CN105943651A - Traditional Chinese medicine composition for treating premature ovarian failure, and application thereof - Google Patents
Traditional Chinese medicine composition for treating premature ovarian failure, and application thereof Download PDFInfo
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Abstract
The invention relates to a traditional Chinese medicine composition for treating premature ovarian failure. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10 to 15 parts of fructus ligustri lucidi, 10 to 15 parts of mulberries, 10 to 15 parts of semen cuscutae, 10 to 15 parts of raspberry and 1 to 5 parts of human placenta. The invention further relates to application of the traditional Chinese medicine composition to the preparation of a medicine for treating premature ovarian failure. The traditional Chinese medicine composition provided by the invention is small in number of ingredients, abundant in raw material, simple to prepare, and environment-friendly, and has a good application scope in curing premature ovarian failure. The prescription and the matching of the traditional Chinese medicine composition provided by the invention are obtained by screening a large number of experiments, different raw materials and the matching thereof can play a remarkable synergistic role, and the curative effect is good.
Description
Technical field
The present invention relates to technical field of Chinese medicines, specifically, be a kind of Chinese medicine composition treating premature ovarian failure
And application.
Background technology
Premature ovarian failure (POF) refers to through, infertile, estrogen deficiency with 40 years old anuresis of women and promote gonad and swash
Element level raises a kind of disease of being characterized, this disease may occur in which menoxenia, warm perspirations, irritated have a sleepless night,
The clinical symptoms such as dyspareunia.Having research display, before 40 years old, the sickness rate of premature ovarian failure is about 1%～3%,
And the sickness rate in 30 years old is about 0.1%.POF not only causes amenorrhea, infertility, adjoint low estrogen
Performance, also can produce impact, serious shadow to all multiple organ of whole body such as nerve, metabolism, cardiovascular and cerebrovascular vessel and skeletons
Ring the normal work of women, bring considerable distress to its physical and mental health and love life simultaneously.
This cause of disease is the most unclear, research both at home and abroad think more premature ovarian failure and heredity, immune, metabolism with
And the factor such as iatrogenic is relevant.Existing research data display chromosome mutation, FSH (FSH)
Interstitialcellstimulating hormone (ICSH) (LH) and receptor variant thereof, Developmental and Metabolic Disorder or medicine effect, chemicotherapy damages, virus
Infecting, immunity and other high risk factors such as factor such as smoking, depression is probably its reason, these factors
Or make ovary congenital ovum number reduce, or make its follicular atresia accelerate, or directly destroyed, make ovum
Bubble premature depletion.
Premature ovarian failure treatment is relatively difficult, and doctor trained in Western medicine uses Hormone Replacement Therapy clinically, needs the finger doctor
Lead lower use estrogen and progestogen.The when that research showing this estrogen and progestogen therapy, have certain effect,
Can improve symptom, but the recovery to ovarian function is unsatisfactory, after drug withdrawal, symptom reappears simultaneously,
Make ovary be in dependent status, have and cause the worse possibility of ovarian function.That is Hormone Replacement Therapy is only
Only serving the effect taken stopgap measures, and this method side effect is big, life-time service exogenous hormones has and causes son
The danger of Endometrium canceration, and increase the sickness rate of coronary heart disease and cholecystopathy.Therefore the effect of this hormone therapy
The most undesirable, there is potential safety hazard simultaneously.In terms of western medical treatment, in addition to hormone replacement therapy,
There is also induced ovulation, auxiliary gives ovum technology, autologous or allosome ovary transplantation technology, immunosuppressant therapy,
Supplement calcium preparation or calcitonin treatment.But these western medical treatment methods are nothing more than recovery, maintenance, substitute ovary merit
Can these several respects.The most also do not have definite effective method can recover the function of ovary, so ovary
The senilism cause of disease is complicated, and treatment difficulty is relatively big, and modern medicine the most not yet makes a breakthrough progress.
