CN112773865A

CN112773865A - Composition with kidney tonifying and menstruation regulating functions and application

Info

Publication number: CN112773865A
Application number: CN202110265903.2A
Authority: CN
Inventors: 阳吉长
Original assignee: Guyitang Hunan Health Technology Co ltd
Current assignee: Guyitang Hunan Health Technology Co ltd
Priority date: 2021-03-11
Filing date: 2021-03-11
Publication date: 2021-05-11

Abstract

The invention discloses a composition with functions of tonifying kidney and regulating menstruation and application thereof, wherein the composition comprises the following components in parts by mass: 55-64 parts of angelica sinensis, 95-105 parts of astragalus membranaceus, 58-64 parts of wolfberry, 97-103 parts of codonopsis pilosula, 190-205 parts of Chinese yam, 95-102 parts of steamed rhizoma polygonati, 98-105 parts of dry motherwort, 36-43 parts of Chinese rose flowers, 94-106 parts of caulis spatholobi, 55-64 parts of salted semen cuscutae, 58-65 parts of salted morinda officinalis, 55-67 parts of vinegar rhizoma cyperi and 35-42 parts of liquorice tablets; the medicines are matched with each other to tonify the kidney and replenish qi, regulate blood and regulate menstruation; can be used for treating premature ovarian failure, menoxenia and primary dysmenorrhea due to kidney deficiency, qi weakness, and blood deficiency and blood stagnation.

Description

Composition with kidney tonifying and menstruation regulating functions and application

Technical Field

The invention belongs to the technical field of traditional Chinese medicine compositions, and particularly relates to a composition with functions of tonifying kidney and regulating menstruation.

Background

Knowledge of dysmenorrhea, irregular menstruation and premature ovarian failure in modern medicine

(1) Dysmenorrhea

Dysmenorrhea is one of the most common gynecological disease symptoms, and clinically appears as lower abdominal pain before and after menstruation or during menstruation, even lumbago, dizziness or nausea and vomiting sometimes, and severe symptoms such as pale complexion, cold sweat, cold hands and feet, severe pain and faint and the like can be seen in severe patients. Modern medicine considers that the disease is divided into primary dysmenorrhea (also called functional dysmenorrhea) and secondary dysmenorrhea according to the condition of the disease. The former is dysmenorrhea caused by no obvious organic lesion in genital organs, is the most common gynecological disease of adolescent women, and has the morbidity of 30-50 percent. The latter refers to dysmenorrhea caused by the obvious organic lesions of reproductive organs, such as endometriosis, hysteromyoma, pelvic inflammation, etc. Primary dysmenorrhea is common in adolescence and usually occurs within 1-2 years after incipient wetness. The lower abdominal pain is the primary symptom associated with the regular onset of the menstrual cycle. Secondary dysmenorrhea is usually progressively aggravated due to intimal dislocation, as is the case with primary dysmenorrhea. The pain begins after menstruation, appears 12 hours before menstruation at the earliest time, and is most severe after 1 st day of menstruation and is relieved after 2-3 days. Pain is often spasmodic. It is generally not accompanied by abdominal muscle tension or rebound pain. The medicine can be accompanied with symptoms of nausea, vomit, diarrhea, dizziness, hypodynamia and the like, and the face is whitish and sweats when the disease is serious, and no abnormal condition is found in gynecological examination.

Secondary dysmenorrhea is usually caused by endometriosis and adenomyosis. The occurrence of primary dysmenorrhea is mainly related to the increase of endometrial prostaglandin content during menstruation. Elevated PGF2 α levels are a major cause of dysmenorrhea. The increase of PGF2 alpha content can cause the over-strong contraction of uterine smooth muscle and vasospasm, and the dysmenorrhea occurs due to uterine ischemia and hypoxia. The increase of vasopressin, endogenous oxytocin, beta-endorphin and other substances, mental and neurological factors are also common reasons for dysmenorrhea. The pathogenesis of the traditional Chinese medicine is mainly as follows: the abnormal uterine contraction, primary dysmenorrhea, is associated with the increase of uterine tension and excessive spastic contraction caused by the enhancement of uterine muscular activity. ② synthesis and release of prostaglandin or leukotriene are excessive. The vasopressin is used as another important pathogenic factor of dysmenorrhea, and many studies have proved that the vasopressin level in pregnant women with primary dysmenorrhea is increased, and the hormone can cause the contraction and strengthening of the smooth muscle of the myometrium and artery wall. Fourthly, cervical stenosis or other factors which lead to the involvement of the peptides on the autonomic nervous system, the immune system and the like are probably related.

(2) Irregular menstruation

Irregular menstruation is a common gynecological disease, which refers to a disease that the menstrual cycle, menstrual period and menstrual volume are abnormal and obvious uncomfortable symptoms appear, and seriously affects and restricts the life and work of women. The establishment of the normal menstrual cycle depends on neuroendocrine regulation of the hypothalamic-pituitary-ovarian (H-P-O) gonadal axis and on the cyclic response of the endometrium to sex hormones, any of which is dysregulated in any of the links leading to menstrual disorders.

The main factors causing irregular menstruation include the following: firstly, menstrual disorder caused by abnormal emotion: mood disorders such as prolonged depression, stress or exposure to major mental irritation and psychological trauma can lead to menstrual disorders or dysmenorrhea, amenorrhea. This is because menstruation is caused by the action of hormones secreted from the ovaries on the endometrium, and the hormones secreted from the ovaries are controlled by the release of hormones from the pituitary and hypothalamus, so that the abnormal function of the ovaries, the pituitary and the hypothalamus affects menstruation.

② cold stimulation causes hypomenorrhea and even amenorrhea: the cold stimulation in the menstrual period of women can cause the excessive contraction of blood vessels in the pelvic cavity, which can cause hypomenorrhea and even amenorrhea.

③ irregular menstruation caused by diet: excessive diet, due to insufficient energy intake of the body, causes a large amount of fat and protein in the body to be consumed, causes obvious estrogen synthesis disorder and deficiency, and influences menstruation, even menstruation rarefaction or amenorrhea.

(iv) menstrual disorder caused by smoking and drinking: certain components of the cigarette and alcohol can interfere with menstrual-related physiological processes, causing menstrual disorders.

(3) Premature ovarian failure

Premature ovarian failure female hormone secretion, sexual function, skin quality, skin color and female three-dimensional posture, and can make face yellow, body state bloated and vagina dry, and enter the yellow face female period in advance, namely, aging comes. When the female and progestational hormones of a human body are deficient, metabolism is disordered, particularly, the bone metabolism is unbalanced, so that calcium loss is accelerated, the female is at risk of osteoporosis, and the chance of suffering from cardiovascular and cerebrovascular diseases is increased. When the premature ovarian failure affects the function of the autonomic nervous system, women can also have the symptoms of climacteric syndromes such as general hot flushes, sweating, emotional instability and the like, and can seriously develop into depression. Premature ovarian failure causes the female to have symptoms of premature degeneration of female characteristics, such as lack of elasticity of skin mucosa, breast atrophy, vaginal secretion reduction, vulvar atrophy and the like. The patient suddenly develops amenorrhea during normal menstruation, and the symptoms are usually manifested as shortened menstrual period, thin menstruation and gradual amenorrhea due to reduced menstrual volume. The menstrual cycle is shortened, and the menstrual cycle and the menstrual period of a few patients are completely disordered.

