Traditional Chinese medicine composition and traditional Chinese medicine preparation for treating sub-health insomnia as well as preparation method and application of traditional Chinese medicine preparation

Abstract

The invention relates to the field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating sub-health insomnia, a traditional Chinese medicine preparation and a preparation method and application thereof. The traditional Chinese medicine composition inherits the overall syndrome differentiation concept of traditional Chinese medicine, and the treatment purpose is achieved by adjusting the functions of internal organs. Radix bupleuri is matched with radix scutellariae for soothing liver-qi stagnation and clearing away internal heat; radix curcumae and fingered citron are used as monarch drugs for promoting qi circulation, relieving depression and regulating qi activity; rhizoma atractylodis macrocephalae, radix fici simplicissimae and radix acanthopanacis semticosi have the effects of tonifying qi and spleen and strengthening middle Prepared fleece-flower root can tonify kidney and strengthen essence; rhizoma pinellinae praeparata can calm adverse-rising energy and guide yang qi to enter yin; the Huai wheat is used for nourishing heart and relieving restlessness and is used as a Semen ziziphi spinosae and poria with hostwood can calm heart, nourish blood Calamus is matched with polygala tenuifolia to relieve mental tranquility, induce resuscitation and And the raw nacre mother of pearl is used as an adjuvant drug. The honey-fried licorice root helps the Huai wheat and the jujube to nourish the heart and tranquilize the mind, can harmonize all the medicines, and is a conductant medicine. The liver-soothing, nerve-soothing and sleep-aiding formula is created for the first time based on the treatment principle of tonifying and applying functions and the treatment method of soothing liver-qi stagnation, nourishing blood and relieving restlessness and aiding sleep and tranquillizing.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition for treating sub-health insomnia, a traditional Chinese medicine preparation, and a preparation method and application thereof. Background Art

[0002] Sub-health is a state of low-quality life between health and disease. Its formation is the result of a combination of psychological, physiological, social and other factors. There are many clinical manifestations of sub-health, among which insomnia or sleep disorders are recognized as one of the most common main symptoms. Sub-health insomnia refers to the symptoms of primary insomnia in a sub-healthy state, mainly manifested as insufficient sleep quality and (or) quantity and decreased daytime function. According to international epidemiological studies: 27% of people worldwide have sleep quality problems. The adverse feelings and decreased daytime function brought by sub-health insomnia to patients have seriously affected their daily lives. Sub-health insomnia not only affects sleep, but also significantly increases the risk of developing severe diseases and psychiatric complications, and aggravates the changes in the patient's existing diseases. Studies have shown that insomnia and depression are closely related and positively correlated, and the various physical and mental diseases caused by depression are more complex and changeable, and the social harm caused is also greater.

[0003] According to traditional Chinese medicine, sub-health insomnia belongs to the category of "insomnia", and the overall pathogenesis is that yang is strong and yin is weak, and yin and yang are out of harmony; combined with modern people's lifestyle, eating habits and mental emotions, the cause of the disease lies in emotional frustration, unhealthy diet, and internal injuries caused by fatigue, involving organs including heart, liver, spleen, lungs and kidneys, especially heart, liver and spleen. From the perspective of pathogenic mechanism, modern people have huge mental pressure, many desires, emotional fire, and poor qi, which is the liver's fault, which is called yang excess; busy work, staying up late to work overtime, overwork the heart and blood, and consume the heart qi, which is the heart's fault; uncontrolled and irregular diet, liking to eat fatty and greasy food, stagnation in the middle jiao, spleen injury, and no way for qi and blood to be produced, which is the spleen's fault, and both are called yin decline; therefore, sub-health insomnia is caused.

