CN108324821B - Traditional Chinese medicine composition with effect of inducing follicular development and application thereof - Google Patents

Traditional Chinese medicine composition with effect of inducing follicular development and application thereof Download PDF

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CN108324821B
CN108324821B CN201810353699.8A CN201810353699A CN108324821B CN 108324821 B CN108324821 B CN 108324821B CN 201810353699 A CN201810353699 A CN 201810353699A CN 108324821 B CN108324821 B CN 108324821B
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traditional chinese
chinese medicine
root
medicine composition
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CN108324821A (en
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赵帅
相珊
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Shandong University of Traditional Chinese Medicine
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/63—Oleaceae (Olive family), e.g. jasmine, lilac or ash tree
    • A61K36/638—Ligustrum, e.g. Chinese privet
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    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/36—Skin; Hair; Nails; Sebaceous glands; Cerumen; Epidermis; Epithelial cells; Keratinocytes; Langerhans cells; Ectodermal cells
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    • A61K36/18—Magnoliophyta (angiosperms)
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Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition with an effect of inducing follicular development and application thereof. The traditional Chinese medicine composition provided by the invention comprises glossy privet fruit, eclipta alba, wolfberry fruit, dodder seed, angelica, white paeony root, prepared rehmannia root, szechuan lovage rhizome, vinegar-processed cyperus tuber, honey-fried licorice root, wine-processed curculigo rhizome, epimedium herb, eucommia bark, himalayan teasel root, donkey-hide gelatin, Chinese taxillus twig, codonopsis pilosula, largehead atractylodes rhizome, baical skullcap root, astragalus root, prepared rehmannia root, wolfberry fruit, villous amomum fruit, Chinese yam. The traditional Chinese medicine composition provided by the invention can effectively promote follicular development, and has a remarkable regulation effect on the expression of local ovarian regulation factors, so that follicular development can be promoted. The traditional Chinese medicine composition can be effectively used for treating female infertility. Meanwhile, the traditional Chinese medicine composition has the characteristics of good medicine effect, high cure rate, low recurrence rate and small toxic and side effects.

Description

Traditional Chinese medicine composition with effect of inducing follicular development and application thereof
Technical Field
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition with an effect of inducing follicular development and application thereof.
Background
Infertility is defined as the lack of any contraceptive measures taken during the year, normal sexual life without successful pregnancy. It is mainly divided into primary infertility and secondary infertility. Primary infertility is never-pregnant; the secondary infertility is infertility after once pregnancy. According to this strict definition, infertility is a common problem, affecting approximately at least 10% to 15% of women of the reproductive age. The primary etiological diagnosis is in turn: ovulation disorders, semen abnormalities, fallopian tube abnormalities, infertility of unknown origin, endometriosis and others such as immunological infertility. Another factor is cervical factors, including cervical stenosis which accounts for more than 5% of all cervical factors. Female infertility is mainly caused by ovulation failure, fallopian tube factors and endometrial receptivity abnormality. Infertility seriously affects family harmony and physical and psychological health of women.
Irregular menstruation, also called as menstrual disorder, is a common gynecological disease manifested as abnormal menstrual cycle or bleeding amount, accompanied by abdominal pain and general symptoms before and during menstruation. The etiology may be organic lesions or dysfunctions. Anovulation caused by dysfunction of one or more links in hypothalamus-pituitary-ovarian axis is one of the pathophysiological bases of menstrual diseases and one of the reasons for infertility, and is a problem which is urgently required to be solved by many patients.
Disclosure of Invention
In order to solve the problems in the prior art, the invention provides a traditional Chinese medicine composition with the effect of inducing follicular development and application thereof.
In order to achieve the purpose, the invention adopts the following scheme:
the invention provides a traditional Chinese medicine composition which comprises the following raw materials in parts by weight: 20-30 parts of glossy privet fruit, 20-30 parts of eclipta alba, 20-30 parts of wolfberry fruit, 20-30 parts of semen cuscutae, 5-20 parts of angelica sinensis, 5-20 parts of radix paeoniae alba, 5-20 parts of prepared rehmannia root, 5-20 parts of ligusticum wallichii, 5-20 parts of vinegar rhizoma cyperi and 2-10 parts of honey-fried licorice root.
Further, the traditional Chinese medicine composition also comprises the following raw materials in parts by weight: 2-10 parts of wine curculigo orchioides, 5-20 parts of epimedium, 20-30 parts of eucommia ulmoides and 20-30 parts of teasel roots.
Further, the traditional Chinese medicine composition also comprises the following raw materials in parts by weight: 5-20 parts of donkey-hide gelatin, 20-30 parts of parasitic loranthus, 20-30 parts of codonopsis pilosula, 5-20 parts of bighead atractylodes rhizome, 5-20 parts of scutellaria baicalensis and 20-30 parts of astragalus membranaceus.
Further, the traditional Chinese medicine composition also comprises the following raw materials in parts by weight: 2-10 parts of fructus amomi, 5-20 parts of Chinese yam, 5-20 parts of dogwood fruit wine, 5-20 parts of rhizoma alismatis, 5-20 parts of poria cocos and 5-20 parts of moutan bark.
