External compound oil for treating sleep disorders and preparation method thereof

Abstract

The application belongs to the technical field of traditional Chinese medicine prescription, and raw materials of the external compound oil include radix rehmanniae 15-30 parts, radix scrophulariae 9-20 parts, fructus gardeniae praeparatus 9-18 parts, calcined os calcis 12-30 parts, calcined concha mallei 12-30 parts, radix salviae miltiorrhizae 9-20 parts, fried zizyphi 15-30 parts, zhi gan cao 4-9 parts, and flos paris 3-9 parts. The application is simple and effective in treating sleep disorders through external application, reduces the damage of western medicine to liver and kidney of patients, reduces the damage to digestive tract, reduces the pain of patients in injection and medicine taking, reduces the time cost of patients, and avoids the allergy caused by adhesive tape. The compound oil obtained by placing the mixed raw materials in virgin olive oil and continuously shaking in a constant temperature shaking table for several days has simple preparation method and low cost. The raw materials used in the application are all from natural Chinese herbal medicine, which is convenient and low in price.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of traditional Chinese medicine prescription, and particularly relates to an external compound oil for treating sleep disorders and a preparation method. BACKGROUND

[0002] In recent years, sleep disorders have a trend of increasing year by year, and the use of sedatives and hypnotics has a large damage to liver and kidney and has drug resistance. Traditional Chinese medicine and acupuncture have certain curative effects on sleep disorders. For example, Chinese patent CN105878886A discloses a medicine for treating sleep disorders, which comprises 12-18 parts of Gastrodia elata, 27-33 parts of Asparagus cochinchinensis, 27-33 parts of Concha Murex, 27-33 parts of Fructus Evonymi, 27-33 parts of Cornus officinalis, 12-18 parts of Poria cocos, 27-33 parts of Polygonum multiflorum, 27-33 parts of Radix Rehmanniae, 7-12 parts of Polygala, and 4-9 parts of Glycyrrhiza. After the components are mixed, the mixture is decocted with water and taken. Most patients take the medicine for 16 doses or so and recover. However, the traditional Chinese medicine needs to be decocted, and the patients need to go to the hospital to take the medicine many times in a treatment course, need to go to the hospital at a specific time to take the medicine, or need to place the medicine decocted for a treatment course in a refrigerator. For example, Chinese patent CN109528919A discloses an insomnia patch for treating insomnia and a preparation method thereof, which comprises a traditional Chinese medicine plaster, non-woven fabric, a magnetic sheet and a release paper. The traditional Chinese medicine plaster is composed of 0.21 parts of each of amber, Jujube seed, Lily, Lotus seed, Cassia seed, Lignum Santali Alba, Lignum Aquilariae Resinatum, Cynanchum paniculatum, pearl powder, Dragon bone, Salvia miltiorrhiza, Albizia flower and Polygala and 0.21 parts of vinegar. The above traditional Chinese medicine needs to be pasted on the patient's body, and is not suitable for patients with sensitive skin and does not have wide applicability. SUMMARY

[0003] The application aims to provide an external compound oil for treating sleep disorders and a preparation method, which can simply and effectively treat sleep disorders through external application, reduce the damage of western medicine to liver and kidney and the damage to digestive tract, alleviate the pain of patients caused by injection and medicine taking, reduce the time cost of patients, and avoid the allergy of patients caused by adhesive tape.

[0004] In order to achieve the above-mentioned purpose, the application provides the following technical scheme.

[0005] The application provides an external compound oil for treating sleep disorders, which comprises the following raw materials in parts by weight: Radix Rehmanniae 15-30 parts, Scutellaria 9-20 parts, Fructus Gardeniae praeparatus 9-18 parts, Dragon bone 12-30 parts, Oyster shell 12-30 parts, Salvia miltiorrhiza 9-20 parts, Fried Jujube seed 15-30 parts, Baked Glycyrrhiza 4-9 parts, and Paris polyphylla 3-9 parts.

[0006] Further, its raw materials include by weight Rehmannia 17-28 parts, Scutellaria 11-18 parts, Fritillary 11-16 parts, calcined Dragon Bone 14-28 parts, calcined Oyster Shell 14-27 parts, Salvia 12-16 parts, fried Jujube seed 19-25 parts, baked Licorice 5-8 parts, Paris polyphylla 6-9 parts.

[0007] Further, by weight, the calcined Dragon Bone 18-25 parts, calcined Dragon Bone is the most sticky and astringent, with the ability to collect, can converge and stabilize the spirit, and astringe and stop leakage, and still has the ability to open in the convergence, has good heavy and stabilizing effect; with Oyster Shell, soft and hard and resolve, nourish Yin and suppress Yang.

[0008] Further, by weight, the calcined Oyster Shell 20-26 parts, the calcined Oyster Shell, liver Yang hyperactivity, salty and cold quality, liver meridian, has the effect of calming liver and suppressing Yang and benefiting Yin, water does not contain wood, Yin deficiency and Yang hyperactivity caused by dizziness, irritability, restlessness, tinnitus, combined with Dragon Bone, has good heavy and stabilizing effect.

