CN118436742A - Traditional Chinese medicine composition with sedative hypnotic and insomnia treatment effects and preparation method thereof - Google Patents
Traditional Chinese medicine composition with sedative hypnotic and insomnia treatment effects and preparation method thereof Download PDFInfo
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- CN118436742A CN118436742A CN202410647293.6A CN202410647293A CN118436742A CN 118436742 A CN118436742 A CN 118436742A CN 202410647293 A CN202410647293 A CN 202410647293A CN 118436742 A CN118436742 A CN 118436742A
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- traditional chinese
- chinese medicine
- jujube
- lily
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Classifications
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- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
The invention discloses a traditional Chinese medicine composition with sedative hypnotic and insomnia treatment effects and a preparation method thereof, and belongs to the technical field of traditional Chinese medicines, wherein the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in parts by weight: 10-30 parts of fried jujube kernel, 10-25 parts of jujube, 5-15 parts of liquorice, 5-15 parts of lucid ganoderma, 5-15 parts of longan pulp, 10-20 parts of lily, 10-20 parts of fingered citron, 10-30 parts of common yam rhizome, 10-20 parts of day lily and 5-15 parts of gastrodia elata. The invention can achieve the effects of calming heart and tranquilizing mind, clearing heart fire and relieving restlessness, nourishing yin and reducing fire, calming and hypnotizing, and treating insomnia, and has remarkable treatment effect on insomnia.
Description
Technical Field
The invention belongs to the technical field of traditional Chinese medicines, and in particular relates to a traditional Chinese medicine composition with sedative-hypnotic and insomnia treatment effects and a preparation method thereof.
Background
Insomnia refers to a neuropsychiatric disorder in which sleep onset or sleep maintenance is difficult under conditions of sufficient sleep time and appropriate environment, and causes daytime dysfunction, and is mainly manifested by sleep onset difficulty, frequent wakefulness, early wakefulness, and non-restorative sleep.
Currently, the sedative hypnotic drugs commonly used in clinic are still the main means for treating insomnia, and comprise benzodiazepines represented by diazepam and lorazepamClass and non-benzodiazepines represented by zaleplon and zopicloneThe same category is clinical conventional medicines. However, the sedative hypnotic drugs commonly used at present have side effects and medication safety problems of different degrees. BenzodiazepinesThe medicine has addiction and dependence after long-term use, and has side effects of somnolence, fine movement disorder, memory decline, etc. Non-benzodiazepinesAlthough the side effects of the medicament like memory disorder and rebound insomnia after medicament withdrawal are small, the medicament can also cause daytime dysfunction such as headache, dizziness, somnolence and the like, and the medicament resistance and the dependence are generated after long-term use.
The chemical drugs have therapeutic effects on single targets, so that the chemical drugs are difficult to interfere with the diseases as a whole, the recovery effect close to physiological sleep cannot be obtained, and the chemical drugs have great side effects. The Chinese herbal medicine compound has complex components and has the functions of overall regulation and treatment of multiple targets, multiple components and multiple channels. A large number of clinical demonstration researches show that the traditional Chinese medicine compound treatment can obtain the recovery effect which is closer to physiological sleep, improves the sleep quality and has less side effect. In recent years, the use of supplementary and alternative drugs for treating insomnia, typified by Chinese herbal medicines, has also been growing in western society, but it is difficult to obtain an ideal therapeutic effect due to lack of long-term clinical experience accumulation and theoretical guidance of traditional Chinese medicine. The traditional Chinese medicine dialectical theory and classical prescription have important advantages in the study of sleep regulation medicines.
The homology of medicine and food is an important concept of traditional Chinese medicine, and the close relationship between medicines and foods is emphasized. On the basis of traditional Chinese medicine differentiation, a list of traditional Chinese medicine food homologous traditional Chinese medicine compatibility formulas are selected, and on the basis of fully utilizing the overall regulation and control advantages of multiple targets of the traditional Chinese medicine compound, the safety and compliance of the medicine are further improved.
Disclosure of Invention
Based on the technical problems of the existing medicines, the inventor creatively prepares the medicinal and edible traditional Chinese medicines such as fried jujube kernels, chinese dates, liquorice, lucid ganoderma, longan pulp, lily, fingered citron, daylily, common yam rhizome, wheat and gastrodia tuber into a prescription through intensive study, and provides a traditional Chinese medicine composition with the effects of calming and hypnotizing and treating insomnia and a preparation method thereof. The invention is a safe, effective and definite-curative traditional Chinese medicine composition, and has the effects of sedative hypnotizing and treating insomnia.
In order to achieve the above purpose, the present invention adopts the following technical scheme:
According to a first aspect of the technical scheme, the invention provides a traditional Chinese medicine composition, which is prepared from the following traditional Chinese medicine raw materials in parts by weight: 10-30 parts of fried jujube kernel, 10-25 parts of jujube, 5-15 parts of liquorice, 5-15 parts of lucid ganoderma, 5-15 parts of longan pulp, 10-20 parts of lily, 10-20 parts of fingered citron, 10-30 parts of common yam rhizome, 10-20 parts of day lily and 5-15 parts of gastrodia elata.
Preferably, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in parts by weight: 15-25 parts of fried jujube kernel, 12-20 parts of jujube, 7-12 parts of liquorice, 7-12 parts of lucid ganoderma, 7-12 parts of longan pulp, 12-20 parts of lily, 12-20 parts of fingered citron, 15-25 parts of common yam rhizome, 12-20 parts of day lily and 7-12 parts of gastrodia elata.
Preferably, the traditional Chinese medicine raw materials in the traditional Chinese medicine composition comprise 20 mass ratio of fried jujube kernels, jujube, liquorice, lucid ganoderma, longan pulp, lily, fingered citron, common yam rhizome, daylily and gastrodia elata: 15:9:9:9:15:15:20:15:9.
