CN1432383A - New use of ledebouriella root - Google Patents
New use of ledebouriella root Download PDFInfo
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- CN1432383A CN1432383A CN 02110522 CN02110522A CN1432383A CN 1432383 A CN1432383 A CN 1432383A CN 02110522 CN02110522 CN 02110522 CN 02110522 A CN02110522 A CN 02110522A CN 1432383 A CN1432383 A CN 1432383A
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- ledebouriella root
- ledebouriella
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- Medicines Containing Plant Substances (AREA)
Abstract
The present invention relates to the new use of ledebouriella root in pharmaceutical industry, especially the application in preparing medicine for treating estrogen and progestogen disequilibrium relative diseases or symptoms. The medicine can be used for preventing or treating women's climacteric syndrome, menoxenia, dysmenorrhea, senile vaginitis, coronary heart disease, hypertension, hyperlipemia and other diseases.
Description
Technical field
The present invention relates to the new purposes of ledebouriella root, relate in particular to it in preparation treatment or prevention and estrogen, the medicine of progestogen dysequilibrium diseases associated symptom or the application in the health product.
Background technology
Wide Radix Saposhnikoviae Epimeredi indica (L.) Rothm-Anisomeles indica (L.) O.Ktze-A.ovata R.Brown extensively is distributed in provinces and cities such as the Jiangxi, Zhejiang, Fujian, Taiwan, Hunan, Guangdong of China, according to " Xinhua's book on Chinese herbal medicine outline " (first, Plant Research Inst., Jiangsu Prov. etc. write, Shanghai science tech publishing house publishes, front page in 1988, the 424th page.) record, functions such as wide Radix Saposhnikoviae is dispeled the wind, dehumidifies, detoxifcation.At present wide Radix Saposhnikoviae is applied to diseases such as treatment flu fever of the body, vomiting, stomachache, bones and muscles pain, skin infection, hemorrhoid.
But wide Radix Saposhnikoviae in preparation treatment or prevention and female, progestogen dysequilibrium diseases associated or the medicine of symptom or the application in the health product, is not appeared in the newspapers so far.
Summary of the invention
Scientific research for many years through the inventor finds that ledebouriella root has the effect that improves ovarian function and regulate estrogen and progestogen, therefore can both treat or prevent with female, that the progestogen dysequilibrium is relevant symptom and disease.
The object of the present invention is to provide a kind of new purposes of ledebouriella root, especially in preparation treatment, prevention and estrogen, progestogen dysequilibrium diseases associated, the medicine of symptom or the application in the health product.
Another object of the present invention is to, provide ledebouriella root in preparation treatment or the medicine of prevention climacteric syndrome or the application in the health product.
Another object of the present invention is to, provide ledebouriella root in preparation treatment or the medicine of prevention menoxenia or the application in the health product.
Another object of the present invention is to, provide ledebouriella root in preparation treatment or prevention of miscarriage, the medicine of habitual abortion or the application in the health product.
Another object of the present invention is to, provide ledebouriella root in preparation treatment or the medicine of prevention senile vaginitis or the application in the health product.
Another object of the present invention is to, provide ledebouriella root in the application of postponing aspect climacteric women menopause, the sexual function improving.
Another object of the present invention is to, provide ledebouriella root in the application aspect climacteric women hair growth promoting skin care, slow down aging.
Another object of the present invention is to, provide ledebouriella root in preparation treatment or the medicine of prevention of osteoporosis, senile vaginitis coronary heart disease and hyperlipidemia or the application in the health product.
Ledebouriella root of the present invention is the live part of a kind of plant, preparation process according to routine, can be based on ledebouriella root, add excipient substances such as conventional excipient, flavoring agent, disintegrating agent, antiseptic, lubricant, wetting agent, binding agent, solvent, thickening agent, solubilizing agent, make any dosage form that is suitable for using clinically, as various dosage forms such as decoct, extractum (powder), granule, tablet or capsules.
Certainly, also can prepare according to following method:
1. preparation decoct.Get ledebouriella root 50 grams, clean, section adds 10 times amount clear water, boils 1 hour, and it is standby to pour out medicinal liquid; Medicinal residues are added 8 times of amount clear water again boiled 1 hour, pour out medicinal liquid.Twice medicinal liquid merges about 500 milliliters of back, and it is oral to make decoct.Every days 100, microlitre divided to take for 5 times.
2. it is an amount of to get ledebouriella root, adds 10 times of amount clear water and boils 1.5 hours, and medicinal liquid is standby, and medicinal residues add 8 times of water gagings, boil 1 hour, get its medicinal liquid, twice medicinal liquid merged, and at 60 ℃ of drying under reduced pressure, 60 ℃ of reclaim under reduced pressure, the extractum that obtains doing.
3. get extract powder after above-mentioned extractum being pulverized.
4. above-mentioned extract powder is added adjuvants such as dextrin, starch and mix thoroughly, granulate then, quality inspection after drying bag distribution packaging is made finished products such as granule, tablet or capsule.