[0004] Since modern medicine has only a few drugs and methods to treat insomnia, and the problem of drug addiction has been raised in recent years, the side effects of long-term drug treatment are more likely to cause damage to the heart, brain, liver and kidneys; therefore, the advantages of traditional Chinese medicine in terms of "simple, effective and cheap" and low or no side effects are more obvious. In traditional Chinese medicine, insomnia is classified as "insomnia", "cannot lie down" and "eyes are not clear". Insomnia means that the patient's sleep quality and sleep time are not satisfied. In mild cases, it is difficult to fall asleep, easy to wake up, wake up from sleep, sleep shallowly, and it is difficult to fall asleep again after waking up. There are many chaotic dreams. In severe cases, the whole night is sleepless. The causes of insomnia are mostly caused by improper diet, emotional frustration, work-rest imbalance, and physical weakness after illness. The fundamental pathogenesis is that yang is strong and yin is weak, and yin and yang are not connected. The treatment is mainly to reconcile the balance of yin and yang, so that the yin and yang of the human body intersect, and the sleep is normal when yin and yang are balanced. For sub-health insomnia, traditional Chinese medicine's idea of ​​"preventing before illness" actively prevents various diseases derived from insomnia; adjusting sleep is of great significance to reducing mental and psychological diseases such as depression and anxiety. However, there are not many prescriptions for sub-health insomnia treatment. Therefore, it is very necessary to find a safe and effective Chinese medicine preparation that can prevent sub-health insomnia before it happens, both for the diagnosis and treatment and prognosis of patients with sub-health insomnia. Summary of the invention

[0005] The purpose of the present invention is to provide a Chinese medicine composition, a Chinese medicine preparation and a preparation method and application thereof for treating sub-health insomnia, so as to solve the problems existing in the above-mentioned prior art. The Chinese medicine composition of the present invention can effectively treat sub-health insomnia, and the treatment effect is significant.

[0006] To achieve the above object, the present invention provides the following solutions:

[0007] The present invention provides a traditional Chinese medicine composition for treating sub-health insomnia, wherein the traditional Chinese medicine composition comprises the following components in parts by weight:

[0008] 12-18 parts of bupleurum, 7-13 parts of scutellaria, 12-18 parts of curcuma, 27-33 parts of quinquefolius, 7-13 parts of pinellia, 12-18 parts of atractylodes, 7-13 parts of ginger, 7-13 parts of jujube, 7-13 parts of roasted liquorice, 27-33 parts of Huai wheat, 12-18 parts of spiny jujube seeds, 17-23 parts of poria, 12-18 parts of polygala, 7-13 parts of calamus, 7-13 parts of citron, 17-23 parts of raw mother-of-pearl, 17-23 parts of acanthopanax, and 12-18 parts of processed polygonum multiflorum.

[0009] Further preferably, the Chinese medicine composition comprises the following components in parts by weight:

[0010] 15 parts of bupleurum, 10 parts of scutellaria, 15 parts of curcuma, 30 parts of quinquefolius, 10 parts of pinellia, 15 parts of atractylodes, 10 parts of ginger, 10 parts of jujube, 10 parts of roasted liquorice, 30 parts of Huai wheat, 15 parts of spiny jujube seeds, 20 parts of poria, 15 parts of polygala, 10 parts of calamus, 10 parts of citron, 20 parts of raw mother-of-pearl, 20 parts of acanthopanax, and 15 parts of processed polygonum multiflorum.

[0011] Further preferably, the calamus is Acorus calamus;

[0012] And / or, the Chinese jujube kernel is raw Chinese jujube kernel.

[0013] At the same time, the composition of the present invention has undergone the following replacements in clinical practice:

[0014] 1. Five-fingered peach is easy to be astragalus

[0015] Astragalus is the dried root of Astragalus mongolica or Astragalus membranaceus, a plant of the Leguminosae family. It is also known as Beiqi because it is abundant in the north. Astragalus is sweet and slightly warm in nature. It has the effects of replenishing qi and strengthening the exterior, diuresis and detoxification, pus discharge, sore astringent and tissue regeneration. Wuzhimaotao, also known as Wuzhaolong, is produced in the south and is also known as Nanqi. It is a plant of the genus Ficus in the genus Ficus of the Moraceae family, and its root is used as medicine. Wuzhimaotao is sweet and neutral in nature. It is a rare and excellent herbal medicine in Lingnan. It can replenish qi without causing fire, replenish qi without raising qi, strengthen the body without hindering evil, and can also eliminate phlegm and relieve asthma, eliminate dampness and promote qi, and relax muscles and activate collaterals. It is more suitable for the humid climate characteristics of Lingnan. In view of the fact that Lingnan is hot and humid, although Astragalus is stronger than Fructus quinquefolii in replenishing qi, it may cause the qi in the meridians to be too full and stagnant. Therefore, many southerners use Astragalus, which is easy to get angry and aggravate insomnia. Fructus quinquefolii can replenish qi and promote qi circulation at the same time, which is beneficial to the circulation of qi and blood in the meridians. It is especially suitable for patients who are weak and cannot be replenished, replenishing qi, promoting qi circulation, removing dampness and calming the mind. In the previous clinical process, the Fructus quinquefolii in the Chinese medicine composition provided by the present invention was replaced with Astragalus, and it was found that the effect was not good. Therefore, Fructus quinquefolii was used for subsequent research.

