CN112168893A

CN112168893A - Application of traditional Chinese medicine composition in improving perimenopausal female syndrome

Info

Publication number: CN112168893A
Application number: CN201910592020.5A
Authority: CN
Inventors: 张磊; 张保献; 李艳英; 李文慧; 杨秀伟; 李军
Original assignee: Increase Tianjin Innovative Medicine Research Co ltd
Current assignee: Increase Tianjin Innovative Medicine Research Co ltd
Priority date: 2019-07-02
Filing date: 2019-07-02
Publication date: 2021-01-05
Anticipated expiration: 2039-07-02
Also published as: CN112168893B

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to an application of a pharmaceutical composition for improving perimenopausal female syndrome. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10-50 parts of mother-of-pearl, 5-30 parts of spina date seed, 2-20 parts of rehmannia root, 2-20 parts of rhizoma picrorhizae, 2-20 parts of cynanchum atratum, 2-20 parts of salvia miltiorrhiza and 1-10 parts of hypericum perforatum. The invention combines the pharmacological research of modern Chinese medicaments, combines the medicaments, has the effects of clearing away the heart-fire and calming the liver, and calming the heart and tranquilizing the mind, and is particularly effective for treating the perimenopausal woman syndrome.

Description

Application of traditional Chinese medicine composition in improving perimenopausal female syndrome

Technical Field

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to an application of a traditional Chinese medicine composition for improving syndrome symptoms of perimenopausal women.

Background

Perimenopause is a transition period of physiological decay that every woman experiences during its life. The perimenopause period is divided into 3 stages, namely, the transition period, the menopause period and the postmenopausal period, which are considered by western doctors. Perimenopausal syndrome refers to a series of symptoms mainly comprising autonomic nervous system dysfunction caused by sex hormone fluctuation or reduction before and after menopause and accompanied with psychological symptoms, and mainly comprises menstrual disorder, vasomotor symptoms, cardiovascular system symptoms and metabolic syndrome, urogenital syndrome, osteoporosis and the like, wherein 90 percent of women exist, and the normal life and work of perimenopausal women are influenced. The patients may have symptoms of hectic fever, flush, increased sweating, menoxenia, frequent micturition, anxiety, vexation, insomnia, dreaminess, and dry skin. Perimenopausal syndrome incidence is reported to be about 85%, with symptoms severely affecting normal life and workers accounting for about 10% to 30%; the onset age is mostly 45-55 years old, the onset can last 2-3 years after menopause, and symptoms can be relieved or eliminated by a few people 5-10 years after menopause, so that great pain is brought to patients.

There is no record of perimenopausal syndrome in ancient books in traditional Chinese medicine, and according to different emphasis of clinical manifestations of patients, the disease category is scattered in insomnia, depression, sweat syndrome, consumptive disease, visceral dryness, palpitation, vertigo and the like, and is complete in multiple symptoms before and after menopause at present.

Description of physiological deterioration changes of women in ancient books is consistent with perimenopause, and is described in Suzhou, ancient Tianzhen treatise: seven, the ren channel is deficient, the taichong pulse is weak, the Tian Decaho is exhausted, the tunnel is obstructed, so the body is bad without son. The traditional Chinese medicine considers that most women can successfully go through perimenopause, but some women can not well regulate the kidney yin and yang due to individual factors, so that the yin and yang of the kidney are disordered, and the yin and yang of viscera are disordered, particularly the heart, the liver and the spleen are mainly used. The study of each family considers that the disease is mainly caused by viscera and kidney, and yin deficiency and yang hyperactivity are caused by deficiency of origin and excess of superficiality. For perimenopausal syndrome, traditional Chinese medicine advocates treatment from the kidney, and many doctors believe that the disease is a complex disease caused by the comprehensive action of the viscera, so they can treat the disease based on the differentiation of syndromes of the viscera. In addition, treatment from phlegm is also advocated, mainly soothing liver and resolving phlegm; or advocate treatment from stasis, mainly regulating and nourishing liver and kidney, activating blood and resolving stasis.

According to the latest national population census results in China, the total number of women in China reaches 6 hundred million, wherein the number of women in perimenopause reaches 1.6 hundred million, and the women are the first in the world. The perimenopausal symptoms of women have obvious rising trend due to factors of families and society in various aspects, and the health condition directly influences the social development and stability to cause a series of diseases, thereby greatly increasing the medical burden of the country.

The use of Hormone Replacement Therapy (HRT) and lifestyle adjustments for diet, exercise, smoking cessation, alcohol restriction, etc. by menopausal women is a general strategy for maintaining the health of perimenopausal and postmenopausal women, and is the most important component in the relief of menopausal syndrome.

Treatment of women with menopausal syndrome with HRT indications has been controversial, as early as 2002, in a follow-up survey by researchers at the feminine health association for 1 year, who found increased risk of coronary, stroke, breast, and venous thromboembolism in patients treated with HRT compared to women who did not use HRT. The 2004 women's health society's experiments showed that in perimenopausal women who had removed the uterus, the risk of coronary heart disease, breast cancer, stroke, venous thromboembolism and the like in patients who had taken estrogen alone was not significantly different from the combined use of estrogen. The study of 13 years of follow-up visit of female health association experiments in 2013 shows that the risk of breast cancer and venous thrombosis of women taking the combination of the estrogen and the progestogen is obviously increased, but the fracture risk is relatively reduced. Contrary to the results of the 2004 study, women taking estrogen alone had a reduced risk of developing breast cancer.

Due to the fact that population quality in China is uneven and the cognition of the public to hormone is insufficient, the fear of perimenopausal syndrome women to hormone treatment is directly caused; secondly, for patients with contraindications, hormone therapy cannot be used conventionally; thirdly, hormone therapy must be administered under the guidance and supervision of doctors, and many patients cannot insist on administration and re-diagnosis for various reasons, so that hormone therapy cannot be widely applied. Non-hormonal treatments, while capable of alleviating perimenopausal symptoms to some extent, have no effective evidence to show significant efficacy at present. Under the treatment background, the traditional Chinese medicine has unprecedented new advantages on the treatment effect of the perimenopausal syndrome.

Disclosure of Invention

In view of the above, the invention provides a traditional Chinese medicine composition for improving perimenopausal female syndrome, and a preparation method, a preparation and application thereof.

In order to achieve the purpose, the invention adopts the following technical scheme:

the first purpose of the invention is to provide a traditional Chinese medicine composition for improving syndrome of perimenopausal women.

A traditional Chinese medicine composition for improving perimenopausal female syndrome is composed of the following raw material medicines: mother-of-pearl, wild jujube seed, rehmannia root, picrorhiza rhizome, cynanchum atratum, red sage root and hypericum perforatum.

Preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10-50 parts of mother-of-pearl, 5-30 parts of spina date seed, 2-20 parts of rehmannia root, 2-20 parts of rhizoma picrorhizae, 2-20 parts of cynanchum atratum, 2-20 parts of salvia miltiorrhiza and 1-10 parts of hypericum perforatum.

Preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 20-40 parts of mother-of-pearl, 5-20 parts of spina date seed, 2-15 parts of rehmannia root, 2-15 parts of rhizoma picrorhizae, 2-15 parts of cynanchum atratum, 2-15 parts of salvia miltiorrhiza and 1-5 parts of hypericum perforatum.

More preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 30 parts of mother-of-pearl, 10 parts of spina date seed, 6 parts of rehmannia root, 6 parts of rhizoma picrorhizae, 4 parts of cynanchum atratum, 6 parts of salvia miltiorrhiza and 2 parts of hypericum perforatum.

More preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 40 parts of mother-of-pearl, 20 parts of spina date seed, 10 parts of rehmannia root, 10 parts of rhizoma picrorhizae, 10 parts of cynanchum atratum, 10 parts of salvia miltiorrhiza and 5 parts of hypericum perforatum.

More preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 40 parts of mother-of-pearl, 15 parts of spina date seed, 15 parts of rehmannia root, 10 parts of rhizoma picrorhizae, 10 parts of cynanchum atratum, 15 parts of salvia miltiorrhiza and 5 parts of hypericum perforatum.

In a specific embodiment, the rehmannia root in the Chinese medicinal composition of the invention is rehmannia root.

The invention mainly uses nacre as a monarch drug, has the functions of calming the liver, suppressing yang hyperactivity, clearing liver fire, strengthening heart meridian and relieving convulsion and soothing the nerves. The spina date seed is sweet in taste, enters heart and liver channels, can nourish heart yin and benefit liver blood to have the effect of soothing the nerves, and is an essential drug for nourishing heart and soothing the nerves; radix rehmanniae, sweet and cold in nature, has the effects of nourishing yin, and bitter and cold in nature, can discharge heat, enters kidney channel to nourish yin and descend fire, and nourish yin and discharge body fluid to discharge latent heat; the two are compatible, and can help monarch drugs to pacify liver and clear heart, and are ministerial drugs together. Picrorhiza rhizome, being cold in nature, enters the blood system of heart and liver meridians and has the effects of reducing deficiency heat, removing bone-steaming, cooling blood and clearing heat; bai Wei is bitter and cold in nature and good at entering blood system, clearing heat and cooling blood, and clearing deficiency heat and benefiting yin; the two are mutually reinforced to clear heat, benefit yin and cool blood; the salvia miltiorrhiza, entering the heart channel, can clear heat and cool blood, relieve restlessness and calm nerves, activate blood and nourish blood to calm the nerves and calm mind; the three medicines are used as adjuvant medicines. Hypericum perforatum, pungent and cold in flavor, enters liver meridian, soothes liver and relieves depression, and clears heat and promotes diuresis as a guiding drug.

The medicines are combined to play the effects of clearing away heart-fire and calming the liver and calming the heart and soothing the nerves, and the traditional Chinese medicine is particularly effective in treating the symptoms of perimenopausal woman syndrome.

The properties and the functions of the raw materials of the traditional Chinese medicine composition are as follows:

mother-of-pearl

The pearl shell medicine material of the year version of Chinese pharmacopoeia 2015 is loaded with the shells of Hyriopsis cumingii (Lea) which is an animal in the family Unionidae, Cristaria plicata (Leach) or Pteria martensii (Dunker) which is an animal in the family Pteria martensii. The Concha Margaritifera is shell of Pteria martensii (Dunker) of Pinctada Margaritifera, and is rarely used for medicinal purposes. The main sources are shells of Hyriopsis cumingii (Lea) and Cristaria plicata (Leach) of Unionidae. Through understanding, the Hyriopsis cumingii is the main parent mussel for cultivating fresh water pearls in China at present, and resources are rich, so that the nacre used is determined to be the shell of Hyriopsis cumingii (Lea) which is a mussel animal.

Salty taste and cold nature. It enters liver and heart meridians. Pacify liver and subdue yang, induce tranquilization and arrest convulsion, improve vision and remove nebula. Can be used for treating headache, vertigo, palpitation, insomnia, conjunctival congestion, nebula, blurred vision. The mother-of-pearl mainly contains several major components of inorganic salt, trace elements and amino acids. Mainly contains calcium carbonate components and other inorganic salt components, such as phosphate, sulfate, silicate, and the like. Contains trace elements such as calcium, magnesium, copper, iron, zinc, manganese, molybdenum, cobalt, strontium, lead, chromium, selenium, copper, iodine, mercury and the like. The Concha Margaritifera also contains small amount of other organic components such as polysaccharide, and oxides such as phosphatidylethanolamine, galactosylceramide, hydroxy fatty acid, etc.

Research shows that the mother-of-pearl has certain sedative-hypnotic effect, while the crude products, baked products and superfine powder of the mother-of-pearl can increase the 5-HT concentration in the brain of mice, and can be one of the mechanisms of the sedative-hypnotic effect. The research results also show that in a mouse tail suspension experiment, the high-dose group of the mother-of-pearl crude product, the low-dose group, the medium-dose group and the high-dose group of the baked product, and the ultra-micro powder low-dose group, the medium-dose group and the high-dose group can reduce the complete immobility time of the mouse tail suspension; in an AMPT-induced mouse tail suspension experiment, the high-dose groups of different processed products of the mother-of-pearl can reduce the complete immobility time of the mouse tail suspension. The pearl shell and the processed product thereof have certain antidepressant effect, wherein ultrafine powder is preferred, and the action mechanism of the pearl shell and the processed product thereof is probably related to that the pearl shell protein can inhibit tyrosine hydroxylase, block tyrosine from synthesizing dopamine and further inhibit the synthesis of norepinephrine.

Wild jujube seed

The semen Ziziphi Spinosae is dry mature seed of Ziziphus jujuba Mill.var. spinosa (Bunge) Hu ex H.F.Chou belonging to Rhamnaceae.

Sweet, sour and mild in nature and taste. It enters liver, gallbladder and heart meridians. Nourish heart and tonify liver, calm heart and induce tranquilization, arrest sweating, promote fluid production. Can be used for treating vexation, insomnia, palpitation, dreaminess, asthenia, hyperhidrosis, body fluid deficiency, and thirst. The semen Ziziphi Spinosae mainly contains saponin, flavone, alkaloid, and fatty acid.

