A traditional Chinese medicine composition for treating insomnia

Abstract

This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for treating insomnia. The invention provides a traditional Chinese medicine composition for treating insomnia, comprising the following raw materials: prepared licorice root, Poria cocos, ginger, cinnamon twig, jujube seed, longan, lotus seed heart, lily bulb, ginseng, bamboo leaf, dragon bone, Ophiopogon japonicus, white peony root, Angelica sinensis, Polygala tenuifolia, Acorus tatarinowii, and Poria cocos sclerotium. The invention also provides a method for preparing the aforementioned traditional Chinese medicine composition, comprising the following steps: weighing and pulverizing the raw materials according to the formula and mixing them; soaking the pulverized mixture in water; decocting after soaking; filtering after decoction; concentrating the filtrate; spray drying to prepare one of the following: granules, powders, capsules, or tablets. The traditional Chinese medicine composition of this invention can effectively improve the symptoms of insomnia, has no obvious adverse reactions in clinical practice, and has long-term health benefits.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and more specifically, to a traditional Chinese medicine composition for treating insomnia. Background Technology

[0002] With rapid societal development and an increasingly fast-paced lifestyle, the factors threatening human health are increasing. Among these, the incidence of chronic diseases is rising year by year, and insomnia, as one of them, has a particularly significant impact. Epidemiological studies show that approximately one-third of the global population faces insomnia problems each year, and this proportion increases with age.

[0003] Insomnia, a common sleep disorder, is characterized by difficulty falling asleep, difficulty maintaining sleep, or early awakening, resulting in sleep duration and quality that do not meet an individual's physiological needs, thus affecting daily life and work efficiency. Insomnia can be caused by a variety of factors, including psychological factors, medical conditions, environmental factors, age factors, medication factors, and dietary factors. Long-term insomnia not only leads to mental fatigue and poor concentration but can also trigger a range of physical and mental health problems, such as anxiety, depression, and weakened immunity.

[0004] In traditional Chinese medicine (TCM) theory, insomnia is categorized under "sleeplessness," "inability to close the eyes," and "inability to sleep." Its pathogenesis is summarized as an imbalance of Yin and Yang, with Yang failing to enter Yin. TCM treatment of insomnia emphasizes holistic regulation, aiming to treat insomnia by harmonizing organ functions, balancing Yin and Yang, Qi and blood, and calming the mind.

[0005] Currently, treatments for insomnia mainly include medication, psychotherapy, and lifestyle modifications. Among these, medication is widely used due to its rapid and direct effects. However, while existing Western medicine treatments for insomnia can achieve certain results in the short term, long-term use may lead to dependence, drug tolerance, and even a series of adverse reactions such as dizziness, headaches, and nausea.

[0006] In contrast, traditional Chinese medicine (TCM) offers unique advantages and potential for treating insomnia. TCM emphasizes holistic treatment, regulating the body's Qi and blood, as well as the functions of the internal organs, to improve sleep. Furthermore, TCM treatment has fewer side effects, higher safety profiles, and better patient compliance. Therefore, in recent years, an increasing number of researchers have begun to focus on the application of TCM in the treatment of insomnia.

[0007] However, existing traditional Chinese medicine (TCM) treatments for insomnia mostly involve single herbs or simple compound preparations, and their efficacy and safety still need improvement. To further enhance the efficacy and safety of TCM treatment for insomnia, this invention provides a TCM composition for treating insomnia. This composition, through the careful selection and combination of various TCM herbs, along with modern pharmacology and clinical experience, aims to improve sleep quality and alleviate insomnia symptoms by regulating the body's Qi and blood, and the functions of the internal organs. Summary of the Invention

[0008] In order to overcome the problems in the prior art, the present invention provides a traditional Chinese medicine composition for treating insomnia.

[0009] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating insomnia, employing the following technical solution:

[0010] A traditional Chinese medicine composition for treating insomnia comprises the following raw materials in parts by weight: 8-14 parts of prepared licorice root, 12-20 parts of Poria cocos, 10-12 parts of fresh ginger, 4-8 parts of cinnamon twig, 10-16 parts of jujube seed, 8-10 parts of longan, 6-12 parts of lotus seed heart, 4-8 parts of lily bulb, 10-16 parts of ginseng, 8-14 parts of bamboo leaf, 6-10 parts of dragon bone, 7-13 parts of Ophiopogon japonicus, 15-20 parts of white peony root, 6-8 parts of Angelica sinensis, 12-15 parts of Polygala tenuifolia, 15-20 parts of Acorus tatarinowii, and 14-16 parts of Poria cocos.