According to a second aspect of the technical scheme of the invention, the preparation method of the traditional Chinese medicine composition comprises the following steps:
Step S1: weighing traditional Chinese medicine raw materials according to mass parts, wherein the traditional Chinese medicine raw materials comprise stir-fried jujube kernels, jujube, liquorice, lucid ganoderma, longan pulp, lily, fingered citron, huai wheat, daylily and gastrodia elata;
Step S2: according to the parts by weight, the traditional Chinese medicine crude drug obtained in the step S1 is heated by 5-30 times of water, and then the first extract and the medicine residue are obtained after reflux and filtration;
step S3: and (3) evaporating the first extract obtained in the step (S2) under reduced pressure to obtain a solid substance of the first extract for later use.
Preferably, in step S2, the water is 10 times the amount of the crude drug of the traditional Chinese medicine obtained in step S1.
Preferably, in step S2, the amount of water is 5-15 times that of the traditional Chinese medicine crude drug obtained in step S1, the traditional Chinese medicine crude drug soaked in water is heated to boil, and then reflux extraction is performed for 1-3 hours.
According to a third aspect of the present invention, there is provided a pharmaceutical formulation comprising a Chinese medicinal composition as described above and a pharmaceutically acceptable carrier, the formulation being any pharmaceutically acceptable formulation, including but not limited to oral formulations, injectable formulations, transdermal absorption formulations and the like.
Preferably, the pharmaceutical formulation dosage form is an oral formulation including, but not limited to, tablets, capsules, granules, pills, powders, pellets, syrups, oral solutions, oral suspensions.
In some embodiments, the pharmaceutical formulation is an injection formulation, including but not limited to, injection solutions, injection suspensions, injection emulsions, injection powders, and other pharmaceutically acceptable injection formulations.
According to a fourth aspect of the technical scheme of the invention, the invention provides application of the traditional Chinese medicine composition in preparing medicines for sedative hypnotizing and treating insomnia.
Compared with the prior art, the invention has the following beneficial technical effects:
1. The traditional Chinese medicine composition is a compound prescription formed by medicinal and edible traditional Chinese medicines such as fried jujube kernels, jujube, liquorice, lucid ganoderma, longan pulp, lily, fingered citron, huai wheat, gastrodia elata and day lily, and has the effects of treating insomnia, calming and hypnotizing. The stir-fried jujube kernel belongs to a heart-nourishing and nerve-soothing medicine, has sweet, sour and flat properties, is attributed to heart, liver and gall meridians, and has the effects of nourishing heart, benefiting liver, soothing nerves, arresting sweating and the like; can be used for treating palpitation and insomnia. The licorice has the effects of tonifying heart qi, tonifying qi and restoring pulse, and has mild property and good effect of harmonizing hundred medicines, and can be used with various cold-heat reinforcing and purging medicines to alleviate intensity or reduce toxic and side effects. Ganoderma has effects of invigorating qi, tranquilizing mind, strengthening body resistance, and consolidating constitution. The fingered citron has warm, sour, bitter and sweet taste, can enter liver and spleen channels, has the efficacy of soothing liver and regulating qi, and is suitable for symptoms such as hypochondriac pain, vexation and irritability, chest distress and discomfort, insomnia and the like caused by liver qi stagnation.
2. The composition has the effects of tranquilizing, hypnotizing and treating insomnia. Pharmacological researches of the system show that the traditional Chinese medicine composition has multiple effects of calming and hypnotizing and treating insomnia, and the whole formula combination of single medicinal materials in the formula has the best synergistic insomnia resisting effect, and the effect is superior to that of the extract of the single medicinal material and the extract of part of the single medicinal material combination.
3. The traditional Chinese medicine composition has the effects of sedative hypnotizing and treating insomnia, and the characteristics of good safety of medicinal and edible composition support the application of the traditional Chinese medicine composition in preventing the diseases, and has the potential value of health care of gateway forward movement, chronic disease management and promotion of national health.
4. The pharmaceutical preparation provided by the invention can be used for prolonging the extinction time of the eversion and the reflection of a mouse by cooperating with the sodium pentobarbital, shortening the extinction latency of the eversion and the reflection, has excellent sedative-hypnotic activity, and has the effects of sedative-hypnotic, and treating or preventing operation insomnia compared with chemical medicines.
Drawings
FIG. 1A is a graph showing the comparison of sleep latency time of mice using the inventive Chinese medicinal composition with each control drug.
FIG. 1B is a graph showing the duration of sleep in mice using a Chinese medicinal composition of the present invention in comparison to various control drugs.
FIG. 2 is a graph showing comparison of spontaneous activity distances of mice using the Chinese medicinal composition of the present invention and each control drug.
Fig. 3A is a graph comparing the total 24 hour sleep time of each control group with the use of the inventive Chinese medicinal composition.
FIG. 3B is a graph showing the total 24-hour sleep-wake time for each control group using a Chinese medicinal composition of the present invention.
FIG. 3C is a graph showing the average length of fragments of 24-hour sleep-wake states using the inventive Chinese medicinal composition in comparison with each control group.
FIG. 3D is a graph comparing the number of fragments in a 24-hour sleep-wake state using a traditional Chinese medicine composition of the present invention with each control group.
Fig. 4A is a graph comparing sleep latency of mice using the inventive composition with each control drug in PCPA induced insomnia experiments.
Fig. 4B is a graph comparing sleep duration of mice using the inventive composition with each control drug in PCPA induced insomnia experiments.
Detailed Description
In order to make the technical problems solved by the present invention, the technical scheme adopted and the obtained beneficial effects more clearly apparent, the present invention is further described in detail below with reference to specific embodiments. The specific embodiments described herein are for purposes of illustration only and are not to be construed as limiting the invention in any way. Unless otherwise defined, all terms used herein have the same meaning as commonly used in the art to which the invention pertains.
The following specific examples are provided to aid in the understanding of the present invention, but it should be understood that the examples and test examples set forth herein are intended to illustrate the invention and are not to be construed in any way as limiting the true scope of the invention as set forth in the claims.
