Traditional Chinese medicine composition for improving sleep quality and application thereof

Abstract

The invention provides a sleep-aiding traditional Chinese medicine composition and application thereof, and the sleep-aiding traditional Chinese medicine composition mainly comprises a polygonum multiflorum extract, and can promote autonomic nerve balance, effectively help sleep, prolong sleep time, increase sleep depth and improve sleep quality.

Description

Technical Field

[0001] The present invention relates to a Chinese medicine composition for aiding sleep, improving sleep quality, treating insomnia and sleep disorders, and in particular to a Chinese medicine composition for aiding sleep, improving sleep quality, treating insomnia and sleep disorders and pharmaceutical use thereof. Background Art

[0002] Sleep disorders are a global health problem. According to data released by the World Sleep Association in 2017, nearly 45% of the world's population has sleep problems. Sleep disorders are particularly prevalent in developed industrialized countries. For example, in 2016, the U.S. Centers for Disease Control and Prevention pointed out that nearly one-third of Americans suffer from sleep problems. Sleep problems not only pose a major threat to personal quality of life and health, but also lead to individuals' lack of concentration, decreased creativity, fatigue at work, poor learning results, and even increase the risk of car accidents, which greatly reduces the productivity of the overall population, thus having a huge impact on the economic productivity and national income of the United States. In the United States, sleep disorders and their subsequent health effects can lead to an overall economic loss of up to $411 billion per year.

[0003] Specifically, the definition of insomnia includes difficulty falling asleep, difficulty maintaining sleep, waking up too early, resulting in poor sleep quality or reduced total sleep time; insomnia can be short-term, lasting from a few days to a week, or long-term, lasting more than a month. According to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, if the above symptoms occur at least three days a week, and symptoms such as fatigue, drowsiness, irritability, difficulty concentrating or physical discomfort occur during the day, which in turn affects study or work, it can be defined as chronic insomnia. Psychological stress or physical discomfort at work are potential causes of insomnia, and insomnia may also be affected by caffeine, nicotine and alcohol. Among all age groups, people over 65 are more likely to suffer from sleep problems; compared with men, women are more likely to suffer from chronic insomnia, which is speculated to be related to the physiological and hormonal changes caused by pregnancy, menopause and the female menstrual cycle. Insomnia is also believed to have a causal relationship with many physical and psychological diseases, including common physical and psychological diseases that modern people are prone to, such as hypertension, diabetes, hyperthyroidism, heartburn, restless legs syndrome, chronic pain, sleep apnea, depression, dementia, and even some lifestyles such as shift work and excessive use of electronic device screens that emit blue light, which are potential risk factors for chronic insomnia or long-term sleep disorders.

[0004] When the potential factors causing insomnia (such as poor bedroom environment, psychological stress, anxiety, physical discomfort, alcohol or drugs, etc.) are eliminated, sleep disorders may be alleviated. However, in the treatment of insomnia and sleep disorders, sleeping pills are widely used because they can act quickly. Common sleeping pills can be divided into two categories. The first category is benzodiazepines (BZDs), such as long-acting diazepam and flunitrazepam, or short-acting brotizolam and midazolam; the second category is non-BZD drugs, such as zolpidem, zaleplon, zopiclon, etc., with the main drug development goals of shortening the time to fall asleep and maintaining the rapid eye movement (REM) sleep structure. Although the above drugs can improve sleep conditions, long-term use has various side effects, including addiction and dementia. Dependence, abuse and tolerance of insomnia drugs are major problems faced by clinicians. Therefore, there is a great need for natural, effective and safe drugs that can help with sleep, improve sleep, and treat insomnia and sleep disorders.

[0005] In summary, there is still a great need for drugs that can solve the above problems in this field. In addition, considering that many people have difficulty swallowing or do not like to take capsules and tablets, there is a particular need for topical drugs that can solve the above problems. Summary of the invention

[0006] The present disclosure provides a traditional Chinese medicine composition, comprising: a Polygonum multiflorum extract; and a Chinese herbal medicine extract different from the Polygonum multiflorum extract, which is selected from at least one of the group consisting of a Gastrodia elata extract, a White Peony Root extract, a Chuanxiong Rhizome extract, a Coptis chinensis extract, a Polygala tenuifolia extract, a Phellodendron chinense extract, a Glechoma longum extract, a Ginseng extract, a Notoginseng extract, a Ginseng ginseng extract, a Salvia miltiorrhiza extract, a Curcuma longa extract, and an Antrodia cinnamomea extract.

[0007] In one embodiment of the present disclosure, based on the total weight of the traditional Chinese medicine composition, the content of the Polygonum multiflorum extract is 0.5 to 2.0%, and the Chinese herbal extract other than the Polygonum multiflorum extract is at least one selected from the group consisting of 0.1 to 0.5% of Gastrodia elata extract, 0.05 to 0.5% of White Peony Root Extract, 0.05 to 0.5% of Chuanxiong Rhizome Extract, 0.05 to 0.5% of Coptis chinensis Extract, 0.05 to 0.5% of Polygala Tenuifolia Extract, 0.05 to 0.5% of Cattail Gramineus Extract, 0.1 to 0.5% of Panax ginseng extract, 0.05 to 0.5% of Panax notoginseng extract, 0.05 to 0.5% of American ginseng extract, 0.05 to 0.5% of Salvia miltiorrhiza extract, 0.1 to 0.9% of Curcuma longa extract, and 0.1 to 0.5% of Antrodia cinnamomea extract.

[0008] In one embodiment of the present disclosure, the Chinese herbal extract comprises Gastrodia elata extract, White Peony Root Extract, Chuanxiong Rhizome Extract and Coptis chinensis extract, and based on the total weight of the Chinese medicine composition, the content of Polygonum multiflorum extract is 1%, the content of Gastrodia elata extract is 0.4%, the content of White Peony Root Extract is 0.2%, the content of Chuanxiong Rhizome Extract is 0.2% and the content of Coptis chinensis extract is 0.2%.

[0009] In one embodiment of the present disclosure, the Chinese herbal extract comprises Polygala tenuifolia extract, Glechoma calamus extract, Ginseng extract, Panax notoginseng extract, American ginseng extract and Salvia miltiorrhiza extract, and based on the total weight of the Chinese medicine composition, the content of Polygonum multiflorum extract is 1%, the content of Polygala tenuifolia extract is 0.25%, the content of Glechoma calamus extract is 0.25%, the content of Ginseng extract is 0.2%, the content of Panax notoginseng extract is 0.1%, the content of American ginseng extract is 0.1% and the content of Salvia miltiorrhiza extract is 0.1%.

[0010] In one embodiment of the present disclosure, the Chinese herbal extract comprises turmeric extract and Antrodia cinnamomea extract, and based on the total weight of the Chinese medicine composition, the content of the Polygonum multiflorum extract is 1%, the content of the turmeric extract is 0.7% and the content of the Antrodia cinnamomea extract is 0.3%.