[0011] Further, the ingredients include the following parts by weight: 10-12 parts of prepared licorice root, 15-17 parts of Poria cocos, 10-12 parts of fresh ginger, 5-7 parts of cinnamon twig, 12-14 parts of jujube seed, 8-10 parts of longan, 8-10 parts of lotus seed heart, 5-7 parts of lily bulb, 12-14 parts of ginseng, 10-12 parts of bamboo leaf, 7-9 parts of dragon bone, 9-11 parts of Ophiopogon japonicus, 16-18 parts of white peony root, 6-8 parts of angelica sinensis, 12-14 parts of Polygala tenuifolia, 16-18 parts of Acorus tatarinowii, and 14-16 parts of Poria cocos.

[0012] Furthermore, the ingredients include the following parts by weight: 11 parts roasted licorice root, 16 parts Poria cocos, 11 parts fresh ginger, 6 parts cinnamon twig, 13 parts jujube seed, 9 parts longan, 9 parts lotus seed heart, 6 parts lily bulb, 13 parts ginseng, 11 parts bamboo leaves, 8 parts dragon bone, 10 parts Ophiopogon japonicus, 17 parts white peony root, 7 parts angelica sinensis, 13 parts polygala tenuifolia, 17 parts acorus tatarinowii, and 15 parts Poria cocos.

[0013] Secondly, the present invention also provides another method for preparing a traditional Chinese medicine composition for treating insomnia, employing the following technical solution:

[0014] A method for preparing a traditional Chinese medicine composition for treating insomnia, specifically including the following preparation steps:

[0015] (1) Weigh the raw materials according to the formula, crush them, and mix them; soak the crushed mixture in water;

[0016] (2) After soaking, decoct; after decoction, filter, concentrate the filtrate, spray dry, and prepare one of the following: granules, powders, capsules, or tablets.

[0017] Furthermore, the soaking time in step (1) shall be no less than 2 hours.

[0018] Furthermore, in step (2), the decoction is performed twice. The amount of water added in the first step is 10-15 times the weight of the mixed powder, and the amount of water added in the second step is 5-10 times the weight of the mixed powder. The total decoction time is 2-3 hours.

[0019] Thirdly, the present invention also provides the use of the traditional Chinese medicine composition for treating insomnia in the preparation of a medicament for treating insomnia or in the preparation of a health food for adjuvant treatment of insomnia.

[0020] Fourthly, the present invention also provides a traditional Chinese medicine preparation comprising a traditional Chinese medicine composition for treating insomnia and pharmaceutically acceptable excipients.

[0021] Furthermore, the traditional Chinese medicine preparation is in the form of granules, tablets, pills, decoctions, powders, ointments, or capsules.

[0022] In summary, the present invention has the following beneficial effects:

[0023] Prepared licorice root has the effects of tonifying the spleen and stomach, replenishing qi and restoring pulse, relieving cough and asthma, and relieving pain. It is sweet in taste and neutral in nature, and enters the heart, lung, stomach, and spleen meridians. It has the functions of strengthening the spleen and replenishing qi, relieving cough and asthma, and clearing heat and detoxifying. It can treat symptoms such as spleen and stomach weakness, qi deficiency and fatigue, and limb weakness, thereby alleviating insomnia symptoms. In addition, prepared licorice root can harmonize the properties of other herbs, enhance their potency, and reduce their toxicity and severity, thus having a therapeutic effect on some patients with drug poisoning. Furthermore, prepared licorice root can also harmonize the effects of other herbs, playing a moderating role in the prescription.

[0024] Poria cocos contains triterpenic acids and polysaccharides, which act on the target-pathways related to sleep disorders, increase the level of γ-aminobutyric acid receptor subunits, decrease the level of γ-subunits, prolong the sleep behavior induced by sodium pentobarbital, and synergistically inhibit the central nervous system with pentobarbital to achieve a hypnotic effect.

[0025] Ginger can promote blood circulation and has a calming effect. It also soothes the stomach and relieves nausea. The renowned Qing Dynasty physician Shao Lansun wrote a special treatise on insomnia, believing it stemmed from "an upset stomach leading to restless sleep," and that treatment should focus on harmonizing the stomach and calming the mind.

[0026] Cinnamon twigs harmonize the Ying and Wei (nutritive and defensive qi) and regulate their circulation to balance Yin and Yang. They have the effects of inducing sweating and relieving muscle tension, assisting Yang in transforming Qi, and warming the meridians and promoting blood circulation.

