CN101843689B - Chinese medicinal composition for treating climacteric syndromes and preparation method thereof - Google Patents
Chinese medicinal composition for treating climacteric syndromes and preparation method thereof Download PDFInfo
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Abstract
The invention relates to the field of Chinese medicaments, and discloses a Chinese medicinal composition for treating climacteric syndromes. Preferably, the Chinese medicinal composition comprises the following raw materials in part by weight: 1,000 to 1,600 parts of white paeony root, 800 to 1,400 parts of glossy privet fruit, and 800 to 1,400 parts of amur corktree bark. The invention also provides a preparation method of the Chinese medicinal composition. The Chinese medicinal composition for treating the climacteric syndromes has the advantages of obvious curative effect, simple formula and small side effects. The preparation method has the advantages of high extraction rate, simple operation, and suitability for industrialized production.
Description
Technical field
The present invention relates to tcm field, be specifically related to a kind of Chinese medicine composition of treating climacteric syndrome and preparation method thereof.
Background technology
Climacteric syndrome refer to the women before and after the menopause because ovarian function fails gradually, decrease in estrogen; Cause the functional disorder of hypothalamic-pituitary-ovarian axis; Appearance is main with the autonomic nervous dysfunction; One group of clinical syndrome with spiritual mental symptoms is called perimenopausal syndrome again.The foreign data statistics has 84.2% women symptom to occur at climacteric; Show according to national census data in 2000; 45 years old-65 years old women of China is about 100,000,000 2 thousand ten thousand, and epidemiological study shows that at least 60% more or less light or heavy menopause relevant symptoms occurs among this crowd.Along with social senilization, women's life-time dilatation, this sick sickness rate has the trend of rising, if the untimely generation that also is directly connected to female old aged people phase disease of treatment.Therefore climacteric syndrome is very harmful to women's physical and mental health, work and life.
To the treatment of this disease, doctor trained in Western medicine is many to be main with estrogen replacement therapy and Hormone Replacement Therapy (HRT), though curative effect is good; But side effect is bigger; Have the increase women to suffer from the possibility of carcinoma of endometrium like estrogen, side reaction can appear in abuse stimulin, long-term single danger that can increase carcinoma of endometrium with stimulin preparation especially dosage more greatly; More harm than good, and this two kinds of Therapeutic Method and be not suitable for each climacteric women.
To above-mentioned present climacteric syndrome treatment present situation and existing problems; We are the basis with distinguished veteran doctors of TCM through proved recipe; Chinese medical discrimination is combined with the modern medicine differential diagnosis of diseases, develop determined curative effect, few side effects, the climacteric syndrome medicine of taking convenience, price economy; Thereby satisfy social needs, and bring favorable economic benefit and social benefit.
Summary of the invention
Goal of the invention of the present invention is to overcome the defective that the western medicine effect is undesirable and side effect is big of existing treatment climacteric syndrome, and a kind of Chinese medicine composition that climacteric syndrome is with strong points, evident in efficacy and side effect is little of treating is provided.
In order to realize the foregoing invention purpose, the present invention adopts following technical scheme:
A kind of Chinese medicine composition of treating climacteric syndrome, its raw material comprises the Radix Paeoniae Alba, Fructus Ligustri Lucidi, Cortex Phellodendri.
The traditional Chinese medical science thinks that perimenopausal syndrome belongs to pre-postmenstrual syndromes, and before and after disconnected, Radix Semiaquilegiae gradually exhausts; Kidney water dries up, and edema with the liver involved is lost and supported, and the hepatic and renal YIN deficiency causes pre-postmenstrual syndromes; The pathogenesis side of sending in view of the above is monarch with the Radix Paeoniae Alba in the side, with the merit of its nourishing blood for regulating menstruation, suppressing the hyperactive liver pain relieving, astringing YIN to stop sweating; With separate blood deficiency, the deficiency of YIN has the thermic menoxenia, deficiecny of liver-YIN causes cards such as dizzy, the rib of headache side of body pain and night sweat due to yin deficiency; Fructus Ligustri Lucidi is a ministerial drug, with the effect of its tonifying liver kidney yin, clearing away heat to improve acuity of vision, removes soreness of waist and knee joint, interior-heat caused by deficiency of YIN, hectic fever due to YIN-deficiency consumptive fever, the numbness of having a dizzy spell etc.; The Cortex Phellodendri heat clearing and damp drying, eliminating fire and detoxication is brought down a fever to remove and is steamed for adjuvant, helps the Radix Paeoniae Alba, the Fructus Ligustri Lucidi subsolution deficiency of YIN to cause and warm sweating, cards such as dysphoria with feverish sensation in the chest palms and soles.Three medicines phase 5 is played liver and kidney tonifying, the effect that nourishing YIN for decreasing fever, relieving restlessness are calmed the nerves altogether.
Chinese medicine composition according to the invention has liver and kidney tonifying; Nourishing YIN for decreasing fever, the relieving restlessness mind-easing function cures mainly female climacteric syndrome; Differential diagnosis in tcm is a syndrome of yin deficiency of liver and kidney, and card sees that to warm sweating, irritated irritability, spiritlessness and weakness, forgetful insomnia, soreness of waist and knee joint, dizziness and tinnitus, xerostomia before and after disconnected just difficult; Menoxenia, the amount polychrome is red or dripping without cease; The few tongue of red tongue, stringy and thready pulse etc.
