CN113018367A - Traditional Chinese medicine composition for treating thin endometrial hypomenorrhea and preparation method and application thereof - Google Patents
Traditional Chinese medicine composition for treating thin endometrial hypomenorrhea and preparation method and application thereof Download PDFInfo
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- CN113018367A CN113018367A CN202110279302.7A CN202110279302A CN113018367A CN 113018367 A CN113018367 A CN 113018367A CN 202110279302 A CN202110279302 A CN 202110279302A CN 113018367 A CN113018367 A CN 113018367A
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses a traditional Chinese medicine composition for treating hypomenorrhea and infertility caused by thin endometrium and a preparation method thereof, wherein the traditional Chinese medicine composition is prepared from 1-6 parts of roasted tortoise plastron, 1-6 parts of roasted turtle shell, 1-6 parts of prepared rehmannia root, 1-9 parts of dogwood fruit, 1-6 parts of fried white paeony root, 0.5-3 parts of fried angelica, 1-9 parts of ligusticum wallichii, 1.5-9 parts of spina date seed, 1-9 parts of roasted rhizoma anemarrhenae, 1-6 parts of poria cocos, 1-6 parts of fried codonopsis pilosula and 1-12 parts of fried bighead atractylodes rhizome. The traditional Chinese medicine compound can effectively improve the symptoms of kidney-yin deficiency type hypomenorrhea and infertility, increase the menstrual flow, promote endometrial hyperplasia and follicle development in the later menstrual period, improve the levels of serum E2 and LH in the ovulation period, improve the levels of E2 and P in the middle luteal period, increase the thickness of endometrium in the middle luteal period, improve the volume of endometrium, and enrich the hypometrorrhagia perfusion in the middle luteal period, thereby improving the receptivity of endometrium, promoting embryo implantation and assisted pregnancy, and having no toxic or side effect and safe and reliable medication.
Description
Technical Field
The invention relates to a traditional Chinese medicine composition, in particular to a traditional Chinese medicine composition for treating thin endometrial hypomenorrhea and application thereof.
Background
Thin Endometrium (TE) is a common disease in gynecology in recent years, the definition of the disease in modern medicine is not clearly unified so far, and generally, the Thin Endometrium is the Endometrium thickness of less than 7mm on the ovulation day of the natural cycle or the trigger day of the ovulation-promoting cycle, and is clinically mainly represented as normal menstrual cycle or late menstrual cycle, but the menstrual flow is too small (< 20 mL). There are studies showing that: the chance of pregnancy will decrease dramatically when the thickness of the endometrium is < 6mm, i.e. below the threshold at which pregnancy can be obtained. With the continuous improvement of the assisted reproduction technology, the thin endometrium is still one of the main reasons for the failure of embryo transplantation and the reduction of pregnancy rate in clinic, and is also other important influencing factors such as infertility, amenorrhea and the like, and the fact that the endometrium is too thin can be caused by a plurality of factors. With the development of modern science and technology, the working pressure is increased, the working rhythm is accelerated, bad living habits, uterine cavity operations such as artificial abortion and the like frequently occur, or uterine cavity infection is combined, or the growth of endometrium is limited due to long-term oral contraceptives and the like, so that the phenomenon of clinical endometrial thinness is common. Most of the Chinese and western medicine clinicians do not have enough knowledge about the disease and have a good progress on treatment, although the case report of 'endometrium planting' is found, compared with a large amount of clinical demands, the Chinese and western medicine clinicians are not as good as the water salary cup. If the disease is not treated effectively in time, the disease not only brings about mental stress, anxiety and other bad moods to the patient, even develops into depression and other psychological disorders, seriously affects the physical and mental health and reproductive health of women, but also has certain influence on harmonious stability of families, society and the like, and becomes a medical problem of important attention.
There is no record of "thin endometrium" or "endometrial hypofunction" in ancient traditional Chinese medicine, but according to the clinical manifestations, the disease can be classified into the categories of "hypomenorrhea", "infertility", "amenorrhea" and other diseases. Most modern Chinese medicine doctors believe that the basis of the disease is deficiency of liver-yin and kidney-yin and deficiency of qi and blood, and the method of tonifying qi and blood of liver and kidney is adopted for the first time, so that the effect is very little. The inventor thinks that the occurrence of the disease is mainly responsible for heart and kidney, kidney essence storage, reproduction governing, and interior primordial yin and primordial yang as congenital root, which is discharged from kidney through water, and the sexual overstrain causes kidney essence consumption, kidney yin deficiency due to injury of golden blade, kidney essence deficiency after long-term decoction, kidney essence deficiency due to five viscera deficiency, and kidney essence and kidney yin deficiency are the cause of the disease. The heart (brain) governs the spirit and blood vessels, is the principal organ of the monarch, the great main of the five zang-organs and six fu-organs, and various external factors can cause malnutrition of the heart-mind, hyperactivity of heart-fire or stagnation of heart-qi. Kidney essence and kidney yin are in harmony with the heart, so that heart fire is not hyperactivity, heart fire is descended to the kidney, kidney essence and kidney yin are not cold, so that water and fire are in harmony with each other, heart and kidney are in balance, and uterus channels and collaterals are unobstructed, so that blood and sea are full, the intima is thick, uterus stores diarrhea is mild, and menstruation is sufficient and regular. If kidney essence and kidney yin are insufficient, blood and sea are empty, the intima is lost to nourishment, and the heart is not nourished by the blood and heart, heart fire is hyperactivity, the heart fire cannot descend to the kidney, the kidney water is not warm, the uterus is cold and cool, the intima cannot grow, the heart and kidney are not crossed, water and fire are lost, Chong and ren are not sufficient, and the blood and sea cannot be filled by the end, the intima is barren, and the menstruation volume is less, and the later period even amenorrhea is not performed and infertility is caused. Certainly, the generation and smooth circulation of menstruation also need the participation of the liver and spleen, the liver stores blood and mainly disperses and purges, the spleen is the source of qi and blood generation in barn house, the liver regulates qi, the spleen qi is healthy and healthy, the uterine vessels and the uterine collaterals are unobstructed, blood and sea are full, the intima is thick, and the degree of uterine storing and purging is high. If liver qi stagnation or hyperactivity of liver qi makes spleen unable to transport, there is unsmooth choking and conception, and blood and sea can not be fully pressed, the intima is barren, which may aggravate symptoms such as small menstruation volume, late menstruation even amenorrhea. The inner membrane and the sperms and eggs (ovum) are better than the soil and the seeds, and the effects of nourishing kidney and heart, leading the yin to grow heavy, leading the blood sea to be full, leading the inner membrane to be thick, regulating yin and yang and causing no infertility are achieved. Therefore, the occurrence of this disease is mainly related to the kidney and heart, involving the liver and spleen.