[0027] Sour jujube seed, sour in taste and neutral in nature, enters the heart, spleen, liver, and gallbladder meridians. It has the effects of calming the mind and soothing the nerves, nourishing the liver and astringing sweat. In the Han Dynasty medical text *Jinkui Yaolue*, it was used to treat "restlessness and insomnia." The Yuan Dynasty physician Zhu Danxi recorded that sour jujube seed is suitable for insomnia caused by blood not returning to the spleen: "It is appropriate to use this to greatly nourish the heart and spleen, so that blood returns to the spleen and the five internal organs are at peace, and sleep will naturally be peaceful." Sour jujube seed is a traditional Chinese medicine, and modern research on its effects on insomnia has been extensively reported. It is also one of the commonly used sedative drugs in clinical practice. It relies on saponins, flavonoids, alkaloids, and other components to exert its pharmacological effects in preventing and treating insomnia. It improves sleep quality by altering the levels of neurotransmitters in the body, thereby achieving the therapeutic purpose.

[0028] Longan, also known as dried longan, is sweet and warm in nature, entering the heart and spleen meridians. It nourishes blood and calms the mind, tonifies the heart and spleen, and is suitable for those with insufficient qi and blood, palpitations, forgetfulness, and insomnia. Li Shizhen described longan as "greatly nourishing" and said, "Among nourishing herbs, dried longan is the best." Longan is not only a good tonic, but in modern times it is also used as a food for preventing and treating insomnia. Studies have shown that it has pharmacological effects such as anti-aging, anti-tumor, immune regulation, and endocrine balancing.

[0029] Lotus seed hearts have the effects of tonifying the kidneys and securing essence, strengthening the spleen and stopping diarrhea, and nourishing the heart and calming the mind. Clinically, they are used in combination with Ophiopogon japonicus, Platycladus orientalis seeds, and Poria cocos to treat vexation, palpitations, and insomnia. Lotus seed hearts are bitter and cold in nature, and enter the heart and kidney meridians. They were first recorded as a food ingredient in the Tang Dynasty's "Compendium of Materia Medica," where they were found to have effects such as clearing heat, stopping bleeding, and calming the mind. Modern clinical research shows that their main components are alkaloids and flavonoids, which not only have sedative and antidepressant effects, but also have pharmacological effects such as lowering blood sugar, antibacterial activity, antioxidation, and regulating blood lipids.

[0030] Lily bulbs enter the lung and heart meridians, and have the functions of moistening the lungs and relieving cough, clearing the heart and calming the mind. They can be used to treat symptoms such as restlessness, palpitations, insomnia, and excessive dreaming. Modern research shows that lily saponins in lily bulbs have certain sedative, hypnotic, antidepressant, and antitumor effects. Therefore, drinking lily bulb tea in daily life can be effective for insomnia caused by upward floating of deficiency heat.

[0031] Ginseng is sweet, slightly bitter, and slightly warm in nature, and enters the spleen, lung, and heart meridians. It has the functions of greatly replenishing vital energy, nourishing qi and blood, calming the mind, and improving intelligence. It is very effective in improving insomnia caused by blood deficiency.

[0032] Bamboo leaves, sweet and bland in taste, and cold in nature, enter the heart, lung, gallbladder, and stomach meridians. The effects of bamboo leaves include clearing heat and relieving irritability, quenching thirst, and calming the mind. The *Shennong Bencao Jing* describes them as having a "clear fragrance that soothes the heart, slightly bitter, and clearing both heat and coolness," and "primarily treating summer heat and thirst." The *Bencao Gangmu* records that they can "remove irritability and heat, promote urination, and clear the mind." Wash fresh bamboo leaves, put them in a pot with an appropriate amount of water, and decoct them until concentrated. Drink the warm liquid as a tea substitute, divided into morning and afternoon doses. This is not only a good tea for relieving summer heat, but also effectively treats symptoms such as restlessness, irritability, and thirst after a febrile illness.

[0033] Dragon bone has the effects of calming the nerves, soothing the liver, suppressing yang, and astringing. It is mainly used to treat restlessness, palpitations, insomnia, epilepsy, and dizziness due to liver yang rising. It has a good effect on relieving anxiety and insomnia and helps improve sleep quality.