(II) understanding of dysmenorrhea, menoxenia and premature ovarian failure in traditional Chinese medicine

(1) Dysmenorrhea

The recognition of traditional Chinese medicine to dysmenorrhea and the record of related dysmenorrhea are firstly seen in the book of 'jin Kui Yao, and Furen miscellaneous disease syndrome and treatment' in the tense Zhongjing of the Han Dynasty: 'leukorrhagia, difficult menstruation and lower abdomen fullness and pain … …' modern Chinese medicine is summarized from experience of predecessors, and it is believed that the generation and development of dysmenorrhea are caused by imbalance of yin and yang, imbalance of qi and blood, viscera dysfunction leading to stasis of thoroughfare and conception vessels, and obstruction of circulation of uterus menstruation blood leading to pain due to 'obstruction of qi circulation leading to pain' and 'pain due to poor appetite and pain'. Or menstrual blood stagnation is caused by rain, wading, swimming or eating raw or cold food during menstrual period, internal injury to cold, or cold dampness in Chong and ren meridians and cells after living in wetland; or yang deficiency of the body, internal excess of yin cold, and deficiency-cold of thoroughfare and conception vessels, which can lead to delayed menstruation, blood stagnation and pain. Or excessive depression, recurrent emotional distress during or before menstrual period, stagnation of liver qi, stagnation of qi, blood stasis, disturbance of qi movement in blood and sea, and unsmooth menstruation, manifested as dysmenorrhea. Or the damp-heat stays in the Chong and ren channels, the Chong and ren channels are obstructed, or the damp-heat in the menstrual period is induced to flow into the Chong and ren channels and uterus, and the dysmenorrhea is caused by the struggle between the damp-heat and the menstrual blood. Or the spleen and stomach are weak in essence, deficient in source of transformation, deficient in both qi and blood, failing to nourish the Chong and ren meridians, accompanied by qi deficiency and blood stagnation, and obstructed qi and blood circulation to cause dysmenorrhea. Or prolonged illness or delayed treatment, impairment of healthy qi, mixed cold and heat, unsmooth qi and blood, and dysmenorrhea due to blood stasis.

The traditional Chinese medicine considers that the main pathogenesis of dysmenorrhea is that during menstrual period and before and after menstruation, because blood and sea gradually change from being filled to being discharged, qi and blood change is large and change rapidly, at the moment, emotion fluctuation, carelessness in daily life or invasion of exogenous pathogenic factors are easy to cause disharmony of Chong and conception channels and blood stasis, or stagnation of cold in channels and collaterals, qi and blood disharmony and obstruction of uterus menstruation blood to cause obstruction of circulation to cause pain, or the Chong and conception uterus is not nourished and is not nourished to cause pain. Cold and cool uncooked and cold food is eaten during the menstrual period, the food is caught in the rain and is cold, and the cold is cooled to visit the Chong and ren meridians and the uterus, so that the dysmenorrhea is caused by congealing cold and blood stasis. In the aspect of treatment, the main principle is to regulate Chong and ren meridians and blood, and in the clinical treatment, according to different syndrome groups, the main principles are to regulate blood and relieve pain during menstruation, and the main principles are to be treated by differentiation of symptoms and factors at ordinary times, and the basic principles are combined with the plain physical condition, or regulate liver, or tonify kidney, or strengthen spleen to make qi and blood smooth, Chong and ren meridians circulate, and menstruation smoothly flows, so that dysmenorrhea can be cured. Generally speaking, dysmenorrhea is not caused by external deficiency or excess, but is caused by qi stagnation and blood stasis, cold-dampness stagnation and damp-heat stagnation; deficiency syndrome is mainly caused by deficiency of qi and blood and deficiency of liver and kidney. Therapeutic method: warming channel, dispelling cold, removing dampness, removing blood stasis, and relieving pain.

(2) Irregular menstruation

The female menstrual physiological changes are from those mentioned in Huangdi's internal classic: "two seven female and six male, with the twelve earthly branches in the day, ren channel is open, Taichong pulse is profuse, and the moon is in the morning. Shenjin ao in Zhongyun of gynecology Yu chi: "expensive" means that something more or less than it is, or two or three months to one or several months to one month, if it comes, or before or after it comes, it is not adjusted. "

The traditional Chinese medicine holds that the irregular menstruation is caused by qi and blood disorder and mainly belongs to the aspects of fatigue, mental state and the like. Impairment of conception and governor vessels can be caused when patients suffer from seven emotions, six exogenous pathogens, overstrain of the prolific nature, kidney qi deficiency and fatigue. If the body of a patient is in a fatigue state for a long time, qi and blood disorder is caused, and internal organs in the body are damaged; if the mood is deep for a long time, depression is easily caused by emotional disorder, so qi stagnation and blood stasis in the body can cause scanty menstruation or short time. The theory of traditional Chinese medicine is that women take blood as the basis, and if the yin blood is insufficient, physiological abnormality is inevitably caused, and various diseases are caused. Although the causes of menstrual disorder are various, the traditional Chinese medicine considers that qi-blood disorder is the main cause of menstrual disorder. The irregular menstruation is caused by the disorder of qi and blood of patients, and the disorder of qi and blood is caused by the stagnation of liver qi, the deficiency of kidney qi and the dysfunction of spleen in transportation, so according to the theory of dialectical treatment of traditional Chinese medicine, the treatment mainly comprises the functions of regulating qi and blood, soothing liver, tonifying kidney and strengthening spleen. The purpose of soothing the liver is to dredge qi and blood of a patient, and the menstruation can be restored to be normal after the qi and blood are harmonized. Tonifying kidney can make patients have sufficient kidney qi and vigorous essence and blood, so that qi and blood can have a source of hair growth, and menstruation can be naturally regulated. The spleen functions to generate blood and invigorate the essence and blood of the patient, so as to harmonize qi and blood and smooth the menstrual blood.

(3) Functional premature ovarian failure

The premature ovarian failure can be classified into infertility, sterility, amenorrhea, irregular menstruation, etc. in the ancient traditional Chinese medicine literature. The earliest findings are in book of changes and auspicious, cloud: "women are three years old and are not pregnant". The name of infertility is first reported in Su Wen & Gu-kong Lun, Yun: the governor vessel is the disease, and the female is infertile. The main etiology and pathogenesis of the ovulation dysfunction infertility are kidney deficiency, liver depression and kidney deficiency and liver depression. Moreover, the long course of disease affects qi, blood, body fluids and many zang organs, so there is a complex pathogenesis of qi, blood and body fluids of zang-fu organs being involved or many zang organs being damaged. It is mainly used for tonifying kidney and regulating yin and yang of kidney, and is also called as discharge promotion according to symptoms. The common clinical symptoms include kidney deficiency, liver depression, blood stasis, phlegm stagnation, liver depression and blood stasis.

