CN108186745A - For treating the pharmaceutical composition of Stein-Leventhal syndrome and its preparation - Google Patents
For treating the pharmaceutical composition of Stein-Leventhal syndrome and its preparation Download PDFInfo
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- CN108186745A CN108186745A CN201810088737.1A CN201810088737A CN108186745A CN 108186745 A CN108186745 A CN 108186745A CN 201810088737 A CN201810088737 A CN 201810088737A CN 108186745 A CN108186745 A CN 108186745A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/484—Glycyrrhiza (licorice)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/65—Paeoniaceae (Peony family), e.g. Chinese peony
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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- Medicines Containing Plant Substances (AREA)
Abstract
The present invention relates to a kind of for treating the pharmaceutical composition and its preparation of Stein-Leventhal syndrome, belong to drug field.It includes total glucoside, glycyrrhiza total flavonoid and Rhizophoraceae plant extracts.In described pharmaceutical composition, the weight proportion of total glucoside, glycyrrhiza total flavonoid and Rhizophoraceae plant extracts is 5~10 parts of total glucoside, 3~8 parts of glycyrrhiza total flavonoid and 1~5 part of Rhizophoraceae plant extracts.The present invention furthermore provides pharmaceutical preparation and related application comprising pharmaceutical composition.
Description
Technical field
The present invention relates to a kind of for treating the pharmaceutical composition and its preparation of Stein-Leventhal syndrome, belongs to drug neck
Domain.
Background technology
Stein-Leventhal syndrome (Polycystic ovary syndrome, PCOS) is that the most common endocrine of women is disorderly
Unrest disease accounts for the 4%~12% of the women of child-bearing age.Clinical signs are oligomenorrhea or amenorrhoea, obesity, crinosity, infertile and double
The increased syndrome of the more capsules of side ovary, classical endocrine feature show as hyperandrogenism, plasma LH (LH)
Level increases, and LH/FSH (follicle-stimulating hormone (FSH)) ratio increases, and oestrone (E1) increases.Also with hyperinsulinemia, tip pancreas islet
Element is resisted and conisting of dyslipidemia.So far, the cause of disease of PCOS remains unknown.It is current research shows that, PCOS is a kind of
Syndrome with genetic heterogeneity feature, it may be possible to multiple or a few oligogene and environmental factor interaction institute
It causes.PCOS seriously affects the quality of life of patient and healthy reproduction level.
Doctor trained in Western medicine is for the treatment of Stein-Leventhal syndrome mostly based on operation or drug at present, such as operation has the ovary wedge-shaped
Resection and Laparoscopic Ovarian centesis or the secretion for increasing follicular stimulating hormone using promoting ovulation drug, promote ovarian follicle
Development reduces blood androgen levels using antiandrogen drug, lutropin (LH) level is reduced using contraceptive, to adjust
Menstrual cycle using gonadotropin releasing hormone drug, reduces the synthesis of androgen, thickens endometrium, so as to be conducive to implantation,
Using Remedies for diabetes, such as melbine, improve glycometabolism etc..But operation wound is big and long-term effect is undesirable, and
Medication effect is limited, and to the generation of long term complication without positive prevention effect, and side effect is big, it is impossible to it takes for a long time,
High recurrence rate after drug withdrawal.
In traditional Chinese medicine and there is no with the accurate corresponding disease name of Stein-Leventhal syndrome, according to Stein-Leventhal syndrome
Clinical signs, should in traditional Chinese medicine " amenorrhoea ", " menstrual disorder ", " infertile " it is corresponding, for the interpretation of the cause, onset and process of an illness of this disease, in
Medicine thinks that the functional disturbances such as itself and kidney,spleen,liver, the heart and phlegm wet, blood stasis are in close relations, and the specific interpretation of the cause, onset and process of an illness includes kidney deficiency, phlegm wet, blood
The stasis of blood, yin deficiency, the deficiency of yang, deficiency of vital energy etc..At present the Chinese medicine of existing treatment Stein-Leventhal syndrome treatment include opening palace ball, the female ball of benefit,
Ginseng and astragalus combination, Longdan Xiegan Tang and sweet Chinese herbaceous peony soup etc..Although above-mentioned Chinese medicine compound prescription have certain therapeutic effect and
Small side effects, but the ingredient of Chinese medicine compound prescription is excessively complicated, quality of medicinal material is unstable to be difficult to quality control, the big action of taking dose
Slowly, it is difficult to promote and apply.