The invention provides a traditional Chinese medicine composition with the effects of calming and hypnotizing and treating insomnia, and particularly relates to a traditional Chinese medicine composition with the effects of calming and hypnotizing and treating insomnia. The inventor creatively combines medicinal and edible traditional Chinese medicinal materials such as fried jujube kernels, jujube, liquorice, lucid ganoderma, longan pulp, lily, fingered citron, daylily, huai wheat and gastrodia elata into a prescription, and the prescription is called as a 'Baifulong jujube tranquillizing prescription'. The Baifulong jujube tranquillizing prescription can be used for prolonging the time of disappearance of the specular reflection of a mouse by cooperating with sodium pentobarbital, shortening the incubation period of disappearance of the specular reflection of the mouse, and has excellent sedative and hypnotic activity; it has effects of tranquilizing, hypnotizing, and treating or preventing insomnia due to high intensity operation.
The Baifulong jujube tranquillizing prescription has definite curative effect and high safety on insomnia, and the Baifulong jujube tranquillizing prescription of the traditional Chinese medicine composition also has sedative and hypnotic effects. The whole formula combination of the single medicinal materials in the formula has the optimal synergistic antidepressant effect, and is superior to the extract of the single medicinal materials and the extract of part of the single medicinal material combination.
The traditional Chinese medicine raw materials used in the Baifulong jujube nerve soothing prescription comprise fried jujube seeds, jujube, liquorice, lucid ganoderma, longan pulp, lily, fingered citron, huai wheat, day lily and gastrodia elata, wherein the fried jujube seeds, the jujube, the liquorice, the lucid ganoderma, the longan pulp, the lily, the fingered citron, the Huai wheat, the day lily and the gastrodia elata are all purchased from Beijing Tongshentang, diazepam is purchased from Shanghai Wanshen pharmaceutical Co, and ICR mice are purchased from St Bei Fu (Beijing) laboratory animal Co.
The traditional Chinese medicine composition of the Baifulong jujube tranquillizing prescription is prepared from the following traditional Chinese medicine raw materials in parts by mass: 10-30 parts of fried jujube kernel, 10-25 parts of jujube, 5-15 parts of liquorice, 5-15 parts of lucid ganoderma, 5-15 parts of longan pulp, 10-20 parts of lily, 10-20 parts of fingered citron, 10-30 parts of common yam rhizome, 10-20 parts of day lily and 5-15 parts of gastrodia elata. In the preferred embodiment, the traditional Chinese medicine composition of the Baifulong jujube nerve soothing prescription is prepared from the following traditional Chinese medicine raw materials in parts by mass: 15-25 parts of fried jujube kernel, 12-20 parts of jujube, 7-12 parts of liquorice, 7-12 parts of lucid ganoderma, 7-12 parts of longan pulp, 12-20 parts of lily, 12-20 parts of fingered citron, 15-25 parts of common yam rhizome, 12-20 parts of day lily and 7-12 parts of gastrodia elata. Further, the mass ratio of the stir-fried jujube kernels, the jujubes, the liquorice, the lucid ganoderma, the longan pulp, the lily, the fingered citron, the common yam rhizome, the wheat, the day lily and the gastrodia elata in the traditional Chinese medicine raw material medicines in the traditional Chinese medicine composition is 20:15:9:9:9:15:15:20:15:9, for example, the prescription of the Baifulong jujube tranquillizing prescription comprises the following medicinal materials in proportion: 20g of fried jujube kernel, 15g of jujube, 9g of liquorice, 9g of lucid ganoderma, 9g of longan pulp, 15g of lily, 15g of fingered citron, 20g of Huai wheat, 15g of day lily and 9g of gastrodia elata.
In another aspect, the invention provides a method for preparing the traditional Chinese medicine composition, which comprises the following steps:
Step S1: weighing traditional Chinese medicine raw materials according to mass parts, wherein the traditional Chinese medicine raw materials comprise stir-fried jujube kernels, jujube, liquorice, lucid ganoderma, longan pulp, lily, fingered citron, huai wheat, daylily and gastrodia elata;
Step S2: according to the parts by weight, the traditional Chinese medicine crude drug obtained in the step S1 is heated by 5-30 times of water, and then the first extract and the medicine residue are obtained after reflux and filtration;
step S3: and (3) evaporating the first extract obtained in the step (S2) under reduced pressure to obtain a solid substance of the first extract for later use.
Preferably, in step S2, water is 10 times the amount of the crude drug of the traditional Chinese medicine obtained in step S1, and reflux-extracting is performed for 2 hours.
Preferably, in step S2, the amount of water is 5-15 times that of the traditional Chinese medicine crude drug obtained in step S1, the traditional Chinese medicine crude drug soaked in water is heated to boil, and then reflux extraction is performed for 1-3 hours.
Further, the invention provides a pharmaceutical preparation which is prepared from the traditional Chinese medicine composition and a pharmaceutically acceptable carrier, wherein the dosage form is any pharmaceutically acceptable dosage form, including but not limited to oral preparations, injection preparations, transdermal absorption preparations and the like. The pharmaceutical preparation is in the form of oral preparation, including but not limited to tablets, capsules, granules, pills, powder, pellets, syrup, oral solution and oral suspension. In some embodiments, the pharmaceutical formulation is an injection formulation, including but not limited to, injection solutions, injection suspensions, injection emulsions, injection powders, and other pharmaceutically acceptable injection formulations. Further, the traditional Chinese medicine composition can be applied to sedative hypnotic and insomnia treatment.
The preparation method of the traditional Chinese medicine composition and the application example thereof are further described below with reference to specific examples.
The preparation method of the traditional Chinese medicine composition with the effects of sedative hypnotic and insomnia treatment comprises the following steps:
Step S1: weighing traditional Chinese medicine raw materials according to mass parts, wherein the traditional Chinese medicine raw materials comprise stir-fried jujube kernels, jujube, liquorice, lucid ganoderma, longan pulp, lily, fingered citron, huai wheat, daylily and gastrodia elata;
The traditional Chinese medicine raw materials are weighed according to the mass parts, namely 10-30 parts of fried jujube kernels, 10-25 parts of jujube, 5-15 parts of liquorice, 5-15 parts of lucid ganoderma, 5-15 parts of longan pulp, 10-20 parts of lily, 10-20 parts of fingered citron, 10-30 parts of Huai wheat, 10-20 parts of day lily and 5-15 parts of gastrodia elata.
