Traditional Chinese medicine composition for insomnia caused by deficiency of both qi and yin as well as processing method and application of traditional Chinese medicine composition

Through a composition containing traditional Chinese medicines such as Prince Ginseng, Ophiopogon japonicus, and Pineaceae, the problem of a wide variety of drugs and major side effects in the prior art for treating insomnia with Qi and Yin deficiency is solved, and the effect of replenishing qi and nourishing yin, calming the mind and calming the mind is achieved, and the sleep quality of insomnia patients is significantly improved.

CN119925512APending Publication Date: 2025-05-06YUEYANG INTEGRATED TRADITIONAL CHINESE & WESTERN MEDICINE HOSPITAL SHANGHAI UNIV OF CHINESE TRADITIONAL MEDICINE
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Patent Information

Application Number
CN202510148708.X
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-02-11
Publication Date
2025-05-06

AI Technical Summary

Technical Problem

In the prior art, there are many types of Chinese medicine formulas used to treat insomnia with Qi and Yin deficiency, with great side effects, and the applicable population is limited, making it difficult to effectively replenish Qi and Yin and improve sleep quality.

Method used

A traditional Chinese medicine composition is proposed, including ginseng, Ophiopogon japonicus, cypress seeds, jujube seeds, poria, zodiac, cypress, cypress, cypress, cinnamon, salvia miltiorrhiza, acacia and licorice, which is made by soaking and decocting and processing methods, and is used to treat insomnia with Qi and Yin deficiency.

Benefits of technology

Through the synergy of the monarch and ministers, this traditional Chinese medicine composition replenishes qi and nourishes yin, calms the mind and stabilizes the mind, significantly improves the sleep quality of insomnia patients and reduces the impact of quality of life.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention belongs to the field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for insomnia caused by deficiency of both qi and yin and a processing method and application thereof, and the traditional Chinese medicine composition comprises the following components in parts by weight: 9-20 parts of radix pseudostellariae, 9-18 parts of radix ophiopogonis, 6-27 parts of semen boitae, 6-25 parts of spina date seed, 6-18 parts of poria with hostwood, 3-18 parts of polygala tenuifolia, 3-18 parts of schisandra chinensis, 6-12 parts of cassia twig, 12-20 parts of salvia miltiorrhiza, 12-18 parts of albizia flower and 3-9 parts of liquorice. Compared with the prior art, the defects that in the prior art, Chinese and western medicine treatment is large in side effect, and traditional Chinese medicine is wide in variety are overcome; according to the scheme, the traditional Chinese medicine composition capable of effectively tonifying qi and yin is provided for treating insomnia caused by deficiency of both qi and yin in both symptoms and root causes.
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Description

Technical Field

[0001] The invention belongs to the field of traditional Chinese medicine, and in particular relates to a traditional Chinese medicine composition for treating insomnia of qi and yin deficiency type, and a processing method and application thereof. Background Art

[0002] Insomnia, whose full name is sleep disorder insomnia, or insomnia for short, is a common health problem that affects the quality and quantity of an individual's sleep. Insomnia can be divided into many types based on clinical manifestations and causes, such as difficulty falling asleep, difficulty maintaining sleep, early awakening, and mixed types. The causes of the disease are complex and diverse, including psychological factors, physiological factors, environmental factors, and lifestyle habits. High-risk groups mainly include the elderly, women (especially menopausal women), those with a history or family history of mental illness, and those who are under long-term high-pressure work. Although insomnia itself does not directly lead to death, long-term insomnia can significantly increase the risk of chronic diseases such as cardiovascular disease and diabetes, and indirectly affect the quality of life and life expectancy.