Chinese medicine composition according to the invention, its raw material preferably includes: the Radix Paeoniae Alba 1000～1600 weight portions, Fructus Ligustri Lucidi 800～1400 weight portions, Cortex Phellodendri 800～1400 weight portions.
Further preferably, the raw material of Chinese medicine composition of the present invention comprises: the Radix Paeoniae Alba 1333 weight portions, Fructus Ligustri Lucidi 1111 weight portions, Cortex Phellodendri 1111 weight portions.
Chinese medicine composition according to the invention directly or indirectly adds acceptable accessories through conventional processing and processes conventional formulations such as granule, pill, powder, tablet, capsule, oral liquid.The preferred dosage form of Chinese medicine composition according to the invention is a capsule.Preferred, said adjuvant comprises calcium hydrogen phosphate.
The present invention also provides a kind of method for preparing of treating the Chinese medicine composition of climacteric syndrome, may further comprise the steps:
Step 1: get the Radix Paeoniae Alba and add alcohol reflux, extracting liquid filtering is got filtrate recycling ethanol, and concentrate drying gets Radix Paeoniae Alba extract;
Step 2: get Fructus Ligustri Lucidi and add alcohol reflux, it is half that extracting liquid filtering is got filtrate recycling ethanol to filtrate volume, thin up, the dry Fructus Ligustri Lucidi extract that gets of centrifuging and taking deposition;
Step 3: get Cortex Phellodendri and add alcohol reflux, extracting liquid filtering is got filtrate recycling ethanol, and concentrate drying gets Cortex Phellodendri extract;
Step 4: said Radix Paeoniae Alba extract, Fructus Ligustri Lucidi extract, Cortex Phellodendri extract are mixed.
As preferably, step 1 is specially: get 70% ethanol that the Radix Paeoniae Alba adds 10 times, 8 times, 6 times weight respectively, reflux was extracted three times in 1.5 hours, 1 hour, 1 hour respectively; Merge extractive liquid, filters, and gets filtrate recycling ethanol; Be concentrated into driedly,, pulverized 40 mesh sieves in 60 ℃ of following vacuum dryings.
As preferably, step 2 is specially: get Fructus Ligustri Lucidi and add 10 times, 8 times weight 80% ethanol, reflux was extracted twice in 2 hours, 1 hour respectively; Merge extractive liquid, filters, and filtrate recycling ethanol is concentrated into filtrate volume one half; The water gaging dilution such as add, the centrifuging and taking deposition is dry, pulverizes 40 mesh sieves.
As preferably, step 3 is specially: get Cortex Phellodendri and add 10 times, 8 times, 6 times weight 65% ethanol respectively, reflux was extracted three times in 1 hour, and merge extractive liquid, filters and gets filtrate recycling ethanol, was concentrated into driedly, and 60 ℃ of following vacuum dryings were pulverized 40 mesh sieves.
More preferably,, the weight ratio of the said Radix Paeoniae Alba, Fructus Ligustri Lucidi and Cortex Phellodendri is 1000～1600: 800～1400: 800～1400.
Zoopery shows that Chinese medicine composition according to the invention can significantly reduce castration rat model horizontal anomalous movement number of times, and the castration rat model is had sedation preferably, also can significantly increase castration rat model E
2Content reduces FSH, LH activity, and imbalance has a better role to castration rat model hormonal system.
It is active that Chinese medicine composition according to the invention can significantly improve castrated rats GSH-PX, reduces castration rat model MDA content, and castration rat model Radical Metabolism is had a better role.
Above result shows; Chinese medicine composition according to the invention can be regulated and improve female climacteric syndrome model castrated rats endocrine; Improve the rat model estrogen level, effectively remove the rat model interior free yl, and the hypothalamus neurotransmitter is had certain influence; Also have sedation preferably, can effectively improve the female climacteric syndrome symptom.
Zoopery finds that also Chinese medicine composition according to the invention can significantly reduce castration mouse autonomic activities number of times, and sedative-hypnotic effect is preferably arranged.
Chinese medicine composition according to the invention also cocoa significantly improves castration model mice memory function, scopolamine is caused the mouse memory obstacle have some improvement.
Chinese medicine composition according to the invention can reduce warm drugs interior-heat caused by deficiency of YIN model mice autonomic activities number of times, significantly reduces the interior-heat caused by deficiency of YIN mouse temperature, and the interior-heat caused by deficiency of YIN model mice is had treatment preferably.
Chinese medicine composition according to the invention also causes the rat diaphoresis to pilocarpine has anti-hidropoiesis preferably.
Chinese medicine composition according to the invention has remedied the deficiency of HRT, according to determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs, and treating both the principal and secondary aspects of a disease, evident in efficacy, side effect is little.Of the present inventionization carried ancient prescription, a kind of Chinese medicine composition of treating climacteric syndrome that provides, and it is little to write out a prescription, and has treating both the principal and secondary aspects of a disease, evident in efficacy, advantages such as side effect is little, taking convenience, price economy, and its production technology is advanced, is beneficial to suitability for industrialized production.
The specific embodiment
The invention discloses a kind of Chinese medicine composition of treating climacteric syndrome and preparation method thereof, those skilled in the art can use for reference this paper content, suitably improve technological parameter and realize.Special needs to be pointed out is that all similarly replace and change apparent to those skilled in the art, they all are regarded as and are included in the present invention.Product of the present invention, method and application are described through preferred embodiment; The related personnel obviously can change or suitably change and combination methods and applications as herein described in not breaking away from content of the present invention, spirit and scope, realizes and use technology of the present invention.