Further, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 25 parts of glossy privet fruit, 25 parts of eclipta alba, 25 parts of wolfberry fruit, 25 parts of dodder seed, 15 parts of angelica, 15 parts of white peony root, 15 parts of prepared rehmannia root, 15 parts of ligusticum wallichii, 15 parts of vinegar-processed cyperus tuber, 6 parts of honey-fried licorice root, 6 parts of winebibber, 15 parts of epimedium herb, 25 parts of eucommia bark, 25 parts of teasel root, 15 parts of donkey-hide gelatin, 25 parts of loranthus parasiticus, 25 parts of codonopsis pilosula, 15 parts of bighead atractylodes rhizome, 15 parts of scutellaria baicalensis, 25 parts of astragalus membranaceus, 6 parts of fructus amomi, 15 parts of Chinese yam, 15 parts of.
The glossy privet fruit is sweet and bitter in taste and cool in nature, and enters liver and kidney meridians. The functional indications are as follows: has the effects of nourishing liver and kidney, improving eyesight and blackening hair, and is mainly used for treating dizziness and tinnitus, soreness and weakness of waist and knees, early white beard and hair, dim eyesight and other diseases clinically.
Dodder seed, sweet in taste and warm in nature, enters liver, kidney and spleen meridians. The functional indications are as follows: nourishing liver and kidney, arresting seminal emission, arresting polyuria, preventing miscarriage, improving eyesight, and relieving diarrhea.
Eclipta alba is sweet and sour in flavor and cold in nature, and enters kidney and liver meridians. The functional indications are as follows: nourishing liver and kidney, cooling blood and stopping bleeding.
Gou Qi Zi is sweet in flavor and neutral in nature, and enters liver and kidney meridians. The functional indications are as follows: nourishing liver and kidney, replenishing vital essence and improving eyesight.
Prepared rehmannia root, radix rehmanniae Praeparata is sweet in nature and slightly warm in taste, and enters liver and kidney meridians. The functions are mainly used for nourishing yin, enriching blood, replenishing vital essence and replenishing marrow.
Dang Gui is sweet and pungent in flavor and warm in nature, and enters liver, heart and spleen meridians. The functional indications are as follows: tonify blood, activate blood, regulate menstruation, alleviate pain, moisten intestines to relieve constipation.
White peony root, radix paeoniae alba, bitter in flavor and slightly cold in nature, has the following main functions: calming liver, relieving pain, nourishing blood, regulating menstruation, astringing yin, and arresting sweating, and can be used for treating headache, giddiness, hypochondriac pain, abdominal pain, limb spasm pain, blood deficiency, sallow complexion, menoxenia, spontaneous sweat, and night sweat.
Chuan Xiong is pungent in flavor and warm in nature, and enters liver, gallbladder and pericardium channels; the functional indications are as follows: promote blood circulation and move qi, dispel wind and alleviate pain.
The nutgrass galingale rhizome is pungent, slightly bitter, slightly sweet and neutral in nature, and enters liver, spleen and triple energizer meridians; the functional indications are as follows: move qi and relieve depression, regulate menstruation and alleviate pain.
Licorice, sweet in taste, neutral in nature, enters heart, lung, spleen and stomach meridians; the functional indications are as follows: invigorating spleen and replenishing qi, clearing away heat and toxic material, eliminating phlegm and relieving cough, relieving spasm and pain, and harmonizing the drugs.
The wine rhizoma curculiginis, pungent, sweet and warm in taste, enters kidney and liver meridians and mainly treats the following functions: warming kidney, strengthening yang, dispelling cold and removing dampness.
The epimedium herb is pungent and sweet in flavor and warm in flavor, enters liver and kidney meridians, and has the main functions: tonify kidney yang, strengthen tendons and bones, dispel wind-damp.
Eucommia bark, cortex eucommiae, sweet in taste, warm in nature, enters liver and kidney meridians, and has the following main functions: tonify liver and kidney, strengthen tendons and bones, prevent abortion.
Teasel root, bitter and pungent in flavor and slightly warm in nature, enters liver and kidney meridians and has the main functions: tonify liver and kidney, strengthen tendons and bones, continue fracture and stop metrorrhagia and metrostaxis.
Donkey-hide gelatin is sweet in taste and neutral in nature, enters lung, liver and kidney meridians, and has the following main functions: tonify blood, nourish yin, moisten dryness and stop bleeding.
Loranthus mulberry mistletoe is bitter and sweet in taste, neutral in nature, and enters liver and kidney meridians; the functional indications are as follows: tonify liver and kidney, strengthen tendons and bones, dispel wind-damp, and prevent abortion.
The codonopsis pilosula is sweet in taste and mild in nature; spleen and lung meridian entered; the functional indications are as follows: tonify middle-jiao and Qi, invigorate spleen and benefit lung.
The white atractylodes rhizome is bitter and sweet in taste, warm in nature, and has the main functions of entering spleen and stomach meridians: invigorate spleen, replenish qi, dry dampness, induce diuresis, stop sweating, prevent abortion.