Prior art discloses the Chinese medicine of multiple treatment ovary, as Chinese patent 2016101383683 discloses
A kind of pharmaceutical safety, toxic effects and therapeutic effect are significantly for suppressing pressing down of premature ovarian failure of women to decline again
Soup, it includes being formed by according to the formula of following weight portion: 10g Radix Scrophulariae, the 10g Radix Rehmanniae, 20g Semen Cuscutae,
20g Fructus Lycii, 10g Fructus Rubi, 10g Semen Plantaginis, 5g Fructus Schisandrae Chinensis, 10g Radix Ophiopogonis, the 30g Radix Astragali, 10g
Oletum Trogopterori, 10g Endothelium Corneum Gigeriae Galli, 10g Radix Angelicae Sinensis and 20g Rhizoma Dioscoreae；This medical instrument has YIN nourishing replenishing essence, tonifies Qi of the kidney,
The effect of nourishing blood and promoting blood circulation, Chinese patent 2015109893389 discloses a kind of Chinese medicine formula treating premature ovarian failure,
Raw material of Chinese medicine by following parts by weight is formulated: Rhizoma Epimedii 2-3 part, Herba pyrolae japonicae 2-3 part, goldspink
Flower 1-3 part, sweet blue or green Herba Saussureae Involueratae 2-3 part, Polyalthia nemoralis A. D C. 2-4 part, Fructus Jujubae 3-5 part, Muraenesocis cinereus ovum 2-3 part, little
Black powder 1-3 part, Radix seu Caulis Verntilaginis Leiocarpae 2-3 part, Radix Astragali 1-3 part, Stigma Croci 1-3 part, Radix Cucubali 1-3 part, this medicine
Being nursed one's health by Chinese medicine, invigorating the spleen and replenishing QI, Yin-nourishing and body fluid promoting, nourishing the liver and kidney, body fluid is sufficient, improves immunity of organisms,
Treatment premature ovarian failure has significant effect.Chinese patent 201010280287X discloses a kind of preventing and treating ovary
Health product of senilism and preparation method thereof, these health product include following raw materials according: Fructus Lycii, Fructus Ligustri Lucidi, Radix Rehmanniae Preparata
Huang, Herba Epimedii, Fructus Psoraleae, Semen Cuscutae；Also include Fructus Rubi, Semen arachidis hypogaeae, Fructus Jujubae, Semen Glycines, these health product
There is the good effect improving ovarian function, the especially women to about 40 years old, have and improve ovary merit
Can, play estrogen-like effects, improve that ovarian failure causes lose weight, the symptom such as hyperhidrosis, adjust
The joint ovary reactivity to promoting sexual gland hormone, promotes the effects such as follicular development.Said medicine is for premature ovarian failure
There is certain curative effect, but a little medicine yet suffers from the shortcoming that flavour of a drug are many, therapeutic effect is not good enough.Therefore,
Flavour of a drug number is less, raw material is easy to get, preparation technology is simple and the obvious medicine of therapeutic effect to need one badly, and
Have not been reported about this kind of medicine at present.
Summary of the invention
It is an object of the invention to for deficiency of the prior art, it is provided that a kind of Chinese drug-treated group treating premature ovarian failure
Compound.
Another purpose of the present invention is to provide the purposes of Chinese medicine composition described above.
For achieving the above object, the present invention adopts the technical scheme that:
A kind of Chinese medicine composition treating premature ovarian failure, described Chinese medicine composition is by the raw material system of following weight portion
Become: Fructus Ligustri Lucidi 10-15 part, Fructus Mori 10-15 part, Semen Cuscutae 10-15 part, Fructus Rubi 10-15 part, river
Car powder 1-5 part.
Preferably, described Chinese medicine composition is prepared by the raw materials in: Fructus Ligustri Lucidi 11-13 part, Mulberry
Shen 11-13 part, Semen Cuscutae 11-13 part, Fructus Rubi 11-13 part, river car powder 2-4 part.
More preferably, described Chinese medicine composition is prepared by the raw materials in: Fructus Ligustri Lucidi 12 parts, Fructus Mori
12 parts, Semen Cuscutae 12 parts, Fructus Rubi 12 parts, 3 parts of river car powder.
For realizing above-mentioned second purpose, the present invention adopts the technical scheme that:
The application in preparation treatment premature ovarian failure medicine of arbitrary described Chinese medicine composition.
Described medicine adds pharmaceutically acceptable carrier as required and is prepared as any pharmaceutical dosage form.
Described medicine also includes the adjuvant pharmaceutically allowed.
