CN102988704A - Traditional Chinese medicine composition for treating menopausal syndrome and preparation method thereof - Google Patents
Traditional Chinese medicine composition for treating menopausal syndrome and preparation method thereof Download PDFInfo
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Abstract
The invention belongs to the field of Chinese medicine pharmacy, and relates to a traditional Chinese medicine composition for treating menopausal syndrome and a preparation method of the traditional Chinese medicine composition. The traditional Chinese medicine composition comprises traditional Chinese medicine radix rehmanniae, radix paeoniae alba, rhizoma anemarrhenae, golden cypress, morinda officinalis, herba epimedii, raw oyster shell, crude dragon bone, radix bupleuri and tuber fleeceflower stem as main medicines, and is blended with auxiliary materials to be prepared into the preparation for treating the symptoms related to menopause, i.e. the heating, the sweating, the agitated emotion, the insomnia and the like. The experiment proves that the traditional Chinese medicine composition provided by the invention has the definite functions for improving the blood serum E2 and reducing the blood serum FSH (follicle-stimulating hormone), the hypothalamus estrogen receptors Er alpha, Er beta gene expression and protein expression can be continuously adjusted, and the situation of hypothalamus aging can be improved, so that the menopausal syndrome can be effectively cured.
Description
Technical field
The invention belongs to the field of Chinese medicines, be specifically related to a kind of Chinese medicine composition for the treatment of menopausal syndrome; In addition, the invention still further relates to the preparation method of this Chinese medicine composition.
Background technology
Menopausal syndrome is high with its sickness rate, the generation that affects female life quality and infirmities of age, the limitation of Hormone Replacement Therapy etc., becomes the worldwide topic of women's medical treatment and healthcare field.It is reported, the menopausal syndrome sickness rate wherein has 25% women and need to seek medical advice because be impatient at up to 85-90%.And the menopausal syndrome duration has individual variation, and the menopause relevant symptoms can continue 1-5 usually, but has 15% sufferer to surpass 15 years, 9% sufferer even still can warm the sweating symptom later at 70 years old.American-European and domestic a plurality of Epidemiological studys show that all the menopause relevant symptoms can affect life, work, the family of climacteric, postmenopausal women as warming sweating, anxious state of mind, insomnia, hyposexuality etc., reduce their quality of life, and be directly connected to the generation that female old aged people phase disease comprises cardiovascular disease, metabolic disease etc., so menopausal syndrome is subject to concern and the attention of medical circle and society day by day.
As the ovarian function failure that the women occurs in aging course, the disease that hypothalamic-pituitary-ovarian Reproductive Axis regulatory function descends and causes, the treatment preferred option hormonotherapy (HT) of menopausal syndrome has definite curative effect.But, a plurality of large sample clinical experiment report HT can increase the women in breast carcinoma, ovarian cancer, carcinoma of endometrium, thrombotic disease, coronary heart disease, apoplexy risk in recent years, HT has taboos disease in addition, think at present the HT risk greater than benefit, therefore increasing sufferer and doctor turn to and select the medicinal plants therapy.
Chinese medicine has complete principle-method-recipe-medicines system, good clinical effectiveness and less side effect, receive publicity always, be devoted to seek comparatively desirable, safely and effectively, the new Chinese medicine of the treatment menopausal syndrome price appropriateness, that accept for numerous women's sufferer.
Summary of the invention
The technical problem to be solved in the present invention provides a kind of Chinese medicine composition of safe and effective, treatment menopausal syndrome that price is appropriate.
Chinese medicine begins to refer in particular to " menopausal syndrome " in the western medicine with " menopausal syndrome " or " menopausal syndrome " side in 1964, and the related indication diagnosis and treatment of in the past menopause sporadically appear in diseases such as " hysteria ", " Bulbus Lilii syndrome ", " sweating syndrome ", " insomnia ", " dizzy ".According to Basic Theories of Chinese Medicine and clinical practice, menopausal syndrome is that the woman is when seventy-seven, kidney-menses-punching is appointed-the day by day aging of uterus Reproductive Axis, kidney essense, liver blood are day by day not enough, are difficult to moisten foster internal organs, yin and yang imbalance, due to the visceral dysfunction, and being seen in many deficiency of YIN in lower, that sun floats on is upper, in outer symptom, as warms sleep feel unwell insomnia, climacteric menstruation of sweating, mood disorders, night and lack of proper care etc.