In a preferred embodiment, the prescription of the passion fruit tranquillizing: 15-25 parts of fried jujube kernel, 12-20 parts of jujube, 7-12 parts of liquorice, 7-12 parts of lucid ganoderma, 7-12 parts of longan pulp, 12-20 parts of lily, 12-20 parts of fingered citron, 15-25 parts of common yam rhizome, 12-20 parts of day lily and 7-12 parts of gastrodia elata.
In the embodiment, 20g of fried jujube kernel, 15g of jujube, 9g of liquorice, 9g of lucid ganoderma, 9g of longan pulp, 15g of lily, 15g of fingered citron, 20g of common yam rhizome, 15g of day lily and 9g of gastrodia tuber.
The step comprises removing impurities in all traditional Chinese medicine raw materials, and preferably removing impurities by combining manual impurity removal and mechanical impurity removal. After removing impurities, cleaning the surface of the traditional Chinese medicine raw material medicine rapidly by clean room temperature clear water, preferably using flowing water flow for cleaning, or using a water gun with water pressure between 0.2MPa and 1.0MPa for blowing cleaning, preferably using a water gun with water pressure between 0.25MPa and 0.80MPa for blowing cleaning; experiments prove that the fried jujube kernels, the liquorice, the lucid ganoderma, the fingered citron, the day lily and the gastrodia elata are sprayed and cleaned by using a water gun with the water pressure of 0.50MPa, and the jujube, the longan pulp, the lily and the Huai wheat are sprayed and cleaned by using a water gun with the water pressure of 0.30 MPa.
The stir-fried jujube kernel is used for calming heart and tranquilizing mind, and fixing and arresting sweating, and the stir-fried jujube kernel Gan Suanqi is flat, has the characteristics of tonifying the inside and arresting the outside, and can tonify the blood and calm the mind, and arrest the deficiency sweat. The stir-fried jujube seeds are preferably fruits harvested in autumn, pulp is removed, the fruits are dried in the sun, jujube seeds are crushed, seeds are taken out, and the seeds are stir-fried for later use. The stir-fried jujube kernel is used for people with neurasthenia, deficiency of body, sweating, emaciation, weakness and emaciation. The use contraindication of stir-baked jujube kernel is that the use time is too long, and people's true qi can be leaked.
The jujube has the effects of replenishing blood, nourishing skin, tonifying spleen, nourishing stomach, calming heart, tranquilizing, nourishing liver, protecting liver, supplementing nutrition and the like. The liquorice is used for tonifying spleen and replenishing qi, and has certain conditioning effects on symptoms such as fatigue, weakness of spleen and stomach, palpitation, shortness of breath and the like; the licorice has the functions of eliminating phlegm and relieving cough, and is favorable for relieving cough and promoting sputum discharge. The ganoderma lucidum is preferably ganoderma lucidum grown in a forest, and the drug effect is highest; or growing Ganoderma lucidum at term planted in artificial greenhouse; ganoderma has effects of softening blood vessel, tranquilizing, and lowering blood pressure and sugar.
In the invention, the fried jujube kernel, the jujube, the licorice and the lucid ganoderma are used together, which is one of the innovation points of the invention. The Chinese date has the effects of replenishing blood, nourishing the face, tonifying spleen and nourishing stomach to make up the defect of the fried jujube kernel that the person leaks true qi, and the liquorice and the lucid ganoderma are compatible to achieve the effects of tranquilizing and allaying excitement and reducing blood sugar when the sugar of the Chinese date is excessively high.
The longan pulp is used for enriching blood and nourishing qi, eliminating fatigue and tranquilizing, so that the longan pulp can quickly supplement energy, restore energy and eliminate physical fatigue after human body is tired, and simultaneously eliminate symptoms of palpitation, insomnia and the like of a nervous system.
The lily can be used for clearing heart fire, relieving restlessness, calming heart and tranquilizing mind, and can be used for treating symptoms such as unresponsiveness of waste heat, absentmindedness, insomnia, dreaminess, mood depression, etc. The lily is rich in vitamins, has the effects of moistening dryness and clearing heat, and can relieve symptoms such as lung dryness, cough and the like. The bergamot has faint scent, mild medicine property, can enter four channels of lung, liver, spleen and stomach, is used for treating chest distress due to lung qi stagnation and spleen and stomach qi stagnation, and is matched with the common yam rhizome wheat, the day lily and the tall gastrodia tuber to achieve the effects of arresting sweating, suppressing sweating, tonifying qi, nourishing heart, removing heat, promoting diuresis, reducing blood pressure, particularly promoting diuresis, calming endogenous wind, relieving spasm, suppressing liver yang, dispelling wind and dredging collaterals, and the compatibility of the bergamot and the common yam rhizome can convert human body moisture into urine and promote excretion.
Step S2: the traditional Chinese medicine raw material obtained in the step S1 is soaked in 5-30 times of water in parts by weight, the soaked traditional Chinese medicine raw material is heated, and then reflux and filtration are carried out to obtain a first extract and dregs;
the step S2 further comprises a step S21 of cleaning the traditional Chinese medicine raw material medicine obtained in the step S1 by using clear water, and then placing the traditional Chinese medicine raw material medicine in a cooling room with the temperature of 18-25 ℃, and naturally cooling. The cooling room needs to be kept clean by ventilation.
In the preferred embodiment, the bulk clean Chinese medicine is crushed into small particles with a particle size of less than 1cm, preferably less than 0.5 cm. For example, licorice, ganoderma lucidum, lily, fingered citron, day lily and gastrodia elata are cut into small particles. The cut and mixed traditional Chinese medicine raw materials are mixed with 5-30 times of water, preferably distilled water or purified water. In another embodiment, the mixed traditional Chinese medicine raw materials are soaked in 7-15 times of water for 1-10 hours, preferably 3-5 hours.