[0016] 2. Raw jujube kernels are easy to stir-fry

[0017] Raw sour jujube seeds have sedative and hypnotic effects, can help fall asleep, relieve tension, anxiety, depression, and relieve symptoms such as memory loss and neurasthenia; can also protect the myocardium, and total saponins of sour jujube seeds can significantly protect myocardial damage caused by hypoxia, sugar deficiency and chlorpromazine; enhance immunity, sour jujube seeds are rich in vitamin C, which can improve the body's antioxidant effect, and can also enhance the phagocytic function of macrophages, thereby enhancing the body's immunity. Fried sour jujube seeds are easy to heat after frying, and raw sour jujube seeds are more gentle than fried sour jujube seeds, which are more suitable for the damp and hot insomnia physique in Lingnan. The previous clinical process replaced the raw sour jujube seeds in the Chinese medicine composition provided by the present invention with fried sour jujube seeds, and found that the effect was not good. Therefore, raw sour jujube seeds were used for subsequent research.

[0018] 3. Buddha's hand and tangerine peel

[0019] Compared with dried tangerine peel, bergamot is better in soothing the liver and relieving depression, while dried tangerine peel is better in drying dampness and strengthening the stomach. "Reading Bencao" says: "Only those with stagnation of liver and spleen qi are suitable (bergamot), and those with insufficient yin and blood also dislike its dryness." Bergamot is one of the authentic medicinal materials in Guangdong, pungent, bitter, sour, and warm; it enters the liver, spleen, stomach, and lung meridians, and has the effects of soothing the liver and regulating qi, harmonizing the stomach and relieving pain, and drying dampness and resolving phlegm. Its soothing the liver and regulating qi is better than dried tangerine peel. Combined with the high life and work pressure of the people in Lingnan area, the proportion of people with insomnia caused by liver qi stagnation is large, so bergamot is selected to soothe the liver and promote qi, relieve depression and calm the mind. Dried tangerine peel tastes pungent, bitter, and warm in nature; it enters the spleen and lung meridians, can regulate qi and strengthen the spleen, and dry dampness and resolve phlegm. It is mainly used to treat spleen and stomach qi stagnation syndrome, vomiting, hiccups, wet phlegm, cold phlegm cough, and chest pain. The previous clinical process replaced the bergamot in the Chinese medicine composition provided by the present invention with dried tangerine peel, and it was found that the effect was not good. Therefore, bergamot was used for subsequent research.

[0020] 4. Huai wheat and easy-floating wheat

[0021] Huai wheat and floating wheat are both Chinese medicinal materials with sweet and cold properties, but their effects are different. Huai wheat has the effects of nourishing the heart and calming the mind, eliminating restlessness and stopping sweating, and is mainly used to treat symptoms such as palpitations, insomnia, night sweats, and spontaneous sweating. Floating wheat has the effects of strengthening the exterior and stopping sweating, invigorating qi, and stopping diarrhea, and is mainly used to treat symptoms such as night sweats, spontaneous sweating, and diarrhea. The two focus on treating different diseases, so Huai wheat is selected to nourish the heart and calm the mind. In the previous clinical process, the Huai wheat in the Chinese medicine composition provided by the present invention was replaced with floating wheat, and its therapeutic effect was also not significant. Therefore, Huai wheat was used for subsequent studies.