[0034] Ophiopogon japonicus, recorded as a superior medicinal herb in the *Shennong Bencao Jing* (Shennong's Classic of Materia Medica), China's first pharmacopoeia, has become a highly profitable crop for farmers due to its valuable tuberous root. Ophiopogon japonicus is also known as "Yu Jiu" (Yu's Leftover Grain), a name derived from a legend: after successfully controlling the floods, Yu the Great ordered the surplus grain to be poured into the river, where a herb, Ophiopogon japonicus, grew, which people called "Yu Yu Liang" (Yu's Surplus Grain). Both *Bencao Yanyi* and *Bencao Beiyao* record that Ophiopogon japonicus has the effects of nourishing yin and generating fluids, moistening the lungs and clearing the heart. It can nourish heart yin, clear heart heat, and has a certain effect of relieving irritability and calming the mind, and can be used for symptoms such as irritability and palpitations caused by heart yin deficiency with heat.

[0035] White peony root is used medicinally. It has a pungent and bitter taste and is slightly toxic. It has the effects of warming the yang and dispelling dampness, replenishing the body and strengthening the spleen and stomach.

[0036] Angelica sinensis, sweet, pungent, and warm in nature, is primarily used to nourish blood, invigorate blood circulation, regulate menstruation and relieve pain, and moisten dryness and lubricate the intestines. It is mainly used for various symptoms of blood deficiency. In traditional Chinese medicine, Angelica sinensis is renowned as the premier blood-nourishing herb. Its blood-nourishing effects can significantly improve symptoms caused by blood deficiency, such as pale complexion, palpitations, numbness in the limbs, and cold hands and feet. Improvement in these symptoms can also help alleviate insomnia caused by blood deficiency.

[0037] Polygala tenuifolia has the effects of calming the mind, improving intelligence, relieving phlegm, and clearing the orifices.

[0038] Acorus calamus has the effects of clearing the orifices and relieving phlegm, refreshing the mind and improving intelligence.

[0039] Poria cocos has the effects of calming the nerves, promoting diuresis, and eliminating dampness.

[0040] The Chinese medicinal herbs used in the formula of this invention are all considered in traditional Chinese medicine to have the effects of calming the mind, sedation, regulating qi and blood, and nourishing the internal organs, making them suitable for treating sleep disorders such as insomnia. Modern pharmacological studies have found that these medicinal herbs contain a variety of effective components, such as flavonoids, saponins, and polysaccharides. These components can regulate neurotransmitters, improve electroencephalogram (EEG) activity patterns, and promote blood oxygen supply, thereby exerting a therapeutic effect on insomnia.

[0041] The traditional Chinese medicine composition of this invention has significant advantages in terms of safety. First, the medicinal materials used in this composition are all traditional Chinese medicines, and their safety and efficacy have been widely recognized through long-term clinical application and verification. Second, these medicinal materials are all considered in traditional Chinese medicine theory to have the effects of calming the mind, sedation, regulating qi and blood, and nourishing the internal organs, and they are mild in nature and flavor, making them less likely to produce side effects.

[0042] Furthermore, the traditional Chinese medicine composition of this invention fully considers the interactions between medicinal materials and the synergistic effect of their efficacy in its formulation, avoiding potential side effects and adverse reactions. Modern pharmacological studies have found that the multiple active ingredients in this composition can work synergistically to achieve better therapeutic effects while reducing the adverse reactions that may be caused by a single medicinal material.

[0043] In this invention, the combination of jujube seed and prepared licorice root helps to nourish the spleen and blood, replenish yin and fluids, and nourish the five internal organs. Simultaneously, the combination of ginseng, cinnamon twig, and jujube seed effectively enhances the therapeutic effect of the traditional Chinese medicine formula for insomnia.

[0044] In practical applications, the traditional Chinese medicine composition of this invention has undergone rigorous clinical trials and verification, proving its safety and efficacy with no obvious toxic side effects. Patients using this composition can significantly improve their sleep quality, alleviate insomnia symptoms, and are less likely to develop dependence or drug tolerance.

[0045] The herbal composition of this invention significantly prolongs the sleep time of SD rats, showing a significant difference compared to the saline group. Furthermore, clinical efficacy trials have demonstrated that the herbal composition of this invention is significantly effective with a low incidence of adverse reactions, exhibiting excellent clinical efficacy and practical application value. Detailed Implementation

[0046] The technical solution of the present invention will be further illustrated below through specific embodiments. Those skilled in the art should understand that the embodiments described are merely illustrative of the present invention and should not be construed as limiting the invention in any way.

[0047] The processes, conditions, reagents, and experimental methods used in implementing this invention, except as specifically mentioned below, are all common knowledge and general knowledge in the field, and this invention does not have any particular limitations. Experimental methods in the embodiments that do not specify specific conditions are generally performed under conventional conditions or as recommended by the manufacturer.