[0003] From the perspective of traditional Chinese medicine, one possible cause of insomnia is deficiency of both qi and yin. Patients with deficiency of both qi and yin usually have obvious symptoms such as physical fatigue, dry mouth and tongue, insomnia, dry stool, palpitations, etc., which will seriously affect the patient's daily life and work in the long run, and greatly reduce the quality of life. For insomnia of both qi and yin deficiency, it can usually be conditioned and treated through Chinese medicine, acupuncture, exercise and diet adjustment; for example, CN102784319A discloses a method for preparing Chinese medicine for treating insomnia of both qi and yin deficiency, which is made of 25 medicinal materials such as wheat, polygonatum, longan meat, northern adenophora, atractylodes, white peony, white hyacinth bean, American ginseng, ophiopogon, bayberry, chicken egg yolk, wolfberry, codonopsis, mulberry, astragalus, polygonatum, spiny jujube seed, albizzia, polygala, night clover, coral, poria, forsythia, cypress seed and licorice, which are soaked, decocted and filtered, but the formula has a wide variety of medicines, and the applicable population is subject to many restrictions.

[0004] Therefore, it is necessary to propose a new type of Chinese medicine formula to regulate the disease and treat insomnia of qi and yin deficiency type, so as to improve the patient's sleep quality and further improve the quality of life. Summary of the invention

[0005] The purpose of the present invention is to solve at least one of the above problems and provide a Chinese medicine composition for insomnia of qi and yin deficiency type, and its processing method and application, which solves the defects of the existing Chinese and Western medicine treatments with large side effects and a wide variety of Chinese medicines; this scheme proposes a Chinese medicine composition that can effectively replenish qi and yin to achieve the treatment of both the symptoms and the root cause of insomnia of qi and yin deficiency type.

[0006] The purpose of the present invention is achieved through the following technical solutions:

[0007] The first aspect of the present invention discloses a Chinese medicine composition for treating insomnia of qi and yin deficiency type, comprising the following components in parts by weight:

[0008] 9-20 parts of Pseudostellariae Radix, 9-18 parts of Ophiopogon japonicus, 6-27 parts of Platycladus orientalis seeds, 6-25 parts of Ziziphus jujuba seeds, 6-18 parts of Poria cocos, 3-18 parts of Polygala tenuifolia, 3-18 parts of Schisandra chinensis, 6-12 parts of Cinnamomum cassia twig, 12-20 parts of Salvia miltiorrhiza, 12-18 parts of Albizzia julibrissin, and 3-9 parts of Licorice.

[0009] Preferably, the following components are included in parts by weight:

[0010] 15 parts of Pseudostellariae Radix, 12 parts of Ophiopogon japonicus, 10 parts of Semen Platycladi, 10 parts of Semen Ziziphi Spinosae, 10 parts of Poria, 6 parts of Polygala tenuifolia, 5 parts of Schisandrae Chinensis, 6 parts of Cinnamomum cassia, 15 parts of Salvia miltiorrhiza, 15 parts of Flos Albizziae, and 5 parts of Licorice.

[0011] Preferably, the Chinese jujube seeds are fried Chinese jujube seeds.

[0012] Preferably, the Polygala tenuifolia is processed Polygala tenuifolia.

[0013] Preferably, the Schisandra chinensis is Schisandra chinensis.

[0014] Preferably, the licorice is roasted licorice.

[0015] The second aspect of the present invention discloses a processing method of a Chinese medicine composition for treating insomnia of Qi and Yin deficiency type as described above, comprising the following steps:

[0016] The components are taken according to the formula, soaked in water and boiled once, the medicinal juice is filtered out, water is added to the medicinal residue and boiled twice, the medicinal juice is filtered out, and the medicinal juices obtained by the two decoctions are combined.

[0017] Preferably, in the first decoction, the mass of water is 8-11 times the total mass of the Chinese medicine composition, and the decoction time is 1-4 hours; in the second decoction, the mass of water is 8-10 times the total mass of the medicinal residue, and the decoction time is 1-4 hours.

[0018] The third aspect of the present invention discloses a use of any of the above-described traditional Chinese medicine compositions for treating insomnia of qi and yin deficiency type in the preparation of a medicine for treating insomnia of qi and yin deficiency type.

[0019] Preferably, the dosage form of the drug is an extract or a decoction.

