CN115501304A

CN115501304A - Traditional Chinese medicine compound composition for treating insomnia with syndrome of hyperactivity of heart-liver fire as well as preparation method and application thereof

Info

Publication number: CN115501304A
Application number: CN202211224889.2A
Authority: CN
Inventors: 王晗; 严士海
Original assignee: Jiangsu Provincial Hospital of Chinese Medicine
Current assignee: Jiangsu Provincial Hospital of Chinese Medicine
Priority date: 2022-10-09
Filing date: 2022-10-09
Publication date: 2022-12-23
Anticipated expiration: 2042-10-09
Also published as: CN115501304B

Abstract

The invention discloses a traditional Chinese medicine compound composition for treating heart-liver fire excess type insomnia and a preparation method and application thereof, wherein the traditional Chinese medicine compound composition is prepared from 5-15 parts of coptis chinensis, 10-30 parts of bamboo leaves, 10-30 parts of scutellaria baicalensis, 15-45 parts of radix rehmanniae, 15-45 parts of white paeony root, 20-60 parts of spina date seeds, 20-60 parts of poria with hostwood, 15-45 parts of cortex albiziae, 15-45 parts of salvia miltiorrhiza and 3-9 parts of honey-fried licorice root. The invention adopts the theory of syndrome differentiation and treatment to carry out proportioning and composing prescriptions, has the advantages of tonifying in clearing, astringing in diarrhea, tonifying without stagnation, purging without injury, and has the effects of clearing away heart-fire, nourishing yin and calming the nerves, so that yang can easily enter yin without excess, yin and blood are sufficient, yang can enter all the way, and natural sleep is improved. Clinical observation experiments show that the compound preparation can reduce the Pittsburgh Sleep Quality Index (PSQI), improve the sleep quality, and has the effects of reducing the time required for falling asleep, prolonging the sleep duration and the like.

Description

Traditional Chinese medicine compound composition for treating insomnia with syndrome of hyperactivity of heart-liver fire as well as preparation method and application thereof

Technical Field

The invention relates to a traditional Chinese medicine compound, in particular to a traditional Chinese medicine compound composition for treating insomnia with hyperactivity of heart-liver fire and a preparation method and application thereof.

Background

Insomnia refers to a type of condition characterized by the frequent inability to attain normal sleep. Some groups have different degrees of insomnia due to high working pressure and irregular life. Western medicines have special side effects for treating insomnia, and traditional Chinese medicines have attracted wide attention of scholars for treating insomnia. The traditional Chinese medicine can avoid a plurality of adverse reactions, effectively improve symptoms and improve life quality, and has obvious characteristics and advantages.

Ancient literature is also called "insomnia", "lying for reading", or "contemplational for contemplation", etc. The insomnia is caused by a plurality of reasons, or the insomnia can be caused by the deficiency of qi and blood, or the body deficiency fire flaming due to yin deficiency, or the qi stagnation, blood stasis, phlegm heat and other pathogenic qi disturbing the mind, or the stomach qi disharmony due to phlegm dampness and food stagnation, which are caused by aging, body weakness, long-term illness and worry. Although the etiology is numerous, it generalizes into two categories: deficiency of healthy qi and excess of pathogenic factors. The book of Lingshu Koushui (Lingshu Kouzi); generally: "Weiqi is good at yang in daytime and yin in half night, yin is good at night, night is good at night, \ 8230, and \8230, yang qi is exhausted, yin qi is in contemplational position, yin qi is exhausted and yang qi is contained. Cloud of the book evil and guest: "jin Jue Qi can be seen in the five zang-organs and six fu-organs, so defensive Qi can only defend outside but can move to yang but not enter yin. Yang predominance results in yang excess, yang predominance results in yang bush, yin deficiency results in eye yellow rice borer.