Because the present invention discloses ledebouriella root first in preparation treatment or prevention and the medicine of estrogen, progestogen dysequilibrium diseases associated or symptom or the application in the health product; therefore ledebouriella root is cooperated medicine or the health product of making separately or with other active component or adjuvant; as long as this medicine or health product are used for the treatment of or prevention and estrogen, progestogen dysequilibrium diseases associated or symptom all belongs to protection scope of the present invention.
Effect of the present invention:
1. ledebouriella root can delay the ovary aging, improves ovarian function, improves body inner estrogen level.
Ledebouriella root is to mice of extracing ovary and the patient invalid (but still effective to part or most of excision person) that ovary is cut entirely.After the medication, ovary can promote estrogen secretion according to self needs of body, improves estrogen level, and compares from the method for external complementing estrogen merely, meets climacteric women physiology more.
2. ledebouriella root can promote body to secrete female, pregnant two kinds of hormones simultaneously.
With put the method for exempting from measure medication before and after variations female, progestogen can find: ledebouriella root also improves the content of progestogen promoting that body improves the estrogenic while, and learns by statistics and handle, and significant difference (P＜0.05) is arranged.Because body can be according to estrogenic variation, at any time produce corresponding progestogen, solved clinically and in using the estrogen process, often needed to add the problem that an amount of progestogen prevent the endometrium canceration, do not need during the medication to follow up a case by regular visits to closely and monitor, make doctor and patient all relieved, accepted by vast climacteric women easily.
3. ledebouriella root has the estrogen-like effect fully.
Ledebouriella root can make the ovary, the uterus weight that have not had the person in middle and old age of fertility female mice increase; The vagina keratinocyte increases, the perineum flushing, and oestrus is obvious; Estradiol, progesterone levels increase in the blood; Endometrium is hypertrophy and sexually revises.And along with dosage continues to increase, its performance is also obvious more, demonstrates tangible dose-effect relationship.
4. ledebouriella root is without any side effects
In acute toxinology experiment, when the half lethal dose of being tried mice (LD50)＞80g/kg, do not find dead mouse.In " teratogenesis " test of " three cause " test, after giving the maximal dose nursing, ledebouriella root not only has no effect to the fetus of being tried mice, and can also help embryo growth and development.
5. can be used for treatment needs to use estrogen, but the patient of hormone contraindication is arranged
In climacteric women, there is quite a few people to suffer from hysteromyoma, hypertension, hyperlipidemia, diabetes, hepatopathy, cerebrovascular accident etc.This class patient should not use the estrogens preparation, but but when needing estrin treatment, it is at a loss what to do that the doctor often feels.The appearance of ledebouriella root medicine, for this class patient provide one new, treat approach safely and effectively.
The specific embodiment
With specific embodiment the present invention is described below, following embodiment further specifies and explains of the present invention, is not used for limiting the present invention.
Embodiment 1
One, material
1, tried thing: contain the ledebouriella root decoct of chicken juice and do not contain the ledebouriella root water decoction of chicken juice, content is 10g/100ml, is provided lot number by consigner trustee Huang Huan: 980501.In the experiment, will contain the ledebouriella root decoct simmer down to of chicken juice: 250g/100ml, 125g/100ml, three concentration of 62.5g/100ml will not contain the ledebouriella root water decoction simmer down to 125g/100ml of chicken juice; Estradiol benzoate, available from commercially available estradiol benzoate, content is 2mg/ml, is produced lot number: 971101 by Shanghai the 9th pharmaceutical factory.In the experiment, be 100 μ g/ml with exquisite oil dilution.
2, animal: the Kunming kind, stopped breeding female kind of mice, body weight 44 ± 3.6g is provided by laboratory animal portion of Shanghai Medical Univ.
Two, method
Get 60 of female mices, be divided into six groups at random, 10 every group, and establish positive controls and negative control.Positive controls subcutaneous injection estradiol benzoate, (People's Health Publisher (second edition) p1286) is 2 μ g/ to the dosage reference literature for Xu Shuyun etc., " pharmacological experimental methodology ", and negative control group gives distilled water and irritates stomach, capacity 0.2ml/10g.Become four dosage groups for the ledebouriella root component, promptly contain chicken juice three dosage of ledebouriella root decoct (12.5g/kg, 25g/kg, 50g/kg) and do not contain the dosage (25g/kg) of chicken juice ledebouriella root water decoction, capacity 0.2ml/10g gives ledebouriella root five days continuously.Observe the mouse vagina keratinocyte once every morning during giving ledebouriella root, to the 6th day (promptly give for the 5th time ledebouriella root after 24 hours), put to death mice, dissect, observe uterus and ovary, and weigh, the genitals is carried out pathologic finding, get blood 1ml by eyeball of mouse simultaneously, with the level of radioimmunity hormone determination estradiol and progesterone.
Three, result
Negative control, positive controls and four see Table 1 to ledebouriella root group vagina keratinocyte smear observed result; The weight ratio of uterus and ovary sees Table 2; The level of serum estradiol and progesterone sees Table 3; Body weight change sees Table 4; Uterus and ovary pathology survey report are seen Table 5.
Four, the result shows
1. the observation by the diagonalization cell, find to give behind three dosage of ledebouriella root decoct the 4th, the 5th day, the Keratinocytic mice number in the full visual field is obviously more than negative control group, and the mice perineum presents flushing, indivedual mouse vagina mouths are crack, and oestrus, symptom was obvious.