The governor vessel … … recorded in Su Wen & Gu-kong Lun is the earliest record of the etiology and pathogenesis of infertility in ancient Chinese medical science, namely that women are infertility caused by this disease … …. The book of changes and Yao lines includes "woman sterility" and "woman three years sterility". Doctors in the past generations of China hold different views on the etiology and pathogenesis of infertility. Nanqi 'Zhu's book (ancient book of dead man) can combine with the son if the essence is sufficient, such as essence and premature ejaculation, which is difficult to breed, and highlights the key of essence in kidney in the process of breeding. "Shen nong Ben Cao (Shen nong's herbal) of Qin Han dynasty means that the wind-cold of women is in the uterus and the woman is pregnant for ten years. For the treatment of miscellaneous diseases and syndromes of both women, it is also indicated for infertility due to cold in the lower abdomen of the housewife. In the West jin period, "woman's son-son, 34883," the first thing in the period of acupuncture and moxibustion in the first second meridian and women's miscellaneous diseases ", the first thing to put forward the mechanism of blood stasis leading to infertility. In the golden period, the theory of pathogenesis of phlegm-dampness infertility was first proposed, wherein the disease is a member with abundant fertility, strong sexual conception, people who tend to drink alcohol, irregular menstruation and inability to produce fetus … …. The etiology of liver-qi stagnation infertility was proposed in "Foucairy women & seeds" of jealousy infertility caused by water retention, whose knowledge is that liver qi stagnation. The Qing Dynasty Chen Xiu Yuan (fundamental and seed of the female) proposes that "there are irregular menstruation and irregular menstruation in women, both of them have the internal injury of seven emotions and the external sensation of six excesses, or the excess of qi and blood and the multiplication of yin and yang. The seed method, which is used to regulate menstruation, is important in treating infertility.

For the three diseases, the existing treatment methods are as follows: moxibustion therapy, acupuncture therapy, acupoint application and acupoint injection therapy, traditional Chinese medicine enema therapy, navel application therapy, massage therapy, medicine therapy and the like; wherein the drug therapy mainly comprises: non-steroidal anti-inflammatory drugs, oral contraceptives, calcium channel blockers, spasmolytic sedatives, and the like; by matching the traditional Chinese medicine acupuncture treatment with moxibustion, yang qi can be stimulated, blood flow supply can be enhanced, medicine and acupuncture stimulation can be effectively enhanced, blood flow velocity can be increased, uterine ischemia symptoms can be improved, uterine muscle spasm can be relieved, and the purpose of activating blood can be achieved, but acupuncture treatment can only temporarily relieve pain, and is not used for treatment; the nonsteroidal anti-inflammatory drug comprises ibuprofen, ketoprofen, flufenamic acid and a prostaglandin synthetase inhibitor, and the inhibition of prostaglandin synthesis has obvious pain relieving effect, only needs to be applied in menstrual period, and has short administration period, convenience and small adverse reaction. The primary dysmenorrhea is the preferred drug, and it should be emphasized that the drug property can be fully exerted only 1 day before menstrual pain occurs, and the application should be continued for 48-72 hours, or the duration of drug application is determined according to the previous days of dysmenorrhea. However, prostaglandin synthetase inhibitors have destructive effect on gastric mucosa, and common adverse reactions include dyspepsia, heartburn, nausea, emesis, abdominal pain, constipation, diarrhea, headache, dizziness and the like. Occasionally, visual impairment and other rare adverse reactions occur; the oral contraceptive for inhibiting ovulation not only reduces the production of prostaglandin but also reduces the production of prostaglandin-producing synthase, reducing the frequency of dysmenorrhea. The compound oral contraceptive has the same treatment effect as the gonadotropin releasing hormone agonist, can reduce the level of pituitary gonadotropin, directly acts on endometrium and ectopic endometrium to cause endometrial atrophy and menses reduction, and can cause artificial amenorrhea similar to pregnancy after long-term continuous administration; western medicine mainly uses female progestogen to regulate menstrual cycle and promote ovulation for treating menstrual disorder, and the scheme is single. It has the functions of regulating the feedback function of hypothalamus-pituitary-ovary axis, shrinking corpus luteum timely and complete falling of inner membrane. However, the hormone therapy is easy to cause disease recurrence after drug withdrawal, and has poor safety. Progesterone, as a hormone drug, has certain side effects, may cause symptoms such as weight gain, sodium water retention and the like, and may cause edema in a serious way. Frequent use of progesterone can cause endometrial atrophy, reduced menstrual volume, and vaginal fungal infection. The disease is easy to recur after hormone therapy is stopped, and the safety is poor.

Disclosure of Invention

Aiming at the problems of the western medicine and the acupuncture method, the invention provides the composition with the functions of tonifying the kidney and regulating the menstruation, which is a traditional Chinese medicine composition and starts from the aspects of liver, kidney, heart and spleen, and the composition can be used for thoroughly treating three diseases of primary dysmenorrhea, irregular menstruation and premature ovarian failure.

The technical scheme of the invention is as follows: a composition with functions of tonifying kidney and regulating menstruation comprises the following components in parts by mass:

55-64 parts of angelica sinensis, 95-105 parts of astragalus membranaceus, 58-64 parts of wolfberry, 97-103 parts of codonopsis pilosula, 190-205 parts of Chinese yam, 95-102 parts of steamed rhizoma polygonati, 98-105 parts of dry motherwort, 36-43 parts of Chinese rose flowers, 94-106 parts of caulis spatholobi, 55-64 parts of salted semen cuscutae, 58-65 parts of salted morinda officinalis, 55-67 parts of vinegar rhizoma cyperi and 35-42 parts of liquorice tablets.

Compared with the prior art, the invention has the beneficial effects that: dang Gui is sweet, pungent and warm. It enters liver, heart and spleen meridians. To enrich and activate blood. Rihuazi materia Medica cloud: for wind-cutting, blood-nourishing, fatigue-breaking, blood-stasis-breaking, blood-nourishing and mass-eliminating. "materia medica justice" cloud: "sweet and heavy flavor" is specially used for tonifying blood, light and pungent flavor, and can also promote blood circulation, tonify middle energizer and move middle energizer, honor qi in blood and also holy herbs in blood; angelica is used as a monarch drug to enrich the blood and regulate menstruation.