The scutellaria is bitter in taste and cold in nature, and has the effects of clearing heat and drying dampness, purging fire and removing toxicity, stopping bleeding, preventing miscarriage and the like.
Astragalus root, sweet, warm; enters lung, spleen, liver and kidney meridians and has the following main functions: protecting liver, promoting urination, resisting aging, resisting stress, lowering blood pressure, and resisting bacteria.
Fructus amomi is pungent in flavor and warm in nature, enters spleen, stomach and kidney channels, and mainly has the functions of resolving dampness, stimulating appetite, warming spleen, checking diarrhea, regulating qi and preventing miscarriage.
The Chinese yam is sweet in taste and neutral in nature, enters spleen channels, lung channels and kidney channels, and has the following main functions: tonify spleen and stomach, promote the production of body fluid and nourish lung, tonify kidney and astringe essence.
Cornus officinalis processed with wine has sour, astringent and slightly warm taste, enters liver and kidney channels, has the functions of tonifying liver and kidney, and arresting seminal emission and controlling depletion, and is used for treating dizziness and tinnitus, soreness and pain of waist and knees, impotence and spermatorrhea, enuresis and frequent micturition, metrorrhagia and metrostaxis, profuse sweat and depletion, internal heat and thirst quenching.
Rhizoma alismatis is sweet in taste and cold in nature, enters kidney and bladder channels, and mainly has the following functions: induce diuresis, clear damp-heat.
Poria cocos is sweet and bland in taste and neutral in nature, and has the functions of benefiting heart, lung, spleen and kidney channels, and mainly has the functions of promoting diuresis and excreting dampness, and tonifying spleen and calming heart.
Cortex moutan is bitter and pungent in flavor, slightly cold in nature, and enters heart, liver and kidney meridians; the functions are mainly used for clearing heat and cooling blood, and promoting blood circulation and removing blood stasis.
For infertility, the traditional Chinese medicine differentiation starts from the holistic concept, takes the principle of kidney domination reproduction as guidance, mainly tonifies kidney, nourishes yin and strengthens yang, regulates qi and blood, regulates the menstrual cycle, regulates the balance between kidney yin and kidney yang, promotes the function of kidney, reestablishes the balance between disordered kidney-sex-stimulating-uterus, thereby regulating endocrine, and achieves the purpose of promoting follicular development and ovulation by combining with the ovarian periodic change.
In the invention, dodder and glossy privet fruit are taken as monarch drugs, eclipta alba and medlar are taken as ministerial drugs, prepared rehmannia root, angelica, white paeony root, szechuan lovage rhizome and vinegar rhizoma cyperi are taken as adjuvant drugs, and honey-fried licorice root is taken as a conductant drug. The prescription can remarkably improve the cure rate of irregular menstruation and amenorrhea; on the basis, the wine rhizoma curculiginis, the epimedium, the eucommia and the teasel root are added, so that the cure rate of irregular menstruation and amenorrhea can be further improved, and the symptoms of abdominal pain during menstruation can be effectively relieved. Based on the research, donkey-hide gelatin, parasitic loranthus, codonopsis pilosula, bighead atractylodes rhizome, scutellaria baicalensis and astragalus mongholicus are added, and the traditional Chinese medicine composition can be used for treating ovulation failure caused by kidney qi (yang) deficiency.
The invention also provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps:
grinding the traditional Chinese medicine components respectively and mixing to obtain a mixture A; soaking the mixture A in edible alcohol, and purifying.
Further, the concentration of the edible alcohol is 52%, and the soaking time is 15 days.
The invention also provides application of the traditional Chinese medicine composition in preparing medicines for treating irregular menstruation and amenorrhea.
The invention also provides application of the traditional Chinese medicine composition in preparing a medicine for treating infertility caused by ovulation failure.
The invention also provides application of the traditional Chinese medicine composition in preparing a medicine for treating polycystic ovary.
The invention has the following beneficial effects:
the traditional Chinese medicine composition provided by the invention can effectively promote follicular development, and has a remarkable regulation effect on the expression of ovarian local regulation factors, so that follicular development can be promoted; the traditional Chinese medicine composition can be effectively used for treating female infertility. Meanwhile, the traditional Chinese medicine composition has the characteristics of good medicine effect, high cure rate, low recurrence rate and small toxic and side effects.
Detailed description of the invention
It is to be understood that the following detailed description is exemplary and is intended to provide further explanation of the invention as claimed. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.
It is noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of exemplary embodiments according to the invention. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, and it should be understood that when the terms "comprises" and/or "comprising" are used in this specification, they specify the presence of the stated features, steps, operations, and/or combinations thereof, unless the context clearly indicates otherwise.
The present invention will be further described with reference to the following specific examples, but the present invention is not limited to these examples.
Example 1
The traditional Chinese medicine composition comprises the following components in parts by weight:
30 parts of glossy privet fruit, 30 parts of eclipta alba, 30 parts of wolfberry fruit, 30 parts of dodder, 20 parts of angelica, 20 parts of white paeony root, 20 parts of prepared rehmannia root, 20 parts of szechuan lovage rhizome, 20 parts of vinegar-processed nutgrass galingale rhizome and 10 parts of honey-fried licorice root.
