A traditional Chinese medicine composition for improving sleep, its preparation method and application

Abstract

This invention discloses a traditional Chinese medicine composition for improving sleep, its preparation method, and its application. The traditional Chinese medicine composition includes: *Scutellaria baicalensis*, *Ipomoea quamoclit*, *Piper kadsura*, *Plantago asiatica*, and *Aster tataricus* in a mass ratio of 0.5–2:1–3:2–6:1–3:1–3. This invention selects various traditional Chinese medicine components and explores their mixing ratios and dosages to prepare the corresponding traditional Chinese medicine composition. Studies have found that compared to single-component formulas, the traditional Chinese medicine composition of this invention, through the synergistic effect between its components, can significantly inhibit the distance of spontaneous activity in mice and increase the sedation rate, thus it can be formulated into a sedative drug. Simultaneously, when the traditional Chinese medicine composition is combined with subthreshold or suprathreshold doses of sodium pentobarbital in mice, it can effectively increase the sleep onset rate, shorten the sleep latency, and significantly prolong the sleep time. Therefore, the traditional Chinese medicine composition of this invention has the effect of improving sleep, providing experimental evidence for its drug development and utilization in the treatment of insomnia.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for improving sleep, its preparation method, and its application. Background Technology

[0002] Sleep is an essential physiological phenomenon for humans. It occupies nearly one-third of a person's life, and its quality is closely related to health, highlighting its importance to everyone. Chronic insomnia has a significant impact on a person's quality of life, functional abilities, and health. Poor sleep and insomnia lead to difficulty concentrating, severely affecting daily life and work. Long-term insomnia also increases the risk of developing diseases such as hypertension and depression.

[0003] Currently, the most widely used drugs for treating insomnia are benzodiazepines, which have proven effective in clinical practice. However, they also have significant side effects, and long-term use of these sleeping pills may lead to dependence, making withdrawal difficult. Therefore, finding new sedative-hypnotic drugs with fewer side effects and better efficacy, especially traditional Chinese medicine combinations, is currently a key focus and challenge in this field of research. Summary of the Invention

[0004] The purpose of this invention is to provide a traditional Chinese medicine composition for improving sleep, its preparation method, and its application. This invention selects a variety of traditional Chinese medicine ingredients, including: *Scutellaria baicalensis*, *Ipomoea quamoclit*, *Piper kadsura*, *Plantago asiatica*, and *Aster tataricus*, and explores their mixing ratios to prepare the corresponding traditional Chinese medicine composition. Through gavage experiments on mice, it was found that the traditional Chinese medicine composition has a sedative and hypnotic effect. It can be made into a drug for improving sleep or a sedative drug for clinical application. Furthermore, it is made from pure natural Chinese herbal medicines, has no toxic side effects on the human body, and can be taken for a long time.

[0005] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0006] This invention provides a traditional Chinese medicine composition comprising: *Smilax glabra*, *Ipomoea quamoclit*, *Piper kadsura*, *Plantago asiatica*, and *Aster tataricus* in a mass ratio of 0.5–2:1–3:2–6:1–3:1–3.

[0007] Huangteng, also known as Tuhuanglian or Tenghuanglian, is the root or stem of Huangteng, a plant in the Menispermaceae family. It is bitter and cold in nature, and enters the heart and liver meridians. It has the effects of clearing heat and detoxifying, promoting diuresis and relieving constipation. It can treat food poisoning, constipation due to heat, dysentery, infectious hepatitis, sores, conjunctivitis, sore throat, etc.

[0008] Iris tectorum, also known as Patrinia scabiosifolia or Elanca arvense, is the dried aerial part of the Brassicaceae plant Iris tectorum. It is pungent and slightly cold in nature and enters the liver, stomach and large intestine meridians. It has the functions of clearing heat and detoxifying, promoting diuresis and reducing swelling, and harmonizing the stomach and improving appetite. It can be used to treat appendicitis, lung abscess, carbuncles and boils, and indigestion in children.

[0009] Piper kaempferia, also known as climbing vine or wind vine, is the dried stem of Piper kaempferia, a plant in the Piperaceae family. It is pungent, bitter, and slightly warm in nature. It enters the liver meridian. Its functions and indications are to dispel wind and dampness, unblock the meridians, and relieve pain. It is used for wind-cold-dampness arthralgia, joint pain, muscle spasms, and difficulty in flexion and extension.