Huang Qi is sweet and warm. Enter lung and spleen meridians. Book of materia medica, Zhan it: astragalus membranaceus is called as qi-tonifying herbs because it enters lung to tonify qi and enters exterior to strengthen defense. "(materia Medica of materia Medica): astragalus membranaceus has the effects of tonifying middle-jiao and spleen and stomach, and is most suitable for people with qi deficiency, spleen deficiency and qi sinking. The skin directly reaches the skin surface muscles of the human body, strengthens and protects yang, and enriches the exterior, which is the best remedy for diseases with exterior deficiency. Astragalus root, radix astragali, a good product for invigorating primordial qi and qi, can produce blood, so astragalus root, a ministerial drug, tonify qi and produce blood. Wolfberry fruit, sweet and neutral. It enters liver and kidney meridians. It has liver and kidney nourishing effect. The book materia Medica is as follows: "Gou Qi Zi is strong and pure in flavor, so it can tonify yin, while yin is yang, so it can tonify qi. Therefore, nourishing yin without yin deficiency and supporting yang to make yang exuberant. Therefore, medlar is taken as a ministerial drug to tonify the kidney and replenish vital essence.

Codonopsis pilosula, Desluo Ben Cao: the recipe of Dang Gui for promoting blood circulation, which is prepared from Codonopsis pilosula, Astragalus membranaceus, etc., is as follows: dangshen has the actions of tonifying spleen and stomach, moistening lung and promoting fluid production, and strengthening and transporting qi, and is not far from ginseng. Especially the more noble ones, it can invigorate the spleen but not dry, nourish stomach yin but not wet, moisten lung but not cold or cool, nourish blood but not greasy, inspire fresh yang, vibrate middle qi without the disadvantage of dryness. Yam, rhizoma Dioscoreae, strengthens kidney and benefits essence. Compendium (compendium): nourishing kidney qi, strengthening spleen and stomach, stopping diarrhea, resolving phlegm and moistening skin and hair. Steaming rhizoma Polygonati has effects of invigorating qi, nourishing yin, invigorating spleen, moistening lung, and invigorating kidney. The original menstrual period was: rhizoma Polygonati has effects of relieving the epigastric distention, invigorating qi, harmonizing five reservoirs, strengthening muscle, and strengthening bone marrow, and is used for nourishing yin. The three ingredients are combined to tonify qi and replenish essence, and are used as adjuvant drugs.

Dry motherwort herb, Ben Cao Zhen (materia Medica): motherwort herb, herba Leonuri, as a essential agent for antenatal and postnatal fetus, has the effects of removing water and promoting blood circulation, removing blood stasis and promoting tissue regeneration, regulating menstruation and removing toxicity. It can remove blood stasis and promote tissue regeneration after being taken for treating blood stranguria, blood block, metrorrhagia and leukorrhagia pain, fetal leakage, birth difficulty, blood halo, furuncle, carbuncle, breast swelling and other symptoms. Pungent flavor can disperse in wind, activate blood, bitter flavor can eliminate stasis and remove accumulation, cold flavor can treat heat, and applied for clinical symptoms, so mother can benefit ears. China rose, flos Rosae chinensis, promotes blood circulation to regulate menstruation. Spatholobus stem, caulis Spatholobi can tonify blood and activate blood. Decoction piece New references: to remove blood stasis, promote blood generation and induce diuresis. The three drugs are combined together to play the effect of promoting blood circulation to restore menstrual flow, and are used as adjuvant drugs.

Dodder seed and morinda root, semen Cuscutae and Morinda officinalis have the effects of tonifying liver and kidney, nourishing essence and blood, strengthening kidney by introducing salt into kidney meridian. Vinegar Cyperus rotundus is used as adjuvant drug for promoting the circulation of qi, preventing greasy taste of various drugs and preventing blood circulation from stagnation.

The Licorice root tablet is used as a guiding drug to harmonize the properties of the drugs.

The medicines are matched with each other to tonify the kidney and replenish qi, regulate blood and regulate menstruation; can be used for treating premature ovarian failure, menoxenia and primary dysmenorrhea due to kidney deficiency, qi weakness, and blood deficiency and blood stagnation.

Further limited, the composition with the functions of tonifying the kidney and regulating menstruation comprises the following components in parts by mass:

60 parts of angelica sinensis, 100 parts of astragalus membranaceus, 60 parts of wolfberry fruits, 100 parts of codonopsis pilosula, 200 parts of Chinese yams, 100 parts of steamed sealwort, 100 parts of dried motherwort, 40 parts of Chinese rose flowers, 100 parts of caulis spatholobi, 60 parts of salted semen cuscutae, 60 parts of salted morinda officinalis, 60 parts of vinegar-processed rhizoma cyperi and 40 parts of liquorice tablets.

The invention also discloses an ointment containing the composition with the functions of tonifying the kidney and regulating menstruation.

Further limited, the paste also comprises the following components: maltose and potassium sorbate.

The invention also discloses a water agent, powder, pill or tablet containing the composition with the functions of tonifying the kidney and regulating menstruation.

The invention also discloses application of the composition with the functions of tonifying the kidney and regulating menstruation in medicines for treating dysmenorrhea.

The invention also discloses application of the composition with the functions of tonifying the kidney and regulating menstruation in preparing a medicament for treating irregular menstruation.

The invention also discloses application of the composition with the functions of tonifying the kidney and regulating menstruation in a medicine for treating premature ovarian failure.

Drawings

FIG. 1 is a microscopic image of the ovaries of a normal control group (animal No. 1F 09);

FIG. 2 is a microscopic image of the ovaries of the model control group (animal No. 2F 10);

FIG. 3 is a view under a microscope of ovaries of a low dose group of ointments (animal No. 3F 04);

FIG. 4 is a view under a microscope of ovaries of a dose group (animal No. 4F 09) in a cream;

FIG. 5 is a photograph under a microscope of ovaries of a cream high dose group (animal No. 5F 05);

FIG. 6 is a microscopic image of ovaries of WUJIBAIFENG pill group (animal No. 6F 05).

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present invention more apparent, the embodiments of the present invention are described in detail and completely, and it is obvious that the described embodiments are a part of the embodiments of the present invention, but not all of the embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

It will be understood by those skilled in the art that, unless otherwise defined, all terms (including 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 will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the prior art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

Example 1

The composition with the functions of tonifying the kidney and regulating menstruation comprises the following components in parts by mass: 55kg of Chinese angelica, 95kg of astragalus membranaceus, 58kg of wolfberry fruit, 97kg of codonopsis pilosula, 190kg of Chinese yam, 95kg of steamed sealwort, 98kg of dried motherwort, 36kg of Chinese rose, 94kg of caulis spatholobi, 55kg of salted semen cuscutae, 58kg of morinda officinalis, 55kg of vinegar-processed rhizoma cyperi and 35kg of liquorice tablets.

The composition with the functions of tonifying the kidney and regulating menstruation is prepared into paste for use, and the preparation method comprises the following steps:

s1: weighing the above components, and taking 13 medicines in total;

s2: decocting the 13 medicines with water twice, adding 8 times of water by mass for the first time, decocting for 2 hours, adding 6 times of water by mass for the second time, decocting for 1.5 hours, mixing decoctions, and filtering with 200 mesh filter cloth to obtain filtrate;

s3: concentrating the filtrate under reduced pressure to obtain a thick paste with a relative density of 1.21-1.25 (60 ℃) for later use, wherein the temperature is controlled at 60-70 ℃ in the concentration process;

s4: adding water with maltose content of 50% and potassium sorbate, stirring, and slightly boiling for 2 hr to obtain syrup;

s5: and (4) mixing the thick paste obtained in the step S3 with the syrup obtained in the step S4, and concentrating the mixture to obtain paste with the relative density of 1.25-1.28 (60 ℃).