Below in conjunction with embodiment, further set forth the present invention:
Embodiment 1: preparation of drug combination according to the invention
Step a: the method for preparing of Radix Paeoniae Alba extract: get Radix Paeoniae Alba 1600g and add 16000 milliliters, 12000 milliliters, 9600 milliliter 70% ethanol, heating and refluxing extraction three times, 1.5 hours time, 1 hour, 1 hour, merge extractive liquid; Filter, filtrate recycling ethanol is concentrated into dried; In 60 ℃ of following vacuum dryings, take out, pulverize; Cross 40 mesh sieves, must the dried cream of about 270g, subsequent use;
Step b: the preparation of Fructus Ligustri Lucidi extract: get Fructus Ligustri Lucidi 1400g and add 14000 milliliters, 11200 milliliter 80% ethanol, heating and refluxing extraction twice, 2 hours time, 1 hour, merge extractive liquid; Filter, filtrate recycling ethanol is concentrated into 1400ml, adds water to 2800 milliliters; Hold over night, centrifugal, get the deposition drying, pulverize; Cross 40 mesh sieves, must the dried cream of about 83g, subsequent use;
Step c: the preparation of Cortex Phellodendri extract: get Cortex Phellodendri 1400g and add 14000 milliliters, 11200 milliliters, 8400 milliliter 65% ethanol, heating and refluxing extraction three times, 1 hour time, 1 hour, 1 hour, merge extractive liquid; Filter, filtrate recycling ethanol is concentrated into dried; In 60 ℃ of following vacuum dryings, take out, pulverize; Cross 40 mesh sieves, must the dried cream of about 157g, subsequent use.
Steps d: with step a, b, the extract obtained mix homogeneously of c.
Embodiment 2: the capsule preparation of pharmaceutical composition according to the invention
Step a: the method for preparing of Radix Paeoniae Alba extract: get Radix Paeoniae Alba 1000g and add 10000 milliliters, 8000 milliliters, 6000 milliliter 70% ethanol, heating and refluxing extraction three times, 1.5 hours time, 1 hour, 1 hour, merge extractive liquid; Filter, filtrate recycling ethanol is concentrated into dried; In 60 ℃ of following vacuum dryings, take out, pulverize; Cross 40 mesh sieves, must the dried cream of about 170g, subsequent use;
Step b: the preparation of Fructus Ligustri Lucidi extract: get Fructus Ligustri Lucidi 800g and add 8000 milliliters, 6400 milliliter 80% ethanol, heating and refluxing extraction twice, 2 hours time, 1 hour, merge extractive liquid; Filter, filtrate recycling ethanol is concentrated at 1: 1 o'clock, and adding water to medical material content is 1: 2; Hold over night, centrifugal, get the deposition drying, pulverize; Cross 40 mesh sieves, must the dried cream of about 42g, subsequent use;
Step c: the preparation of Cortex Phellodendri extract: get Cortex Phellodendri 800g and add 8000 milliliters, 6400 milliliters, 4800 milliliter 65% ethanol, heating and refluxing extraction three times, 1 hour time, 1 hour, 1 hour, merge extractive liquid; Filter, filtrate recycling ethanol is concentrated into dried; In 60 ℃ of following vacuum dryings, take out, pulverize; Cross 40 mesh sieves, must the dried cream of about 89g, subsequent use.
Steps d: add the about 60g of calcium hydrogen phosphate,, be sub-packed in 1000 capsules, promptly get with step a, b, the extract obtained mix homogeneously of c.
Embodiment 3: the capsule preparation of pharmaceutical composition according to the invention
Step a: the method for preparing of Radix Paeoniae Alba extract: get Radix Paeoniae Alba 1333g and add 13330 milliliters, 10664 milliliters, 7998 milliliter 70% ethanol, heating and refluxing extraction three times, 1.5 hours time, 1 hour, 1 hour, merge extractive liquid; Filter, filtrate recycling ethanol is concentrated into dried; In 60 ℃ of following vacuum dryings, take out, pulverize; Cross 40 mesh sieves, must the dried cream of about 226g, subsequent use;
Step b: get Fructus Ligustri Lucidi 1111g and add 11110 milliliters, 8888 milliliter 80% ethanol, heating and refluxing extraction twice, 2 hours time, 1 hour, merge extractive liquid; Filter, filtrate recycling ethanol is concentrated at 1: 1 o'clock, and adding water to medical material content is 1: 2; Hold over night, centrifugal, get the deposition drying, pulverize; Cross 40 mesh sieves, must the dried cream of about 66g, subsequent use;
Step c: get Cortex Phellodendri 1111g and add 11110 milliliters, 8888 milliliters, 6666 milliliter 65% ethanol, heating and refluxing extraction three times, 1 hour time, 1 hour, 1 hour, merge extractive liquid; Filter, filtrate recycling ethanol is concentrated into dried; In 60 ℃ of following vacuum dryings, take out, pulverize; Cross 40 mesh sieves, must the dried cream of about 124g, subsequent use.
Steps d: add the about 83g of calcium hydrogen phosphate,, be sub-packed in 1000 capsules, promptly get with step a, b, the extract obtained mix homogeneously of c.