Step S23, heating and boiling: after soaking, heating the soaked traditional Chinese medicine raw material mixture to boiling by using slow fire, and keeping boiling for 15-30 minutes, preferably 20 minutes; the mild fire temperature in this embodiment is preferably controlled to any temperature between 120 degrees celsius and 260 degrees celsius, and more preferably to any temperature between 150 degrees celsius and 180 degrees celsius. In a preferred embodiment, a slow fire at 160 degrees celsius is used.
Step S24, micro-boiling heating: then the heating temperature is reduced to keep the soaked traditional Chinese medicine raw material mixture at weak boiling for 15-30 minutes, and the slow fire heating temperature is preferably reduced to any temperature between 80-100 ℃; in a preferred embodiment, a slow fire heating at 90 degrees celsius, 95 degrees celsius, or 98 degrees celsius is used.
Step S25, reflux extraction: and separating the effective component substances to be extracted from the soaked traditional Chinese medicine raw material mixture by using a reflux extraction device. The reflux extraction device preferably employs a high temperature condensing reflux device.
Further, filtering the concentrated Chinese medicinal raw material mixture by adopting a Chinese medicinal liquid filter residue, and filtering the residue by adopting a Chinese medicinal liquid filter with any aperture or sieve mesh of 100-800 meshes; preferably, the residue is filtered by a Chinese medicinal liquid filter with a pore size of 300 mesh, 400 mesh or 500 mesh to obtain a first extract (i.e. filtrate) and residue.
Step S3: and (3) evaporating the first extract obtained in the step (S2) under reduced pressure to obtain a solid substance of the first extract for later use.
The reduced pressure drying in this example means that the first extract is placed in a reduced pressure drying system at a pressure of 0.5 to 0.8 normal atmospheric pressure, preferably 0.7 normal atmospheric pressure. Evaporating and drying the liquid first extract under reduced pressure to obtain solid substance of the first extract for later use.
The decompression drying system is the core equipment for decompression drying, and is mainly characterized in that the decompression drying system can control the change of pressure and temperature in a closed space so as to control the evaporation speed and the drying degree of the liquid first extract. The decompression drying system consists of a vacuum system, a heating system, a temperature sensor and the like. The vacuum pump is used for pumping out the gas in the closed space to form a low-pressure environment; the vacuum pump is preferably a mechanical vacuum pump, a rotary oil seal vacuum pump or a rotary dry vacuum pump.
The reduced pressure drying system further includes a low temperature condenser for receiving the evaporated moisture and condensing it into a liquid state to ensure a degree of dryness inside the reduced pressure drying system.
Embodiment two, it improves on the basis of embodiment one. The invention provides a preparation method of a traditional Chinese medicine composition of a Baifulong jujube tranquillizing prescription, which comprises the following step S2: and (2) heating, refluxing and filtering the traditional Chinese medicine raw material in the step (S1) with 5-15 times of water to obtain a first extract and dregs. Preferably, in some embodiments, the water is 10 times the amount in step S2. Preferably, in some embodiments, 5-15 times the amount of water in step S2 is heated to boiling. Preferably, in some embodiments, the reflux extraction in step S2 is carried out for 2 hours
The invention provides a pharmaceutical preparation prepared from a pharmaceutically acceptable carrier according to the first extract prepared by the preparation method of the traditional Chinese medicine composition, wherein the dosage form is any pharmaceutically acceptable dosage form, including but not limited to oral preparations, injection preparations, transdermal absorption preparations and the like.
In some embodiments, the pharmaceutical formulation is an oral formulation including, but not limited to, tablets, capsules, granules, pills, powders, pellets, syrups, oral solutions, oral suspensions.
In some embodiments, the pharmaceutical formulation is an injection formulation, including but not limited to, injection solutions, injection suspensions, injection emulsions, injection powders, and other pharmaceutically acceptable injection formulations. Further, the pharmaceutical preparation is applied to sedative hypnotic and insomnia treatment.
Embodiment three, which is an improvement over embodiment one. The invention provides a Baifulong jujube nerve soothing prescription, namely a traditional Chinese medicine composition with the effects of tranquilizing and hypnotizing and treating insomnia, which is prepared from fried jujube kernels, jujube, liquorice, lucid ganoderma, longan pulp, lily, fingered citron, huai wheat, daylily and gastrodia elata.
The preparation method comprises the following steps:
step S1: weighing 20g of fried jujube kernel, 15g of jujube, 9g of liquorice, 9g of lucid ganoderma, 9g of longan pulp, 15g of lily, 15g of fingered citron, 20g of common yam rhizome, 15g of day lily and 9g of tall gastrodia tuber according to the mass parts;
Step S2: heating and reflux-extracting the Chinese medicinal materials in the step S1 with 10 times of water for 2 hr, and filtering to obtain a first extract and residue.
Step S3: and (3) decompressing and evaporating the first extract in the step (S2) to dryness.
The preparation prepared from the traditional Chinese medicine composition with the effects of tranquilizing, hypnotizing and treating insomnia of the above-mentioned Baifulong jujube tranquillizing prescription is tested and verified in hypnosis, central inhibition and insomnia intervention effect on PCPA models.
Test example 1: hypnotic effect of traditional Chinese medicine extract:
1.1 experimental animals: ICR mice, male, SPF grade, 22-25g, purchased from St Bei Fu (Beijing) laboratory animals Co.
1.2 Test sample: the traditional Chinese medicine composition with the effects of calming and hypnotizing and treating insomnia is prepared according to the traditional Chinese medicine composition, extracts with corresponding quality are weighed according to the extraction rate and the medicinal material dosage, and physiological saline is added to prepare suspension for stomach irrigation.
1.3 Test method: mice were fed adaptively for one week after purchase, and were randomly divided into 4 groups according to body weight, 10 groups each, which were respectively a solvent control group (physiological saline), a positive control group (diazepam, 3 mg/kg), a low dose of the Chinese medicinal composition (in terms of crude drug mass, 5 g/kg), a medium dose of the Chinese medicinal composition (in terms of crude drug mass, 10 g/kg) and a high dose of the Chinese medicinal composition (in terms of crude drug mass, 20 g/kg). The administration method is as follows:
(1) The positive control group and the Chinese medicinal composition were respectively administered by intragastric administration for 5 consecutive days (20 ml/kg) 1 time a day. The solvent control group was given an equal volume of physiological saline by gavage.
