Sports soothing cream as well as preparation method and application thereof

Abstract

The invention relates to a sports soothing composition, which comprises an aromatic plant extract, and the aromatic plant extract comprises the following components in parts by mass: 4-6 parts of peppermint essential oil, 3-5 parts of ginger essential oil, 0.05-0.2 part of saffron crocus essential oil, and 0.5-2 parts of myrrh essential oil. The exercise relieving composition can be prepared into a preparation for relieving delayed muscular soreness or fatigue, the preparation takes effect after cooling, the relieving effect is fast, no sensitization side effect exists, and the effect is better than that of similar products.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of biological medicine, in particular to a sports soothing paste for relieving delayed muscle soreness and a preparation method and application thereof. BACKGROUND

[0002] Delayed muscle soreness (DOMS) refers to a delayed pain phenomenon of muscle after intense exercise, which occurs 8-24 hours after exercise and lasts for 3-7 days. The symptom gradually worsens within 24 hours after exercise, reaches a peak at 48 hours, and then gradually subsides, disappearing after 5-7 days. It is accompanied by adverse reactions such as muscle soreness, muscle strength decline, and muscle stiffness. In physical training and military training, the most common is delayed muscle soreness, which refers to the discomfort and muscle soreness of the exercise site after high-volume training, especially sudden increase in intensity or new non-habitual exercise. Delayed muscle soreness seriously affects normal training and can also cause other injuries to the trainees. If the injury is not treated in time, the best treatment opportunity may be missed, leading to more serious injury or prolonged recovery time. The peak of delayed muscle soreness occurs around 24-48 hours after exercise, which means that the adverse effects of delayed muscle soreness on athletes are most severe during the 24-48 hour period after exercise. Therefore, it is of great significance to prepare a drug for relieving delayed muscle soreness, and it is of more practical significance to reduce the adverse effects during the 24-48 hour period in the prevention and treatment process.

[0003] In the field of traditional Chinese medicine, delayed muscle soreness is one of the common diseases in the department of bone trauma in traditional Chinese medicine. The basic pathogenesis is qi stagnation and blood stasis, and uncoordination of collaterals. The "Lingshu Benzheng" says: "The meridians are the channels for the movement of qi and blood, and the yin and yang, and the tendons and bones, and the joints are also benefited. It is clear that the tendons and meridians are the channels for blood, and if damaged by external force, the collaterals will be damaged. "Zabingyuanliu Xiyechong" says: "Falling, flashing and bruising, suddenly receiving the body, from the outside to the inside, qi and blood are injured, which is a disease", indicating that the pathological factors of acute tendon injury are qi stagnation and blood stasis. "Shengji Zonglu · Shouzhe E Xue Bushi San" says: "If the injury is caused by the movement of the meridians, the blood flow is not smooth, and the blood stasis is not dispersed, which causes swelling and pain. It explains that after the meridians are damaged, qi stagnation and blood stasis, blood stasis and obstruction of collaterals, causing swelling and pain. At the same time, "Shengji Zonglu · Shouzhe E Xue Bushi San" proposes: "Be careful when moving, be hit by things, tendon and bone injury, blood and qi stumble, or stay and accumulate blood stasis, swelling and pain, should be treated quickly. External application of muscle, internal application of tonifying and nourishing medicine, can complete the limbs", indicating that the treatment is mainly external application of medicine to eliminate blood stasis and swelling, and internal application of tonifying medicine to enhance the immune function of the human body.

[0004] Current methods for relieving delayed muscle soreness include taking anti-inflammatory drugs such as aspirin, flurbiprofen, etc.; taking vitamin C daily to prevent and alleviate muscle soreness; applying diclofenac diethylamine externally to relieve pain after soft tissue injury; taking appropriate protein nutritional supplements such as branched-chain amino acids, etc. to maintain muscle structure, reduce the symptoms of delayed muscle soreness, and promote physical function recovery; and using physiotherapy methods such as heat therapy, acupuncture therapy, massage therapy, and nerve electrical stimulation therapy. Chinese medicine treatment of acute soft tissue injury and muscle soreness often uses externally applied blood-activating and stasis-removing, swelling-relieving and pain-relieving drugs, and internally taken blood-activating, qi-flowing and pain-relieving, and tonifying drugs to achieve the effect of treating both symptoms and root causes, but the treatment effect still needs to be further improved. Herbal compound preparations have unique advantages and characteristics in the treatment of delayed muscle soreness, acute soft tissue injury, etc. due to the rapid absorption and metabolism of small molecules of aromatic plant extracts and the lack of dependence and addiction.

[0005] Therefore, it is of great significance to develop a Chinese medicine compound external preparation with clear mechanism, safety and effectiveness, and controllable quality for treating delayed muscle soreness. SUMMARY

[0006] To overcome at least one problem in the prior art, the present application provides a sports soothing cream prepared by a unique combination of aromatic plant extracts, which is a safe and effective, stable and controllable, simple and easy-to-use ointment with the effects of activating blood and removing stasis, swelling relief and pain relief.

[0007] To achieve the above-mentioned object, the present application adopts the following technical solutions:

[0008] The first aspect of the present application is to provide a sports soothing composition comprising aromatic plant extracts, the aromatic plant extracts comprising the following components in mass parts: 4-6 parts of peppermint essential oil, 3-5 parts of ginger essential oil, 0.05-0.2 parts of saffron essential oil, and 0.5-2 parts of myrrh essential oil. It can be understood that the combination and component ratio of the above-mentioned aromatic plant extracts have good sports soothing effect. It can be understood that the mass parts of the components can be, for example, 40-60 g of peppermint essential oil, 30-50 g of ginger essential oil, 0.5-2 g of saffron essential oil, and 5-20 g of myrrh essential oil.