Therefore, different treatment principles for insomnia caused by different diseases are different, and the traditional Chinese medicine compound is screened and constructed according to the pathogenesis characteristics of the insomnia with the syndrome of hyperactivity of heart-liver fire, so that the traditional Chinese medicine compound has a good treatment effect on the insomnia with the syndrome of disturbance of heart-fire or disharmony between heart and kidney.

Disclosure of Invention

The invention aims to: the invention aims to solve the defects of the prior art and provide the traditional Chinese medicine compound which is scientific and reasonable in proportion, adopts the treatment principles of clearing away heart-fire, purging fire, nourishing yin and soothing the nerves and screens the formula to obtain a good treatment effect on the insomnia caused by the heart-fire disturbing the mind or the heart-kidney imbalance. The invention also aims to provide a preparation method and application of the traditional Chinese medicine compound composition.

The technical scheme is as follows: in order to realize the purpose, the invention adopts the technical scheme that:

a traditional Chinese medicine compound composition for treating insomnia with syndrome of hyperactivity of heart-liver fire comprises the following raw material medicines in parts by weight: 5 to 15 parts of coptis, 10 to 30 parts of bamboo leaves, 10 to 30 parts of scutellaria baicalensis, 15 to 45 parts of radix rehmanniae, 15 to 45 parts of white peony roots, 20 to 60 parts of spina date seeds, 20 to 60 parts of poria with hostwood, 15 to 45 parts of cortex albiziae, 15 to 45 parts of salvia miltiorrhiza and 3 to 9 parts of honey-fried licorice roots.

As a preferred scheme, the traditional Chinese medicine compound composition for treating insomnia with hyperactivity of heart-fire and liver-fire is prepared from the following raw material medicines in parts by weight: 5 to 10 parts of coptis, 10 to 20 parts of bamboo leaves, 10 to 20 parts of scutellaria baicalensis, 15 to 30 parts of radix rehmanniae, 15 to 30 parts of white peony roots, 20 to 40 parts of spina date seeds, 20 to 40 parts of poria with hostwood, 15 to 30 parts of cortex albiziae, 15 to 30 parts of salvia miltiorrhiza and 3 to 6 parts of honey-fried licorice roots.

As a preferred scheme, the traditional Chinese medicine compound composition for treating insomnia with hyperactivity of heart-fire and liver-fire is characterized by being prepared from the following raw material medicines in parts by weight: 5 parts of coptis chinensis, 10 parts of bamboo leaves, 10 parts of scutellaria baicalensis, 15 parts of radix rehmanniae, 15 parts of radix paeoniae alba, 20 parts of spina date seeds, 20 parts of poria with hostwood, 15 parts of cortex albiziae, 15 parts of salvia miltiorrhiza and 3 parts of honey-fried licorice roots.

The invention can prepare the extract of the traditional Chinese medicine compound composition and a pharmaceutically acceptable carrier into a medicament in the dosage form of mixture, paste, oral liquid, granules, capsules, tablets, powder injection, dropping pills or injection;

a preparation method of a medicine with the effect of treating metabolic syndrome comprises the following steps:

(1) Taking coptis chinensis, bamboo leaves, scutellaria baicalensis, radix rehmanniae, radix paeoniae alba, spina date seeds, poria with hostwood, cortex albiziae, salvia miltiorrhiza and radix glycyrrhizae preparata according to parts by weight, adding water with the weight of 6-20 times of the weight of the medicinal materials, decocting or extracting with ethanol under reflux for 1-3 times, and each time for 0.5-2 hours, combining extracting solutions, and concentrating to obtain an extract for later use;

(2) Mixing the extract obtained in step (1) with pharmaceutically acceptable vehicle, and making into mixture, unguent, oral liquid, granule, capsule, tablet, powder for injection, dripping pill or injection;

when the extracts of the raw materials of the traditional Chinese medicine compound provided by the invention are prepared into oral liquid, the extracts of the raw materials are dissolved in distilled water, filtered, and the pH value is adjusted to prepare the oral liquid.