[0010] Plantain seed is the dried, mature seed of the plant Plantainaceae. It is sweet and cold in nature and enters the liver, kidney, lung, and small intestine meridians. It has the effects of clearing heat and promoting diuresis, draining dampness and relieving strangury, improving eyesight, and eliminating phlegm. It is used for edema and abdominal distension, painful strangury due to heat, summer diarrhea due to dampness, red and swollen eyes, and cough due to phlegm and heat.

[0011] Aster tataricus is the dried root and rhizome of the plant Asteraceae family. It is pungent, bitter, and warm in nature. It enters the lung meridian. Its functions and indications are to moisten the lungs and lower qi, resolve phlegm and stop cough. It is used for cough with excessive phlegm, cough that is new or chronic, and cough with hemoptysis due to overwork.

[0012] Furthermore, the traditional Chinese medicine composition includes: *Scutellaria baicalensis*, *Ipomoea quamoclit*, *Piper kadsura*, *Plantago asiatica*, and *Aster tataricus* in a mass ratio of 1:2:4:2:2.

[0013] The present invention also provides a method for preparing the traditional Chinese medicine composition, comprising: preparing powdered *Pteris vittata*, *Ipomoea quamoclit*, *Piper kadsura*, *Plantago asiatica* and *Aster tataricus*, and mixing them in proportion to obtain the traditional Chinese medicine composition.

[0014] Furthermore, the preparation method of the powdered rattan is as follows: take the rattan stem, wash it clean, cut it into sections, dry it in the sun, grind it into powder, remove impurities by fine sieving with a filter screen, and then dry it naturally at 28-33℃ for 48 hours. Pack it in a glass bottle and seal the opening to obtain the powdered rattan.

[0015] Furthermore, the preparation method of the powdered Astragalus membranaceus, Piper kadsura, Plantago asiatica or Aster tataricus is as follows: take the medicinal materials, remove impurities, moisten them, cut them into sections or thick slices, dry them, grind them into powder, pack them in glass bottles, seal the opening, and obtain the powdered Astragalus membranaceus, Piper kadsura, Plantago asiatica or Aster tataricus respectively.

[0016] The present invention also provides the application of the aforementioned traditional Chinese medicine composition in the preparation of sleep-improving drugs.

[0017] Furthermore, the traditional Chinese medicine composition, in combination with sodium pentobarbital, can significantly improve the sleep onset rate, shorten the sleep latency, and prolong the sleep duration.

[0018] Furthermore, the dosage of the traditional Chinese medicine composition is 150-600 g / kg, and the dosage of sodium pentobarbital is 40-65 mg / kg.

[0019] The present invention also provides the application of the aforementioned traditional Chinese medicine composition in the preparation of sedative drugs.

[0020] Furthermore, when the dosage of the traditional Chinese medicine composition is 150–600 g / kg, it can inhibit spontaneous activity distance and increase sedation rate.

[0021] Compared with the prior art, the beneficial effects of the present invention are as follows: The present invention provides a traditional Chinese medicine composition for improving sleep, its preparation method and application. The present invention selects a variety of traditional Chinese medicine components, including: *Scutellaria baicalensis*, *Ipomoea quamoclit*, *Piper kadsura*, *Plantago asiatica*, and *Aster tataricus*, and explores their mixing ratio and dosage to prepare the corresponding traditional Chinese medicine composition. Studies have found that, compared with single-component formulas, the traditional Chinese medicine composition of the present invention can significantly inhibit the spontaneous activity distance of mice and increase the sedation rate through the synergistic effect between the components, thus it can be made into a sedative drug. At the same time, when the traditional Chinese medicine composition is combined with subthreshold or suprathreshold doses of sodium pentobarbital in mice, it can effectively increase the sleep onset rate of mice, shorten the sleep latency and significantly prolong the sleep time. Therefore, the traditional Chinese medicine composition of the present invention has the effect of improving sleep, providing experimental evidence for its drug development and utilization in the treatment of insomnia. Detailed Implementation

[0022] The technical solution of the present invention will be clearly and completely described below with reference to the embodiments thereof. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0023] Example 1: Comparison of single-component and compound compositions

[0024] 1. Experimental animals: Clean-grade male Kunming mice, weighing 18-22 g. They were housed in a well-ventilated animal laboratory with alternating light and dark conditions for 12 hours each, at an ambient temperature of (22±2)℃ and a relative humidity of (55±5)%. Sufficient food and free access to water were provided. They were used after 7 days of acclimatization.