[0022] Since ancient times, ginger and jujube have been inseparable. Although ginger and jujube are ordinary things in daily life, they are widely used in traditional Chinese medicine prescriptions. This is fully reflected in "Treatise on Febrile Diseases" and "Golden Chamber". "Compendium of Materia Medica" says: Ginger is used to protect the body, and jujube is used to nourish the body, but it can only treat the deficiency in the solid and the deficiency in the deficiency. However, the solid in the deficiency is not what it can do. In the prescription, ginger and jujube harmonize the spleen and stomach, nourish the blood and calm the mind, and moderate the medicinal properties. Ginger is fragrant and unobstructed, and it is matched with jujube, so it will not be too dispersed and consume qi. Jujube is sticky and sweet, and ginger is pungent and dispersing, so it will not be too defensive and hinder the spleen. The two medicines cooperate with each other, and they have the function of transforming yang with pungent and sweet, but they are also hard and soft. At the same time, ginger, jujube and licorice are used together frequently and are widely used, running through the six meridians, covering yin and yang, exterior and interior, cold and heat, and deficiency and excess. The rules of the combined compatibility of these three herbs, including the compatibility of nature and flavor, the compatibility of efficacy and the compatibility of dosage, are of great significance in guiding the standardized use of drugs in clinical practice. The combination of Chinese jujube seeds, poria and polygala has the effects of benefiting the heart, nourishing the liver and calming the mind. Among them, Chinese jujube seeds are sour and belong to the heart, liver and gallbladder meridians. They benefit the mind and settle sleep, calm the mind and expel troubles. They are more nourishing and have the effects of protecting the myocardium and enhancing immunity. They are often used to help fall asleep and relieve tension; poria is sweet and light, replenishes the heart qi and benefits the mind, calms the mind and calms the mind, and is more penetrating; polygala is bitter and warm, relieves depression and relieves heart qi, dispels phlegm, relieves depression and calms the mind, and is more inclined to relieve depression. The combination of the three herbs can calm the mind and calm the mind, promote sleep and calm the mind. It can treat symptoms such as insomnia and palpitations caused by deficiency of blood in the heart and liver and lack of nourishment of the mind.

[0023] The present invention provides application of the above-mentioned traditional Chinese medicine composition in preparing medicine for treating sub-health insomnia.

[0024] The present invention provides a medicine for treating sub-health insomnia, and the raw materials for preparing the medicine include the above-mentioned traditional Chinese medicine composition.

[0025] Preferably, the drug further comprises pharmaceutically acceptable excipients.

[0026] Preferably, the dosage form of the drug includes a liquid dosage form and a solid dosage form.

[0027] Preferably, the liquid dosage form comprises a mixture; and the solid dosage form comprises granules.

[0028] The present invention provides a method for preparing the above-mentioned medicine, comprising the following steps:

[0029] Mix the bupleurum, the scutellaria, the curcuma, the quinquefolius, the pinellia, the atractylodes, the ginger, the jujube, the roasted liquorice, the triticale, the spiny jujube seeds, the poria, the polygala, the calamus, the citron, the raw pearl mother-of-pearl, the acanthopanax and the processed polygonum multiflorum to obtain a raw material;

[0030] The raw materials are mixed with water and boiled to obtain the medicine.

[0031] Preferably, the mass volume ratio of the raw material to the water is 7g:25mL.

[0032] The present invention discloses the following technical effects:

[0033] The Chinese medicine composition of the present invention inherits the concept of holistic syndrome differentiation in traditional Chinese medicine, and starts from regulating the functions of the internal organs to achieve the purpose of treatment. The present invention uses Xiao Chaihu Decoction as the base formula for addition and subtraction. Among them, Chaihu is combined with Huangqin to soothe the liver and relieve depression, clear and purge internal heat; Curcuma is combined with Citrus palm to promote qi and relieve depression, and regulate the qi mechanism, which are all monarch drugs. Atractylodes, five-fingered peach and Acanthopanax invigorate qi and strengthen the spleen, and protect the middle jiao; processed Polygonum multiflorum nourishes the kidney and replenishes essence; processed Pinellia ternata reduces adverse effects and guides yang qi to enter yin; Huai wheat nourishes the heart and relieves restlessness, which are all minister drugs. Ziziphus jujuba seeds are combined with Poria to calm the heart, nourish blood and calm the mind; Acorus calamus is combined with Polygala tenuifolia to calm the mind and open the orifices, and connect the heart and kidney; raw mother-of-pearl calms the nerves and calms the mind, which are all adjuvant drugs. Ginger is combined with jujube to harmonize the spleen and stomach, and roasted licorice helps Huai wheat and jujube to nourish the heart and calm the mind, and can harmonize all the drugs, which are the guiding drugs. The present invention takes the treatment principle of both benefit and supplement, takes soothing the liver and relieving depression, nourishing blood and eliminating restlessness, and helping sleep and calming the mind as the treatment method, and creates the first soothing the liver and calming the mind and helping sleep prescription. The whole prescription uses the thinking method of harmonizing the form, qi and spirit, and treating the disease and symptoms at the same time, and the idea of ​​"preventing disease" runs through the whole, focusing on regulating the heart, liver and spleen, focusing on soothing the liver, relieving depression and clearing away heat, strengthening the spleen and nourishing qi and blood, supplemented by the function of eliminating restlessness and calming the mind, calming the heart and helping sleep, so that yin and yang intersect, and play the effect of "yin and yang are balanced". The Chinese medicine preparation of the present invention is composed of several Chinese medicinal materials, which cooperate with each other and promote synergistically, and can effectively treat sub-health insomnia. The present invention is a pure Chinese medicine preparation with mild medicinal properties, no stimulation, no toxic side effects, and simple preparation method and process, which is convenient for quality control. The present invention uses all the medicines together, with soothing the liver and relieving depression, strengthening the spleen and replenishing qi as the general outline, and calming the heart and eliminating restlessness, nourishing blood and calming the mind. This prescription is strictly compatible and reasonable, and has a significant effect on treating sub-health insomnia, and a high clinical cure rate. DETAILED DESCRIPTION