[0009] Further, by weight, the fried Jujube seed 22-24 parts, fried Jujube seed has volatile oil such as four ring triterpenes and five ring triterpenes saponins, its main active ingredients, has the effect of calming the nerves and anti-anxiety.

[0010] Further, by weight, the baked Licorice 5-7 parts, has the effect of nourishing Yin, nourishing blood, benefiting Qi, tonifying Yang, restoring pulse and calming, during the oral administration of the disease, cold, sticky and other indigestible food, or irritating food such as chili, should be avoided, among them, especially pregnant and lactating women, old people with prostate hypertrophy and difficulty in urination, long-term alcoholics and people with alcohol addiction, people with unstable mood in daily life should not be taken, but through the baked Licorice and other raw materials of the present application are polished into powder and soaked in virgin olive oil, its effect does not change, during the application period, eating cold, sticky and other indigestible food, or irritating food such as chili has no effect on the therapeutic effect, pregnant and lactating women, old people with prostate hypertrophy and difficulty in urination, long-term alcoholics and people with alcohol addiction, people with unstable mood in daily life can also be applied for a certain period of time.

[0011] Further, by weight, Paris polyphylla 7-8 parts, Paris polyphylla has small toxicity, bitter and cold, enters the liver meridian, has the effect of clearing heat and resolving toxicity, cooling liver and calming shock, is suitable for shock and epilepsy, high fever and coma, etc.

[0012] In addition, Rehmannia: has the effect of nourishing Yin, generating fluid, clearing heat and cooling blood.

[0013] Scutellaria: has the effect of clearing heat and drying dampness, purging fire and resolving toxicity, stopping bleeding and stabilizing fetus.

[0014] Fritillary: has the effect of purging fire and relieving blood.

[0015] Salvia miltiorrhiza Bunge: has the effects of benefiting qi, promoting blood circulation, nourishing blood, dredging heart and pericardium, and stopping distress and fullness.

[0016] The application also provides a preparation method of the external use compound oil for treating sleep disorders, and the preparation method comprises the following steps:

[0017] (1) weighing the weight of each raw material of the external use compound oil;

[0018] (2) removing impurities and sterilizing the raw materials;

[0019] Preferably, the sterilization treatment can be performed by using microwave sterilization, steam sterilization or ozone sterilization on the raw materials;

[0020] (3) drying the raw materials;

[0021] (4) mixing according to the combined components and grinding into medium powder;

[0022] (5) sealing the ground mixed powder in a glass jar;

[0023] (6) pouring 300-400 ml of virgin olive oil into the glass jar, and continuously placing the glass jar in a constant temperature shaker for 12-15 days;

[0024] (7) after standing for 2-4 days, filtering out all the soaked oil;

[0025] (8) sub-packaging the soaked oil into glass bottles with graduated droppers, and waiting for use.

[0026] Further, the ground powder of the mixed raw materials passes through a 65 mesh sieve, but no more than 60% of the powder can pass through an 80 mesh sieve.

[0027] According to the 2010 edition of the Chinese Pharmacopoeia, the medium powder can pass through a No. 4 sieve, but is mixed with no more than 60% of the powder that can pass through a No. 5 sieve, and the specifications of the standard drug sieve No. 1-9 are as follows: No. 1 sieve: 10 mesh; No. 2 sieve: 24 mesh; No. 3 sieve: 50 mesh; No. 4 sieve: 65 mesh; No. 5 sieve: 80 mesh; No. 6 sieve: 100 mesh; No. 7 sieve: 120 mesh; No. 8 sieve: 150 mesh; and No. 9 sieve: 200 mesh.

[0028] Further, the temperature of the constant temperature shaker is kept at 25-35℃, the frequency is 180-220 revolutions per minute, and the shaker vibration is performed for 8-10 hours per day.

[0029] The three acupoint lines are smeared on the human body, the acupoint line 1 is located on the heart pericardium meridian, from the wrist horizontal line to the wrist horizontal line 3 inches, the smearing direction is from the wrist horizontal line upward, the acupoint line 2 is from the wind eye to the sleep inducing point, the smearing direction is from the wind eye to the sleep inducing point, and the acupoint line 3 is from the taixi point to the taixi point 3 inches, the smearing direction is from the taixi point upward, and there are two acupoint lines on the left and right sides, and a total of six acupoint lines, 1ml of traditional Chinese medicine oil is used for each acupoint line, and the smearing is performed back and forth for ten times, until the oil is absorbed, and each time is 15 minutes, including preparation time.