Embodiment 4: the granule preparation of pharmaceutical composition according to the invention
Step a: the method for preparing of Radix Paeoniae Alba extract: get Radix Paeoniae Alba 1333g and add 13330 milliliters, 10664 milliliters, 7998 milliliter 70% ethanol, heating and refluxing extraction three times, 1.5 hours time, 1 hour, 1 hour, merge extractive liquid; Filter, filtrate recycling ethanol is concentrated into dried; In 60 ℃ of following vacuum dryings, take out, pulverize; Cross 40 mesh sieves, must the dried cream of about 226g, subsequent use;
Step b: get Fructus Ligustri Lucidi 1111g and add 11110 milliliters, 8888 milliliter 80% ethanol, heating and refluxing extraction twice, 2 hours time, 1 hour, merge extractive liquid; Filter, filtrate recycling ethanol is concentrated at 1: 1 o'clock, and adding water to medical material content is 1: 2; Hold over night, centrifugal, get the deposition drying, pulverize; Cross 40 mesh sieves, must the dried cream of about 66g, subsequent use;
Step c: get Cortex Phellodendri 1111g and add 11110 milliliters, 8888 milliliters, 6666 milliliter 65% ethanol, heating and refluxing extraction three times, 1 hour time, 1 hour, 1 hour, merge extractive liquid; Filter, filtrate recycling ethanol is concentrated into dried; In 60 ℃ of following vacuum dryings, take out, pulverize; Cross 40 mesh sieves, must the dried cream of about 124g, subsequent use.
Steps d: add starch, dextrin,, promptly get with step a, b, the extract obtained granule of processing of c.
Embodiment 5: the observation of curative effect of Chinese medicine composition according to the invention
Chinese medicine composition according to the invention has liver and kidney tonifying; The effect that nourishing YIN for decreasing fever, relieving restlessness are calmed the nerves clinically is used to treat female climacteric syndrome; In order to verify its curative effect; For clinical trial provides foundation, we have carried out experimental study to the main pharmacodynamics of Chinese medicine composition according to the invention, the result are reported as follows at present:
1 test material
1.1 experimental animal
The Wistar rat, female; The KM mice, female; By Qingdao City's laboratory animal and zoopery center credit number is provided: SCXK (Shandong) 20030010.
1.2 test drug
Receive the reagent thing: Chinese medicine composition according to the invention, step a, b, the extract obtained mixture of c in the arbitrary example of embodiment 1-4.
Positive control drug: female precious ball, Tongrentang Pharmaceutical Factory, Beijing TongrenTang Co., Ltd, lot number 703505802.
2 contents of the test
2.1 Chinese medicine composition according to the invention is to the influence of castrated rats simulation female climacteric syndrome
2.1.1 animal divides into groups, administration
Getting 60 female rats anaesthetizes with pentobarbital sodium; Abdominal part carries out abdominal part up to be fixed; Skin and the about 1.5-2cm of dorsal muscles are cut in midaxillary line and the 2cm infall cropping apart from the spinal column outside under the most last rib of rat back, extract ovary behind the fallopian tube of ligation ovary lower end; Postoperative is with uterus angular convolution abdominal cavity, suture muscles and skin.Extract the opposite side ovary with quadrat method, inject 3 days penicillins continuously in case infect, postoperative beginning in the 5th day vaginal smear is observed the rat oestrous cycle, and continuous 5 days, the oestrous cycle (all being in diestrus) no longer occurring with rat be that castration is successful.Random packet is a model group, positive drug group and receive the large, medium and small dose groups of reagent, and 10/ group, other gets 10 female rats (not doing the castration operation) as the normal control group.Postoperative began by the gastric infusion of dosage shown in the table 1 on the 9th day; Wherein female precious ball is equivalent to 5 times of people's clinical application amount; The large, medium and small dosage of Chinese medicine composition according to the invention is equivalent to 10 times, 5 times, 2.5 times of people's clinical application amount respectively; Matched group and model group are irritated stomach equivalent ordinary water, 1 time/day, continuous 30 days.Each is organized the rat fasting and can't help water 12h and test to next day.
2.1.2 index determining
2.1.2.1 open wild movable observing
1h after each treated animal last administration observes rat autonomic activities situation to open wild test method(s), is about to each treated animal and places respectively
High 40cm; Length and width are 80cm, and perisporium is a black, and the bottom surface is divided into 25 that area equates with black line; Pass through bottom surface square number as the horizontal anomalous movement score with animal; As vertical activity score, every rat only carries out 1 time to be measured, each 3min recording level, vertical activity score with upright number of times.
2.1.2.2 hormone serum level and hypothalamus detect neurotransmitter and detect
The rat extracting blood separation of serum detects E2, FSH, LH, β-EP content in the serum to put the method for exempting from, and detects GSH-PX, SOD, MDA activity and content; Put to death rat and take off thalamus rapidly, detect E, NA, DA, 5-HT content in the neurotransmitter hypothalamus with high performance liquid chromatogram-electrochemical detection method.
2.1.3 result of the test
The result sees table 1-4.
Table 1 Chinese medicine composition according to the invention is opened the influence (
n=10) of wild test to castrated rats
Annotate: compare with matched group,
*P＜0.05,
*P＜0.01; Compare with model group,
△P＜0.05,
△ △P＜0.01.
The result shows that castration rat model horizontal anomalous movement increased frequency has significance meaning (P＜0.01) with normal control group difference, and vertical movable increasing do not have the significance meaning with normal control group difference; The female precious ball (positive drug) and the large, medium and small dose groups rat level of more relaxing, vertical activity do not have the significance meaning with normal control group difference.Positive drug, the large, medium and small dose groups rat of Chinese medicine composition according to the invention and model group comparison level are movable to be reduced, and positive drug, more relax in, the small dose group rat has significance meaning (distinguishing P＜0.05, P＜0.05, P＜0.01) with model group rat horizontal anomalous movement difference; Positive drug, the more easypro more vertical activity variance with model group of large, medium and small dose groups rat do not have the significance meaning.