[0034] Various exemplary embodiments of the present invention will now be described in detail. This detailed description should not be considered as limiting the present invention, but should be understood as a more detailed description of certain aspects, features, and embodiments of the present invention.

[0035] It should be understood that the terms described in the present invention are only for describing a particular embodiment and are not intended to limit the present invention. In addition, for the numerical range in the present invention, it should be understood that each intermediate value between the upper and lower limits of the scope is also specifically disclosed. The intermediate value in any stated value or stated range, and each smaller range between any other stated value or intermediate value in the described range is also included in the present invention. The upper and lower limits of these smaller ranges can be independently included or excluded in the scope.

[0036] Unless otherwise indicated, all technical and scientific terms used herein have the same meanings as those generally understood by those skilled in the art. Although the present invention describes only preferred methods and materials, any methods and materials similar or equivalent to those described herein may also be used in the implementation or testing of the present invention. All documents mentioned in this specification are incorporated by reference to disclose and describe the methods and / or materials associated with the documents. In the event of a conflict with any incorporated document, the content of this specification shall prevail.

[0037] It will be apparent to those skilled in the art that various modifications and variations may be made to the specific embodiments of the present invention description without departing from the scope or spirit of the present invention. Other embodiments derived from the present invention description will be apparent to those skilled in the art. The present invention description and examples are exemplary only.

[0038] The words “include,” “including,” “have,” “contain,” etc. used in this document are open-ended terms, meaning including but not limited to.

[0039] Unless otherwise specified, the Chinese medicinal materials used in the present invention can be purchased conventionally by those skilled in the art.

[0040] Example 1

[0041] A traditional Chinese medicine preparation for treating sub-health insomnia, the raw materials comprising the following components by weight: 15 parts (15g) of bupleurum, 10 parts (10g) of scutellaria, 15 parts (15g) of curcuma, 30 parts (30g) of quinquefolius, 10 parts (10g) of pinellia, 15 parts (15g) of atractylodes, 10 parts (10g) of ginger, 10 parts (10g) of jujube, 10 parts (10g) of roasted liquorice, 30 parts (30g) of Huai wheat, 15 parts (15g) of spiny jujube seeds, 20 parts (20g) of poria, 15 parts (15g) of polygala, 10 parts (10g) of calamus, 10 parts (10g) of citron, 20 parts (20g) of raw mother-of-pearl, 20 parts (20g) of acanthopanax senticosus and 15 parts (15g) of processed polygonum multiflorum.

[0042] Preparation method: After mixing the above raw materials, add 1000 mL of water and boil until the medicinal juice is concentrated to 600 mL to obtain a traditional Chinese medicine preparation (Shugan Anshen Zhumian Decoction);

[0043] Usage: 600mL of Chinese medicine preparation, take warm 3 times a day, morning, noon and evening, 1 dose per day, 1 month as a course of treatment.

[0044] Embodiment 2 Chinese medicine granules

[0045] A Chinese medicine granule for treating sub-health insomnia, the raw materials comprising the following components in parts by mass: 15 parts (15g) of bupleurum, 10 parts (10g) of scutellaria, 15 parts (15g) of curcuma, 30 parts (30g) of quinquefolius, 10 parts (10g) of pinellia, 15 parts (15g) of atractylodes, 10 parts (10g) of ginger, 10 parts (10g) of jujube, 10 parts (10g) of roasted liquorice, 30 parts (30g) of Huai wheat, 15 parts (15g) of spiny jujube seeds, 20 parts (20g) of poria, 15 parts (15g) of polygala, 10 parts (10g) of calamus, 10 parts (10g) of citron, 20 parts (20g) of raw mother-of-pearl, 20 parts (20g) of acanthopanax senticosus and 15 parts (15g) of processed polygonum multiflorum.