[0048] Unless otherwise stated, all technical terms and scientific terms used in this specification have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. However, in the event of any conflict, the specification containing the definitions shall prevail.

[0049] The mechanism of traditional Chinese medicine (TCM) in treating insomnia is mainly based on the theories of Zang-Fu organs and meridians, and Qi and blood. Firstly, TCM believes that insomnia is related to the functional imbalances of organs such as the heart, liver, spleen, and kidneys. Therefore, TCM treatment for insomnia focuses on regulating the functions of these organs, such as through methods like clearing heat and purging fire, nourishing Yin and tonifying the kidneys, and soothing the liver and relieving stagnation, to improve organ function and thus alleviate insomnia symptoms. Furthermore, TCM also believes that Qi and blood are the foundation of human life activities, and stagnation of Qi and blood can lead to insomnia. Therefore, TCM treatment for insomnia focuses on regulating the flow of Qi and blood, such as through methods like promoting blood circulation and removing blood stasis, and tonifying Qi and nourishing blood, to improve the state of Qi and blood and thus alleviate insomnia symptoms.

[0050] The present invention proposes a traditional Chinese medicine composition for treating insomnia, comprising the following raw materials in parts by weight: 10-12 parts of prepared licorice root, 15-17 parts of Poria cocos, 10-12 parts of fresh ginger, 5-7 parts of cinnamon twig, 12-14 parts of jujube seed, 8-10 parts of longan, 8-10 parts of lotus seed heart, 5-7 parts of lily bulb, 12-14 parts of ginseng, 10-12 parts of bamboo leaf, 7-9 parts of dragon bone, 9-11 parts of Ophiopogon japonicus, 16-18 parts of white peony root, 6-8 parts of angelica sinensis, 12-14 parts of Polygala tenuifolia, 16-18 parts of Acorus tatarinowii, and 14-16 parts of Poria cocos.

[0051] The preparation method of the traditional Chinese medicine composition for treating insomnia includes the following steps:

[0052] (1) Weigh the raw materials according to the formula, crush them and mix them; add water to soak the crushed mixture; soak for no less than 2 hours;

[0053] (2) After soaking, decoct the mixture; the first water addition is 10-15 times the weight of the powder mixture, the second water addition is 5-10 times the weight of the powder mixture, and the total decoction time is 2-3 hours; after decoction, filter the mixture, concentrate the filtrate, spray dry it, and prepare it into one of the following: granules, powders, capsules, or tablets.

[0054] The present invention will be further explained below with reference to specific embodiments:

[0055] Example 1

[0056] The traditional Chinese medicine composition used in this embodiment for treating insomnia is made from the following raw materials in parts by weight: 11 parts roasted licorice root, 16 parts Poria cocos, 11 parts fresh ginger, 6 parts cinnamon twig, 13 parts jujube seed, 9 parts longan, 9 parts lotus seed heart, 6 parts lily bulb, 13 parts ginseng, 11 parts bamboo leaf, 8 parts dragon bone, 10 parts Ophiopogon japonicus, 17 parts white peony root, 7 parts Angelica sinensis, 13 parts Polygala tenuifolia, 17 parts Acorus tatarinowii, and 15 parts Poria cocos.

[0057] The preparation method of the traditional Chinese medicine composition includes:

[0058] (1) Weigh the raw materials according to the formula, crush them, and mix them; add water to the crushed mixture and soak it for 2 hours;

[0059] (2) After soaking, decoct the mixture; add water for the first time at 12 times the weight of the powder mixture and decoct for 1.5 hours; add water for the second time at 8 times the weight of the powder mixture and decoct for 1 hour; after decoction, filter the mixture, concentrate the filtrate, spray dry it, and prepare it into granules to obtain the Chinese herbal composition for treating insomnia.

[0060] Example 2

[0061] The traditional Chinese medicine composition used in this embodiment for treating insomnia is made from the following raw materials in parts by weight: 10 parts of prepared licorice root, 17 parts of Poria cocos, 10 parts of fresh ginger, 7 parts of cinnamon twig, 12 parts of jujube seed, 10 parts of longan, 8 parts of lotus seed heart, 7 parts of lily bulb, 12 parts of ginseng, 12 parts of bamboo leaf, 7 parts of dragon bone, 11 parts of Ophiopogon japonicus, 16 parts of white peony root, 8 parts of Angelica sinensis, 12 parts of Polygala tenuifolia, 18 parts of Acorus tatarinowii, and 14 parts of Poria cocos.