Menstruation regulation, pregnancy promotion and miscarriage prevention are unique advantages of traditional Chinese medicines, so that a traditional Chinese medicine composition which is reasonable in formula compatibility, reliable in curative effect and good in safety and can be used for treating thin endometrial hypomenorrhea and infertility is necessarily designed and researched on the basis of the prior art.
Disclosure of Invention
The purpose of the invention is as follows: the invention aims to solve the defects of the prior art and provide the traditional Chinese medicine compound composition which is scientific and reasonable in proportion, has good effects of treating thin endometrial hypomenorrhea and infertility, and is safe and reliable and low in adverse reaction.
The technical scheme is as follows: in order to achieve the above purpose, the invention adopts the technical scheme that:
a traditional Chinese medicine composition for treating thin endometrial hypomenorrhea and infertility comprises the following raw materials in parts by weight:
1-6 parts of roasted tortoise plastron, 1-6 parts of roasted turtle shell, 1-6 parts of prepared rehmannia root, 1-9 parts of cornus officinalis, 1-6 parts of fried white paeony root, 0.5-3 parts of fried angelica, 1-9 parts of ligusticum wallichii, 1.5-9 parts of spina date seed, 1-9 parts of roasted rhizoma anemarrhenae, 1-6 parts of poria cocos, 1-6 parts of fried codonopsis pilosula and 1-12 parts of fried bighead atractylodes rhizome.
Preferably, the traditional Chinese medicine composition for treating thin endometrial hypomenorrhea and infertility is prepared from the following raw materials in parts by weight:
1-3 parts of roasted tortoise plastron, 1-3 parts of roasted turtle shell, 1-3 parts of prepared rehmannia root, 1-4.5 parts of cornus officinalis, 1-3 parts of fried white paeony root, 0.5-1.5 parts of fried angelica, 1-4.5 parts of ligusticum wallichii, 1.5-4.5 parts of spina date seed, 1-4.5 parts of roasted rhizoma anemarrhenae, 1-3 parts of poria cocos, 1-3 parts of fried codonopsis pilosula and 1-6 parts of fried bighead atractylodes rhizome.
More preferably, the above-mentioned traditional Chinese medicine composition for treating hypomenorrhea and infertility with thin endometrium is prepared from the following raw materials in parts by weight:
1 part of roasted tortoise plastron, 1 part of roasted turtle shell, 1 part of prepared rehmannia root, 1 part of cornus officinalis, 1 part of fried white peony root, 1 part of fried angelica, 1 part of ligusticum wallichii, 1.5 parts of spina date seed, 1 part of roasted rhizoma anemarrhenae, 1 part of poria cocos, 1.5 parts of fried codonopsis pilosula and 1 part of fried bighead atractylodes rhizome.
The preparation method of the traditional Chinese medicine composition for treating thin endometrial hypomenorrhea is characterized by comprising the following steps of:
(1) taking roasted tortoise plastron, roasted turtle shell, prepared rehmannia root, dogwood fruit, fried white paeony root, fried Chinese angelica, szechuan lovage rhizome, spina date seed, roasted rhizoma anemarrhenae, poria, fried codonopsis pilosula and fried bighead atractylodes rhizome according to the parts by weight, firstly adding water with the weight of 5-20 times of that of a medicinal material for soaking, then decocting and extracting for 1-3 times, each time for 1-3 hours, combining extracting solutions, and concentrating to obtain an extract;
(2) preparing the extract of the step (1) and pharmaceutically acceptable carriers into granules, powder, tablets, capsules, pills, mixtures or extracts.
When the compound traditional Chinese medicine composition is prepared into tablets, the extract of the compound traditional Chinese medicine composition is added with carrier lactose or corn starch, lubricant magnesium stearate is added if necessary, the mixture is uniformly mixed, and then the mixture is tabletted to prepare the tablets.
When the invention is prepared into capsules, the extract of the traditional Chinese medicine compound composition is added with carrier lactose or corn starch to be uniformly mixed, granulated and then encapsulated to prepare the capsules.
When the Chinese medicinal composition is prepared into granules, the extract of the Chinese medicinal compound composition and a diluent lactose or corn starch are uniformly mixed, granulated, dried and prepared into the granules.