[0025] 2. Drugs and reagents:

[0026] The single components are: *Coptis chinensis* group, *Ipomoea aquatica* group, *Piper kadsura* group, *Plantago asiatica* group, and *Aster tataricus* group;

[0027] The compound composition comprises vine, scutellaria, pissula, plantain seed, and aster in a mass ratio of 1:2:4:2:2.

[0028] The preparation method is as follows: (1) Take the stem of the rattan, wash it clean, cut it into sections, dry it in the sun and grind it into powder. Use a filter screen (No. 2 sieve) to remove impurities, and then dry it naturally at 28-33℃ for 48 hours. Pack it in a glass bottle and seal the opening to obtain the powdered rattan.

[0029] (2) Take the following herbs: Rhizoma Scutellariae, Rhizoma Piperis, Semen Plantaginis and Radix Asteris, remove impurities, moisten and cut into sections, dry, grind into powder, place in a ventilated and dry place, put in a glass bottle and seal.

[0030] (3) Mix the components in proportion and dissolve them in physiological saline.

[0031] Saline control group: Administered an equal volume of saline.

[0032] Sodium pentobarbital; Estazolam tablets (Shandong Xinyi Pharmaceutical Co., Ltd., National Drug Approval Number: H37023047, Specification: 1mg / tablet).

[0033] 3. Main instrument: Experimental animal spontaneous activity tester, manufactured by Ningbo Anlai Technology Co., Ltd.

[0034] 4. Dosage grouping and administration time of test samples:

[0035] The experiment consisted of 10 groups: a saline control group; a *Pteris vittata* group (600 mg / kg·bw); a *Ipomoea quamoclit* group (600 mg / kg·bw); a *Piper kadsura* group (600 mg / kg·bw); a *Plantago asiatica* group (600 mg / kg·bw); an *Aster tataricus* group (600 mg / kg·bw); an estazolam (0.5 mg / kg) positive control group; and low, medium, and high dose groups of a traditional Chinese medicine compound, with daily oral gavage doses of 150, 300, and 600 mg / kg·bw, respectively. The experiment began 30 days after administration.

[0036] 5. Mouse spontaneous activity experiment:

[0037] One hundred and twenty mice were randomly divided into groups of 12 each. All mice were administered the drug via gavage once daily for 30 days. Initial and final body weights were recorded. Sixty minutes after the last gavage administration, the mice were placed in an animal spontaneous activity testing device for 5 minutes to acclimatize. Their spontaneous activity distance within those 5 minutes was recorded.

[0038] All data were statistically processed using SPSS 23.0 software. Experimental results are expressed as mean ± SEM. One-way ANOVA was used for comparisons among multiple groups, and LSD-t tests were employed for pairwise multiple comparisons between groups. P A value <0.05 indicates that the difference is statistically significant.

[0039] The effects of each treatment group on mouse body weight are shown in Table 1, and the results of measuring the distance of spontaneous activity of mice in each treatment group are shown in Table 2.

[0040] Table 1. Effects of different treatment groups on mouse body weight

[0041] Group Dosage (mg / kg) Number of animals (individuals) Initial body weight (g) Final weight (g) saline group — 12 19.51±0.34 22.09±0.35 Huang Teng Group 600 12 19.63±0.34 21.39±0.27 Group of Michelia champaca 600 12 19.21±0.37 21.17±0.34 Sea Breeze Vine Group 600 12 19.12±0.42 21.56±0.43 Psyllium group 600 12 19.70±0.18 21.18±0.44 Aster Group 600 12 19.30±0.61 21.77±0.15 estazolam group 0.5 12 19.21±0.45 21.58±0.47 Low-dose group of traditional Chinese medicine compound composition 150 12 19.64±0.35 21.46±0.28 Medium Dosage Group of Traditional Chinese Medicine Compound Composition 300 12 19.92±0.33 21.89±0.24 High-dose group of traditional Chinese medicine compound composition 600 12 20.11±0.33 21.57±0.34

[0042] Note: Compared with the saline group. a P <0.01

[0043] Table 2. Effects of different treatment groups on spontaneous activity in mice.