2. as seen from Table 2, except that low dose, the t check of uterus weight mean through between group of middle dosage group and heavy dose of group and positive controls is significantly higher than negative control group (P＜0.05 or P＜0.01), and the ovary weight of heavy dose group and positive controls is also obviously greater than negative control group (P＜0.05).
3. in to estradiol in the mice blood and progesterone level mensuration, compare with negative control group, to estrogen level is rarely seen increase trend is arranged, but do not have notable difference with the ledebouriella root group.To progesterone level, in containing the ledebouriella root of chicken juice, high dose group all reaches significance level (P＜0.05).
4. genitals's pathological anatomy is found, increase with endometrium of mouse body of gland number behind the ledebouriella root, local body of gland increases, and the body of gland epithelial nucleus increases, and multiple layer is arranged, Interstitial cell increases, the number that changes along with the increase mouse propagation organ of dosage is 2/10,4/10, and 8/10 ratio increases, dosage and have the middle dosage situation of chicken juice suitable in the no chicken juice, positive controls is 9/10.
5. in the experimentation, each organizes the mice body weight does not have obvious change.
Five, conclusion
By above experiment, we find to contain the ledebouriella root decoct of chicken juice through irritating three kinds of dosage (12.5g/kg of stomach, 25g/kg and 50g/kg) with do not contain a dosage of ledebouriella root water decoction (25g/kg) of chicken juice after, the keratinocyte in the female mice vagina significantly increases; The uterus, the weight of ovary has tangible increase, check through pathological section, find that the endometrial gland number increases, local body of gland increases and body of gland epithelium nucleus number increases, in each dosage group, along with degree endometrial hyperplasia phenomenon has from small to large appearred in the increase of dosage, and show dose-effect relationship, and the endometrial hyperplasia phenomenon also appears in no chicken group part mice, and the pathomorphism and the positive controls of endometrial hyperplasia are basic identical; In the mensuration to serum estrogen and progestogen, its estrogen level has increase trend, but does not have the significance difference; And progesterone level is in containing the ledebouriella root of chicken juice, and high dose group significantly increases (P＜0.05).
Mice keratinocyte situation of change during table 1 administration
I: keratinocyte is counted 0-50; II: keratinocyte is counted 50-100; III: keratinocyte is counted 100-150; IV: keratinocyte is several more than 150.Table 2 ledebouriella root is to the influence of Mouse Uterus and ovary
Annotate: with the influence of t check and negative control group comparison sheet 3 ledebouriella roots estrogen and progesterone hormone
Annotate: with the influence of t check and negative control group comparison sheet 4 ledebouriella roots the mice body weight
| Group | Uterus g/100g | Ovary g/100g | ???????????P | |
| The uterus | Ovary | |||
| ??12.5g/kg | ??0.38±0.11 | ??0.06±0.011 | ||
| ??25g/kg | ??0.45±0.14 | ??0.062±0.02 | ??P＜0.05 | |
| ??50g/kg | ??0.53±0.12 | ??0.076±0.03 | ??P＜0.01 | ??P＜0.05 |
| 25vg/kg (no chicken juice) | ??0.40±0.07 | ??0.06±0.02 | ??P＜0.01 | |
| Positive control | ??0.43±0.09 | ??0.061±0.009 | ??P＜0.01 | ??P＜0.05 |
| Negative control | ??0.31±0.062 | ??0.049±0.009 | ||
| Group | ?????????????N＝10 | ?????????????P | ||
| Estradiol | Progesterone | Estradiol | Progesterone | |
| ??12.5g/kg | 82.9±20 | ??2.56±2.68 | ||
| ??25g/kg | 86.2±31 | ??3.4±1.9 | ??P＜0.05 | |
| ??50g/kg | 99.2±29 | ??3.7±2.1 | ??P＜0.05 | |
| 25g/kg (no chicken juice) | 94.6±37 | ??3.56±4.7 | ||
| Positive control | 103.9±33.8 | ??8.52±4.5 | ????P＜0.05 | ??P＜0.01 |
| Negative control | 85.1±20.7 | ??1.65±1.5 | ||
Table 5 ledebouriella root mouse experiment pathological replacement
The method of inspection: 10% formalin normal saline is fixed, paraffin section, HE dyeing, observation by light microscope.Pathological number group microscopy is negative 10 endometrium of mouse of 98001-as a result, the body of gland epithelial cell is cube, monolayer alignment, 98011 contrast bodies of gland are rounded or oval, and ovary is seen follicle and corpus luteum.
2/10 endometrium of mouse body of gland number increases, and local body of gland increases, body of gland 98012-
Low dose of epithelial nucleus increases, and multiple layer is arranged, and Interstitial cell increases, and arranges fine and close.98022
Ovary is seen follicle and corpus luteum.
4/10 endometrium of mouse body of gland number increases, and local body of gland increases, body of gland 98023-
Middle dosage epithelial nucleus increases, and part body of gland epithelial cell is column, and multiple layer arranges 98033
Interstitial cell increases, and arranges fine and close.Ovary is seen follicle and corpus luteum.