The preparation method of the traditional Chinese medicine composition comprises the following steps:
step S1: respectively grinding fructus Ligustri Lucidi, Ecliptae herba, fructus Lycii, semen Cuscutae, radix Angelicae sinensis, radix Paeoniae alba, radix rehmanniae Preparata, rhizoma Ligustici Chuanxiong, Vinegar rhizoma Cyperi, and radix Glycyrrhizae Preparata, and mixing to obtain mixture A;
step S2: soaking the mixture A in 52% edible alcohol for 15 days, and purifying.
(I) the subject
The patients with irregular menstruation, infertility and amenorrhea 30 cases come from subsidiary hospitals of Shandong Chinese medicine university in 2015, 5 months to 2017 months.
Diagnostic criteria of traditional Chinese medicine
The diagnosis of traditional Chinese medicine is incorporated by reference to the standard of diagnosis of traditional Chinese medicine in the "guiding principle of clinical research on new Chinese medicine for treating irregular menstruation, infertility and amenorrhea" in the first edition of 1993:
menstrual disorder: the two consecutive periods have advanced or delayed menstrual cycle for more than 7 days and less than 2 weeks, abnormal menstrual flow, or prolonged menstrual period.
② amenorrhea: when the age is over 16 years old, the first tide still comes, or the menstruation is stopped more than 3 cycles before the original menstruation cycle, or the menstruation is not started for 6 months.
Thirdly, infertility: after marriage, the male and the female live together, the sexual life is normal, the sperm motility and other functions of the male are normal, and the male can not receive the pregnancy after not contraception for more than 1 year.
Inclusion criteria
(1) Those who meet the above diagnostic criteria for irregular menstruation, infertility and amenorrhea;
(2) women older than 18 years, younger than 40 years;
(3) female patients who volunteered to participate in the observation study and signed informed consent.
Exclusion criteria
(1) Hormone preparations such as artificial cycle, ovulation promoting medicine, contraceptive, etc. are taken or used within 3 months;
(2) organic lesions such as genital organ malformation, congenital gonadal dysplasia, fallopian tube obstruction, adhesion, endometriosis and the like;
(3) amenorrhea caused by hypoovarianism, even premature ovarian failure and the like;
(4) hyperthyroidism, hypothyroidism, cushing's syndrome, hyperprolactinemia and other endocrine gland dysfunction causes;
(5) serious diseases such as liver and kidney dysfunction, cardiovascular and cerebrovascular diseases, psychosis and blood diseases;
(6) the patients with the dysfunction are judged by the curative effect or the patients with the influence on the observation of the curative effect and the personal safety due to the incomplete data and the like without taking the medicine according to the advice of the doctor.
Standard of case loss
All patients who meet the inclusion standard and sign informed consent after screening quit the right of clinical observation at any time, and if all clinical observations are not completed, all patients belong to the case of abscission no matter how quit.
(II) the treatment method comprises the following steps:
the Chinese medicinal composition of this example 1 was administered twice daily
The evaluation standard of curative effect is as follows:
and (3) curing: the clinical symptoms and physical signs disappear, the functional activities return to normal, and the indexes return to normal after being checked.
Improvement: the clinical symptoms and signs are obviously improved or improved, and each index is slightly improved after examination.
And (4) invalidation: the clinical symptoms and signs are not improved, and the examination indexes are not improved.
(III) treatment effect:
the traditional Chinese medicine composition of the embodiment is taken to treat irregular menstruation and amenorrhea, the cure rate is 85%, the improvement rate is 7%, and the failure rate is 8%.
Example 2
After a patient with irregular menstruation takes the traditional Chinese medicine composition in the example 1, the cure rate can reach 85%, but the symptoms of abdominal pain of the patient during menstruation are not effectively improved. In order to overcome the defects of the traditional Chinese medicine composition in the embodiment 1, the wine rhizoma curculiginis, the epimedium, the eucommia ulmoides and the teasel roots are further added on the basis of the embodiment 1.
The traditional Chinese medicine composition comprises the following components in parts by weight: 30 parts of glossy privet fruit, 30 parts of eclipta alba, 30 parts of wolfberry fruit, 30 parts of dodder seed, 20 parts of angelica, 20 parts of white paeony root, 20 parts of prepared rehmannia root, 20 parts of ligusticum wallichii, 20 parts of vinegar rhizoma cyperi, 10 parts of honey-fried licorice root, 10 parts of curculigo orchioides, 20 parts of epimedium herb, 30 parts of eucommia bark and 30 parts of teasel root.
The preparation method of the traditional Chinese medicine composition is similar to that of example 1.
The test is carried out according to the method of the embodiment 1, and the traditional Chinese medicine composition disclosed by the embodiment is used for treating the irregular menstruation, wherein the cure rate is 92%, the improvement rate is 3%, the failure rate is 5%, and the symptoms of the abdominal pain during menstruation can be obviously improved.