The dosage form of described medicine is capsule, granule, tablet, oral liquid, mixture or syrup.
The invention has the advantages that:
The advantages such as 1, the medicine of the present invention is made up of pure Chinese medicine, has and has no side effect, and price is low, pass through
Oral medication, is more easy to be accepted by patients.
2, the medicine flavour of a drug number of the present invention is few, abundant raw materials, and preparation technology is simple, environmentally friendly,
Good application prospect is had in treatment premature ovarian failure.
3, the Chinese medicine composition compatibility theory of the present invention meets the theory of the traditional Chinese medical science " monarch ", different former
Material and proportioning thereof have obvious synergism.
4, the proportioning of Chinese medicine composition of the present invention is obtained by great many of experiments screening, has eutherapeutic
Advantage.
Detailed description of the invention
Below in conjunction with detailed description of the invention, the present invention is expanded on further.Should be understood that these embodiments are only used for
The present invention is described rather than limits the scope of the present invention.In addition, it is to be understood that reading what the present invention recorded
After content, the present invention can be made various changes or modifications by those skilled in the art, and these equivalent form of values are same
Sample falls within the application appended claims limited range.
Embodiment 1 treats the preparation () of premature ovarian failure medicine
Fructus Ligustri Lucidi 12 parts, Fructus Mori 12 parts, Semen Cuscutae 12 parts, Fructus Rubi 12 parts, 3 parts of river car powder.
Conventional method decocts.
Embodiment 2 treats the preparation (two) of premature ovarian failure medicine
Fructus Ligustri Lucidi 10 parts, Fructus Mori 10 parts, Semen Cuscutae 10 parts, Fructus Rubi 10 parts, 1 part of river car powder.
Conventional method decocts.
Embodiment 3 treats the preparation (three) of premature ovarian failure medicine
Fructus Ligustri Lucidi 15 parts, Fructus Mori 10 parts, Semen Cuscutae 10 parts, Fructus Rubi 10 parts, 1 part of river car powder.
Conventional method decocts.
Embodiment 4 treats the preparation (four) of premature ovarian failure medicine
Fructus Ligustri Lucidi 15 parts, Fructus Mori 15 parts, Semen Cuscutae 10 parts, Fructus Rubi 10 parts, 1 part of river car powder.
Conventional method decocts.
Embodiment 5 treats the preparation (five) of premature ovarian failure medicine
Fructus Ligustri Lucidi 15 parts, Fructus Mori 15 parts, Semen Cuscutae 15 parts, Fructus Rubi 10 parts, 1 part of river car powder.
Conventional method decocts.
Embodiment 6 treats the preparation (six) of premature ovarian failure medicine
Fructus Ligustri Lucidi 15 parts, Fructus Mori 15 parts, Semen Cuscutae 15 parts, Fructus Rubi 15 parts, 1 part of river car powder.
Conventional method decocts.
Embodiment 7 treats the preparation (seven) of premature ovarian failure medicine
Fructus Ligustri Lucidi 15 parts, Fructus Mori 15 parts, Semen Cuscutae 15 parts, Fructus Rubi 15 parts, 5 parts of river car powder.
Conventional method decocts.
Embodiment 8 treats the preparation (eight) of premature ovarian failure medicine
Fructus Ligustri Lucidi 11 parts, Fructus Mori 11 parts, Semen Cuscutae 11 parts, Fructus Rubi 11 parts, 2 parts of river car powder.
Conventional method decocts.
Embodiment 9 treats the preparation (nine) of premature ovarian failure medicine
Fructus Ligustri Lucidi 13 parts, Fructus Mori 11 parts, Semen Cuscutae 11 parts, Fructus Rubi 11 parts, 2 parts of river car powder.
Conventional method decocts.
Embodiment 10 treats the preparation (ten) of premature ovarian failure medicine
Fructus Ligustri Lucidi 13 parts, Fructus Mori 13 parts, Semen Cuscutae 11 parts, Fructus Rubi 11 parts, 2 parts of river car powder.
Conventional method decocts.
Embodiment 11 treats the preparation (11) of premature ovarian failure medicine
Fructus Ligustri Lucidi 13 parts, Fructus Mori 13 parts, Semen Cuscutae 13 parts, Fructus Rubi 11 parts, 2 parts of river car powder.
