CN101721624A - Traditional Chinese medicine composition for treating menopausal syndrome and prepration method thereof - Google Patents

Abstract

The invention discloses a traditional Chinese medicine composition for treating menopausal syndrome, which comprises pharmaceutical raw materials as active ingredients or active extracts thereof and a pharmaceutical carrier, wherein the pharmaceutical raw materials comprise 60 parts of rehmannia root, 60 parts of oriental waterplantain rhizome, 60 parts of dwarf lilyturf tuber, 60 parts of figwort root, 60 parts of radix rehmanniae preparata, 120 parts of Indian buead, 120 parts of magnetite, 120 parts of common curculigo rhizome, 40 parts of tree peony bark, 120 parts of nacre, 60 parts of Chinese magnoliavine fruit, 120 parts of caulis polygoni multiflori, 60 parts of prepared tuber fleeceflower root, 120 parts of blighted wheat and 120 parts of gambir plant. The composition has no toxicity or side effects and has the functions of nourishing yin, stopping irritation and tranquilization. The traditional Chinese medicine composition is used for menopausal hot flashes, sweating, dizziness, tinnitus, irritation and insomnia. The traditional Chinese medicine composition has convenient administration and high efficacy and is clinically widely used, and the effective rate is more than 90%.

Description

A kind of Chinese medicine composition for the treatment of climacteric syndrome and preparation method thereof

Technical field

The invention belongs to the Chinese medicine preparation technical field, relate to a kind of Chinese medicine composition for the treatment of climacteric syndrome and its production and use.

Background technology

Climacteric is impassable physiological periods of people, is to be not the physiological phenomenon of transfer with people's will, is the rule of vital movement.Climacteric is meant that mainly the women from the one section period of period of duration to the geratic period transition, is the period that ovarian function fails gradually.Start from 40 years old, last 10-20, during this period, menopause is a kind of important physical sign.Because of the sex hormones secretion amount reduces, the syndrome based on autonomic nervous dysfunction appears, claim climacteric syndrome.The typical symptom of climacteric syndrome comprises the blood vessel symptom: the normal a burst of heating of patient, or sometimes hot and sometimes cold, go out profuse sweating, dizziness is arranged sometimes, can take place several times every day or tens times, and how at night-time attack.The women who has in addition occur stuffy, breathe hard, symptom such as palpitating speed, hypertension, all owing to vascular dysfunctions causes.The nervous system symptom: patient's shakiness of being in a bad mood more, emotional, easily nervous, insomnia, dreaminess, symptoms such as hypomnesis.The menstruation aspect: before menopause, menoxenia is a climacteric women typical case symptom.The symptom that metabolization causes: abdominal part and buttocks etc. is located athero; Arthralgia, the especially gonalgia are comparatively obvious, are the general symptom of climacteric women; Osteoporosis: mainly show as sore waist and aching in the waist and the back.

Along with China enters the society of the aged gradually, just seem more and more important about the research of menopausal syndrome.Modern medicine is used hormone replacement therapy and is comprised: 1. estradiol: every day 1-2 gram or estriol intravaginal every day 0.5mg, every month logotype 24-26 day; Periodically add and use progestogen, as norethindrone 0.5-1mg every day, or medroxyprogestetone acetate 6-10g, used 7-10 day, and often brought out cyclic hemorrhage in every month.2. female, progestogen use in conjunction: amount of estrogen is the same, and the progestogen consumption is the 1/3-1/2 of aforementioned quantities.Or Weradys/day, peace official's Progesterone 2ug/ day, the two the next day be used alternatingly.3. nilestriol: each 1-2mg, adds after 3 months with medroxyprogestetone acetate 6-10mg/ day, 4. livial per 2 weeks 1 time: each 2.5mg, the Western medicine of every day 1 time or the like comes endocrine regulation.

These above-mentioned Therapeutic Method toxic and side effects are bigger, and Chinese medicine often can be obtained satisfied effect.The thinking of climacteric syndrome Chinese medicine is open, and is dirty for taking into account the heart, liver, spleen etc. on this basis at kidney tonifying, reaches treating both the principal and secondary aspects of a disease, integrally-regulated effect; Modern study shows, the Chinese medicine coordinating YIN and YANG is not only on hormonal readiness, also cerebral cortex hypothalamus, hypophysis, each link of gonad axis, Radical Metabolism etc. is all being had regulating action, whole regulation and control women body function state, and improve women's immunologic function.In sum, Chinese medicine climacteric syndrome determined curative effect, few side effects has shown good prospect.

Summary of the invention

The inventor is engaged in the Chinese medicine development work of treatment climacteric syndrome for many years, on the clinical application experiential basis of summing up accumulation for many years, in conjunction with theory of Chinese medical science, although read the books of a large amount of Chinese medicines about the treatment climacteric syndrome. how can from numerous medical materials, filter out the medical material of therapeutic effect, how the medical material that screens is effectively made up, how selecting reasonable proportioning to reach efficient, nontoxic purpose is arduous, a careful job.As everyone knows, the size of the dosage of drug and its effective ingredient are dependence at blood middle concentration height and action intensity thereof, and the dosage of medical material is too small, effect do not occur, and dosage is excessive, the symptom of poisoning might occur.The size of medical material dosage also influences the power of pharmacological action and presenting of drug effect, even can effect be changed.Adopt the specific consumption of medicinal raw material based on the treatment rule of determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs, compatibility mutually just can reach the purpose of best treatment gastroenteropathy.