[0020] Compared with the prior art, the present invention has the following beneficial effects:

[0021] This formula uses Radix Pseudostellariae and Semen Platycladi as the main ingredients, and Radix Ophiopogonis, stir-fried Semen Ziziphi Spinosae, Poria, Radix Polygalae (processed), and Fructus Schisandrae Chinensis (processed) as the auxiliary ingredients, and is supplemented with Cinnamon Twig, Salvia Miltiorrhiza, Flos Albiziae, and Licorice (honey roasted). Radix Pseudostellariae is sweet and bitter in taste, slightly warm in nature, and enters the heart, spleen, and lung meridians. It has the functions of greatly replenishing vital energy, nourishing yin, and promoting fluid production. Semen Platycladi is mainly used to nourish the heart qi, moisten the kidney, improve intelligence, and calm the mind. The two complement each other and are both main ingredients, aiming to replenish qi and nourish yin, and nourish the heart and calm the mind. Radix Ophiopogonis, stir-fried Semen Ziziphi Spinosae, Poria, Radix Polygalae, and Fructus Schisandrae Chinensis are all auxiliary ingredients, which can clear the heart and relieve troubles, open the heart and improve intelligence, promote fluid production and restrain sweat, and connect the heart and kidney. The main ingredients and auxiliary ingredients are used together to replenish the root of qi and yin deficiency, and treat the symptoms of restlessness at the same time. The main ingredients and auxiliary ingredients are treated at the same time, and the patient can sleep well at night. The whole formula has the effects of nourishing qi and yin, calming the mind and stabilizing the spirit, and connecting the heart and kidney. DETAILED DESCRIPTION

[0022] The present invention is described in detail below with reference to specific embodiments, but this is by no means a limitation of the present invention.

[0023] Unless otherwise specified in the following description, the reagents used are conventional commercial products, the methods used are well known in the art, and all matters not mentioned are prior arts.

[0024] A Chinese medicine composition for treating insomnia of qi and yin deficiency type, comprising the following components in parts by weight:

[0025] 9-20 parts of Pseudostellariae Radix, 9-18 parts of Ophiopogon japonicus, 6-27 parts of Platycladus orientalis seeds, 6-25 parts of Ziziphus jujuba seeds, 6-18 parts of Poria cocos, 3-18 parts of Polygala tenuifolia, 3-18 parts of Schisandra chinensis, 6-12 parts of Cinnamomum cassia twig, 12-20 parts of Salvia miltiorrhiza, 12-18 parts of Albizzia julibrissin, and 3-9 parts of Licorice.

[0026] Further preferred are: 15 parts of Pseudostellariae Radix, 12 parts of Ophiopogon japonicus, 10 parts of Platycladus orientalis seeds, 10 parts of Ziziphus jujuba seeds, 10 parts of Poria cocos, 6 parts of Polygala tenuifolia, 5 parts of Schisandra chinensis, 6 parts of Cinnamomum cassia twig, 15 parts of Salvia miltiorrhiza, 15 parts of Flos Albizziae, and 5 parts of Licorice.

[0027] Among them, the Chinese jujube kernel is stir-fried Chinese jujube kernel, the Polygala tenuifolia is processed Polygala tenuifolia, the Schisandra chinensis chinensis (processed) is used, and the licorice is roasted licorice.

[0028] A processing method of the above Chinese medicine composition for insomnia of qi and yin deficiency type comprises the following steps:

[0029] The components are taken according to the formula, soaked in water and boiled once, the medicinal juice is filtered out, water is added to the medicinal residue and boiled twice, the medicinal juice is filtered out, and the medicinal juices obtained by the two decoctions are combined.

[0030] Further preferably, in the first decoction, the mass of water is 8-11 times the total mass of the traditional Chinese medicine composition, and the decoction time is 1-4 hours; in the second decoction, the mass of water is 8-10 times the total mass of the residue, and the decoction time is 1-4 hours.