[0046] The preparation of the Chinese medicine granules of the present invention adopts the existing conventional granule preparation method, which will not be repeated here. For example, 1. The solvent extraction method obtains the extract, and the solvent extraction method includes decoction, reflux, percolation, double extraction and then impregnation; 2. Concentration and drying to obtain Chinese medicine granules; 3. Screening of granule excipients to obtain the best excipients; 4. Quality inspection, including appearance inspection, solubility, moisture, particle size, etc. The above-mentioned Chinese medicine granules are packaged according to 10g / bag. Dosage: Twice a day, one bag at a time, take after meals.

[0047] Effect example 1:

[0048] 1.1. General information:

[0049] A total of 144 patients with subhealth insomnia admitted to the outpatient clinic in 2019 were selected, including 65 males and 79 females; aged 26-72 years old, with an average age of (47.36±5.78) years old; and a course of disease of 3-6 months. The selected patients were divided into an observation group and a control group according to the random number table method, with 72 cases in each group. There were 33 males and 39 females in the observation group; aged 28-60 years old, with an average age of (43.78±7.41) years old; the severity of insomnia: 37 cases of mild, 26 cases of moderate, and 9 cases of severe. There were 32 males and 40 females in the control group; aged 26-62 years old, with an average age of (42.38±8.19) years old; the severity of insomnia: 38 cases of mild, 27 cases of moderate, and 7 cases of severe. There was no significant difference in gender (χ2=0.169, P=0.681), age (t=1.460, P=0.148), and sleep level (χ2=0.176, P=0.915) between the two groups (P>0.05), and the two groups were comparable.

[0050] 1.2 Diagnostic criteria:

[0051] (1) Western medicine diagnostic criteria: Refer to the "Guidelines for the Diagnosis and Treatment of Insomnia in Chinese Adults", any one of the following conditions must be met: difficulty falling asleep, early awakening, lack of recovery after awakening in the morning, or persistent sleep disorder, and the above symptoms still occur under the premise of a good sleeping environment. In addition, at least one type of daytime functional impairment caused by insomnia occurs (including decreased learning or work status, decreased memory or mental strength, fatigue or discomfort, daytime sleepiness, and mood swings).

[0052] (2) TCM diagnostic criteria: Refer to the Internal Medicine of Traditional Chinese Medicine, which is characterized by restlessness and insomnia, frequent dreams and easy awakening or confusion, palpitations, fatigue, dull complexion, poor appetite, abdominal distension, pale tongue, thin coating, and weak pulse.

[0053] 1.3 Inclusion and Exclusion Criteria:

[0054] (1) Inclusion criteria: patients who met the diagnostic criteria of traditional Chinese medicine and Western medicine, had a disease course of 3-6 months, and were aged >18 years; patients who were receiving treatment for the first time and had not taken other hypnotic drugs within 2 weeks; patients whose total PSQI score was less than 7 points; patients who were willing to cooperate with the treatment and had good compliance; and patients who signed the informed consent form.

[0055] (2) Exclusion criteria: those who do not meet the diagnostic criteria; those aged >18 years; those with severe depression or anxiety; pregnant or lactating women; those who have received other sleep treatments; (6) those who reject treatment; those who are allergic to the medication; and those who do not take medication as directed by the doctor.

[0056] 1.4. Treatment method: The control group was treated with oryzanol tablets (Guangdong Hengjian Pharmaceutical, 10 mg / tablet) and vitamin B1 (Jinan Yongning Pharmaceutical, 5 mg / tablet), both of which were taken orally at 20 mg each time, 3 times a day, 1 month as 1 course of treatment, and 2 courses of treatment were taken in a row. The observation group was treated with the Chinese medicine preparation prepared in Example 1 on the basis of the control group, 600 mL of Chinese medicine preparation, 3 times a day, 1 dose per day, 1 month as 1 course of treatment, and 2 courses of treatment were taken in a row. Dietary guidance and exercise guidance were given to both groups during treatment.