(2) After the last gastric administration for 40min, each group was intraperitoneally injected with sodium pentobarbital (42 mg/kg,5 ml/kg), and the mice were placed in an independent space at about 25℃and the administration time was recorded.
(3) Observing the sleep state of the mouse, recording the vanishing time of the eversion and reflection, namely keeping the mouse in the supine position for 60 seconds without recovering, and looking the mouse to sleep; the recovery time of the normal inversion of the mice, namely that the mice with the normal inversion can recover spontaneously within 60 seconds, is recorded, and three times are continued, and the mice are regarded as the sleep end.
(4) The sleep latency period, which is the time of disappearance of the specular reflection-administration time, and the sleep time, which is the time of recovery of the specular reflection-time of disappearance of the specular reflection, were calculated separately.
1.4 Experimental results: see fig. 1A and 1B.
Fig. 1A is a graph showing comparison of sleep latency time of mice using the inventive composition with each control drug, and the results of fig. 1A specifically show: the positive drug diazepam significantly shortens the sleep latency (p < 0.001). The single gastric lavage administration of the medium-dose traditional Chinese medicine composition (10 g/kg) and the high-dose traditional Chinese medicine composition (20 g/kg) of the traditional Chinese medicine composition can shorten the sleep latency period induced by sodium pentobarbital, and has a significant difference (p is less than 0.01) compared with a solvent control group.
Fig. 1B is a graph showing the continuous comparison of sleep time of mice using the inventive composition with each control drug, and the results of fig. 1B specifically show: the positive drug diazepam can significantly prolong the sleep time of mice (p < 0.001). The single gastric lavage administration of 20g/kg of the traditional Chinese medicine composition also significantly improves the sleep duration of mice, and the difference compared with a solvent control group has statistical significance (p is less than 0.01).
The pentobarbital sodium synergetic hypnotic experiment is a classical experiment for verifying the sedative hypnotic effect of the medicine, and the fact that the first extract and the pentobarbital sodium are superior to the single pentobarbital sodium can prove that the extract of the traditional Chinese medicine composition has sedative hypnotic effect, and the synergistic effect of the pentobarbital sodium and the pentobarbital sodium can prolong the time for losing the specular reflection of mice. The result shows that the traditional Chinese medicine composition extract has definite sedative hypnotic effect.
Test example 2: the central inhibitory effect of the extract of the Chinese medicinal composition.
1.1 Experimental animals: ICR mice, male, SPF grade, 22-25g, purchased from St Bei Fu (Beijing) laboratory animals Co.
1.2 Test sample: the prepared traditional Chinese medicine composition extract is weighed according to the extraction rate and the medicinal material dosage, and physiological saline is added into the extract to prepare suspension for stomach irrigation. The diazepam is converted into the administration dosage of mice according to the clinical use dosage, and the solid with corresponding mass is weighed to prepare physiological saline solution for stomach irrigation.
1.3 Laboratory apparatus: open field experimental box.
1.4 Experimental method: mice were fed adaptively for one week after purchase, and were randomly divided into 3 groups according to body weight, 10 groups each, which were respectively a solvent control group (physiological saline), a positive control group (diazepam, 3 mg/kg), a low dose of the Chinese medicinal composition (in terms of crude drug mass, 5 g/kg), a medium dose of the Chinese medicinal composition (in terms of crude drug mass, 10 g/kg) and a high dose of the Chinese medicinal composition (in terms of crude drug mass, 20 g/kg). The treatment method comprises the following steps:
(1) The positive control group and the extract of the Chinese medicinal composition of the present invention were respectively administered with the corresponding medicines (20 ml/kg) by intragastric administration for 5 consecutive days 1 time a day. The solvent control group was given an equal volume of physiological saline by gavage.
(2) After the last gastric lavage administration for 40min, the mice were placed in a universal test box (50×50×40 cm) for spontaneous activity experiments, and after the mice were adapted for 5min, the test was started, and the spontaneous activity trace of the mice after 10min was analyzed. The total distance of spontaneous activities was analyzed by recording the trace of spontaneous activities of mice using DigBehv behavioral analysis system.
1.5 Experimental results: see fig. 2. Fig. 2 is a graph comparing spontaneous movement distances of mice using the inventive Chinese medicinal composition with each control drug.
The results show that compared with the solvent control group, the positive drug diazepam group has significantly reduced spontaneous activity total distance, and the difference has statistical significance (p < 0.001). The total distance of spontaneous activities of the high-dose group of the traditional Chinese medicine composition is also obviously reduced (p is less than 0.005).
The result shows that the extract of the traditional Chinese medicine composition has a central inhibition effect.
Test example 3: regulating function of traditional Chinese medicine composition extract on normal rat sleep
Experimental animals: SD rats, 8, male, SPF grade, 180-250 g, purchased from Fukang Biotechnology Co., ltd.
Experimental instrument: DSI wireless physiological signal acquisition system (Dataquest A.R.T.4.31), HD-S02 type small animal wireless physiological signal telemetering implant, neuroScore.1.1 brain electricity analysis software.
Sample to be tested: based on the experimental results, a high-dose traditional Chinese medicine composition (20 g/kg based on the mass of crude drugs) with remarkable action effect is selected as the preferred dose for the subsequent experiment. The prepared traditional Chinese medicine composition extract is prepared into extractum with corresponding concentration according to the extraction rate, and is used for stomach irrigation. The diazepam is converted into rat administration dosage according to clinical use dosage, and solid with corresponding mass is weighed to prepare physiological saline solution for stomach irrigation.