When the extracts of the raw materials of the traditional Chinese medicine compound provided by the invention are prepared into tablets, the raw materials and lactose or corn starch are added with lubricant magnesium stearate if necessary, the mixture is uniformly mixed, granulated and then tableted to prepare the tablets.

When the extract of the traditional Chinese medicine compound provided by the invention is prepared into capsules, the extract of each raw material and carrier lactose or corn starch are uniformly mixed, granulated and then encapsulated to prepare the capsules.

When the extracts of the raw materials of the traditional Chinese medicine compound provided by the invention are prepared into granules, the extracts of the raw materials and diluent lactose or corn starch are uniformly mixed, granulated, dried and prepared into the granules.

When the extracts of the raw materials of the traditional Chinese medicine compound provided by the invention are prepared into powder injection, the extracts of the raw materials are frozen, dried and sterilized to prepare the powder injection.

Has the beneficial effects that: according to the traditional Chinese medicine theory of treatment based on syndrome differentiation, the coptis chinensis is used as a monarch drug in the formula, and is bitter in taste and cold in nature; it enters heart, spleen, stomach, liver, gallbladder and large intestine meridians, and clears heart-fire. Bamboo leaves are sweet and light in flavor and cold in nature; it enters heart, lung and stomach meridians, and has the effects of clearing away heat, relieving restlessness, promoting salivation and inducing diuresis. The scutellaria baicalensis is bitter in taste and cold in nature, enters the channels of the lung, the gallbladder, the spleen, the large intestine and the small intestine, clears heat and dries dampness, and purges fire and detoxifies, and the combination of the scutellaria baicalensis and the bamboo leaves strengthens the effect of the coptis chinensis on clearing away heart-fire and purging fire is taken as a ministerial drug.

Radix rehmanniae, sweet and cold; heart, liver and kidney meridians entered; clear heat and cool blood, nourish yin and promote the production of body fluid. White peony root, radix Paeoniae alba, bitter and sour in taste and slightly cold in nature, enters liver and spleen meridians and has the actions of nourishing blood and yin. The wild jujube seeds are sweet and sour in taste and mild in nature; it enters liver, gallbladder and heart meridians, and has the actions of nourishing heart, tonifying liver, tranquilizing mind, arresting sweating and promoting the production of body fluid. Poria with hostwood, sweet, bland, mild; tranquilize the heart, induce tranquilization and induce diuresis. Cortex albiziae, neutral in nature; sweet in taste; entering heart and liver meridians, has the effects of resolving depression, regulating blood, calming heart and eliminating carbuncle and swelling. Salvia miltiorrhiza is bitter in taste and slightly cold; it is also effective in activating blood and dispelling blood stasis, dredging channels and relieving pain, clearing away heart-fire and relieving restlessness, cooling blood and resolving carbuncle. The six medicines are used as adjuvant medicines for nourishing yin, tranquilizing mind and calming heart. Licorice root, radix Glycyrrhizae coordinates the effects of the other drugs in the recipe.

The whole formula has the effects of tonifying, astringing in diarrhea, tonifying without stagnation, and purging without injury, and has the effects of clearing away heart-fire, nourishing yin and soothing the nerves, so that yang is not excessive and can easily enter yin, yin blood is sufficient and yang enters all, and natural sleep is improved.

Clinical observation experiments show that the compound preparation can reduce the Pittsburgh Sleep Quality Index (PSQI), improve the sleep quality, and has the effects of reducing the time required for falling asleep, prolonging the sleep duration and the like.

Animal experiments show that the traditional Chinese medicine compound can effectively improve the physical conditions of the insomnia rats such as food intake, hair color, weight and the like; the sleep latency of the rat with insomnia is shortened, and the sleep duration is prolonged, so that the preparation method plays a definite treatment role in treating insomnia. Research results show that the traditional Chinese medicine compound provided by the invention embodies the comprehensive curative effects of the heart-fire clearing effect unit and the yin nourishing effect unit. The traditional Chinese medicine compound composition provided by the invention has small toxic and side effects after long-term use and is safe and reliable to use.