[0057] 1.5. Observation indicators:

[0058] 1.5.1. Clinical efficacy The efficacy of the two groups after two courses of treatment was evaluated with reference to the efficacy criteria for insomnia in the "Efficacy Criteria for Diagnosis and Efficacy of TCM Diseases and Syndromes". Cured: The patient fell asleep for more than 6 hours at night and entered a deep sleep, and was not easily awakened; markedly effective: The patient's sleep improved, the number of awakenings decreased, and it was no longer difficult to fall asleep again, but the full night sleep time was still less than 6 hours; effective: The patient's sleep improved to a certain extent, but the full night sleep after treatment was less than 4 hours; ineffective: The patient's sleep did not improve. Effective rate = (cured + markedly effective + effective) / total number of cases × 100%.

[0059] 1.5.2. Sleep quality The Pittsburgh Sleep Quality Index (PSQI) was used to evaluate the sleep quality of patients before and after treatment. PSQI includes 7 items: sleep quality, sleep time, sleep time, sleep efficiency, sleep disorders, hypnotic drugs, and daytime function. Each item is scored from 0 to 3 points. The total score of PSQI = the total score of the 7 items, a total of 0 to 21 points. The higher the score, the worse the sleep quality. ≥7 points means poor sleep quality.

[0060] 1.5.3 Quality of life The World Health Organization Quality of Life Brief Scale (WHOQOL-BREF) was used to assess the quality of life of patients before and after treatment. The scale includes 26 items in four areas: physiology, psychology, social relations and environment. The average score of the scores of the following items in each area is multiplied by 4, which is the score of the four aspects, with a total score of 0-100. The higher the score, the better the quality of life.

[0061] 1.6 Application of statistical methods:

[0062] SPSS19.0 was used for statistical analysis of the data. indicates t test; count data χ 2 Test, P < 0.05 was considered statistically significant.

[0063] 2. Results:

[0064] 2.1 Clinical efficacy of the two groups before and after treatment

[0065] The results of the clinical efficacy survey of the two groups before and after treatment are shown in Table 1. The results showed that the total effective rate of the observation group was 90.27%, and the total effective rate of the control group was 88.88%, which was significantly higher in the observation group than in the control group, and the difference was statistically significant (P < 0.05).

[0066] Table 1 Comparison of clinical efficacy between the two groups (n)

[0067] Grouping n cure Effective efficient invalid Efficiency Observation Group 72 14 38 13 7 90.27％ Control group 72 9 28 27 8 88.88％

[0068] 2.2 Comparison of PSQI scores between the two groups before and after treatment

[0069] The comparison results of PSQI scores before and after treatment between the two groups are shown in Table 2. The results showed that there was no statistically significant difference in PSQI scores between the two groups before treatment (P>0.05); the PSQI scores of the two groups after treatment were significantly lower than those before treatment (P<0.05), and the PSQI score of the observation group after treatment was significantly lower than that of the control group, and the difference was statistically significant (P<0.05).

[0070] Table 2 Comparison of PSQI scores between the two groups before and after treatment ( point)

[0071]

[0072]

[0073] Note: Compared with the group before treatment, * represents P < 0.05; compared with the control group, # represents P < 0.05.

[0074] 2.2 Comparison of WHOQOL-BREF scores between the two groups before and after treatment

[0075] The comparison results of WHOQOL-BREF scores before and after treatment between the two groups are shown in Table 3. The results showed that the WHOQOL-BREF scores of the two groups of patients after treatment were significantly higher than those before treatment (P>0.05), and the scores of the observation group were significantly higher than those of the control group, and the difference was statistically significant (P>0.05).

[0076] Table 3 Comparison of WHOQOL-BREF scores between the two groups before and after treatment ( point)

[0077]

[0078] Note: Compared with the group before treatment, * represents P < 0.05; compared with the control group, # represents P < 0.05.

[0079] From the above experimental results, it can be seen that the total effective rate of the Chinese medicine preparation provided by the present invention in treating sub-health insomnia is more than 90%, and the ineffective rate is less than 10%. It can be seen that the Chinese medicine composition provided by the present invention can treat sub-health insomnia and has a significant therapeutic effect.

[0080] A one-year follow-up survey was conducted on the above patients, with a total of 94 cases followed up, of which 72 patients showed no obvious recurrence, 19 patients had mild recurrence, and 3 patients had severe recurrence.