The invention provides a kind of Chinese medicine composition for the treatment of menopausal syndrome, it mainly is to be made by the crude drug of following weight portion: Radix Rehmanniae 1-12 part, Radix Paeoniae Alba 1-8 part, Rhizoma Anemarrhenae 1-8 part, Cortex Phellodendri 1-8 part, Radix Morindae Officinalis 1-8 part, Herba Epimedii 1-12 part, Concha Ostreae 3-24 part, Os Draconis 3-24 part, Radix Bupleuri 1-8 part, Caulis Polygoni Multiflori 2-24 part.The preferred weight proportioning is: 1.5 parts in the Radix Rehmanniae, 1 part of the Radix Paeoniae Alba, 1 part of the Rhizoma Anemarrhenae, 1 part of Cortex Phellodendri, 1 part of Radix Morindae Officinalis, 1.5 parts of Herba Epimedii, 3 parts of Concha Ostreae, 3 parts of Os Draconis, 1 part of Radix Bupleuri, 3 parts of Caulis Polygoni Multiflori.
The present invention selects the Radix Rehmanniae, the Radix Paeoniae Alba, the Rhizoma Anemarrhenae, Cortex Phellodendri, Radix Morindae Officinalis, Herba Epimedii, Concha Ostreae, Os Draconis, Radix Bupleuri, Caulis Polygoni Multiflori to make up, with the combination of these medical materials so that each efficacy of drugs produces synergism, thereby effective menopausal syndrome.Described menopausal syndrome relevant symptoms also comprises the climacteric menstruation imbalance to warm sweating, mood disorders, insomnia as main.Crude drug medical material involved in the present invention is recorded Chinese medicine by Chinese Pharmacopoeia one one of version in 2000, and meets the pharmacopeia prescription.
The monarch drug Radix Rehmanniae, Herba Epimedii in the Chinese medicine composition of the present invention, the ministerial drug Radix Paeoniae Alba, Radix Morindae Officinalis, the Rhizoma Anemarrhenae, Cortex Phellodendri, Os Draconis, Concha Ostreae, Caulis Polygoni Multiflori, Radix Bupleuri.Radix Rehmanniae yin nourishing, the Radix Paeoniae Alba is enriched blood, and mutual reinforcement between is for using; The Radix Rehmanniae, the Radix Paeoniae Alba of nourishing YIN, monoyin and monoyang are closed in Radix Morindae Officinalis, Herba Epimedii tonifying YANG; The Rhizoma Anemarrhenae, Cortex Phellodendri are purged heat, and close Radix Morindae Officinalis, the Herba Epimedii of warming YANG, a cold heat; Radix Paeoniae Alba yin fluid astringing, Radix Bupleuri is soothing the liver, and one receives one falls apart; The SHENGLONGMU tranquillization with heavy prescription is joined clearly sun of Radix Bupleuri ascension, one rise and one drop; The Caulis Polygoni Multiflori sweet in the mouth is flat, enters heart spleen two warps, and regulating plant is neural well.Whole prescription focuses on " accent " word, can improve well the patient and warm the symptoms such as sweating, vexed insomnia.
Chinese medicine composition of the present invention can adopt the conventional method of Chinese medicine preparation to be prepared into any oral preparations, such as water decoction, tablet, granule, capsule etc.