[0044] Group Dosage (mg / kg) Number of animals (individuals) Independent activity distance (cm) saline group — 12 2061.42±117.89 Huang Teng Group 600 12 1930.28±32.30 Group of Michelia champaca 600 12 1859.84±61.22 Sea Breeze Vine Group 600 12 1911.23±88.64 Psyllium group 600 12 1839.57±78.70 Aster Group 600 12 1816.39±95.90a estazolam group 0.5 12 745.83±61.15a Low-dose group of traditional Chinese medicine compound composition 150 12 1798.83±94.23 Medium Dosage Group of Traditional Chinese Medicine Compound Composition 300 12 1512.83±149.06a High-dose group of traditional Chinese medicine compound composition 600 12 871.42±54.89a

[0045] Note: Compared with the saline group. a P <0.01

[0046] According to the results in Table 1, compared with the saline group, there were no statistically significant differences in the initial and final body weights of mice in the single-herb group, the various dosage groups of the traditional Chinese medicine compound, and the estazolam positive group. P >0.05), indicating that the single-ingredient drugs and the traditional Chinese medicine compound composition had no significant effect on the body weight gain of mice, that is, the traditional Chinese medicine composition had no effect on the normal growth of mice. According to the results in Table 2, compared with the saline group, the Aster tataricus group (600 mg / kg), the medium-to-high dose traditional Chinese medicine compound composition groups (300-600 mg / kg), and the estazolam positive control group all effectively reduced the spontaneous movement distance of mice. P <0.01), which means that the traditional Chinese medicine composition of the present invention has a significant inhibitory effect on the spontaneous activity of mice through the synergistic effect between the components, and the effect is dose-dependent, that is, the greater the dose, the stronger the effect.

[0047] 6. Direct Sleep Experiment:

[0048] One hundred and twenty mice were randomly divided into groups of 12 each. All mice were administered the drug via gavage once daily for 30 days. Sixty minutes after the last administration, sedation or sleep was observed in each group. The number of sedated mice and the number of mice falling asleep were recorded, and the sedation rate and sleep rate were calculated. Sedation was defined as a mouse remaining still for ≥15 seconds. Sleep was defined as the time it took for the righting reflex to disappear for ≥60 seconds.

[0049] Sedation rate = (Number of mice that remained still for more than 15 seconds / Total number of experimental mice) × 100%;

[0050] Sleep rate = (Number of mice that fall asleep / Total number of experimental mice) × 100%.

[0051] Data were statistically processed using SPSS 23.0 software. Experimental results are expressed as mean ± SEM, and χ² is used as the statistical metric. 2 The test was statistically analyzed. PA value <0.05 indicates a statistically significant difference. The results are shown in Table 3.

[0052] Table 3. Effects of different treatment groups on direct sleep in mice.

[0053] Group Dosage (mg / kg) Number of animals (individuals) Sedative count (number) Sedation rate (%) Number of birds falling asleep Sleep onset rate (%) saline group — 12 0 0 0 0 Huang Teng Group 600 12 4 33.3a 0 0 Group of Michelia champaca 600 12 1 8.33 0 0 Sea Breeze Vine Group 600 12 2 16.7 0 0 Psyllium group 600 12 3 25 0 0 Aster Group 600 12 2 16.7 0 0 estazolam group 0.5 12 12 100a 0 0 Low-dose group of traditional Chinese medicine compound composition 150 12 3 25 0 0 Medium Dosage Group of Traditional Chinese Medicine Compound Composition 300 12 6 50a 0 0 High-dose group of traditional Chinese medicine compound composition 600 12 10 83.3a 0 0

[0054] Note: Compared with the saline group. a P <0.01

[0055] The results in Table 3 show that each treatment group improved the sedation rate of mice to varying degrees. The single-dose group of *Huang Teng* (600 mg / kg) and the high-dose group of the traditional Chinese medicine compound (300-600 mg / kg) significantly increased the sedation rate of mice (compared to the saline group). P <0.01), where the high-dose group of the traditional Chinese medicine compound composition showed little difference from the estazolam positive control group, and no sleep phenomena occurred in any group, with a sleep onset rate of 0%. These results indicate that, compared to the single-component group, the traditional Chinese medicine composition of this invention can significantly improve the sedation rate of mice through the synergistic effect between its components, exhibiting dose-dependent effects, and without a direct sleep effect.