[0030] The calcined dragon bone, calcined oyster shell and fried jujube seed are astringent drugs, wherein the calcined dragon bone and calcined oyster shell have the effect of astringing and consolidating; the fried jujube seed has the effect of stopping sweating and calming the nerves, since the astringent drugs mainly enter the lung meridian or the large intestine meridian, the external use compound oil is smeared on the three acupoint lines of the human body, the acupoint and meridian are smeared, the external use compound oil is more easily absorbed, and the effect of calming the nerves and calming the nerves is achieved.

[0031] The present application has the following beneficial effects:

[0032] (1) The present application is simple and effective in treating sleep disorders by external application, and also reduces the damage of western medicine to the liver and kidney of the patient, the damage to the digestive tract, and the pain of the patient in receiving injections and taking medicine, reduces the time cost of the patient, and avoids the allergy caused by the adhesive tape of the patient;

[0033] (2) The compound oil obtained by placing the mixed raw materials in virgin olive oil in a constant temperature shaking bed and continuously shaking and standing for several days has the advantages of simple preparation method and low cost;

[0034] (3) The raw materials used in the present application are all derived from natural Chinese herbal medicines, which are convenient to obtain and low in price. DETAILED DESCRIPTION

[0035] The specific embodiments of the present application are described in detail below, and it should be pointed out that the examples are only specific descriptions of the present application, and should not be regarded as a limitation of the present application, the purpose of the examples is to enable those skilled in the art to better understand and reproduce the technical scheme of the present application, and the protection scope of the present application should still be limited by the scope defined in the claims.

[0036] Olive oil does not contain any artificial chemicals, its fatty acid composition and a variety of natural fat-soluble vitamins have very good moisturizing effect on the skin. Olive oil is rich in a variety of vitamins A, D, E, K: among them, vitamin A can moisturize dry skin and prevent skin wrinkles; Vitamin D can promote human metabolism, protect and strengthen skin elasticity, and prevent the formation of fine lines; Vitamin E can moisturize dry skin, and has the function of inhibiting sebaceous secretion and regulating skin state for oily skin, and can also promote blood circulation, decompose fat in the body, help hormone secretion, inhibit skin aging and elasticity decline; Vitamin K can make the skin have natural elasticity and absorb excess subcutaneous fat; Vitamin F can prevent cholesterol deposition, promote hair growth, help calcium absorption, treat heart disease, help weight loss, and prevent and treat acne. The latest research shows that the polyphenols contained in olive oil have antioxidant effect, which can effectively avoid the phenomenon of spots and wrinkles caused by cell aging due to oxidation of fat.

[0037] Example 1

[0038] The application provides a compound oil for treating sleep disorders, and raw materials of the compound oil include 15 parts of radix rehmanniae, 10 parts of radix scrophulariae, 10 parts of charred gardenia, 15 parts of calcined oyster shell, 15 parts of calcined oyster shell, 15 parts of salvia miltiorrhiza, 15 parts of fried zizyphus jujuba, 5 parts of licorice, and 5 parts of paris polyphylla.

[0039] The preparation method comprises the following steps:

[0040] (1) the weight of each raw material of the compound oil is weighed;

[0041] (2) the raw materials are impurity-removed and sterilized;

[0042] Preferably, the sterilization treatment can be performed by using microwave sterilization, steam sterilization or ozone sterilization on the raw materials;

[0043] (3) the raw materials are dried;

[0044] (4) the raw materials are mixed according to the combined components, and are ground into a powder;

[0045] (5) the ground mixed powder is sealed in a glass jar;

[0046] (6) 300 ml of virgin olive oil is poured into the glass jar, and is placed in a constant-temperature shaking bed for 15 days;

[0047] (7) after standing for 4 days, all the soaking oil is filtered out;

[0048] (8) the soaking oil is divided into glass bottles with graduated droppers and is ready for use.

[0049] Example 2

[0050] The application provides a compound oil for treating sleep disorders, wherein the raw materials of the compound oil include 15 parts of radix rehmanniae, 10 parts of radix scrophulariae, 15 parts of charred fructus gardeniae, 30 parts of calcined dragon bone, 30 parts of calcined concha murex, 10 parts of salvia miltiorrhiza, 20 parts of fried zizyphi semen praeparatum, 5 parts of licorice, and 5 parts of paris polyphylla.

[0051] The preparation method comprises the following steps:

[0052] (1) weighing the weight of each raw material of the compound oil for external use;

[0053] (2) removing impurities and sterilizing the raw materials;

[0054] Preferably, the sterilization treatment can be performed by using microwave sterilization, steam sterilization or ozone sterilization on the raw materials;

[0055] (3) drying the raw materials;

[0056] (4) mixing the combined components and grinding into medium powder;

[0057] (5) sealing the ground mixed powder in a glass jar;

[0058] (6) pouring 300 ml of virgin olive oil into the glass jar, and continuously placing the glass jar in a constant-temperature shaking bed for 15 days;

[0059] (7) after standing for 4 days, filtering out all the soaked oil;

[0060] (8) packaging the soaked oil into glass bottles with droppers with scales, and waiting for use.