The invention follows the composing principle of 'monarch, minister, assistant and guide' through a great deal of clinical practice and research, and the prescription takes the product of stir-fried tortoise plastron and stir-fried turtle shell blood as the monarch drug for tonifying kidney essence. Fructus Corni, radix rehmanniae Preparata, radix Angelicae sinensis, radix Paeoniae alba, and rhizoma Ligustici Chuanxiong are used as ministerial drugs with kidney invigorating and yin nourishing effects. Prepared rehmannia root, radix rehmanniae Praeparata enters liver and kidney meridians, has the effects of enriching blood and nourishing yin, replenishing essence and benefiting marrow, moistens kidney and nourishes kidney yin, and ancient clouds can greatly nourish five internal organs and true yin and greatly nourish true water. Corni fructus is sour and astringent, slightly warm, moist, enters liver and kidney meridians, and has effects of tonifying liver and kidney, and tonifying but not drastic, and is the essential drug for balancing yin and yang. It is especially good for liver and kidney yin deficiency when it is combined with shan Yu. Angelica sinensis, radix Paeoniae alba and Ligusticum wallichii are effective in nourishing yin and blood, and angelica sinensis is sweet and warm in nature and moist in nature, is good at tonifying blood, and is a holy medicine for tonifying blood and has the function of tonifying middle-jiao. Bai Shao enters liver and spleen meridians, is sour in flavor, nourishes blood and astringes yin, and soothes liver and nourishes ying. Chuan Xiong is pungent and warm in property and moving and strong in activating blood and moving qi, and combined with Shu Di Huang, Dang Gui and Bai Shao to form a Siwu decoction to tonify without stagnation, so as to achieve the effect of tonifying blood and regulating blood. The spina date seed and the roasted rhizoma anemarrhenae are used for assisting in clearing heat and nourishing yin, and nourishing heart and soothing nerves. Wild jujube seed, semen Ziziphi Spinosae is sweet and sour in nature, nourishing blood and liver, tranquilizing mind by nourishing the heart, and is combined with Chuan Xiong to strengthen the middle energizer. The rhizoma anemarrhenae has the effects of nourishing yin, clearing heat and relieving restlessness, and is matched with monarch and minister medicines to play the roles of nourishing blood, soothing nerves, clearing heat and relieving restlessness. The codonopsis pilosula, the bighead atractylodes rhizome and the poria cocos are used for tonifying spleen and replenishing qi. The codonopsis pilosula has the effects of tonifying spleen and lung qi, tonifying qi and blood, tonifying qi and generating blood, and tonifying qi and generating body fluid, and the bighead atractylodes rhizome mainly enters spleen and stomach channels, and is a first important medicine for tonifying qi and strengthening spleen, which is reputed to be used together with the codonopsis pilosula, so that the effect of tonifying qi and recovering spleen transportation is achieved. Poria cocos, being sweet and mild in nature, is neutral in nature and neutral in mind when strengthening the spleen. The medicines are combined, and can be used in later period to replenish essence and marrow, make yin grow heavy, blood sea be full, and intima grow, so that it has the effects of nourishing kidney and nourishing heart. The traditional Chinese medicine composition has definite curative effect on scanty menstruation, later stage even infertility caused by kidney yin deficiency and heart failure nursing, and clinically shows soreness and weakness of waist and knees, dizziness and tinnitus, dysphoria with smothery sensation in chest, insomnia and restlessness in sleep, and yellow urine and stool.
Has the advantages that: compared with the prior art, the traditional Chinese medicine composition for treating thin endometrial hypomenorrhea and infertility has the following advantages:
the traditional Chinese medicine composition provided by the invention is obtained by screening a large number of experiments according to the pathogenesis of thin endometrium and by treatment based on syndrome differentiation under the guidance of the traditional Chinese medicine theory, and the experimental results show that the traditional Chinese medicine compound can effectively improve the symptoms of kidney-yin deficiency type hypomenorrhea, increase the menstrual flow, promote endometrial hyperplasia at the later period of menstruation, promote the development of follicles and improve preovulatory serum E2LH levels, improved luteal phase E2The level of the endometrium is increased, the endometrial volume is increased, and the hypoxemia perfusion in the middle luteal phase is enriched, so that the thin endometrium is improved, the endometrial receptivity is improved, and the implantation of the embryo is promoted to aid the pregnancy.
Meanwhile, the preparation method of the traditional Chinese medicine compound composition provided by the invention is simple to operate, the process is controllable, and industrial production can be realized. The traditional Chinese medicine compound composition provided by the invention has the advantages of no pathological damage to heart, brain, liver, spleen, kidney and other important visceral organs, good safety, low adverse reaction, convenience in taking and low price.
Detailed Description
The invention will be better understood from the following examples. However, those skilled in the art will readily appreciate that the specific material ratios, process conditions and results thereof described in the examples are illustrative only and should not be taken as limiting the invention as detailed in the claims.
Example 1
1. A Chinese medicinal composition for treating thin endometrial hypomenorrhea and infertility is prepared from the following raw materials in parts by weight:
10g of roasted tortoise plastron, 10g of roasted turtle shell, 10g of prepared rehmannia root, 10g of cornus officinalis, 10g of fried white peony root, 10g of fried angelica, 10g of ligusticum wallichii, 15g of spina date seed, 10g of roasted rhizoma anemarrhenae, 10g of poria cocos, 15g of fried codonopsis pilosula and 10g of fried bighead atractylodes rhizome.
2. The preparation method of the traditional Chinese medicine composition for treating thin endometrial hypomenorrhea and infertility comprises the following steps:
taking 10g of roasted tortoise plastron and 10g of roasted turtle shell, adding 10 times of water, decocting for 10 minutes, then adding 10g of prepared rehmannia root, 10g of cornus officinalis, 10g of fried white paeony root, 10g of fried angelica, 10g of ligusticum wallichii, 15g of spina date seed, 10g of roasted rhizoma anemarrhenae, 10g of poria cocos, 15g of fried codonopsis pilosula and 10g of fried bighead atractylodes rhizome, adding 10 times of water into medicinal materials, decocting and extracting for 2 hours, filtering, taking filtrate, adding 10 times of water into dregs, extracting for 1 hour, filtering, taking filtrate, combining the two filtrates, taking the filtrate, carrying out heat sealing in a bag, carrying out high-temperature sterilization at 105 ℃, and packaging to.
Example 2
1. A Chinese medicinal composition for treating thin endometrial hypomenorrhea and infertility is prepared from the following raw materials in parts by weight:
60g of roasted tortoise plastron, 60g of roasted turtle shell, 60g of prepared rehmannia root, 90g of cornus officinalis, 60g of fried white paeony root, 30g of fried angelica, 90g of ligusticum wallichii, 90g of spina date seed, 90g of roasted rhizoma anemarrhenae, 60g of poria cocos, 60g of fried codonopsis pilosula and 120g of fried bighead atractylodes rhizome.