[0056] 7. Effect on the number of mice falling asleep after subthreshold doses of sodium pentobarbital:

[0057] One hundred and twenty mice were randomly divided into groups of 12 each. All mice were administered the drug via gavage once daily for 30 days. Sixty minutes after the last gavage administration, the mice were intraperitoneally injected with sodium pentobarbital at a dose of 40 mg / kg (subthreshold dose of sodium pentobarbital: the dose that results in a 10-20% sleep rate in mice). The number of mice that fell asleep within 30 minutes of administration, after which their righting reflex disappeared for more than 60 seconds, was observed and recorded, and the sleep rate was calculated.

[0058] Data were statistically processed using SPSS 23.0 software. Experimental results are expressed as mean ± SEM. The subthreshold dose of sodium pentobarbital for hypnosis was analyzed using the chi-square test. 2 The test was statistically analyzed. P A value <0.05 indicates a statistically significant difference. The results are shown in Table 4.

[0059] Table 4. Effects of different treatment groups on sleep onset rate in mice receiving subthreshold doses of sodium pentobarbital

[0060] Group Dosage (g / kg) Number of animals / Number of animals asleep (individuals) Sleep onset rate (%) saline group — 12 / 2 16.6 Huang Teng Group 600 12 / 3 25 Group of Michelia champaca 600 12 / 4 33.3 Sea Breeze Vine Group 600 12 / 3 25 Psyllium group 600 12 / 6 50 Aster Group 600 12 / 3 25 estazolam group 0.5 12 / 9 75a Low-dose group of traditional Chinese medicine compound composition 150 12 / 4 33.3 Medium Dosage Group of Traditional Chinese Medicine Compound Composition 300 12 / 6 50 High-dose group of traditional Chinese medicine compound composition 600 12 / 8 66.7b

[0061] Note: Compared with the saline group. a P <0.01

[0062] According to the results in Table 4, compared with the saline group, after 30 days of continuous administration, the high-dose group of the traditional Chinese medicine compound composition significantly improved the sleep onset rate, and the difference was statistically significant. P The difference was <0.01), and there was little difference in the estazolam positive control group. Furthermore, compared to the single-dose group, both the number of sleepers and the sleep onset rate were significantly improved. These results indicate that the traditional Chinese medicine composition described in this invention, through the synergistic effect between its components, can significantly improve the sleep onset rate of subthreshold doses of sodium pentobarbital in mice, thus demonstrating its sleep-improving effect.

[0063] 8. Effects of suprathreshold doses of sodium pentobarbital on sleep latency and sleep duration in mice:

[0064] One hundred and twenty mice were randomly divided into groups of 12 each. All mice were administered the drug via gavage once daily for 30 days. Sixty minutes after the last administration, the mice were intraperitoneally injected with sodium pentobarbital at a dose of 65 mg / kg (supreme-threshold dose of sodium pentobarbital: the dose that achieves 100% sleep onset in mice). Sleep latency (time from injection of sodium pentobarbital to the disappearance of the righting reflex) and sleep duration (time from the disappearance of the righting reflex to its recovery) were observed and recorded for each group.

[0065] Data were statistically processed using SPSS 23.0 software. All experimental results are expressed as mean ± SEM. One-way ANOVA was used for comparisons among multiple groups, and LSD-t tests were employed for pairwise multiple comparisons between groups. P A value <0.05 indicates a statistically significant difference. The results are shown in Table 5.

[0066] Table 5. Effects of different treatment groups on sleep latency and sleep duration in mice treated with suprathreshold doses of sodium pentobarbital.