The total saponins of semen Ziziphi Spinosae are the main active substances with sedative and hypnotic effects. It has effects on nerve cells, neurotransmitters, receptors and sleep parameters. Zhang et al applied microdialysis technology to study the influence of jujuboside A on the level of glutamic acid in rat hippocampus. The results show that large dose of jujuboside A can remarkably antagonize the increase of hippocampal glutamic acid level induced by penicillin sodium, which indicates that jujuboside A can influence the hippocampal excitability signal pathway mediated by glutamic acid (Glu). Chen et al report that spina date seed saponin A generates spina date seed sapogenin after hydrolysis, and the spina date seed sapogenin can penetrate through a blood brain barrier to be combined with key residues on a gamma-aminobutyric acid (GABA) receptor binding site to form a hydrogen bond so as to play a role in calming and hypnosis. Cao et al determined the sleep parameters of rats by electroencephalogram, and the results showed that total sleep time and rapid eye movement sleep time (REM) can be significantly prolonged by total saponins of spine date seed in the daytime, without significant effect on non-rapid eye movement sleep time (NREM), while total sleep time and NREM can be significantly prolonged at night, without significant effect on Slow Wave Sleep (SWS) and REM.

The semen Ziziphi Spinosae total flavone has good anxiolytic and antidepressant effects. New research results show that the flavonoid component in the spina date seed alcohol extract is an anxiolytic active component. Zhao Zhaozhou et al divides spina date seed total flavonoids into three dosage groups of low, medium and high, and continuously drenches the stomach to give 7 days to despair model mice, and performs ethological test on the mice, and the results show that the three dosage groups can reduce forced swimming and tail suspension immobility time of the mice. Yangyi and the like adopt a uniform design method, and the optimal compatibility of total saponins and total flavonoids which are used for screening the anti-depression active components of the spina date seeds is as follows through a reserpine antagonistic experiment and a mouse forced swimming experiment: total flavone 17.8mg/kg, total saponin 113.4 mg/kg.

In recent years, researches show that the active ingredients with hypnotic and sedative effects of the spina date seed also comprise the spina date seed oil, and the spina date seed oil extracted by different processes has equivalent sedative-hypnotic effects.

Dried rehmannia root

The rehmanniae radix is dried root tuber of Rehmannia Rehmannia glutinosa Libosch of Scrophulariaceae.

Sweet in nature and taste and cold in nature. It enters heart, liver and kidney meridians. Has the functions of clearing heat and cooling blood, nourishing yin and promoting the production of body fluid. Can be used for treating heat entering nutrient-blood, epidemic febrile disease, macula, hematemesis, epistaxis, yin injury due to fever, crimson tongue, polydipsia, constipation due to body fluid consumption, fever due to yin deficiency, bone steaming, fatigue, internal heat, and diabetes. The main chemical components of dried rehmannia root include iridoid, saccharides, amino acids and trace elements.

Rehmannia root has a significant inhibitory effect on the central nervous system. The radix rehmanniae water extract is injected into the abdominal cavity of the mouse (1.5 g/kg and 3g/kg), and the times of the autonomous activities of the mouse are obviously reduced after 40 min. Experiments also show that the radix rehmanniae water extract has synergistic hypnotic effect with the pentitalopram sodium and the thiopentan sodium with the same administration dosage and can antagonize the exciting effect of the alramezone on mice but can not resist the convulsion effect caused by the nitric acid strychnine and the pentaerythrine. This indicates that Sheng Di Huang has obvious sedative effect, and the acting part may be brain stem network ascending excitement system and cerebral cortex.

Prepared rehmannia root

This product is a processed product of rehmannia glutinosa.

Sweet in nature and taste, slightly warm. It enters liver and kidney meridians. Has the functions of enriching blood, nourishing yin, replenishing vital essence and replenishing marrow. Can be used for treating blood deficiency, sallow complexion, cardiopalmus, menoxenia, metrorrhagia, metrostaxis, deficiency of liver-yin and kidney-yin, soreness of waist and knees, hectic fever, night sweat, nocturnal emission, internal heat, diabetes, giddiness, tinnitus, and early white beard and hair. Radix rehmanniae Preparata contains small amount of iridoid, monoterpene, amino acids and trace elements.

Radix rehmanniae Preparata has effect of delaying mouse aging. Experiments show that the rehmanniae vaporata decoction can enhance gSH-Px activity and reduce LPO content in serum, thereby achieving the effect of delaying senility. In addition, experimental research shows that the prepared rehmannia root has the effect of enriching the blood, has certain proliferation and differentiation effects on hematopoietic stem cells, and also has closely related effects on a bone marrow hematopoietic system. Radix rehmanniae Preparata has effect in improving hyperthyroidism type yin deficiency.

Picrorhiza rhizome

Dried rhizome of Picrorhiza scrophulariiflora Pennell of Scrophulariaceae.

Bitter in property and cold in nature. It enters liver, stomach and large intestine meridians. It can reduce deficiency heat, remove malnutritional fever, clear damp-heat. Can be used for treating hectic fever due to yin-deficiency, infantile malnutrition fever, dysentery due to damp-heat pathogen, jaundice, dark urine, and hemorrhoid with swelling and pain. The chemical components of rhizoma picrorhizae mainly include iridoid, cucurbitacin and phenol glycoside; in addition, the composition also contains very small amount of mannitol, picrorhizal sterol, acetovanillone, aromatic acid, etc.

The picroside II can improve depression symptoms by antagonizing the hyperfunction of hypothalamus-pituitary-adrenal axis, and has a certain antidepressant effect. Relevant researches show that the picroside II has the effect of relieving behavioral injury of a depression model, can obviously reduce the contents of adrenocorticotropic hormone and corticosterone in the plasma of a rat, and can obviously reduce the immobility time of forced swimming of the rat of the depression model.

Bai Wei

The Cynanchum atratum is dried root and rhizome of Cynanchum atratum Bge or Cynanchum versicolor Bge. By investigating market and interview drug distributor, the current market of Cynanchum atratum drug products mainly come from Cynanchum atratum bge.

Bitter, salty and cold in nature. It enters stomach, liver and kidney meridians. Has the functions of clearing heat, cooling blood, promoting urination, treating stranguria, detoxifying and treating sore. Can be used for treating fever due to pathogenic heat, yin deficiency, bone steaming, fatigue, puerperal fever due to blood deficiency, heat stranguria, blood stranguria, carbuncle, cellulitis, and toxic swelling. Radix Cynanchi Atrati contains C21 steroid saponin, cynanchum atratum extract, volatile oil, cardiac glycoside and trace elements. Radix Cynanchi Atrati has antipyretic effect. The Xuebaoyun and the like use upright cynanchum atratum water decoction, and the comparison of the antipyretic action of alcohol extract and ether extract on rat yeast fever shows that the upright cynanchum atratum water extract 3.4, 4.9 and 7.0/kg has obvious antipyretic action on fever, but the alcohol extract and the ether extract have no obvious effect on the rat yeast fever.