2. The preparation method of the traditional Chinese medicine composition for treating thin endometrial hypomenorrhea comprises the following steps:
60g of roasted tortoise plastron, 60g of roasted turtle shell, 60g of prepared rehmannia root, 90g of cornus officinalis, 60g of fried white paeony root, 30g of fried Chinese angelica, 90g of szechuan lovage rhizome, 90g of spina date seed, 90g of roasted rhizoma anemarrhenae, 60g of poria, 60g of fried codonopsis pilosula and 120g of fried bighead atractylodes rhizome are taken, 2 times of water is added for soaking for 1 hour, the mixture is placed in a multifunctional extraction tank and decocted for two times by adding water, 10 times of water is added for the first time, the decoction is carried out for 2 hours, and the decoction. Adding 8 times of water to the second time, decocting for 1 hr, collecting the decoctions, filtering, concentrating the filtrate, adding lactose as carrier, adding magnesium stearate as lubricant, mixing, and tabletting.
Example 3
1. A Chinese medicinal composition for treating thin endometrial hypomenorrhea and infertility is prepared from the following raw materials in parts by weight:
30g of roasted tortoise plastron, 30g of roasted turtle shell, 30g of prepared rehmannia root, 45g of cornus officinalis, 30g of fried white paeony root, 15g of fried angelica, 45g of ligusticum wallichii, 45g of spina date seed, 45g of roasted rhizoma anemarrhenae, 30g of poria cocos, 30g of fried codonopsis pilosula and 60g of fried bighead atractylodes rhizome.
2. The preparation method of the traditional Chinese medicine composition for treating thin endometrial hypomenorrhea and infertility comprises the following steps:
firstly, 30g of roasted tortoise plastron, 30g of roasted turtle shell, 30g of prepared rehmannia root, 45g of cornus officinalis, 30g of fried white paeony root, 15g of fried angelica, 45g of ligusticum wallichii, 45g of spina date seed, 45g of roasted rhizoma anemarrhenae, 30g of poria cocos, 30g of fried codonopsis pilosula and 60g of fried bighead atractylodes rhizome are taken, 2 times of water of the total medicinal materials is added for soaking for 1 hour, then the mixture is placed in a multifunctional extraction tank, water is added for decoction twice, 12 times of water of the total medicinal materials is added for decoction for extraction for 2 hours for the first time, 10 times of water of the total medicinal materials is added for decoction extraction for 1 hour for the second time, decoction solutions are combined, filtered, decompressed and concentrated, corn starch.
Example 4
1. A Chinese medicinal composition for treating thin endometrial hypomenorrhea and infertility is prepared from the following raw materials in parts by weight:
60g of roasted tortoise plastron, 60g of roasted turtle shell, 20g of prepared rehmannia root, 30g of cornus officinalis, 20g of fried white paeony root, 10g of fried angelica, 30g of ligusticum wallichii, 30g of spina date seed, 30g of roasted rhizoma anemarrhenae, 20g of poria cocos, 20g of fried codonopsis pilosula and 40g of fried bighead atractylodes rhizome.
2. The preparation method of the traditional Chinese medicine composition for treating thin endometrial hypomenorrhea and infertility comprises the following steps:
(1) firstly, 60g of roasted tortoise plastron, 60g of roasted turtle shell, 20g of prepared rehmannia root, 30g of cornus officinalis, 20g of fried white paeony root, 10g of fried angelica, 30g of ligusticum wallichii, 30g of spina date seed, 30g of roasted rhizoma anemarrhenae, 20g of poria cocos, 20g of fried codonopsis pilosula and 40g of fried bighead atractylodes rhizome are taken, 2 times of water of the total medicinal materials is added for soaking for 1 hour, then the mixture is placed in a multifunctional extraction tank and is decocted for two times by adding water, 15 times of water of the total medicinal materials is added for decoction and extraction for 2 hours for the first time, 12 times of water of the total medicinal materials is added for decoction and extraction for 1 hour for the second time, decoction solutions are combined, filtered and decompressed and concentrated to.
Example 5
First, experimental material
(I) an experimental subject
The clinic of the department of traditional Chinese medicine of Jiangsu province is in line with the thin endometrium, and the differentiation of the syndromes of kidney yin deficiency type of 58 patients with scanty menstruation is performed.
(II) Experimental medicine and taking method
1. The extract of the traditional Chinese medicine composition of embodiment 1 of the present invention (10 g of tortoise plastron, 10g of turtle shell, 10g of prepared rehmannia root, 10g of cornus officinalis, 10g of parched white peony root, 10g of parched angelica sinensis, 10g of ligusticum wallichii, 15g of spine date seed, 10g of rhizoma anemarrhenae preparata, 10g of poria cocos, 15g of parched codonopsis pilosula and 10g of parched white atractylodes rhizome) is administered in the morning and evening in 1 package (150 ml) per time 2 times a day.
2. Prepared capsule of placenta hominis: 0.35 g/capsule and 9 capsules of a 3 plate/box are produced by Tianmu pharmaceutical industry Co Ltd in Huangshan City and purchased by a pharmacy of traditional Chinese medicine institute in Jiangsu province. It is administered at a dose of 4 granules per time and 2 times per day.
II, diagnosis standard
Reference is made to "gynecology of traditional Chinese medicine" (tenth edition of teaching materials in the university of traditional Chinese medicine and pharmacy, Youguan's program), 9 th edition of teaching materials in the university of high nationality, gynecology and obstetrics' diagnostic standards for diseases ".
1. Western diagnostic criteria:
the thickness of the endometrium is less than 7mm at the ovulation day of the natural menstrual cycle or the trigger day of the ovulation-promoting cycle.
1.2.2 Chinese medicine diagnosis standard:
the main symptoms are: the menstrual flow is obviously less than the normal menstrual flow of 1/2 at ordinary times or less than 20ml at normal or later menstrual cycle, or the menstruation time is less than 2 days, or even the menstruation is finished by dropping;
secondary symptoms: soreness and weakness of waist and knees, dizziness, tinnitus, dysphoria with feverish sensation in chest, palms and soles, insomnia, hardness in stool, and yellow urine;
typical tongue veins: red tongue with little coating and thready and rapid pulse.
The main symptoms are essential, and the secondary symptoms are 2 or more items plus tongue pulse to diagnose.