In clinical use, the bottled amount of the ointment is 200g per bottle, the storage is sealed storage, and the effective period is 24 months; the application and dosage are as follows: orally administered 15-20 g once, 3 times a day.

Example 2

The composition with the functions of tonifying the kidney and regulating menstruation comprises the following components in parts by mass: 60kg of angelica, 100kg of astragalus, 60kg of medlar, 100kg of codonopsis pilosula, 200kg of Chinese yam, 100kg of steamed sealwort, 100kg of dried motherwort, 40kg of Chinese rose, 100kg of caulis spatholobi, 60kg of salted semen cuscutae, 60kg of morinda officinalis, 60kg of vinegar rhizoma cyperi and 40kg of liquorice tablets.

s1: weighing the above components, and taking 13 medicines in total;

Example 3

The composition with the functions of tonifying the kidney and regulating menstruation comprises the following components in parts by mass: 64kg of Chinese angelica, 105kg of astragalus, 64kg of medlar, 103kg of codonopsis pilosula, 205kg of Chinese yam, 102kg of steamed sealwort, 105kg of dried motherwort, 43kg of Chinese rose, 106kg of suberect spatholobus stem, 64kg of salted dodder, 65kg of salted morinda officinalis, 67kg of vinegar rhizoma cyperi and 42kg of liquorice tablets are prepared into paste for use, and the preparation method comprises the following steps:

s1: weighing the above components, and taking 13 medicines in total;

Drug effect verification

The drug used in the drug efficacy verification experiment was the ointment prepared in example 2

Experiment 1 influence on Tripterygium glycosides induced premature ovarian failure rat model

1 method of experiment

1.1 animal groups

The animals qualified for quarantine are randomly divided into 6 groups, namely a normal control group, a model control group, a paste low, medium and high dose group and a black-bone chicken white phoenix pill group, wherein each group comprises 10 animals.

1.2 dosage design for test and control

The clinical planned dose of the ointment for adults is 54g crude drugs/day, the clinical equivalent dose of rats is 54 multiplied by 0.018 multiplied by 5 is 4.86g crude drugs/kg according to the conversion of the body surface area, and the low, medium and high doses of the ointment are 1/2, 1 and 2 times of the clinical equivalent dose. The clinical dosage of the Wuji Baifeng pill for adults is 12 g/day, the equivalent dosage of rats converted according to a body surface area method is 1.08g/kg, and the experiment is carried out by adopting 1.12g/kg in combination with literature.

The volume and dose administered to the animals are shown in Table 1-1.

TABLE 1-1 dosage form for paste administration

Ointment preparation:

low dose: 3.537g of the extract (7.29g crude drug) was weighed, dissolved in a suitable amount of purified water under stirring, and diluted to 30mL (243mg crude drug/mL).

The medium dosage is as follows: 7.074g of the extract (14.58g of crude drug) was weighed, dissolved in a suitable amount of pure water under stirring, and diluted to 30mL (486mg of crude drug/mL).

High dose: 14.148g of extract (29.16g of crude drug) is weighed, added with a proper amount of pure water, stirred and dissolved, and diluted to 30mL (972mg of crude drug/mL).

Wuji Baifeng Wan (white Phoenix Bolus of Black-bone Chicken): taking 28 pills (3.36g) of the black-bone chicken white phoenix pills, adding a proper amount of pure water, stirring and dissolving, and then adding the pure water to dilute to 30mL (112 mg/mL).

1.3 routes of administration, methods

The administration route is as follows: administered orally.

Administration volume: 10mL/kg

Frequency and time of administration: 1 time per day

The administration period is as follows: 2 weeks

1.4 Molding administration

After the quarantine is finished and the rats are grouped, the rats of other groups copy the premature ovarian failure model by tripterygium glycosides except the normal control group, 50mg/kg of tripterygium glycosides are administered by gavage, and the normal control group is gavage with pure water with the same volume for 1 time every day for 14 days continuously. After the molding is finished, the medicine with the corresponding dose is administrated by the intragastric administration of 10mL/kg, and the pure water with the same volume as the intragastric administration of the normal control group and the model control group is administrated for 1 time every day for 14 days continuously and weighed once a week.

1.5 detection index

The animals were weighed before administration, and after administration, physical signs of appearance, behavioral activities, secretions, excretions, diet, death, etc. were closely observed and recorded for each group of animals, and weighed once a week.

Fasting is carried out for 14h after the last administration, blood is collected by anesthesia on the next day, serum is collected by centrifugation, and the content of FSH, LH and E2 in the serum is detected by an ELISA method.

Ovaries were dissected out, fixed in formalin, pathologically examined, and observed for follicular and luteal changes by HE staining.

1.6 statistical analysis method

SPSS16.0 software is adopted for data statistics, experimental data are expressed as ' x +/-S ', multiple groups of comparisons are firstly compared with each other to carry out uniform variance and normality, single-factor analysis of variance is adopted for testing when the uniform variance meets the normality, Nonparamric T test is adopted for testing when the uniform variance does not meet the normality, and Tamhane ' S T2 test is adopted for testing when the uniform variance meets the normality. P <0.05 indicates statistical significance, and P <0.01 indicates that the differences tested are of significant significance.

2. Results of the experiment

2.1 Effect on rat serum estradiol (E2), Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH)

A decrease in E2 content, an increase in FSH content, is indicative of a decrease in ovarian function, whereas a decrease in LH content is mainly due to luteal insufficiency.

The experimental results show that: compared with a normal control group, the serum E2 and LH content of the model control group is obviously reduced (P <0.01), the serum FSH content is obviously increased (P <0.01), and the successful replication of the premature ovarian failure model is prompted; compared with a model control group, the serum E2 content of the paste high-dose group and the black-bone chicken white phoenix bolus group is obviously increased (P is less than 0.05), the serum FSH content of the paste low-dose group, the serum FSH content of the paste medium-dose group and the black-bone chicken white phoenix bolus group is obviously reduced (P is less than 0.01), the serum LH content of the paste low-dose group is obviously increased (P is less than 0.05), and the serum LH content of the paste medium-dose group, the serum LH content of the paste high-dose group and the black-bone chicken white phoenix bolus group is obviously increased (P is less than 0.01), so that the paste. The results are shown in tables 1-2.

TABLE 1-2 Effect of ointments on rat serum E2, FSH and LH ((R))

n＝10)

Note: "+" indicates P <0.05, "+" indicates P <0.01, compared to the normal control group; compared to the model control group, "Δ" indicates P <0.05 and "Δ Δ" indicates P < 0.01.