Therefore, the inventor gropes to be surprised to find through the long term test of decades: a certain amount of Radix Rehmanniae, Rhizoma Alismatis, Radix Ophiopogonis, Radix Rehmanniae Preparata, Radix Scrophulariae, Poria, common curculigo wine, Magnetitum, Cortex Moutan, Concha Margaritifera, Fructus Schisandrae Chinensis, Caulis Polygoni Multiflori, Radix Polygoni Multiflori Preparata, Fructus Tritici Levis, Ramulus Uncariae Cum Uncis medical material are mixed, the treatment climacteric syndrome is had peculiar curative effect, and total effective rate is up to more than 90%.For this reason, the inventor has carried out a large amount of trial tests, under the prerequisite that guarantees curative effect, the further perfect different proportionings of the Chinese medicine of respectively distinguishing the flavor of, finally finished test of the present invention, developed voluntarily and had no side effect the treatment climacteric syndrome Chinese medicine composition of taking convenience, called after " GENGNIANAN " for the time being.Therefore,

One of purpose of the present invention has been to disclose the Chinese medicine composition of treatment climacteric syndrome.

Two of purpose of the present invention has been to disclose the preparation method of treatment climacteric syndrome Chinese medicine composition.

Three of purpose of the present invention has been to disclose the application of compositions aspect preparation treatment climacteric syndrome medicine.

The detailed technical scheme of the present invention is as follows: the invention discloses a kind of Chinese medicine composition for the treatment of climacteric syndrome, it comprises that described raw medicinal material comprises as the raw medicinal material of the following parts by weight of active ingredient or its activity extract and pharmaceutically useful carrier:

Radix Rehmanniae 20-80 part Rhizoma Alismatis 20-80 part 20-80 Radix Ophiopogonis part

Radix Scrophulariae 20-80 part Radix Rehmanniae Preparata 20-80 part Poria 60-150 part

Magnetitum 60-150 part Rhizoma Curculiginis 60-150 part Cortex Moutan 10-60 part

Concha Margaritifera 60-150 part Fructus Schisandrae Chinensis 20-80 part Caulis Polygoni Multiflori 60-150 part

Radix Polygoni Multiflori Preparata 20-80 part Fructus Tritici Levis 60-150 part Ramulus Uncariae Cum Uncis 60-150 part.

The present invention preferably treats climacteric syndrome, and wherein the raw medicinal material ratio of weight and number is:

Radix Rehmanniae 40-80 part Rhizoma Alismatis 40-80 part 40-80 Radix Ophiopogonis part

Radix Scrophulariae 40-80 part Radix Rehmanniae Preparata 40-80 part Poria 100-150 part

Magnetitum 100-150 part Rhizoma Curculiginis 100-150 part Cortex Moutan 30-60 part

Concha Margaritifera 100-150 part Fructus Schisandrae Chinensis 40-80 part Caulis Polygoni Multiflori 100-150 part

Radix Polygoni Multiflori Preparata 40-80 part Fructus Tritici Levis 100-150 part Ramulus Uncariae Cum Uncis 100-150 part.

The treatment climacteric syndrome that the present invention is more preferably, wherein the raw medicinal material ratio of weight and number is:

60 parts of 60 portions of Rhizoma Alismatis of Radix Rehmanniae 60 parts of Radix Ophiopogonis

120 parts in 60 parts of Poria of 60 parts of Radix Rehmanniae Preparata of Radix Scrophulariae

40 parts of 120 parts of Cortex Moutans of 120 portions of Rhizoma Curculiginises of Magnetitum

120 parts of 60 parts of Caulis Polygoni Multiflori of 120 parts of Fructus Schisandrae Chinensis of Concha Margaritifera

120 parts of 120 parts of Ramulus Uncariae Cum Uncis of 60 portions of Fructus Tritici Levis of Radix Polygoni Multiflori Preparata.

In a preferred embodiment of the present invention,, make activity extract with described raw medicinal material solvent extraction.Preferred solvent is selected from water, ethanol or their mixture.

Chinese medicine composition of the present invention can be any dosage form of intestinal canal administration and parenterai administration, preferably raw medicinal material or its activity extract and any or several pharmaceutically acceptable carrier fully is mixed and made into oral formulations.Preferred oral formulations is tablet, granule, drop pill, pill or capsule.