[0009] Further, the aromatic plant extracts comprise the following components in mass parts: 5 parts of peppermint essential oil, 4 parts of ginger essential oil, 0.1 part of saffron essential oil, and 1 part of myrrh essential oil.

[0010] Further, the peppermint essential oil is peppermint essential oil.

[0011] Further, the sports soothing composition further comprises the following components in mass parts: 0.5-2 parts of menthol and 0.5-1 part of natural camphor.

[0012] In the present application, menthol, peppermint essential oil and natural camphor have the cooling and penetration promoting effect; ginger essential oil has the heating and transdermal absorption promoting effect, and through the matching, the components in the composition first pass through the skin barrier through the penetration promoting effect, and then are quickly absorbed through the skin through the heating effect, so that the rapid relieving effect is achieved.

[0013] The aromatic plant extract used in the present application has a long history of application in China, and the “aromatic opening” medicinal materials are first set in the Bencao Gangmu in the Ming Dynasty, and are classified into more than 70 families in the “Drug Pharmacology”, the volatile components are screened, the terpenoids in the pharmacological research of the volatile components are determined, including monoterpene, sesquiterpene and oxygen derivatives have the effects of antibacterial, anti-inflammatory and analgesia. The components in the aromatic plant extract used in the present application have the following effects, and the effect of motion relief is more obvious after the components are matched.

[0014] Saffron: also known as CROCUS SATIVUS, the flower of the Iris family, sweet, flat; heart, liver meridian, with the effect of activating blood and removing blood stasis, relieving depression and opening knot. Saffron is a medicine and food dual-purpose traditional Chinese medicinal material, which has the effects of activating blood and unblocking channels, removing blood stasis and relieving pain. The components in saffron essential oil have certain anti-inflammatory effect, which can reduce local inflammatory reaction. Some components in saffron essential oil can inhibit the release of neurotransmitters, thereby playing a role in analgesia. Saffron essential oil has the effects of antioxidant, improving microcirculation, lightening and calming, can promote local blood circulation, and help to relieve muscle tension and pain.

[0015] Myrrh: the dried resin of Commiphora myrrha Engl. or Commiphora molmol Engl. Myrrh is good for activating blood, and blood activation can stop pain, swelling and muscle growth, so it has the effects of analgesia, swelling and muscle growth, and can be used as a main medicine for trauma. Modern pharmacological studies have shown that it mainly contains volatile oil, resin, furan sesquiterpene compounds, and has the effects of removing blood stasis, relieving pain, swelling and muscle growth. Myrrh essential oil has the effects of anti-inflammatory, antioxidant, promoting wound healing and relieving pain.

[0016] Mint (Mentha haplocalyx): the leaf of Labiatae plant, which has the effects of dispelling wind-heat, clearing the head and eyes, benefiting the throat, promoting rash and dispersing the liver and qi. Modern pharmacological studies have shown that it also has the effects of analgesia, antipruritic, anti-stimulation and bactericidal. Peppermint essential oil has the effects of cooling analgesia and relieving muscle tension.

[0017] Ginger: ginger (Zingiber officinale) root oil, rhizome of Zingiberaceae plant, which has the effects of relieving superficies and dispelling cold, warming middle and stopping vomiting, resolving phlegm and relieving cough. Ginger essential oil has the effects of promoting blood circulation, anti-inflammatory and analgesic.

[0018] The second aspect of the present application provides a preparation prepared from the sports soothing composition of any one of the first aspect of the present application, which is prepared with pharmaceutically acceptable adjuvants as active ingredients. It can be understood that the above-mentioned pharmaceutically acceptable adjuvants are adaptively selected according to the specific dosage form required to be prepared, and the above-mentioned pharmaceutically acceptable adjuvants are all adjuvants commonly used in the art.

[0019] Further, the types of the preparation include ointments, tablets, emulsions.

[0020] Further, the preparation is a sports soothing ointment prepared with the sports soothing composition and ointment auxiliary ingredients.

[0021] Further, the ointment auxiliary ingredients include a base and a warming agent.

[0022] Further, the base is at least one of ethoxylated hydrogenated castor oil and polyethylene glycol, propylene glycol, carbomer 940, ethanol, phenoxyethanol / ethylhexylglycerin, sodium hydroxide and water, and the warming agent is vanillyl butyl ether.

[0023] In the present application, ethoxylated hydrogenated castor oil and polyethylene glycol serve as emulsifiers, cosolvents, and enhance the dispersibility of essential oils in the aqueous phase; vanillyl butyl ether is a warming agent, which provides local warming, promotes skin microcirculation, and helps to soothe and relax muscles; propylene glycol is a humectant and thickening agent, a solubilizer; carbomer 940 is a gel base thickening agent; ethanol is a penetration enhancer; phenoxyethanol / ethylhexylglycerin is a preservative, which has bacteriostatic efficacy.

[0024] Further, the sports soothing ointment includes the following components in mass parts: 4-6 parts of peppermint essential oil, 3-5 parts of ginger essential oil, 0.05-0.2 parts of saffron essential oil, 0.5-2 parts of myrrh essential oil, 0.5-2 parts of menthol, 0.5-1 part of natural camphor, 10-20 parts of ethoxylated hydrogenated castor oil and polyethylene glycol, 2-4 parts of vanillyl butyl ether, 20-30 parts of propylene glycol, 2.5-3 parts of carbomer 940, 40-60 parts of ethanol, 3-5 parts of phenoxyethanol / ethylhexylglycerin, 0.7-1 part of sodium hydroxide, and 350-400 parts of water.