[0062] The preparation method of the traditional Chinese medicine composition includes:

[0063] (1) Weigh the raw materials according to the formula, crush them, and mix them; add water to the crushed mixture and soak it for 2 hours;

[0064] (2) After soaking, decoct the mixture; add water for the first time at 12 times the weight of the powder mixture and decoct for 1.5 hours; add water for the second time at 8 times the weight of the powder mixture and decoct for 1 hour; after decoction, filter the mixture, concentrate the filtrate, spray dry it, and prepare it into granules to obtain the Chinese herbal composition for treating insomnia.

[0065] Example 3

[0066] The traditional Chinese medicine composition used in this embodiment for treating insomnia is made from the following raw materials in parts by weight: 12 parts roasted licorice root, 15 parts Poria cocos, 12 parts fresh ginger, 5 parts cinnamon twig, 14 parts jujube seed, 8 parts longan, 10 parts lotus seed heart, 5 parts lily bulb, 14 parts ginseng, 10 parts bamboo leaf, 9 parts dragon bone, 9 parts Ophiopogon japonicus, 18 parts white peony root, 6 parts angelica sinensis, 14 parts polygala tenuifolia, 16 parts acorus tatarinowii, and 16 parts poria cocos.

[0067] The preparation method of the traditional Chinese medicine composition includes:

[0068] (1) Weigh the raw materials according to the formula, crush them, and mix them; add water to the crushed mixture and soak it for 2 hours;

[0069] (2) After soaking, decoct the mixture; add water for the first time at 12 times the weight of the powder mixture and decoct for 1.5 hours; add water for the second time at 8 times the weight of the powder mixture and decoct for 1 hour; after decoction, filter the mixture, concentrate the filtrate, spray dry it, and prepare it into granules to obtain the Chinese herbal composition for treating insomnia.

[0070] Comparative Example 1

[0071] The traditional Chinese medicine composition used to treat insomnia in this comparative example is made from the following raw materials in parts by weight: 11 parts licorice, 16 parts poria cocos, 11 parts ginger, 6 parts cinnamon twig, 13 parts jujube seed, 9 parts longan, 9 parts lotus seed heart, 6 parts lily bulb, 13 parts ginseng, 11 parts bamboo leaf, 8 parts dragon bone, 10 parts ophiopogon japonicus, 17 parts white peony root, 7 parts angelica sinensis, 13 parts polygala tenuifolia, 17 parts acorus tatarinowii, and 15 parts poria cocos.

[0072] The preparation method of the traditional Chinese medicine composition includes:

[0073] (1) Weigh the raw materials according to the formula, crush them, and mix them; add water to the crushed mixture and soak it for 2 hours;

[0074] (2) After soaking, decoct the mixture; add water for the first time at 12 times the weight of the powder mixture and decoct for 1.5 hours; add water for the second time at 8 times the weight of the powder mixture and decoct for 1 hour; after decoction, filter the mixture, concentrate the filtrate, spray dry it, and prepare it into granules to obtain the Chinese herbal composition for treating insomnia.

[0075] Comparative Example 2

[0076] The traditional Chinese medicine composition used to treat insomnia in this comparative example is made from the following raw materials in parts by weight: 11 parts prepared licorice root, 16 parts Poria cocos, 11 parts fresh ginger, 6 parts cinnamon twig, 13 parts jujube, 9 parts longan, 9 parts lotus seed heart, 6 parts lily bulb, 13 parts ginseng, 11 parts bamboo leaves, 8 parts dragon bone, 10 parts Ophiopogon japonicus, 17 parts white peony root, 7 parts Angelica sinensis, 13 parts Polygala tenuifolia, 17 parts Acorus tatarinowii, and 15 parts Poria cocos.

[0077] The preparation method of the traditional Chinese medicine composition includes:

[0078] (1) Weigh the raw materials according to the formula, crush them, and mix them; add water to the crushed mixture and soak it for 2 hours;

[0079] (2) After soaking, decoct the mixture; add water for the first time at 12 times the weight of the powder mixture and decoct for 1.5 hours; add water for the second time at 8 times the weight of the powder mixture and decoct for 1 hour; after decoction, filter the mixture, concentrate the filtrate, spray dry it, and prepare it into granules to obtain the Chinese herbal composition for treating insomnia.

[0080] Comparative Example 3

[0081] This comparative proportion of a traditional Chinese medicine composition for treating insomnia is made from the following raw materials in parts by weight: 11 parts roasted licorice root, 16 parts Poria cocos, 11 parts fresh ginger, 13 parts jujube seed, 9 parts longan, 9 parts lotus seed heart, 6 parts lily bulb, 11 parts bamboo leaf, 8 parts dragon bone, 10 parts Ophiopogon japonicus, 17 parts white peony root, 7 parts angelica sinensis, 17 parts acorus tatarinowii, and 15 parts Poria cocos.