8/10 endometrium of mouse body of gland number increases, and local body of gland increases, and body of gland 98034-epithelial nucleus increases, and the part glandular epithelium is column, and multiple layer is arranged,
Heavy dose of 98043 Interstitial cells increase, and arrange fine and close.Ovary is seen follicle and corpus luteum.One little
The ovarian medulla proliferation of fibrous tissue of Mus.
4/10 endometrium of mouse body of gland number increases, and local body of gland increases, and body of gland 98044-does not have chicken
Epithelial nucleus increases, and the part glandular epithelium is column, and multiple layer is arranged, dosage in 98054
Interstitial cell increases, and arranges fine and close.Ovary is seen follicle and corpus luteum.
9/10 endometrium of mouse body of gland number increases, and local body of gland increases, the body of gland 98055-positive
Epithelial nucleus increases, and nuclear arrangement is tight and be multiple layer, and Interstitial cell increases 98065 contrasts
Many, arrange fine and close.Ovary is seen follicle and corpus luteum.
Conclusion: in each dosage group, along with degree endometrial hyperplasia phenomenon has from small to large appearred in the increase of dosage, the endometrial hyperplasia phenomenon also appears in no chicken group part mice, and the pathomorphism and the positive controls of endometrial hyperplasia are basic identical.
Embodiment 2
One, material:
1, tried thing: ledebouriella root extractum and three kinds of extracts.Ledebouriella root extractum (powder) is provided by consigner trustee Huang Huan, is made into 0.5g/ml in the use; Water solublity ledebouriella root (powder accounts for extractum 68.5%) is made into 0.34g/vml in using; Alcohol dissolubility ledebouriella root (viscous solution accounts for extractum 28.2%) is made into 0.144g/ml in the use; Ester dissolubility ledebouriella root (70% solution accounts for extractum 3.2%) is made into 0.023g/ml in the use; Water-soluble ledebouriella root, pure molten ledebouriella root and the molten ledebouriella root of ester in use dissolve with 0.5%CMC; Estradiol benzoate, available from commercially available estradiol benzoate, content is 2mg/ml, is produced lot number: 000202 by Shanghai the 9th pharmaceutical factory.In the experiment, be 100 μ g/ml with the oil dilution.
2, animal: the Kunming kind, stopped breeding female kind of mice, body weight 47.0 ± 4.5g is provided by laboratory animal portion of Fudan University.
Two, method
Observe the mouse vagina smear every day before the administration, continuous five days, rejects the female Mus that obvious reflection in rutting period is arranged.Get 100 of female mices, be divided into 10 groups at random, 10 every group, and establish positive controls and negative control.Positive controls subcutaneous injection estradiol benzoate, (People's Health Publisher (second edition) p1286) is 2 μ g/ to the dosage reference literature for Xu Shuyun etc., " pharmacological experimental methodology ", and negative control group gives 0.5%CMC and irritates stomach, capacity 0.1ml/10g.Ledebouriella root extractum, water-soluble ledebouriella root, pure molten ledebouriella root, the molten ledebouriella root of ester respectively becomes into two dosage groups, be heavy dose of group of ledebouriella root extractum and small dose group (5g/kg, 2.5g/kg), heavy dose of group of water-soluble ledebouriella root and small dose group (3.4g/kg, 1.7g/kg), heavy dose of group of the molten ledebouriella root of alcohol and small dose group (1.44g/kg, 0.72g/kg), heavy dose of group of the molten ledebouriella root of ester and small dose group (0.16g/kg, 0.08g/kg).Heavy dose of gastric capacity 0.1ml/10g that irritates, low dose of gastric capacity 0.05ml/10g, the successive administration five days of irritating.Observe the mouse vagina keratinocyte once every morning during the administration, to the 6th day (promptly give for the 5th time ledebouriella root after 24 hours), puts to death mice, dissects, and observes the uterus, and weigh.
Three, result
Negative control, positive controls and ledebouriella root extractum group, water-soluble ledebouriella root group, pure molten ledebouriella root group, the molten ledebouriella root group of ester.The weight ratio in uterus sees Table 6; Vagina keratinocyte smear observation structure sees Table 7.
The result shows:
1. as seen from Table 6, ledebouriella root extractum group, heavy dose in the molten ledebouriella root group of alcohol, the t check that reaches uterus weight mean through between group of positive controls is significantly higher than negative control group (P＜0.05 or P＜0.01), and water-soluble ledebouriella root group is compared no significant difference with the molten ledebouriella root group of ester with negative control group.
2. by the observation of diagonalization cell, find to give ledebouriella root extractum, behind the pure molten ledebouriella root dosage, expire the Keratinocytic mice number in the visual field obviously more than negative control group, Keratinocytic continuing to increase, and the mice perineum presents flushing, indivedual mouse vagina mouths are crack, and oestrus, symptom was obvious.See Table 7.
3. in the experimentation, each organizes the mice body weight does not have obvious change.