Conventional method decocts.
Embodiment 12 treats the preparation (12) of premature ovarian failure medicine
Fructus Ligustri Lucidi 13 parts, Fructus Mori 13 parts, Semen Cuscutae 13 parts, Fructus Rubi 13 parts, 2 parts of river car powder.
Conventional method decocts.
Embodiment 13 treats the preparation (13) of premature ovarian failure medicine
Fructus Ligustri Lucidi 13 parts, Fructus Mori 13 parts, Semen Cuscutae 13 parts, Fructus Rubi 13 parts, 4 parts of river car powder.
Conventional method decocts.
Embodiment 14 treats the preparation (14) of premature ovarian failure medicine
Fructus Ligustri Lucidi 12 parts, Fructus Mori 11 parts, Semen Cuscutae 13 parts, Fructus Rubi 11 parts, 2 parts of river car powder.
Conventional method decocts.
Embodiment 15 treats the preparation (15) of premature ovarian failure medicine
Fructus Ligustri Lucidi 14 parts, Fructus Mori 13 parts, Semen Cuscutae 13 parts, Fructus Rubi 11 parts, 2 parts of river car powder.
Conventional method decocts.
Embodiment 16 treats the preparation (16) of premature ovarian failure medicine
Fructus Ligustri Lucidi 13 parts, Fructus Mori 11 parts, Semen Cuscutae 11 parts, Fructus Rubi 13 parts, 3 parts of river car powder.
Conventional method decocts.
It should be noted that the conventional method decoction described in embodiment 1-16 is the making of Chinese medicine decoction routine
Method, crude drug boiling that will be described becomes decoction.
Embodiment 17 treats the preparation of premature ovarian failure medicinal tablet/capsule
The arbitrary described medicine of Example 1-16, adds 8-12 times amount water, decocts 1-3 hour, leach medicine
Juice.Add 10 times amount water again, decoct 1.5-2.5 hour, leach medicine juice, merge secondary decocting liquid, stand, filter
Take supernatant, concentrate, let cool, add concentrated solution 2.5 times amount ethanol, stir precipitates overnight.Take supernatant,
It is concentrated into thick extractum；Add pharmaceutical aids, vacuum drying, pulverize and pelletize, be pressed into tablet or fill dress glue
Capsule.
Embodiment 18 treats the preparation of premature ovarian failure drug particles
The arbitrary described medicine of Example 1-16, adds 8-10 times amount water, decocts 2.5-3.5 hour, leach
Medicine juice.Add 10 times amount water again, decoct 2 hours, leach medicine juice, merge secondary decocting liquid, stand, leaching
Supernatant, concentrates, lets cool, and adds concentrated solution 2 times amount ethanol, stirs precipitates overnight.Take supernatant, concentrate
To thick extractum；Add suitable pharmaceutical aids, pelletize, be dried, granulate, obtain 20g granule, subpackage 10g/ bag.
Embodiment 19 treats the preparation of premature ovarian failure drug mixture/oral liquid/syrup
The arbitrary described medicine of Example 1-16, adds 8-10 times amount water, decocts 3 hours, leach medicine juice.
Add 8 times amount water again, decoct 2 hours, leach medicine juice, merge secondary decocting liquid, stand, leaching supernatant,
Concentrate, let cool, add concentrated solution 2 times amount ethanol, stir precipitates overnight.Take supernatant, be concentrated into thick extractum；
Add suitable pharmaceutical aids, make mixture, oral liquid or syrup.
Embodiment 20 treats premature ovarian failure zoopery
1 material and method
1.1 experimental subject
Female KM kind mice, in 8-10 week, raises under room temperature, freely drinks water and ingest.