[0082] The preparation method of the traditional Chinese medicine composition includes:

[0083] (1) Weigh the raw materials according to the formula, crush them, and mix them; add water to the crushed mixture and soak it for 2 hours;

[0084] (2) After soaking, decoct the mixture; add water for the first time at 12 times the weight of the powder mixture and decoct for 1.5 hours; add water for the second time at 8 times the weight of the powder mixture and decoct for 1 hour; after decoction, filter the mixture, concentrate the filtrate, spray dry it, and prepare it into granules to obtain the Chinese herbal composition for treating insomnia.

[0085] Comparative Example 4

[0086] Patent CN115252753B discloses a traditional Chinese medicine composition for treating insomnia and its application. Specifically, it relates to a traditional Chinese medicine composition for treating insomnia, whose main active ingredients, by mass parts, include: 10-25 parts of cinnamon twig, 10-25 parts of white peony root, 5-25 parts of licorice root, 10-30 parts of ginger, 15-30 parts of jujube, 10-30 parts of ginseng, 10-30 parts of angelica root, 10-30 parts of morinda root, and 10-30 parts of ophiopogon root.

[0087] The traditional Chinese medicine composition used to treat insomnia in this comparative example is made from the following raw materials in parts by weight: 15g cinnamon twig, 15g white peony root, 15g prepared licorice root, 20g fresh ginger, 20g jujube, 10g sun-dried ginseng, 15g angelica root, 15g morinda root, and 10g ophiopogon root.

[0088] The preparation method of the traditional Chinese medicine composition includes:

[0089] (1) Weigh the raw materials according to the formula, crush them, and mix them; add water to the crushed mixture and soak it for 2 hours;

[0090] (2) After soaking, decoct the mixture; add water for the first time at 12 times the weight of the powder mixture and decoct for 1.5 hours; add water for the second time at 8 times the weight of the powder mixture and decoct for 1 hour; after decoction, filter the mixture, concentrate the filtrate, spray dry it, and prepare it into granules to obtain the Chinese herbal composition for treating insomnia.

[0091] Animal pharmacodynamic experiments:

[0092] Effect of sodium pentobarbital on sleep time in SD rats: Seventy SD rats were randomly divided into seven groups: a saline control group, a granule group prepared according to the formulation in Example 1, granule groups prepared according to the formulations in Comparative Examples 1-4, and a diazepam positive control group, with 10 rats in each group. The SD rats were healthy male SD rats, SPF grade, weighing 200-220g, purchased from Beijing Vital River Pharmaceutical Co., Ltd. It should also be noted that all drugs required in this invention are commercially available.

[0093] Example and Comparative group: 10.0 g / kg of fine drug powder was administered by gavage at a dose of 5 ml / kg and a volume of 0.2 ml / 10 g.

[0094] Positive control group for diazepam: Administered 1 mg / kg diazepam via gavage;

[0095] The normal saline control group was given the same volume of normal saline by gavage.

[0096] Sixty minutes after oral administration, each group of SD rats was given sodium pentobarbital at 40 mg / kg via intraperitoneal injection. The sleep time of the SD rats was recorded (the time from the disappearance of the righting reflex was defined as the time of sleep onset, and the time from the disappearance of the righting reflex to its recovery was defined as the sleep duration). The results are shown in Table 1 below:

[0097] Table 1

[0098]

[0099] Note: Compared with the saline group, * indicates P < 0.05, and ** indicates P < 0.01.

[0100] The results in Table 1 show that the herbal composition of this invention significantly prolonged the sleep time of SD rats, showing a significant difference compared to the saline group. This result proves that the drug of this invention has a significant sedative-hypnotic effect, and this discovery is of great significance for drug development and clinical application. Furthermore, a comparison with existing formulations also shows that its performance still has certain advantages over existing technologies.

[0101] Clinical efficacy trials:

[0102] 1. Insomnia patients were selected and randomly divided into 6 groups of 50 people each. The basic data were analyzed and compared. The test results showed no difference (P>0.05), indicating comparability. (1) Inclusion criteria: ① Those who meet the relevant diagnostic criteria for insomnia in "Internal Medicine of Traditional Chinese Medicine"; ② Those who meet the relevant diagnostic criteria for insomnia in "Chinese Classification and Diagnostic Criteria for Mental Disorders" (CCMD-3); ③ Those who have not taken sedative-hypnotic drugs for one month before the study; ④ Those who understand the research content and can actively cooperate with the researchers. (2) Exclusion criteria: ① Those who are allergic or have contraindications to the drugs in the study; ② Those who have endocrine or infectious diseases; ③ Those who have serious liver, heart, or kidney diseases; ④ Those who have recently participated in other clinical studies.