[0011] In one embodiment of the present disclosure, the Chinese herbal extract comprises Gastrodia elata extract, White Peony Root Extract, Chuanxiong Extract, Coptis chinensis Extract, Polygala Tenuifolia Extract, Shichangpu Extract, Ginseng Extract, Panax Notoginseng Extract, American Ginseng Extract, Salvia Miltiorrhiza Extract, Curcuma Longa Extract, and Antrodia Cinnamomea Extract, and based on the total weight of the Chinese medicine composition, the content of Polygonum multiflorum extract is 0.5%, the content of Gastrodia elata extract is 0.12%, the content of White Peony Root Extract is 0.06%, the content of Chuanxiong Extract is 0.06%, the content of Coptis chinensis Extract is 0.06%, the content of Polygala Tenuifolia Extract is 0.15%, the content of Shichangpu Extract is 0.15%, the content of Ginseng Extract is 0.12%, the content of Panax Notoginseng Extract is 0.06%, the content of American Ginseng Extract is 0.06%, the content of Salvia Miltiorrhiza Extract is 0.06%, the content of Curcuma Longa Extract is 0.3%, and the content of Antrodia Cinnamomea Extract is 0.3%.

[0012] In one embodiment of the present disclosure, the Chinese herbal extract comprises a Polygonum multiflorum extract and a Panax notoginseng extract, and the ratio of the Polygonum multiflorum extract to the Panax notoginseng extract in the Chinese medicine composition is 1.3:1 to 1:10.

[0013] In one embodiment of the present disclosure, the Polygonum multiflorum extract is extracted from the root tuber, stem, leaf or other parts of Polygonum multiflorum. For example, the root tuber of Polygonum multiflorum can be processed into processed Polygonum multiflorum.

[0014] The present disclosure further provides a use of a Polygonum multiflorum extract in preparing a medicine for aiding sleep, improving sleep quality, and treating insomnia and sleep disorders.

[0015] In one embodiment of the present disclosure, the drug for aiding sleep, improving sleep quality, treating insomnia and sleep disorders comprises: based on the total weight of the drug, 0.5 to 2.0% of a Polygonum multiflorum extract; and a Chinese herbal extract different from the Polygonum multiflorum extract, which is selected from at least one of the group consisting of 0.1 to 0.5% of a Gastrodia elata extract, 0.05 to 0.5% of a White Peony Root extract, 0.05 to 0.5% of a Chuanxiong extract, 0.05 to 0.5% of a Coptis chinensis extract, 0.05 to 0.5% of a Polygala tenuifolia extract, 0.05 to 0.5% of a Shichangpu extract, 0.1 to 0.5% of a Panax ginseng extract, 0.05 to 0.5% of a Panax notoginseng extract, 0.05 to 0.5% of an American ginseng extract, 0.05 to 0.5% of a Salvia miltiorrhiza extract, 0.1 to 0.9% of a Curcuma longa extract, and 0.1 to 0.5% of an Antrodia cinnamomea extract.

[0016] In one embodiment of the present disclosure, the sleep aid and improvement of sleep quality include relieving stress, relaxing, balancing the autonomic nervous system, reducing sympathetic nervous activity, increasing parasympathetic nervous activity, improving subjective sleep quality, accelerating the time to fall asleep, extending sleep time, increasing sleep depth, reducing sleep disorders, reducing the use of sleeping pills, improving daytime function, or any combination of two or more thereof.

[0017] In one embodiment of the present disclosure, the sleep aid and improvement of sleep quality include: reducing peripheral blood flow, reducing heart rate, reducing respiratory rate, or a combination of two or more thereof.

[0018] In one embodiment of the present disclosure, the effective amount of the Polygonum multiflorum extract of the traditional Chinese medicine composition is 0.001 mg to 100 mg per kilogram of body weight.

[0019] In one embodiment of the present disclosure, the drug is an oral agent, a spray, an aerosol or an essential oil.

[0020] In one embodiment of the present disclosure, the drug is an external medicine or an oral medicine.

[0021] In one embodiment of the present disclosure, the drug is an external medicine and is applied to the back of the ear, the neck and / or the hands of the subject.

[0022] In one embodiment of the present disclosure, the drug is an external medicine and is applied to one or more acupoints of the subject including Anmian, Yifeng, Taiyang, Yintang, Fengchi, Shenmen and Neiguan.

[0023] The present invention achieves the purpose of helping sleep, improving sleep quality, and treating insomnia and sleep disorders by administering a traditional Chinese medicine composition containing a Polygonum multiflorum extract to a subject. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figures 1A to 1E The diagrams are respectively Tai Chi diagrams of a heart rate variability (HRV) detector before and after using the Chinese medicine composition formulas 1 to 5 disclosed in the present invention. Figure 1A Formula 1 plant extract; Figure 1B Formula 2 is a sleeping plant extract; Figure 1C Formula 3 is a blood stasis-removing plant extract; Figure 1D Formula 4 is an anti-inflammatory plant extract; Figure 1E Formula 5 comprehensive plant extracts.

[0025] Figures 2A to 2F The present invention shows that the composition of the present invention improves sleep after a single use in an isoflurane (IF)-induced sleep mouse model; Figure 2A The established isoflurane-induced sleep model is shown; Figures 2B to 2F The effects of Formulations 1 to 5 of the present disclosure on sleep onset time and sleep duration are presented respectively.

[0026] Figures 3A to 3E The results showed that in a pentobarbital-induced sleep mouse model, the Polygonum multiflorum extract disclosed in the present invention had a different sleep-inducing effect than Polygonum multiflorum Thunb. and Panax notoginseng. Figure 3A It showed that Polygonum multiflorum extract significantly shortened the time to fall asleep and prolonged the duration of sleep; Figure 3B It showed that any dose of Polygonum multiflorum extract could not significantly shorten the time to fall asleep; Figure 3C It showed that any dose of Panax notoginseng could not significantly shorten the time to fall asleep; Figure 3D It shows that when the ratio of Polygonum multiflorum to Panax notoginseng is between 1:1 and 1:2, the use of Panax notoginseng can enhance the effect of Polygonum multiflorum in prolonging sleep time; Figure 3E It shows that when the ratio of Polygonum multiflorum to Panax notoginseng is between 1.3:1 and 1:3, and after 14 days of use, Panax notoginseng can enhance the effect of Polygonum multiflorum in prolonging sleep time.

[0027] Figure 4 It was shown that long-term feeding (200 mg / kg body weight) of the Polygonum multiflorum extract in the composition of the present invention to diabetic and Alzheimer's co-morbid mice for 2 months significantly prolonged their sleep time. DETAILED DESCRIPTION

[0028] The technical solutions described in the embodiments of the present disclosure will be described more clearly and completely below. Obviously, the described embodiments are only part of the many embodiments covered by the present disclosure and are not intended to limit the scope of the present disclosure. The present disclosure can also be implemented or applied in similar or different embodiments. Other embodiments obtained by technicians in the relevant technical field without creation, such as modification, change, replacement of a certain element or a combination thereof, are all included in the scope of the present disclosure.

[0029] Further note that the singular forms "a", "an" and "the" described herein are intended to include plural referents unless otherwise expressly limited to one referent. In addition, unless the context clearly indicates otherwise, the term "or" and the term "and / or" can be used interchangeably.

[0030] The terms "include", "comprising", "containing", "having", etc. described herein refer to the presence of certain elements (such as components or steps, etc.) in the articles, methods, uses, etc. of the present disclosure, and unless the context clearly indicates otherwise, those unrecorded or unspecified elements are also open-ended and exist in the articles, methods, uses of the present disclosure, regardless of whether they are necessary or not. That is, those unrecorded or unspecified elements are not restrictedly excluded.

[0031] The term "subject" as described herein refers to animals, such as mammals, including but not limited to primates (e.g., humans), cows, sheep, goats, horses, dogs, cats, rabbits, rats, mice, etc. In one embodiment of the present disclosure, the subject is a human.