The invention also discloses the preparation method of treatment climacteric syndrome Chinese medicine composition, comprising:

A. the raw medicinal material with recipe quantity drops in the extraction pot, adds to be selected from water, and ethanol or its mixture reflux as solvent, collect filtrate, and 2-3 time so repeatedly, the filtration back concentrates and obtains activity extract; With activity extract with make oral formulations after pharmaceutically acceptable carrier fully mixes; Perhaps

B. Fructus Tritici Levis, Magnetitum, the Concha Margaritifera powder with recipe quantity is broken into fine powder, sieves, and be standby; With adding Radix Rehmanniae, Radix Rehmanniae Preparata, Radix Scrophulariae, Poria, Rhizoma Curculiginis, Radix Ophiopogonis water 1000-3000ml, decoct 2-3 time, filter, filtrate is condensed into clear paste; Fructus Schisandrae Chinensis, Caulis Polygoni Multiflori, Radix Polygoni Multiflori Preparata, Rhizoma Alismatis, Cortex Moutan, Ramulus Uncariae Cum Uncis carry out percolation with 75-95% ethanol as solvent, and diacolation liquid recycling ethanol is condensed into clear paste; With above-mentioned two kinds of clear paste and above-mentioned fine powder mixing, make coarse granule, drying is pulverized, and sieves, and makes granule, and cold drying is sieved, and adds magnesium stearate, mixing, compacting is in flakes.

The present invention when with the mixture of second alcohol and water when extracting solvent, concentration of ethanol is 75～95% (V/V).

In a preferred embodiment of the present invention, the activity extract that obtains among the method a further through organic solvent extraction, is made refining extract; Be that 1: 1.0～2.0 ratio is fully mixed them according to refining extract and Polyethylene Glycol ratio of weight and number then, make drop pill.Wherein organic solvent is methanol, ethanol, chloroform, ethyl acetate or n-butyl alcohol.Preferred alcohol or ethyl acetate and n-butyl alcohol.Polyethylene Glycol wherein can be a Polyethylene Glycol-6000, the mixture of Polyethylene Glycol-4000 or Polyethylene Glycol-6000 and Polyethylene Glycol-4000.Wherein the weight ratio of Macrogol 4000 and polyethylene glycol 6000 mixture is generally 1: 0.1-10.

The effect of the Chinese crude drug of respectively distinguishing the flavor of that the present invention is selected is as follows: Radix Rehmanniae Preparata, Radix Ophiopogonis, Radix Scrophulariae, the Radix Polygoni Multiflori, Concha Margaritifera, Magnetitum have nourishing YIN for suppressing the hyperactive YANG, make negative and positive coordinate the normal effect of function; But Poria, Rhizoma Alismatis, Cortex Moutan pathogenic fire purging are with yin nourishing; Fructus Schisandrae Chinensis, Fructus Tritici Levis, Caulis Polygoni Multiflori nourishing blood to tranquillize the mind, the arresting sweating that promotes the production of body fluid can be treated hectic fever, sweating, vexed, insomnia; Ramulus Uncariae Cum Uncis is gone into liver and clearing heat, reducing the minister-fire, steadily blood pressure.

Radix Rehmanniae Preparata, Radix Ophiopogonis, Radix Scrophulariae, Radix Polygoni Multiflori are all mended congenital Kidney-Yinly in the prescription of the present invention, and invigorating the liver and kidney, benefiting essence-blood, nourishing YIN and clearing away heat are with Zhi Qiben; Rhizoma Curculiginis, warming the kidney to invigorate YANG makes Yin grows while yang is generating; Poria, Cortex Moutan, Rhizoma Alismatis play the light spleen that oozes respectively and wet, and it is turbid to lead kidney off, and the effect of the liver-fire of coming down in torrents prevents that the YIN nourishing love is evil, and pathogenic fire purging is with yin nourishing; Concha Margaritifera, Magnetitum tranquillizing and allaying excitement, it is dizzy to control dizziness and tinnitus; Fructus Schisandrae Chinensis reinforcing the heart gas, nourishing the heart to keep a sound mind, the arresting sweating that promotes the production of body fluid, arresting seminal emission Gu Yin controls spontaneous perspiration, night sweat; The Fructus Tritici Levis tranquilizing by nourishing the heart is controlled palpitation and insomnia; Ramulus Uncariae Cum Uncis is gone into liver and clearing heat, the having a dizzy spell for the treatment of the liver sun rising.

Chinese medicine composition of the present invention can be mixed and made into oral formulations with above-mentioned each medical material and any or several pharmaceutically acceptable pharmaceutical carrier.For example decoction, tablet, granule, drop pill, pill or capsule or the like.For example above-mentioned all flavor medical materials are mixed grinding to the powder altogether, be respectively charged into capsule, each 3 grams, day 2-4 time.Special situation can suitable being regulated according to patient's the state of an illness.

Pharmaceutical carrier of the present invention comprises: lactose, sucrose, starch, microcrystalline Cellulose, sorbitol, calcium phosphate; Binding agent, for example syrup, gelatin, hydroxypropyl emthylcellulose, polyvinylpyrrolidone, starch, dextrin; Disintegrating agent, for example microcrystalline Cellulose, carboxymethyl starch sodium, sodium carboxymethyl cellulose, crospolyvinylpyrrolidone; Lubricant, for example magnesium stearate; High-molecular bone frame material, for example hydroxypropyl emthylcellulose, hydroxypropyl cellulose, ethyl cellulose, Brazil wax, hydrogenated vegetable oil, acrylic resin; Filmogen for example, hydroxypropyl emthylcellulose, polyvinylpyrrolidone, acrylic resin or the like.