1.2.3 Chinese medicine symptom score Standard
(1) Traditional Chinese medicine syndrome scoring standard
(ii) chief symptom scoring
Chief complaints | 0 | 2 is divided into | 4 is divided into | 6 minutes |
Menstrual flow | >Past menstruation volume 1/2 | >Past menstruation volume 1/3 | <Sanitary towel used after passing through 1/3 | Drop for cleaning |
In the menstrual period | 3<Time is less than or equal to 7 | 2<Time is less than or equal to 3 | 1<Time is less than or equal to 2 | ≤1 |
② secondary symptom score
Symptom/score | 0 | 1 | 2 | 3 |
Soreness and weakness of waist and knees | Is free of | Idol | Frequency of operation | Lumbago with a broken edge and failure to relieve |
Dizziness and tinnitus | Is free of | Is occasionally provided with | Frequency of operation | Recurrent attacks |
Feverish sensation in the chest, palms and soles | Is free of | Is occasionally provided with | Frequency of operation | Is not easy to relieve |
Sleeplessness | Is free of | Is occasionally provided with | Frequency of operation | Is not easy to relieve |
Drying of stool | Is free of | Is provided with | ||
Scanty and yellow urine | Is free of | Is provided with |
(2) Standard of graduation of symptoms
Mild: the traditional Chinese medicine syndrome integral is less than or equal to 10 points;
medium: the traditional Chinese medicine syndrome integral is more than or equal to 11 minutes and less than or equal to 20 minutes;
and (3) severe degree: the syndrome integral of traditional Chinese medicine is more than or equal to 21 points.
1.3 case selection criteria
1.3.1 case inclusion criteria:
(1) age: 21-40 year old female;
(2) those who meet the criteria for Western diagnosis;
(3) those who meet the diagnostic criteria of traditional Chinese medicine;
(4) informed consent, volunteer test;
(5) no other medicine is taken 3 months before and during the treatment period;
(6) the routine of hematuria and excrement, the functions of liver and kidney, the thyroid function, prolactin and serum testosterone are all in normal ranges, and the routine examination of electrocardiogram is normal.
1.3.2 case exclusion criteria
(1) Hypofunction of ovary or hypomenorrhea caused by drugs;
(2) adding related hormone medicines used within 3 months before the study;
(3) patients with serious primary diseases such as heart and lung diseases, liver and kidney diseases and the like and psychoses are combined.
1.3.3 knockout and shed case criteria
(1) After inclusion, cases that do not meet the inclusion criteria are rejected.
(2) Poor compliance of the subjects, serious adverse events, complications or special physiological changes, unsuitability for further tests and automatic withdrawal are all cases of abscission.
Third, experimental method and grouping
1. 58 patients with scanty menstruation due to deficiency of kidney-yin were randomly divided into two groups, 30 patients in the treatment group were administered with the Chinese medicinal composition of example 1 of the present invention, and 28 patients in the control group were administered with HECHEDACHE Capsule (Tianmu pharmaceutical Co., Ltd., Huangshan City).
The medicine taking method comprises the following steps:
2. treatment groups: it is administered 2 times per day, 1 bag per time, and divided into morning and evening at day 5 of menstruation for 10 days or until ovulation stops.
Control group: it is administered 2 times per day and 4 granules per time at day 5 of menstruation for 10 days or until ovulation stops.
Fourth, observe the index
1. General data: patient age, course of disease, menstrual history, health history, medication history, etc. (see appendix one)
2. And (4) safety observation: blood routine, liver and kidney functions were monitored before and after treatment, and adverse reactions that may occur at any time were recorded. Clinically occurring adverse reactions were analyzed as irrelevant, possibly relevant, likely relevant, positively relevant, and inconclusive.
3. Index of therapeutic efficacy
(1) Clinical symptom changes: according to the symptom score standard, the improvement of the major symptoms and the minor symptoms is observed after scoring once before and after the treatment.
(2) Monitoring the development condition of follicles by gynecological B ultrasonic every other day from the 10 th day of the menstrual cycle, recording the size of dominant follicles (maximum diameter of follicles) on the ovulation day and the thickness of endometrium on the ovulation day: the treatment is recorded once before and after treatment.
(3) Serum E2, LH levels were measured at pre-ovulation or at day 15 of the menstrual cycle: the treatment is recorded once before and after treatment.
(4) Blood was drawn at mid luteal (day 7 after ovulation or day 7 with BBT up on ultrasound B monitoring) 8-9 in the morning, and serum E2, P levels were determined and recorded once before and after treatment.
(5) The three-dimensional B-ultrasonic examination of the vaginal uterine cavity is performed in the morning at mid-luteal period (7-9 days after ovulation monitoring by B-ultrasonic or 7-9 days after BBT rising), and the intimal thickness, the intimal volume, the Vascular Index (VI), the blood Flow Index (FI) and the vascular blood flow index (VFI) of the endometrial region are recorded and recorded once before and after treatment respectively.
4. Criteria for therapeutic effect
(1) Clinical overall curative effect judgment standard
The method is divided into four grades according to relevant sections of Chinese gynaecology and obstetrics science by combining clinical treatment: has healing, obvious effect, effectiveness and no effect.
(2) Determination of clinical efficacy criteria
And (3) healing: the menstruation amount is restored to the plain menstruation amount 1/2, the secondary symptoms basically disappear, the curative effect index is more than or equal to 90 percent, and no relapse is observed in the 3-month menstruation period after the treatment.
The effect is shown: the menstruation amount is recovered to the plain menstruation amount 1/2, most of secondary symptoms disappear or are obviously relieved, the curative effect index is more than or equal to 70 percent and less than 90 percent, or the relapse within a 3-month menstruation period is observed after the recovery.
The method has the following advantages: the menstrual flow is increased before but not recovered to the Pinsu menstrual flow 1/2, the minor symptoms are partially disappeared or alleviated, the curative effect index is more than or equal to 30 percent and less than 70 percent, and partial symptoms are repeated after the treatment is finished but are alleviated before the treatment.
And (4) invalidation: the primary symptoms are not improved (the menstrual flow or the menstrual period is not improved), the secondary symptoms are present and even aggravated, and the curative effect index is less than 30%.