2.2 Effect on ovarian and uterine coefficients

Compared with a normal control group, the ovarian coefficient of the model control group is obviously reduced (P <0.01), and the uterine coefficient is obviously reduced (P < 0.05); compared with the model control group, the ovarian coefficient and the uterine coefficient of the paste low-dose group are obviously increased (P is less than 0.01), the uterine coefficient is obviously increased (P is less than 0.05), and the ovarian coefficient and the uterine coefficient of the paste medium-dose group, the paste high-dose group and the black-bone chicken white phoenix bolus group are obviously increased (P is less than 0.01). The results are shown in tables 1-3.

Table 1-3 effect of ointments on ovarian and uterine coefficients in rats: (

n＝10)

2.3 Effect on ovary

From the microscopic images shown in FIGS. 1-6, the observation results show that: the morphological structure of all levels of ovarian follicles in the normal control group is clear, degeneration necrosis and inflammatory cell infiltration are not seen, and bleeding and inflammatory cell infiltration are not seen in interstitial substance; the number of ovarian atresia follicles of the model control group is increased, the number of follicles and corpus luteum at each level is reduced, the structure of the follicles is irregular, the arrangement of granulosa cells is disordered, and the number of layers is reduced; compared with a model control group, the number of atretic follicles of each dose group of the paste and the black-bone chicken white phoenix bolus group is reduced, the number of follicles and corpus luteum of each level is increased, the follicle structure is relatively regular, and the granular cell arrangement is regular, wherein the treatment effect of the black-bone chicken white phoenix bolus group is optimal, and the treatment effects of the medium and low dose groups of the paste are similar.

3. Conclusion

The experimental results show that: under the test condition, the ointment can improve the content of E2 and LH in the serum of the premature ovarian failure model rat to different degrees, reduce the content of FSH, improve the degree of ovarian lesion and prompt that the ointment has a certain treatment effect on the premature ovarian failure model rat.

Experiment 2 Effect of the ointment on mouse uterine development

1 method of experiment

1.1 dosage design for test and control

Ointment preparation: the clinical adult dose is 54g crude drug/day, the clinical equivalent dose of mouse converted according to body surface area is 54 × 0.0026 × 50 to 7.02g crude drug/kg, and the low, medium and high dose of the ointment is 1/2, 1 and 2 times of the clinical equivalent dose. The clinical dosage of the Wuji Baifeng pill for adults is 12 g/day, the equivalent dosage of the Wuji Baifeng pill converted into a mouse by a body surface area method is 1.56g/kg, and the experiment is carried out by adopting 2.04 g/kg in combination with the literature.

The volume and dose administered to the animals are shown in Table 2-1.

TABLE 2-1 dosage form for paste administration

1.2 pharmaceutical preparation

Ointment preparation:

low dose: 1.703g of extract (3.51g of crude drug) was weighed, dissolved in a suitable amount of purified water under stirring, and diluted to 20mL (175.5mg of crude drug/mL).

The medium dosage is as follows: 3.406g of the extract (7.02g of crude drug) was weighed, dissolved in a suitable amount of purified water under stirring, and diluted to 20mL (351mg of crude drug/mL).

High dose: 6.812g of the extract (14.04g of crude drug) was weighed, dissolved in a suitable amount of pure water under stirring, and diluted to 20mL (702mg of crude drug/mL).

Wuji Baifeng Wan (white Phoenix Bolus of Black-bone Chicken): 2.04g of Wuji Baifeng pills (17 pills) are taken, added with a proper amount of pure water, stirred and dissolved, and then diluted to 20mL (102g crude drug// mL) by adding the pure water.

1.3 routes of administration, methods

The administration route is as follows: oral drench

Administration volume: 20mL/kg

Frequency and time of administration: 1 time per day

The administration period is as follows: 7 days

1.4 administration by groups

After quarantine is finished, animals are randomly divided into 5 groups according to body weight, and each group comprises 10 animals, namely a normal control group, a low-dose group, a medium-dose group, a high-dose group and a black-bone chicken white phoenix bolus group. The corresponding dose of the drug is infused in the stomach of each administration group, and the equal volume of pure water is infused in the stomach of the normal control group animals for 1 time per day for 7 days continuously.

1.5 detection index

After the last administration, fasting is carried out for 14h, the uterus and the ovary are dissected, the wet weight is weighed, and the uterus coefficient and the ovary coefficient are calculated, wherein the uterus coefficient is the weight of the uterus/the weight of the ovary, and the ovary coefficient is the weight of the ovary/the weight of the ovary.

1.6 statistical analysis method

2 results of the experiment

Compared with a normal control group, the uterus coefficient (P <0.01) and the ovary coefficient (P <0.05) of the ointment high-dose group are obviously increased, and the uterus coefficient and the ovary coefficient (P <0.01) of the black-bone chicken and white phoenix bolus group are obviously increased, which indicates that the ointment can promote the development of the uterus and the ovary. The results are shown in Table 2-2.

TABLE 2-2 Effect of ointments on mouse uterine and ovarian coefficients: (

n＝10)

3 conclusion

The experimental results show that: under the test conditions, the high dose of the ointment can increase the uterus and ovary coefficients of the mice.

Experiment 3 Effect of the ointment on the rat model of dysmenorrhea

1 method of experiment

1.1 animal groups

Selecting qualified quarantine rats, weighing, and randomly grouping according to body weight, wherein the groups include normal control group, model control group, paste low, medium and high dosage groups, and black-bone chicken Baifeng pill group, each group contains 10 animals.

1.2 dosage design for test and control

The volume and dose administered to the animals are shown in Table 3-1.

TABLE 3-1 dosage form for paste drug administration

1.3 pharmaceutical formulation

Ointment preparation:

low dose: 3.537g of extract (7.29g crude drug) is weighed, added with proper amount of pure water, stirred and dissolved, and diluted to 30mL (243mg crude drug/mL).

Wuji Baifeng Wan (white Phoenix Bolus of Black-bone Chicken): taking 28 pills (3.36g) of the black-bone chicken white phoenix pills, adding a proper amount of pure water, stirring and dissolving, and then adding the pure water to dilute to 30mL (112mg crude drug/mL).

1.4 routes of administration, methods

The administration route is as follows: oral drench

Administration volume: 10mL/kg

Frequency and time of administration: 1 time per day

The administration period is as follows: 10 days

1.5 Molding administration

The administration was started after the grouping, except for the normal control group, rats in each group were injected subcutaneously with diethylstilbestrol peanut oil solution every day for 10 consecutive days, 3.2mg/kg per rat every first and 10 days, and 2mg/kg per rat every day every other time. And simultaneously, the corresponding dose of medicine is administrated by each group through intragastric administration, and equal volume of pure water is administrated by a normal control group and a model control group through intragastric administration for 1 time every day for 10 consecutive days, and the weight is weighed once a week.

1.6 detection index

The animals were weighed before administration, and after administration, physical signs, behavioral activities, secretions, excretions, diet, death, etc. were closely observed and recorded for each group of animals.

