CN102846906B - Medicament for treating premature ovarian failure and preparation method thereof - Google Patents
Medicament for treating premature ovarian failure and preparation method thereof Download PDFInfo
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- CN102846906B CN102846906B CN201210302638.1A CN201210302638A CN102846906B CN 102846906 B CN102846906 B CN 102846906B CN 201210302638 A CN201210302638 A CN 201210302638A CN 102846906 B CN102846906 B CN 102846906B
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Abstract
The invention discloses a medicament for treating premature ovarian failure and a preparation method thereof. The medicament for treating premature ovarian failure comprises the following traditional Chinese medicine raw material extracts, by weight: 4-18 parts of a Pueraria extract, 2-20 parts of a yam extract, 2-15 parts of a grape seed extract, 3-20 parts of an angelica extract, 2-10 parts of a soybean extract, 3-15 parts of a spinadateseed extract, 3-13 parts of a raspberry extract and 2-10 parts of a pearl powder. The components in the medicament for treating premature ovarian failure are proportioned according to the principles of warming uterus, nourishing ovary, nourishing yin, tonifying kidney, promoting blood circulation, removing blood stasis, regulating menstruation, arresting leucorrhoea, and inducing diuresis for removing edema, so that the medicament for treating premature ovarian failure has significant clinical effect and high effective rate. In addition, the medicine for treating premature ovarian failure is a safe pure natural herb, and has no toxic or side effect, no damage to liver and kidney function, and no adverse reaction. The medicament for treating premature ovarian failure provided by the invention has a simple preparation method, stable and reliable drug performance, high production efficiency and low production cost.
Description
Technical field
The invention belongs to technical field of medicine, be specifically related to a kind of medicine for the treatment of premature ovarian failure and preparation method thereof.
Background technology
Premature ovarian failure, refer to the women of built Regulations of Error Equation menstruation, before 40 years old, because persistence amenorrhea and sexual organ's atrophy appear in ovarian function decline, often there are rising and the estrogenic decline of Gonadotropin Level, before 40 years old, the sickness rate of premature ovarian failure is about 1% ~ 3%, and sickness rate in 30 years old is about 0.1%.Clinical manifestation companion sees symptom before and after the menopause such as hectic fever hyperhidrosis in various degree, insomnia and dreamful sleep, irritated irritability, cardiopalmus, tired, nervous, vaginal dryness, sexual disorder, sterility and infertility, amenorrhea in advance, make patient's geromorphism, adjust timely and treat if can not get, can cause the appearance of osteoporosis, cardiovascular and cerebrovascular disease chronic diseases, directly affect female life quality, have a strong impact on women's normal work, bring very big misery to its physical and mental health and love life simultaneously.
Premature ovarian failure, its cause of disease it be unclear that so far, so the research of this disease has been become to focus and the difficult point of domestic and international reproductive development circle.At present both at home and abroad research think more premature ovarian failure and hereditary, immune, metabolism and the factor such as iatrogenic relevant.Show chromosome mutation by research data; FSH (FSH) interstitialcellstimulating hormone (ICSH) (LH) and receptor variant thereof; Developmental and Metabolic Disorder or drug effect; chemicotherapy damage; viral infection; immunity and other high risk factors as the factor such as smoking, depression may be its reason; these factors or make the congenital ovum decreased number of ovary; or its follicular atresia is accelerated; or directly destroyed; make follicle premature depletion, generally adopt hormone replacement therapy for the treatment modern medicine of premature ovarian failure.
But premature ovarian failure treatment is more difficult, and doctor trained in Western medicine adopts Hormone Replacement Therapy clinically, need under doctor's guidance, use estrogen and progestogen.When research shows this estrogen and progestogen therapy, have certain effect, can improve symptom, but unsatisfactory to the recovery of ovarian function, after drug withdrawal simultaneously, symptom reappears, and makes ovary in dependent status, has the worse possibility of the ovarian function of causing.That is to say that Hormone Replacement Therapy has only played the effect taking stopgap measures, and this method side effect is large, life-time service exogenous hormones has the danger that causes endometrium canceration, and increases the sickness rate of coronary heart disease and cholecystopathy.Therefore the effect of this hormone therapy is undesirable, has potential safety hazard simultaneously.Aspect western medical treatment, except hormone replacement therapy, also there is induced ovulation, assist and give ovum technology, autologous or allosome ovary transplantation technology, immunosuppressant therapy, supplements calcium preparation or calcitonin treatment.But these western medical treatment methods are nothing more than recovery, and maintenance, substitutes these several respects of ovarian function.Up to the present also do not have definite effective method can recover the function of ovary, so premature ovarian failure cause of disease complexity, treatment difficulty is larger, and modern medicine not yet makes a breakthrough and carries out so far.