[0032] The terms "effective amount or therapeutically effective dose", "sufficient therapeutic amount or dose" or "effective or sufficient amount or dose" as used herein refer to a dose that produces a therapeutic effect on a subject to which it is administered.

[0033] The term "pharmaceutically acceptable excipient" as used herein refers to a substance that helps to administer an active agent to a subject and be absorbed by the subject. Pharmaceutical excipients useful in the present disclosure include, but are not limited to, binders, fillers, disintegrants, lubricants, coatings, sweeteners, flavoring agents, and pigments. Those skilled in the art will appreciate that other types of known pharmaceutical excipients may also be used in the present disclosure.

[0034] The term "treat / treating / treatment" as used herein refers to any indicator of success in the treatment or improvement of discomfort or symptoms (e.g., insomnia), including any objective or subjective parameter, such as relief; relief; reduction of symptoms, or making symptoms, injuries, pathologies, or states more tolerable to the subject; reduction of the frequency or duration of symptoms or discomfort states, or in some cases, prevention of the onset of symptoms or discomfort states. The treatment or improvement of symptoms can be based on any objective or subjective parameter, including, for example, heart rate variability testing or sleep quality scales.

[0035] The term "about" as used herein means that the error or range of the numerical value, numerical range or ratio is within 20%, preferably within 10%, and more preferably within 5% of the numerical value, numerical range or ratio. The quantitative values ​​described herein are approximate values, which means that they can be derived even if the term "about" is not used.

[0036] The numerical ranges described herein are inclusive and combinable, and any numerical value falling within the numerical ranges described herein can be used as the maximum or minimum value to derive a sub-range; for example, the numerical range of "0.0001 wt % to 2 wt %" should be understood to include any sub-range between the minimum value of 0.0001 wt % and the maximum value of 2 wt %, for example: 0.0001 wt % to 1.5 wt %, 0.01 wt % to 2 wt % and 0.005 wt % to 1 wt % and other sub-ranges. In addition, the multiple numerical endpoints described herein can be optionally used as the maximum or minimum value to derive a numerical range; for example, 0.0001, 0.01 or 50 mg / kg body weight can derive a numerical range of 0.0001 to 0.01 mg / kg body weight, 0.0001 to 50 mg / kg body weight or 0.01 to 50 mg / kg body weight.

[0037] The purpose of the present invention is to provide a safe and effective Chinese medicine composition for helping sleep, treating insomnia and improving sleep quality and its use.

[0038] The present disclosure provides a traditional Chinese medicine composition for aiding sleep, improving sleep quality, treating insomnia and sleep disorders, the components of which include a Polygonum multiflorum extract, and one or more of the following Chinese herbal extracts different from the Polygonum multiflorum extract: a Gastrodia elata extract, a White Peony Root extract, a Chuanxiong extract, a Coptis chinensis extract, a Polygala tenuifolia extract, a Glechoma longifolia extract, a Ginseng extract, a Panax notoginseng (also known as Panax notoginseng) extract, an American ginseng extract, a Salvia miltiorrhiza extract, a Curcuma longa extract, and an Antrodia cinnamomea extract.

[0039] In one embodiment of the present disclosure, based on the total weight of the Chinese medicine composition or the medicament, the content of the Polygonum multiflorum extract is 0.5 to 2.0%, for example, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9 or 2.0%, and the herbal extract other than the Polygonum multiflorum extract is selected from 0.1 to 0.5% of Gastrodia elata extract, 0.05 to 0.5% of White Peony Root Extract, 0.1 to 0.5% of Radix Paeoniae Alba Extract, 0.1 to 0.5% of Radix Gastrodiae ... Paeoniae Alba Extract, 0.1 to 0.5% of Radix Paeoniae Alba Extract, 0.1 to 0.5% of 0.05 to 0.5% of Chuanxiong extract, 0.05 to 0.5% of Coptis chinensis extract, 0.05 to 0.5% of Polygala tenuifolia extract, 0.05 to 0.5% of Phellodendron chinense extract, 0.1 to 0.5% of Panax ginseng extract, 0.05 to 0.5% of Panax notoginseng extract, 0.05 to 0.5% of American ginseng extract, 0.05 to 0.5% of Salvia miltiorrhiza extract, 0.1 to 0.9% of Curcuma longa extract and 0.1 to 0.5% of Antrodia cinnamomea extract.

[0040] In some embodiments of the present disclosure, based on the total weight of the traditional Chinese medicine composition or the medicine, the content of the Gastrodia elata extract may be 0.1, 0.12, 0.2, 0.3, 0.4 or 0.5%; the content of the white peony root extract may be 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.2, 0.3, 0.4 or 0.5%; the content of the Chuanxiong rhizome extract may be 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.2, 0.3, 0.4 or 0.5%. 9, 0.1, 0.2, 0.3, 0.4 or 0.5%; the content of Coptis chinensis extract can be 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.2, 0.3, 0.4 or 0.5%; the content of Polygala tenuifolia extract can be 0.05, 0.1, 0.15, 0.2, 0.25, 0.3, 0.4 or 0.5%; the content of Cattail calamus extract can be 0.05, 0.1, 0.15, 0.2, The content of Panax notoginseng extract can be 0.1, 0.12, 0.15, 0.2, 0.3, 0.4 or 0.5%; the content of Panax notoginseng extract can be 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.2, 0.3, 0.4 or 0.5%; the content of American ginseng extract can be 0.05, 0.06, 0.07, 0.08, 0.09, 0. 1, 0.2, 0.3, 0.4 or 0.5%; the content of salvia miltiorrhiza extract can be 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.2, 0.3, 0.4 or 0.5%; the content of turmeric extract can be 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8 or 0.9%; the content of Antrodia cinnamomea extract can be 0.1, 0.2, 0.3, 0.4 or 0.5%. Others can be added as a base 0.3% xanthan gum aqueous solution, 0.01% wintergreen oil and the rest water.

[0041] In one embodiment of the present disclosure, the Chinese medicine composition is prepared by the following steps:

[0042] a) All raw materials were extracted with 75% ethanol for 7 days in the following ratios, filtered and set aside: processed Polygonum multiflorum, 1:12 (w / v; g:mL); traditional Chinese medicine: Gastrodia elata, white peony root, Chuanxiong, Coptis chinensis, Polygala tenuifolia, Shichangpu, Ginseng, Panax notoginseng, American ginseng, Salvia miltiorrhiza, Curcuma longa, Antrodia cinnamomea, each in 1:12 (w / v; g:mL);

[0043] b) The Radix Polygoni Multiflori ethanol extract and the traditional medicinal material ethanol extract were mixed, and a 0.3% xanthan gum aqueous solution and 100 ppm wintergreen oil were added as a matrix.

[0044] In one embodiment of the present disclosure, the components of the traditional Chinese medicine composition include Polygonum multiflorum extract (Formula 1: plant essence).

[0045] In one embodiment of the present disclosure, the components of the traditional Chinese medicine composition include Polygonum multiflorum extract, Gastrodia elata extract, White Peony Root extract, Ligusticum chuanxiong extract, and Coptis chinensis extract (Formula 2: Sleep-inducing plant extract).

[0046] In one embodiment of the present disclosure, the components of the traditional Chinese medicine composition include Polygonum multiflorum extract, Polygala tenuifolia extract, Phellodendron chinense extract, Panax ginseng extract, Panax notoginseng extract, American ginseng extract, and Salvia miltiorrhiza extract (Formula 3: Blood stasis-removing plant essence).