After the corresponding drugs of each group are irrigated for 45min on the 10 th day, the rats of each group are injected with oxytocin 10U/kg in the abdominal cavity, and the number of animals with writhing reaction and the times of writhing are observed and recorded within 30 min. Twisting reaction: the abdominal muscles contract and indent, the buttocks and one side of the limbs rotate inward, and the trunk and the hind limbs extend.

After the number of times of body detection is finished, blood is collected through anesthesia, serum is collected through centrifugation, and the content of progesterone P, estradiol E2 and beta-endorphin beta-EP in the serum is detected.

1.7 statistical analysis method

2 results of the experiment

Animals were simulated for dysmenorrhea symptoms by continuous administration of diethylstilbestrol to increase uterine sensitivity followed by another injection of oxytocin to induce pain from the spastic contractions of the uterus. It has been reported that a decrease in progesterone (P) suggests a decrease in ovarian function due to female luteal insufficiency, resulting in hypoprogesterone secretion and thus low progesterone. Beta-endorphins (beta-EP) are a class of neuro-polypides with morphine-like activity, have endogenous analgesic effects and participate in the regulation of reproductive endocrine. beta-EP is restricted by sex hormones, progesterone can significantly improve the secretion of beta-EP, while estradiol inhibits the effect of progesterone on beta-EP. Therefore, a decrease in the level of β -EP in the luteal phase leads to a malfunction in uterine function, and is considered to be one of the causes of dysmenorrhea.

The experimental result shows that compared with a normal control group, the number of writhing times of the model control group is obviously increased (P is less than 0.01), the contents of serum progesterone (P) and beta-endorphin (beta-EP) are obviously reduced (P is less than 0.01), and the content of estradiol (E2) is obviously increased (P is less than 0.05); compared with a model control group, the times of body twisting of the paste low-dose group are obviously reduced (P is less than 0.05), the times of body twisting of the paste medium, high-dose group and the black-bone chicken white phoenix bolus group are obviously reduced (P is less than 0.01), the contents of P and beta-EP of the paste medium, high-dose group and the black-bone chicken white phoenix bolus group are obviously increased (P is less than 0.01), and the contents of E2 of the paste low, medium and high-dose group and the black-bone chicken white phoenix bolus group are obviously reduced (P is less than 0.01), which indicates that the paste can relieve the symptoms of dysmenorrheal. The results are shown in Table 3-2.

TABLE 3-2 Effect of ointments on rat dysmenorrhea and serum P, E2 and beta-EP levels ((

n＝10)

3 conclusion

The experimental results show that: under the test condition, the ointment can reduce the body twisting times of the rat dysmenorrhea model to a certain extent, increase the P and beta-EP content of the rat model with dysmenorrhea, reduce the E2 content and prompt that the ointment has the function of improving the dysmenorrhea.

Second, clinical trial

1. Clinical trial of primary dysmenorrhea

1.1 general data

200 patients diagnosed with primary dysmenorrhea, which are treated in hospitals from 2 months to 2020 months in 11 months in valley medical hall of Hunan province, namely Changsha Yuhua Jinghao mansion department, women and young health care institute reproductive center of Hunan province and Hunan pond city center, are randomly divided into a control group and a treatment group, wherein the control group comprises 65 patients and the treatment group comprises 135 patients; the patients are 15-40 years old, the average age is 23.6 years old, and the control group and the treatment group have no statistical difference in comparison with baseline data such as age, disease course and marital history and have comparability.

1.2 diagnostic criteria

All accord with the diagnosis standard of primary dysmenorrhea in the guidelines of clinical research of new Chinese medicines and the science of obstetrics and gynecology of China: lower abdominal periodic pain during or before and after menstrual period; no organic lesion appears through gynecological examination and B-ultrasonic examination.

1.3 Observation index and evaluation Standard

Observation indexes are as follows: the effective rate of treating primary dysmenorrhea is obvious: after treatment, the uncomfortable symptoms such as abdominal pain and the like disappear, and no relapse occurs after 3 months of continuous menstruation period after the medicine is stopped; the method has the following advantages: the discomfort symptoms such as abdominal pain and the like are relieved after treatment, and no relapse occurs after the medicine is stopped for 2 months continuously through a period; and (4) invalidation: the above standard is not achieved.

The effective rate of the primary dysmenorrhea is the sum of the effective rate and the percentage of the effective rate in the total cases.

1.4 methods of treatment

Control group: ibuprofen sustained release tablets, 400 mg/time, 3 times/day, started orally 3 days before menstruation, treatment groups: the ointment prepared in example 2 was selected, and the dosage for each time was: 18g, 3 times a day.

1.5 statistical results:

two groups of curative effects are as follows: in 135 cases of the treatment group, 93 cases of obvious effect, 36 cases of effective effect and 6 cases of ineffective effect exist, and the total effective rate is 95.6 percent; in 65 cases of the control group, 29 cases were effective, 15 cases were effective, and 21 cases were ineffective, and the total effective rate was 67.7%. The total effective rates of the two groups are compared, and the significant difference shows that the clinical curative effect of the treatment group is obviously superior to that of the control group. In addition, by follow-up visit at later stage, after 6 months, 8 cases of 29 cases of control group showed recurrence and aggravation, while 93 cases of treatment group showed no recurrence and aggravation, indicating that the disease was completely cured.

1.6 safety

Neither group of patients experienced significant adverse events during the treatment period.

2. Clinical test for irregular menstruation

2.1 general data

176 cases of patients diagnosed with irregular menstruation were selected from hospitals in the department of outpatient service of Changsha Yuhua Jinghao mansion, the Fuju health care institute reproductive center of Hunan province and Hunan Tan City center hospitals from No. 2 month to No. 11 month in 2017 to No. 2020, and were randomly divided into a control group and a treatment group, 40 cases of the control group and 136 cases of the treatment group; the patients are 20-45 years old, the average age is 26.4 years old, and the comparison between the control group and the treatment group on the baseline data such as age, disease course and marital history has no statistical difference and is comparable.

2.2 diagnostic criteria:

all accord with the standard of menoxenia diagnosis in the guidelines of clinical research on new Chinese medicines and the science of Chinese obstetrics: menstrual cycle, menstrual period and menstrual volume are abnormal and obvious discomfort symptoms appear.

2.3 Observation index and evaluation Standard

Observation indexes are as follows: the effective rate of treating irregular menstruation shows: through treatment, uncomfortable symptoms such as abnormal menstrual cycle, menstrual period and menstrual flow disappear, and the menstrual cycle, menstrual period and menstrual flow do not change obviously after the medicine is stopped for 3 months continuously; the method has the following advantages: through treatment, uncomfortable symptoms such as abnormal menstrual cycle, menstrual period and menstrual flow disappear, and the menstrual cycle, menstrual period and menstrual flow do not change obviously after the medicine is stopped for 2 months continuously; and (4) invalidation: the above standard is not achieved.

The effective rate of the irregular menstruation treatment is the sum of the effective rate and the effective rate accounting for the total number of cases.