1.2 reagent
Estradiol valerate tablet, effective ingredient 1mg/ sheet；
Cyclophosphamide for injection, 0.2g/ bottle, lot number: 12031425；
Progesterone radioimmunoassay kits
Estradiol radioimmunoassay kit
1.3 experimental technique
Normal female kunming mice, is divided into matched group, aging model group, treatment group, compares one group, comparison
Two groups, compare three groups and positive drug group, often group 10, except matched group injecting normal saline every day, remaining
The continuous intraperitoneal injection of cyclophosphamide of each experimental group (25mg/kg), injection 5 days, prepare premature ovarian failure mould continuously
Type.Treatment group, control group mice give gastric infusion.Wherein treatment group mice gives weight described in embodiment 1
The Chinese medicine composition of amount part, it is containing crude drug amount 0.25g/ml that conventional method decocts to concentration, and dosage is
600mg/kg.Compare one group of Chinese medicine composition giving following weight portion: Fructus Ligustri Lucidi 12 parts, Semen Cuscutae 12
Part, Fructus Rubi 12 parts, 3 parts of river car powder, conventional method decoction is containing crude drug amount 0.25g/ml to concentration,
Dosage is 600mg/kg.Compare two groups of Chinese medicine compositions giving following weight portion: Fructus Ligustri Lucidi 12 parts,
Fructus Mori 12 parts, Semen Cuscutae 12 parts, Fructus Rubi 12 parts, conventional method decoction is containing crude drug amount to concentration
0.25g/ml, dosage is 600mg/kg.Compare three groups of Chinese medicine compositions giving following weight portion: Fructus Ligustri Lucidi
Son 6 parts, Fructus Mori 20 parts, Semen Cuscutae 20 parts, Fructus Rubi 20 parts, 6 parts of river car powder, conventional method is decocted
Boiling to concentration as containing crude drug amount 0.25g/ml, dosage is 600mg/kg.Positive group mice gives valeric acid female two
Alcohol 0.085mg/kg, gastric infusion.All administration mice successive administrations 4 weeks.Experiment terminates rear eyeball of mouse
Take blood, estradiol (E2) and the level of progesterone (P) in detection serum.De-cervical vertebra is put to death, take ovary,
Weighing rapidly in uterus, calculates organ index respectively；Left uterine and ovary are fixed with 10% formalin,
Paraffin section, HE dyes, measures mean endometrial thickness with micrometer under the microscope；Counting ovary
The quantity of total follicle, observes granular cell form and the number of plies, and tissue is with or without fibrosis and necrosis.Organ index
=organ weights (mg)/weight (100g).
2 data process&analysis
With SPSS software, test data is carried out statistical analysis, calculates meansigma methods and the standard deviation of observation index,
Group difference is compared with t inspection.
3 results
3.1 on female mice uterus and the impact of ovarian index
Result is as shown in table 1, compares with blank group, and uterus and the ovarian index of model group mice significantly reduce
(P<0.05)；Compare with model group, treatment group, compare three groups and estradiol valerate group all can significantly improve
Uterus and ovarian index (P < 0.05).
Table 1 different dosing is on Mouse Uterus and the impact of ovarian index
| Group | n | Uterus index % | Ovarian index % |
| Blank group | 10 | 138.31±46.35 | 32.47±4.86 |
| Model group | 10 | 70.67±21.33* | 18.64±3.48* |
| Treatment group | 10 | 125.16±36.58# | 30.28±4.22# |
| Compare one group | 10 | 90.16±26.47 | 22.17±4.15 |
| Compare two groups | 10 | 95.48±24.63 | 23.18±4.22 |
| Compare three groups | 10 | 112.57±30.86# | 29.33±4.71# |
| Positive drug group | 10 | 140.68±34.62# | 32.44±5.05# |
Note: compare * P < 0.05 with blank group；Compare with model group, #p < 0.05.
3.2 couples of female mice serum E2Impact with P content
Result is as shown in table 2, and compared with blank group, E2 and the P level of model group mice significantly reduces
(P<0.05)；Compare with model group, treatment group and estradiol valerate group all can significantly improve high estradiol and
Progesterone level (P < 0.05).
Estradiol in mice serum and progesterone content are affected by table 2 different dosing
| Group | n | E2(pg/mL) | P(ng/mL) |
| Blank group | 10 | 3.52±0.48 | 15.34±4.25 |
| Model group | 10 | 1.16±0.25* | 7.28±2.77* |
| Treatment group | 10 | 2.96±0.33# | 13.58±3.31# |
| Compare one group | 10 | 1.58±0.38 | 9.21±1.85 |
| Compare two groups | 10 | 1.79±0.34 | 9.35±3.27 |
| Compare three groups | 10 | 1.66±0.52 | 9.81±2.65 |
| Positive drug group | 10 | 3.13±0.28# | 15.84±3.71# |
Note: compare * P < 0.05 with blank group；Compare with model group, #p < 0.05.