[0047] In one embodiment of the present disclosure, the components of the traditional Chinese medicine composition include Polygonum multiflorum extract, Curcuma longa extract, and Antrodia cinnamomea extract (Formula 4: anti-inflammatory plant extract).

[0048] In one embodiment of the present disclosure, the components of the traditional Chinese medicine composition include Polygonum multiflorum extract, Gastrodia elata extract, White Peony Root extract, Chuanxiong extract, Coptis chinensis extract, Polygala tenuifolia extract, Phellodendron chinense extract, Panax ginseng extract, Panax notoginseng extract, American ginseng extract, Salvia miltiorrhiza extract, Curcuma longa extract, and Antrodia cinnamomea extract (Formula 5: Comprehensive Plant Essence).

[0049] In one embodiment of the present disclosure, the Polygonum multiflorum extract is extracted from the tuberous roots, stems or leaves of Polygonum multiflorum, preferably the tuberous roots of Polygonum multiflorum, and more preferably the processed Polygonum multiflorum prepared from the tuberous roots of Polygonum multiflorum.

[0050] In one embodiment of the present disclosure, the Chinese herbal extract comprises Polygonum multiflorum extract and Panax notoginseng extract, and the ratio of the Polygonum multiflorum extract to the Panax notoginseng extract in the Chinese medicine composition is 1.3:1 to 1:10, for example, 1.3:1, 1:2, 1:3 or 1:10.

[0051] In one embodiment of the present disclosure, the formula of the Chinese medicine composition is as shown in Table 1 below.

[0052] Table 1. Formula and composition ratio of the disclosed Chinese medicine composition

[0053]

[0054]

[0055] In one embodiment of the present disclosure, the effective amount of the active ingredient in the Chinese medicine composition is about 0.01 mg to about 10 mg per 70 kg body weight of a person. In another embodiment of the present disclosure, the effective amount of the active ingredient is about 1 mg to about 5 mg per 70 kg body weight of a person. In another embodiment of the present disclosure, the effective amount of the active ingredient is about 10 mg to about 100 mg per 70 kg body weight of a person, for example, about 20 mg to about 80 mg per 70 kg body weight, about 20 mg to about 50 mg per 70 kg body weight, about 25 mg to about 50 mg per 70 kg body weight, about 30 mg to about 50 mg per 70 kg body weight, about 35 mg to about 50 mg per 70 kg body weight, or about 30 mg to about 40 mg per 70 kg body weight.

[0056] In one embodiment of the present disclosure, the content of the Polygonum multiflorum extract as an effective active ingredient in the Chinese medicine composition is about 0.01% by weight to 10% by weight. In another embodiment of the present disclosure, the content of the Polygonum multiflorum extract is between about 0.1% by weight and 5% by weight. In another embodiment of the present disclosure, the content of the Polygonum multiflorum extract is between about 0.5% by weight and 2.0% by weight. In another embodiment of the present disclosure, the content of the Polygonum multiflorum extract is about 0.01%, about 0.1%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, about 0.9%, about 1%, about 1.2%, about 1.5%, about 1.8%, about 2%, about 3%, about 4%, or about 5% by weight; the aforementioned multiple numerical endpoints can be optionally selected as maximum or minimum values ​​to derive a numerical range.

[0057] In one embodiment of the present disclosure, the effective amount of the Polygonum multiflorum extract in the traditional Chinese medicine composition is about 0.001 mg / kg body weight to 100 mg / kg body weight, for example, about 0.001, about 0.005, about 0.01, about 0.05, about 0.1, about 0.2, about 0.3, about 0.4, about 0.5, about 0.6, about 0.7, about 0.8, about 0.9, about 1, about 1.5, about 2, about 2.5, about 3. About 3, about 3.5, about 4, about 4.5, about 5, about 6, about 7, about 8, about 9, about 10, about 15, about 20, about 25, about 30, about 35, about 40, about 45, about 50, about 55, about 60, about 65, about 70, about 75, about 80, about 85, about 90, about 95, or about 100 mg / kg body weight; the aforementioned multiple numerical endpoints can be optionally set as maximum or minimum values ​​to derive a numerical range.

[0058] In one embodiment of the present disclosure, the effective amount of the Polygonum multiflorum extract of the traditional Chinese medicine composition is about 10 mg / kg body weight, about 20 mg / kg body weight, about 30 mg / kg body weight, about 40 mg / kg body weight or about 50 mg / kg body weight.

[0059] Fallopia multiflora (scientific name: Fallopia multiflora or polygonum multiflorum) is also commonly known as Shouwu (shou-wu, ho shou wu, fo-ti, fo-ti-teng, Chinese knotweed, climbing knotweed, flowery knotweed, fleece flower), belonging to the Polygonaceae family, and its roots and vines are all traditional Chinese medicines. Compendium of Materia Medica records: "This substance is warm in nature and bitter in taste. Bitterness nourishes the kidneys, warms the liver, and astringency can astringe the essence. Therefore, it can nourish the blood and liver, consolidate the essence and kidneys, strengthen the tendons and bones, and darken the hair. It is a good tonic medicine." He Shouwu has been traditionally used by the Chinese as a tonic and anti-aging medicine, especially for improving hair loss and premature graying of hair. Modern scientific literature confirms that the root tubers of Polygonum multiflorum have many medicinal effects, including delaying aging, immunomodulation, lipid-lowering and liver protection; the main component of Polygonum multiflorum is tetrahydroxystilbeneglucoside (TSG, with the chemical formula of 2,3,5,4'-Tetrahydroxystilbene-2-O-β-D-glucoside).

[0060] The present invention provides a traditional Chinese medicine composition for aiding sleep, improving sleep quality, and treating insomnia and sleep disorders. The composition mainly comprises an effective amount of Polygonum multiflorum extract.

[0061] The term "insomnia" as used herein refers to a symptom of not being able to fall asleep naturally, which may be difficulty falling asleep (difficulty falling asleep) or difficulty maintaining deep sleep for a long time. Insomnia is generally accompanied by daytime mental fatigue, sleepiness, irritability, or depression, and may be short-term, lasting from a few days to a week, or long-term, lasting for more than a month.

[0062] The term "sleep disorder" as used herein refers to abnormalities associated with sleep in humans or other animals, including dyssomnia, i.e., the inability to fall asleep; or abnormal conditions of being unable to sustain sleep, such as insomnia, sleep apnea syndrome, restless legs syndrome, or narcolepsy; parasomnias, i.e., abnormal semi-awake states during sleep or between sleep and waking, such as somnambulism, sleep talking, bedwetting, teeth grinding, night terrors, etc.; sleep disorders associated with medical or mental illnesses, such as depression, anxiety, or chronic diseases; and proposed sleep disorders, such as sleep disorders in women before and after the menstrual cycle, after menopause, or during pregnancy.

[0063] The term "sleep aid" as used herein refers to but is not limited to the following features: relieving stress, relaxing, balancing the autonomic nervous system, accelerating the time to fall asleep (or shortening the latency to fall asleep), extending the total sleep time, or any combination of two or more thereof.

[0064] The term "balanced autonomic nervous system" as used herein refers to but is not limited to the following features: reducing sympathetic nervous system activity, increasing parasympathetic nervous system activity, reducing peripheral blood flow, reducing heart rate and respiratory rate, or any combination of two or more thereof.