2.4 methods of treatment

Control group: progesterone tablets, 4 mg/time, 3 times/day, injected starting 3 days before menstruation, treatment groups: the ointment prepared in example 2 was selected, and the dosage for each time was: 20g, 3 times a day.

2.5 statistical results

Two groups of curative effects are as follows: in 136 cases of the treatment group, 95 cases of the treatment group are obvious, 37 cases of the treatment group are effective, 4 cases of the treatment group are ineffective, and the total effective rate is 97.1 percent; in 40 cases of the control group, 26 cases were effective, 12 cases were effective, and 2 cases were ineffective, and the total effective rate was 95.0%. The total effective rates of the two groups are compared, and the significant difference shows that the clinical curative effect of the treatment group is obviously superior to that of the control group. In addition, by follow-up visit at the later stage, after 6 months, 18 cases of the control group showed disease relapse in 26 cases, while 95 cases of the treatment group showed no relapse and aggravation cases, indicating that the disease was completely cured.

2.6 safety

Patients in the treated group did not show any significant adverse events during the treatment period, and for 12 cases in the group, symptoms of weight gain and sodium water retention were observed, and in 2 cases, edema was observed.

3. Functional premature ovarian failure

3.1 general data

120 patients diagnosed with premature ovarian failure were selected from the department of outpatient service of Changsha Yuhua Jinghao, Kyoho health care hospital, the reproductive center of women and young health care hospital, and Hunan Tan City center hospitals, which were linked to the TCM outpatient service Limited in the valley medical hall of Hunan, from 1 month to 11 months in 2016, and were randomly divided into a control group and a treatment group. 78 treatment groups, age 23-41 years, mean 36.64 years; amenorrhea or menstruation occurs for 0.5-5 years, and the average time is 2.31 years; 42 control groups with the age of 24-40 years and the average age of 34.29 years; the amenorrhea or menstruation occurs for 0.5-5 years, and the average is 1.67 years. The 2 data are statistically processed, and have no significance (P >0.05) in the difference of age and disease condition, and are comparable.

3.2 diagnostic criteria:

according to clinical manifestations and diagnostic criteria for premature ovarian failure [ Xuling, Song et A army ] clinical manifestations and diagnostic criteria for premature ovarian failure [ J ]. J.Utility J.J.2003, 19(4):195-196 ]. Age less than 40 years; second, the menstrual cycle is established, but amenorrhea suddenly appears for more than 4 months without inducement; or hypomenorrhea before amenorrhea for more than 4 months; ③ blood estrogen and gonadotropin levels: there were 2 or more serum FSH >40IU/L (two times separated by 1 month), E2<73.2pmol/L, Prolactin (PRL) was normal.

3.3 Observation index and evaluation Standard

Has obvious effect that the menstruation approaches to the normal cycle (within 40 days), the menstruation automatically flows for 1 time within 3 months after the medicine is stopped, and other symptoms are improved. The traditional Chinese medicine composition is effective in treating 1 time of menstruation within 3 months and improving other symptoms. No effect, continuous treatment for 3 months, no effect of menstruation.

3.4 methods of treatment

Control group: 0.25mg of stilbestrol is used from the 5 th day of the menstrual cycle or the current day of the doctor, 1 time and 20 days per day, and 4mg of Angongprogesterone is added at the 16 th day of the medicine taking, 1 time and 7 days per 12h or 10mg of progesterone is used for intramuscular injection, 1 time and 5 days per day, and the menstrual cycle is continuously used for 3 months; treatment groups: the ointment prepared in example 2 was selected, and the dosage for each time was: 19g, 3 times a day, continuously taking until menstruation comes, stopping taking in menstrual period, and taking 3 months of menstruation with a period of 1 course continuously for 3 courses.

3.5 statistical results

Two groups of curative effects are as follows: in 78 cases of the treatment group, 59 cases are effective, 16 cases are effective, 3 cases are ineffective, and the total effective rate is 96.15%; in 42 cases of the control group, 26 cases of significant effect, 10 cases of effect and 6 cases of no effect exist, and the total effective rate is 85.71%. The total effective rates of the two groups are compared, and the significant difference shows that the clinical curative effect of the treatment group is obviously superior to that of the control group.

Measurement of serum sex hormone parameter comparison before and after two groups of treatment

As shown in table 1, after the treatment group and the control group, FSH (follicle stimulating hormone) was significantly decreased, and E2 (estradiol) was significantly increased, which had a significant statistical significance compared to the group before the treatment; after the treatment group, the FSH level is obviously reduced compared with the control group, and the E2 level is obviously increased and has obvious statistical difference.

TABLE 1 comparison of serum sex hormone parameters before and after two groups of treatment

Item	Before treatment of treatment group	After treatment of treatment group	Before treatment of control group	After treatment of control group
					FSH(IU/L)	67.13±13.01	32.46±10.46*	64.59±13.18	51.67±11.26**
E2(pmol/L)	43.12±11.49	71.28±11.67*	39.41±13.24	88.46±10.21**

Note: comparison before and after treatment of each group, < 0.05; 0.01.

3.6 safety

In summary, the traditional Chinese medicine composition of the present invention is prepared into other dosage forms, and the same or similar results are obtained in experiments, which are not listed and prevent the tiredness of the description, and the application claims a traditional Chinese medicine formula (combination invention) rather than a dosage form or a preparation method, so that any dosage form prepared by adopting the traditional Chinese medicine formula of the present invention and a medicine for treating ovarian functional premature senility, irregular menstruation and primary dysmenorrhea belong to the scope of the protection of the present application.

The traditional Chinese medicine composition has scientific components, rich raw materials, low price, reasonable compatibility and mutual support, has the effects of tonifying kidney and qi and regulating blood and menstruation, is effectively used for treating functional premature ovarian failure, irregular menstruation and primary dysmenorrhea, has good curative effect and safe medication, is a great innovation in traditional Chinese medicines, and has practical clinical significance.

The invention is not limited to the above alternative embodiments, and any other various forms of products can be obtained by anyone in the light of the present invention, but any changes in shape or structure thereof, which fall within the scope of the present invention as defined in the claims, fall within the scope of the present invention.

Claims

1. The composition with the functions of tonifying the kidney and regulating menstruation is characterized by comprising the following components in parts by mass:

2. The composition with the functions of tonifying the kidney and regulating menstruation according to claim 1, which is characterized by comprising the following components in parts by mass:

3. An ointment comprising the composition for tonifying kidney and regulating menstruation according to claim 1 or 2.

4. The paste of claim 3, further comprising the following components: maltose and potassium sorbate.

5. An aqueous preparation, powder, pill or tablet comprising the composition for tonifying kidney and regulating menstruation according to claim 1 or 2.

6. Use of the composition for tonifying kidney and regulating menstruation according to claim 1 or 2 in the preparation of a medicament for treating dysmenorrhea.

7. Use of the composition for tonifying kidney and regulating menstruation according to claim 1 or 2 in the preparation of a medicament for treating irregular menstruation.

8. Use of the composition for tonifying kidney and regulating menstruation according to claim 1 or 2 in the treatment of premature ovarian failure.