Four, conclusion
By above experiment, we find ledebouriella root extractum through irritate two kinds of dosage of stomach (5g/kg, 2.5g/kg) with pure molten ledebouriella root (1.44g/kg) after, the keratinocyte in the female mice vagina significantly increases; The weight in uterus has tangible increase, in extractum dosage group and pure molten ledebouriella root group, along with the enlarged uterus weight of dosage also along with increase, and show dose-effect relationship.
Table 6 ledebouriella root is to the influence of Mouse Uterus
Annotate: with the mice keratinocyte situation of change (n=10) after t check and 7 administrations of negative control group comparison sheet
I: keratinocyte is counted 0-50; II: keratinocyte is counted 50-100; III: keratinocyte is several more than 150.
| Group | Uterus weight g/100g | ????P＜ | ????P＞ | |
| The extractum ledebouriella root | ??5g/kg | ?0.448±0.12 | ????0.05 | |
| ??2.5g/kg | ?0.415±0.0702 | ????0.05 | ||
| Water-soluble ledebouriella root | ??3.4g/kg | ?0.387±0.0763 | ????0.05 | |
| ??1.7g/kg | ?0.400±0.121 | ????0.05 | ||
| The molten ledebouriella root of alcohol | ??1.44g/kg | ?0.442±0.13 | ????0.05 | |
| ??0.72g/kg | ?0.351±0.124 | ????0.05 | ||
| The molten ledebouriella root of ester | ??0.16g/kg | ?0.402±0.12 | ????0.05 | |
| ??0.08g/kg | ?0.388±0.135 | ????0.05 | ||
| Negative control | ?0.318±0.0847 | |||
| Positive control | ?0.548±0.0728 | ????0.01 | ||
| Group | ???D1 | ????D2 | ???D3 | ???D4 | ???D5 | Sum | ||
| Ledebouriella root extractum | 5g/kg | ????I | ????5 | ????4 | ????3 | ????5 | ????4 | ????21 |
| ????II | ????3 | ????3 | ????4 | ????3 | ????3 | ????16 | ||
| ????III | ????0 | ????1 | ????0 | ????0 | ????0 | ????1 | ||
| 2.5g/k ???g | ????I | ????4 | ????5 | ????4 | ????5 | ????3 | ????21 | |
| ????II | ????2 | ????2 | ????4 | ????2 | ????2 | ????12 | ||
| ????III | ????0 | ????0 | ????0 | ????1 | ????1 | ????2 | ||
| Water-soluble ledebouriella root | 3.4g/k ???g | ????I | ????4 | ????5 | ????5 | ????2 | ????5 | ????21 |
| ????II | ????1 | ????1 | ????1 | ????3 | ????0 | ????6 | ||
| ????III | ????0 | ????0 | ????1 | ????0 | ????0 | ????1 | ||
| 1.7g/k ???g | ????I | ????2 | ????5 | ????4 | ????3 | ????3 | ????17 | |
| ????II | ????1 | ????1 | ????2 | ????4 | ????2 | ????10 | ||
| ????III | ????0 | ????0 | ????0 | ????1 | ????0 | ????1 | ||
| The molten ledebouriella root of alcohol | 1.44g/ ???kg | ????I | ????5 | ????6 | ????3 | ????7 | ????8 | ????29 |
| ????II | ????3 | ????1 | ????3 | ????0 | ????0 | ????7 | ||
| ????III | ????0 | ????0 | ????0 | ????0 | ????1 | ????1 | ||
| 0.72g/ ???kg | ????I | ????7 | ????5 | ????4 | ????8 | ????6 | ????30 | |
| ????II | ????0 | ????1 | ????3 | ????1 | ????1 | ????6 | ||
| ????III | ????0 | ????0 | ????0 | ????1 | ????0 | ????1 | ||
| The molten ledebouriella root of ester | 0.16g/ ???kg | ????I | ????5 | ????6 | ????6 | ????5 | ????7 | ????29 |
| ????II | ????1 | ????1 | ????1 | ????3 | ????2 | ????8 | ||
| ????III | ????0 | ????0 | ????0 | ????1 | ????0 | ????1 | ||
| 0.08g/ ???kg | ????I | ????5 | ????5 | ????4 | ????6 | ????3 | ????13 | |
| ????II | ????1 | ????1 | ????1 | ????0 | ????0 | ????3 | ||
| ????III | ????0 | ????0 | ????0 | ????0 | ????0 | ????0 | ||
| Negative control | ????I | ????5 | ????2 | ????4 | ????3 | ????3 | ????17 | |
| ????II | ????0 | ????0 | ????0 | ????0 | ????0 | ????0 | ||
| ????III | ????0 | ????0 | ????0 | ????0 | ????0 | ????0 | ||
| Positive control | ????I | ????1 | ????0 | ????0 | ????3 | ????2 | ????6 | |
| ????II | ????1 | ????6 | ????6 | ????6 | ????6 | ????25 | ||
| ????III | ????3 | ????4 | ????4 | ????1 | ????2 | ????14 | ||
Embodiment 3 one, material are subjected to reagent thing and reagent: 1. ledebouriella root extractum (powder), be equivalent to 1/10 ledebouriella root crude drug, by consigner trustee---Mr. Huang Huan provides.
2. water solublity ledebouriella root (powder) accounts for ledebouriella root extractum 68.5%.