[0031] The specific processing methods vary slightly depending on the dosage form being processed and prepared:

[0032] Extract:

[0033] Take the Chinese medicine composition according to the above formula, add 8-11 times the total weight of water, decoct for 3 hours, and filter out the juice; add 8 times the weight of the residue of the medicine, decoct for 3 hours, and filter out the juice. Combine the two decoctions, let stand, filter out the supernatant, concentrate, cool, add 3.5 times the weight of alcohol of the concentrate, stir and precipitate overnight. Take the supernatant and concentrate it to a thick extract; further add appropriate pharmaceutical excipients to make a mixture, oral liquid or syrup for easy administration.

[0034] Decoction:

[0035] Take the Chinese medicine composition according to the above formula, add water to cover the medicinal materials by 2-3 cm, soak at room temperature for 30 minutes, boil the first decoction with high heat, then turn to low heat and keep boiling for 20-25 minutes, filter to get about 200mL of the first medicinal liquid; add water to immerse the medicinal residue, boil it with high heat, then turn to low heat and keep boiling for 20-25 minutes, filter to get about 200mL of the second medicinal liquid; combine the two medicinal liquids, divide them into two parts evenly, and take them once in the morning and evening. 2 weeks is a course of treatment, and a total of 2 courses of treatment are given.

[0036] Example 1: Clinical trial of Chinese medicine composition for treating insomnia

[0037] 1 Basic Information

[0038] 1.1 Research subjects

[0039] All cases were 92 patients with insomnia diagnosed as qi and yin deficiency type who visited the outpatient and inpatient departments of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine from January 2021 to January 2024. The total study time was 1 month, and the clinical efficacy of this Chinese medicine composition was observed.

[0040] 1.2 Diagnostic criteria for insomnia:

[0041] 1.2.1 Western medicine diagnostic criteria:

[0042] According to the International Classification of Sleep Disorders, Third Edition (ICSD-3) diagnostic criteria, AF must meet the following criteria:

[0043] A. The patient reports, or the patient's parents or caregivers observe, one or more of the following:

[0044] (1) Difficulty falling asleep (sleep latency > 30 min);

[0045] (2) difficulty maintaining sleep (number of awakenings ≥ 2 times);

[0046] (3) waking up earlier than the expected time to wake up (1 hour earlier than the expected time to wake up);

[0047] (4) Refusing to go to bed at an appropriate time;

[0048] (5) Difficulty falling asleep without intervention from parents or caregivers.

[0049] B. The patient reports, or the patient's parents or caregivers observe, 1 or more of the following associated with difficulty sleeping at night:

[0050] (1) Fatigue or malaise;

[0051] (2) decreased attention, concentration, or memory;

[0052] (3) impairment of social, family, occupational, or academic functions;

[0053] (4) emotional instability or irritability;

[0054] (5) Daytime sleepiness;

[0055] (6) behavioral problems (e.g., hyperactivity, impulsivity, or aggression);

[0056] (7) Decreased motivation, energy, or work initiative;

[0057] (8) prone to making mistakes or accidents;

[0058] (9) Being very concerned or dissatisfied with their sleep quality.

[0059] C. These sleep / wake complaints are not fully explained by inadequate sleep opportunity (eg, adequate sleep time) or environment (eg, dark, quiet, safe, comfortable environment).

[0060] D. These sleep difficulties and related daytime symptoms occur at least 3 times per week.

[0061] E. These sleep difficulties and related daytime symptoms have persisted for at least 3 months.

[0062] F. The sleep difficulties and associated daytime symptoms are not better explained by another sleep disorder.

[0063] 1.2.2 TCM diagnostic criteria:

[0064] Referring to the diagnostic criteria for "Insomnia" in the "Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes" and combining clinical practice, the TCM diagnostic criteria for insomnia due to Qi and Yin deficiency were formulated:

[0065] (1) Difficulty falling asleep, or waking up easily after falling asleep, and being unable to fall asleep again after waking up, or even being unable to sleep all night, for more than 4 consecutive weeks;

[0066] (2) No other organic diseases or causes that interfere with sleep;

[0067] (3) Often accompanied by symptoms such as fatigue, shortness of breath, irritability, dry mouth and throat, hot flashes in the afternoon, hot hands and feet, night sweats, and scanty coating of the tongue.