Test shows, in the Chinese medicine composition according to the invention, low dose can significantly reduce castration rat model horizontal anomalous movement number of times, and the castration rat model is had sedation preferably.
Table 2 Chinese medicine composition according to the invention is to the influence (
n=10) of hormone in the castrated rats serum
Annotate: compare with the normal control group,
*P＜0.05,
*P＜0.01,
* *P＜0.001; Compare with model group,
△P＜0.05,
△ △P＜0.01,
△ △ △P＜0.001.
The result shows that castration model group rat and normal rats be serum estradiol (E relatively
2) the content minimizing, follicle stimulating hormone (FSH), the active increase of lutropin (LH), and significance meaning (P＜0.05, P＜0.01, P＜0.01 respectively) is all arranged; The positive drug and the large, medium and small dose groups rat E that more relaxes
2There is not the significance meaning with normal control group comparing difference; Chinese medicine composition according to the invention big or middle dose groups rat FSH and matched group compare, the active reduction, and difference has significance meaning (P＜0.01, P＜0.01 respectively); Large, medium and small dose groups rat LH of positive drug and Chinese medicine composition according to the invention and normal control group compare, and activity increases, and difference does not have significance meaning (P＜0.001, P＜0.05, P＜0.01, P＜0.01 respectively).Positive drug and the large, medium and small dose groups rat of Chinese medicine composition according to the invention E
2Compare with castration model group rat, content increases, and difference does not have significance meaning (all P＜0.05); More relax large, medium and small dose groups rat FSH and model group rat relatively, the active reduction, difference has significance meaning (P＜0.001, P＜0.001, P＜0.01 respectively); Large, medium and small dose groups rat LH of Chinese medicine composition according to the invention and model group rat are compared, the active reduction, and difference has significance meaning (all P＜0.01).
Test shows that Chinese medicine composition according to the invention can significantly increase castration rat model E
2Content reduces FSH, LH activity, and imbalance has a better role to castration rat model hormonal system.
Table 3 Chinese medicine composition according to the invention is to the influence (
n=10) of castrated rats serum free radical
Annotate: compare with the normal control group,
*P＜0.05,
*P＜0.01,
* *P＜0.001; Compare with model group,
△P＜0.05,
△ △P＜0.01,
△ △ △P＜0.001.
The result shows, castration rat model reduced glutathione (GSH-PX), the active reduction of superoxide dismutase (SOD), and malonaldehyde (MDA) content increases, but does not have the significance meaning with normal control group comparing difference; The large, medium and small dosage GSH-PX of positive drug and Chinese medicine composition according to the invention, SOD, MDA do not have the significance meaning with normal control group comparing difference.Large, medium and small dose groups rat of Chinese medicine composition according to the invention and model group compare, and the GSH-PX activity increases, and difference all has significance meaning (all P＜0.05); Dose groups rat and model group compare in the Chinese medicine composition according to the invention, and the SOD activity increases, and difference has significance meaning (P＜0.05); Large, medium and small dose groups rat of Chinese medicine composition according to the invention and model group compare, and MDA content reduces, and difference does not have the significance meaning.
Test shows; It is active that Chinese medicine composition according to the invention can significantly improve castrated rats GSH-PX; It is active that dosage can significantly improve castrated rats SOD in the Chinese medicine composition according to the invention; Chinese medicine composition according to the invention can reduce castration rat model MDA content, and castration rat model Radical Metabolism is had a better role.
Table 4 Chinese medicine composition according to the invention is to the influence (
n=10) of hormone in the castrated rats hypothalamus
| Group | Dosage/gkg -1 | ?N | E | NA | DA | 5-HT |
| Contrast | The equivalent ordinary water | 10 | 0.659±0.129 | 1.849±0.332 | 10.219±2.553 | 0.877±0.394 |
| Model | The equivalent ordinary water | 10 | 0.644±0.176 | 2.170±0.513 | 9.677±1.767 | 0.978±0.247 |
| Female precious ball | 0.533 | 10 | 0.706±0.185 | 2.379±0.497 | 10.844±2.293 | 0.799±0.230 |
| Heavy dose of | 5.333 | 10 | 0.717±0.202 | 2.556±0.173 | 10.176±1.876 | 0.853±0.264 |
| Middle dosage | 2.667 | 10 | 0.675±0.157 | 2.452±0.476 | 10.072±2.270 | 0.874±0.227 |
| Low dose of | 1.333 | 10 | 0.653±0.127 | 2.257±0.377 | 11.182±2.586 | 0.870±0.306 |
Annotate: compare with the normal control group,
*P＜0.05,
*P＜0.01,
* *P＜0.001; Compare with model group,
△P＜0.05,
△ △P＜0.01,
△ △ △P＜0.001.
The result shows that castration model group rat hypothalamus neurotransmitter epinephrine (E), dopamine (DA) content reduce, and norepinephrine (NA), serotonin (5-HT) content increase, and do not have the significance meaning with normal control group comparing difference.Positive drug and the large, medium and small dose groups of Chinese medicine composition according to the invention and model group comparison E, NA, DA increase, and serotonin (5-HT) content reduces, difference there are no significant meaning.
More than test shows; Chinese medicine composition according to the invention can be regulated and improve female climacteric syndrome model (castration) rat endocrine; Improve the rat model estrogen level, effectively remove the rat model interior free yl, and the hypothalamus neurotransmitter is had certain influence; Also have sedation preferably, can effectively improve the female climacteric syndrome symptom.