Example 3
The basic pathogenesis of the disease is kidney deficiency, liver depression, phlegm dampness and blood stasis, because the kidney essence deficiency, liver qi depression and blood stasis and phlegm turbidity pathological products can all cause ovulation failure. The kidney deficiency is the main cause and pathogenesis of ovulation failure because the kidney governs reproduction and controls menstruation and pregnancy of women. In the embodiment 1 of the invention, dodder and glossy privet fruit are taken as monarch drugs, eclipta alba and medlar are taken as ministerial drugs, prepared rehmannia root, angelica, white paeony root, szechuan lovage rhizome and vinegar rhizoma cyperi are taken as adjuvant drugs, and honey-fried licorice root is taken as a conductant drug. On the basis of the medicine taking in the embodiment 1, the addition of the wine rhizoma curculiginis, the epimedium herb, the eucommia bark and the teasel root can improve the cure rate of irregular menstruation and can also improve the symptoms of abdominal pain during menstruation of patients. Further research shows that donkey-hide gelatin, parasitic loranthus, codonopsis pilosula, bighead atractylodes rhizome, scutellaria baicalensis and astragalus mongholicus are continuously added on the basis of the embodiment 1 and the embodiment 2, and the traditional Chinese medicine composition can be used for treating ovulation failure caused by kidney qi (yang) deficiency.
The traditional Chinese medicine composition comprises the following components in parts by weight: 30 parts of glossy privet fruit, 30 parts of eclipta alba, 30 parts of wolfberry fruit, 30 parts of dodder seed, 20 parts of angelica, 20 parts of white paeony root, 20 parts of prepared rehmannia root, 20 parts of ligusticum wallichii, 20 parts of vinegar-processed rhizoma cyperi, 10 parts of honey-fried licorice root, 10 parts of curculigo orchioides, 20 parts of epimedium herb, 30 parts of eucommia bark, 30 parts of teasel root, 20 parts of donkey-hide gelatin, 30 parts of loranthus parasiticus, 30 parts of codonopsis pilosula, 20 parts of bighead atractylodes rhizome, 20.
The preparation method of the traditional Chinese medicine composition is similar to that of example 1.
In this example, the patients with renal qi (yang) deficiency and ovulation failure were examined and examined.
(I) the subject
The diagnosis of the cases from the subsidiary hospital of Shandong Chinese medicine university at 5-2017 months in 2015 is 100 patients with kidney qi (yang) deficiency ovulation failure, and the cases are randomly divided into two groups: traditional Chinese medicine and clomiphene medicine.
Western diagnostic criteria:
the western medicine diagnosis refers to the diagnosis standard of ovulation-free in the ' diagnosis standard of female infertility ' revised by the special Committee of gynaecology and obstetrics of the Chinese society of Chinese traditional and western medicine ' in the third academic conference;
clinical symptoms: menstrual cycle disorders (thin menstruation, even amenorrhea, or irregular vaginal bleeding).
And (3) routine gynecological examination: no obvious abnormality is seen in the uterus and the annexes; uterus is slightly small, and no obvious abnormality is found in the rest; or the uterus is normal in size and shape, and the accessible ovary of one side or two sides of the accessory area is enlarged and changed.
Diagnostic criteria of traditional Chinese medicine
The diagnosis of traditional Chinese medicine is incorporated by reference to the standard of diagnosis of traditional Chinese medicine in the "guiding principle of clinical research on new Chinese medicine for treating irregular menstruation, infertility and amenorrhea" in the first edition of 1993:
menstrual disorder: the two consecutive periods have advanced or delayed menstrual cycle for more than 7 days and less than 2 weeks, abnormal menstrual flow, or prolonged menstrual period.
② amenorrhea: when the age is over 16 years old, the first tide still comes, or the menstruation is stopped more than 3 cycles before the original menstruation cycle, or the menstruation is not started for 6 months.
And thirdly, infertility, after marriage, the male and the female live together, normal sexual life, normal functions of sperm motility and the like of the male, and people who have not been contraceptive for more than 1 year and cannot be pregnant.
Traditional Chinese medicine kidney qi (yang) deficiency type syndrome differentiation standard
The method is formulated according to the deficiency syndrome of the Chinese traditional and western medicine integrated society of traditional Chinese medicine and New drug clinical research guidelines and the 'reference standard for differentiating the deficiency syndrome of traditional Chinese medicine' formulated by the revised professional committee of the research on senile diseases:
kidney deficiency syndrome:
(1) kidney qi deficiency type
Menstrual disorder (menstrual cycle, abnormal menstruation volume, abnormal menstruation color and even amenorrhea), soreness and weakness of waist and legs, pale tongue,
thin and white tongue coating, weak ulnar pulse, frequent nocturia or urinary incontinence, thin leucorrhea, dyspnea, shortness of breath, deafness or tinnitus, tiredness, fatigue, insomnia and night sweat.
The diagnosis can be confirmed when any two of the first, second, third and fourth-nine are met.
(2) Type of deficiency of Kidney Yang
Menstrual disorder A (hypomenorrhea, even amenorrhea), B aversion to cold, cold limbs, C pale tongue, thin and white coating, deep and thready pulse, weakness of the ulnar pulse, D soreness of the waist and knees, heel pain, E alopecia, tooth loss, F listlessness, G hyposexuality, infertility, H soreness of the waist and knees, soreness of the waist and knees (caused by trauma already eliminated), I clear and long urine, frequent micturition, or uroschesis, urinary incontinence, J tinnitus and deafness in stool pool.