In addition, the present invention also provides the preparation method of above-mentioned Chinese medicine composition, and it prepares by following step:
Get above-mentioned half amount of formula ratio medicine, add water 3-8 and doubly measure, soak after 1 hour, decocted 1 hour, add again water 3-8 and doubly measure, decocted 45 minutes, filter, merge decoction liquor, concentrating under reduced pressure, drying under reduced pressure gets dry extract, is ground into fine powder (crossing 80 orders).Second half crude drug was pulverized 80 orders, and was mixed with extract powder with CO60 sterilization (irradiation dose 8k), added an amount of pharmaceutic adjuvant, behind the mix homogeneously with 60～70% ethanol as the agent of binding agent granulation.
Described pharmaceutic adjuvant is selected from mannitol, lactose, cane sugar powder, magnesium stearate, aspartame, a kind of or its combination in any in Mentholum and the oleum Citri sinensis essence.
The invention provides the another kind of preparation method of above-mentioned Chinese medicine composition, comprise the steps:
With the medicinal water boiling and extraction of above-mentioned raw materials 2 times, decoct for the first time and add water 1000-1500ml, decocting time is 30-60 minute, gets residue juice, decocts for the second time to add water 500-1000ml, decocting time is 30-45 minute, gets residue juice.
Modern medicine generally acknowledges that the perimenopausal syndrome pathogenic factor is ovarian function decline before and after the menopause, and estrogen level rapid fluctuation or rapid drawdown occur and causes a series of physiology, pathological change; Be that the Reproductive Axis regulatory function that the women occurs in aging course descends, a kind of multisystem function that causes is lost compensatory state.Therefore there is the situation that the reproductive hormone adjusting is not normal and the hypothalamic-pituitary-ovarian Reproductive Axis old and feeble and deposit in this phase women.Chinese medicine composition of the present invention is verified through zoopery, the result shows, Chinese medicine composition of the present invention to 5 monthly age of castration the SD rat not only have rising tune joint serum E2, the effect of falling tone joint serum FSH, low estrogen receptor ERa, ER beta gene expression and protein expression in the rising tune joint castrated rats hypothalamus is to improve the body sex hormone regulation; Can also improve castrated rats hypothalamus low SOD activity and T-AOC, reduce the MDA that raises in the castrated rats hypothalamus, improve castrated rats hypothalamus mitochondrial DNA damage gene C oI, CoIII and express, improve the body tissue aging.As seen, medicine of the present invention has similar estrogen-like effects on the one hand, can slow down the body tissue aging on the other hand, thereby improve the stress ability that body sharply descends to ovarian hormone, promote the interior environmental change of organism adaptation menopause front and back, reply estrogen is low warming of causing, the symptoms such as sweating, mood disorders, thus menopausal syndrome can effectively be treated.
The specific embodiment
The invention will be further elaborated by the following examples:
Embodiment 1 granule
Weighting raw materials: Radix Rehmanniae 5g, Radix Paeoniae Alba 5g, Rhizoma Anemarrhenae 5g, Cortex Phellodendri 5g, Radix Morindae Officinalis 5g, Herba Epimedii 5g, Concha Ostreae 15g, Os Draconis 15g, Radix Bupleuri 5g, Caulis Polygoni Multiflori 10g.
Get above-mentioned half amount of formula ratio medicine, add 3 times of amounts of water, soak after 1 hour, decocted 1 hour, add again 3 times of amounts of water, decocted 45 minutes, filter, merge decoction liquor, concentrating under reduced pressure, drying under reduced pressure gets dry extract, is ground into fine powder (crossing 80 orders).Second half crude drug was pulverized 80 orders, and was mixed with extract powder with CO60 sterilization (irradiation dose 8k), added mannitol, lactose, cane sugar powder, aspartame, Mentholum, behind the mix homogeneously with 60% ethanol as the agent of binding agent granulation, pack, every bag 15 gram, oral 2 times of every day, each 1 bag.
Embodiment 2 granules
Weighting raw materials: Radix Rehmanniae 60g, Radix Paeoniae Alba 40g, Rhizoma Anemarrhenae 40g, Cortex Phellodendri 40g, Radix Morindae Officinalis 40g, Herba Epimedii 60g, Concha Ostreae 120g, Os Draconis 120g, Radix Bupleuri 40g, Caulis Polygoni Multiflori 120g.