[0061] Example 3

[0062] The application provides a compound oil for treating sleep disorders, wherein the raw materials of the compound oil include 10 parts of radix rehmanniae, 9 parts of radix scrophulariae, 9 parts of charred fructus gardeniae, 30 parts of calcined dragon bone, 30 parts of calcined concha murex, 15 parts of salvia miltiorrhiza, 20 parts of fried zizyphi semen praeparatum, 5 parts of licorice, and 5 parts of paris polyphylla.

[0063] The preparation method comprises the following steps:

[0064] (1) weighing the weight of each raw material of the compound oil for external use;

[0065] (2) removing impurities and sterilizing the raw materials;

[0066] Preferably, the sterilization treatment can be performed by using microwave sterilization, steam sterilization or ozone sterilization on the raw materials;

[0067] (3) drying the raw materials;

[0068] (4) mixing the combined components and grinding into medium powder;

[0069] (5) The ground mixed powder is sealed in a glass jar;

[0070] (6) 300 ml of virgin olive oil is poured into the glass jar, and is placed in a constant temperature shaker for 15 days continuously;

[0071] (7) After standing for 4 days, all the soaked oil is filtered out;

[0072] (8) The soaked oil is divided into glass bottles with graduated droppers and is ready for use.

[0073] Example 4

[0074] The application provides a compound oil for external use for treating sleep disorders, raw materials of the compound oil for external use including Rehmannia glutinosa 15 parts, Scutellaria baicalensis 9 parts, Fructus Gardeniae praeparatus 9 parts, Oyster shell calcined 20 parts, Oyster shell calcined 20 parts, Salvia miltiorrhiza 10 parts, Semen ziziphi spinosae 20 parts, Radix glycyrrhizae 5 parts, and Paris polyphylla 5 parts.

[0075] The preparation method comprises the following steps:

[0076] (1) The weights of the raw materials of the compound oil for external use are weighed;

[0077] (2) The raw materials are impurity-removed and sterilized;

[0078] Preferably, the sterilization treatment can be performed by using microwave sterilization, steam sterilization or ozone sterilization;

[0079] (3) The raw materials are dried;

[0080] (4) The raw materials are mixed according to the combined components and are ground into powder;

[0081] (5) The ground mixed powder is sealed in a glass jar;

[0082] (6) 300 ml of virgin olive oil is poured into the glass jar, and is placed in a constant temperature shaker for 15 days continuously;

[0083] (7) After standing for 4 days, all the soaked oil is filtered out;

[0084] (8) The soaked oil is divided into glass bottles with graduated droppers and is ready for use.

[0085] Example 5

[0086] The application provides a compound oil for external use for treating sleep disorders, raw materials of the compound oil for external use including Rehmannia glutinosa 15 parts, Scutellaria baicalensis 9 parts, Fructus Gardeniae praeparatus 9 parts, Oyster shell calcined 20 parts, Oyster shell calcined 20 parts, Salvia miltiorrhiza 15 parts, Semen ziziphi spinosae 15 parts, Radix glycyrrhizae 5 parts, and Paris polyphylla 5 parts.

[0087] The preparation method comprises the following steps:

[0088] (1) weighing the weight of each raw material of the external compound oil;

[0089] (2) removing impurities and sterilizing the raw materials;

[0090] Preferably, the sterilization treatment can be performed by microwave sterilization, steam sterilization or ozone sterilization on the raw materials;

[0091] (3) drying the raw materials;

[0092] (4) mixing according to the combined ingredients and grinding into medium powder;

[0093] (5) sealing the ground mixed powder in a glass jar;

[0094] (6) pouring 300 virgin olive oil into the glass jar and placing it in a constant temperature shaker for 15 consecutive days;

[0095] (7) after standing for 4 days, filtering out all the soaked oil;

[0096] (8) packaging the soaked oil into glass bottles with graduated droppers for use.

[0097] Example 6

[0098] The application provides an external compound oil for treating sleep disorders, and raw materials of the external compound oil include 10 parts of radix rehmanniae, 9 parts of radix scrophulariae, 9 parts of charred gardenia, 20 parts of calcined dragon bone, 30 parts of calcined oyster shell, 15 parts of salvia miltiorrhiza, 20 parts of fried zizyphus jujuba, 5 parts of licorice, and 5 parts of paris polyphylla.

[0099] The preparation method comprises:

[0100] (1) weighing the weight of each raw material of the external compound oil;

[0101] (2) removing impurities and sterilizing the raw materials;

[0102] Preferably, the sterilization treatment can be performed by microwave sterilization, steam sterilization or ozone sterilization on the raw materials;

[0103] (3) drying the raw materials;

[0104] (4) mixing according to the combined ingredients and grinding into medium powder;

[0105] (5) sealing the ground mixed powder in a glass jar;

[0106] (6) pouring 300 virgin olive oil into the glass jar and placing it in a constant temperature shaker for 15 consecutive days;

[0107] (7) after standing for 4 days, filtering out all the soaked oil;

[0108] (8) The soaked oil is divided into glass bottles with a graduated dropper and is ready for use.