2.2 Chinese medicine composition according to the invention is to the influence of castration mouse sedation
2.2.1 Chinese medicine composition according to the invention is to the influence of castration female mice autonomic activities
2.2.1.1 animal divides into groups, administration
Get 60 female KM mices and anaesthetize, shave off dorsal body setae (spine portion after the rib), sterilization skin with pentobarbital sodium; On the sarolemma of ovary portion, do a little otch, take out ovary with the ophthalmology tweezers then, with silk thread ligation and excision; Suture muscles and skin are coated with iodine tincture, extract the opposite side ovary with quadrat method; 3 days penicillins of injection are in case infect postoperative beginning in the 5th day vaginal smear observation mice oestrous cycle, continuous 5 days continuously; Not having oestrous cycle variation person fully with the mouse ovarian excision is that castration is qualified, chooses the castration eligible and is used for test.Random packet is a model group, positive drug group and receive the large, medium and small dose groups of reagent, and 10/ group, other gets 10 female mices (not doing the castration operation) as the normal control group.Postoperative began by the gastric infusion of dosage shown in the table 4 on the 9th day; Wherein female precious ball is equivalent to 10 times of people's clinical application amount; The large, medium and small dosage of Chinese medicine composition according to the invention is equivalent to 20 times, 10 times, 5 times of people's clinical application amount respectively; Normal control group and model group are irritated stomach equivalent ordinary water, 1 time/day, continuous 10 days.Each is organized rat diet drinking-water and is not limit.
2.2.1.2 index determining
Each treated animal is 1h after the last administration, places the free movable appearance of ZYC-1 type respectively, behind the adaptation 3min, and movable number of times in the record 5min.
2.2.1.3 result of the test
The result sees table 5.
Table 5 Chinese medicine composition according to the invention is to the influence (
n=10) of castration mouse autonomic activities
| Group | Dosage/gkg -1 | Number of animals | Autonomic activities number/inferior |
| Normal control | The equal-volume ordinary water | 10 | 512.6±130.142 |
| Model | The equal-volume ordinary water | 10 | 560.3±152.504 |
| Female precious ball | 16.667 | 10 | 548.5±164.335 |
| Heavy dose of | 10.667 | 10 | 417.0±20.460 △ |
| Middle dosage | 5.333 | 10 | 491.3±144.092 |
| Low dose of | 2.667 | 10 | 456.5±200.534 |
Annotate: compare with the normal control group,
*P＜0.05,
*P＜0.01,
* *P＜0.001; Compare with model group,
△P＜0.05,
△ △P＜0.01,
△ △ △P＜0.001.
The result shows that castration model mice autonomic activities increases, but compares with the normal control group, and difference does not have the significance meaning; The large, medium and small dose groups mice of Chinese medicine composition according to the invention autonomic activities reduces, and Chinese medicine composition according to the invention heavy dose organizes mice autonomic activities number of times and model group compares, and difference has significance meaning (P＜0.05).
The result shows that Chinese medicine composition heavy dose according to the invention can significantly reduce castration mouse autonomic activities number of times, and sedation is preferably arranged.
2.2.2 Chinese medicine composition according to the invention is to the influence [4] of pentobarbital sodium subliminal hypnosis castration model mice sleep
2.2.2.1 animal divides into groups, administration
Get 60 female KM mice spays, vaginal smear is removed 50 random packet administrations of gesture success mice to confirm castration success (same 2.2.1); Other gets 10 female mices (not doing the castration operation) as the normal control group; By body weight it is divided into 6 groups (same 2.2.1) at random, each organizes mouse stomach administration (the same 2.2.1 of dosage), and the normal control group is irritated stomach equivalent ordinary water; Irritate stomach every day 1 time, continuous 10 days.Water is can't help in fasting before the last administration.
2.2.2.2 index detects
1h after the last administration, lumbar injection 35mgkg at once
-1Pentobarbital sodium places mice on 37 ℃ of warm hot plates and to observe, and allly positive and negative areflexia in 30min, occurs and reaches the above person of 1min and promptly sleep, and the number of mice sleep respectively organized in record.
2.2.2.3 result of the test
The result sees table 6.
Table 6 Chinese medicine composition according to the invention to castration model mice subliminal hypnosis sleep influence
| Group | Dosage/gkg -1 | Number of animals/only | The sleep number/only |
| Normal control | The equal-volume ordinary water | 10 | 3 |
| Model | The equal-volume ordinary water | 10 | 1 |
| Female precious ball | 16.667 | 10 | 2 |
| Heavy dose of | 10.667 | 10 | 4 |
| Middle dosage | 5.333 | 10 | 7△ |
| Low dose of | 2.667 | 10 | 3 |
Annotate: compare with the ordinary water group,
△P＜0.05.
The result shows that dose groups and model group compare in the Chinese medicine composition according to the invention, and the mice sleep number of elements increases, and difference has the significance meaning.
The result shows that dosage has better sedative-hypnotic effect to castration mouse in the Chinese medicine composition according to the invention.
2.3 the test of Chinese medicine composition memory function according to the invention
2.3.1 Chinese medicine composition according to the invention causes the influence of mouse memory acquired disturbance to scopolamine
2.3.3.1 animal divides into groups, administration
Get 60 of female KM mices, body weight (20 ± 2) g is divided into normal control group, model group, positive drug group at random and receives the large, medium and small dose groups of reagent by body weight; 10/; Each treated animal gastric infusion (the same 2.2.1 of dosage), normal control group and model group are irritated stomach equivalent ordinary water, 1 time/d; Continuous 10 days, each was organized mice diet drinking-water and is not limit.