3. pure dissolubility ledebouriella root (viscous solution) accounts for ledebouriella root extractum 28.2%.
4. pure dissolubility ledebouriella root (solution, concentration 70%) accounts for ledebouriella root extractum 3.2%.
5. propylene glycol of chlorine (commercially available, chemical pure); Progesterone, commercially available, to produce by Shanghai GM Pharmaceutical joint stock company limited, lot number is 010501; With 0.5%CMC as solvent.
Compound method:
1. ledebouriella root extractum divides two dosage groups, heavy dose: 5g/kg, and low dose: 2.5g/kg is made into 0.5g/ml with ledebouriella root extractum, heavy dose of stomach 1ml/100g that irritates, low dose of filling gastric capacity is 0.5gml/100g.
2. the water solublity ledebouriella root divides two dosage groups, heavy dose: 3.4g/kg, and low dose: 1.7g/kg is made into 0.34g/ml with the water solublity ledebouriella root, heavy dose of stomach 1ml/100g that irritates, low dose of filling gastric capacity is 0.5gml/100g.
3. two dosage groups of pure dissolubility ledebouriella root, heavy dose: 1.44g/kg, concentration: 0.287g/kg irritates stomach 0.5ml/100g, low dose: 0.718g/kg, concentration 0.144g/ml irritates stomach 0.5gml/100g.
4. two dosage groups of ester dissolubility ledebouriella root, heavy dose of 0.229g/kg, concentration 0.0457g/ml irritates stomach 0.5ml/100g; 0.115g/kg concentration 0.02285g/ml irritates stomach 0.5ml/100g.
Animal:
Adult SD male rat and female rats, body weight are 230 ± 40, are provided by Fudan University's animal center.
Two, method
Select the male rat of mating ability for use, continuous irrigation stomach propylene glycol of chlorine, every day 5mg/kg, administration 5 days, beginning mates with female Mus, looks into vaginal smear every day.The person is pseudo-fetus first day to find there is the sperm by female Mus vagina picture.Pseudo-fetus the 5th day, an Aconitum carmichaeli Debx. palace with the injection needle scratch and pour into the 0.2ml paraffin oil, is got and done 100 of operation pseudo-fetus female rats, divide 10 groups, 10 every group, irritate stomach institute reagent thing, continuous five days.Dissected in 24 hours behind the about medicine of last, claim the weight of animals and wound side and control sides uterus weight.And by formula calculate the deciduoma weight of matched group and the every 100g body weight of administration group.Negative control is irritated stomach 0.5%CMC, 1ml/100g.Positive control is given the rat skin lower injection Progesterone, and 2mg/ only.
Three, result
Positive controls, negative control group, the weight of the rat deciduoma of ledebouriella root extractum group and three kinds of extractum extracts sees Table 8.
The result shows:
1. ledebouriella root extractum group, water solublity ledebouriella root group, the heavy dose group of the molten ledebouriella root of ester have been compared notable difference (P＜0.05) with the feminine gender group.
2. ledebouriella root extractum group, water solublity ledebouriella root group, the heavy dose of the molten ledebouriella root group of ester is compared the trend that deciduoma weight has increase with low dose.
Four, conclusion
By above experiment, we find that ledebouriella root extractum is heavy dose of and low dose of, and it is heavy dose of and low dose of by the water-soluble ledebouriella root of ledebouriella root extraction, the heavy dose of the molten ledebouriella root of ester that is extracted by ledebouriella root, the deciduoma of rat is obviously than negative control group big (P＜0.05) after irritating stomach.In each dosage group, along with dosage increases, the also corresponding increase of the weight of deciduoma shows dose-effect relationship.
Table 8 ledebouriella root and extract are to the influence (n=10) of female rats deciduoma
| Group | Deciduoma g/100g | ???P＜ | ???P＞ | |
| Ledebouriella root extractum | ??5g/kg | ??0.439±0.133 | ??0.01 | |
| ??2.5g/kg | ??0.407±0.157 | ??0.05 | ||
| Water-soluble ledebouriella root | ??3.4g/kg | ??0.503±0.177 | ??0.01 | |
| ??1.7g/kg | ??0.490±0.139 | ??0.01 | ||
| The molten ledebouriella root of alcohol | ??1.44g/kg | ??0.345±0.169 | ??0.05 | |
| ??0.72g/kg | ??0.325±0.0898 | ??0.05 | ||
| The molten ledebouriella root of ester | ??0.16g/kg | ??0.462±0.120 | ??0.01 | |
| ??0.08g/kg | ??0.364±0.163 | ?0.05 | ||
| Negative control | ??0.284±0.0589 | |||
| Positive control | ??0.509±0.234 | ??0.01 | ||
Annotate: compare with t experience and negative control group.
Embodiment 4 ledebouriella roots are in the acute toxicity test report of mice
Purpose: measure the acute toxicity or the maximum tolerated dose of mouse stomach ledebouriella root decoct, and observe its symptom and death condition.
Given the test agent: ledebouriella root, faint yellow corase meal is provided by consigner trustee Mr. Huang Huan.