[0081] Typical cases:

[0082] Case 1: Xu, male, had sub-health insomnia for 10 months in December 2023, often insomnia, 15-20 times / month, and insomnia was significant after busy work and mental stress. He reported that he had taken Bailemian capsules orally for about half a year, 4 capsules at a time, twice a day; because the effect was not significant, he stopped taking the medicine on his own. After taking the Shugan Anshen Zhumian Decoction prepared in Example 1 of the present invention for 4 weeks, his energy improved, fatigue improved, sleep improved, and bowel movements were 1-2 times a day.

[0083] Case 2: Jin, female, sub-health, insomnia, body heaviness and fatigue for 4 months, obvious memory loss, increased chloasma, scanty menstruation, difficulty falling asleep, shallow sleep and easy awakening after falling asleep, and dreaminess. After taking the Soothing Liver Anshen Aid Mian Decoction prepared in Example 1 of the present invention for 4 weeks, fatigue was significantly improved, sleep was good, complexion was ruddy, and no recurrence occurred.

[0084] Case 3: Zheng, male, 26 years old, fatigue and weakness for 2 years, accompanied by insomnia for 1 year. In the past 2 years, due to work pressure, he suffered from insomnia, fatigue, weakness, sudden awakening after falling asleep, unable to fall asleep after waking up, backache and weak legs from time to time, and the effect of treatment with Chinese and Western medicine for 2 years was not obvious. After taking the Soothing Liver Anshen Aid Mian Decoction prepared in Example 1 of the present invention for 4 weeks, fatigue was significantly improved, he felt that he could fall asleep without any hindrance, awakening after sleeping basically disappeared, there was no chest tightness and sweating, he was energetic, gained weight, and insomnia and awakening did not recur.

[0085] In summary, the Chinese medicine composition provided by the present invention can relieve symptoms such as fatigue, drowsiness, dizziness, etc. in patients with sub-health insomnia, and has the effects of replenishing qi and raising yang, and invigorating qi and strengthening the exterior; clinical experiments have verified that the medicine has a definite effect in treating sub-health insomnia. After a 3-month follow-up investigation, the long-term effect is more significant, and it is worthy of clinical promotion and application.

[0086] The embodiments described above are only descriptions of the preferred modes of the present invention, and are not intended to limit the scope of the present invention. Without departing from the design spirit of the present invention, various modifications and improvements made to the technical solutions of the present invention by ordinary technicians in this field should all fall within the protection scope determined by the claims of the present invention.

Claims

1. A Chinese medicine composition for treating sub-health insomnia, characterized in that: The Chinese medicine composition comprises the following components in parts by weight: 12-18 parts of bupleurum, 7-13 parts of scutellaria, 12-18 parts of curcuma, 27-33 parts of quinquefolius, 7-13 parts of pinellia, 12-18 parts of atractylodes, 7-13 parts of ginger, 7-13 parts of jujube, 7-13 parts of roasted liquorice, 27-33 parts of Huai wheat, 12-18 parts of spiny jujube seeds, 17-23 parts of poria, 12-18 parts of polygala, 7-13 parts of calamus, 7-13 parts of citron, 17-23 parts of raw mother-of-pearl, 17-23 parts of acanthopanax, and 12-18 parts of processed polygonum multiflorum.

2. Use of the Chinese medicine composition according to claim 1 in the preparation of a medicine for treating sub-health insomnia.

3. A medicine for treating sub-health insomnia, characterized in that: The raw materials for preparing the medicine include the traditional Chinese medicine composition according to claim 1.

4. The drug according to claim 3, characterized in that The medicine also includes pharmaceutically acceptable auxiliary materials.

5. The drug according to claim 4, characterized in that The dosage form of the drug includes liquid dosage form and solid dosage form.

6. The drug according to claim 5, characterized in that The liquid dosage form includes a mixture; the solid dosage form includes granules.

7. The method for preparing the drug according to claim 3, characterized in that: The following steps are involved: Mix the bupleurum, the scutellaria, the curcuma, the quinquefolius, the pinellia, the atractylodes, the ginger, the jujube, the roasted liquorice, the triticale, the spiny jujube seeds, the poria, the polygala, the calamus, the citron, the raw pearl mother-of-pearl, the acanthopanax and the processed polygonum multiflorum to obtain a raw material; The raw materials are mixed with water and boiled to obtain the medicine.

8. The preparation method according to claim 7, characterized in that: The mass volume ratio of the raw material to the water is 7g:25mL.

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