The diagnosis can be confirmed when there are any two of A + B + C and D-J.
Case selection criteria
Inclusion criteria
(1) Those who meet the above diagnostic criteria for renal deficiency and ovulation disorders;
(2) women older than 18 years, younger than 40 years;
(3) female patients who volunteered to participate in the observation study and signed informed consent.
Exclusion criteria
(1) Hormone preparations such as artificial cycle, ovulation promoting medicine, contraceptive, etc. are taken or used within 3 months;
(2) organic lesions such as genital organ malformation, congenital gonadal dysplasia, fallopian tube obstruction, adhesion, endometriosis and the like;
(3) amenorrhea caused by hypoovarianism, even premature ovarian failure and the like;
(4) hyperthyroidism, hypothyroidism, cushing's syndrome, hyperprolactinemia and other endocrine gland dysfunction causes;
(5) serious diseases such as liver and kidney dysfunction, cardiovascular and cerebrovascular diseases, psychosis and blood diseases;
(6) the patients with the dysfunction are judged by the curative effect or the patients with the influence on the observation of the curative effect and the personal safety due to the incomplete data and the like without taking the medicine according to the advice of the doctor.
Standard of case loss
All patients who meet the inclusion standard and sign informed consent after screening quit the right of clinical observation at any time, and if all clinical observations are not completed, all patients belong to the case of abscission no matter how quit.
(II) methods of treatment
The traditional Chinese medicine comprises: the later period of administration of the composition of example 3;
western medicine group: clomiphene is orally taken at 50mg/d beginning on day 5 of menstrual flow, and is taken once a day for 5d continuously.
(3) Observation indexes are as follows:
follicular development: follicular development was monitored by B-ultrasound starting on day 10 of menstruation, 1 time every other day. Dominant follicles >15mm, monitored daily until ovulation.
Endometrial status and scoring criteria: and B ultrasonic testing the thickness, the shape, the B ultrasonic echo and the endometrial and subintimal blood flow in the ovulation period or the LH peak day. Endometrial color ultrasound scoring criteria: the thickness of the endometrium is less than 6mm 0 min; 6-8 mm 1 min; greater than 8mm 3 min. Endometrial morphology: type C is 0 min; type B1 is divided; type A is divided into 3 parts. Endometrial echo: uneven 0 points; evenly dividing by 1; endometrial blood flow: lack of score 0; the existence rate is 1 point; riches for 3 points. Subintimal blood flow: lack of score 0; the existence rate is 1 point; riches for 3 points.
Recording of pregnancy: and recording the number of pregnant patients per period, and counting the pregnancy rate.
(4) Performing statistical analysis
Statistical analysis was performed using the SPSS 22.0 statistical software package: counting data is described by relative numbers, chi-square test is adopted for comparison among groups, and Fisher accurate test is adopted when T is less than 1; the measurement data is statistically described by means of the mean ± standard deviation (normal distribution) or m (q) (non-normal distribution). All statistics were performed by two-sided test, and differences were considered statistically significant with P ≤ 0.05.
(III) results of the experiment
Follicular development:
the maximum diameter of the dominant follicle before and after treatment in two groups of patients is shown in Table 1
Table 1 two groups of patients had a preponderance of follicles maximum diameter (cm,
Figure GDA0002900178100000091
)
group of Number of examples Dominant follicular diameter prior to treatment Dominant follicular diameter after treatment
Chinese medicine 50 1.423±0.122 1.748±0.136a
Western medicine group 50 1.496±0.236 1.867±0.144a
Note: compared with the group before treatment,aP<0.05
as can be seen from Table 2, the comparison of the maximum diameter of the follicle before treatment (P > 0.05) in two groups of patients by non-parametric test indicates that the maximum diameter of the follicle before treatment in two groups of patients is comparable without any difference; the maximum diameter (P <0.05) of the dominant follicle of two groups of patients before and after treatment is different, which shows that the two groups are effective, thereby proving that the traditional Chinese medicine composition can effectively promote the development of the follicle.
Endometrial ultrasound scoring
Endometrial ultrasound scoring before and after treatment is shown in table 2 for two groups of patients.
Table 2 two groups of patients had endometrial ultrasound scores before and after treatment (cm,
Figure GDA0002900178100000101
)
group of Number of examples Endometrial ultrasound scoring prior to treatment Endometrial ultrasound scoring after treatment
Chinese medicine 50 5.72±2.18 11.12±2.24a
Western medicine group 50 5.68±2.66 7.08±2.16
Note: compared with the group before treatment,aP<0.05。
as can be seen from Table 2, the endometrial ultrasound scores of the traditional Chinese medicine groups are different before and after treatment, which shows that the traditional Chinese medicine groups can improve the endometrial ultrasound scores.
Pregnancy rate:
statistics of pregnancy rates after treatment for the two groups of patients are shown in table 3.