Invention content
The first aspect of the present invention is to provide a kind of pharmaceutical composition for being used to treat Stein-Leventhal syndrome, including white
The total glycosides of Chinese herbaceous peony, glycyrrhiza total flavonoid and Rhizophoraceae plant extracts.
In one embodiment, the Rhizophoraceae plant includes mangrove, Bruguiera conjugata, Radix Kandeliae candelis and ceriops tagal etc..Into one
Step ground, the Rhizophoraceae plant extracts refer to its ligroin extraction.
In another embodiment, the preparation method of the Rhizophoraceae plant extracts is as follows:Raw medicinal material is taken to crush,
40 mesh sieve is crossed, with 70% ethyl alcohol, 80 DEG C of extraction 1h of 5 times of amounts, three times, merging filtrate is concentrated under reduced pressure into medicinal extract, Ran Houxiang for extraction
The petroleum ether that 5 times of amounts are added in medicinal extract is extracted, and is extracted 5 times repeatedly, merges petroleum ether layer extract, is concentrated under reduced pressure, vacuum
It is drying to obtain.
In yet another embodiment, in described pharmaceutical composition, total glucoside, glycyrrhiza total flavonoid and Rhizophoraceae plant carry
Total glucoside, 3~8 parts of glycyrrhiza total flavonoid and 1~5 part of the Rhizophoraceae plant extract that the weight proportion for taking object is 5~10 parts
Object.
In scheme is further carried out, in described pharmaceutical composition, total glucoside, glycyrrhiza total flavonoid and Rhizophoraceae plant
The weight proportion of extract is 8 parts of total glucoside, 6 parts of glycyrrhiza total flavonoid and 5 parts of Rhizophoraceae plant extracts.
In the present invention, total glucoside and glycyrrhiza total flavonoid can be bought to obtain by commercial channel, can also pass through
It is prepared by methods known in the art.
The second aspect of the present invention is to provide the pharmaceutical preparation comprising described pharmaceutical composition, including tablet, capsule, delays
Release tablet formulations, pill, granule, dispersible tablet or powder.
In one embodiment, the pharmaceutical preparation is made of pharmaceutical composition and auxiliary material, and the auxiliary material, which is selected from, to form sediment
Powder, pregelatinized starch, starch slurry, beta-cyclodextrin, carbomer, microcrystalline cellulose, hydroxypropyl methyl cellulose, low substituted hydroxy-propyl
Cellulose, calcium carboxymethylcellulose, polyethylene glycol (PEG), sodium carboxymethylcellulose, methylcellulose, ethyl cellulose, sweet dew
Alcohol, lauryl sodium sulfate, croscarmellose sodium, lactose, polyvinylpyrrolidone (PVP), crosslinked polyethylene pyrroles
In alkanone, magnesium stearate, talcum powder, superfine silica gel powder, Aspartame, orange flavor, sodium bicarbonate, sodium carbonate, enteric coating powder
It is one or more.
In a preferred embodiment, the auxiliary material includes microcrystalline cellulose, pregelatinized starch and magnesium stearate, specifically
Parts by weight are 50~70 parts of microcrystalline cellulose, 30~50 parts of pregelatinized starch and 1~5 part of magnesium stearate.
The third aspect of the present invention is to provide described pharmaceutical composition and is preparing treatment Stein-Leventhal syndrome, excessive androgen
Mass formed by blood stasis and the external application promoted in oocyte maturation drug.
In medical usage described above, basis is needed for the administration time and administration number of times of pharmaceutical composition of the present invention
Depending on the specific diagnostic result of the state of an illness, within this technical scope grasped in those skilled in the art.It for example, will be to mouse or big
The therapeutic scheme of mouse is applied on the person, and all drugs can be by the drug to the effective dose of mouse to the effective dose of people
It converts, this is easy to implement for those of ordinary skill in the art.