[0067] Group Dosage (g / kg) Number of animals (individuals) Sleep latency (s) Sleep duration (s) saline group — 12 176.50±4.93 1623.75±42.77 Huang Teng Group 600 12 176.75±5.33 1544.00±44.52 Group of Michelia champaca 600 12 180.00±3.94 1654.42±212.73 Sea Breeze Vine Group 600 12 165.92±5.23 1849.00=222.07 Psyllium group 600 12 167.08±7.47 2020.25±244.94 Aster Group 600 12 172.67±4.08 1876.83±147.01 estazolam group 600 12 108.58±6.84a 9067.08±452.08a Low-dose group of traditional Chinese medicine compound composition 150 12 196.00±11.04 3279.41±336.93a Medium Dosage Group of Traditional Chinese Medicine Compound Composition 300 12 131.67±8.20a 6574.25±483.34a High-dose group of traditional Chinese medicine compound composition 600 12 113.08±3.76a 8961.50±514.76a

[0068] Note: Compared with the saline group. a P <0.01

[0069] The results in Table 5 show that, compared with the saline group, the medium and high doses of the traditional Chinese medicine compound composition significantly shortened the sleep latency of mice, while all dose groups of the traditional Chinese medicine compound composition significantly prolonged the sleep time, and the differences were statistically significant. P <0.05), with increasing dosage of the traditional Chinese medicine compound composition, the sleep time of mice gradually increased, and the high-dose group of the traditional Chinese medicine compound composition showed little difference from the estazolam positive control group. However, the single-component group showed no significant difference from the saline group. These results indicate that, compared to single-component groups, the traditional Chinese medicine composition of this invention significantly increased the hypnotic effect on mice through synergistic action.

[0070] Based on the above results, the traditional Chinese medicine composition of the present invention mixes and formulates the components in a certain proportion to produce a synergistic effect. It can not only significantly inhibit the spontaneous activity of mice, but also significantly increase the sleep onset rate of subthreshold doses of pentobarbital sodium, and significantly shorten the sleep latency and prolong the sleep time of suprathreshold doses of pentobarbital sodium. That is, it has a significant sedative-hypnotic effect and can be made into corresponding sedative drugs or sleep-improving drugs, providing experimental evidence for its development and utilization in the treatment of insomnia.

[0071] Example 2: Exploration of the formulation ratio of the compound composition

[0072] To explore the optimal ratio of the traditional Chinese medicine compound composition, the components were mixed in different proportions, as follows:

[0073] Compound composition B: includes vine in a mass ratio of 1:2:4:2:2, ...

[0074] Compound composition C: includes vine, scutellaria, vine of sea breeze, plantain seed and aster in a mass ratio of 2:3:6:3:3.

[0075] The above three groups of compound compositions were used to conduct experiments on spontaneous activity in mice, direct sleep, the effect on the number of mice falling asleep with subthreshold doses of sodium pentobarbital, and the effect on sleep latency and sleep duration in mice with suprathreshold doses of sodium pentobarbital. The experimental procedures were the same as in Example 1, and the results are shown in Tables 6-10.

[0076] Table 6. Effect of the proportion of the compound composition on mouse body weight.

[0077] Group Dosage (mg / kg) Number of animals (individuals) Initial body weight (g) Final weight (g) saline group — 12 19.51±0.34 22.09±0.35 Compound Composition B 600 12 20.11±0.33 21.57±0.34 Compound Composition C 600 12 19.40±0.34 20.24±0.54

[0078] Note: Compared with the saline group. a P <0.01

[0079] Table 7. Effects of the proportions of the compound composition on spontaneous activity in mice.

[0080] Group Dosage (mg / kg) Number of animals (individuals) Independent activity distance (cm) saline group — 12 2061.42±117.89 Compound Composition B 600 12 871.42±54.89a Compound Composition C 600 12 1704.00±108.84a

[0081] Note: Compared with the saline group. a P <0.01

[0082] Table 8. Effects of the proportions of the compound composition on direct sleep in mice.

[0083] Group Dosage (mg / kg) Number of animals (individuals) Sedative count (number) Sedation rate (%) Number of birds falling asleep Sleep onset rate (%) saline group — 12 0 0 0 0 Compound Composition B 600 12 10 83.3a 0 0 Compound Composition C 600 12 3 25 0 0

[0084] Note: Compared with the saline group. a P <0.01

[0085] According to the results in Table 6-8, compared with the saline blank control group, compound composition B had no effect on the weight gain of mice, while compound composition C had a certain effect on the weight gain of mice. At the same time, the spontaneous activity distance of compound composition C was higher than that of compound composition B, and the sedation rate of compound composition C was lower than that of compound composition B. These results indicate that compound composition B has a relatively better sedation effect on mice than compound composition C.