[0109] Example 7

[0110] The present application provides a kind of external compound oil for treating sleep disorders, and the raw materials of the external compound oil include radix rehmanniae 15 parts, radix scrophulariae 9 parts, charred gardenia 9 parts, calcined dragon bone 12 parts, calcined oyster 12 parts, salvia miltiorrhiza 9 parts, fried jujube seed 15 parts, charred licorice 4 parts, seven leaf 3 parts.

[0111] The preparation method comprises:

[0112] (1) the weight of each raw material of the external compound oil is weighed;

[0113] (2) impurities and sterilization are carried out on the raw materials;

[0114] Preferably, the sterilization treatment can be carried out by microwave sterilization, steam sterilization or ozone sterilization on the raw materials;

[0115] (3) the raw materials are dried;

[0116] (4) the components are mixed according to the combination, and the powder is polished;

[0117] (5) the polished mixed powder is sealed in a glass jar;

[0118] (6) 300 virgin olive oil is poured into the glass jar, and is placed in a constant temperature shaking bed for 15 days;

[0119] (7) after standing for 4 days, all the soaked oil is filtered out;

[0120] (8) the soaked oil is divided into glass bottles with a graduated dropper and is ready for use.

[0121] Example 8

[0122] The present application provides a kind of external compound oil for treating sleep disorders, and the raw materials of the external compound oil include radix rehmanniae 15 parts, radix scrophulariae 9 parts, charred gardenia 9 parts, calcined dragon bone 12 parts, calcined oyster 12 parts, salvia miltiorrhiza 9 parts, fried jujube seed 15 parts, charred licorice 4 parts, seven leaf 3 parts.

[0123] The preparation method comprises:

[0124] (1) the weight of each raw material of the external compound oil is weighed;

[0125] (2) impurities and sterilization are carried out on the raw materials;

[0126] Preferably, the sterilization treatment can be carried out by microwave sterilization, steam sterilization or ozone sterilization on the raw materials;

[0127] (3) Dry the raw materials;

[0128] (4) Mix the ingredients and grind into a fine powder;

[0129] (5) Seal the ground mixture in a glass jar;

[0130] (6) Pour 300 ml of virgin olive oil into the glass jar and place it in a constant temperature shaker for 15 consecutive days;

[0131] (7) After 4 days of standing, filter out all the infused oil;

[0132] (8) Package the infused oil in glass bottles with graduated droppers and store for later use.

[0133] Experimental Example 1

[0134] At a certain clinic, 80 volunteers with sleep disorders were recruited, and the inclusion criteria were as follows: the volunteers were willing to accept treatment, fill out questionnaires, and cooperate with the investigation. The 80 volunteers were divided into 8 groups, with 10 volunteers in each group; and the external compound oil prepared by Example 1-Example 8 was applied respectively.

[0135] The prepared traditional Chinese medicine oil was applied on three meridian lines of the human body: Meridian Line 1 was located on the Hand Shu Yin Meridian, from the wrist horizontal line to 3 inches above the wrist horizontal line, and the application direction was from the wrist horizontal line upwards; Meridian Line 2 was from the Xifeng point to the Anmian point, and the application direction was from the Xifeng point to the Anmian point; Meridian Line 3 was from the Taixi point to 3 inches above the Taixi point, and the application direction was upwards from the Taixi point. There were two meridian lines on the left and right sides, a total of 6 meridian lines, 1 ml of traditional Chinese medicine oil for each meridian line, and the oil was absorbed after 10 times back and forth on each meridian line, including preparation time, each time for 15 minutes.

[0136] Observation Index

[0137] (1) Psychological fluctuation.

[0138] Judgment by sleep disorder rating scale (SDRS) score: the quantitative evaluation of treatment effect uses SDRS, which includes 10 items, each item scored 0-4 points, the higher the score, the more severe the sleep disorder, and the score range is 0-40. It is mainly used to evaluate the recent sleep status, so it is more suitable for comparing the curative effects before and after treatment.

[0139] (2) Sleep quality.

[0140] Pittsburgh sleep quality score (sleep efficiency, sleep time, sleep quality, sleep time) was used to evaluate the sleep quality of the three groups before and after treatment, the lower the score, the better the treatment effect, and the score > 7 points without pathological sleep disorder.

[0141] Efficacy:

[0142] ①Cure: Symptoms such as insomnia and awakening completely disappear;

[0143] ② Significantly effective: Symptoms are alleviated, with occasional insomnia and awakening, and sleep of more than 8 hours per day;

[0144] ③Effective: Symptoms improved, insomnia and frequent awakenings, less than 8 hours of sleep per day;

[0145] ④ Invalid: None of the above indicators are met;

[0146] Total effective rate = (cured + markedly effective + effective) / total number of cases × 100%.