(3) Evaluation criteria of therapeutic effect of menstruation volume
And (3) healing: the menstrual amount is recovered to the plain menstrual amount 1/2, the menstrual period is more than or equal to 2 days, and no relapse is observed in the 3-month menstrual period after treatment;
the effect is shown: the menstruation volume is restored to be equal to or more than 1/2 days of Pingsu menstruation volume or the menstrual period is more than or equal to 2 days, or the relapse is observed within 3 months of menstruation period after recovery;
the method has the following advantages: increased menstrual flow before menstruation but not restored to Pinsu menstrual flow 1/2 or prolonged menstrual period before menstruation but less than 2 days;
and (4) invalidation: before the treatment, the menstruation and menstrual period are the same.
(4) Judgment of traditional Chinese medicine symptom curative effect
The curative effect of the traditional Chinese medicine syndrome is judged according to the integral
Therapeutic index = [ (pre-treatment integral-post-treatment integral) ÷ pre-treatment integral) ] X100%
The cure rate is n more than 90 percent.
Has obvious effect, n is more than or equal to 70 percent, and n is less than 90 percent.
Effective, n is more than or equal to 30 percent and n is less than 70 percent.
Ineffective, n < 30%.
5. Safety index determination
The routine blood and the liver and kidney functions of the two groups before and after treatment are within a normal range, and no adverse reaction occurs in the research period.
Fifthly, data processing
Data were statistically processed using SPSS 25.0. All the measured data are described and counted by means of average +/-standard deviation, and if the measured data accord with the normal distribution, t test is carried out; if the normal distribution is not satisfied, the average number of the samples is compared by adopting a rank sum test. The comparison between the grade data is checked by chi-square. All tests used a two-sided test, and differences were considered statistically significant if the P-value was less than or equal to 0.05.
Sixthly, the results
1. The effect of the traditional Chinese medicine compound composition on the total curative effect is shown in the table 1:
TABLE 1 comparison of the combined therapeutic effects of two groups of patients
Group of | Number of examples | Recovery method | Show effect | Is effective | Invalidation | Total effective rate |
Treatment group | 30 | 12 | 6 | 9 | 3 | 90% |
Control group | 28 | 7 | 9 | 4 | 8 | 71.4% |
As can be seen from the results in Table 1, after the treatment, the two groups of comprehensive curative effects are tested by rank sum, and have significant difference with P less than 0.05. Indicating that the treatment group is superior to the control group.
2. The influence of the traditional Chinese medicine compound composition on the evaluation of the menstruation volume before and after treatment is shown in the table 2:
TABLE 2 comparison of menstrual score between two groups of patients
Group of | Number of examples | Recovery method | Show effect | Is effective | Invalidation | Total effective rate |
Treatment group | 30 | 9 | 10 | 8 | 3 | 90% |
Control group | 28 | 5 | 7 | 8 | 8 | 71.4% |
As can be seen from the results in Table 2, the treated group and the control group were significantly different (P < 0.05) according to the rank-sum test, indicating that the treated group was superior to the control group in increasing the menstrual blood volume.
3. The results of the influence of the traditional Chinese medicine compound composition on the Chinese medicine symptom integral are shown in the table 3:
TABLE 3 integral comparison of two groups of syndromes before and after treatment
Number of examples | Before treatment | After treatment | P | |
Treatment group | 30 | 14.17±1.11 | 4.33±1.37 | <0.01 |
Control group | 28 | 13.93±1.02 | 7.71±1.49 | <0.01 |
P | 0.322 | <0.01 |
As can be seen from Table 3, the integration of the syndrome of the two groups of traditional Chinese medicine before treatment has no significant difference (P is more than 0.05), and synchronous comparison can be carried out; after treatment, the clinical symptom scores of the two groups are obviously different (P is less than 0.05), and compared among the groups, the treatment group has obvious advantage compared with the control group.
4. Improved follicular development
TABLE 4 comparison of Pre-ovulatory follicle diameter size (mm) before and after treatment
Number of examples | Before treatment | After treatment | P | |
Control group | 28 | 17.96±1.71 | 18.14±1.27 | 0.634 |
Treatment group | 30 | 17.77±1.89 | 19.10±1.67 | <0.01 |
P | 0.678 | 0.018 |
As can be seen from table 4, there was no significant difference in the maximum follicle diameter in the first two groups before treatment (P > 0.05); the maximum follicle diameter before and after the treatment of the treatment group is significantly different (P is less than 0.05), and the maximum follicle diameter before and after the treatment of the control group is relatively non-different (P is more than 0.05); the comparison of the maximum follicle diameter of the two groups after treatment, with P <0.05, shows that the treatment group is superior to the control group in promoting follicle development.
5. Improvement of membrane thickness in ovulatory day endometrium
TABLE 5 comparison of thickness (mm) of ovulation day endometrium in two groups before and after treatment
Number of examples | Before treatment | After treatment | P | |
Control group | 28 | 7.84±1.01 | 8.80±1.00 | <0.01 |
Treatment group | 30 | 7.58±0.87 | 9.50±0.96 | <0.01 |
P | 0.305 | 0.009 |
As can be seen from Table 5, there was no significant difference in endometrial thickness between the day of ovulation in the first two groups of treatments (P > 0.05); the comparison of the endometrium thicknesses before and after the two groups of treatment shows that the difference (P is less than 0.05) is significant, but the comparison between the groups shows that the treatment group is better than the control group in promoting the endometrial growth.
6. Pre-ovulatory or menstrual cycle day 15 serum E2Improvement of the level
TABLE 6 Pre-ovulatory serum E2 levels (ng/L) in both pre-and post-treatment groups
Number of examples | Before treatment | After treatment | P | |
Control group | 28 | 237.61±50.69 | 251.21±46.87 | 0.041 |
Treatment group | 30 | 256.53±48.94 | 283.27±58.86 | <0.01 |
P | 0.154 | 0.026 |
As can be seen from Table 6, serum E in the first two groups was treated2No significant difference in level (P > 0.05); e2 level was significantly increased before and after treatment (P < 0.05) in the treatment group, and E was significantly increased before and after treatment in the control group2The level comparison has significant difference (P is less than 0.05); compared among groups, P after treatment is less than 0.05, and the difference has statistical significance.