In recent years, along with Chinese medicine development, be more and more concerned with the chemotherapy that natural plant kind medicine substitutes in doctor trained in Western medicine.Chinese medicine has the integrally-regulated effect of multisystem too many levels, can improve ovarian function, improves ovarian reserve ability, promotes follicular development and ovulation, and regulating menstruation and assisting pregnancy is antiabortive, in long-term clinical practice, is confirmed.Traditional Chinese medical herbal treatment primary disease, obtain certain curative effect, but this curative effect is not ideal at present, and effective percentage is low, is in particular in: 1. be all used as medicine with the former medicine complete feed of Chinese medicine at present, drug effect is received impact, and effect is undesirable; 2 prescription compatibilities are unreasonable.Just because of these causes, cause existing treatment premature ovarian failure Chinese medicine clinical effectiveness desirable not to the utmost.
Summary of the invention
The object of the invention is to overcome the above-mentioned deficiency of prior art, a kind of medicine of two curative effect premature ovarian failure with treating both the principal and secondary aspects of a disease is provided.
Another object of the present invention is to provide the preparation method of the simple premature ovarian failure medicine of a kind of technique.
In order to realize foregoing invention object, technical scheme of the present invention is as follows:
Treat a medicine for premature ovarian failure, comprise the raw material of Chinese medicine extract components of following weight portion:
And, a kind of preparation method of medicine for the treatment of premature ovarian failure, it comprises the steps:
Take each raw material of Chinese medicine extract components by the formula of the medicine of above-mentioned treatment premature ovarian failure;
Each described raw material of Chinese medicine extract components is mixed, and sterilization, adopts peroral dosage form technique to make the medicine of described treatment premature ovarian failure.
The medicine of above-mentioned treatment premature ovarian failure adopts warm palace to support nest, enriching yin and nourishing kidney, activating blood circulation to dissipate blood stasis, and the principles of formulating prescriptions of adjusting meridian and stopping leukorrhea, inducing diuresis to remove edema are carried out the each component of proportioning.Using Radix Puerariae extract, soybean extract, Rhizoma Dioscoreae extract as the principal agent for the treatment of, as monarch, nourish ovary, balance estrogen and progestogen, life lengthening, reaches the economic benefits and social benefits for the treatment of both the principal and secondary aspects of a disease, reach female pregnant with mending, two-ways regulation incretion balance, delays premature ovarian failure and the object of recovering ovarian function; Taking Radix Angelicae Sinensis extract, Fructus Rubi extract two medicines mutually 5 for minister principal drug assistance altogether, taking Semen Vitis viniferae extract, Semen Ziziphi Spinosae extract two taste medicines as assistant, reach calm the nerves, antioxidation, the object of raising autoimmune function; Margarita powder energy convulsion, defying age.Therefore, the medicine Chinese medicine composition clinical effectiveness of this treatment premature ovarian failure is remarkable, and effective percentage is high.In addition, the medicine that the present invention treats premature ovarian failure is pure natural medical herbs, has no side effect, and without hepatic and renal function injure, there is no untoward reaction, safety.
The preparation method of above-mentioned treatment premature ovarian failure medicine only need be mixed each component by formula, adopts the peroral dosage form technique of existing maturation to prepare the medicine of this treatment premature ovarian failure.The method technique is simple, technology maturation, and pharmaceutical properties is reliable and stable, has effectively improved production efficiency, has reduced production cost.
Brief description of the drawings
Fig. 1 is the flow chart of the preparation method of embodiment of the present invention treatment premature ovarian failure medicine.
Detailed description of the invention
In order to make object of the present invention, technical scheme and advantage clearer, below in conjunction with drawings and Examples, the present invention is further elaborated.Should be appreciated that specific embodiment described herein, only in order to explain the present invention, is not intended to limit the present invention.
Chinese medicine is thought and hypo-ovaria is indicated the arrival of female aging.Primary disease belongs to the categories such as " blood depletion ", " blood every ", " amenorrhea ", " infertility ".As " treasure-married woman of boudoir Men-amenorrhea is proved for the third time " sayed: " married woman's taste prolonged deficiency, or shape win menopause, by heat sparkled, wasting, time see yearningly dry, name of disease day blood depletion menopause ".The cause of disease of primary disease may be summarized to be: natural endowment deficiency, and kidney qi is not contained, and punching appoints a QI and blood not fill and gradually to exhaustion; Internal injury caused by excess of seven emotions causes stagnation of QI due to depression of the liver blood stasis, and retardance is appointed in punching, and QI and blood secretly consumes; Or excessive thinking damage heart spleen, punching times declines and causes less amenorrhea; Serious disease prolonged illness consumption impairment of YIN liquid, or the consumption such as exhaustion due to sexual indulgence, fecund, induced abortion, the abortion essence and blood of having a rest, a punching senilism; Menstrual period, puerperal, diseases caused by exogenous pathogenic factor six evil, fought mutually with blood, and the resistance punching of becoming silted up is appointed, and causes amenorrhea.