The present invention screens the proportioning of the active component of Radix Glycyrrhizae and Radix Paeoniae Alba on the basis of the sweet Chinese herbaceous peony soup of tradition, and
Prescription research is carried out with reference to the abundant sea-plant resource in China and sweet Chinese herbaceous peony soup, as a result, it has been found that mangrove section plant and sweet Chinese herbaceous peony soup
In the presence of more apparent synergistic effect, so as to obtain it is a kind of in treatment Stein-Leventhal syndrome and it is external promote egg mother cell into
Ripe aspect has the pharmaceutical composition of splendid effect.
Specific embodiment
Can also the present invention further be understood by embodiment, wherein the embodiment illustrates some preparations or user
Method.It is to be appreciated, however, that these embodiments do not limit the present invention.The change of the present invention of currently known or further exploitation
Change is considered within the scope of the invention described herein and claimed below.
The preparation of 1 effective ingredient in Chinese of embodiment
1) total glucoside
Radix paeoniae alba decoction pieces 10kg is taken, with 12 times of amount water refluxing extractions three times, each 3h merges extracting solution, 50 DEG C of reduced pressures
To 500ml or so, upper D101 macroporous resin columns, be washed to efflux it is colourless after, with 70% ethanol elution, dosage 3BV (cylinders
Product), flow velocity 2BV/h collects eluent, and 50 DEG C are concentrated under reduced pressure into 100ml, and concentrate is laid in porcelain dish, is dried in vacuo to obtain the final product
Total glucoside (175.3g)
2) glycyrrhiza total flavonoid
With 85 DEG C of the NaOH solution extraction 3h of the 0.4mol/L of 30 times of amounts, filtrate is collected by filtration in extracting liquorice medicine materical crude slice 5kg, and 60
After DEG C being concentrated under reduced pressure plus ethyl alcohol is to 70%, stands overnight, filtrate is collected by filtration, filtrate is concentrated under reduced pressure into 500ml or so 60 DEG C,
Upper AB-8 macroporous resin columns, be washed to efflux it is colourless after, with 80% ethanol elution, dosage 2BV (column volume), flow velocity 1BV/h,
Eluent is collected, 60 DEG C are concentrated under reduced pressure into 100ml, and concentrate is laid in porcelain dish, are dried in vacuo up to glycyrrhiza total flavonoid
(137.9g)。
3) ceriops tagal extract
Ceriops tagal bark 10kg is taken, crushed 40 mesh sieve, with 70% ethyl alcohol, 80 DEG C of extraction 1h of 5 times of amounts, extraction three times, is closed
And filtrate, 1L is concentrated under reduced pressure into, is then extracted with petroleum ether, ethyl acetate and the n-butanol of 5 times of amounts, extracted repeatedly successively
5 times, the extract liquor that different extractants obtain is collected respectively, is concentrated under reduced pressure, and vacuum drying drying is to get ceriops tagal oil respectively
Ether extract, ethyl acetate extract and n-butanol extract.
The external model screening of 2 pharmaceutical composition weight proportion of embodiment
It takes in 6 well culture plate of NCI-H295R cell inoculations, uses DMEM:F12 (volume ratios 1:1) culture medium (adds in culture medium
Add 2.5 volume % newborn bovine serum and 1 volume %ITS+PREMIX, BD Biosciences companies) cultivated (37 DEG C, 5%
CO2) to cell density be about 80% when, addition Forskolin (25 μm of ol/L) and related drugs, every group of each 4 multiple holes, mould
Type group only adds Forskolin (25 μm of ol/L), and blank group gives equivalent culture medium, continues after cultivating 48h, takes each hole supernatant
Testosterone concentration is measured by ELISA kit.
Concrete outcome is as follows:
1) total glucoside and the screening of the proportioning of glycyrrhiza total flavonoid
It is examined through Oneway-ANOVA,##Represent the P compared with blank group<0.01, * * represents the P compared with model group<0.01
It can be seen from the results above that for inhibiting for androgen secretion, total glucoside is 2:1 or 1:Inhibit when 0.75
Best results.
2) total glucoside, glycyrrhiza total flavonoid and the proportioning screening of ceriops tagal extract weight
It is examined through Oneway-ANOVA,##Represent the P compared with blank group<0.01, * * represents the P compared with model group<0.01
The result shows that after ceriops tagal extract is added, ethyl acetate and n-butanol extract do not play composition
Apparent synergistic effect, and ceriops tagal ligroin extraction and total glucoside and glycyrrhiza total flavonoid are in terms of androgen secretion is inhibited
Produce apparent synergistic effect.According to the above results we determined that total glucoside, glycyrrhiza total flavonoid and ceriops tagal petroleum ether carry
It is 8 to take object weight proportion:6:5.