[0025] Further, the motion soothing cream includes the following components by mass: 5 parts of peppermint essential oil, 4 parts of ginger essential oil, 0.1 part of saffron essential oil, 1 part of myrrh essential oil, 1 part of menthol, 0.75 part of natural camphor, 15 parts of ethoxylated hydrogenated castor oil and polyethylene glycol, 3 parts of eugenyl butyl ether, 25 parts of propylene glycol, 2.8 parts of carbomer 940, 50 parts of ethanol, 4 parts of phenoxyethanol / ethylhexylglycerin, 0.84 parts of sodium hydroxide, and 3875.1 parts of water (total amount).

[0026] Further, the cream auxiliary component further includes other additives, which include preservatives, cosolvents, emulsifiers, antioxidants, thickeners, and other additives commonly used in the art.

[0027] A third aspect of the present application is to provide a preparation method of a motion soothing cream, including the following steps:

[0028] S1, stirring and dissolving peppermint essential oil, ginger essential oil, saffron essential oil, myrrh essential oil, menthol, natural camphor, ethoxylated hydrogenated castor oil and polyethylene glycol, and eugenyl butyl ether;

[0029] S2, adding propylene glycol and stirring uniformly;

[0030] S3, adding water and stirring until transparent;

[0031] S4, after adding carbomer 940 and stirring to wet, performing homogenization and dispersion;

[0032] S5, adding ethanol and phenoxyethanol / ethylhexylglycerin and stirring uniformly;

[0033] S6, adding a solution of sodium hydroxide and stirring until smooth;

[0034] S7, after detecting that the PH value is qualified, discharging to obtain the preparation.

[0035] Further, the solution of sodium hydroxide is obtained by configuring sodium hydroxide and water. Specifically, 0.84 parts of sodium hydroxide and 7.56 parts of water are configured to obtain. 379.95 parts of water is used in S3.

[0036] Further, the preparation method specifically includes the following steps:

[0037] S01, stirring peppermint essential oil, ginger essential oil, saffron essential oil, myrrh essential oil, menthol, natural camphor, ethoxylated hydrogenated castor oil and polyethylene glycol, and eugenyl butyl ether until the solids are completely dissolved, with a stirring speed of 300 rpm and a stirring time of 30 min;

[0038] S02, adding propylene glycol and stirring uniformly, with a stirring speed of 400 rpm and a stirring time of 5 min;

[0039] S03, add water and stir until transparent, stirring speed 600 rpm, stirring time 10 min;

[0040] S04, add carbomer 940 and stir, stirring speed 600 rpm, stirring time 30 min, after complete wetting, homogenizer homogenization, homogenizer parameter 4000 rpm, homogenization time 10 min, until complete dispersion;

[0041] S05, add ethanol and phenoxyethanol / ethylhexylglycerin and stir until uniform, stirring speed 10 rpm, stirring time 5 min;

[0042] S06, add sodium hydroxide solution and stir until uniform and smooth, stirring speed 10 rpm, stirring time 30 min;

[0043] S07, after detecting the PH value of 5.9-6.6, discharge to obtain the preparation.

[0044] The fourth aspect of the present application is to provide the use of the above-mentioned sports soothing composition, preparation or sports soothing paste in the preparation of a preparation for relieving delayed muscle soreness or fatigue.

[0045] Compared with the prior art, the present application has the following beneficial effects by adopting the above technical solutions:

[0046] The sports soothing paste of the present application is compatible, and has the functions of activating blood, removing blood stasis, reducing swelling and relieving pain, so as to achieve the purpose of relieving blood stasis, swelling and muscle soreness, and is safe, non-toxic and side effect-free, simple in composition, and has better effect on relieving muscle soreness than diclofenac diethylamine. The above-mentioned sports soothing paste is good at treating blood stasis, muscle soreness or muscle fatigue caused by injury, and is suitable for relieving muscle soreness and soft tissue injury caused by physical training and military training. BRIEF DESCRIPTION OF DRAWINGS

[0047] In order to make the content of the present application more easily understood, the present application will be further described in detail below according to specific embodiments of the present application and in combination with the drawings, in which:

[0048] Figure 1 is the HE staining microscopic examination result graph of the formula screening in example 1 of the present application;

[0049] Figure 2 is the experimental result graph of the administration day and the whole test period of the administration group and the solvent control group animals in the skin administration toxicity test of SD rats in example 3 of the present application;

[0050] Figure 3 is the skin result graph of the administration site in the skin irritation test of rabbits in example 3 of the present application;

[0051] Figure 4is a guinea pig allergic test result graph in the embodiment 3 of the present application;

[0052] Figure 5 is a HE staining pathological result graph in the animal experiment effect verification in the embodiment 4 of the present application;

[0053] Figure 6 is a clinical investigation result analysis graph in the embodiment 4 of the present application. DETAILED DESCRIPTION

[0054] The technical solutions in the embodiments of the present application will be clearly and completely described in combination with the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative work belong to the scope of protection of the present application. The experimental methods not specified in the following embodiments are generally determined according to national standards. The experimental materials not specified in the following embodiments are all commercially available raw materials. The equipment used in each step in the following embodiments is conventional equipment. If there is no corresponding national standard, it is determined according to the general international standard, conventional conditions, or according to the conditions suggested by the manufacturer. Unless otherwise specified, all parts are by weight, and all percentages are mass percentages. Unless otherwise defined or specified, all professional and scientific terms used in the present application have the same meaning as those familiar to those skilled in the art. In addition, any method and material similar or equivalent to that described can be applied to the method of the present application.