Detailed Description

The invention is further described in the following examples in connection with specific embodiments thereof, it is to be understood that these examples are included solely for the purpose of illustration and are not intended as limitations on the scope of the invention, as modifications of various equivalent forms of the invention which would occur to those skilled in the art upon reading the present disclosure are intended to be within the scope of the invention as defined in the appended claims.

Example 1

1. A traditional Chinese medicine compound composition for treating insomnia with syndrome of hyperactivity of heart-liver fire is prepared from the following raw material medicines by weight: 5g of coptis chinensis, 10g of bamboo leaves, 10g of scutellaria baicalensis, 15g of radix rehmanniae, 15g of radix paeoniae alba, 20g of spina date seeds, 20g of poria with hostwood, 15g of cortex albiziae, 15g of salvia miltiorrhiza and 3g of honey-fried licorice roots.

2. The preparation method of the traditional Chinese medicine compound composition for treating insomnia with hyperactivity of heart-liver fire comprises the following steps:

(1) Taking 5g of coptis chinensis, 10g of bamboo leaves, 10g of scutellaria baicalensis, 15g of radix rehmanniae, 15g of white paeony roots, 20g of spina date seeds, 20g of poria with hostwood, 15g of cortex albiziae, 15g of salvia miltiorrhiza and 3g of honey-fried licorice roots according to the parts by weight, adding water with the weight 15 times of that of the medicinal materials, decocting and extracting for 2 times, each time for 1 hour, combining extracting solutions, and concentrating to obtain an extract for later use;

(2) And (2) adding the extract obtained in the step (1) into a diluent cyclodextrin, uniformly mixing, grading, drying and preparing into granules.

Example 2

1. A traditional Chinese medicine compound composition for treating insomnia with hyperactivity of heart-liver fire is prepared from the following raw material medicines by weight: 10g of coptis chinensis, 20g of bamboo leaves, 20g of scutellaria baicalensis, 30g of radix rehmanniae, 30g of radix paeoniae alba, 40g of spina date seeds, 40g of poria with hostwood, 30g of cortex albiziae, 30g of salvia miltiorrhiza and 6g of honey-fried licorice roots.

(1) Taking 10g of coptis chinensis, 20g of bamboo leaves, 20g of scutellaria baicalensis, 30g of radix rehmanniae, 30g of white peony roots, 40g of spina date seeds, 40g of poria with hostwood, 30g of cortex albiziae, 30g of salvia miltiorrhiza and 6g of honey-fried licorice roots according to the weight parts, adding water with the weight being 12 times of that of the medicinal materials, decocting and extracting for 2 times, each time for 1 hour, combining extracting solutions, and concentrating to obtain an extract for later use;

(2) And (2) uniformly mixing the extract obtained in the step (1) with a carrier corn starch, granulating, and encapsulating to prepare capsules.

Example 3

1. A traditional Chinese medicine compound composition for treating insomnia with syndrome of hyperactivity of heart-liver fire is prepared from the following raw material medicines by weight: 15g of coptis chinensis, 30g of bamboo leaves, 30g of scutellaria baicalensis, 45g of radix rehmanniae, 45g of radix paeoniae alba, 60g of spina date seeds, 60g of poria with hostwood, 45g of cortex albiziae, 45g of salvia miltiorrhiza and 9g of honey-fried licorice roots.

2. The preparation method of the traditional Chinese medicine compound composition for treating insomnia with hyperactivity of heart-fire and liver-fire comprises the following steps:

(1) Taking 15g of coptis chinensis, 30g of bamboo leaves, 30g of scutellaria baicalensis, 45g of radix rehmanniae, 45g of white paeony roots, 60g of spina date seeds, 60g of poria with hostwood, 45g of cortex albiziae, 45g of salvia miltiorrhiza and 9g of honey-fried licorice roots according to the weight parts, adding water with the weight 10 times that of the medicinal materials, decocting and extracting for 3 times, each time for 1 hour, combining extracting solutions, and concentrating to obtain an extract for later use;

(2) And (2) adding lactose serving as a diluent and magnesium stearate serving as a lubricant into the extract obtained in the step (1), uniformly mixing, granulating, and tabletting to prepare tablets.