[0068] 1.3 Treatment options:

[0069] This prescription (15g of Pseudostellariae Radix, 12g of Radix Ophiopogonis, 10g of Semen Platycladi, 10g of Semen Ziziphi Spinosae, 10g of Poria, 6g of Polygala, 5g of Schisandrae Chinensis, 6g of Cinnamon Twig, 15g of Salvia Miltiorrhiza, 15g of Albizzia Julibrissin, and 5g of Licorice) was selected. The above components were added with water to cover the medicinal materials by 2-3 cm, and soaked at room temperature for 30 minutes. The first decoction was boiled with high heat, then turned to low heat and kept boiling for 20-25 minutes, and filtered to obtain about 200mL of the first medicinal liquid; then water was added to immerse the medicinal residue, first boiled with high heat, then turned to low heat and kept boiling for 20-25 minutes, and filtered to obtain about 200mL of the second medicinal liquid; the two medicinal liquids were combined and divided into two equal portions, and taken once in the morning and evening. 2 weeks is a course of treatment, and a total of 2 courses of treatment are given.

[0070] 1.4 Observation indicators:

[0071] 1.4.1 Efficacy evaluation criteria:

[0072] The efficacy was evaluated according to the Guiding Principles for Clinical Research of New Chinese Medicines.

[0073] Clinical recovery: Sleep time returns to normal, or nighttime sleep time is ≥ 6 hours, sleep is deep, and the patient is full of energy after waking up.

[0074] Significant effect: Sleep is significantly improved, sleep time increases by ≥3h, sleep depth increases, but total sleep time is ≤6h.

[0075] Effective: Sleep time increased by ≤3h compared with before treatment.

[0076] Ineffective: Insomnia did not improve or worsened after treatment.

[0077] Calculate the total effective rate using the formula:

[0078] Total effective rate (%) = (number of cases with clinical recovery + marked effect + effective) / total number of cases × 100%

[0079] 1.4.2 TCM symptom scoring

[0080] Before and after treatment, the patients' TCM symptoms of "Qi and Yin deficiency syndrome" were scored, including restlessness and insomnia, fatigue, shortness of breath, dry mouth and throat, hot flashes in the afternoon, hot hands and feet, night sweats, and little tongue coating. Each symptom was divided into four levels: none, mild, moderate, and severe, and the values ​​were 0, 1, 2, and 3 respectively. The cumulative score was the total TCM symptom score.

[0081] 1.4.3 Pittsburgh Sleep Quality Index (PSQI)

[0082] The Pittsburgh Sleep Quality Index (PSQI) was used for evaluation before and after treatment. The 19th self-assessment item and 5 other-assessment items were not included in the scoring. The first 18 self-assessment items consisted of 7 components: sleep quality, sleep onset time, sleep time, sleep efficiency, sleep disorders, hypnotic drugs, and daytime dysfunction. Each component was scored on a scale of 0 to 3. The cumulative scores of each component were added up to the total PSQI score, ranging from 0 to 21. The higher the score, the worse the sleep quality.

[0083] 1.4.4 Insomnia Severity Index (ISI)

[0084] The Insomnia Severity Index (ISI) was used to evaluate the severity of insomnia before and after treatment. The ISI includes seven items: difficulty falling asleep, difficulty maintaining sleep, early awakening, satisfaction with sleep patterns, the degree of interference of sleep problems on daytime function, the degree of impact of sleep problems on quality of life, and the degree of concern about sleep problems. Each item is scored from 0 to 4 points, and the total score is 28 points. The higher the score, the more severe the insomnia.

[0085] 1.5 Statistical analysis

[0086] The efficacy was evaluated by retrospective self-control method. The experimental data were processed by SPSS27.0 statistical software. The measurement data were expressed as mean ± standard deviation and the t test was used; the count data were expressed as X 2 The difference was considered statistically significant when P ≤ 0.05.

[0087] 2 Results

[0088] (1) After 4 weeks of treatment, the efficacy of the patients was as follows: 26 cases were cured, 29 cases were markedly effective, 18 cases were effective, and 19 cases were ineffective. The total effective rate was 79.35%, see Table 1.