The experimental method comprises the following steps:
(1) Implant surgery
Animals were subjected to surgery by adaptive feeding for one week after purchase, and anesthetized rats were injected intraperitoneally with 3ml/kg of 10% chloral hydrate. Skin is prepared in the head and neck operation area, and after shaving, the skin is disinfected by using iodophor and alcohol cotton balls. The rat is placed on the brain stereotactic instrument operating table in the prone position, the position of the adapter is adjusted, and the head of the rat is fixed. The head skin was cut longitudinally, the length of the cut was 2cm, the skull was exposed, and periosteum was scraped off. Finding bregma points, marking the left and right positions of the points by a surgical knife at the positions of 2mm respectively, drilling a hole by a skull drill, stripping the front end wire sheath of the implant sub-lead to expose the metal lead, bending and then placing the lead under the skull without puncturing the dura mater, and recording the brain electrical activity. The implant body portion is placed subcutaneously in the back of the rat. After completion of the surgery, the wound was sutured, the rats were placed in a warm environment until awakening, and antibiotics were injected intraperitoneally one week continuously after the surgery.
(2) Administration and Signal acquisition
Rats were collected after one week post-operative recovery for sleep, spontaneous activity Baseline data as self-control (Baseline), and the next day was randomized into 2 groups of 4 animals each, with positive control (diazepam 3mg/kg, i.g.) and drug-food homolog (20 g/kg, i.g.). And after each group of drug administration, putting the groups back into the original feeding cage, and opening the implants to acquire brain electrical signals after 30min, wherein the duration is 24 hours. After the first electroencephalogram test is finished, the drug eluting period is 7 days, and one-time cross repeated measurement is carried out between groups.
(3) Electroencephalogram analysis
The brain electrical signals are scored for sleep in units of 10s using a NeuroScore.1.1 brain electrical analysis software default rodent sleep analysis module (Rodent sleep scoring model), and the raw signals are classified according to brain electrical characteristics, respectively as awake, active awake, non-rapid eye movement sleep, and rapid eye movement sleep.
Experimental results: see fig. 3A, 3B, 3C, 3D. Fig. 3A is a graph showing a comparison of total sleep time of 24 hours using the inventive composition and each control group, fig. 3B is a graph showing a comparison of total sleep-wake time of 24 hours using the inventive composition and each control group, fig. 3C is a graph showing a comparison of average length of fragments of a 24-hour sleep-wake state using the inventive composition and each control group, and fig. 3D is a graph showing a comparison of the number of fragments of a 24-hour sleep-wake state using the inventive composition and each control group.
Fig. 3A shows that the total sleep time of the traditional Chinese medicine composition is significantly different (p < 0.01) compared with the self-control, and the medicine and food homology formula can increase the total sleep time of rats.
Fig. 3B shows that the traditional Chinese medicine composition can significantly increase the non-rapid eye movement sleep period time (p < 0.01) of rats and inhibit the active awake time (p < 0.01). The result shows that the medicine and food homology prescription can increase the sleeping depth of rats, and the effect is equivalent to that of diazepam.
Fig. 3C shows that the extract of the medicinal and edible formula can significantly prolong the average duration of the non-rapid eye movement sleep stage segment and shorten the average duration of the active awake segment. In fig. 3D statistics of the number of fragments in sleep-wake states, the homology between medicine and food reduced the number of fragments of non-rapid eye movement sleep, with significant differences compared to the self-control (p < 0.05). The result shows that the medicine and food homologous formula reduces the number of slow wave sleep fragments while increasing the average duration of slow wave sleep, and improves the sleep continuity.
The result shows that the medicinal and edible formula extract can increase the sleep time and the sleep depth of rats at the brain electrical level, increase the number of non-rapid eye movement sleep stage fragments, prolong the duration of the non-rapid eye movement sleep stage fragments, reduce the activity degree and have the function of promoting sleep.
Test example 4: insomnia intervention effect of Chinese medicinal composition extract on PCPA model.
1.1 Experimental animals: ICR mice, male, SPF grade, 22-25g, purchased from St Bei Fu (Beijing) laboratory animals Co.
1.2 Test sample: the prepared traditional Chinese medicine composition extract is prepared by weighing the extractum with corresponding mass according to the extraction rate and the medicinal material dosage, and adding physiological saline to prepare suspension for stomach irrigation. The diazepam is converted into the administration dosage of mice according to the clinical use dosage, and the solid with corresponding mass is weighed to prepare physiological saline solution for stomach irrigation.
1.3 Experimental method: mice were fed adaptively for one week after purchase, and were randomly divided into 6 groups according to body weight, 10 groups each, respectively, a solvent control group (vehicle, physiological saline), a positive control group (diazepam, 3 mg/kg), a PCPA model group (400 mg/kg, i.p.), a low dose of the Chinese medicinal composition (in terms of crude drug mass, 5 g/kg), a medium dose of the Chinese medicinal composition (in terms of crude drug mass, 10 g/kg), and a high dose of the Chinese medicinal composition (in terms of crude drug mass, 20 g/kg). The administration method is as follows:
(1) The positive control group and the Chinese medicinal composition were each administered with the corresponding drug (20 ml/kg) by intragastric administration for 5 consecutive days, 1 time a day, and the solvent control group was administered with an equal volume of physiological saline by intragastric administration. Starting on the third day of self-administration, mice of each group were molded by intraperitoneal injection PCPA (400 mg/kg,10 ml/kg) for 3 consecutive days, with the exception of the solvent control group, which was administered an equal volume of physiological saline by intraperitoneal injection once a day.
(2) After each group was last lavaged for 40min, pentobarbital sodium (42 mg/kg,5 ml/kg) was intraperitoneally injected, and mice were placed in an independent space at about 25 ℃ and the administration time was recorded.
(3) Observing the sleep state of the mouse, recording the vanishing time of the eversion and reflection, namely keeping the mouse in the supine position for 60 seconds without recovering, and looking the mouse to sleep; the recovery time of the normal inversion of the mice, namely that the mice with the normal inversion can recover spontaneously within 60 seconds, is recorded, and three times are continued, and the mice are regarded as the sleep end. The sleep latency period, which is the time of disappearance of the specular reflection-administration time, and the sleep time, which is the time of recovery of the specular reflection-time of disappearance of the specular reflection, were calculated separately.