7. Improved serum LH levels before ovulation or at day 15 of the menstrual cycle
TABLE 7 Pre-ovulation serum LH levels (miU/mL) in both groups before and after treatment
Number of examples | Before treatment | After treatment | P | |
Control group | 28 | 15.32±9.71 | 21.99±9.83 | <0.01 |
Treatment group | 30 | 16.03±11.64 | 28.16±17.52 | <0.01 |
P | 0.938 | 0.243 |
As can be seen from Table 7, there was no significant difference in preovulatory LH levels in the first two groups treated (P > 0.05); the treated group and the control group have significant difference (P is less than 0.05) in comparison of preovulatory serum LH before and after treatment, and have no difference (P is more than 0.05) in comparison between the groups.
8. Middle luteal phase E2Improvement of the level
TABLE 8 luteal phase E2 level (ng/L) before and after treatment in both groups
Number of examples | Before treatment | After treatment | P | |
Control group | 28 | 121.29±7.37 | 131.96±6.66 | <0.001 |
Treatment group | 30 | 122.93±7.71 | 162.89±6.89 | <0.001 |
P | 0.128 | <0.001 |
As can be seen from Table 8, mid-luteal serum E was obtained in the first two groups2No significant difference in level (P)>0.05); mid-luteal serum E in the last two groups2Comparison, P<0.05, all have significant differences. Comparison between groups after treatment P<0.05, there was a significant difference.
9. Improvement of mid-luteal P level
TABLE 9 mid-luteal P levels (ng/ml) before and after treatment in two groups
Number of examples | Before treatment | After treatment | P | |
Control group | 28 | 11.65±2.10 | 14.22±1.83 | <0.001 |
Treatment group | 30 | 13.49±5.45 | 16.89±1.24 | <0.001 |
P | 0.379 | <0.001 |
As can be seen from Table 9, there was no significant difference in mid-luteal P levels (P >0.05) between the two groups of patients before treatment; after treatment, the P level in the middle of corpus luteum of the two groups is improved, and the P level is obviously different (P is more than 0.05). P <0.05 compared among groups after treatment, there was a significant difference.
10. Endometrial condition under three-dimensional B-ultrasound of middle corpus luteum uterine cavity
TABLE 10 three-dimensional B-ultrasonography intima condition of uterine cavity in middle of corpus luteum of the first two groups
Number of examples | Inner film thickness (mm) | Inner film volume (ml) | |
Control group | 28 | 0.69±0.21 | 2.01±0.78 |
Treatment group | 30 | 0.67±0.19 | 1.93±0.82 |
P | 0.650 | 0.460 |
TABLE 11 three-dimensional B-ultrasonography intima condition of middle uterine cavity of corpus luteum of two groups after treatment
Number of examples | Inner film thickness (mm) | Inner film volume (ml) | |
Control group | 28 | 0.78±0.15 | 2.34±0.65 |
Treatment group | 30 | 0.86±0.20 | 2.42±0.90 |
P | 0.022 | 0.974 |
As can be seen from tables 10 and 11, there was no significant difference in the thickness of the endometrium and the volume of the endometrium (P >0.05) under three-dimensional B-ultrasound in the middle uterine cavity of the corpus luteum in the first two groups before treatment; after treatment, the thickness comparison P of the two groups of intima is less than 0.05, and the two groups of intima have significant difference. Compared with the volume of the intima of the two groups after treatment, the P is more than 0.05, and no significant difference exists. Compared with the two groups after treatment, the intima thickness and the intima volume are both improved obviously (P is less than 0.001).
11. Endometrial blood flow perfusion condition under three-dimensional B-ultrasound of middle corpus luteum uterine cavity
TABLE 12 three-dimensional B-ultrasound endometrial blood perfusion in the middle uterine cavity of the first two groups of corpus luteum
Number of examples | VI | FI | VFI | |
Control group | 28 | 1.70±0.97 | 22.74±1.70 | 0.42±0.22 |
Treatment group | 30 | 1.79±1.17 | 21.91±1.69 | 0.43±0.27 |
P | 0.630 | 0.068 | 0.554 |
TABLE 13 three-dimensional B-ultrasound endometrial blood perfusion in mid-luteal uterine cavity of two groups after treatment
Number of examples | VI | FI | VFI | |
Control group | 28 | 1.79±0.49 | 25.01±1.59 | 0.41±0.14 |
Treatment group | 30 | 2.49±0.68 | 23.81±1.58 | 0.59±0.25 |
P | <0.001 | 0.008 | <0.001 |
As can be seen from tables 12 and 13, there was no significant difference in VI, FI and VFI in mid-luteal phase in the first two groups before treatment (P > 0.05); the differences of VI, FI and VFI in the two groups after treatment have statistical significance (P is less than 0.05). Compared with the control group FI, the control group FI has statistical significance when P is less than 0.05 when compared with the control group FI before treatment, and the control group FI has statistical significance when P is more than 0.05 when compared with the control group FI before treatment and the control group VFI (P = 0.829) when compared with the control group FI before treatment, P is more than 0.05, and the difference is not statistically significant.