The present invention further discloses Chinese medicine composition at the good effect that is had aspect the treatment climacteric syndrome disease.Below by concrete clinical experiment data, further instruction in addition:

The clinical experiment method:

In the hospital of traditional Chinese hospital, Tianjin, with 100 routine climacteric syndrome patients, be divided into treatment at random and organize 50 examples, matched group 50 examples, treatment group patient all takes GENGNIANAN, and matched group 50 examples are treated with GUHAN YANGSHENG JING.Effective 26 examples are organized in treatment as a result, produce effects 19 examples, and total effective rate is 90%, effective 20 examples of matched group, produce effects 12 examples, total effective rate 64% is learned processing P＜0.05 by statistics and obviously is better than matched group.

Now experimental result is summarized as follows:

One, physical data

Clinical climacteric syndrome patient 100 examples of observing altogether are the outpatient.Adopt contrast method at random, the patient is divided into treatment group and matched group.Two groups have comparability at aspect no significant differences such as the age course of disease and severity extents.

1. age

Patient age distribution situation (table one)

	The example number	40-45 year	45-50 year	50-55 year	Mean age
						The treatment group	??50	??8	??32	??10	??48.6
Matched group	??50	??6	??33	??11	??49.8

Treatment group and matched group are learned by statistics and are handled P＞0.05, and the patient is the difference not statistically significant in age distribution.

2. the course of disease:

Patient's course of disease situation (table two)

	The example number	＜2 years	3 years-	4 years-	5 years-	6 years-
							The treatment group	??50	?5	??19	??12	??8	??6
Matched group	??50	?6	??20	??10	??7	??7

3. severity extent

Patient's course of disease situation (table three)

	The example number	Slightly	Moderate	Severe
					The treatment group	??50	??22	??20	??8
Matched group	??50	??21	??22	??7

Table two, table three are learned by statistics and are handled P＞0.05, and two groups of zero differences are described.

4. concomitant symptoms

Patient's concomitant symptoms is (table four) relatively

	The example number	Coronary heart disease	Hypertension	Diabetes
					The treatment group	??50	??21	??24	??14

	The example number	Coronary heart disease	Hypertension	Diabetes
					Matched group	??50	??20	??26	??15

X ²＜3.84??P＞0.05

5. traditional Chinese medical science symptom tongue arteries and veins distribution situation

Patient's symptom, tongue arteries and veins distribution situation (table five)

	The example number	The hectic fever sweating	Dizzy	Tinnitus	Dysphoria	Dry mouth and throat	Dry stool	Dark coloured urine	The few tongue of red tongue	Thready and rapid pulse
											The treatment group	??50	??49	??48	??24	??50	??28	??30	??12	??50	??50
Matched group	??50	??46	??49	??28	??50	??25	??28	??16	??50	??50

Two, therapeutic outcome

1. efficacy analysis

Efficacy analysis table (table six)

	The example number	Produce effects	Effectively	Invalid	Increase the weight of	Total effective rate
							Matched group	??50	??19?38％	??26?52％	??5?10％	??0	??90％
The treatment group	??50	??12?24％	??20?40％	??18?36％	??0	??64％

Analyze u=2.3 P＜0.05 difference significance through Ridit.

GENGNIANAN is to patient's curative effect comparison (table seven) in various degree

	The example number	Produce effects	Effectively	Invalid	Increase the weight of	Total effective rate
							Slightly	??22	??9?40.9％	??11?50％	??2?9.1％	??0	??90.9％
Moderate	??20	??7?35％	??11?35％	??2?10％	??0	??90％
							Severe	??8	??3?37.5％	??4?50％	??1?12.5％	??0	??87.5％

Patient's symptom treatment improvement situation is (table eight) relatively

Analyze u=2.04 P＜0.05 through Ridit

	Treatment group (the few tongue of red tongue)	Matched group (the few tongue of red tongue)
			Before the treatment	??50	??50
Treatment back (improvement)	??38	??24

Picture of the tongue changes (table ten) before and after the patient treatment

	Treatment group (thready and rapid pulse)	Matched group (thready and rapid pulse)
			Before the treatment	??50	??50
Treatment back (improvement)	??41	??27

Changes in heart rate (table ten one) before and after the patient treatment

	The example number	Before the treatment	After the treatment
				Matched group	??50	??96.4	??94.2
The treatment group	??50	??92.6	??90.3

Treatment group T=1.0 matched group T=0.78 P＞0.05

Blood pressure (mmHg) (table ten two) before and after the patient treatment

The treatment group has certain effect for improving climacteric hypertension.

2. safety detects

Routine blood test, routine urinalysis, just equal no change before and after conventional all patients.

Liver function, renal function situation of change (table ten three)

Three, analysis of adverse reactions

GENGNIANAN is without any side effects, in 50 examples of observing, 3 example clothes future trouble gastral cavilty portion discomforts is arranged, and anorexia is more the causing of product because of YIN nourishing, but spontaneous remission after the drug withdrawal.