[0055] It should be noted that the embodiments in the present application and the features in the embodiments can be combined with each other without conflict. The present application will be further described in combination with specific embodiments, but not as a limitation of the present application.

[0056] In some specific embodiments of the present application, a sports soothing composition is provided, which comprises an aromatic plant extract, the aromatic plant extract comprising the following components by mass fraction: 4-6 parts of peppermint essential oil, 3-5 parts of ginger essential oil, 0.05-0.2 parts of saffron essential oil, and 0.5-2 parts of myrrh essential oil. A sports soothing cream is provided, which comprises the following components by mass fraction: 4-6 parts of peppermint essential oil, 3-5 parts of ginger essential oil, 0.05-0.2 parts of saffron essential oil, 0.5-2 parts of myrrh essential oil, 0.5-2 parts of menthol, 0.5-1 part of natural camphor, 10-20 parts of ethoxylated hydrogenated castor oil and polyethylene glycol, 2-4 parts of eugenyl butyl ether, 20-30 parts of propylene glycol, 2.5-3 parts of carbomer 940, 40-60 parts of ethanol, 3-5 parts of phenoxyethanol / ethylhexylglycerin, 0.7-1 part of sodium hydroxide, and 350-400 parts of water.

[0057] In the following examples, ginger essential oil was purchased from Ei Zhen Trade (Shanghai) Co., Ltd., saffron essential oil was purchased from Mujiu Wild (Shanghai) Technology Co., Ltd., myrrh essential oil was purchased from Ningbo Youxi Trade Co., Ltd., German chamomile, ylang-ylang, and wintergreen essential oils were purchased from Nanyang Xuemaier Biological Technology Co., Ltd., mugwort essential oil was purchased from Shanghai Yuan Ye Biological, Italian helichrysum flower, yarrow, and frankincense essential oils were purchased from Doteri Co., Ltd., anhydrous ethanol, propylene glycol, and sodium hydroxide were purchased from National Pharmaceutical Group Chemical Reagent Co., Ltd., carbomer 940 was purchased from Shanghai Qianfei Chemical Co., Ltd., ALKAMULS CRH 40 was purchased from BASF China Co., Ltd., Sensehot was purchased from Nanjing Shengde Baibai Biological Technology Co., Ltd., menthol and natural camphor were purchased from Jiangxi Xinsen Natural Plant Oil Co., Ltd., HZ PRESERV PE910 was purchased from Shanghai Koin Industrial Co., Ltd., diclofenac diethylamine emulsion was purchased from Haleon CH SARL, all of which were commercially available products.

[0058] Example 1 - Screening of Formulas

[0059] This example provides the screening of the best sports soothing composition.

[0060] Formula 1: Italian helichrysum flower essential oil, German chamomile essential oil, yarrow essential oil, ylang-ylang essential oil, peppermint essential oil, wintergreen essential oil in a ratio of 3:2:1.75:0.25:1:0.5.

[0061] Formula 2: Mugwort essential oil, ginger essential oil, pepper essential oil, saffron essential oil, myrrh essential oil, frankincense essential oil, peppermint essential oil, German chamomile essential oil, yarrow essential oil in a ratio of 3:3:2:0.1:1:1:4:1:1.

[0062] Formula 3: Ginger essential oil, saffron essential oil, myrrh essential oil, frankincense essential oil, peppermint essential oil, yarrow essential oil in a ratio of 4:0.1:1:1:4:1.

[0063] Formula 4: Peppermint essential oil: ginger essential oil: saffron essential oil: myrrh essential oil in a ratio of 5:4:0.1:1.

[0064] The peppermint essential oil in the composition is obtained by steam distillation extraction process. The extraction process steps are as follows: fresh peppermint leaves are quickly washed with clean water, then the peppermint leaves are cut or crushed, 100 g of crushed peppermint is weighed, placed in a flask, mixed with 700 mL of water by shaking, and then a volatile oil measuring device and a reflux condenser are connected. Water is added to the upper end of the condenser to fill the scale part of the volatile oil measuring device, and when the overflow enters the flask, stop. Place in an electric heating jacket or use other suitable methods to heat slowly to boiling, and keep it at a low boil for about 5 hours, until the oil amount in the measuring device no longer increases, stop heating, and place for a while. Open the piston at the lower end of the measuring device, and slowly release the water until the oil layer reaches the 5 mm mark above the 0 line. Place for more than 1 hour, then open the piston to make the oil layer drop to the 0 line. Read the essential oil amount, and calculate the yield of the peppermint essential oil in the test sample (%). Collect the peppermint essential oil, dehydrate with anhydrous sodium sulfate, label, and store in a refrigerator for standby use. Essential oil yield (%) = essential oil mass (g) / peppermint leaf mass (g) x 100%.