[0089] Table 1 Clinical efficacy statistics

[0090]

[0091] (2) Compared with before treatment, the TCM symptom scores and PSQI and ISI scores of the patients were significantly decreased, and the difference was statistically significant (P<0.05), as shown in Table 2.

[0092] Table 2 Comparison of TCM symptom scores and PSQI and ISI scores before and after treatment

[0093]

[0094] Note: *P<0.05, compared with before treatment; #P<0.05, compared with 2 weeks of treatment.

[0095] (3) Safety analysis

[0096] No adverse reactions such as nausea, vomiting, and abdominal pain were observed after oral administration of Chinese medicine.

[0097] Example 2: Animal experiment on the treatment of insomnia with Chinese medicine composition

[0098] 1 Experimental animals and groups

[0099] 70 SPF healthy male SD rats, aged 6-8 weeks and weighing (200±20) g, were purchased from Beijing Weitonglihua Experimental Animal Technology Co., Ltd. They were raised normally, with a temperature of 20±2°C, a humidity of 50%-60%, a normal day and night cycle, and free access to food and water. The animals were fed adaptively for 1 week before modeling and drug administration.

[0100] 2. Drugs

[0101] Test drugs: Radix Pseudostellariae, Semen Platycladi, Ophiopogon japonicus, stir-fried Semen Ziziphi Spinosae, Poria, Polygala tenuifolia, Schisandra chinensis, Cassia twig, Salvia miltiorrhiza, roasted Licorice root, Astragalus, Polygonum multiflorum, Flos Albiziae.

[0102] Positive control drug: diazepam tablets, specification: 2.5 mg (prepared with normal saline to a suspension of 0.9 mg / mL before use).

[0103] 3 Experimental methods

[0104] 3.1 Modeling:

[0105] 70 rats were randomly divided into 10 as normal control group, and the remaining 60 rats were modeled; the modeling method was to intraperitoneally inject 400mg / kg chlorophenylalanine (PCPA) suspension for 2 consecutive days, and observe the status of each group after 2 days. The results showed that except for the normal control group, the mice in the other treatment groups showed phenomena such as disappearance of circadian rhythm and strong aggressiveness, indicating that the insomnia model was successfully established.

[0106] Grouping: The model rats were randomly divided into experimental group 1, experimental group 2, control group 1, control group 2, model control group, and positive control group, with 10 rats in each group.

[0107] 3.2 Administration

[0108] The experimental rats were gavaged with 10 mL / kg of drug, once a day, for 7 consecutive days. The specific grouping and dosing schedule of each group are as follows:

[0109] Experimental group 1: Radix Pseudostellariae 15g, Semen Platycladi 9g, Radix Ophiopogonis 9g, Roasted Semen Ziziphi Spinosae 20g, Radix Poriae 15g, Radix Polygalae 6g, Fructus Schisandrae Chinensis 9g, Cinnamomum Cassiae 9g, Radix Salviae Miltiorrhizae 15g, Flos Albiziae 15g, Radix Glycyrrhizae Radix 9g. According to the conventional preparation method of decoction, the raw materials are decocted with water to prepare decoction, and the daily equivalent dose of rats is 10.44g / kg (equivalent to 6.3 times of the clinical equivalent dose).

[0110] Experimental group 2: Pseudostellariae Radix 18g, Platycladus Semen 27g, Ophiopogon japonicus 18g, stir-fried Semen Ziziphi Spinosae 25g, Poria 18g, Polygala tenuifolia 18g, Schisandrae Chinensis 18g, Cinnamomum cassia twig 9g, Salvia miltiorrhiza 15g, Albizzia julibrissin 15g, and Radix Glycyrrhizae Radix 9g. According to the conventional preparation method of decoction, the raw materials are decocted with water to prepare a decoction, and the daily equivalent dose for rats is 10.44g / kg.