Four, reject case history:

In 100 routine patients, two examples therapy discontinued is for some reason arranged, 1 example adds Western medicine so rejected.Model case 1

Chen Xiaoxia, woman, 48 years old, patient medical history number: 1431.

The patient has family history of hypertension, hypertension occurs before 5 years, and hypertension 170-100mmHg when the highest obeys nifedipine usually, and sorbitrate etc. make blood pressure maintain normal level.In this year, it is irregular that menstruation appears in the patient, and 3-4 is a menstruation over the month, with irritated irritability, hectic fever sweating, vertigo and tinnitus, dry mouth and throat, food-intake is few, loses night and gets into bed, night sweat, cardiopalmus just not in, the time have the inclination forerunner's discomfort, increase with hypertension, coronary heart disease treatment, nothing is clearly better, for further treasure controls outpatient service.

Have a medical check-up: the T:36.4 degree, P80 time/minute, R18 time/minute, BP150/95mmHg, pronunciation is normal, nutrition is medium, and god cooperates clearly, active posture, and two lungs (-), heart circle is little, auscultation S1 is low pure, and each auscultatory valve areas is not heard pathologic murmur, the smooth softness of abdomen, and the liver taste do not touch, two lower limb pneumonedema.The few tongue of red tongue, thready and rapid pulse.

Through gynecological's ultrasound diagnosis: the uterus size is normal.

Chinese medical discrimination thinks that the patient belongs to the deficiency of YIN, disturbs on the asthenic fire and causes irritated irritability, and vertigo and tinnitus is difficult then hectic fever sweating of arresting sweating, the mouthfeel parched throat a little less than the deficiency of YIN sun.

GENGNIANAN PIAN is used in treatment, 3 times on ordinary days, each 6, adheres to taking medicine 16-30 days.Patient's two weeks back further consultation.Main suit's symptom obviously alleviates, vexed dizzy alleviating, and the hectic fever sweating takes a turn for the better, and insomnia tinnitus all has alleviating in various degree.Look into BP:140/80mmHg, the heart (-), lung (-), two weeks again, symptom disappears substantially, and blood pressure is in normal range.This case history belongs to produce effects.

Model case 2

Zhang Sumei, woman 51 years old, workman, outpatient service number: 1378

Climacteric symptom 5 years appears in patient's amenorrhea 3 years, and is once heavy when light during the integrative therapy symptom.Symptom is obvious in this year, the easy dry irritability of disposition, spontaneous sweating occurs frequently, insomnia and dreamful sleep, vertigo and tinnitus, blood pressure is at 170-150/100-90mmHg, soreness of the waist and knees is unable, dryness of the mouth and throat, the few tongue of red tongue, thready and rapid pulse without strength. look into electrocardio 2,3, the WF.S-T section is forced down. the auscultation heart (-), lung (-). and Chinese medical discrimination is thought the liver-kidney yin deficiency treatment with GENGNIANAN PIAN, every day 3 times, each 6.

Two all further consultations after patient's medication, easy dry irritability alleviates, and still has sweating more, and vertigo and tinnitus takes a turn for the better to some extent, still insomnia, the main suit is the steady 150/90mmHg of blood pressure recently, and symptom alleviates, and electrocardiogram and preceding no change continue medication 1 month.Patient's further consultation afterwards in month, tell: symptom disappears substantially, and the still tired back sense soreness of waist is unable, for consolidating curative effect, only advises and need take 2-3 week, and this case belongs to produce effects.

Model case 3

Wang Juan begins to find what the build of oneself changed from one's mid-40s, just begun also just to feel fat, after several years weight increase nearly 20 kilograms, it is very too fat to move that the figure becomes, particularly waist and buttocks are loose unusually.Therefore health go fromes bad to worse, and often shows as uncomfortable in chest, nervous, dyspnea, weak, facial a burst of flushing usually all over the body, numb limbs and tense tendons.Loss of appetite, gastrointestinal dysfunction, constipation, menoxenia and sexual hypofunction are treated repeatedly to various big hospital, and symptom does not take a turn for the better all the time.After inspection is done in gynecological's outpatient service, find that just pituitary hormone obviously rises at last, ovarian hormone obviously descends, demonstrate climacteric in advance, the premature ovarian failure symptom.Be diagnosed as climacteric syndrome.Through taking " GENGNIANAN " oral every heavy 0.3g, one time 6,3 times on the one treatment, 6 months treatment takes a turn for the better, and body weight decreases drastically, symptom uncomfortable in chest, nervous, dyspneic complete obiteration, work of putting into of whole heart enthusiasm and life now suffered.

Five, brief summary

1. efficacy analysis

GENGNIANAN PIAN treatment type of hyperactivity of fire caused by deficiency of YIN climacteric syndrome 50 examples, matched group 50 examples are treated with GUHAN YANGSHENG JING, through clinical observation, are summarized as follows:

Treatment group: produce effects 19 examples, 138%; Effective 26 examples account for 52%; Invalid 5 examples account for 10%; Total effective rate is 90%.