[0147] Statistical analysis

[0148] The efficacy data are quantitative data using chi-square test, 80 volunteers are divided into 8 groups, 10 in each group; that is, group 1 smears the external use compound oil made in Example 1; that is, group 2 smears the external use compound oil made in Example 2; that is, group 3 smears the external use compound oil made in Example 3; that is, group 4 smears the external use compound oil made in Example 4; that is, group 5 smears the external use compound oil made in Example 5; that is, group 6 smears the external use compound oil made in Example 6; that is, group 7 smears the external use compound oil made in Example 7; that is, group 8 smears the external use compound oil made in Example 8; 8 groups of volunteers smeared Chinese medicine oil three times a week, ten times a course of treatment, smeared for 3 courses of treatment, and the data after 3 courses of treatment of each group were measured. The efficacy comparison data are shown in Table 1.

[0149] Table 1

[0150] Group Number of participants Cure Markedly effective Effective Ineffective Total effective rate Group 1 10 8 2 0 0 100％ Group 2 10 7 2 0 1 90％ Group 3 10 8 1 1 0 100％ Group 4 10 7 2 1 0 100％ Group 5 10 6 3 1 0 100％ Group 6 10 8 1 1 0 100％ Group 7 10 7 1 2 0 100％ Group 8 10 9 1 0 0 100％

[0151] result

[0152] According to the efficacy data in Table 1, the total effective rate of the external compound oil prepared by using Examples 1 and Examples 3-8 is 100%, and the total effective rate of the external compound oil prepared by using Example 2 is 90%. It can be seen that the present scheme has a significant effect on the treatment of sleep disorders as a whole. Among them, the external compound oil prepared by using Example 8, which includes 30 parts of raw rehmannia root, 20 parts of scutellaria baicalensis, 18 parts of scorched gardenia, 30 parts of calcined dragon bone, 30 parts of calcined oyster, 20 parts of salvia miltiorrhiza, 30 parts of stir-fried spiny jujube seeds, 9 parts of roasted liquorice root, and 9 parts of seven-leaf flos rubra, has the best effect, with 9 people cured and 1 person showing significant effect.

[0153] Experimental Example 2

[0154] In order to further illustrate the technical advancement of the present invention, an experimental comparison is now used to further illustrate it.

[0155] In a certain clinic, 117 volunteers with sleep disorders were recruited, and the inclusion criteria were as follows: volunteers willing to accept treatment, fill out questionnaires, and cooperate with the investigation. They were divided into acupuncture group, traditional Chinese medicine group, and observation group. The acupuncture group received acupuncture treatment, three times a week, and ten times a course; the traditional Chinese medicine group took traditional Chinese medicine, 28 days as a course; the observation group used this method to smear traditional Chinese medicine oil, three times a week, and ten times a course. The data were measured after 3 courses of treatment. The external compound oil used in the observation group was prepared from any one of Examples 1-8.

[0156] The treatment method of the observation group was to smear the prepared traditional Chinese medicine oil on three meridian lines of the human body: Meridian Line 1 was located on the Hand Shyin Meridian, from the wrist horizontal line to 3 inches above the wrist horizontal line, and the smearing direction was from the wrist horizontal line upwards; Meridian Line 2 was from the Nifeng Acupoint to the Anmian Acupoint, and the smearing direction was from the Nifeng Acupoint to the Anmian Acupoint; Meridian Line 3 was from the Taixi Acupoint to 3 inches above the Taixi Acupoint, and the smearing direction was upwards from the Taixi Acupoint. There were two on the left and two on the right, a total of six meridian lines, 1 ml of traditional Chinese medicine oil per meridian line, and ten times back and forth for each meridian line until the oil was absorbed. Including preparation time, each time was 15 minutes.

[0157] Exclusion criteria for volunteers:

[0158] ① Those with serious organic diseases;

[0159] ② Those with coagulation dysfunction and malignant tumors;

[0160] ③ Those who do not cooperate and have incomplete follow-up data.

[0161] Observation indicators

[0162] (1) Psychological fluctuations.

[0163] Determined by sleep disorder rating scale (SDRS) score: the quantitative evaluation of treatment effect uses SDRS, which includes 10 items, each item scored 0-4 points, the higher the score, the more severe the sleep disorder, the score range is 0-40. It is mainly used to evaluate the recent sleep status, so it is more suitable for comparing the efficacy before and after treatment.

[0164] (2) Sleep quality.

[0165] Pittsburgh sleep quality score (sleep efficiency, sleep time, sleep quality, sleep time) was used to evaluate the sleep quality of the three groups before and after treatment, and the lower the score, the better the treatment effect.

[0166] Adverse reactions:

[0167] The adverse reactions of each group during treatment were recorded, including dizziness, stomach pain, fatigue, palpitation, etc.