Get above-mentioned half amount of formula ratio medicine, add 8 times of amounts of water, soak after 1 hour, decocted 1 hour, add again 8 times of amounts of water, decocted 45 minutes, filter, merge decoction liquor, concentrating under reduced pressure, drying under reduced pressure gets dry extract, is ground into fine powder (crossing 80 orders).Second half crude drug was pulverized 80 orders, and was mixed with extract powder with CO60 sterilization (irradiation dose 8k), added mannitol, lactose, cane sugar powder, aspartame, Mentholum, behind the mix homogeneously with 70% ethanol as the agent of binding agent granulation, pack, every bag 15 gram, oral 2 times of every day, each 1 bag.
Embodiment 3 granules
Weighting raw materials: Radix Rehmanniae 7.5g, Radix Paeoniae Alba 5g, Rhizoma Anemarrhenae 5g, Cortex Phellodendri 5g, Radix Morindae Officinalis 5g, Herba Epimedii 7.5g, Concha Ostreae 15g, Os Draconis 15g, Radix Bupleuri 5g, Caulis Polygoni Multiflori 15g.
Get above-mentioned half amount of formula ratio medicine, add 5 times of amounts of water, soak after 1 hour, decocted 1 hour, add again 5 times of amounts of water, decocted 45 minutes, filter, merge decoction liquor, concentrating under reduced pressure, drying under reduced pressure gets dry extract, is ground into fine powder (crossing 80 orders).Second half crude drug was pulverized 80 orders, and was mixed with extract powder with CO60 sterilization (irradiation dose 8k), added mannitol, lactose, cane sugar powder, aspartame, Mentholum, behind the mix homogeneously with 65% ethanol as the agent of binding agent granulation, pack, every bag 15 gram, oral 2 times of every day, each 1 bag.
Embodiment 4 water decoctions
Weighting raw materials: Radix Rehmanniae 20g, Radix Paeoniae Alba 10g, Rhizoma Anemarrhenae 10g, Cortex Phellodendri 10g, Radix Morindae Officinalis 20g, Herba Epimedii 20g, Concha Ostreae 40g, Os Draconis 40g, Radix Bupleuri 15g, Caulis Polygoni Multiflori 30g.
With the medicinal water boiling and extraction of above-mentioned raw materials 2 times, decoct for the first time and add water 1200ml, decocting time is 40 minutes, gets residue juice 150ml, decocts for the second time to add water 700ml, decocting time is 35 minutes, gets residue juice 150ml, every day oral secondary, each 150ml.
Embodiment 5 water decoctions
Weighting raw materials: Radix Rehmanniae 15g, Radix Paeoniae Alba 10g, Rhizoma Anemarrhenae 9g, Cortex Phellodendri 9g, Radix Morindae Officinalis 9g, Herba Epimedii 15g, Concha Ostreae 30g, Os Draconis 30g, Radix Bupleuri 9g, Caulis Polygoni Multiflori 30g.
With the medicinal water boiling and extraction of above-mentioned raw materials 2 times, decoct for the first time and add water 1000ml, decocting time is 30 minutes, gets residue juice 150ml, decocts for the second time to add water 500ml, decocting time is 30 minutes, gets residue juice 150ml, every day oral secondary, each 150ml.
Embodiment 6 water decoctions
Weighting raw materials: Radix Rehmanniae 15g, Radix Paeoniae Alba 10g, Rhizoma Anemarrhenae 9g, Cortex Phellodendri 9g, Radix Morindae Officinalis 9g, Herba Epimedii 15g, Concha Ostreae 30g, Os Draconis 30g, Radix Bupleuri 9g, Caulis Polygoni Multiflori 30g.
With the medicinal water boiling and extraction of above-mentioned raw materials 2 times, decoct for the first time and add water 1500ml, decocting time is 60 minutes, get residue juice 150ml, for the second time decoction adds water 1000ml, and decocting time is 45 minutes, get residue juice 150ml, every day oral secondary, each 150ml.