Example 4 control group I

1. A traditional Chinese medicine compound composition for treating insomnia with syndrome of hyperactivity of heart-liver fire is prepared from the following raw material medicines by weight: 5g of coptis root, 10g of bamboo leaf, 10g of scutellaria root and 15g of salvia miltiorrhiza.

2. The preparation method is the same as example 1.

EXAMPLE 5 control group II

1. A traditional Chinese medicine compound composition for treating insomnia with hyperactivity of heart-liver fire is prepared from the following raw material medicines by weight: 15g of radix rehmanniae, 15g of white peony root, 20g of spina date seed, 20g of poria with hostwood and 15g of cortex albiziae.

2. The preparation method is the same as example 1.

Example 6 clinical study

1. Data of clinical experiments

The diagnosis standard of primary insomnia is determined according to the American psychiatric society mental disease diagnosis and statistics manual: 1) Prominent complaints are difficulty falling asleep or maintaining sleep or lack of recovery of energy after sleep for at least 1 month. 2) Sleep problems (or concomitant daytime fatigue) result in clinically significant distress or impairment of social, occupational, and other important functions. 3) Sleep problems not only occur in the course of narcolepsy, respiratory-related sleep disorders, and the like. 4) Sleep problems not only occur in the course of other psychiatric disorders (e.g. major depressive disorder, bipolar disorder, generalized anxiety disorder, delirium). 5) Sleep problems are not due to direct physiological effects of drugs or physical states.

The standard of traditional Chinese medicine syndrome differentiation refers to the key points of syndrome differentiation of insomnia in the second edition of the internal science of traditional Chinese medicine, the new century and the standard of curative effect of diagnosis of internal medicine diseases in traditional Chinese medicine in the standards of the pharmaceutical industry of the people's republic of China, and the diagnosis standard of the syndrome of hyperactivity of heart-liver fire in clinic is drawn up.

Inclusion criteria 1) the diagnostic criteria for primary insomnia were met. 2) The disease course of insomnia is more than 1 month. 3) Meets the syndrome differentiation standard of the heart-liver fire hyperactivity in traditional Chinese medicine. 4) The Pittsburgh sleep quality index total score (PSQI) is more than or equal to 7. 5) Hamilton depression scale 17 item (HAMD) score <7 points. 6) Hamilton anxiety scale 14 items (HAMA) score <14 points. 7) The age is 18-75 years. 8) Voluntarily, and with informed consent.

Exclusion criteria 1) secondary insomnia caused by systemic disease and external environmental interference factors. 2) Patients with severe primary disease (e.g.: cardiovascular and cerebrovascular, pulmonary, hepatic, renal, endocrine, and hematopoietic systems, etc.). 3) Suffering from a severe psychotic disorder. 4) Sleep apnea syndrome. 5) Professional drivers, overhead operators. 6) Allergic to known components of the medicine. 7) Pregnant, lactating, and planned pregnant. 8) Alcoholics and/or psychoactive drug use, drug abusers and dependents. 9) Family history of mental diseases. 10 ) other clinical trial participants were enrolled within approximately 1 month.

2. Grouping and administration of drugs

The extract is randomly divided into two groups, one group is a control group (Wuling capsule, 3 capsules at a time and 3 times a day), and the other group is the extract of the traditional Chinese medicine compound prepared in the embodiment 1 of the invention, and the dosage is 1 bag (15 g/bag) at a time and 2 times a day. The administration period was 1 month.