[0065] The term "improving sleep quality" as used herein refers to, but is not limited to, the following features: increasing sleep depth, reducing sleep disorders, improving subjective sleep quality, reducing the use of hypnotic drugs, improving daytime function, or any combination of two or more thereof.

[0066] In one embodiment of the present disclosure, the Chinese medicine composition can help sleep, improve sleep quality, treat insomnia and sleep disorders. In another embodiment of the present disclosure, the Chinese medicine composition can relieve stress, relax, balance the autonomic nerves, reduce sympathetic nerve activity, increase parasympathetic nerve activity, improve subjective sleep quality, accelerate sleep onset, increase sleep time, increase sleep depth, reduce sleep disorders, reduce the use of hypnotic drugs and improve daytime function.

[0067] In one embodiment of the present disclosure, the Chinese medicine composition can reduce peripheral blood flow, heart rate and respiratory rate.

[0068] The present invention provides a use of the traditional Chinese medicine composition in preparing a medicine for aiding sleep, treating insomnia and improving sleep quality.

[0069] In one embodiment of the present disclosure, the subject to be administered is a mammal. In one embodiment of the present disclosure, the mammal is a human. In another embodiment of the present disclosure, the mammal is a non-human mammal.

[0070] In one embodiment of the present disclosure, the traditional Chinese medicine composition further comprises a pharmaceutically acceptable carrier or excipient.

[0071] In one embodiment of the present disclosure, the pharmaceutically acceptable carrier or excipient includes, but is not limited to, ethanol, polysorbate, laurocapram, hydroxyethylcellulose, phenoxyethanol, vanillyl butyl ether and propylene glycol.

[0072] In one embodiment of the present disclosure, the Chinese medicine composition may include but is not limited to other ingredients such as pharmaceutically acceptable carriers, additives, adjuvants and / or excipients. For example, the composition may include but is not limited to one or more of the group consisting of gel forming agents, solvents, solubilizers, stabilizers, tension enhancers, penetration enhancers, essential oils, pH regulators, wetting agents, surfactants, buffers, preservatives, viscosity regulators, emulsifiers, gas propellants, suspending agents, flavoring agents, colorants and antibacterial agents.

[0073] In one embodiment of the present disclosure, suitable antibacterial agents include, but are not limited to, paraben compounds (e.g., parabens, methyl paraben, ethyl paraben, propyl paraben, butyl paraben, heptyl paraben, benzyl paraben, isobutyl paraben, isopropyl paraben, or pharmaceutically acceptable salts thereof), chlorhexidine acetate, metronidazole, silver ions, sorbic acid, benzalkonium chloride, benzethonium chloride, benzyl alcohol, boric acid, ciprofloxacin, hexadecyltrimethylammonium odorate, cetylpyridinium chloride, chlorhexidine, chlorobutanol, chlorocresol, chloroxylenol, cresol, ethanol, glycerol, hexidineamine, imide urea, phenol, phenoxyethanol, phenylethanol, phenylmercuric nitrate, propylene glycol and sodium thiomercurate. One or any combination of more than two of the group consisting of. In one embodiment of the present disclosure, the antibacterial agent is selected from the group consisting of p-hydroxybenzoic acid esters, methyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, propyl p-hydroxybenzoate, butyl p-hydroxybenzoate, heptyl p-hydroxybenzoate, benzyl p-hydroxybenzoate, isobutyl p-hydroxybenzoate, isopropyl p-hydroxybenzoate and sodium salts thereof, or any combination of two or more thereof.

[0074] In one embodiment of the present disclosure, suitable gel forming agents include, but are not limited to, one or more combinations of two or more selected from the group consisting of polyacrylic acid, methylcellulose, carboxymethylcellulose, hydroxyethylcellulose, hydroxyethylmethylcellulose, hydroxypropylmethylcellulose, polyvinylpyrrolidone, chitosan, carboxymethylchitosan, hyaluronic acid, alginic acid, aloe vera gel, guar gum, hydroxypropyl guar gum, fenugreek gum, gum arabic, xanthan gum, agar, carrageenan, pectin, gelatin and tragacanth gum. In at least one embodiment of the present disclosure, the gel forming agent is selected from the group consisting of polyacrylic acid, methylcellulose, carboxymethylcellulose, hydroxyethylcellulose, hydroxyethylmethylcellulose, hydroxypropylmethylcellulose and pharmaceutically acceptable salts thereof.

[0075] In one embodiment of the present disclosure, suitable essential oils include, but are not limited to, peppermint oil, lavender oil, rosemary oil, Ceylon cinnamon oil, anise oil, eucalyptus oil, wintergreen oil, cinnamon oil, clove oil, thyme oil, sage oil, sage oil, nutmeg oil, fennel oil, lemon oil, sweet orange oil, cardamom oil, coriander seed oil, avocado oil, bergamot oil, birch oil, black spruce oil, butter, melaleuca oil, basil oil, tangerine oil, lime oil, ginger oil, grapefruit oil, laurel oil, golden chrysanthemum oil, caraway oil, marjoram oil, geranium oil, lemongrass oil, melissa oil, allspice oil, palmarosa oil, frankincense oil, pine needle oil, bergamot oil, orange blossom oil, rose oil and jasmine oil. One or any combination of two or more of the group consisting of.

[0076] In one embodiment of the present disclosure, the Chinese medicine composition is administered to the subject topically or systemically. In one embodiment of the present disclosure, the Chinese medicine composition is administered to the subject orally or topically.

[0077] In one embodiment of the present disclosure, the Chinese medicine composition can be administered in various forms, and can be used as a pharmaceutical composition or a food composition. In one embodiment of the present disclosure, the Chinese medicine composition is in the form of a powder, tablet, capsule, solution, tonic or food.

[0078] In one embodiment of the present disclosure, the Chinese medicine composition is formulated into a form selected from the group consisting of solution, liniment, lotion, spray, aerosol, ointment, foam, cream, gel, paste, patch, glue, film, oral cream, powder and essential oil. Preferably, the Chinese medicine composition is formulated into a spray, aerosol or essential oil.

[0079] In one embodiment of the present disclosure, the topical administration of the Chinese medicine composition comprises the following steps: 5 to 10 minutes before going to bed, applying the Chinese medicine composition of the present disclosure to the subject's ears, shoulders, neck and / or hands. In one embodiment of the present disclosure, the Chinese medicine composition of the present disclosure is applied to several or more acupoints of the subject's Anmian acupoint, Yifeng acupoint, temple, Yintang acupoint, Fengchi acupoint, Shenmen acupoint, and Neiguan acupoint.

[0080] In one embodiment of the present disclosure, the Chinese medicine composition can be used 1 to 4 times a day, 1 to 4 times a week, or 1 to 4 times a month. In another embodiment of the present disclosure, the Chinese medicine composition can be used every 1, 2, 3, 4, 5, 6, or 7 days. In another embodiment of the present disclosure, the Chinese medicine composition can be used continuously for 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 14 days, 30 days, 2 months, or 3 months.

[0081] The present disclosure is further illustrated below with specific embodiments so that those skilled in the art can better understand the advantages and effects of the present disclosure and implement them, but the embodiments should not be construed as limiting the scope of the present disclosure.