Embodiment 7 tablets
Weighting raw materials: Radix Rehmanniae 20g, Radix Paeoniae Alba 10g, Rhizoma Anemarrhenae 10g, Cortex Phellodendri 10g, Radix Morindae Officinalis 20g, Herba Epimedii 20g, Concha Ostreae 40g, Os Draconis 40g, Radix Bupleuri 15g, Caulis Polygoni Multiflori 30g.
This crude drug is processed into 10 order medicinal powders, adds 9 times of water gagings and soak 20min, with 340W microwave power radiation 50min, filter, get filtrate, concentrate drying gets dry extract, adds appropriate amount of auxiliary materials, makes tablet, every 0.6 gram, oral 2 times of every day, each 5.
Below by test example beneficial effect of the present invention is further elaborated:
Test example 1 is improved Serum Sex Hormones effect development test
1, medicine Chinese medicine composition water decoction of the present invention.
Press pharmacodynamic study related animal dosage translation method, the premarin consumption is 0.073mg/kg.d, and Chinese medicine composition consumption of the present invention is 19.37g crude drug/kg.d.Chinese medicine composition water decoction heating evaporation is become concentrated decotion, calculate by every rat oral gavage 1.5-2ml.
2,3 monthly age of animal SPF level SD female rats is 72, body weight 300 ± 25g, and Shanghai Univ. of Traditional Chinese Medicine's Experimental Animal Center provides.
3, method
54 3 months old rats row castrations operations are rear as castration menopausal state model, random packet after 1 week of postoperative recuperation, wherein 18 rats are as the model group of blank, 18 Chinese drug-treated group as traditional Chinese medicine composition for treating of the present invention, 18 Western medicine groups as the premarin randomized controlled treatment, other 18 3 months old rats adaptabilities are fed and 1 week were begun experiment as youth's group, and be 8 weeks experimental period.
Radioimmunology detects Serum Sex Hormones FSH, LH, E2.
4, show such as the result of table 1, Chinese medicine composition of the present invention to 5 monthly age of castration the SD rat have rising tune joint serum E2, the effect of falling tone joint serum FSH.
Table 1 is respectively organized castration 5 months old rats serum FSHs, LH, E2 level relatively
Annotate: each treatment group is compared with blank model group, * * * P＜0.001.
Test example 2 is regulated the development test of ER-α mRNA receptor acting
1, Experimental agents and laboratory animal are with test example 1.
2, method
The experiment group technology is with test example 1.
Hypothalamus is drawn materials: after rat anesthesia is got blood, take off head, open cranium along the dorsal part median line fast, fully exposing brain also carefully opens, disconnect optic chiasma, separate and the taking-up hypothalamus with neural separation bar, cutting along median line rapidly on ice, get half hypothalamus and weigh, place the Eppendorf centrifuge tube in-60 ℃ of preservations.Real-time PCR and westernblot method detect rat hypothalamus estrogen receptor ER
a, ER
βGene expression and protein expression.
3, the result such as table 2 shows, Chinese medicine composition of the present invention can save low estrogen receptor ERa, ER beta gene expression and protein expression in the castrated rats hypothalamus by rising tune.
Table 2 is respectively organized rat hypothalamus ER
a, ER
βMRNA level and ER
a, ER
βProtein content relatively
Annotate: each treatment group is compared with blank model group, * * * P＜0.001, * P＜0.05.
Test example 3 is regulated the old and feeble effect of hypothalamus development test
1, Experimental agents and laboratory animal are with test example 1.
2, method
The experiment group technology is with test example 1.
Xanthine oxidase detects tissue SOD, and thiobarbituricacidα-(TBA) colorimetric analysis detects and organizes MDA, and spectrophotometric colorimetric determination tissue T-AOC, LDH operate by the test kit requirement.The Realtime PCR method detects inferior colliculus cerebral tissue mitochondrion mt-DNA lesioned gene index Co I, CoIII.