TABLE 3 statistics of pregnancy rates after treatment for two groups of patients
Group of Number of examples Pregnancy Non-pregnant
Chinese medicine 50 13(26％) 37(74％)
Western medicine group 50 11(22％) 39(78％)
As shown in Table 3, the traditional Chinese medicine can promote pregnancy, and the pregnancy rate can reach 26 percent, which is higher than that of a positive control group.
Example 4
Polycystic ovary syndrome (polycystic ovary PCOS) is one of the most common endocrine disorder diseases of women of reproductive age, is the main cause of anovulatory infertility and accounts for 30-60% of anovulatory infertility patients. The invention simultaneously researches the influence of the traditional Chinese medicine composition in the embodiment 3 on the generation of the ovarian follicles of the polycystic ovarian syndrome, and the effect is not very obvious; in order to improve the treatment effect on polycystic ovary syndrome, fructus amomi, Chinese yam, dogwood fruit wine, rhizoma alismatis, poria cocos and moutan bark are added on the basis of example 3.
The traditional Chinese medicine composition comprises the following components in parts by weight: 25 parts of glossy privet fruit, 25 parts of eclipta alba, 25 parts of wolfberry fruit, 25 parts of dodder seed, 15 parts of angelica, 15 parts of white peony root, 15 parts of prepared rehmannia root, 15 parts of ligusticum wallichii, 15 parts of vinegar-processed cyperus tuber, 6 parts of honey-fried licorice root, 6 parts of winebibber, 15 parts of epimedium herb, 25 parts of eucommia bark, 25 parts of teasel root, 15 parts of donkey-hide gelatin, 25 parts of loranthus parasiticus, 25 parts of codonopsis pilosula, 15 parts of bighead atractylodes rhizome, 15 parts of scutellaria baicalensis, 25 parts of astragalus membranaceus, 6 parts of fructus amomi, 15 parts of Chinese yam, 15 parts of.
(one) study subject: female SD rats, 50, weight 180 ~ 230 g.
50 female SD rats weighing 180-230 g are taken by gavage for letrozole lmg/kg (body weight)/day, dissolved in 1% of carboxymethyl cellulose C (MC), and raised for 21 days. Blood was collected and testosterone (T) and Insulin (INS) levels were measured. Continuous appearance of vaginal keratinocytes was observed and tested in combination with serum T, INS, and those who met the standard were used as PCOS rat models, and rats successfully prepared from the models were divided into 2 groups according to a random number table, i.e., test group and control group. (II) the treatment method comprises the following steps: drug treatment was performed on day 22 after animals received letrozole treatment.
The test group was subjected to intragastric administration of 2ml of the Chinese medicinal materials of example 4 (equivalent to the amount commonly used by adults, in terms of body surface area), and the control group was subjected to intragastric administration of 2ml of physiological saline once a day for 22 consecutive days. After the completion of the administration on day 43, the vaginal smear was fasted at eight points in the evening during the estrus period, weighed at eight points in the next morning, and embedded in paraffin and sliced in selected rat ovaries.
(III) observation of indices
Carrying out immune histochemical analysis on ovarian tissues of selected rat ovarian paraffin embedded sections: the detection is carried out by an immunohistochemical Envision method, the working concentration is 1:20, and the positive expression is that brown yellow (tan) particles appear in cytoplasm according to the operation of the DAB detection kit instruction.
Expression of ovarian local regulatory factor AMH: 2 sections prepared from the same rat ovary are subjected to AMH immunohistochemistry with the same magnification (X20) and the same area, 2-3 positions are selected in the same area as much as possible, and the PU value is calculated respectively and then the average value is obtained.
TNF- α, S P immunohistochemistry for LIF expression: DAB coloration is detected by an immunohistochemical SP method, the section thickness is 4mm, and antigen restoration and HE staining are carried out. And negative and positive controls were analyzed. And (3) judging an immunohistochemical result: positive staining was specific for the surrounding cell membrane and was a brownish yellow particle. Semi-quantitative scoring is carried out on the distribution range and the comprehensive staining intensity, and the negative is O; the staining was clearly stronger than negative but still weak for 1 point; the dyeing clarity is 2 points; the staining intensity was 3 points. Score 0 for positive cells < 5%; 5% < 10% for 1 point; 10% -30% is 2 minutes; > 30% in 3 points. The expression intensity score was added to the above two scores.
Detection of ovarian local regulatory factor IGF-1: immunohistochemistry was performed according to the ABC kit instructions. IGF-1 was quantified using a national emphasis laboratory (neurobiology) Leica Qwin Image quantification analyzer with 10 fields per section and 5 sections per specimen (averaged for integrated optical density).
PCOS has not yet been defined in its etiology, and many studies suggest that ovarian hyperandrogenism results in overabundance of follicles by promoting primordial follicular development, thereby achieving the effect of inhibiting FSH-induced aromatase activity, and that impaired FSH function and/or premature LH action hinder selection of dominant follicles.
Ovarian local regulators are a class of hormone-like polypeptides with a wide range of biological activities. Anti-mullerian hormone (AMH) is one of the transforming growth factors β, expressed mainly in granulosa cells, produced in the gonads. The primary cause of premature ova in patients with PCOS is hyperandrogenism, suggesting that AMH plays a role in pathogenesis by modulating androgens and/or other effects. Animal experiments suggest that AMH may inhibit follicular growth through regulation involved in primordial follicular recruitment and cycle recruitment.