3. Observation of the index and results

3.1 Baseline comparison of two general data sets

Before treatment, the two groups have no significant difference in sex, age, weight, height, resting heart rate, respiration, body temperature, traditional Chinese medicine symptoms, pittsburgh sleep quality index, time required for falling asleep, sleep duration, awakening frequency and the like. The data are shown in tables 1 and 2.

Table 1: baseline comparison of two general data sets

Table 2: baseline comparison of two general data sets

3.2 Main therapeutic index

3.2.1 two groups of results of comparison of the traditional Chinese medicine syndrome curative effects

As shown in Table 3, the total effective rate of the control group after treatment is 76.92%, and the significant effective rate is 53.85%. The total effective rate of the traditional Chinese medicine compound in the embodiment 1 is 88.46%, and the significant efficiency is 73.8%. There was a significant difference between the two.

TABLE 3 comparison of the curative effects of two groups of syndromes of traditional Chinese medicine

P <0.05 compared to control group

3.2.2 Pittsburgh Sleep Quality Index (PSQI).

As shown in Table 4, the quality index of Pittsburgh sleep in the control group after treatment is 9.81 +/-1.90, the quality index of Pittsburgh sleep in the traditional Chinese medicine compound in the example 1 is 7.15 +/-1.51, and the value of the traditional Chinese medicine compound in the example 1 is obviously lower than that of the control group, which indicates that the sleep quality is better.

Table 4: comparison result of sleep quality indexes of two groups of Pittsburgh

Sleep quality index	Number of examples	Before administration	After administration
				Control group	26	13.35±2.56	9.81±1.90
Example 1 Chinese herbal Compound	26	13.10±1.72	7.15±1.51*

P <0.05 compared to control group

3.3 Secondary efficacy index

3.3.1 time required to go to sleep

The time required for the two groups to fall asleep before treatment was not significantly different, and the time required for the Chinese herbal compound of example 1 to fall asleep after treatment was significantly lower than that of the control group, as shown in Table 5.

Table 5: results of comparing the time required for two groups to fall asleep

P <0.05 compared to control group

3.3.2 duration of sleep

There was no significant difference in sleep duration between the groups before treatment, and the sleep duration of the herbal combination of example 1 was significantly greater than the control group after treatment, as shown in table 6.

Table 6: comparison of sleep durations of two groups

Duration of sleep (h)	Number of examples	Before administration (h)	After administration (h)
				Control group	26	4.99±0.50	5.53±0.46
Example 1 Chinese herbal Compound	26	4.78±0.49	5.85±0.53*

P <0.05 compared to control group

3.3.3 number of nighttime awakenings

There was no significant difference in the number of awakenings in the first two groups, and the number of awakenings in the herbal combination of example 1 was significantly less than the control group after treatment, as shown in table 7.

Table 7: results of two groups of awakenings

Number of awakenings	Number of examples	Before administration (times)	After administration (next time)
				Control group	26	3.88±0.86	2.65±0.75
EXAMPLE 1 Chinese herbal composition	26	3.75±0.78	2.10±0.72*

P <0.05 compared to control group

Example 5 animal experiments

1. Preparing a model: SD rats are modeled by adopting p-chlorophenylalanine (PCPA) which is used as a tryptophan hydroxylase inhibitor and can block and exhaust the synthesis of intracerebral 5-hydroxytryptamine, and the PCPA suspension (350 mg/kg) is injected into the abdominal cavity to induce insomnia.

2. Experimental grouping and dosing: a normal control group; a model group; the positive drug group (diazepam, 0.02 g/kg) is taken 1 time a day; example 1 Chinese herbal compound (2.7 g/kg), control group I (2.7 g/kg) of example 4, and control group II (2.7 g/kg) of example 5. The normal control group and the model group are given with the same amount of normal saline and are given with 10mL/kg gastric lavage.