[0103] 2. Methods: The control group received Western medicine treatment, taking 10 mg of zolpidem tartrate tablets (manufacturer: Lunan Better Pharmaceutical Co., Ltd., approval number: H20020372, specification: 10 tablets / box) orally once daily before bedtime. They also took 20 mg of oryzanol (manufacturer: Guangdong Hengjian Pharmaceutical Co., Ltd., approval number: H44020613, specification: 10 mg * 100 tablets) orally twice daily. The experimental group received the same prescription as in Example 1 and Comparative Examples 1-4, decocted with water and taken once daily, divided into two doses, morning and evening. All patients adhered to the treatment regimen for one month.

[0104] 3. Judgment indicators: (1) The Pittsburgh Sleep Quality Index (PSQI) was used to evaluate the treatment effectiveness: a reduction in the score of 76-100% was defined as cured, a reduction in the score of 51-75% was defined as significantly effective, a reduction in the score of 26-50% was defined as effective, and a reduction in the score of less than 25% was defined as ineffective. (2) The incidence of adverse reactions in 6 groups was assessed: palpitations, abnormal liver function, headache, gastrointestinal discomfort, etc.

[0105] 4. Statistical analysis was performed using SPSS 25.0 statistical software. Quantitative data were analyzed using... The data were expressed as t-tests for comparisons among the six groups; count data were expressed as rates, and comparisons among groups were expressed as chi-square tests. 2 The test was performed, with P < 0.05 considered statistically significant.

[0106] The efficacy of the six groups was compared in the table below. The differences between the groups were statistically significant (P < 0.05), as detailed in Table 2 below:

[0107] Table 2

[0108]

[0109] The incidence rates (in cases %) of adverse reactions in the six groups are shown in Table 3 below:

[0110] Table 3

[0111]

[0112] Based on the comparison of the aforementioned tables, the traditional Chinese medicine composition of this invention has significant therapeutic effects and a low incidence of adverse reactions, demonstrating excellent clinical efficacy and practical application value.

[0113] This specific embodiment is merely an explanation of the present invention and is not intended to limit the invention. After reading this specification, those skilled in the art can make modifications to this embodiment without contributing any inventive step, but such modifications are protected by patent law as long as they fall within the scope of the claims of the present invention.

Claims

1. A traditional Chinese medicine preparation for treating insomnia, characterized in that, It is composed of the following ingredients in parts by weight: 11 parts prepared licorice root, 16 parts Poria cocos, 11 parts fresh ginger, 6 parts cinnamon twig, 13 parts jujube seed, 9 parts longan, 9 parts lotus seed heart, 6 parts lily bulb, 13 parts ginseng, 11 parts bamboo leaves, 8 parts dragon bone, 10 parts Ophiopogon japonicus, 17 parts white peony root, 7 parts angelica sinensis, 13 parts polygala tenuifolia, 17 parts acorus tatarinowii, and 15 parts Poria cocos. The preparation method of the traditional Chinese medicine preparation for treating insomnia includes the following steps: (1) Weigh the raw materials according to the formula, crush them, and mix them; then soak the crushed mixture in water; (2) After soaking, decoct; after decoction, filter, concentrate the filtrate, spray dry, and prepare one of granules, powders, capsules, or tablets.

2. The method for preparing the traditional Chinese medicine preparation for treating insomnia according to claim 1, characterized in that, Includes the following steps: (1) Weigh the raw materials according to the formula, crush them, and mix them; then soak the crushed mixture in water; (2) Soak and then decoct; After decoction, the solution is filtered, concentrated, spray-dried, and prepared into one of the following: granules, powders, capsules, or tablets.

3. The method for preparing the traditional Chinese medicine preparation for treating insomnia according to claim 2, characterized in that, The soaking time in step (1) shall not be less than 2 hours.

4. The method for preparing the traditional Chinese medicine preparation for treating insomnia according to claim 2, characterized in that, In step (2), the decoction is done in two stages. The amount of water added in the first stage is 10-15 times the weight of the mixed powder, and the amount of water added in the second stage is 5-10 times the weight of the mixed powder. The total decoction time is 2-3 hours.

5. The use of the traditional Chinese medicine preparation for treating insomnia as described in claim 1 in the preparation of a drug for treating insomnia.

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