Root of red-rooted salvia

The Saviae Miltiorrhizae radix is dried root and rhizome of Salvia milirhizorrhiza bge.

Bitter in property and slightly cold in nature. It enters heart and liver meridians. Has the functions of promoting blood circulation, removing blood stasis, stimulating the menstrual flow, relieving pain, clearing away the heart-fire, relieving restlessness, cooling blood and eliminating carbuncle. Can be used for treating thoracic obstruction, cardialgia, abdominal pain, hypochondriac pain, abdominal mass, pain due to pyretic arthralgia, vexation, insomnia, menoxenia, dysmenorrhea, amenorrhea, and pyocutaneous disease with swelling and pain. The Saviae Miltiorrhizae radix chemical components mainly comprise fat-soluble components and water-soluble components, wherein the fat-soluble components mainly comprise tanshinone diterpene compounds, and the water-soluble components mainly comprise polyphenol acid compounds.

The pharmacological experiment result proves that: tanshinone has estrogen-like activity and acts via the ovary. Tanshinone has estrogen-like activity and also has antiandrogen activity. The mice are injected with the salvia miltiorrhiza in the abdominal cavity, which shows that the dose dependence inhibits the autonomic activity and can obviously enhance the inhibition effect of the central depressant such as chlorpromazine and meprobamate on the autonomic activity. It also can enhance the sleep effect of sodium pentobarbital or barbital. Protects the pentylenetetrazol, strychnine and securinine against convulsion, increases the dose for producing convulsion, and has no obvious effect on convulsion. The red sage root obviously reduces the spontaneous electrical activity of the cerebral cortex, the issuing threshold value is increased after the repeated stimulation is caused, the repeated electrical response which is generated when the cerebral cortex is singly stimulated is reduced, and when the amplitude of the electrical activity of the cerebral cortex is reduced, the components with higher frequency are not obviously increased, so the reduction of the electrical activity is not the desynchronizing result. It is speculated that the inhibitory effect of Salvia miltiorrhiza on cerebral cortex may be achieved by inhibiting the activity of cAMP and increasing the level of cAMP.

Hypericum perforatum L.var

By consulting the traditional Chinese medicine professional books and local standards of Hypericum perforatum recorded in Chinese materia medica, Chinese medicine dictionary, Chinese medicine national medicinal material quality standard 2003 edition of Guizhou province and the like, the basic and medicinal parts of Hypericum perforatum recorded in Chinese pharmacopoeia 2015 edition are consistent with those of Hypericum perforatum L. In addition, "Hypericum perforatum L." was searched for in Chinese botanical, and the results showed that the plant was Hypericum perforatum belonging to Hypericum genus of Guttiferae family, and some regions were commonly called "Hypericum microphyllum" or "Hypericum microphyllum". From the above data, it can be known that Hypericum perforatum and Hypericum perforatum belong to the same drug material and are synonyms of the same species, so the original source and the medicinal part should be the dry aerial part of Hypericum perforatum L. of Guttiferae collected in the 2015 edition of Chinese pharmacopoeia.

Pungent and cold. It enters liver meridian. Soothing liver, relieving depression, clearing away heat, promoting diuresis, relieving swelling, and promoting lactation. Can be used for treating stagnation of liver-qi, emotional disorder, chest distress, joint swelling and pain, acute mastitis, and oliguria. The main components of herba Hyperici perforati include benzodianthrone, flavone, phloroglucinol, volatile oil, coumarin, and other components such as procyanidin, tannin, sitosterol, various xanthone compounds, various amino acids, epoxy xanthophyll, etc.

Hypericum perforatum has been a common medicament for treating depression at home and abroad, and hypericin and flavonoid compounds are considered as main anti-depression components of hypericin and flavonoid compounds. The anti-depression effect of the hypericum perforatum extract is researched by a mouse tail suspension experiment and a rat forced swimming experiment model for heroic storage and the like, and the hypericum perforatum extract containing 0.35% of hypericin is proved to have obvious anti-depression effect on a behavior despair animal depression model, can resist the disappointing behaviors of mice and rats, shortens the disappointing time of mouse tail suspension, and obviously shortens the immobility time of rat forced swimming. Muller et al have shown through research that hyperforin is a noncompetitive reuptake inhibitor of various neurotransmitters including 5-hydroxytryptamine (5-HT), Dopamine (DA), Norepinephrine (NA), gamma-aminobutyric acid (GABA) and L-glutamic acid, and can selectively inhibit the reuptake of neurotransmitters by competing for the binding site of the transporter, thereby achieving antidepressant effect. Singer et al have shown that hyperforin can reduce sodium ion concentration gradient of synaptosome cells, eliminate driving force of neurotransmitter transporter operation, and produce antidepressant effect.

Girzu and the like research the sedative effect of different doses of the hypericum perforatum extract on mice, and find that different doses (13.25, 19.6, 26.5, 132.5, 662.5 and 3312.5mg/kg) can inhibit the locomotor activity of the mice and have sedative and hypnotic effects, but the inhibitory effect is strongest at 26.5mg/kg, the inhibitory rate is 50.7 percent, and the effect is equivalent to that of a diazepam group.

The second purpose of the invention is to provide a preparation method of the traditional Chinese medicine composition.

The effective components contained in the traditional Chinese medicine composition can be prepared as follows: drying the above materials, grinding into powder, and mixing to obtain effective components.

The effective components contained in the traditional Chinese medicine composition can be prepared as follows: extracting the above raw materials with water or ethanol of different concentrations, concentrating the extractive solution, and drying to obtain crude extract; and/or further refining by water extraction and alcohol precipitation, column chromatography, and steam distillation to obtain effective components.

The effective components contained in the traditional Chinese medicine composition are preferably prepared by the following steps:

the first scheme is as follows: extracting Concha Margaritifera with water for 1-3 times, each time adding water amount 6-12 times of the total weight of the medicinal materials, each time extracting for 1-3 hr, filtering, and mixing filtrates; extracting the rest six materials such as semen Ziziphi Spinosae with water for 2-3 times, each time adding water amount 6-12 times of the total weight of the six materials, each time extracting for 1-3 hr, filtering, mixing the filtrate with the above extractive solution, concentrating to fluid extract with relative density of 1.20-1.30 at 60-70 deg.C, drying, and pulverizing into fine powder.

Scheme II: adding water into Concha Margaritifera, extracting with 6-12 times of the total weight of seven medicinal materials for 1-3 hr, adding semen Ziziphi Spinosae and other six materials, extracting for 1-3 hr, extracting the residue with water for 2-3 times, each time adding water with amount of 6-12 times of the total weight of seven medicinal materials for 1-3 hr, filtering, mixing the filtrate with the above extractive solution, concentrating to obtain fluid extract with relative density of 1.20-1.30 at 60-70 deg.C, drying, and pulverizing into fine powder.