2.3.3.2 index determining
Each treated animal respectively at the last administration after 1h, all the other respectively organize mouse stomach scopolamine 3mg/kg except that normal group, carry out diving tower training behind the 10min; Adapt to 3min, training 5min tests behind the 24h again; Mice is placed on the diving tower wrong in the record 5min (coming) number of times from diving tower.
2.3.3.3 result of the test
The result sees table 7.
Table 7 Chinese medicine composition according to the invention causes the influence
of mouse memory acquired disturbance to scopolamine
| Group | Dosage/gkg -1 | Number of animals/only | Errors number |
| Normal control | The equal-volume ordinary water | 10 | 0.3±0.675 |
| Model | The equal-volume ordinary water | 10 | 1.0±0.816 |
| Female precious ball | 16.667 | 10 | 0.8±1.135 |
| Heavy dose of | 10.667 | 10 | 0.6±0.699 |
| Middle dosage | 5.333 | 10 | 0.5±0.527 |
| Low dose of | 2.667 | 10 | 0.4±0.516 |
Annotate: compare with the normal control group,
*P＜0.05,
*P＜0.01,
* *P＜0.001; Compare with model group,
△P＜0.05,
△ △P＜0.01,
△ △ △P＜0.001.
The result shows that the model group mouse wrong times increases, but compares with the normal control group, and difference does not still have the significance meaning, and each administration group mice and model group comparison error number of times reduce, and difference does not still have the significance meaning.
The result shows that Chinese medicine composition according to the invention causes the mouse memory obstacle to scopolamine and has some improvement.
2.3.2 Chinese medicine composition according to the invention is to the influence of castration mouse learning and memory function
2.3.2.1 animal divides into groups, administration
Get 50 of female KM mices, body weight (20 ± 2) g, the castration modeling is the same; Inspection castration eligible is used for test, is divided into model group, positive drug group at random and receives the large, medium and small dose groups of reagent, 10/ by body weight; Other gets 10 female mices (not doing the castration operation) and does the normal control group, and in postoperative beginning in the 9th day administration, dosage is with same 2.2.1; 1 time/day, continuous 10 days, each was organized mice diet drinking-water and is not limit.
2.3.2.2 index determining
Each treated animal is trained before respectively at the last administration, and test memory achievement behind the administration 24h is surveyed and jumped off platform for the 1st time and starve the errors number in incubation period and the 5min.
2.3.2.3 result of the test
The result sees table 8.
Table 8 Chinese medicine composition according to the invention is to the influence
of castration mouse memory function
| Group | Dosage/gkg -1 | Number of animals/only | Errors number |
| Normal control | The equal-volume ordinary water | 10 | 0.2±0.422 |
| Model | The equal-volume ordinary water | 10 | 1.1±0.994 * |
| Female precious ball | 16.667 | 10 | 0.3±0.483△ |
| Heavy dose of | 10.667 | 10 | 0.8±0.632 * |
| Middle dosage | 5.333 | 10 | 0.6±0.699 |
| Low dose of | 2.667 | 10 | 0.3±0.483 △ |
Annotate: compare with the normal control group,
*P＜0.05,
*P＜0.01,
* *P＜0.001; Compare with model group,
△P＜0.05,
△ △P＜0.01,
△ △ △P＜0.001.
The result shows that castration model mice errors number increases, and normal matched group difference has significance meaning (P＜0.05); Chinese medicine composition small dose group mouse wrong times according to the invention reduces than model group, and difference has significance meaning (P＜0.05).
The result shows that Chinese medicine composition low dose according to the invention can significantly be improved castration model mice memory function.
2.4 Chinese medicine composition according to the invention causes the influence of mice interior-heat caused by deficiency of YIN model to warm drugs
2.4.1 animal grouping, modeling, administration
Get 60 of female KM mices; Body weight (20 ± 2) g is normal control group, model group, positive drug group with its random packet and receives the large, medium and small dose groups of reagent Chinese medicine composition according to the invention by body weight, except that the normal control group, respectively organizes mouse stomach and gives the warm drugs modeling; Dosage is 0.2ml/10g; The normal control group is irritated stomach equivalent ordinary water, irritates stomach every day 1 time, continuous 2 weeks.Each organizes the mice gastric infusion same period (the same 2.1.1 of dosage), and normal control group, model group are irritated stomach equivalent ordinary water, irritate stomach every day 1 time, and in continuous 2 weeks, each is organized mice diet drinking-water and does not limit.
2.4.2 index detects
Each treated animal is 1h after the last administration, and surveying record mouse temperature (anus temperature) places the free movable appearance of ZYC-1 type then respectively, behind the adaptation 3mi n, and movable number of times in the record 5min.
2.4.3 result of the test
The result sees table 9.
Table 9 Chinese medicine composition according to the invention is to the influence
of interior-heat caused by deficiency of YIN model mice
| Group | Dosage/gkg -1 | Number of animals | Autonomic activities number of times/inferior | Body temperature/℃ |
| Normal control | The equal-volume ordinary water | 10 | 788.3±151.950 | 38.220±0.238 |
| Model | The equal-volume ordinary water | 10 | 833.0±128.961 | 38.473±0.272 * |
| Female precious ball | 16.667 | 10 | 780.7±158.139 | 38.022±0.338 △△ |
| Heavy dose of | 10.667 | 10 | 722.5±141.945 | 38.173±0.324 △ |
| Middle dosage | 5.333 | 10 | 705.1±140.203 △ | 37.778±0.505 *△△ |
| Low dose of | 2.667 | 10 | 720.2±108.881 △ | 37.842±0.529 △△ |
Annotate: compare with the normal control group,
*P＜0.05,
*P＜0.01,
* *P＜0.001; Compare with model group,
△P＜0.05,
△ △P＜0.01,
△ △ △P＜0.001.