[0082] Example 1: Effect of the disclosed Chinese medicine composition on autonomic nervous system activity

[0083] The autonomic nervous activity of human subjects was evaluated using a heart rate variability (HRV) detector (SC-101, Leadtek Technology). All subjects rested for 30 minutes to ensure that the body was in a calm state, and then underwent HRV testing. Apply 1 mL of the Chinese medicine composition disclosed in the present invention to each subject's left and right hands, located at the Yifeng point, Anmian point, and Fengchi point. After 10 minutes, the HRV test was performed again to observe the changes in the average heart rate and the Tai Chi diagram. The results show that after using any of the formulations of the Chinese medicine composition disclosed in the present invention, the heart rate of the subjects decreased, while the parasympathetic nervous activity increased (Table 2). Figures 1A to 1E The Tai Chi diagrams are respectively the HRV detection diagrams before and after using the Chinese medicine composition formulas 1 to 5 of the present invention.

[0084] Table 2. Heart rate variability detector data for each formula

[0085] formula * △ Heart rate Parasympathetic activity 1 -6 1.2 2 -12 0.3 3 -6 1.0 4 -14 6.6 5 -5 1.3

[0086] *△ refers to the difference between the amount before and after use

[0087] Example 2: Sleep-aiding effect of the Chinese medicine composition disclosed in the present invention on mice

[0088] In order to evaluate the sleep-inducing effect of the Chinese medicine composition disclosed in the present invention, an isoflurane-induced sleep mouse (hair-depleted C57JBL / 6 mouse) model was established. Oral administration of GABA (γ-aminobutyric acid; 66 mg / kg) and 5-hydroxytryptamine (5-HTP; 24 mg / kg) was used as a positive control, i.e., oral administration of the GABA combination "G66+H24".

[0089] All experimental procedures followed the Guide for the Care and Use of Laboratory Animals and were approved by the Agency for Laboratory Animal Research (No. 110-370-5).

[0090] 8-week-old male C57BL6 mice were used to remove the back hair of each mouse using electronic clippers and depilatory cream one week before the sleep experiment. The next week, the mice were fasted overnight and received oral GABA combination or applied to the back skin with the formula of the disclosed Chinese medicine composition 1 hour or 30 minutes before isoflurane-induced sleep. Individual mice were placed in a box with isoflurane (4%) for 2 minutes, and the time when the mouse lost its reflex was recorded as the time to fall asleep (sleep latency); two minutes later, the mouse was taken out, the abdomen was facing up, and the time when the mouse turned the body to the correct direction was recorded to calculate the sleep time. Data are presented as mean ± standard deviation, and statistical analysis was performed using GraphPad Prism (GraphPad; USA), and unpaired Student's t test was used for single parameter comparison, and P value less than 0.05 was significant (*P<0.05, **P<0.01, ***P<0.001).

[0091] Figure 2A The established isoflurane (IF)-induced sleep mouse model showed that the sleep onset time and sleep duration were both within 1 minute. The test results showed that formulas 1 to 5 of the disclosed composition could significantly prolong the sleep time when used once compared with no use. Among them, formula 4 could significantly shorten the sleep onset time and prolong the sleep time, and the effect was better than the oral GABA combination "G66+H24" ( Figures 2B to 2F ).

[0092] The above results show that the Chinese medicine composition disclosed in the present invention exhibits excellent sleep-aiding effect.

[0093] Example 3: Comparison of Polygonum multiflorum and Radix Polygoni Multiflori and synergistic effect of Polygonum multiflorum and Radix Notoginseng

[0094] In order to compare the sleep-inducing effects of the Polygonum multiflorum extract disclosed in the present invention and Polygonum multiflorum vine, mice were orally given a threshold dose of pentobarbital to induce them to fall asleep, and whether the use of the Polygonum multiflorum extract, Polygonum multiflorum vine extract, and Panax notoginseng extract (oral administration) disclosed in the present invention can shorten the time for mice to fall asleep and prolong their sleep duration; with the disappearance of the righting reflex as an indicator, the time of falling asleep is the starting time of the disappearance of the righting reflex, and the sleep duration is the time from the disappearance of the righting reflex to the recovery. Diazepam (1.0 mg / kg) was orally given to mice as a positive control. Eight mice were used in each group of experiments.

[0095] A. Short-term (single use) effects

[0096] The results showed that compared with the unadministered control group, administration of 50 mg / kg or 150 mg / kg of the Polygonum multiflorum extract disclosed herein could significantly shorten the time to fall asleep and prolong the duration of sleep ( Figure 3A); on the other hand, compared with the untreated control group, administration of 50 mg / kg or 150 mg / kg of Polygonum multiflorum extract significantly prolonged sleep duration, however, any dose of Polygonum multiflorum extract could not significantly shorten the time to fall asleep ( Figure 3B ); On the other hand, compared with the control group, administration of 100mg / kg or 200mg / kg of Panax notoginseng can significantly prolong the duration of sleep ( Figure 3C ). Figures 3A to 3C In the table, *, ** and *** indicate P<0.05, P<0.01 and P<0.001, respectively, compared with the non-administered control group (formulation volume of 0).

[0097] B. Synergistic Effect

[0098] The sleep-inducing effect of the combined use of the Polygonum multiflorum extract and Panax notoginseng disclosed in the present invention was further tested. The results of a single combined administration of Polygonum multiflorum (50 mg / kg) and Panax notoginseng to mice showed that when the dose of Panax notoginseng was 50 to 100 mg / kg, it had the effect of enhancing Polygonum multiflorum in prolonging sleep duration; but when Panax notoginseng was at a higher dose (200 mg / kg), it weakened the effect of Polygonum multiflorum in prolonging sleep duration. Therefore, when the ratio of Polygonum multiflorum to Panax notoginseng was between 1:1 and 1:2, Panax notoginseng could enhance the effect of Polygonum multiflorum in prolonging sleep time ( Figure 3D ). Figure 3D In the table, *, ** and *** indicate P<0.05, P<0.01 and P<0.001, respectively, compared with the non-medicated control group; and #, ## and ### indicate P<0.05, P<0.01, P<0.001, respectively, compared with the experimental group given different doses of Panax notoginseng and the experimental group only given Polygonum multiflorum (Polygonum multiflorum - 50 mg / kg and Panax notoginseng - 0 mg / kg).

[0099] The results of a mouse test 14 days after the combined administration of Polygonum multiflorum (50 mg / kg) and Panax notoginseng showed that when the dose of Panax notoginseng was 37.5 to 150 mg / kg, it enhanced the effect of Polygonum multiflorum in prolonging sleep duration, and the enhancement effect was proportional to the dose of Panax notoginseng. Therefore, when the ratio of Polygonum multiflorum to Panax notoginseng was between 1.3:1 and 1:3, Panax notoginseng could enhance the effect of Polygonum multiflorum in prolonging sleep time ( Figure 3E ). Figure 3E In the table, *, ** and *** indicate P<0.05, P<0.01 and P<0.001, respectively, compared with the non-medicated control group; and #, ## and ### indicate P<0.05, P<0.01, P<0.001, respectively, compared with the experimental group given different doses of Panax notoginseng and the experimental group only given Polygonum multiflorum (Polygonum multiflorum - 50 mg / kg and Panax notoginseng - 0 mg / kg).

[0100] The above results show that in terms of sleep-aiding effect, the Polygonum multiflorum extract disclosed in the present invention is significantly superior to Polygonum multiflorum vine extract and Panax notoginseng in shortening the time to fall asleep. When Polygonum multiflorum and Panax notoginseng are used together at a specific ratio, they have a synergistic effect on improving sleep.