[0086] Table 9. Effect of the proportion of the compound composition on the sleep rate in mice receiving subthreshold doses of sodium pentobarbital.

[0087] Group Dosage (g / kg) Number of animals / Number of animals asleep (individuals) Sleep onset rate (%) saline group — 12 / 2 16.6 Compound Composition B 600 12 / 8 66.7b Compound Composition C 600 12 / 4 33.3

[0088] Note: Compared with the saline group. a P <0.01

[0089] Table 10. Effects of the proportions of the compound composition on sleep latency and sleep duration in mice receiving above-threshold doses of sodium pentobarbital.

[0090] Group Dosage (g / kg) Number of animals (individuals) Sleep latency (s) Sleep duration (s) saline group — 12 176.50±4.93 1623.75±42.77 Compound Composition B 600 12 113.08±3.76a 8961.50±514.76a Compound Composition C 600 12 188.41±8.31 2302.50±185.62a

[0091] Note: Compared with the saline group. a P <0.01

[0092] Based on the results in Tables 9-10, after 30 days of continuous administration, the sleep onset rate of compound composition C in mice was lower than that of compound composition B. Although compound composition C could prolong sleep time to some extent, the sleep duration was still shorter than that of compound composition B. These results indicate that the hypnotic effect of compound composition B was significantly better than that of compound composition C.

[0093] Based on the above test results, compared with compound composition C, compound composition B, in which the mass ratio of Huangteng, Ximing, Haifengteng, Cheqianzi and Ziwan is 1:2:4:2:2, can significantly exert the synergistic effect between the components, thereby significantly improving the sedative and hypnotic effect of the traditional Chinese medicine composition.

[0094] The above description is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any changes or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in the present invention should be included within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition, characterized in that, The raw materials of the traditional Chinese medicine composition are: *Pteris vittata*, *Ipomoea quamoclit*, *Piper kadsura*, *Plantago asiatica*, and *Aster tataricus* in a mass ratio of 1~2:2~3:4~6:2~3:2~3.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The raw materials of the traditional Chinese medicine composition are: *Smilax china*, *Ipomoea aquatica*, *Piper kadsura*, *Plantago asiatica*, and *Aster tataricus* in a mass ratio of 1:2:4:2:

2.

3. The method for preparing the traditional Chinese medicine composition according to any one of claims 1 or 2, characterized in that, The method includes: preparing powdered *Pteris vittata*, *Ipomoea quamoclit*, *Piper kadsura*, *Plantago asiatica* and *Aster tataricus*, and mixing them in proportion to obtain the traditional Chinese medicine composition.

4. The preparation method according to claim 3, characterized in that, The preparation method of the powdered rattan is as follows: take the rattan stem, wash it clean, cut it into sections, dry it in the sun, grind it into powder, sieve it with a filter to remove impurities, and then dry it naturally at 28-33℃ for 48 hours. Pack it in a glass bottle and seal the opening to obtain the powdered rattan.

5. The preparation method according to claim 3, characterized in that, The preparation method of the powdered Astragalus membranaceus, Piper kadsura, Plantago asiatica or Aster tataricus is as follows: take the medicinal materials, remove impurities, moisten them, cut them into sections or thick slices, dry them, grind them into powder, pack them in glass bottles, seal the opening, and obtain the powdered Astragalus membranaceus, Piper kadsura, Plantago asiatica or Aster tataricus respectively.

6. The use of the traditional Chinese medicine composition according to any one of claims 1-2 in the preparation of a sleep-improving drug.

7. The application according to claim 6, characterized in that, The traditional Chinese medicine composition, in synergy with sodium pentobarbital, can significantly improve the sleep onset rate, shorten the sleep latency, and prolong the sleep duration.

8. The application according to claim 7, characterized in that, The dosage of the traditional Chinese medicine composition is 150-600 g / kg, and the dosage of sodium pentobarbital is 40-65 mg / kg.

9. The use of the traditional Chinese medicine composition according to any one of claims 1-2 in the preparation of sedative drugs.

10. The application according to claim 9, characterized in that, When the dosage of the traditional Chinese medicine composition is 150-600 g / kg, it can inhibit spontaneous activity distance and increase sedation rate.