[0111] Control group 1: (replace Pseudostellariae Radix with Astragalus, remove stir-fried Ziziphus jujuba seeds and Poria) Astragalus 15g, Platycladus Semen 9g, Ophiopogon 9g, Polygala 6g, Schisandrae Chinensis 9g, Cinnamomum cassia twig 9g, Salvia miltiorrhiza 15g, Albizzia julibrissin 15g, and Glycyrrhiza uralensis 9g. According to the conventional preparation method of decoction, the raw materials are decocted with water to prepare a decoction, and the daily equivalent dose of rats is 10.44g / kg.

[0112] Control group 2: (replace stir-fried jujube seeds with Polygonum multiflorum, remove Polygala tenuifolia) Pseudostellariae Radix 18g, Platycladus Semen 27g, Ophiopogon japonicus 18g, Polygonum multiflorum 15g, Poria 18g, Schisandrae Chinensis 18g, Cinnamomum cassia twig 9g, Salvia miltiorrhiza 15g, Albizzia julibrissin 15g, and Radix Glycyrrhizae Radix 9g. According to the conventional preparation method of decoction, the raw materials are decocted with water to prepare a decoction, and the daily equivalent dose of rats is 10.44g / kg.

[0113] Model control group: administered with an equal volume of normal saline;

[0114] Positive control group: diazepam was administered orally at a dose of 0.9 mg / kg (the corresponding volume was calculated based on body weight);

[0115] Normal control group: administered with an equal volume of normal saline.

[0116] 4 Pentobarbital sodium sleep test

[0117] 30 minutes after the last administration, the rats were intraperitoneally injected with sodium pentobarbital (30 mg / kg). The time from sodium pentobarbital injection to the disappearance of the righting reflex was recorded as the sleep latency; the time from the disappearance of the righting reflex to the recovery of the righting reflex was recorded as the sleep duration. The specific test results are shown in Table 3.

[0118] Table 3 Statistics of sleep status of rats in each group

[0119]

[0120] Note: *P<0.05, compared with the normal control group; #P<0.05, compared with the model control group; !P<0.05, compared with the control group.

[0121] 5 Results

[0122] From the data analysis in Table 3, it can be seen that compared with the normal control group, the rats in the model control group showed significant sleep disorders, with a significantly prolonged sleep latency (P<0.05) and a significantly shortened sleep duration (P<0.05). Compared with the model control group, each drug-treated group can effectively improve the sleep condition of rats, as shown by a significantly shortened sleep latency (P<0.05) and a significantly prolonged sleep duration (P<0.05). In particular, compared with the control groups one and two, the improvement effect of the rats in the experimental groups one and two was more significant, with a greater reduction in sleep latency (P<0.05) and a more significant extension of sleep duration (P<0.05). In addition, comparing the experimental groups one and two, the performance test data increased less under the condition of a significant increase in the dosage of the formula, indicating that it is difficult to further improve the sleep quality under the dosage of the formula of the experimental group one; therefore, considering the dosage, effect, cost and other factors, the dosage of the formula used in the experimental group one is more appropriate, and if a better medication effect is required, the dosage of the components can be appropriately increased.

[0123] The results show that the Chinese medicine composition provided by the present invention has the effect of significantly shortening the sleep latency and prolonging the sleep duration of insomnia model mice, reflecting a good potential for improving insomnia.

[0124] In summary, this formula uses Radix Pseudostellariae and Semen Platycladi as the monarch, Radix Ophiopogonis, stir-fried Semen Ziziphi Spinosae, Poria, Radix Polygalae (processed), Fructus Schisandrae Chinensis (processed) as the ministers, and is supplemented with Cinnamon Twig, Salvia Miltiorrhizae, Flos Albiziae, and Licorice (honey roasted). Radix Pseudostellariae is sweet and bitter in taste, slightly warm in nature, and enters the heart, spleen, and lung meridians, and has the functions of greatly replenishing vital energy, nourishing yin, and promoting fluid production. Semen Platycladi is mainly used to nourish the heart qi, moisten the kidney dryness, and improve intelligence and tranquilize the mind. The two complement each other and are the monarch medicine, aiming to replenish qi and nourish yin, nourish the heart and tranquilize the mind. Radix Ophiopogonis, stir-fried Semen Ziziphi Spinosae, Poria, Radix Polygalae, and Fructus Schisandrae Chinensis are the ministers, which can clear the heart and relieve troubles, open the heart and improve intelligence, promote fluid production and restrain sweat, and connect the heart and kidney. The monarch and ministers are used together to replenish the root of qi and yin deficiency, and treat the symptoms of restlessness at the same time, and treat both the symptoms and the root, so that you can sleep well at night. The whole formula has the effects of nourishing qi and yin, calming the mind and stabilizing the spirit, and connecting the heart and kidney.