1.4 Experimental results: see fig. 4A and 4B. Fig. 4A is a graph comparing sleep latency of mice using the inventive composition with each control drug in PCPA-induced insomnia experiments, and fig. 4B is a graph comparing sleep duration of mice using the inventive composition with each control drug in PCPA-induced insomnia experiments.
The results of the PCPA induced insomnia experiment showed that mice in the PCPA model group had a trend of prolonged sleep latency (time to fall asleep) (fig. 4A) and significantly shortened sleep duration (fig. 4B) compared to the solvent control group. The positive drug diazepam and the medium-high dosage Chinese medicinal composition can obviously shorten the sleep latency of a model mouse, and have equivalent effect. The positive drug diazepam and the medium-high dosage Chinese medicinal composition can remarkably prolong the sleep duration of a model mouse.
The result shows that the traditional Chinese medicine composition extract can improve the insomnia of mice caused by PCPA.
Through the description of the technical scheme, the beneficial effects of the traditional Chinese medicine composition on sedative-hypnotic and insomnia treatment are further described. The invention combines the ideas of 'early disease prevention, disease prevention change and recovery prevention after disease recovery' of traditional Chinese medicine with the 'early discovery and early treatment' treatment principle of disease, is assisted in the traditional Chinese medicine to have the characteristics of multi-target and multi-system integral regulation, and is widely applied to the prevention and treatment of depression, anxiety and various fatigue.
The homology of medicine and food is a summary of the relation between medicine and food and application of the traditional Chinese medicine, since ancient times, the traditional Chinese medicine has the knowledge of 'medicine from food, tableware medicine function and medicine edibility', and the medical value of food is utilized for health care and disease prevention and treatment, namely 'diet care' and 'diet therapy'. The traditional Chinese medicine composition with homology of medicine and food is used for treating insomnia, and has remarkable advantages in medication safety and compliance compared with chemical medicines while the characteristics of multi-channel synergistic regulation and control of the traditional Chinese medicine compound are brought into play.
The concept of homology of medicine and food is deeply implemented through the formula, and the homology of medicine and food refers to the fact that the formula of the traditional Chinese medicine with homology of medicine and food can be used as medicines and foods, so that the potential safety hazard of long-term medication can be further reduced, and the compliance of patients is improved. The medicine and food homologous traditional Chinese medicine is a component for the development of healthy Chinese construction and large healthy industry, is a material foundation of human health community facing chronic diseases, and has important potential value in the aspect of chronic disease treatment.
The preferred embodiments of the present invention are described above in detail. However, the present invention is not limited to the specific details of the above embodiments, and various simple modifications may be made to the technical solution of the present invention within the scope of the technical concept of the present invention. These simple variants are all within the scope of protection of the present invention.
In addition, the respective specific features described in the above embodiments may be combined in any manner without contradiction. The various possible combinations of the invention are not described in detail in order to avoid unnecessary repetition. Moreover, any combination of the various embodiments of the invention may be made without departing from the spirit of the invention, which should also be considered as being disclosed herein.
Claims (10)
1. The traditional Chinese medicine composition is characterized by being prepared from the following traditional Chinese medicine raw materials in parts by weight: 10-30 parts of fried jujube kernel, 10-25 parts of jujube, 5-15 parts of liquorice, 5-15 parts of lucid ganoderma, 5-15 parts of longan pulp, 10-20 parts of lily, 10-20 parts of fingered citron, 10-30 parts of common yam rhizome, 10-20 parts of day lily and 5-15 parts of gastrodia elata.
2. The traditional Chinese medicine composition according to claim 1, which is characterized by being prepared from the following traditional Chinese medicine raw materials in parts by mass: 15-25 parts of fried jujube kernel, 12-20 parts of jujube, 7-12 parts of liquorice, 7-12 parts of lucid ganoderma, 7-12 parts of longan pulp, 12-20 parts of lily, 12-20 parts of fingered citron, 15-25 parts of common yam rhizome, 12-20 parts of day lily and 7-12 parts of gastrodia elata.
3. The traditional Chinese medicine composition according to claim 2, wherein the mass ratio of the stir-fried jujube kernels, the jujubes, the liquorice, the lucid ganoderma, the longan pulp, the lily, the fingered citron, the common wheat, the daylily and the gastrodia elata in the traditional Chinese medicine raw materials in the traditional Chinese medicine composition is 20:15:9:9:9:15:15:20:15:9.
4. A process for preparing the Chinese medicinal composition according to any one of claims 1 to 3, comprising the steps of:
Step S1: weighing traditional Chinese medicine raw materials according to mass parts, wherein the traditional Chinese medicine raw materials comprise stir-fried jujube kernels, jujube, liquorice, lucid ganoderma, longan pulp, lily, fingered citron, huai wheat, daylily and gastrodia elata;
Step S2: according to the parts by weight, the traditional Chinese medicine crude drug obtained in the step S1 is heated by 5-30 times of water, and then the first extract and the medicine residue are obtained after reflux and filtration;
step S3: and (3) evaporating the first extract obtained in the step (S2) under reduced pressure to obtain a solid substance of the first extract for later use.
5. The method according to claim 4, wherein in the step S2, water is 10 times of the amount of the crude drug of the traditional Chinese medicine obtained in the step S1.
6. The method according to claim 4, wherein in step S2, water is 5-15 times the amount of the crude drug of the traditional Chinese medicine obtained in step S1, the crude drug of the traditional Chinese medicine soaked in water is heated to boil, and then reflux extraction is performed for 2 hours.
7. A pharmaceutical formulation comprising the pharmaceutical composition of any one of claims 1-3 and a pharmaceutically acceptable carrier, wherein the formulation is any pharmaceutically acceptable formulation.
8. The pharmaceutical formulation of claim 7, wherein the dosage form is an oral formulation, an injectable formulation, or a transdermal formulation.
9. The pharmaceutical formulation of claim 7, wherein the pharmaceutical formulation is an oral formulation selected from the group consisting of tablets, capsules, granules, pills, powders, pellets, oral solutions, and oral suspensions.
10. Use of a Chinese medicinal composition according to any one of claims 1-3 in sedative hypnotic, insomnia treatment medicaments.
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