[0168] Efficacy:

[0169] ① Cure: insomnia and wakefulness symptoms completely disappeared;

[0170] ② Marked effect: symptoms were reduced, occasionally insomnia and wakefulness, more than 8 hours of sleep per day;

[0171] ③ Effective: symptoms improved, insomnia, wakefulness, less than 8 hours of sleep per day;

[0172] ④ Ineffective: the above indicators were not reached;

[0173] Total effective rate = (cure + marked effect + effective) / total number of cases x 100%.

[0174] Statistical analysis

[0175] Efficacy data for quantitative data using chi-square test, efficacy data as shown in Table 2.

[0176] Table 2

[0177] Group Number of participants Cure Markedly effective Effective Ineffective Total effective rate Acupuncture group 39 16 9 5 9 76.92％ Chinese medicine group 39 14 8 6 11 71.79％ Observation group 39 20 7 10 2 94.87% *▲ ]]

[0178] Note: * compared with acupuncture, χ2= 5.186, P = 0.023▲ compared with Chinese medicine group χ2= 7.477, P = 0.006 PSQI data before and after treatment data as shown in Table 3

[0179] Table 3

[0180]

[0181] PSQI data before and after treatment difference data as shown in Table 4

[0182] Group Number of participants Difference Acupuncture group 39 8.95±4.48 Chinese medicine group 39 7.82±4.30 Observation group 39 10.59±3.31

[0183] SDRS score before and after treatment data as shown in Table 5.

[0184] Table 5

[0185] Group Number of participants Before treatment After treatment t value P value Acupuncture group 39 25.67±3.99 16.72±3.49 12.464 0.000 Chinese medicine group 39 25.62±3.88 17.79±3.97 11.365 0.000 Observation group 39 24.10±3.93 13.51±4.49 20.001 0.000

[0186] SDRS score before and after treatment difference data as shown in Table 6;

[0187] Table 6

[0188]

[0189] Adverse reaction data for quantitative data using chi-square test, adverse reaction data as shown in Table 7;

[0190] Table 7

[0191] Group Number of participants Stomachache Weakness Palpitation Dizziness Total incidence Acupuncture group 39 1 3 2 2 8(20.5) Chinese medicine group 39 5 2 1 1 9(23.1) Observation group 39 0 2 0 0 2 (5.1) *▲ ]]>

[0192] Note: * Compared with acupuncture group, χ2=4.192, P=0.042▲Compared with traditional Chinese medicine group χ2=5.186, P=0.023Results

[0193] According to the efficacy data of Table 2, of the 39 people in the acupuncture group who participated in the treatment, 16 recovered, 9 showed significant effect, 5 were effective, and 9 were ineffective, with a total effective rate of 76.92%; of the 39 people in the traditional Chinese medicine group who participated in the treatment, 14 recovered, 8 showed significant effect, 6 were effective, and 11 were ineffective, with a total effective rate of 71.79%; of the 39 people in the observation group who participated in the treatment, 20 recovered, 7 showed significant effect, 10 were effective, and 2 were ineffective, with a total effective rate of 94.87%;

[0194] Among them, the number of people who recovered in the observation group was more than that in the acupuncture group and the traditional Chinese medicine group, and the number of people who were ineffective in the observation group was only 2, which was much lower than that in the acupuncture group and the traditional Chinese medicine group. The total effective rate of the observation group was 94.87%, which could be clearly seen that the external compound oil using the scheme was the best.

[0195] According to Table 3-4, the difference in PSQI data before and after treatment can be known. The difference in PSQI data before and after treatment in the acupuncture group was 8.95±4.48; the difference in PSQI data before and after treatment in the traditional Chinese medicine group was 7.82±4.30; the difference in PSQI data before and after treatment in the observation group was 10.59±3.31. The difference in PSQI data before and after treatment in the observation group was larger than that in the acupuncture group and the traditional Chinese medicine group.

[0196] According to Table 5-6, the SDRS score data before treatment was subjected to K-S normality test, and the P values of the acupuncture group, the traditional Chinese medicine group and the observation group were 0.520, 0.533 and 0.489 respectively, which basically conformed to the normal distribution; the paired t test was used for intragroup comparison; the independent sample t test was used for intergroup difference comparison.

[0197] According to the comparison data of SDRS score before and after treatment, the difference in SDRS score before and after treatment in the acupuncture group was 7.41±2.57; the difference in SDRS score before and after treatment in the traditional Chinese medicine group was 7.82±4.29; the difference in SDRS score before and after treatment in the observation group was 11.28±3.65. The decrease in score before and after treatment in the observation group was larger than that in the acupuncture group and the traditional Chinese medicine group.

[0198] According to the comparison data of Table 5, the incidence of adverse reactions in the acupuncture group was 80%, the incidence of adverse reactions in the traditional Chinese medicine group was 90%, and the incidence of adverse reactions in the observation group was 20%. The incidence of adverse reactions in the observation group was much lower than that in the acupuncture group and the traditional Chinese medicine group.

[0199] In summary, the sleep status of the patient is obviously improved by the present application, and the incidence of adverse reactions is low.