Matched group: produce effects 12 examples account for 24%; Effective 20 examples account for 40%; Invalid 18 examples account for 36%; Total effective rate 64%.Learn processing P＜0.05 by statistics and obviously be better than matched group.Analyze u=2.3 P＜0.05 through Ridit for two groups, prove two groups of difference significances.

Six, discussing clinically, the performance of climacteric syndrome has:

(1) flushing and hectic fever are levied in the paroxysm of cardiovascular symptom, promptly feel chest, cervical region and facial heating suddenly, and above-mentioned position skin is rubescent in the form of sheets simultaneously, perspiration then, fear of cold, can be diffused into back and whole body sometimes, last the several seconds by several minutes.Attack times is indefinite, and every day is for several times to tens of times, and is cold during intermittent fever, sways the emotion, works and sleep, and often makes the patient feel very painful.The reason of flushing is had different versions, due to having that the persistence of thinking estrogen is low-level and distending the blood vessels.Suddenly vasodilation is quickened SkBF and flushing is taken place.Climacteric women also transient hypertension can occur, and is more obvious based on systolic pressure rising and fluctuation, accompany sometimes cardiopalmus, uncomfortable in chest, breathe hard, symptom such as dizzy, these change mainly is because due to the vasomotoricity imbalance.

(2) spirit, neural symptom climacteric women often have worry, depression, emotional, have a sleepless night, cry well, hypomnesis, absent-minded etc., being happy and angry uncertainly sometimes, similar phrenoplegia.Generally the women of these symptoms taking place climacteric is with to pass by mental status instability relevant.

(3) menstruation and genitals change, and menstrual cycle begins disorder before the menopause, menostaxis, increase even metrorrhagia through blood volume, and some women can have cycle stretch-out, decrescence few through blood volume, later ischomenia; Minority women ischomenia is suddenly also arranged, the atrophy gradually of sexual organ and secondary sex characteristics owing to estrogenic minimizing.

(4) bone and joint symptom climacteric women often have arthralgic performance, generally involve knee joint more.Because estrogen descends, bone absorption is quickened, and causes osteoporosis.On the other hand, the climacteric women activity reduces, and the skeleton mechanical compression is weakened, and bone absorption speed causes osteoporosis than the fast growth of bone, the clinical manifestation lumbago and backache.

Treatment climacteric syndrome Chinese medicine composition of the present invention (being preferably GENGNIANAN PIAN) has nourishing YIN and clearing away heat, and the effect that relieving restlessness is calmed the nerves also has certain antihypertensive effect for involutional hypertension.So the clinical deficiency of YIN that is used for has hot climacteric syndrome, thereby eliminates the easy dry irritability of disposition, spontaneous sweating occurs frequently, insomnia and dreamful sleep, vertigo and tinnitus, and dysphoria unstable blood pressure etc. is levied, and effect is obvious.

The specific embodiment

The following examples can help those skilled in the art more fully to understand the present invention.But do not limit the present invention in any way, the umber in the embodiment of the invention can be chosen as gram or kilogram according to the actual needs.

Embodiment 1

[prescription] Radix Rehmanniae 60g Rhizoma Alismatis 60g 60g Radix Ophiopogonis Radix Scrophulariae 60g

Radix Rehmanniae Preparata 60g Poria 120g Magnetitum 120g Rhizoma Curculiginis 120g

Cortex Moutan 40g Concha Margaritifera 120g Fructus Schisandrae Chinensis 60g Caulis Polygoni Multiflori 120g

Radix Polygoni Multiflori Preparata 60g Fructus Tritici Levis 120g Ramulus Uncariae Cum Uncis 120g

[method for making] drops into the raw medicinal material of above-mentioned recipe quantity in the extraction pot, adds 2000ml water, decocts 50 minutes, uses 85% ethanol 3000ml then, refluxes, and collects filtrate, and 2-3 time so repeatedly, the filtration back concentrates and obtains activity extract; With activity extract, drying is pulverized, and sieves, and makes granule, and cold drying is sieved, and adds magnesium stearate, mixing, and compacting is made sheet in flakes.The bag film-coat, promptly.

Embodiment 2

[prescription] Radix Rehmanniae 60g Rhizoma Alismatis 60g 60g Radix Ophiopogonis Radix Scrophulariae 60g

Radix Rehmanniae Preparata 60g Poria 120g Magnetitum 120g Rhizoma Curculiginis 120g

Cortex Moutan 40g Concha Margaritifera 120g Fructus Schisandrae Chinensis 60g Caulis Polygoni Multiflori 120g

Radix Polygoni Multiflori Preparata 60g Fructus Tritici Levis 120g Ramulus Uncariae Cum Uncis 120g

[method for making] above ten five tastes, Fructus Tritici Levis, Magnetitum, Concha Margaritifera powder are broken into fine powder, sieve, and be standby; Radix Rehmanniae, Radix Rehmanniae Preparata, Radix Scrophulariae, Poria, Rhizoma Curculiginis, Radix Ophiopogonis add the 3000ml decocting and boil secondary, 3 hours for the first time, 2 hours for the second time, filter, it is 1.8 clear paste that filtrate is condensed into relative density;

Fructus Schisandrae Chinensis, Caulis Polygoni Multiflori, Radix Polygoni Multiflori Preparata, Rhizoma Alismatis, Cortex Moutan, Ramulus Uncariae Cum Uncis carry out percolation with 90% ethanol as solvent, and diacolation liquid recycling ethanol is condensed into relative density and is 1.25 clear paste.With above-mentioned two kinds of clear paste and above-mentioned fine powder mixing, make coarse granule, drying is pulverized, and sieves, and makes granule, and cold drying is sieved, and adds magnesium stearate, mixing, compacting is in flakes.The bag film-coat, promptly.