3. Observation of indexes and results

3.1. Modeling of rats in each group and behavioral changes after drug administration treatment

All rats did not die during modeling and drug administration intervention. During the period of injecting PCPA for 12-48h by 5 molding groups, the diet and water intake of rats are obviously increased, the rats show certain excitatory behaviors, the rats have obvious irritability, increased activities and increased aggressiveness in the daytime, the sensitivity to external sound, light and other stimulation is enhanced, the self circadian rhythm disappears, the total sleep quantity is seriously reduced, the insomnia is almost completely achieved, and the success of molding the insomnia rats is shown; after the 5 modeling groups are injected with PCPA for 72-96h, the skin and hair are loose, the skin and hair are dull, the head is often lowered, the spirit is not vibrating, the food intake and the activity are reduced, the sensitivity to external stimulation is weakened, the weight is slowly increased, the weight of some rats is reduced, and the fatigue state is serious; after the administration, the rats in each administration group improve the feeding, activity, sleep, hair color, weight and external stimulation, while the states of some rats in the model control group are unchanged, and the states of other rats are worse; the normal control group was normal during both molding and intervention.

After modeling, compared with a normal control group, the increase of the body weight of the rat with 5 modeling groups is obviously reduced, negative increase appears, and the difference has statistical significance (P is less than 0.05); after the administration treatment, the weight increase of the rats in the model control group is obviously reduced compared with that in the normal control group, and the difference has statistical significance (P is less than 0.05), and the weight increase of the rats in each administration group is obviously increased compared with that in the model control group, and the difference has statistical significance (P is less than 0.05). The body weight recovery degree of the control group I and the control group II is worse than that of the traditional Chinese medicine compound in the example 1, and the significant difference exists. The results are shown in Table 8.

TABLE 8 weight change after rat model creation and after treatment with drug (

n＝10)

Group of	Change in body weight after molding (g)	Weight change after treatment (g)
			Normal control group	11.89±2.57	32.67±7.01
Model control group	-26.40±2.80▲	26.30±3.95▲
			Positive control group	-28.70±4.90▲	42.40±6.50*
EXAMPLE 1 Chinese herbal composition	-28.80±5.29▲	44.80±5.98*
			Control group I	-28.20±7.71▲	35.20±8.69*#
Control group II	-28.20±5.92▲	37.90±4.61*#

Note: comparison with normal control group: p <0.05, indicated by "a-solidup"; comparison with model control group: p <0.05 is denoted by "+"; compared with the traditional Chinese medicine compound in the example 1, P is less than 0.05 and is represented by "#" in

3.2. Effect on sleep time in rats

Compared with a normal control group, the sleep latency of the rats in the model control group is obviously prolonged, the sleep duration is obviously shortened, and the difference has statistical significance (P is less than 0.05), which indicates that the model building is successful; compared with a model control group, the sleep-in latent period of the rats in each administration group is obviously shortened, the sleep duration is obviously prolonged, and the difference has statistical significance (P is less than 0.05). In example 1, the improving effect of the Chinese herbal compound on the sleep-onset latency and the sleep duration is obviously better than that of 2 control groups, and the difference is significant (P is less than 0.05). The result shows that the traditional Chinese medicine compound can obviously shorten the sleep latency of the insomniacs, prolong the sleep duration and has obvious hypnotic effect on the insomniacs. The results are shown in Table 9.

TABLE 9 sleep time comparison of rats in groups: (

n＝10)

Group of	Latent period of falling asleep (min)	Duration of sleep (min)
			Normal control group	9.11±1.84	128.89±16.38
Model control group	15.90±2.60▲	61.40±12.59▲
			Positive control group	11.80±2.35*	109.90±14.48*
EXAMPLE 1 Chinese herbal composition	10.10±2.13*	112.90±13.74*
			Control group I	13.20±2.20*#	94.60±12.29*#
Control group II	12.20±2.44*#	86.60±14.93*#

Note: comparison with normal control group: the P is less than 0.05 and is represented by 'tangle-solidup' table; comparison with model control group: p <0.05 is indicated by ". Times.. Compared with the traditional Chinese medicine compound in the embodiment 1, P is less than 0.05 and is indicated by "#".