Result above shows: the Chinese medicine composition of the present invention can improve uterus, ovary organ index, increases son
Endometrium thickness, also makes that the development of ovary is good, follicle increasing number simultaneously, and improves to a certain extent
Estradiol, progesterone content in serum.Uterus, ovary organ index are to evaluate tested material estrogen effect
Common counter, is all proportionate with internal estrogen level.The Chinese medicine composition of the prompting present invention is to slowing down ovum
The decline of nest function has certain effect.
Embodiment 21 treats premature ovarian failure clinical experiment
1 physical data
In patient's totally 120 example that the court's Out-patient Clinic of Department of Gynecology is medical during selecting in February ,-2016 in March, 2015,
Be randomly divided into treatment group and matched group, often group patient at the aspect such as age, the course of disease through statistical procedures without significantly
Sex differernce (P > 0.05), has comparability.
2 diagnostic criterias
2.1 Western medicine diagnose standards
With reference to " clinical manifestation of premature ovarian failure and diagnostic criteria " and " obstetrics and gynecology " standard.
(1) 40 years old anuresis warp of clinical manifestation, how with perimenopausal syndrome symptom；
(2) hormone serum level measures follicle stimulating hormone FSH>40U/L, estradiol E2<73.2pmol/L,
Lutropin LH is normal or raises；
(3) the insensitive syndrome of ovary, germinal aplasia etc. are got rid of；
(4) B ultrasonic shows without dominant follicle, without organic disease.
2.2 tcm diagnosis standards
According to " China's obstetrics and gynecology " amenorrhea, premature ovarian failure chapters and sections, " disease of tcm Standardization of diagnosis and curative effect "
Belong to renal deficiency type.
(1) primary symptom: menopause before 40 years old, infrequent menstruation to amenorrhea or suddenly menolipsis, soreness of the waist and knees, Shi Huo
Warm sweating, time or fear of cold be afraid of cold；
(2) secondary disease: dizziness and tinnitus, fatigue and weakness, insomnia and dreamful sleep, hyposexuality, leukorrhagia amount is few, face
The few China of color；Light red tongue or red thin fur, thready and weak pulse or thin string.
The selection of 3 cases
3.1 inclusive criteria
(1) diagnostic criteria of doctor trained in Western medicine POF and Standards of Chinese Medical Syndrome Differentiation person are met；
(2) 2 times or above serum estrone FSH>40U/L, estradiol E2<73.2pmol/L, corpus luteum
Generate element LH normal or raise (twice inspection intervals more than one month)；
(3) age is between 18-40 year；
(4) patient willingness participates in this research and can actively coordinate further consultation, completes clinical observers；
(5) other medicines therapist is not used during treatment.
3.2 exclusion standard
(1) inclusive criteria is not met and not by regulation medication, it is impossible to judge the infull person of curative effect or data；
(2) have genital malformation, lack as etc. organic disease person；
(3) there is the amenorrhea caused by immune factor, inherited genetic factors；
(4) there are the severe primary diseases such as cardiovascular and cerebrovascular vessel, liver, kidney, hemopoietic system, or affect it
The serious disease of fertility, such as tumor；
(5) to drugs allergy sufferers.
4 Therapeutic Method
Use random, the method for comparison, patient is divided into treatment group and matched group totally four groups, often organizes disease
Example physical data no significant difference, has comparability (P > 0.05).
Treatment group uses the Chinese medicine composition of weight portion described in embodiment 1, and conventional method decocts to concentration as containing
Crude drug amount 0.25g/ml, every day 1 dose, 1 dose is 10mL.
Compare one group of Chinese medicine composition using following weight portion: Fructus Ligustri Lucidi 12 parts, Semen Cuscutae 12 parts, cover
12 parts of basin, 3 parts of river car powder, conventional method decoction is containing crude drug amount 0.25g/ml, every day 1 to concentration
Agent, 1 dose is 10mL.
Compare two groups use following weight portions Chinese medicine compositions: Fructus Ligustri Lucidi 12 parts, Fructus Mori 12 parts, Herba cuscutae
Son 12 parts, Fructus Rubi 12 parts, conventional method decoct to concentration be containing crude drug amount 0.25g/ml, every day 1 dose,
1 dose is 10mL.