Embodiment 3

[prescription] Radix Rehmanniae 40g Rhizoma Alismatis 40g 40g Radix Ophiopogonis Radix Scrophulariae 40g

Radix Rehmanniae Preparata 40g Poria 100g Magnetitum 100g Rhizoma Curculiginis 100g

Cortex Moutan 40g Concha Margaritifera 100g Fructus Schisandrae Chinensis 30g Caulis Polygoni Multiflori 100g

Radix Polygoni Multiflori Preparata 40g Fructus Tritici Levis 100g Ramulus Uncariae Cum Uncis 100g

[method for making] above ten five tastes, Fructus Tritici Levis, Magnetitum, Concha Margaritifera powder are broken into fine powder, sieve, and be standby; Radix Rehmanniae, Radix Rehmanniae Preparata, Radix Scrophulariae, Poria, Rhizoma Curculiginis, Radix Ophiopogonis add the 1000ml decocting and boil secondary, 3 hours for the first time, 2 hours for the second time, filter, it is 1.2 clear paste that filtrate is condensed into relative density; Fructus Schisandrae Chinensis, Caulis Polygoni Multiflori, Radix Polygoni Multiflori Preparata, Rhizoma Alismatis, Cortex Moutan, Ramulus Uncariae Cum Uncis carry out percolation with 75% ethanol as solvent, and diacolation liquid recycling ethanol is condensed into relative density and is 1.20 clear paste.With above-mentioned two kinds of clear paste and above-mentioned fine powder mixing, granulate, sieve, drying, encapsulated, promptly.

Embodiment 4

[prescription] Radix Rehmanniae 80g Rhizoma Alismatis 80g 80g Radix Ophiopogonis Radix Scrophulariae 80g

Radix Rehmanniae Preparata 80g Poria 150g Magnetitum 150g Rhizoma Curculiginis 150g

Cortex Moutan 80g Concha Margaritifera 1500g Fructus Schisandrae Chinensis 60g Caulis Polygoni Multiflori 150g

Radix Polygoni Multiflori Preparata 80g Fructus Tritici Levis 150g Ramulus Uncariae Cum Uncis 150g

[method for making] medicinal material extract: according to above-mentioned recipe quantity with the ethanol of 70% weight and aqueous mixtures reflux, extract, 2 times, each mixture with 2100ml second alcohol and water extracted 1 hour, filtrate is condensed into extractum, add 250ml water, make extractum become suspension, reuse ethyl acetate and n-butyl alcohol extract respectively 2 times, and each 250ml, extract are concentrated into the dried refining extract that becomes after filtering and merging.Get substrate 24.9g part, Polyethylene Glycol-6000,54.2 part, Polyethylene Glycol-4000,6.9 part glycerol is put in the container, is heated to 80 ℃ in water-bath, treat whole fusions after, add 21.5 parts of refining extracts, be stirred to dissolving evenly.The medicinal liquid for preparing is transferred in the reservoir, and airtight and insulation is at 80 ℃, and regulator solution titer valve splashes in 25 ℃ of methyl-silicone oils, with the drop pill drop that forms to the greatest extent and wipe methyl-silicone oil, and drying, promptly.

Embodiment 5

Radix Rehmanniae 60g Rhizoma Alismatis 60g 60g Radix Ophiopogonis Radix Scrophulariae 80g

Radix Rehmanniae Preparata 80g Poria 130g Magnetitum 120g Rhizoma Curculiginis 100g

Cortex Moutan 40g Concha Margaritifera 100g Fructus Schisandrae Chinensis 70g Caulis Polygoni Multiflori 150g

Radix Polygoni Multiflori Preparata 60g Fructus Tritici Levis 120g Ramulus Uncariae Cum Uncis 100g.

Each component is pulverized, and the mix homogeneously that sieves adds 3.5% Mel then and makes pill.

Embodiment 6

Radix Rehmanniae 70g Rhizoma Alismatis 60g 80g Radix Ophiopogonis Radix Scrophulariae 80g

Radix Rehmanniae Preparata 80g Poria 100g Magnetitum 100g Rhizoma Curculiginis 120g

Cortex Moutan 40g Concha Margaritifera 120g Fructus Schisandrae Chinensis 80g Caulis Polygoni Multiflori 120g

Radix Polygoni Multiflori Preparata 60g Fructus Tritici Levis 150g Ramulus Uncariae Cum Uncis 100g.