The experimental results show that the traditional Chinese medicine compound can effectively improve the physical conditions of the insomnia rats such as food intake, hair color, weight and the like; the sleep latency of the rat with insomnia is shortened, and the sleep duration is prolonged, so that the preparation method plays a definite treatment role in treating insomnia.

The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, various modifications and amendments can be made without departing from the principle of the present invention, and these modifications and amendments should also be considered as the protection scope of the present invention.

Claims

1. A traditional Chinese medicine compound composition for treating insomnia with syndrome of hyperactivity of heart-liver fire is characterized by comprising the following raw material medicines in parts by weight: 5 to 15 parts of coptis, 10 to 30 parts of bamboo leaves, 10 to 30 parts of scutellaria, 15 to 45 parts of radix rehmanniae, 15 to 45 parts of white peony roots, 20 to 60 parts of spina date seeds, 20 to 60 parts of poria with hostwood, 15 to 45 parts of cortex albiziae, 15 to 45 parts of salvia miltiorrhiza and 3 to 9 parts of honey-fried licorice roots.

2. The compound traditional Chinese medicine composition for treating insomnia caused by hyperactivity of heart-fire and liver-fire as claimed in claim 1, is characterized by being prepared from the following raw material medicines in parts by weight: 5 to 10 parts of coptis chinensis, 10 to 20 parts of bamboo leaves, 10 to 20 parts of scutellaria baicalensis, 15 to 30 parts of radix rehmanniae, 15 to 30 parts of white peony roots, 20 to 40 parts of spina date seeds, 20 to 40 parts of poria with hostwood, 15 to 30 parts of cortex albiziae, 15 to 30 parts of salvia miltiorrhiza and 3 to 6 parts of honey-fried licorice roots.

3. The compound traditional Chinese medicine composition for treating insomnia caused by hyperactivity of heart-fire and liver-fire as claimed in claim 2, which is characterized by being prepared from the following raw material medicines in parts by weight: 5 parts of coptis chinensis, 10 parts of bamboo leaves, 10 parts of scutellaria baicalensis, 15 parts of radix rehmanniae, 15 parts of radix paeoniae alba, 20 parts of spina date seeds, 20 parts of poria with hostwood, 15 parts of cortex albiziae, 15 parts of salvia miltiorrhiza and 3 parts of honey-fried licorice roots.

4. A traditional Chinese medicine compound composition for treating insomnia caused by hyperactivity of heart-fire and liver-fire is characterized in that an extract of the traditional Chinese medicine compound composition of any one of claims 1 to 3 and a pharmaceutically acceptable carrier are prepared into a medicine in the dosage forms of mixture, paste, oral liquid, granules, capsules, tablets, powder injection, dropping pills or injection.

5. The process for producing a pharmaceutical composition for treating metabolic syndrome according to claim 4, comprising the steps of:

(1) Taking coptis chinensis, bamboo leaves, scutellaria baicalensis, radix rehmanniae, radix paeoniae alba, spina date seeds, poria with hostwood, cortex albiziae, salvia miltiorrhiza and honey-fried licorice roots according to the parts by weight of any one of claims 1 to 3, adding water with the weight of 6 to 20 times of the weight of the medicinal materials, decocting or extracting with ethanol under reflux for 1 to 3 times, each time for 0.5 to 2 hours, combining extracting solutions, and concentrating to obtain an extract for later use.

(2) Mixing the extract obtained in step (1) with pharmaceutically acceptable vehicle, and making into mixture, unguent, oral liquid, granule, capsule, tablet, powder for injection, dripping pill or injection.

6. The use of the compound traditional Chinese medicine composition of any one of claims 1 to 3 in the preparation of a medicament for treating insomnia.

7. The use of the compound traditional Chinese medicine composition of any one of claims 1 to 3 in the preparation of a medicament for treating insomnia caused by hyperactivity of heart-fire and liver-fire.