The result shows that normal control group relatively interior-heat caused by deficiency of YIN model mice autonomic activities number of times increases, no significance meaning, and fervescence, difference has significance meaning (P＜0.05); Positive drug and the large, medium and small dose groups mice of Chinese medicine composition according to the invention autonomic activities reduce, and difference does not have the significance meaning, and dosage body temperature reduces in the Chinese medicine composition according to the invention, and difference has significance meaning (P＜0.05).Compare with model group, positive drug and the large, medium and small dose groups mice of Chinese medicine composition according to the invention autonomic activities reduce, and difference does not have the significance meaning, and body temperature reduces, and difference has significance meaning (P＜0.01, P＜0.05, P＜0.01, P＜0.01 respectively).
The result shows that Chinese medicine composition according to the invention can reduce warm drugs interior-heat caused by deficiency of YIN model mice autonomic activities number of times, significantly reduces the interior-heat caused by deficiency of YIN mouse temperature, and the interior-heat caused by deficiency of YIN model mice is had treatment preferably.
2.5 influence to rat sweat gland secretion due to the PILO
2.5.1 animal divides into groups, administration
Get 50 of Wistar rats, female, body weight (200 ± 20) g; Be divided into ordinary water group, positive drug group and the large, medium and small dose groups of Chinese medicine composition according to the invention, 10 every group, gastric infusion at random by body weight; The same 2.1.1 of dosage; The ordinary water group is irritated stomach equivalent ordinary water, and continuous 10 days, each treated animal diet water inlet was not limit.
2.5.2 index detects
30min after the last administration, each organizes rat skin lower injection pilocarpine 3.5mg100g
-1, behind the 30min, each group rat paw portion is wiped away with dried cotton swab gently dried, after rat paw skin is coated and field-Gao wall reagent A liquid, is to be dried, very thin again coating and field-Gao wall reagent B liquid, every then 10mi n observed and recorded antiperspirant is counted 1 time, observes 30min altogether.
2.5.3 date processing
Data result is represented with
; Carry out statistical analysis with the SPSS11.5 statistical software; T check between group, the comparing difference significance.
2.5.4 result of the test
The result sees table 10.
Table 10 Chinese medicine composition according to the invention causes the influence
of rat sweat secretion to pilocarpine
Annotate: compare with the ordinary water group,
*P＜0.05,
*P＜0.01,
The result shows that the big or middle dose groups rat of Chinese medicine composition according to the invention antiperspirant is counted and reduced than the ordinary water group, and difference has significance meaning (all P＜0.05).
The result shows that the big or middle dosage of Chinese medicine composition according to the invention causes the rat diaphoresis to pilocarpine has anti-hidropoiesis preferably.
The above only is a preferred implementation of the present invention; Should be pointed out that for those skilled in the art, under the prerequisite that does not break away from the principle of the invention; Can also make some improvement and retouching, these improvement and retouching also should be regarded as protection scope of the present invention.
Claims (4)
1. a Chinese medicine composition of treating climacteric syndrome is characterized in that, its raw material consists of: the Radix Paeoniae Alba 1000～1600 weight portions, Fructus Ligustri Lucidi 800～1400 weight portions, Cortex Phellodendri 800～1400 weight portions; Prepare by following method: get 70% ethanol that the Radix Paeoniae Alba adds 10 times, 8 times, 6 times weight respectively; Reflux was extracted three times in 1.5 hours, 1 hour, 1 hour respectively, and merge extractive liquid, filters; Get filtrate recycling ethanol; Be concentrated into driedly,, pulverized 40 mesh sieves and get Radix Paeoniae Alba extract in 60 ℃ of following vacuum dryings; Get Fructus Ligustri Lucidi and add 10 times, 8 times weight 80% ethanol, reflux extracted twice, merge extractive liquid, in 2 hours, 1 hour respectively; Filter, filtrate recycling ethanol is concentrated into filtrate volume one half, thin up; The centrifuging and taking deposition is dry, pulverizes 40 mesh sieves and gets Fructus Ligustri Lucidi extract; Get Cortex Phellodendri and add 10 times, 8 times, 6 times weight 65% ethanol respectively, reflux 1 hour is extracted three times, and merge extractive liquid, filters and gets filtrate recycling ethanol, is concentrated into driedly, and 60 ℃ of following vacuum dryings were pulverized 40 mesh sieves and got Cortex Phellodendri extract; Said Radix Paeoniae Alba extract, Fructus Ligustri Lucidi extract, Cortex Phellodendri extract are mixed.
2. Chinese medicine composition according to claim 1 is characterized in that, its raw material consists of: the Radix Paeoniae Alba 1333 weight portions, Fructus Ligustri Lucidi 1111 weight portions, Cortex Phellodendri 1111 weight portions.
3. claim 1 or 2 described Chinese medicine compositions directly or indirectly add the clinical preparation that acceptable accessories is processed through conventional processing.
4. clinical preparation according to claim 3 is characterized in that said adjuvant comprises calcium hydrogen phosphate.
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