Compare three groups use following weight portions Chinese medicine compositions: Fructus Ligustri Lucidi 6 parts, Fructus Mori 20 parts, Herba cuscutae
Son 20 parts, Fructus Rubi 20 parts, 6 parts of river car powder, conventional method decoction is containing crude drug amount 0.25g/ml to concentration,
Every day 1 dose, 1 dose is 10mL.
5 observation index
5.1 clinical efficacy indexes
Tcm symptom standards of grading, with reference to " new Chinese medicine guideline of clinical investigations "
Note: menstruation is cardinal symptom, coefficient is 4, and it is aching and limp for waist, hectic fever sweating situation is minor symptom,
Coefficient is 2, and remaining is accompanied symptoms, and coefficient is 1.
5.2 Testing index
Basis blood FSH, LH, E2 level determination: before all patient treatments and after treatment through row the 3rd day early
Upper empty stomach 8-10 point blood drawing (amenorrhea person is in unlimited time).Use enzyme-linked immunosorbent assay serum FSH, LH,
E2 content.
5.3 safety observations
It is bad that the vital sign (body temperature, breathing, blood pressure, pulse) of patient and period of taking medicine are likely to occur
Reaction.
6 efficacy assessment standards
6.1 Evaluation of Synthetic Effect of Holistic
Recovery from illness: menstruation recovery is normal, and low estrogen symptom and other clinical symptoms disappear substantially, serumal sharp
Element (E2, FSH, LH) is normal, n >=90.
Effective: menstruation, close to normal, is risen in 3 months after drug withdrawal automatically, low estrogen symptom and other face
Bed symptom alleviates, and Serum Sex Hormones is close normal, 60%≤n ＜ 90%.
Effective: menstruation not yet recovers normal, low estrogen symptom and other clinical symptom reliefs, serumal sharp
Have fluctuation, 30%≤n ＜ 60%.
Invalid: before and after treatment, clinical symptoms and serum hormone measure without significant change, n < 30%.
Wherein, scoring before TCM syndrome therapeutic index n=(marking after scoring-treatment before treatment)/treatment
6.2 TCM syndrome efficacy assessment standards
Recovery from illness: after treatment, symptom, sign disappear, n >=90%；
Effective: symptom, sign partial disappearance, 60%≤n ＜ 90% after treatment；
Effective: after treatment, symptom, sign have been alleviated, 30%≤n ＜ 60%；
Invalid: symptom after treatment, sign are not improved or only small part is improved, n ＜ 30%.
7 results
Total effects after 7.1 treatments
Treatment group efficacy result is as follows: cure 24 examples (68.6%), and effective 10 examples (28.6%) are invalid
1 example (2.86%), total effective rate 97.1%.
Compare one group of efficacy result as follows: cure 7 examples (25.9%), effective 12 examples (44.4%), invalid
8 examples (29.6%), total effective rate 70.3%.
Compare two groups of efficacy results as follows: cure 7 examples (28.0%), effective 12 examples (48.0%), invalid
6 examples (24.0%), total effective rate 76.0%.
Compare three groups of efficacy results as follows: cure 18 examples (54.5%), effective 14 examples (42.4%), nothing
Imitate 1 example (3.0%), total effective rate 96.9%.
Treatment group compares with matched group cure rate, and treatment group is apparently higher than matched group (P < 0.05).
3 four groups of patient's comparitive study of table
| Group | n | Cure | Effective | Invalid | Total effective rate |
| Treatment group | 35 | 24 | 10 | 1 | 34 (97.1%) |
| Compare one group | 27 | 7* | 12 | 8 | 19 (70.3%) * |
| Compare two groups | 25 | 7* | 12 | 6 | 19 (76.0%) * |
| Compare three groups | 33 | 18* | 14 | 1 | 32 (96.9%) |
Note: compare * P < 0.05 with treatment group.
The comparison of TCM symptom score before and after 7.2 treatments
After (1) four group for the treatment of, TCM symptom score is decreased obviously P < 0.05 compared with before treatment, has statistics
Learn meaning.