Collocation method: get ledebouriella root 50g (1 bag), put into the large beaker of 1000ml, adding distil water 400ml boils the back and boiled 1 hour with little fire, and decocting liquid is poured in another beaker for the first time, and then add the 400ml distilled water in large beaker, two fry in shallow oil and also boil 1 hour, remove slag, and merge secondary decocting liquid, be concentrated into 25ml, be the dark brown magma.Concentration is 2g/ml.
Animal: Kunming kind white mice, body weight 18-20g is provided by Shanghai Medical Univ's animal center.
Method: (1) primary test through irritating stomach (60g/kg and 80g/kg), has no adverse reaction and death condition, so carry out mtd test.
(2) each 10 of mice male and female are got in formal test, and fasting was irritated stomach by body weight after 4 hours, and dosage is 80g/kg, and the filling gastric capacity is 0.4ml/10g.Observe its symptom and death condition in seven days after irritating stomach.
The result: after giving ledebouriella root, mice is all right, and rarely seen part animal in 4 hours, has temporary movable minimizing phenomenon, and reactivates gradually after administration.Observed seven days continuously, no animal dead, its maximum tolerated dose is 80g/kg.The LD of ledebouriella root
50＞80g/kg.
Embodiment 5 treatment climacteric syndromes
Insomnia, forgetful, depressed, irritated, emotional flushing, hectic fever, perspiration, symptom such as nervous are because estrogen secretion reduces, cause vasodilation and shrink a series of performances of imbalance, and also be that modal symptom appears in climacteric women the earliest.Ledebouriella root can make these symptoms obviously alleviate or disappear.
Clinical data
Treatment number: 12 people; Age: 45-51 year; Medicining times and number that effect occurs: 4 times 2 people, 5 times 3 people, 6 times 5 people, 7 times 2 people; Effective number: 8 people, DeGrain person 4 people.
The case report
Lee *, the woman, 51 years old, professor, the patient comes from tcm family, also is the beneficiary who takes ledebouriella root for a long time, and because busy normal sense is tired, and energy is poor, the companion is irritated simultaneously before not obeying ledebouriella root, perspires, and is uncomfortable from head to foot.Behind the clothes ledebouriella root, energy and muscle power are obviously improved, and all more than ten six or seven hours, do not feel tired in work every day now at all, and involutional malaise symptoms obviously is eased.Particularly, owing to she adheres to taking for a long time, in the period again after the menstruation menolipsis.
Embodiment 6 treatment menoxenias
The women is after 40 years old, and estrogen secretion begins to reduce, and makes originally that stable hormonal readiness is fluctuation status, causes menoxenia, menostaxis or shortening occur, and is few for a long time during amount of bleeding, or menolipsis phenomenon such as bleed profusely again after the several months.This class patient is in ledebouriella root treatment group, and the people's of 80-90% symptom has obtained control in various degree.
Clinical data
The treatment number: 84 people, the age: 30-48 year, wherein: 30-35 year 15 people, 36-40 year 26 people, 41-45 year 24,46-48 year 19 people.Medicining times and number that effect occurs: 2 times 36 people, 3 times 21 people, 4 times 18 people, 5 times 9 people.Effective number: 72 people, DeGrain person 10 people, nonresponder: 2 people (DeGrain and nonresponder are menoxenia, do not get rid of the patient with inflammation or organic disease).
The case report
Pueraria lobota * *, 32 years old, technician, patient once accepted the ledebouriella root Drug therapy for twice because of miscarrying, and back natural labor one girl takes medicine.Fertility back ordinary circumstance is good, and to drench drop unclean but often feel menstruation, and leucorrhea is thin clearly, and is continuous more than, accompanies the abdomen soreness of waist of trembling with fear simultaneously, fatigue and weak.After giving the ledebouriella root Drug therapy once more, above-mentioned symptom disappears, and menstrual period are normal, and is clean through the back, has rosy cheeks, and body constitution is health than before obviously.
Embodiment 7 treatment miscarriage and habitual abortions
Clinical data
Treatment number: 51 people, age: 24-40 year, abortion times: 1 time 9 people; 2 times 19 people; 3 times 14 people; 4 times 6 people; 5 times 3 people.Medicining times and number that effect occurs: 2 times 8 people; 3 times 16 people; 4 times 15 people; 5 times 12 people.Effective number: 45 people; Invalid number: 6 people (wherein 4 people find organic disease, and 2 people do not adhere to the therapy discontinued of taking medicine after taking 2 medicines again).
The case report
What * *, the woman, 38 years old, workman, patient married 10 years, and next year pregnancy after marriage connects pregnant five times, all miscarriages without reason about 50 days of at every turn becoming pregnant.Once repeatedly got examination in hospital, Mr. and Mrs both sides all do not find organic disease, through various prevent miscarriage medicine and method treatments, all to no effect.Give ledebouriella root conditioning before the 6th pregnancy, take medicine being prone to a few days ago appending of miscarriage in the past again after the pregnancy, continuous two courses of treatment, miscarriage takes place again, full-term pregnancy, natural labor one boy.