[0101] Example 4: Long-term use data of the Polygonum multiflorum extract disclosed herein

[0102] In order to test the effect of long-term use, APP / PS1 transgenic mice, a mouse model of Alzheimer's disease, were used. They were given a high-fat diet (60% of the energy source was fat) starting at 8 weeks of age, and then 100 mg / kg of streptozotocin was injected intraperitoneally two weeks later. Mice with diabetes and Alzheimer's disease were induced between 12 and 14 weeks of age. At the beginning of 14 weeks of age, the co-morbid mice were divided into two groups, one group was given 200 mg / kg of the plant extract formula 1 disclosed herein orally daily, and the other group was only given an equal amount of starch as a control (starch group). Feeding continued for two months. Healthy mice with a normal diet were also raised for comparison. At the end of the experiment, the sleep time of each group was compared to evaluate the long-term efficacy of the plant extract formula 1 disclosed herein in helping sleep and improving sleep.

[0103] The results showed that the sleep time of the diabetic and Alzheimer's co-morbid mice that only ate starch (starch group; 5 mice) was shorter than that of the healthy mice that ate a normal diet (NCD (WT) group; 5 mice), indicating that the co-morbid mice had sleep disorders. For the co-morbid mice with sleep disorders, the administration of the plant extract formula 1 200 mg / kg (i.e., Polygonum multiflorum 200 mg / kg group; 5 mice) of the present disclosure had a significant (P<0.05) effect of prolonging sleep time ( Figure 4 ). This result shows that the Polygonum multiflorum extract disclosed in the present invention has excellent sleep-inducing effect under long-term use.

[0104] Example 5: Physiological Feedback Data Evaluation

[0105] The autonomic nervous system mainly regulates visceral activities throughout the body. It is divided into two parts: sympathetic and parasympathetic. It is affected by both sympathetic and parasympathetic nerves. When relaxed or happy, sympathetic nerve activity decreases, parasympathetic nerve activity increases, the heart rate slows down, the breathing rate decreases, and the peripheral blood flow is lower.

[0106] In order to evaluate the efficacy of the disclosed Chinese medicine composition in balancing the autonomic nervous system in relaxing, relieving emotions and relieving stress, a human trial was conducted. The inclusion conditions of the trial are: 1) healthy adult men and women between 30 and 50 years old; 2) no obvious symptoms of hypertension, diabetes, heart disease, skin disease or other chronic diseases that require regular medication, and no medication one week before the start of the trial; 3) able to accept follow-up at the time point set by the trial; 4) voluntary participants who understand all the contents of the informed consent form. The trial complies with the ethical standards for human trials (human trial approval number: Guangtian Hospital 10911). A total of 20 subjects signed the informed consent form and entered the trial, and all of them completed the trial.

[0107] The experimental data were statistically analyzed using SPSS12.0, and the paired sample t-test was used to analyze the differences before and after the intervention. The p value was less than 0.05 and was considered significant.

[0108] The experiment compared the differences in the subjects' physiological feedback parameters before and after the intervention measures. Thought technology physiological feedback devices were used to measure brain wave signals, peripheral blood flow (blood volume pulse; BVP), heart rate, respiratory rate and electroencephalogram (electroencephalogram; EEG). The relative humidity of the environment was controlled at 50±5% and the temperature was 20±2℃. The test sites were: forehead, earlobes, and fingers of the right hand. The first test was on the first day of intervention, and the second test was on the eighth day of intervention. Each test lasted 10 minutes. The test items included:

[0109] A. Blood volume pulse (BVP): The blood volume pulse is usually measured at the fingertips. The contraction of blood vessels is controlled by the sympathetic nerves. Therefore, blood volume will increase under stress conditions such as pain, hunger, fear or anger, and decrease when relaxed.

[0110] B. Heart Rate (HR): Heart rate is affected by the sympathetic and parasympathetic nerves. When you are relaxed or happy, your heart rate is slower; it increases under emotional stimulation such as anxiety, fear or excitement.

[0111] C. Respiration (RES): Place a respiration detector above the breast through the armpit to assess the chest respiration rate and amplitude per minute. The normal respiration rate is 8 to 12 times / minute, and deep breathing is about 6 times / minute. A slow rate and large amplitude indicate relaxation.

[0112] D. Electroencephalogram (EEG): EEG is a graph that records the change of potential difference between two points on the skull over time, usually in microvolts (one millionth of a volt). The generation of potential difference is related to the cell membrane potential. Brain waves are divided into Alpha (α), Beta (β), Delta (δ), and Theta (θ) waves according to different frequencies.

[0113] The essential oil formulation of the Chinese medicine composition disclosed herein, the sleep-inducing plant extract (Formula 2), was applied to the shoulders and neck of the subjects, a total of 5 drops (about 0.25 mL). The test results showed that the peripheral blood flow, heart rate and respiratory rate all decreased after 10 minutes, with an average decrease of 27% in peripheral blood flow (from 8.21±4.59 to 5.97±3.99, p<0.001), 3% in heart rate (from 68.27±10.45 to 66.07±9.68, p<0.05), and 6% in respiratory rate (from 15.15±1.77 to 14.22±2.88, p<0.05); it is obvious that the Chinese medicine composition disclosed herein has the effect of relieving stress and relaxing (Table 3).

[0114] Table 3. Physiological feedback data before and after using the disclosed Chinese medicine composition (n=20)

[0115]

[0116] Improvement rate = [(before use - after use) / before use] * 100%;

[0117] Or improvement rate = [(before use - 7 days after use) / before use] * 100%

[0118] *p<0.05, **p<0.01, ***p<0.001

[0119] Example 6: Sleep quality assessment

[0120] The sleep quality of the subjects in Example 5 was assessed using the Pittsburgh Sleep Quality Index (PSQI) (Table 4).

[0121] Table 4. Pittsburgh Sleep Quality Scale Assessment Items

[0122]

[0123] Among the 20 subjects, 17 had an initial PSQI>5 and 3 had a PSQI≦5. After using the disclosed composition for 7 days, 10 subjects had PSQI>5, 10 subjects had PSQI≦5, and a total of 7 subjects had improved sleep quality, with an average improvement rate of 31% (PSQI decreased from 9.05±3.14 to 6.25±2.67; p<0.001); among them, C1's personal subjective sleep quality improved by an average of 33% (1.65±0.67 to 1.10±0.55; p<0.01), C2's sleep onset latency decreased by an average of 41% (1.35±1.14 to 0.80±0.89; p<0.01), C6's average number of times of using sleeping pills decreased by 80% (0.25±0.55 to 0.05±0.22; p<0.05), and C7's daytime functional operation improved by an average of 34% (2.05±0.69 to 1.35±0.67, p<0.001) (Table 5).

[0124] Table 5. Pittsburgh Sleep Quality Scale Assessment Results (n=20)

[0125] Pre-test Post-test 7 p Improvement rate C1 1.65±0.67 1.10±0.55 0.002 33％** C2 1.35±1.14 0.08±0.89 0.00 1 41％** C3 1.45±0.94 1.10±0.91 0.130 24％ C4 1.05±1.19 0.75±1.02 0.379 29％ C5 1.25±0.55 1.10±0.31 0.186 12％ C6 0.25±0.55 0.05±0.22 0.042 80％* C7 2.05±0.69 1.35±0.67 0.000 34％*** Total score 9.05±3.14 6.25±2.67 0.000 31％***

[0126] Improvement rate = [(before use - after use) / before use] * 100%

[0127] *p<0.05, **p<0.01, ***p<0.001

[0128] Although some specific embodiments of the present disclosure have been described in detail above, those skilled in the art may make various modifications and changes to the embodiments shown without departing from the teachings and advantages of the present disclosure. Therefore, such modifications and changes should still be included in the scope of the present disclosure as set forth in the appended claims.