[0065] A rat exercise injury model is constructed, and divided into a quiet control group, a model group, and a treatment group (respectively set as composition 1, composition 2, composition 3, and composition 4), with 8 rats in each group. After adaptive feeding, 3-day exercise treadmill adaptation training is performed (eliminate those who refuse to run or perform poorly), and modeling is performed after the adaptive training is completed. The treadmill is set at a slope of 16°, with the speed gradually increasing to 26 m / min, and lasting for 50 minutes. The stimulation method is to stimulate the tail with sound, light, or a brush to ensure the exercise intensity. Exhaustion is determined by multiple immobility, ineffective stimulation, accompanied by rapid breathing, limb weakness, or head hanging behavior. After modeling, continuous administration is performed for 3 days. Each composition is diluted to 1% with coconut oil as the base oil, and applied to the skin by the hind limb application method, 0.5 mL / day. After 3 days, the quadriceps muscle tissue is taken for pathological analysis. HE staining is used for microscopic examination to evaluate muscle fiber rupture, necrosis degree, and inflammatory cell infiltration, and the injury repair effects of different groups are compared.

[0066] Composition screening: the HE staining microscopic examination results show that Figure 1 After 3 days of continuous administration, compared with the model group, the inflammatory cell infiltration degree and cell gap of composition 1, composition 2, composition 3, and composition 4 are improved to a certain extent. Among them, the cell gap of composition 4 is significantly reduced, the inflammatory cell infiltration is significantly reduced, which is more significant than composition 1, composition 2, and composition 3, and the cell shape is more regular than the other three groups. It shows that composition 4 is better than the other three groups. The composition of composition 4 is simpler and more specific than the other three groups, with lower side effects. Moreover, peppermint, ginger, and saffron in composition 4 are both medicine and food, with higher safety.

[0067] Example 2 - Preparation of exercise soothing paste

[0068] The present example provides the composition of the best sports soothing composition (the sports soothing cream of the best composition in the following example experiments is the best composition in Table 1), which is shown as follows:

[0069] 5000g of sports soothing cream is prepared, and the raw materials are shown in Table 1 below:

[0070] Table 1 - Best composition of sports soothing composition

[0071]

[0072]

[0073] The present example prepares the sports soothing composition into a sports soothing cream, and the best preparation steps include:

[0074] (1) Add phase A to the main pot and stir until the solids are completely dissolved, with a stirring speed of 300 rpm and a stirring time of 30 min;

[0075] (2) Continue to add phase B in the above (1) and stir until uniform, with a stirring speed of 400 rpm and a stirring time of 5 min;

[0076] (3) Slowly add water to phase G while stirring in the above (2) until transparent, with a stirring speed of 600 rpm and a stirring time of 10 min;

[0077] (4) Continue to add phase C in the above (3), with a stirring speed of 600 rpm and a stirring time of 30 min, and then homogenize after completely wetting, with a homogenizer parameter of 4000 rpm and a homogenizing time of 10 min, until completely dispersed.

[0078] (5) Continue to add phases D and E in the above (4) and stir until uniform, with a stirring speed of 10 rpm and a stirring time of 5 min;

[0079] (6) Continue to add phase F in the above (5) and stir until the material is uniform and smooth, with a stirring speed of 10 rpm and a stirring time of 30 min.

[0080] (7) After detecting that the PH value is qualified (5.9-6.6), discharge.

[0081] In addition to the above optimal composition of the sports soothing composition, each component can ensure certain effects within a suitable proportion range. The sports soothing cream comprises the following components in mass parts: 4-6 parts of peppermint essential oil, 3-5 parts of ginger essential oil, 0.05-0.2 parts of saffron essential oil, 0.5-2 parts of myrrh essential oil, 0.5-2 parts of menthol, 0.5-1 part of natural camphor, 10-20 parts of ethoxylated hydrogenated castor oil and polyethylene glycol, 2-4 parts of eugenyl butyl ether, 20-30 parts of propylene glycol, 2.5-3 parts of carbomer 940, 40-60 parts of ethanol, 3-5 parts of phenoxyethanol / ethylhexylglycerin, 0.7-1 part of sodium hydroxide, and 350-400 parts of water. Specifically, the following Table 2 shows the raw material composition of the sports soothing cream (5000 g of the sports soothing cream is prepared, and the unit is mass g):

[0082] Table 2 - Composition of the sports soothing composition

[0083]

[0084]

[0085] The preparation method is the same as above.

[0086] Example 3 - Preclinical safety evaluation

[0087] The test was conducted by a third-party testing unit, the Drug Safety Evaluation Center of the Navy Medical University. It included SD rat skin administration toxicity test, rabbit skin irritation test, and guinea pig allergy test.

[0088] 1. SD rat skin administration toxicity test

[0089] The possible toxic reactions and death of SD rats caused by single skin administration of the sports soothing cream were observed. The test had a drug administration group and a solvent control group, each with 10 animals, half male and half female. The test product group was given the sports soothing cream, and the solvent control group was given the sports soothing cream base preparation, 1 g per animal. The animals were shaved in the administration area before the test. The left side was shaved (6 cm x 6 cm). During the test administration, the test product or control product was applied to the left side (3 cm x 3 cm). Body weight was recorded in the morning on the day of administration, and body weight was measured on d1, d7, and d14 after administration. The observation period was 14 days.

[0090] The results are shown in Table 2: Figure 2 No obvious abnormalities were observed in the animals of the drug administration group and the solvent control group on the day of administration and throughout the test period. During the test period, no animals in either group died, and there were no obvious changes in the appearance, behavior, activity, gait, spirit, excretion, and fur of the animals. No obvious abnormalities were observed in the skin administration sites of the drug administration group and the control group. The body weight of the animals in the drug administration group increased normally on d1, d7, and d14, and the growth rate was close to that of the solvent control group.