(2) after treatment of control group, TCM symptom score difference compares with treatment group, P < 0.05, has significance
Difference.
These results suggest that four groups of medicines all energy substantially reduction of patient tcm symptom, and treatment group is better than matched group.
The comparison of TCM symptom score before and after the treatment of 4 four groups of table
Before and after 7.3 4 groups of treatments, E2 value compares
Before after (1) four group for the treatment of, estrogen level is relatively treated substantially height P < 0.05, there is statistical significance.
(2) after treatment of control group, estrogen level difference compares with treatment group, P < 0.05, has significance poor
Different.
The above results illustrates that four groups of medicines all can improve estrogen level, and treatment group is better than matched group.
The comparison of E2 value before and after the treatment of 5 four groups of table
Before and after 7.4 treatments, four groups of FSH values compare
(1) after treatment, four groups of FSH levels are decreased obviously before relatively treating, and P < 0.05 has statistical significance.
(2) after treatment of control group, FSH differential horizontal compares with treatment group, P < 0.05, has significant difference.
The above results illustrates that four groups of medicines all can reduce FSH level, and treatment group is better than matched group.
The comparison of FSH value before and after the treatment of 6 four groups of table
The Chinese medicine composition of the present invention can improve chain reaction in patients with premature ovarian blood serum E2 value, reduces FSH level, right
Patient's tcm clinical practice symptom is significantly improved, it is possible to regulation menstruation, ovulation rate, to improving ovary merit
, ovarian failure can be delayed to have significant therapeutic effect, be a kind of effective, safe POF curative
Thing, can use clinically.
The above is only the preferred embodiment of the present invention, it is noted that common for the art
Technical staff, on the premise of without departing from the inventive method, it is also possible to makes some improvement and supplements, these
Improve and supplement and also should be regarded as protection scope of the present invention.
Claims (8)
1. the Chinese medicine composition treating premature ovarian failure, it is characterised in that described Chinese medicine composition is by following heavy
The raw material of amount part is made: Fructus Ligustri Lucidi 10-15 part, Fructus Mori 10-15 part, Semen Cuscutae 10-15 part, Fructus Rubi
10-15 part, river car powder 1-5 part.
Treat the Chinese medicine composition of premature ovarian failure the most according to claim 1, it is characterised in that described Chinese medicine
Compositions is prepared by the raw materials in: Fructus Ligustri Lucidi 11-13 part, Fructus Mori 11-13 part, Semen Cuscutae 11-13
Part, Fructus Rubi 11-13 part, river car powder 2-4 part.
Treat the Chinese medicine composition of premature ovarian failure the most according to claim 1, it is characterised in that described Chinese medicine
Compositions is prepared by the raw materials in: Fructus Ligustri Lucidi 12 parts, Fructus Mori 12 parts, Semen Cuscutae 12 parts, cover
12 parts of basin, 3 parts of river car powder.
4. claim 1-3 arbitrary described Chinese medicine composition application in preparation treatment premature ovarian failure medicine.
Application the most according to claim 4, it is characterised in that described premature ovarian failure is renal deficiency type ovary morning
Decline.
Application the most according to claim 4, it is characterised in that described medicine adds medicine as required can
The carrier accepted is prepared as any pharmaceutical dosage form.
Application the most according to claim 4, it is characterised in that described medicine also includes pharmaceutically allowing
Adjuvant.
Application the most according to claim 4, it is characterised in that the dosage form of described medicine be capsule, granule,
Tablet, oral liquid, mixture or syrup.
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| CN109820918A (en) * | 2019-01-15 | 2019-05-31 | 浙江省立同德医院 | A kind of Chinese materia medica preparation and preparation method thereof for treating anovulatory infertility |
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| CN109820918A (en) * | 2019-01-15 | 2019-05-31 | 浙江省立同德医院 | A kind of Chinese materia medica preparation and preparation method thereof for treating anovulatory infertility |
| CN113398078A (en) * | 2021-08-03 | 2021-09-17 | 山西黄河中药有限公司 | Granular traditional Chinese medicine for improving ovarian reserve function and preparation method thereof |
| CN113398078B (en) * | 2021-08-03 | 2022-05-20 | 山西黄河中药有限公司 | Granular traditional Chinese medicine for improving ovarian reserve function and preparation method thereof |
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