Therefore, the present invention is based on this theory of Chinese medical science, use YIN nourishing invigorating YANG, train first the kidney invigorating, the gentle essence of adding, reason kidney and blood, depressed liver-energy dispersing and QI regulating, happy mechanism of qi, Yin Yang balancing, educates the ovum principle of stimulating the menstrual flow, and a kind of medicine with treating both the principal and secondary aspects of a disease and the significant two curative effect premature ovarian failure of clinical effectiveness is provided.The medicine of this treatment premature ovarian failure comprises the raw material of Chinese medicine extract components of following weight portion:
Particularly, the meridian distribution of property and flavor of above-mentioned Radix Puerariae extract: cool in nature, sweet in the mouth, pungent; Return spleen, stomach warp.Composition pharmacology: the underground tuber that Radix Puerariae is huge has been put aside " phytoestrogen " and the derivant thereof, b-sitosterol, stigmasterol, coumestrol, puerarin, mirificoumestan, kwakhurin and the mirificin that include isoflavone (different Huang, ketoside, daidzein, genistin, isoflavone wood alkali and puerarin).Effect application: Radix Puerariae isoflavone has estrogen action, contain special hormone, the plant estrogen that it is rare---high activity isoflavone can effectively be nursed one's health endocrine, nourish the metabolic capacity of the endogenous estrogen of the person, Yin Yang balancing, coordination internal organs, raising and recovery human body self, comprehensive adjustment estrogen, the discomfort that the women that releives menstruation causes, can promote women's skin care, especially obvious to middle-aged women and the effect of menopausal women face-nourishing health-care.
This Radix Puerariae extract must be to extract from Radix Puerariae, and concrete extracting method is for to pulverize rear employing alcohol steep by Radix Puerariae, and concrete extracting technology is with reference to well known in the art.Adopting alcohol steep, be mainly in order to obtain fat-soluble functional component in Radix Puerariae, and its cost is low, nontoxic, and can effectively make the fat-soluble functional component in Radix Puerariae effectively leach, as functional components such as Miroestrol. and the micro-female alcohol of deoxidation.Certainly functional component is not only the micro-female alcohol of Miroestrol. and deoxidation, also has other functional components.
The meridian distribution of property and flavor of above-mentioned Rhizoma Dioscoreae extract: sweet, cold; Return lung, the heart, stomach warp.Composition pharmacology: containing chlorogenic acid, inositol, dioscin and pure cellulose.Effect application: Rhizoma Dioscoreae dioscin, due to similar to the progestogen molecular structure of ovarian secretion in body, has very strong progestogen action; There is spleen reinforcing, support lung, reinforce the kidney, effect of benefit essence, can treat diarrhea due to hypofunction of the spleen, lack of appetite edema, cough and asthma due to lung deficiency, quench one's thirst, seminal emission, leukorrhagia, the frequent micturition etc. of suffering from a deficiency of the kidney, simultaneously Rhizoma Dioscoreae is for various febrile diseases, dispelling wind-heat, kind removing summer-heat blood poison also, have antibacterial, antiviral, antiinflammatory, antipyretic, regulate immunization.
This Rhizoma Dioscoreae extract must be to extract from Rhizoma Dioscoreae, and concrete extracting method is for to pulverize rear employing alcohol steep by Rhizoma Dioscoreae, and concrete extracting technology is with reference to well known in the art.Adopting alcohol steep, be mainly in order to obtain fat-soluble functional component in Rhizoma Dioscoreae, and its cost is low, nontoxic, and can effectively make the fat-soluble functional component in Rhizoma Dioscoreae effectively leach, as functional components such as Rhizoma Dioscoreae dioscins.Certainly functional component is not only Rhizoma Dioscoreae dioscin, also has other functional components.
The meridian distribution of property and flavor of above-mentioned soybean extract: bitter, acrid, cold; Return Liver Channel.Composition pharmacology: contain triterpene and glycoside thereof, sterol and glycoside thereof, flavonoid, coumarin, organic acid, volatile oil and saccharide etc.Effect application: the estrogen action that the isoflavone in soybean extract has, the level of energy two-ways regulation women body inner estrogen; Simultaneously relieve inflammation or internal heat improving eyesight, mass dissipating and swelling eliminating of Semen sojae atricolor, has liver heat removing, blood pressure lowering, blood sugar lowering, antibacterial, antiinflammatory, antiallergic and antivirus action.As preferred embodiment, above-mentioned soybean extract is the extract in bean cake or the plumule of Semen sojae atricolor.This bean cake is or/and the functional component content in embryo extract is high, particularly isoflavone content.