[0091] Conclusion: The single dose of the Qungongchuang Ointment has no obvious toxic effect on the SD rats.

[0092] 2. Skin irritation test in rabbits

[0093] The skin irritation of the Qungongchuang Ointment was observed in rabbits. 18 healthy rabbits were randomly divided into 3 groups according to the body weight, 6 in each group, half male and half female. The left side of the rabbits was smeared with the Qungongchuang Ointment (low dose group, 0.25 g per rabbit; middle dose group, 0.5 g per rabbit; high dose group, 1 g per rabbit), and the right side was smeared with the control product (Qungongchuang Ointment base preparation), as self-control. The animals were shaved on the administration area before the test, and the left and right sides were each shaved (10 cm x 10 cm). During the test, the test product was smeared on the left side, and the control product was smeared on the right side. The administration area was 4.5 cm x 5.5 cm. The observation time points for the single dose of skin irritation test were 30-60 minutes, 24 hours, 48 hours and 72 hours after the administration. The appearance, behavior and activity of the rabbits were observed every day, and the redness and edema of the administration site were observed. If moderate or severe irritation occurred at the end of the observation period, the administration site was dissected and the local histopathology was examined.

[0094] Table 3 - Evaluation of skin irritation intensity

[0095]

[0096] The results are shown in Table 3 and Figure 3 There were no obvious abnormalities in the appearance, behavior and activity of the rabbits in each dose group. No redness, edema, congestion or purulent exudation was observed on the left and right sides of the administration site.

[0097] Conclusion: The Qungongchuang Ointment has no obvious skin irritation in rabbits.

[0098] 3. Allergic test in guinea pigs

[0099] To observe the sensitization of the Yunduao ointment on guinea pigs. 40 healthy guinea pigs were randomly divided into 4 groups according to body weight: solvent control group, positive control group, medium-dose group, high-dose group, 10 in each group, half male and half female. The first stage is the sensitization period: on the left abdomen of guinea pigs, the high-dose group (1g per guinea pig), the medium-dose group (0.5g per guinea pig), the solvent control group was given (Yunduao ointment base preparation), and the positive control group was given 1% 2,4-dinitrochlorobenzene, 0.2mL / time, using transdermal application for administration, the test was performed 3 times on the 1st, 7th, and 14th days, and the skin redness, edema and other abnormal reactions were observed 1h and 24h after each administration. The second stage is the challenge period: on the right abdomen of guinea pigs, once challenged on the 14th day after the last administration of sensitization, the high-dose group was 1g per guinea pig, the medium-dose group was 0.5g per guinea pig, the solvent control group was given Yunduao ointment base preparation, and the positive control group was given 1% 2,4-dinitrochlorobenzene, 0.2mL / time. The skin redness, edema and other abnormal reactions were observed 24h and 48h later.

[0100] Table 4 - Incidence of allergic reactions in guinea pigs and results determination

[0101]

[0102] Results are shown in Table 4 and Figure 4 : No obvious redness and edema were observed in the high-dose group after challenge, the incidence of allergic reactions in the medium-dose and high-dose groups of Yunduao ointment and the solvent control group was 0%, and the incidence of allergic reactions in the positive control group was 100%.

[0103] Conclusion: Yunduao ointment has no sensitization effect on guinea pigs when administered transdermally.

[0104] The above safety experiment proves that the Yunduao ointment of the present embodiment has high safety using simple and safe components.

[0105] Example 4 - Efficacy verification of Yunduao ointment

[0106] This example verifies the effectiveness of the Yunduao ointment prepared in Example 2 in relieving delayed muscle soreness or fatigue.

[0107] 1. Animal experiment effect verification

[0108] (1) Experimental animals and grouping

[0109] A rat exercise injury model was constructed, and divided into a quiet control group, a model group, a treatment group (Yunduao ointment group), and a positive drug control group (diclofenac diethylamine group), 8 in each group. After adaptive feeding, 3 days of exercise treadmill adaptation training were performed (rejecting those who refused to run or performed poorly), and modeling was performed after the adaptation training was completed.

[0110] (2) Modeling

[0111] Treadmill setting: slope 16°, speed gradually increased to 26 m / min, lasting 50 minutes. Stimulation method: sound, light or brush stimulation of the tail to ensure the intensity of exercise. Exhaustion criteria: rats stopped moving several times, stimulation was ineffective, accompanied by rapid breathing, weakness of limbs or head hanging behavior. Drug administration and observation: after modeling, the treatment group and the positive drug control group were continuously smeared with drugs for 3 days, using the hind limb smearing method, 1 g / time, once a day, and the quadriceps muscle tissue was taken after three days for pathological analysis.

[0112] (3) HE staining microscopy

[0113] Assess the degree of muscle fiber rupture, necrosis and inflammatory cell infiltration, and compare the repair effects of different groups.

[0114] (4) Experimental results

[0115] 1) The HE staining pathological results are as follows Figure 5

[0116] Figure 5 The (a) figure in the figure is a representative HE staining microscopy of the quadriceps muscle section of SD rats after 3 days of continuous drug administration. Scale bar = 50 μm. (b) The figure is a quantitative analysis of the average cross-sectional area (CSA) of skeletal muscle fibers. Data represent the mean ± SEM from 8 independent rats (n = 8 in each group). According to one-way ANOVA, followed by Tukey HSD (Honestly Significant Difference) post-hoc test, * indicates significant difference, ** indicates extremely significant difference when P < 0.05.