The third scheme is as follows: mixing all the medicinal materials, reflux-extracting with 40-80% ethanol for 2-3 times, each time the ethanol amount is 4-10 times of the total amount of the medicinal materials, extracting for 1-3 hr, mixing extractive solutions, filtering, concentrating the filtrate to fluid extract with relative density of 1.20-1.30 at 60-70 deg.C, drying, and pulverizing into fine powder.

And the scheme is as follows: extracting Concha Margaritifera with water for 1-3 times, each time adding water amount 6-12 times of the total weight of the medicinal materials, each time extracting for 1-3 hr, filtering, and mixing filtrates; reflux-extracting rhizoma picrorhizae, Saviae Miltiorrhizae radix, and radix Cynanchi Atrati with 40-80% ethanol for 2-3 times, wherein the amount of ethanol is 4-10 times of the total amount of the three medicinal materials each time, the extraction time is 1-3 hr, filtering, mixing filtrates, and recovering ethanol under reduced pressure; extracting the rest three materials with water for 2-3 times, each time adding water amount 6-12 times of the total weight of the three materials, each time extracting for 1-3 hr, filtering, mixing the filtrate with the above two extractive solutions, concentrating to obtain fluid extract with relative density of 1.20-1.30 at 60-70 deg.C, drying, and pulverizing into fine powder.

And a fifth scheme: mixing all the medicinal materials, adding water, extracting for 2-3 times, each time adding water amount 6-12 times of the total weight of the medicinal materials, each time extracting for 1-3 hr, mixing extractive solutions, filtering, concentrating the filtrate to obtain fluid extract with relative density of 1.15-1.20 at 60-70 deg.C, adding ethanol to make ethanol content 40-70%, standing for 12-24 hr, filtering, concentrating the filtrate to obtain fluid extract with relative density of 1.20-1.30 at 60-70 deg.C, drying, and pulverizing into fine powder.

The third purpose of the invention is to provide a preparation of the traditional Chinese medicine composition.

The Chinese medicinal composition can be made into granule, pill, capsule, tablet, suspension, and syrup. The preparation comprises effective amount of the above composition and acceptable pharmaceutical carriers, such as filler, disintegrant, wetting agent, binder, lubricant, correctant, etc.

The filler can be selected from starch, sucrose, dextrin, calcium sulfate, calcium hydrogen phosphate, light magnesium oxide, calcium carbonate, microcrystalline cellulose, mannitol, lactose, pregelatinized starch, etc.

The disintegrant may be selected from dry starch, sodium hydroxymethyl starch, low-substituted hydroxypropyl cellulose, crospovidone, croscarmellose sodium, surfactant, effervescent disintegrant, etc.

The wetting agent may be selected from distilled water, ethanol, and the like.

The binder can be selected from sugar powder and syrup, starch slurry, polyvinylpyrrolidone, cellulose derivatives, mucilage, dextrin, etc.

The lubricant is selected from stearic acid, calcium stearate, magnesium stearate, silica gel micropowder, hydrogenated vegetable oil, polyethylene glycol 4000 and 6000, sodium or magnesium lauryl sulfate, pulvis Talci, etc.

The flavoring agent is one or more of adjuvants for regulating taste, including but not limited to aspartame, mannitol, stevioside, sucrose, sodium citrate, cherry essence, etc.

Preferably, the preparation of the traditional Chinese medicine composition is granules, and the preparation steps of the granules are as follows:

step 1, adding water into the traditional Chinese medicine composition, decocting for 2-3 times, wherein the weight of the water added for each time is 6-12 times of the total weight of the traditional Chinese medicine composition, decocting for 1-3 hours, combining the decoctions for each time, filtering out dregs of decoction, then concentrating under reduced pressure to obtain a concentrated solution with the relative density of 1.25-1.35 at 60 ℃, drying, and crushing into fine powder.

And 2, taking 1-4 parts of another excipient, uniformly mixing the excipient with the fine powder obtained in the step 1, adding a proper amount of a flavoring agent, adding a proper amount of a wetting agent, performing wet granulation, and drying to obtain the finished product.

The fourth purpose of the invention is to provide the application of the traditional Chinese medicine composition in preparing medicines for improving syndrome symptoms of perimenopausal women.

Preferably, the perimenopausal syndrome symptoms refer to one or more of insomnia, depression, sweating syndrome, consumptive disease, dry heart, palpitation, vertigo and the like; these symptoms are often expressed as hot flashes, flushes, increased sweating, altered menses, frequent urination, anxiety, restlessness, insomnia, dreaminess, dry skin, etc.

The invention has the beneficial effects that:

1. the invention combines the modern traditional Chinese medicine pharmacological research, mainly clears heart and calms liver, calms heart and calms nerves, and is used for improving the symptoms of the syndrome of perimenopausal women.

2. The traditional Chinese medicine composition is used for improving the symptoms of the syndrome of perimenopausal women, and is proved by clinical use to have definite curative effect, no obvious toxic or side effect, flexible prescription application and low cost.

3. The Chinese medicinal composition is prepared into granules, and has the advantages of remarkable curative effect, short treatment course, convenience in use and low irritation.

4. The traditional Chinese medicine composition disclosed by the invention is scientific and rigorous in formula, simple in preparation method, low in preparation cost and great in clinical application value.

Detailed Description

The invention is illustrated below with reference to specific examples. It will be understood by those skilled in the art that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention in any way.

The experimental procedures in the following examples are conventional unless otherwise specified. The raw materials and reagents used in the following examples are all commercially available products unless otherwise specified.

Example 1

Taking 10g of mother-of-pearl, adding water which is 12 times of the total weight of the seven medicinal materials, extracting for 3 hours, taking 30g of spina date seed, 2g of radix rehmanniae recen, 10g of hypericum perforatum, 20g of picrorhiza rhizome, 2g of salvia miltiorrhiza and 20g of cynanchum atratum, continuously extracting for 3 hours, adding water into dregs for 2 times, adding water which is 8 times of the total weight of the seven medicinal materials for each time, extracting for 3 hours, filtering, combining the filtrate with the extracting solution, concentrating to obtain clear paste with the relative density of 1.20-1.30 at the temperature of 60-70 ℃, drying, crushing into fine powder, taking 1 part of excipient (mixture of dextrin and soluble starch according to the weight ratio of 1: 4) for mixing with the fine powder, adding 0.05 part of aspartame, adding a wetting agent, granulating by a wet method, drying, and preparing into granules.