3, the result such as table 3 and table 4 shows, Chinese medicine composition of the present invention can improve castrated rats hypothalamus low SOD activity and T-AOC, reduce the MDA that raises in the castrated rats hypothalamus, improve castrated rats hypothalamus mitochondrial DNA damage gene C oI, CoIII and express.
Table 3 is respectively organized rat hypothalamus T-AOC, MDA, SOD relatively
Table 4 is respectively organized the expression of rat hypothalamus CoI mRNA, CoIII mRNA
Annotate: each treatment group is compared with blank model group, * * * P＜0.001, * * P＜0.01.
Claims (9)
1. Chinese medicine composition for the treatment of menopausal syndrome, it is characterized in that, mainly be to be made by the crude drug of following weight portion: Radix Rehmanniae 1-12 part, Radix Paeoniae Alba 1-8 part, Rhizoma Anemarrhenae 1-8 part, Cortex Phellodendri 1-8 part, Radix Morindae Officinalis 1-8 part, Herba Epimedii 1-12 part, Concha Ostreae 3-24 part, Os Draconis 3-24 part, Radix Bupleuri 1-8 part, Caulis Polygoni Multiflori 2-24 part.
2. press the Chinese medicine composition for the treatment of menopausal syndrome claimed in claim 1, it is characterized in that, the consumption of described crude drug is: 1.5 parts in the Radix Rehmanniae, 1 part of the Radix Paeoniae Alba, 1 part of the Rhizoma Anemarrhenae, 1 part of Cortex Phellodendri, 1 part of Radix Morindae Officinalis, 1.5 parts of Herba Epimedii, 3 parts of Concha Ostreae, 3 parts of Os Draconis, 1 part of Radix Bupleuri, 3 parts of Caulis Polygoni Multiflori.
3. by the Chinese medicine composition of claim 1 or 2 described treatment menopausal syndromes, it is characterized in that, described menopausal syndrome relevant symptoms is to warm sweating, mood disorders, insomnia as main.
4. by the Chinese medicine composition of claim 1 and 2 described treatment menopausal syndromes, it is characterized in that, described menopausal syndrome also comprises the climacteric menstruation imbalance.
5. the preparation method such as each described Chinese medicine composition of claim 1-4 is characterized in that, comprises the steps:
(1) get half amount of crude drug of described weight ratio, add water 3-8 and doubly measure, soak after 1 hour, decocted 1 hour, add again water 3-8 and doubly measure, decocted 45 minutes, filter, merge decoction liquor, concentrating under reduced pressure, drying under reduced pressure gets dry extract, is ground into extract powder;
(2) second half crude drug was pulverized 80 orders, and was mixed with extract powder with CO60 sterilization, added an amount of pharmaceutic adjuvant, behind the mix homogeneously with 60～70% ethanol as the agent of binding agent granulation.
6. the preparation method of Chinese medicine composition as claimed in claim 5 is characterized in that, in the step (1), crosses 80 orders and is ground into extract powder.
7. the preparation method of Chinese medicine composition as claimed in claim 5 is characterized in that, in the step (2), described second half crude drug was pulverized 80 orders; Described with the CO60 sterilization, its irradiation dose is 8k.
8. by the Chinese medicine composition for the treatment of menopausal syndrome claimed in claim 5, it is characterized in that, in the step (2), described pharmaceutic adjuvant is selected from mannitol, lactose, cane sugar powder, magnesium stearate, aspartame, a kind of or its combination in any in Mentholum and the oleum Citri sinensis essence.
9. preparation method such as each described Chinese medicine composition of claim 1-4, it is characterized in that, comprise the steps: crude drug water boiling and extraction 2 times, decoct for the first time and add water 1000-1500ml, decocting time is 30-60 minute, gets residue juice, decocts for the second time to add water 500-1000ml, decocting time is 30-45 minute, gets residue juice.
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Application publication date: 20130327 |