[0117] As shown in Figure 5 (a), the HE staining microscopy results show that after 3 days of continuous drug administration, the cells in the control group (Control) are regular in shape, uniform in size, and closely arranged; the cells in the model group (model) are irregular in shape, have different sizes, and have increased intercellular gaps, with inflammatory cell infiltration (blue arrow); both the treatment group (Treatment) and the positive drug control group (Positive control) have improved, with reduced inflammatory cell infiltration, and the cell shape in both groups is more regular than that in the model group, and the intercellular gap in the treatment group is significantly reduced, better than that in the positive control group. As shown in Figure 5 (b), the treatment group significantly reduces the reduction of quadriceps muscle cross-sectional area, indicating that the treatment group has a good effect on improving muscle damage, and the effect is better than that of the positive control group.

[0118] 2 Verification of the effect of clinical trial

[0119] ​This example verifies the effect of the sports soothing cream prepared from the sports soothing composition in Example 2 in relieving delayed muscle soreness, and the experimental steps specifically include:

[0120] (1) Test method: subjects were enrolled, 60 cases of servicemen with discomfort and muscle soreness in the movement parts after basic unit military training were selected and randomly divided into three groups: blank control group, treatment group (sports soothing cream group), and positive drug control group (diclofenac diethylamine group). Cases with physical abnormalities that may affect objective evaluation were excluded. There were 20 male cases in each group, with an average age of 25±7 years. After heavy exercise training and sudden increase in intensity exercise (full squat jump as training exercise), discomfort and muscle soreness occurred in the movement parts.

[0121] (2) Treatment method: reasonable diet and rest exercise guidance were given to the three groups. Diclofenac diethylamine emulsion commonly used in the market was used as the positive control drug. After exercise, the treatment group and the positive drug control group used sports soothing cream or diclofenac diethylamine emulsion to gently rub the painful parts on this basis, so that the ointment penetrated the skin, and the ointment was used once every eight hours, with the same amount of ointment, three times a day.

[0122] (3) Observation index: the test time points were immediately after exercise 0h (before treatment), 24h after exercise (after treatment), and 48h after exercise (after treatment).

[0123] Blood index: serum creatine kinase CK, lactate dehydrogenase LD, IL-6 were determined by Beckman X20 automatic biochemical analyzer.

[0124] Pain level: subjective test was conducted by using the international public VAS visual analog pain scale, and the higher the score, the higher the pain level of the subject. During the experiment, the subjects needed to score according to their own pain level. Pain level subjective test process: the subjects in (1) were asked to complete five times of self-weighted deep squat at 0h immediately after exercise, 24h after exercise, and 48h after exercise, and score according to their own pain during deep squat.

[0125] (4) Statistical method

[0126] SPSS statistical software was used for data processing, and normality test and variance analysis were conducted on all data. All data were expressed as M±SD, and group comparison was conducted by using variance analysis of group design for statistical test. If the variance result showed P<0.05, it indicated that there was a significant difference between groups, and further Tukey HSD test was used for pairwise comparison. P<0.05 was considered to have statistical significance.

[0127] (5) Experimental results

[0128] 1) The detection results of blood indexes are shown in Tables 5 and 6:

[0129] Table 5 - Blood index test results (CK and LD)

[0130]

[0131] Table 6 - Blood index test results (IL-6)

[0132]

[0133]

[0134] In the above table, F: variance analysis statistics reflecting the difference between groups, the larger the value, the more significant the difference between groups;

[0135] P: P < 0.05 indicates that there is a statistically significant difference between groups, P > 0.05 indicates that there is no significant difference between groups;

[0136] The same column data marked with the same letter indicates that there is no significant difference (P > 0.05), and the different letters indicate that there is a significant difference (P < 0.05), and the same below.

[0137] From the above table, the CK, LD, and IL-6 levels (reflecting the inflammation of the subject's tissues) of the treatment group and the positive drug control group at 24h and 48h were significantly lower than those of the blank control group (P < 0.05), indicating that the exercise soothing cream and diclofenac diethylamine have good effects on CK, LD clearance, inflammation inhibition, and muscle recovery promotion. Compared with the positive drug control group, the CK, LD, and interleukin-6 reduction levels of the treatment group were lower than those of the positive drug control group, and there was a significant difference (P < 0.05), indicating that the treatment effect of the exercise soothing cream was better than that of diclofenac diethylamine.

[0138] 2) The detection results of the pain level are shown in the following table 7:

[0139] Table 7 - VAS visual analog pain scale score

[0140] Group Baseline Immediately after exercise 0h 24h after exercise 48h after exercise Blank control group 0±0.00 1.72±0.69 4.36 ± 1.41 a ]] 4.83 ± 1.26 a ]] Treatment group 0±0.00 1.46±0.49 2.07 ± 0.52 b ]] 2.96 ± 1.17 b ]] Positive drug control group 0±0.00 1.64±0.51 3.07 ± 1.25 c ]] 3.74 ± 0.96 c ]] F － 0.204 71.171 28.625 P － >0.05 <0.05 <0.05

[0141] From the above table, the VAS visual analog pain scale scores of the treatment group and the positive drug control group at 24h and 48h were reduced to a certain extent, and the VAS visual analog pain scale score of the treatment group was significantly lower than that of the other groups (P < 0.05). The visual analog scale score of the subjects in the treatment group was significantly better than that of the positive drug control group (P < 0.05) at 24h and 48h after exercise.