Make refining extract according to above-mentioned method according to embodiment 2, then with other medical material mix homogeneously, add 3 parts of amylum pregelatinisatums, 2.5 parts of magnesium stearate, mix homogeneously is granulated tabletting bag film-coat.

Claims (10)

1. Chinese medicine composition for the treatment of climacteric syndrome, it comprises that described raw medicinal material comprises as the raw medicinal material of the following parts by weight of active ingredient or its activity extract and pharmaceutically useful carrier:

Radix Rehmanniae 20-80 part Rhizoma Alismatis 20-80 part 20-80 Radix Ophiopogonis part

Radix Scrophulariae 20-80 part Radix Rehmanniae Preparata 20-80 part Poria 60-150 part

Magnetitum 60-150 part Rhizoma Curculiginis 60-150 part Cortex Moutan 10-60 part

Concha Margaritifera 60-150 part Fructus Schisandrae Chinensis 20-80 part Caulis Polygoni Multiflori 60-150 part

Radix Polygoni Multiflori Preparata 20-80 part Fructus Tritici Levis 60-150 part Ramulus Uncariae Cum Uncis 60-150 part.

2. the described Chinese medicine composition of claim 1, wherein the raw medicinal material ratio of weight and number is:

Radix Rehmanniae 40-80 part Rhizoma Alismatis 40-80 part 40-80 Radix Ophiopogonis part

Radix Scrophulariae 40-80 part Radix Rehmanniae Preparata 40-80 part Poria 100-150 part

Magnetic 100-150 part Rhizoma Curculiginis 100-150 part Cortex Moutan 30-60 part

Concha Margaritifera 100-150 part Fructus Schisandrae Chinensis 40-80 part Caulis Polygoni Multiflori 100-150 part

Radix Polygoni Multiflori Preparata 40-80 part Fructus Tritici Levis 100-150 part Ramulus Uncariae Cum Uncis 100-150 part.

3. the described Chinese medicine composition of claim 1, raw medicinal material ratio of weight and number wherein is:

60 parts of 60 portions of Rhizoma Alismatis of Radix Rehmanniae 60 parts of Radix Ophiopogonis

120 parts in 60 parts of Poria of 60 parts of Radix Rehmanniae Preparata of Radix Scrophulariae

40 parts of 120 parts of Cortex Moutans of 120 portions of Rhizoma Curculiginises of magnetic

120 parts of 60 parts of Caulis Polygoni Multiflori of 120 parts of Fructus Schisandrae Chinensis of Concha Margaritifera

120 parts of 120 parts of Ramulus Uncariae Cum Uncis of 60 portions of Fructus Tritici Levis of Radix Polygoni Multiflori Preparata.

4. the described Chinese medicine composition of claim 1, wherein said activity extract are to adopt water, ethanol or their mixture as solvent extraction.

5. each described Chinese medicine composition of claim 1～4 is characterized in that wherein said raw medicinal material or its activity extract and any or several pharmaceutically acceptable carrier are mixed and made into oral formulations.

6. the described Chinese medicine composition of claim 5, oral formulations wherein is tablet, granule, drop pill, pill or capsule.

7. prepare the preparation method of the Chinese medicine composition of each described treatment climacteric syndrome of claim 1～6, it comprises:

A. the raw medicinal material with recipe quantity drops in the extraction pot, adds to be selected from water, and ethanol or its mixture reflux as solvent, collect filtrate, and 2-3 time so repeatedly, the filtration back concentrates and obtains activity extract; With activity extract with make oral formulations after pharmaceutically acceptable carrier fully mixes; Perhaps

B. Fructus Tritici Levis, Magnetitum, the Concha Margaritifera powder with recipe quantity is broken into fine powder, sieves, and be standby; To add Radix Rehmanniae, Radix Rehmanniae Preparata, Radix Scrophulariae, Poria, Rhizoma Curculiginis, Radix Ophiopogonis water, decoct, filter, filtrate is condensed into clear paste; Fructus Schisandrae Chinensis, Caulis Polygoni Multiflori, Radix Polygoni Multiflori Preparata, Rhizoma Alismatis, Cortex Moutan, Ramulus Uncariae Cum Uncis carry out percolation with 75%-95% ethanol as solvent, and diacolation liquid recycling ethanol is condensed into clear paste; With above-mentioned two kinds of clear paste and above-mentioned fine powder mixing, make coarse granule, drying is pulverized, and sieves, and makes granule, and cold drying is sieved, and adds magnesium stearate, mixing, compacting is in flakes.

8. the preparation method of claim 7 comprises also that wherein the activity extract that will obtain among the method a further through organic solvent extraction, makes refining extract; Be that 1: 1.0～2.0 ratio is fully mixed them according to refining extract and Polyethylene Glycol ratio of weight and number then, make drop pill.

9. the preparation method of claim 8, wherein organic solvent is methanol, ethanol, chloroform, ethyl acetate or n-butyl alcohol.

10. the application of each described compositions of claim 1～6 in the medicine of preparation treatment climacteric syndrome.