Influence of 3 pharmaceutical composition of embodiment to progestational hormone and HCG joint modeling PCO rats
Modeling:24 age in days SD female rats, urethane anesthesia are taken, lower abdomen notch 0.5cm is embedded to every with skin bushing burying needle
Root levonorgestrel oxime containing 75mg silica gel stick (3mm), sews up the incision and sterilizes.The neck injection human chorionic in 27 age in days
Only, 2 times a day, co-injection 9 days, in 24 age in days, only myometrial suture sterilizes control group film promoting sexual gland hormone (HCG) 1.5IU/, and 27
Normal saline is only injected during age in days.
Administration:Since 36 ages in days, administration group rat starts gavage and gives medicinal composition solution, control group and model group
Normal saline is given, specific dosage regimen is as follows:
After administration 12 days, disconnected neck is put to death after taking blood, measures rat body weight and ovary weight.Blood sample 2000r/min from
Heart 10min, takes serum,;Using measured by radioimmunoassay each group rat blood serum follicular stimulating hormone (Follicle Stimulating
Hormone, FSH), lutropin (Luteinizing Hormone, LH), estradiol (Estradiol, E2), testosterone
The level of (Testosterone, T), sex hormone binding globulin (Sex hormone-binding globulin, SHBG).
Estradiol (Estradiol, E2)
Concrete outcome is as follows:
1) each group rat body weight and ovary weight
Weight (g) | Ovary weight (g) | |
Control group | 101.7±8.9 | 0.011±0.02 |
Model group | 123.1±11.2# | 0.024±0.03## |
Group 1 | 110.9±6.4 | 0.018±0.01* |
Group 2 | 115.4±7.1 | 0.022±0.02 |
Group 3 | 126.2±5.9 | 0.023±0.02 |
Group 4 | 107.4±5.3* | 0.014±0.04** |
Group 5 | 112.4±6.9 | 0.017±0.02** |
2) each group rat blood serum hormonal readiness influences
4 pharmaceutical composition of embodiment is to the maturation in vitro facilitation of Rat Oocytes
Embodiment 2 and 3 shows improvement result of the pharmaceutical composition to Stein-Leventhal syndrome and hyperandrogenism, and
This improvement result is realized by adjusting rat sex hormone secretion in vivo, therefore we have further investigated medicine group
Maturation in vitro facilitation of the object to immature oocyte is closed, this has preferably the external supplementary reproduction of human or animal
Application value.
The acquisition of egg mother cell:The SD rats of female 23 ages in days or so, weight 50g or so are taken, PMSG is injected intraperitoneally
(15IU/ only) after PMSG Injection 48h, puts to death rat, back surgery is taken out ovary, is placed in M199 culture solutions, stereoscopic aobvious
Under micro mirror, antral follicles are punctured with five and half sterilizing pillows, the coated egg mother cell of ovarian cumulus (CEO) is released, is washed with culture solution
It after washing, is incubated in culture dish with the density of 40 pieces/ware, (it includes 1%FBS, 0.23mM acetone for M199 culture solutions for culture solution
The streptomysin and penicillin of sour sodium, IBMX, 2mM glutamine of 100mM and 100U/ml), after cultivating 1h, into each culture dish
Egg mother cell carry out pharmaceutical intervention, culture for 24 hours, using germinal vesicle breakdown (GVBD) as oocyte nuclear maturation mark, with the
Marks of the one polar body PB1 as Cytoplasmic maturation, calculates the GVBD rates of each group and PB1 rates.
Concrete outcome is as follows:
GVBD (%) | PB1 (%) | |
Control group | 34 ± 3.9% | 29 ± 2.4% |
Group 1 | 83 ± 4.6% | 78 ± 3.7% |
Group 2 | 65 ± 3.4% | 57 ± 3.1% |
The total glucoside of a concentration of 0.4mg/L of pharmaceutical composition in the culture solution of group 1,0.3mg/L glycyrrhiza total flavonoids and
0.25mg/L ceriops tagal ligroin extractions
The total glucoside of a concentration of 0.54mg/L of pharmaceutical composition and 0.41mg/L glycyrrhiza total flavonoids in the culture solution of group 2
The content of present invention merely illustrates some claimed specific embodiments, one of them or more skill
Recorded technical characteristic can be combined with arbitrary one or more technical solutions in art scheme, these are combined and obtain
Technical solution also in the application protection domain, technical solution is disclosed in the present invention just as obtained from these are combined
It is specifically recorded in content the same.