[0142] 3) Questionnaire survey

[0143] Select 60 cases of military training task heavy, often appear exercise discomfort, muscle soreness of officers and soldiers in the basic unit, distribute exercise soothing paste, use after training according to their own conditions. Exclude the condition that the body may affect the objective evaluation. Fill in the questionnaire after use. Summarize the questionnaire results.

[0144] The results show that ( Figure 6 ), exercise soothing paste use effect first cooling (promote penetration) and then heating (promote absorption), menthol, peppermint essential oil, natural camphor has cooling and promoting penetration; Ginger essential oil, safrole butyl ether has heating and promoting transdermal absorption, through the matching of the components in the composition first through the skin barrier by promoting penetration, and then through the heating effect to promote the rapid transdermal absorption of components, to achieve rapid soothing effect. The soothing effect is fast, and the side effect of sensitization is better than that of similar products.

[0145] The above describes the specific embodiments of the present application in detail, but it is only as an example, the present application is not limited to the above described specific embodiments. For those skilled in the art, any equivalent modification and substitution of the present application are also within the scope of the present application. Therefore, any equivalent transformation and modification without departing from the spirit and scope of the present application should be covered within the scope of the present application.​

Claims

1. A motion-relieving composition, characterized in that: The motion-relieving composition comprises an aromatic plant extract, which comprises the following components in parts by mass: 4 to 6 parts of peppermint essential oil, 3 to 5 parts of ginger essential oil, 0.05 to 0.2 parts of saffron essential oil, and 0.5 to 2 parts of myrrh essential oil.

2. The motion-relieving composition according to claim 1, characterized in that: The aromatic plant extract comprises the following components in parts by mass: 5 parts of peppermint essential oil, 4 parts of ginger essential oil, 0.1 parts of saffron essential oil, and 1 part of myrrh essential oil.

3. The motion-relieving composition according to claim 1, characterized in that: The motion-relieving composition further comprises the following components in parts by weight: 0.5 to 2 parts of menthol and 0.5 to 1 part of natural camphor.

4. A preparation prepared from the motion-relieving composition according to any one of claims 1 to 3, characterized in that: The preparation is prepared with the motion-relieving composition as an active ingredient and pharmaceutically acceptable excipients.

5. The preparation according to claim 4, characterized in that The types of the preparation include ointments, tablets, and emulsions; preferably, the preparation is a motion-relieving cream, which includes a motion-relieving composition and ointment auxiliary ingredients.

6. The preparation according to claim 5, characterized in that The auxiliary ingredients of the ointment include a matrix and a warming sensation imparting agent; preferably, the matrix is ​​ethoxylated hydrogenated castor oil and at least one of polyethylene glycol, propylene glycol, carbomer 940, ethanol, phenoxyethanol / ethylhexylglycerin, sodium hydroxide and water, and the warming sensation imparting agent is vanillyl butyl ether.

7. The preparation according to claim 5, characterized in that The sports relief cream includes the following components in parts by mass: 4-6 parts of peppermint essential oil, 3-5 parts of ginger essential oil, 0.05-0.2 parts of saffron essential oil, 0.5-2 parts of myrrh essential oil, 0.5-2 parts of menthol, 0.5-1 parts of natural camphor, 10-20 parts of ethoxylated hydrogenated castor oil and polyethylene glycol, 2-4 parts of vanillyl butyl ether, 20-30 parts of propylene glycol, 2.5-3 parts of carbomer 940, 40-60 parts of ethanol, 3-5 parts of phenoxyethanol / ethylhexylglycerin, 0.7-1 parts of sodium hydroxide, and 350-400 parts of water.

8. A method for preparing the preparation according to claim 6 or 7, comprising the following steps: S1. Stir and dissolve peppermint essential oil, ginger essential oil, saffron essential oil, myrrh essential oil, menthol, natural camphor, ethoxylated hydrogenated castor oil, polyethylene glycol and vanillyl butyl ether; S2. Add propylene glycol and stir evenly; S3. Add water and stir until transparent; S4. Add Carbomer 940, stir until moist, and then mix thoroughly to disperse. S5. Add ethanol and phenoxyethanol / ethylhexylglycerin and mix well; S6. Add sodium hydroxide solution and stir until the mixture is smooth and homogeneous; S7, discharging the material after the pH value is tested and qualified to obtain the preparation.

9. The preparation method according to claim 8, characterized in that The specific steps include: S01, stirring peppermint essential oil, ginger essential oil, saffron essential oil, myrrh essential oil, menthol, natural camphor, ethoxylated hydrogenated castor oil, polyethylene glycol, and vanillyl butyl ether until the solids are completely dissolved, at a stirring speed of 300 rpm and a stirring time of 30 min; S02, add propylene glycol and stir evenly, stirring speed 400 rpm, stirring time 5 min; S03, add water and stir until transparent, stirring speed 600 rpm, stirring time 10 min; S04, add Carbomer 940 and stir at a speed of 600 rpm for 30 min. After it is completely wetted, homogenize with a homogenizer at a speed of 4000 rpm for 10 min until it is completely dispersed; S05, add ethanol and phenoxyethanol / ethylhexylglycerin and stir evenly at a stirring speed of 10 rpm for 5 minutes; S06, add sodium hydroxide solution and stir until it is uniform and smooth, stirring speed 10 rpm, stirring time 30 min; S07. After detecting that the pH value is 5.9-6.6, the material is discharged to obtain the preparation.

10. Use of the motion-relieving composition according to any one of claims 1 to 3 or the preparation according to any one of claims 4 to 8 in the preparation of a preparation for relieving delayed onset muscle soreness or fatigue.

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