Example 2

Mixing Concha Margaritifera 20g, semen Ziziphi Spinosae 20g, radix rehmanniae 10g, herba Hyperici perforati 8g, rhizoma picrorhizae 15g, Saviae Miltiorrhizae radix 10g, and radix Cynanchi Atrati 15g, reflux-extracting with 80% ethanol for 2 times, wherein the ethanol amount is 4 times of the total amount of the medicinal materials each time, the extraction time is 3 hr, mixing extractive solutions, filtering, concentrating the filtrate to fluid extract with relative density of 1.20-1.30 at 60-70 deg.C, drying, pulverizing into fine powder, adding appropriate amount of adjuvants, mixing, further granulating, and making into capsule.

Example 3

Extracting 30g of Concha Margaritifera with water for 3 times, wherein the amount of water added is 8 times of the total weight of the medicinal materials, the extraction time is 3 hr, filtering, and mixing filtrates; taking 10g of spina date seed, 6g of radix rehmanniae recen, 6g of hypericum perforatum, 4g of picrorhiza rhizome, 6g of salvia miltiorrhiza and 2g of cynanchum atratum, adding water for 2 times, wherein the water amount is 8 times of the total weight of the six medicinal materials each time, the extraction time is 3 hours each time, filtering, combining the filtrate with the extracting solution, concentrating to obtain clear paste with the relative density of 1.20-1.30 at the temperature of 60-70 ℃, drying, crushing into fine powder, and mixing with a proper amount of auxiliary materials to prepare the dry suspension.

Example 4

Extracting Concha Margaritifera 40g with water for 1 time (the amount of water is 12 times of the total weight of the medicinal materials), extracting for 1 hr, filtering, and mixing filtrates; reflux-extracting rhizoma picrorhizae 10g, Saviae Miltiorrhizae radix 15g, and radix Cynanchi Atrati 10g with 40% ethanol for 2 times, wherein the amount of ethanol is 10 times of the total amount of the three medicinal materials, the extraction time is 1 hr, filtering, mixing filtrates, and recovering ethanol under reduced pressure; extracting semen Ziziphi Spinosae 15g, radix rehmanniae 15g, and herba Hyperici perforati 5g with water for 2 times, each time adding water amount 12 times of the total weight of the three medicinal materials, each time extracting for 1 hr, filtering, mixing the filtrate with the above two extractive solutions, concentrating to obtain fluid extract with relative density of 1.20-1.30 at 60-70 deg.C, mixing with appropriate amount of adjuvants, and making into tablet.

Example 5

Taking 50g of mother-of-pearl, 5g of spina date seed, 20g of radix rehmanniae, 1g of hypericum perforatum, 2g of rhizoma picrorhizae, 20g of salvia miltiorrhiza and 2g of cynanchum atratum, mixing, adding water for extraction for 1 time, wherein the water amount is 6 times of the total weight of the medicinal materials, the extraction time is 1 hour, combining the extracting solutions, filtering, concentrating the filtrate to obtain clear paste with the relative density of 1.15-1.20 at the temperature of 60-70 ℃, adding ethanol to ensure that the ethanol content is 70%, standing for 24 hours, filtering, concentrating the filtrate to obtain clear paste with the relative density of 1.20-1.30 at the temperature of 60-70 ℃, drying, crushing into fine powder, mixing with a proper amount of auxiliary materials, dissolving in water, stirring, heating to boil for sterilization.

Example 6

30g of mother-of-pearl, 10g of spina date seed, 6g of radix rehmanniae, 6g of rhizoma picrorhizae, 4g of cynanchum atratum, 6g of salvia miltiorrhiza and 2g of hypericum perforatum, and the raw materials are crushed, mixed uniformly, added with a proper amount of adhesive and prepared into watered pills.

Example 7

Extracting Concha Margaritifera 40g with water for 2 times, each time adding water amount 8 times of the total weight of the medicinal materials, extracting for 2 hr, filtering, and mixing filtrates; reflux-extracting rhizoma picrorhizae 10g, Saviae Miltiorrhizae radix 10g, and radix Cynanchi Atrati 10g with 60% ethanol for 2 times, wherein the amount of ethanol is 6 times of the total amount of the three medicinal materials, the extraction time is 2 hr, filtering, mixing filtrates, and recovering ethanol under reduced pressure; extracting semen Ziziphi Spinosae 20g, radix rehmanniae 10g, and herba Hyperici perforati 5g with water for 2 times, each time adding water amount 8 times of the total weight of the three medicinal materials, each time extracting for 2 hr, filtering, mixing the filtrate with the above two extractive solutions, concentrating to obtain fluid extract with relative density of 1.20-1.30 at 60-70 deg.C, drying, and pulverizing into fine powder. Mixing sugar powder 1 part with the fine powder, adding citric acid 0.01 part and cherry essence 0.01 part, adding humectant, wet granulating, drying, and making into granule. Example 8, 30g of nacre is taken, water is added for extraction for 2 times, the water addition amount is 12 times of the total weight of the medicinal materials each time, the extraction time is 2 hours each time, filtration is carried out, and filtrates are combined for later use; taking 10g of spina date seed, 6g of radix rehmanniae recen, 2g of hypericum perforatum, 6g of picrorhiza rhizome, 6g of salvia miltiorrhiza and 4g of cynanchum atratum, adding water for 2 times, wherein the water amount is 12 times of the total weight of the six medicinal materials each time, the extraction time is 2 hours each time, filtering, combining the filtrate with the extracting solution, concentrating to obtain clear paste with the relative density of 1.20-1.30 at the temperature of 60-70 ℃, drying, and crushing into fine powder to obtain the traditional Chinese medicine.

Example 9

Example 15: mixing 40g of mother-of-pearl, 5g of spina date seed, 10g of radix rehmanniae, 3g of hypericum perforatum, 6g of rhizoma picrorhizae, 3g of salvia miltiorrhiza and 5g of cynanchum atratum, adding water for extraction for 2 times, wherein the water addition amount is 8 times of the total weight of the medicinal materials, the extraction time is 2 hours, combining the extracting solutions, filtering, concentrating the filtrate to obtain clear paste with the relative density of 1.15-1.20 at the temperature of 60-70 ℃, drying, crushing into fine powder, mixing 0.2 part of lactose with the fine powder, adding 0.01 part of stevioside, adding a wetting agent, granulating by a wet method, drying, and preparing the traditional Chinese medicine.