[0200] Case 1:

[0201] A woman, 50 years old, began to have difficulty falling asleep due to family disputes. She went to various hospitals for treatment and took estazolam, alprazolam, and diazepam, but the effect was not obvious. She then switched to traditional Chinese medicine, but she stopped taking it due to stomach pain and diarrhea. During the process, she experienced anxiety, restlessness, and excessive thinking. Physical examination showed poor spirit, dark yellow complexion, and a terrified look in her eyes. The tongue coating was thick and yellow, and the appetite was poor. She had no energy and was afraid of needles, so she refused acupuncture. She was then treated with traditional Chinese medicine essential oil acupoint massage. After one course of treatment, she could sleep for about 3 hours every night. She was advised to reduce the dosage of diazepam. After another course of treatment, she could sleep for about 5 hours every night. Her mental state improved, and she was satisfied with the treatment. She had a smile on her face, and she rarely took diazepam.

[0202] Case 2:

[0203] A man, 75 years old, was in good health before retirement and enjoyed sports. After retirement, he began to have difficulty falling asleep. He started climbing mountains with friends, and his sleep improved. However, he developed knee joint degenerative changes and pain after climbing mountains, so he stopped climbing. He then had difficulty falling asleep and was given diazepam by the community hospital. The medication was effective, but he was worried about the side effects and developed chest tightness. He stopped taking the medication and had difficulty falling asleep all night, accompanied by increased nocturia, which affected his daily life. He refused to take medication for his sleep disorder due to his underlying hypertension and coronary heart disease, which required him to take three medications daily. He was treated with traditional Chinese medicine acupoint smearing to relieve sleep disorders. After one course of treatment, he could sleep for about 4 hours every night. After three courses of treatment, he could sleep for about 5-6 hours every night, with 2-3 hours of deep sleep. He continued to take three courses of treatment every year, and his sleep status was maintained well. His chest tightness also improved significantly.

[0204] Although the preferred embodiments of the present application have been described, those skilled in the art can make additional changes and modifications to these embodiments once they understand the basic inventive concept. Therefore, the appended claims are intended to include the preferred embodiments and all changes and modifications falling within the scope of the present application.

Claims

1. An external compound oil for treating sleep disorders, characterized by, The raw medicinal materials are as follows in terms of weight parts: Rehmannia 15-30 parts, Scutellaria 9-20 parts, Fructus Gardeniae praeparatus 9-18 parts, Oyster Shell 12-30 parts, Salvia 9-20 parts, Zizyphus 15-30 parts, Licorice 4-9 parts, and Paris 3-9 parts.

2. The external compound oil for treating sleep disorders according to claim 1, characterized in that, The raw medicinal materials are as follows in terms of weight parts: Rehmannia 17-28 parts, Scutellaria 11-18 parts, Fructus Gardeniae praeparatus 11-16 parts, Oyster Shell 14-28 parts, Salvia 12-16 parts, Zizyphus 19-25 parts, Licorice 5-8 parts, and Paris 6-9 parts.

3. The external compound oil for treating sleep disorders according to claim 1, characterized in that, The Oyster Shell is 18-25 parts in terms of weight.

4. The external compound oil for treating sleep disorders according to claim 1, characterized in that, The Oyster Shell is 20-26 parts in terms of weight.

5. The external compound oil for treating sleep disorders according to claim 1, characterized in that, The Zizyphus is 22-24 parts in terms of weight.

6. The external compound oil for treating sleep disorders according to claim 1, characterized in that, The Licorice is 5-7 parts in terms of weight.

7. The external compound oil for treating sleep disorders according to claim 1, characterized in that, The Paris is 7-8 parts in terms of weight.

8. A method for preparing an external compound oil for treating sleep disorders, characterized by, The preparation method is used for preparing the external compound oil as claimed in any one of claims 1-7, and the preparation method comprises the following steps: (1) weighing each raw medicinal material of the external compound oil; (2) removing impurities and sterilizing the raw medicinal materials; (3) drying the raw medicinal materials; (4) mixing the combined ingredients and grinding into a powder; (5) sealing the ground mixed powder in a glass jar; (6) pouring 300-400 ml of virgin olive oil into the glass jar, and continuously placing the glass jar in a constant temperature shaker for 12-15 days; (7) after standing for 2-4 days, filtering out all the soaked oil; (8) sub-packaging the soaked oil into glass bottles with graduated droppers, and waiting for use.

9. The preparation method of the external compound oil for treating sleep disorders according to claim 8, characterized in that, The ground powder of the mixed raw medicinal materials passes through a 65-mesh sieve, but no more than 60% of the powder can pass through an 80-mesh sieve.

10. The method for preparing a topical compound oil for treating sleep disorders according to claim 8, characterized in that: The temperature of the constant temperature shaker is kept at 25-35℃, the frequency is 180-220 revolutions per minute, and the shaker vibrates for 8-10 hours per day.

Images