-72 parts of unprocessed radix aconiti, 15-60 parts of lycopodium clavatum, 15-60 parts of garden balsam stem, 23-90 parts of salvia miltiorrhiza and 10-38 parts of rhubarb by weight, 10-40 parts of dried ginger, 10-24 parts of lithospermum, 3-10 parts of nervonic acid, 5-20 parts of methyl salicylate, 1-10 parts of vanillyl butyl ether, 20-120 parts of dimethyl sulfoxide, 807-30 parts of tween-807, 25-100 parts of glycerol, 25-100 parts of propylene glycol, 5-20 parts of menthol and a proper amount of purified water; the traditional Chinese medicine composition comprises saffron, clematis root, corydalis tuber, teasel root, unprocessed radix aconiti, lycopodium clavatum, garden balsam stem, salvia miltiorrhiza, rhubarb, dried ginger and lithospermum, all traditional Chinese medicinal materials meet the requirements of Chinese pharmacopoeia (one part), the nervonic acid composition comprises nervonic acid and vanillyl butyl ether, the nervonic acid composition meets the requirements of related national standards, the auxiliary materials comprise but are not limited to methyl salicylate, dimethyl sulfoxide, tween-80, glycerol, propylene glycol, menthol, carbomer, hydroxyethyl cellulose and purified water, and all the auxiliary materials meet the requirements of related national standards.
2. The external preparation as set forth in claim 1, which comprises liniment, spray or gel.
3. The nervonic acid composition of claim 1, wherein: the nervonic acid and the vanillyl butyl ether are combined to be applied to the external product for reducing swelling and easing pain, and the external product has the effect of improving the curative effect of reducing swelling and easing pain.
4. The topical Chinese medicinal composition for decreasing swelling and easing pain containing nervonic acid as claimed in claim 1, wherein the preparation method comprises the following steps: step one, weighing 11 traditional Chinese medicines such as saffron and the like according to a ratio, removing impurities, crushing into 20 meshes, putting into a container, adding 75% ethanol with the weight 8-10 times of the weight of the medicinal materials, soaking for 30 days, then heating and refluxing for one time, extracting for 1 hour at the extraction temperature of 80 ℃, and recovering ethanol under reduced pressure to ensure that the ethanol content in the extracting solution reaches 38% to obtain a traditional Chinese medicine extracting solution mother solution; dissolving nervonic acid in a proper amount of ethanol, adding the dissolved nervonic acid into the mother solution while stirring, wherein the stirring speed is 30 revolutions per minute; step three, weighing methyl salicylate, vanillyl butyl ether, dimethyl sulfoxide, tween-80, glycerol, propylene glycol and menthol at one time, adding the weighed materials into mother liquor, adding purified water to the total amount, stirring for 30 minutes at a stirring speed of 30 revolutions per minute, and adjusting the pH value of the mixed liquor to 6-7.5; step four, if the gel is prepared, 1 percent of carbomer is taken and soaked in purified water for 10 hours, and is combined with the traditional Chinese medicine extracting solution, and other steps are the same; and step five, preparing the liniment, the spray and the gel according to the conventional process.
5. The external traditional Chinese medicine composition containing nervonic acid for detumescence and analgesia as claimed in claim 1, which is characterized in that: it is used in preparing medicine for treating soft tissue injury, osteoarthritis, rheumatism, rheumatoid arthritis, cervical spondylopathy, etc.
CN202210852437.2A 2022-07-21 2022-07-21 A topical Chinese medicinal composition containing nervonic acid for relieving swelling and pain, and its preparation method Pending CN115105580A (en)

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