Example 10: mixing Concha Margaritifera 50g, semen Ziziphi Spinosae 5g, radix rehmanniae 20g, herba Hyperici perforati 1g, rhizoma picrorhizae 2g, Saviae Miltiorrhizae radix 20g, and radix Cynanchi Atrati 2g, adding water for 1 time, adding water amount 6 times of the total weight of the medicinal materials, extracting for 1 hr, mixing extractive solutions, filtering, concentrating the filtrate to obtain fluid extract with relative density of 1.15-1.20 at 60-70 deg.C, adding ethanol to reach ethanol content of 70%, standing for 24 hr, filtering, concentrating the filtrate to obtain fluid extract with relative density of 1.20-1.30 at 60-70 deg.C, drying, pulverizing into fine powder, mixing with appropriate amount of adjuvants, and making into tablet.

Example 11: extracting 30g of Concha Margaritifera with water for 3 times, wherein the amount of water added is 8 times of the total weight of the medicinal materials, the extraction time is 3 hr, filtering, and mixing filtrates; taking 10g of spina date seed, 6g of radix rehmanniae recen, 6g of hypericum perforatum, 4g of rhizoma picrorhizae, 6g of salvia miltiorrhiza and 2g of cynanchum atratum, adding water for 2 times, wherein the water amount is 8 times of the total weight of the six medicinal materials each time, the extraction time is 3 hours each time, filtering, combining the filtrate with the extracting solution, concentrating to obtain clear paste with the relative density of 1.20-1.30 at the temperature of 60-70 ℃, drying, crushing into fine powder, adding 0.01 part of silicon dioxide, and performing dry granulation to obtain the traditional Chinese medicine.

Example 12: taking 20g of mother-of-pearl, adding 6 times of water which is equivalent to 12 times of the total weight of seven medicinal materials, extracting for 2 times, extracting for 2 hours, taking 15g of spina date seed, 3g of rehmannia root, 10g of hypericum perforatum, 2g of rhizoma picrorhizae, 10g of salvia miltiorrhiza and 1g of cynanchum atratum, continuously extracting for 3 hours, adding water into dregs of a decoction for 2 times, adding 8 times of water which is equivalent to 8 times of the total weight of the seven medicinal materials each time, extracting for 1 hour each time, filtering, combining the filtrate with the extracting solution, concentrating to clear paste with the relative density of 1.20-1.30 at the temperature of 60-70 ℃, drying and crushing into fine powder, taking 0.2 parts of excipient (starch) to be uniformly mixed with the fine powder, adding 0.05 parts of aspartame, adding a wetting agent.

Example 13: mixing Concha Margaritifera 40g, semen Ziziphi Spinosae 5g, rehmanniae radix 10g, herba Hyperici perforati 3g, rhizoma picrorhizae 6g, Saviae Miltiorrhizae radix 3g, and radix Cynanchi Atrati 5g, reflux-extracting with 60% ethanol for 2 times, wherein the ethanol amount is 6 times of the total amount of the medicinal materials each time, the extraction time is 2 hr, mixing extractive solutions, filtering, concentrating the filtrate to fluid extract with relative density of 1.20-1.30 at 60-70 deg.C, drying, and pulverizing into fine powder. Mixing excipient (soluble starch) 0.5 parts with the fine powder, adding mannitol 0.03 parts, adding humectant, wet granulating, and drying.

Example 14: extracting Concha Margaritifera 20g with water for 2 times, each time adding water amount 8 times of the total weight of the medicinal materials, extracting for 2 hr, filtering, and mixing filtrates; reflux-extracting 2g rhizoma picrorhizae, 10g Saviae Miltiorrhizae radix, and 1g radix Cynanchi Atrati with 60% ethanol for 2 times, wherein the amount of ethanol is 6 times of the total amount of the three medicinal materials, the extraction time is 2 hr, filtering, mixing filtrates, and recovering ethanol under reduced pressure; extracting semen Ziziphi Spinosae 15g, radix rehmanniae 3g, and herba Hyperici perforati 10g with water for 2 times, each time adding water amount 8 times of the total weight of the three medicinal materials, each time extracting for 2 hr, filtering, mixing the filtrate with the above two extractive solutions, concentrating to obtain fluid extract with relative density of 1.20-1.30 at 60-70 deg.C, drying, and pulverizing into fine powder. And mixing sugar powder 1 part with the fine powder, adding citric acid 0.01 part and cherry essence 0.01 part, adding humectant, wet granulating, and drying.

Example 15: mixing 40g of mother-of-pearl, 5g of spina date seed, 10g of radix rehmanniae, 3g of hypericum perforatum, 6g of rhizoma picrorhizae, 3g of salvia miltiorrhiza and 5g of cynanchum atratum, adding water for extraction for 2 times, wherein the water amount is 8 times of the total weight of the medicinal materials, the extraction time is 2 hours, combining the extracting solutions, filtering, concentrating the filtrate to obtain clear paste with the relative density of 1.15-1.20 at the temperature of 60-70 ℃, adding ethanol to ensure that the ethanol content is 60%, standing for 12 hours, filtering, concentrating the filtrate to obtain clear paste with the relative density of 1.20-1.30 at the temperature of 60-70 ℃, drying and crushing into fine powder to obtain the traditional Chinese medicine. And mixing 0.2 part of lactose with the fine powder, adding 0.01 part of stevioside, adding a wetting agent, performing wet granulation, and drying to obtain the product.

Examples of drug efficacy test: research of different extraction processes of the traditional Chinese medicine composition on neuroendocrine regulation mechanism of rat model with climacteric syndrome

1. Experimental medicine and instrument

1.1 medicaments

Preparing concentrated solution with density of 1.20-1.30 obtained by extracting crude drugs with the amount of 64g crude drugs per person per day according to the daily prescription, preparing the concentrated solution into high and low concentrations, feeding 1ml per rat by intragastric administration, and dividing 180-220 g female rats into 8 groups according to a digital random table method respectively: a sham operation group, a model control group, a water extraction process mind tranquilizing granule low-dose group (2.88g crude drug/kg), a water extraction process mind tranquilizing granule high-dose group (5.76g crude drug/kg), an alcohol precipitation process mind tranquilizing granule low-dose group (2.88g crude drug/kg), an alcohol precipitation process mind tranquilizing granule high-dose group (5.76g crude drug/kg), a water extraction alcohol precipitation process mind tranquilizing granule low-dose group (2.88g crude drug/kg), and a water extraction alcohol precipitation process mind tranquilizing granule high-dose group (5.76g crude drug/kg). The rat high dose group and the daily prescription dose of a human are converted according to the following formula: 64 × 0.018/0.2 ═ 5.76g crude drug/kg, the low dose group was one-half of the high dose group.

1.2 instruments and reagents

1.2.1 Instrument

One hundredth electronic balance: TP-1102, Sidoolis instruments systems, Beijing; one-tenth-of-ten-thousandth analytical balance: BP121S, Sartorius (Sartorius); nikon fluorescence microscope (shanghai culture science ltd); TDZ5-WS multi-rack auto-balancing centrifuge; and (5) performing gastric lavage.