[0125] The above description of the embodiments is to facilitate the understanding and use of the invention by those skilled in the art. It is obvious that those skilled in the art can easily make various modifications to these embodiments and apply the general principles described herein to other embodiments without creative work. Therefore, the present invention is not limited to the above embodiments, and improvements and modifications made by those skilled in the art based on the disclosure of the present invention without departing from the scope of the present invention should be within the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for insomnia of Qi and Yin deficiency type, characterized in that: The composition comprises the following components in parts by weight: 9-20 parts of Pseudostellariae Radix, 9-18 parts of Ophiopogon japonicus, 6-27 parts of Platycladus orientalis seeds, 6-25 parts of Ziziphus jujuba seeds, 6-18 parts of Poria cocos, 3-18 parts of Polygala tenuifolia, 3-18 parts of Schisandra chinensis, 6-12 parts of Cinnamomum cassia twig, 12-20 parts of Salvia miltiorrhiza, 12-18 parts of Albizzia julibrissin, and 3-9 parts of Licorice.

2. A Chinese medicine composition for treating insomnia of Qi and Yin deficiency type according to claim 1, characterized in that: The composition comprises the following components in parts by weight: 15 parts of Pseudostellariae Radix, 12 parts of Ophiopogon japonicus, 10 parts of Semen Platycladi, 10 parts of Semen Ziziphi Spinosae, 10 parts of Poria, 6 parts of Polygala tenuifolia, 5 parts of Schisandrae Chinensis, 6 parts of Cinnamomum cassia, 15 parts of Salvia miltiorrhiza, 15 parts of Flos Albizziae, and 5 parts of Licorice.

3. A Chinese medicine composition for treating insomnia of Qi and Yin deficiency type according to claim 1 or 2, characterized in that: The sour jujube seeds are fried sour jujube seeds.

4. A Chinese medicine composition for treating insomnia of Qi and Yin deficiency type according to claim 1 or 2, characterized in that: The Polygala described is processed Polygala.

5. A Chinese medicine composition for treating insomnia of Qi and Yin deficiency type according to claim 1 or 2, characterized in that: The Schisandra chinensis is Schisandra chinensis.

6. A Chinese medicine composition for treating insomnia of Qi and Yin deficiency type according to claim 1 or 2, characterized in that: The licorice is roasted licorice.

7. A method for processing the Chinese medicine composition for treating insomnia of Qi and Yin deficiency type according to any one of claims 1 to 6, characterized in that: The steps include: The components are taken according to the formula, soaked in water and boiled once, the medicinal juice is filtered out, water is added to the medicinal residue and boiled twice, the medicinal juice is filtered out, and the medicinal juices obtained by the two decoctions are combined.

8. The processing method of a Chinese medicine composition for treating insomnia of Qi and Yin deficiency type according to claim 7, characterized in that: In the first decoction, the mass of water is 8-11 times the total mass of the Chinese medicine composition, and the decoction time is 1-4 hours; in the second decoction, the mass of water is 8-10 times the total mass of the medicinal residue, and the decoction time is 1-4 hours.

9. Use of the traditional Chinese medicine composition for insomnia of qi and yin deficiency type according to any one of claims 1 to 6 in the preparation of a medicine for treating insomnia of qi and yin deficiency type.

10. The use according to claim 9, characterized in that: The dosage form of the medicine is extract or decoction.

Citation Information

Patent Citations

  • Method for preparing traditional Chinese medicine for treating insomnia caused by deficiency of both qi and yin

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