Claims (9)
1. it is a kind of for treating the pharmaceutical composition of Stein-Leventhal syndrome, including total glucoside, glycyrrhiza total flavonoid and mangrove
Section's plant extracts.
2. pharmaceutical composition according to claim 1, which is characterized in that the Rhizophoraceae plant includes mangrove, Bruguiera conjugata, autumn
Eggplant tree and ceriops tagal etc..
3. pharmaceutical composition according to claim 2, which is characterized in that raw medicinal material is taken to crush, 40 mesh sieve is crossed, with 5 times
70% ethyl alcohol, 80 DEG C of extraction 1h of amount, three times, merging filtrate is concentrated under reduced pressure into medicinal extract for extraction, and 5 times of amounts are then added in into medicinal extract
Petroleum ether extracted, repeatedly extract 5 times, merge petroleum ether layer extract, be concentrated under reduced pressure, be dried in vacuo drying.
4. pharmaceutical composition according to claim 1, which is characterized in that in described pharmaceutical composition, total glucoside, Radix Glycyrrhizae
Total glucoside that the weight proportion of general flavone and Rhizophoraceae plant extracts is 5~10 parts, 3~8 parts of glycyrrhiza total flavonoid and 1~
5 parts of Rhizophoraceae plant extracts.
5. pharmaceutical composition according to claim 4, which is characterized in that total glucoside, glycyrrhiza total flavonoid and Rhizophoraceae are planted
The weight proportion of object extract is 8 parts of total glucoside, 6 parts of glycyrrhiza total flavonoid and 5 parts of Rhizophoraceae plant extracts.
6. a kind of pharmaceutical preparation for including any one of claim 1-5 described pharmaceutical compositions, including tablet, capsule, sustained release
Tablet, pill, granule, dispersible tablet or powder.
7. pharmaceutical preparation according to claim 6, which is characterized in that the pharmaceutical preparation is by pharmaceutical composition and auxiliary material
Composition, the auxiliary material are selected from starch, pregelatinized starch, starch slurry, beta-cyclodextrin, carbomer, microcrystalline cellulose, hydroxypropyl methyl
Cellulose, low-substituted hydroxypropyl cellulose, calcium carboxymethylcellulose, polyethylene glycol (PEG), sodium carboxymethylcellulose, methyl are fine
Tie up element, ethyl cellulose, mannitol, lauryl sodium sulfate, croscarmellose sodium, lactose, polyvinylpyrrolidone
(PVP), crosslinked polyvinylpyrrolidone, magnesium stearate, talcum powder, superfine silica gel powder, Aspartame, orange flavor, sodium bicarbonate,
It is one or more in sodium carbonate, enteric coating powder.
8. pharmaceutical preparation according to claim 7, which is characterized in that the auxiliary material includes microcrystalline cellulose, pregelatinated forms sediment
Powder and magnesium stearate, microcrystalline cellulose that specific parts by weight are 50~70 parts, 30~50 parts of pregelatinized starch and 1~5 part
Magnesium stearate.
9. any one of claim 1-5 described pharmaceutical compositions prepare treatment Stein-Leventhal syndrome, hyperandrogenism and
The external application promoted in oocyte maturation drug.
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Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN101049350A (en) * | 2007-01-25 | 2007-10-10 | 赵振江 | Oral combined health protective prescription for treating acquired pathological female sterility |
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CN101049350A (en) * | 2007-01-25 | 2007-10-10 | 赵振江 | Oral combined health protective prescription for treating acquired pathological female sterility |
Non-Patent Citations (3)
Title |
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崔风云;等: "甘芍汤治疗多囊卵巢综合征60例", 《实用中医药杂志》 * |
张蕾;等: "海洋植物秋茄根中二萜类化合物及其抗妇科肿瘤活性的研究", 《青岛医药卫生》 * |
郭庆丰;等: "角果木属植物化学成分及药理活性研究进展", 《中国中药杂志》 * |
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