1.2.2 reagents

Physiological saline, ethanol, distilled water, and the like.

1.3 Experimental animals

SD rat: weight 180-220 g, female rat, SPF grade (Specific Pathogen Free) purchased from sbefu (beijing) biotechnology limited; license number: SCXK (Jing) 2018-.

Animal house: license of experimental facility: SYXK (Kd) 2017-0026; the facility management follows national standard GB14925-2001 Experimental animal environment and facility

Feeding conditions are as follows: the method is characterized in that artificial illumination is adopted for a 12-hour light and shade period, the ambient temperature is maintained at 19-29 ℃, the humidity is 40% -80%, the illumination time is 8: 00-17: 00, and a ventilation system is provided for keeping indoor air smooth; animals were housed in polycarbonate mouse cages, bedding was changed periodically 2 times a week, water and feed were changed periodically every morning.

Feed: standard rat pellet feeds were provided by Schbefu (Beijing) Biotechnology Inc.

Drinking water: the animals were allowed free access to drinking water, and the water bottles and fresh water were changed daily.

2. Test method

Dividing 180-220 g female rats into 12 groups according to a digital random table method: a sham operation group, a model control group, a positive control group (Anjinyi, that is, estradiol is 0.18mg/kg), clear paste obtained by a water extraction nacre decocting process (example 1), a low dose group (2.88g crude drug/kg), clear paste obtained by a water extraction nacre decocting process (example 1) and a high dose group (5.76g crude drug/kg); decocting Concha Margarit with water and other materials respectively to obtain fluid extract (example 3), low dose group (2.88g crude drug/kg), and decocting Concha Margarit with water and other materials respectively to obtain fluid extract (example 3), high dose group (5.76g crude drug/kg); the clear paste obtained by the alcohol extraction process (example 2) is used in a low-dose group (2.88g crude drug/kg) and the clear paste obtained by the alcohol extraction process (example 2) is used in a high-dose group (5.76g crude drug/kg); the clear paste obtained by the partial water extraction and partial alcohol extraction process (example 4) is a low-dose group (2.88g of crude drug/kg), the clear paste obtained by the partial water extraction and partial alcohol extraction process (example 4) is a clear paste obtained by the high-dose group (5.76g of crude drug/kg) and is subjected to the water extraction and alcohol precipitation process (example 5), the clear paste obtained by the water extraction and alcohol precipitation process (example 5) is a low-dose group (2.88g of crude drug/kg), and the clear paste obtained by the water extraction and alcohol precipitation process (example 5) is a high. Except the sham operation group, the rats in other groups are subjected to bilateral ovariectomy, and are continuously smeared with vaginal cast-off cells for 5 days after ovariectomy for 1 week, and if no estrus cycle change is proved, the model building is successful. In the sham group, only partial fat around the ovary was removed, and the smear of vaginal cast cells showed normal estrous cycle. Starting the gavage at 13d after the operation, and continuously gavage for 28d 1 time a day, wherein distilled water is given to a sham operation group and a model control group, and the corresponding test substances are given to the other groups, and the administration volume is 1ml/100 g. After the last administration for 24 hr, collecting blood from femoral artery of rat, standing for 40min, centrifuging at 3500r/min for 15min, separating serum, standing at-20 deg.C

And storing in a low-temperature refrigerator to be tested. The contents of E2, FSH and LH in serum were determined by radioimmunoassay and the results were as follows:

TABLE 1 rat serum LH, FSH, E2 levels

Compared to the sham group:^◆P＜0.05；^◆◆p is less than 0.05; compared to the model set:^▼P＜0.05；^▼▼P＜0.05

as can be seen from the table, after bilateral ovariectomy, the hormone levels of the rats in each group were changed, and were significantly different from those in the blank group; the positive group of estradiol can obviously improve the neuroendocrine of a rat model with climacteric syndrome; the high and low dose groups of the five preparation processes have regulating effect on the neuroendocrine of a rat model with climacteric syndrome, and the five processes have no statistical significance difference; there was no statistical difference between the high and low dose groups of the five drugs.

Claims

1. The application of a traditional Chinese medicine composition in preparing a medicine for improving perimenopausal female syndrome is disclosed, wherein the traditional Chinese medicine composition is composed of the following raw material medicines in parts by weight: 10-50 parts of mother-of-pearl, 5-30 parts of spina date seed, 2-20 parts of rehmannia root, 2-20 parts of rhizoma picrorhizae, 2-20 parts of cynanchum atratum, 2-20 parts of salvia miltiorrhiza and 1-10 parts of hypericum perforatum.

2. The use as claimed in claim 1, characterized in that said syndrome symptoms in perimenopausal women are one or more of insomnia, depression, sweating, consumptive disease, dryness of the heart, palpitations, dizziness, hot flashes, flushing, increased sweating, menstrual changes, frequent urination, anxiety, restlessness, insomnia, dreaminess, dry skin.

3. The use according to claim 1 or 2, wherein the composition consists of the following raw material drugs in parts by weight: 20-40 parts of mother-of-pearl, 5-20 parts of spina date seed, 2-15 parts of rehmannia root, 2-15 parts of rhizoma picrorhizae, 2-15 parts of cynanchum atratum, 2-15 parts of salvia miltiorrhiza and 1-5 parts of hypericum perforatum.

4. The use according to claim 1 or 2, wherein the composition consists of the following raw material drugs in parts by weight: 30 parts of mother-of-pearl, 10 parts of spina date seed, 6 parts of rehmannia root, 6 parts of rhizoma picrorhizae, 4 parts of cynanchum atratum, 6 parts of salvia miltiorrhiza and 2 parts of hypericum perforatum.

5. The use according to claim 1 or 2, wherein the composition consists of the following raw material drugs in parts by weight: 40 parts of mother-of-pearl, 20 parts of spina date seed, 10 parts of rehmannia root, 10 parts of rhizoma picrorhizae, 10 parts of cynanchum atratum, 10 parts of salvia miltiorrhiza and 5 parts of hypericum perforatum.

6. The use according to claim 1 or 2, wherein the composition consists of the following raw material drugs in parts by weight: 40 parts of mother-of-pearl, 15 parts of spina date seed, 15 parts of rehmannia root, 10 parts of rhizoma picrorhizae, 10 parts of cynanchum atratum, 15 parts of salvia miltiorrhiza and 5 parts of hypericum perforatum.

7. The use according to claim 1 or 2, wherein the rehmannia is rehmannia glutinosa.

8. The use of claim 1 or 2, wherein the dosage form of the traditional Chinese medicine composition is granules, tablets, capsules, pills, dry suspensions, oral liquid or decoction.