From the above experimentsThe results show that (1) the total curative effect is as follows: the total effective rate of the treatment group is 93.3 percent, the total effective rate of the control group is 71.4 percent, and the test P shows that<0.05, the two groups had statistical differences. The two groups of medicines have the curative effect on the kidney-yin deficiency type hypomenorrhea, but the curative effect of the treatment group is better than that of the control group. (2) Changes in the course of the amount: the integral of the menstruation volume before and after the two groups of treatment is P<0.05, there was a statistical difference, indicating that both groups of drugs improved the symptoms of hypomenorrhea. Comparison between groups post treatment P<0.05, there was a statistical difference, indicating that the treatment group had better efficacy than the control group. (3) The traditional Chinese medicine symptom improvement condition is as follows: integral comparison of Chinese medicine symptoms before and after two groups of treatment P<0.05, there were statistical differences, which indicated that both groups of drugs can improve the syndrome of kidney-yin deficiency. Comparison between groups post treatment P<0.05, there was a statistical difference, indicating that the treatment group had better efficacy than the control group. (4) Effect on maximum follicle diameter before ovulation: the maximum follicle diameter of the treated group is significantly different before and after treatment (P is less than 0.05), the maximum follicle diameter of the control group is not different before and after treatment (P is more than 0.05), and the maximum follicle diameters of the two groups after treatment are compared, P is less than 0.05, which indicates that the treated group is superior to the control group in promoting the later stage follicle development. (5) Effect on preovulatory endometrial thickness: after treatment, the thickening P of the endometrium is less than 0.05 on ovulation days in two groups, which has statistical significance, and the comparison between the groups has statistical difference, which indicates that the treatment group is superior to the control group in promoting the growth of the endometrium. (6) For preovulatory serum E2The effects of LH: before and after two groups of treatment E2And LH levels were all significantly different by less than 0.05, compared between the two groups after treatment, E2The level difference has statistical significance, the LH level difference has no statistical significance, and the results show that the two groups can improve the preovulatory serum E2LH level. (7) In mid luteal phase E2, P: the middle luteal phases E2 and P were improved after treatment in both groups, P was less than 0.05, and was statistically significant, compared between groups, P<0.05, indicating that the treatment group improved mid luteal phase E2P level was superior to control group. (8) In the middle corpus luteum period uterine cavity three-dimensional B-ultrasound lower endometrium aspect: after the two groups of treatment, the thickness of the endometrium and the volume of the intima at the middle luteal period are both improved, wherein P is less than 0.05, and the significant difference exists, and compared with the groups, the thickness of the intima has significant difference (P is less than 0).05) There was no significant difference in intimal volume (P >0.05), indicating that the treatment groups were better able to increase mid-luteal endometrium thickness, and both groups were able to increase mid-luteal intimal volume. (9) In mid-luteal endometrial blood perfusion: after treatment, the differences of VI, FI and VFI in two groups have statistical significance (P is less than 0.05), compared in two groups, the differences of VI, FI and VFI in the treatment groups are obviously improved compared with those before treatment and have statistical significance (P is less than 0.05), and compared with those before treatment, FI in the control group is compared with P<0.05, statistically significant, VI, VFI compared before treatment, P>0.05, the difference was not statistically significant. The treatment group is superior to the control group in enriching luteal medium-term subintimal blood perfusion.
The experimental result shows that the traditional Chinese medicine compound composition provided by the invention can effectively improve the symptoms of kidney-yin deficiency type hypomenorrhea and infertility, increase the menstrual flow, promote endometrial hyperplasia and follicular development in the later period of menstruation and improve the serum E in the ovulatory period2LH levels, improved luteal phase E2The level of P, the thickness of the endometrium in the middle luteal phase is increased, the volume of the endometrium is increased, and the hypoxemic perfusion of the endometrium in the middle luteal phase is enriched, so that the receptivity of the endometrium is improved, and the implantation of the embryo is promoted to aid the pregnancy.
The above embodiments are merely illustrative of the technical concept and features of the present invention, and the present invention is not limited thereto, and equivalent changes and modifications made according to the spirit of the present invention should be covered thereby.
Claims (5)
1. A traditional Chinese medicine composition for treating thin endometrial hypomenorrhea and infertility is characterized by comprising the following raw materials in parts by weight:
1-6 parts of roasted tortoise plastron, 1-6 parts of roasted turtle shell, 1-6 parts of prepared rehmannia root, 1-9 parts of cornus officinalis, 1-6 parts of fried white paeony root, 0.5-3 parts of fried angelica, 1-9 parts of ligusticum wallichii, 1.5-9 parts of spina date seed, 1-9 parts of roasted rhizoma anemarrhenae, 1-6 parts of poria cocos, 1-6 parts of fried codonopsis pilosula and 1-12 parts of fried bighead atractylodes rhizome.
2. The traditional Chinese medicine composition for treating hypomenorrhea and infertility caused by thin endometrium according to claim 1, is characterized by being prepared from the following raw materials in parts by weight:
1-3 parts of roasted tortoise plastron, 1-3 parts of roasted turtle shell, 1-3 parts of prepared rehmannia root, 1-4.5 parts of cornus officinalis, 1-3 parts of fried white paeony root, 0.5-1.5 parts of fried angelica, 1-4.5 parts of ligusticum wallichii, 1.5-4.5 parts of spina date seed, 1-4.5 parts of roasted rhizoma anemarrhenae, 1-3 parts of poria cocos, 1-3 parts of fried codonopsis pilosula and 1-6 parts of fried bighead atractylodes rhizome.
3. The traditional Chinese medicine composition for treating thin endometrial hypomenorrhea and infertility according to claim 2, which is prepared from the following raw materials in parts by weight:
1 part of roasted tortoise plastron, 1 part of roasted turtle shell, 1 part of prepared rehmannia root, 1 part of cornus officinalis, 1 part of fried white peony root, 1 part of fried angelica, 1 part of ligusticum wallichii, 1.5 parts of spina date seed, 1 part of roasted rhizoma anemarrhenae, 1 part of poria cocos, 1.5 parts of fried codonopsis pilosula and 1 part of fried bighead atractylodes rhizome.
4. A method of preparing a Chinese medicinal composition for treating low grade endometrial hypomenorrhea according to any of claims 1 to 3, comprising the steps of:
(1) taking roasted tortoise plastron, roasted turtle shell, prepared rehmannia root, dogwood fruit, fried white paeony root, fried Chinese angelica, szechuan lovage rhizome, spina date seed, roasted rhizoma anemarrhenae, poria, fried codonopsis pilosula and fried bighead atractylodes rhizome according to the parts by weight, firstly adding water with the weight of 5-20 times of that of a medicinal material for soaking, then decocting and extracting for 1-3 times, each time for 1-3 hours, combining extracting solutions, and concentrating to obtain an extract;
(2) preparing the extract of the step (1) and pharmaceutically acceptable carriers into granules, powder, tablets, capsules, pills, mixtures or extracts.
5. Use of a composition according to any one of claims 1 to 3 in the manufacture of a medicament for the treatment of hypomenorrhea and infertility.
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