Embodiment 8 postpones the sexual function improving in menopause
Menopause is the sign that women's gonad function falls into a decline.The morning and evening of its appearance, can reflect the ability of body sexual life aspect to a certain extent.In the climacteric women of accepting the ledebouriella root treatment, part is the patient who is in menoxenia, is about to face menopause.After treatment, all pleasantly surprised discovery oneself of these patients is clocklike in the period again, and the sexual life harmony, and quality of life improves.In 42 routine users, effective percentage is 86.3%.
The case report
Lee *, the woman, 53 years old, the patient was because of flushing, hectic fever climacteric syndrome require the treatment of clothes ledebouriella root, take two courses of treatment after, not only above-mentioned symptom disappears, and finds also that simultaneously original sparse menstruation begins to recover normal again, and leucorrhoea grow in quantity, the sexual life harmony.
Embodiment 9 hair growth promoting skin care slow down aging
The traditional Chinese medical science is thought: " essence of the kidney being reflected on the hair is had one's ideas straightened out in ear ", alopecia, poliosis, hard of hearing, tinnitus be suffer from a deficiency of the kidney due to.Equally, modern medicine is also thought: hypophysis and gonad play a leading role in the human senility process.
Ledebouriella root can not only be anti-loss, poliosis, hard of hearing, the tinnitus of treatment, and can also drive away senile plaque, chloasma, makes the skin exquisiteness glossy.In 27 routine users, effective percentage is 68%.
The case report
Hair *, the woman, 37 years old, losing hair appearred suddenly in patient's any reason of thing the year before, begin on a small quantity, afterwards in the form of sheets, the last whole several leading light that all takes off, the periwig working of having to.For suffering from a deficiency of the kidney, the invalid clothes ledebouriella root that changes after taking traditional Chinese medicine, large dose oral administration began long hair after two months through tcm diagnosis, and existing black hair is all over the face had rosy cheeks.
Embodiment 10 treatments and prevention of osteoporosis, senile vaginitis, hyperlipidemia and coronary heart disease
Climacteric women causes sickness rate such as osteoporosis, cardiovascular and cerebrovascular disease, senile vaginitis to be increased sharply because hormone in vivo sharply descends, and has a strong impact on people's physical and mental health.Ledebouriella root can delay the ovarian function decline, and the estrogen fall that slows down is steadily tided over climacteric body.Simultaneously,, promote cholesterol metabolism, effectively prevent the generation of diseases such as hypertension, hyperlipidemia, coronary heart disease, obesity, osteoporosis because estrogenic effect can prevent that bone calcium runs off in a large number.
Claims (7)
1. ledebouriella root is in preparation treatment, prevention and estrogen, progestogen dysequilibrium diseases associated, the medicine of symptom or the application in the health product.
2. the application of ledebouriella root as claimed in claim 1 is characterized in that, described symptom is a climacteric syndrome.
3. the application of ledebouriella root as claimed in claim 1 is characterized in that, described disease is a menoxenia.
4. the application of ledebouriella root as claimed in claim 1 is characterized in that, described disease is miscarriage, habitual abortion.
5. the application of ledebouriella root as claimed in claim 1 is characterized in that, this ledebouriella root is to climacteric women deferrable menopause, sexual function improving.
6. the application of ledebouriella root as claimed in claim 1 is characterized in that, this ledebouriella root is to climacteric women energy hair growth promoting skin care, slow down aging.
7. the application of ledebouriella root as claimed in claim 1 is characterized in that, this disease is osteoporosis, senile vaginitis, hyperlipidemia and coronary heart disease.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2005028491A1 (en) * | 2003-09-19 | 2005-03-31 | Shanghai Yao Gang Biological Technology Co., Ltd. | Epimeredi glycoside a, the formulation containing thereof and their preparation method |
| JP2007505839A (en) * | 2003-09-19 | 2007-03-15 | 上海薬港生物技術有限公司 | Wide windbreak glycoside A, broad windbreak extract preparation containing the same, and preparation method thereof |
| CN101317522B (en) * | 2007-06-09 | 2010-12-08 | 李兴代 | From wild plant into domestic cultivation and large area cultivation method for ebimexedi idica |
-
2002
- 2002-01-09 CN CN 02110522 patent/CN1209126C/en not_active Expired - Lifetime
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2005028491A1 (en) * | 2003-09-19 | 2005-03-31 | Shanghai Yao Gang Biological Technology Co., Ltd. | Epimeredi glycoside a, the formulation containing thereof and their preparation method |
| JP2007505839A (en) * | 2003-09-19 | 2007-03-15 | 上海薬港生物技術有限公司 | Wide windbreak glycoside A, broad windbreak extract preparation containing the same, and preparation method thereof |
| CN100413876C (en) * | 2003-09-19 | 2008-08-27 | 上海药港生物技术有限公司 | Epimeridinoside A and epimeredi indica root extract preparation containing same and preparing method therefor |
| JP4933257B2 (en) * | 2003-09-19 | 2012-05-16 | 上海薬港生物技術有限公司 | Wide windbreak glycoside A, broad windbreak extract preparation containing the same, and preparation method thereof |
| CN101317522B (en) * | 2007-06-09 | 2010-12-08 | 李兴代 | From wild plant into domestic cultivation and large area cultivation method for ebimexedi idica |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1209126C (en) | 2005-07-06 |
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