TNF-alpha (tumor necrosis factor) participates in the regulation of the function of an endocrine system in the forms of autocrine, paracrine and long-distance action through receptor mediation, and the previous experiments prove that the TNF-alpha can influence the secretion of steroid hormone and stimulate the differentiation of related cells to regulate the release of reproductive hormone, plays a role in inhibiting the secretion of estrogen and progestogen of granulosa cells, and has certain influence on chronic inflammation and oxidation resistance.
IGF-1 (insulin-like growth factor-1) cross-reacts with insulin (Ins) in the immune mechanism, structurally resembling the cognate insulin family. That is, IGF-1 can stimulate each target organ to produce hyperandrogenism through Ins receptor to further cause PCOS, and free IGF-1 in PCOS serum interacts with hyperandrogenism and hyperinsulinemia as a cause-effect interaction, thereby promoting the further development of PCOS pathophysiology.
(IV) statistical analysis
Statistical analysis was performed using the SPSS 22.0 statistical software package: counting data is described by relative numbers, chi-square test is adopted for comparison among groups, and Fisher accurate test is adopted when T is less than 1; the measurement data is statistically described by means of the mean ± standard deviation (normal distribution) or m (q) (non-normal distribution). All statistics were performed by two-sided test, and differences were considered statistically significant with P ≤ 0.05.
(V) results of the experiment
Light mirror result
Primary follicles, growing follicles and mature follicles are found under a test group, and most follicles are normally developed follicles in the cortex; the number of the granular cell layers is 4-5, so that the granular cells are obviously increased and are regular; the cell layer of the follicle membrane is obviously thinned, and the quantity of corpus luteum tissues is obviously increased. Under the control group, the follicular membrane cell layer is increased and is often yellowed, but the follicular granular cells are reduced, the ovarian cortex interstitial cells are scattered in a plexiform yellowed cell nest, and the interstitial cell proliferation is obvious.
The two groups of PCO rats TNF-alpha, LIF, AMH and IGF-1 are compared and shown in the following table 4:
TABLE 4 comparison of two groups TNF- α, LIF, AMH, IGF-1: (
Figure GDA0002900178100000132
)
Figure GDA0002900178100000131
As shown in Table 4, compared with the control group, the AMH expression intensity of the test group is reduced (P < 0.05); LIF is mainly expressed in ovarian granulosa cell, stromal cell and follicular fluid. The ovary LIF expression level of the rats in the test group is obviously increased, and the difference is very obvious compared with that of the control group (P < 0.05). TNF-alpha is mainly expressed in ovarian granulosa cells, and also in theca cells. The expression level of the ovarian TNF-alpha of the rats in the test group is obviously reduced, and the difference is very obvious compared with that in the control group (P < 0.05). IGF-1 is mainly expressed in theca cells, mesenchymal cells and ovarian granulosa cells. The expression level of the rat ovary IGF-1 in the test group is obviously reduced, and the difference is very obvious compared with the control group (P < 0.05).
The above description is of the preferred embodiment of the invention. It is to be understood that the invention is not limited to the particular embodiments described above, in that devices and structures not described in detail are understood to be implemented in a manner common in the art; those skilled in the art can make many possible variations and modifications to the disclosed embodiments, or equivalent variations, without departing from the spirit and scope of the invention, using the methods and techniques disclosed above. Therefore, any simple modification, equivalent change and modification made to the above embodiments according to the technical essence of the present invention are still within the scope of the protection of the technical solution of the present invention, unless the contents of the technical solution of the present invention are departed.

Claims (4)

1. The traditional Chinese medicine composition is characterized by being prepared from the following raw materials in parts by weight: 25 parts of glossy privet fruit, 25 parts of eclipta alba, 25 parts of wolfberry fruit, 25 parts of dodder seed, 15 parts of angelica, 15 parts of white peony root, 15 parts of prepared rehmannia root, 15 parts of ligusticum wallichii, 15 parts of vinegar-processed cyperus tuber, 6 parts of honey-fried licorice root, 6 parts of winebibber, 15 parts of epimedium herb, 25 parts of eucommia bark, 25 parts of teasel root, 15 parts of donkey-hide gelatin, 25 parts of loranthus parasiticus, 25 parts of codonopsis pilosula, 15 parts of bighead atractylodes rhizome, 15 parts of scutellaria baicalensis, 25 parts of astragalus membranaceus, 6 parts of fructus amomi, 15 parts of Chinese yam, 15 parts of.
2. The preparation method of the traditional Chinese medicine composition according to claim 1, which is characterized by comprising the following steps:
grinding and mixing the Chinese medicinal ingredients of claim 1 respectively to obtain a mixture A; soaking the mixture A in edible alcohol, and purifying.
3. The method of claim 2, wherein the edible alcohol concentration is 52% and the soaking time is 15 days.
4. The use of the composition of claim 1 in the preparation of a medicament for the treatment of polycystic ovary disease.
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