Claims

1. A Chinese medicine composition comprising: Polygonum multiflorum extract; and The Chinese herbal extract different from the Polygonum multiflorum extract is selected from at least one of the group consisting of Gastrodia elata extract, White Peony Root extract, Chuanxiong Rhizome extract, Coptis chinensis extract, Polygala tenuifolia extract, Phellodendron chinense extract, Panax ginseng extract, Notoginseng extract, American ginseng extract, Salvia miltiorrhiza extract, Curcuma longa extract and Antrodia cinnamomea extract.

2. The Chinese medicine composition according to claim 1, based on the total weight of the Chinese medicine composition, the content of the Polygonum multiflorum extract is 0.5 to 2.0%, and the Chinese herbal extract other than the Polygonum multiflorum extract is at least one selected from the group consisting of 0.1 to 0.5% of Gastrodia elata extract, 0.05 to 0.5% of White Peony Root Extract, 0.05 to 0.5% of Chuanxiong Rhizome Extract, 0.05 to 0.5% of Coptis chinensis Extract, 0.05 to 0.5% of Polygala Tenuifolia Extract, 0.05 to 0.5% of Phellodendron chinense Extract, 0.1 to 0.5% of Panax ginseng Extract, 0.05 to 0.5% of Panax notoginseng Extract, 0.05 to 0.5% of American ginseng Extract, 0.05 to 0.5% of Salvia miltiorrhiza Extract, 0.1 to 0.9% of Curcuma Longa Extract and 0.1 to 0.5% of Antrodia cinnamomea Extract.

3. The Chinese medicine composition according to claim 1, wherein The Chinese herbal extract comprises Gastrodia elata extract, White Peony Root extract, Ligusticum chuanxiong extract and Coptis chinensis extract, and based on the total weight of the Chinese medicine composition, the content of Polygonum multiflorum extract is 1%, the content of Gastrodia elata extract is 0.4%, the content of White Peony Root extract is 0.2%, the content of Ligusticum chuanxiong extract is 0.2% and the content of Coptis chinensis extract is 0.2%.

4. The Chinese medicine composition according to claim 1, wherein The Chinese herbal extract comprises Polygala tenuifolia extract, Glechoma longituba extract, Ginseng extract, Panax notoginseng extract, American ginseng extract and Salvia miltiorrhiza extract, and based on the total weight of the Chinese medicine composition, the content of Polygonum multiflorum extract is 1%, the content of Polygala tenuifolia extract is 0.25%, the content of Glechoma longituba extract is 0.25%, the content of Ginseng extract is 0.2%, the content of Panax notoginseng extract is 0.1%, the content of American ginseng extract is 0.1% and the content of Salvia miltiorrhiza extract is 0.1%.

5. The Chinese medicine composition according to claim 1, wherein The Chinese herbal extract comprises turmeric extract and Antrodia cinnamomea extract, and based on the total weight of the Chinese medicine composition, the content of the Polygonum multiflorum extract is 1%, the content of the turmeric extract is 0.7% and the content of the Antrodia cinnamomea extract is 0.3%.

6. The Chinese medicine composition according to claim 1, wherein The Chinese herbal extract comprises Gastrodia elata extract, White Peony Root extract, Chuanxiong extract, Coptis chinensis extract, Polygala tenuifolia extract, Shichangpu extract, Ginseng extract, Panax notoginseng extract, American ginseng extract, Salvia miltiorrhiza extract, Curcuma longa extract, and Antrodia cinnamomea extract, and based on the total weight of the Chinese medicine composition, the content of Polygonum multiflorum extract is 0.5%, the content of Gastrodia elata extract is 0.12%, the content of White Peony Root extract is 0.06%, the content of Chuanxiong extract is 0.06%, the content of Coptis chinensis extract is 0.06%, the content of Polygala tenuifolia extract is 0.15%, the content of Shichangpu extract is 0.15%, the content of Ginseng extract is 0.12%, the content of Panax notoginseng extract is 0.06%, the content of American ginseng extract is 0.06%, the content of Salvia miltiorrhiza extract is 0.06%, the content of Curcuma longa extract is 0.3%, and the content of Antrodia cinnamomea extract is 0.3%.

7. The Chinese medicine composition according to claim 1, wherein The Chinese herbal medicine extract comprises a Panax notoginseng extract, and the ratio of the Polygonum multiflorum extract to the Panax notoginseng extract in the Chinese herbal medicine composition is 1.3:1 to 1:

10.

8. The Chinese medicine composition according to claim 1, wherein The Polygonum multiflorum extract is extracted from the root tuber, stem or leaf of Polygonum multiflorum.

9. Use of a Polygonum multiflorum extract in the preparation of a medicine for aiding sleep, improving sleep quality, and treating insomnia and sleep disorders.

10. The use according to claim 9, wherein The content of the Polygonum multiflorum extract is 0.5 to 2.0% based on the total weight of the drug, and the drug further comprises: The Chinese herbal extract different from the Polygonum multiflorum extract is selected from at least one of the group consisting of 0.1 to 0.5% of Gastrodia elata extract, 0.05 to 0.5% of White Peony Root Extract, 0.05 to 0.5% of Chuanxiong Rhizome Extract, 0.05 to 0.5% of Coptis chinensis Extract, 0.05 to 0.5% of Polygala Tenuifolia Extract, 0.05 to 0.5% of Phellodendron chinense Extract, 0.1 to 0.5% of Panax ginseng extract, 0.05 to 0.5% of Panax notoginseng extract, 0.05 to 0.5% of American ginseng extract, 0.05 to 0.5% of Salvia miltiorrhiza extract, 0.1 to 0.9% of Curcuma longa extract and 0.1 to 0.5% of Antrodia cinnamomea extract.

11. The use according to claim 9 or 10, wherein The sleep aid and improvement of sleep quality include relieving stress, relaxing, balancing the autonomic nervous system, reducing sympathetic nervous activity, increasing parasympathetic nervous activity, improving subjective sleep quality, accelerating the time to fall asleep, extending sleep time, increasing sleep depth, reducing sleep disorders, reducing the use of sleeping pills, improving daytime function, or any combination of two or more thereof.

12. The use according to claim 9 or 10, wherein The sleep aid and sleep quality improvement include: reducing peripheral blood flow, reducing heart rate, reducing breathing rate, or a combination of two or more thereof.

13. The use according to claim 9 or 10, wherein The effective amount of the Polygonum multiflorum extract in the traditional Chinese medicine composition is 0.001 mg to 100 mg per kilogram of body weight.

14. The use according to claim 9 or 10, wherein The medicine is in the form of oral preparation, spray, aerosol or essential oil.

15. The use according to claim 9 or 10, wherein The medicine is an external medicine or an oral medicine.

16. The use according to claim 15, wherein The drug is for external use and is intended for application behind the ears, décolleté, and / or hands of a subject.

17. The use according to claim 15, wherein The medicine is an external medicine and is applied to one or more acupoints of the test subject including the Anmian point, Yifeng point, temple, Yintang point, Fengchi point, Shenmen point and Neiguan point.

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