This Semen sojae atricolor or bean cake or/and the concrete extracting method of embryo extract be: after Semen sojae atricolor or plumule are pulverized or bean cake is adopted to alcohol steep, concrete extracting technology is with reference to well known in the art.Adopt alcohol steep, be mainly in order to obtain Semen sojae atricolor or bean cake or/and plumule extract in fat-soluble functional component, and its cost is low, nontoxic, and can effectively make Semen sojae atricolor or bean cake or/and the fat-soluble functional component of plumule in extracting effectively leaches.
The meridian distribution of property and flavor of above-mentioned Radix Angelicae Sinensis extract: bitter, cold; GUIXIN, liver, stomach, large intestine, urinary bladder channel.Composition pharmacology: containing multiple alkaloid and multiple flavone compound.Effect application: heat clearing and damp drying, parasite killing, diuresis, there is heat-clearing and toxic substances removing, loose carbuncle detumescence, enrich blood and invigorate blood circulation, menstruction regulating and pain relieving, loosening bowel to relieve constipation.For blood deficiency and yellow complexion, dizzy cardiopalmus, menoxenia, amenorrhea dysmenorrhea, asthenia cold abdominalgia, dryness of the intestine constipation, rheumatic arthralgia etc.
The meridian distribution of property and flavor of above-mentioned Semen Ziziphi Spinosae extract: acrid, sweet, warm; Return liver, kidney channel; 1. " herbal classic ": main trusted subordinate's cold and heat, pathogens agglomerating gas is poly-, painful limbs, arthralgia chiefly caused by damp pathogen; 2. not " not Lu ": main vexatious insomnia, umbilicus is pain up and down, and blood turns chronic diarrhea, sweating due to debility excessive thirst, invigorating middle warmer, the liver benefiting gas, hard muscles and bones, helps cloudy gas, makes us fertile strong; 3. " property of medicine opinion ": main muscles and bones wind, fry end and take it as soup; 4. supplement to the Herbal: many raw making of sleeping, must not sleep and fry; 5. Wang Haogu: control milk-livered sleeplessness, tremble with fear also, fry clothes; Control somnolence due to gallbladder-excess, heat also, use by life; 6. " book on Chinese herbal medicine converges and says ": astringing QI is calmed the nerves, and flourish muscle is supported marrow, stomach function regulating activating the spleen; 7. " book on Chinese herbal medicine is new again ": suppressing the hyperactive liver is regulated the flow of vital energy, nourishing lung-YIN, warming middle-JIAO dampness removing, astringing QI hidroschesis, beneficial will is breathed out surely, hearing-improing and eyesight improving.Composition pharmacology: Semen Ziziphi Spinosae is containing Determination of multiple metal elements such as 17 seed amino acids such as alkaloid, triterpenes, flavonoid, threonine (threonine) and potassium, sodium, calcium, zinc, ferrum, copper, manganese.Contain again ferulic acid (ferulic acid), vitamin C and plant sterol, cyclic adenosine monophosphate (cyclic adenosine3 ', 5 '-monophosphate) etc.Effect application: mind tranquilizing and the heart calming, nourishing the liver, arresting sweating, kidney-replenishing, bone and muscle strengthening, wind-damp dispelling, there is raising hypophysis---the effect of interrenal system function, and can enhancing antibody formation effect, suppress virus copying and breeding in vivo, improve body immunity effect.
This Radix Angelicae Sinensis extract, the concrete extracting method of Semen Ziziphi Spinosae extract are: respectively Radix Angelicae Sinensis, Semen Ziziphi Spinosae crude drug are pulverized to the rear alcohol steep that adopts respectively, concrete extracting technology is with reference to well known in the art.
The meridian distribution of property and flavor of above-mentioned Semen Vitis viniferae extract: sweet, micro-hardship, be slightly cold; Attach to the lung and stomach meridians.Composition pharmacology: containing compositions such as procyanidin (OPC) and trichosanthin and enzyme inhibitor classes, wherein Procyanidin in Grape Seed Extracts is a kind of free radical scavenger efficiently.The oxidative function of its free radical resisting is 50 times, ascorbic 20 times of vitamin E.Can remove poisonous free radical in human body, protection human cell tissue exempts from, by the oxidative damage of free radical, to prevent the diseases relevant with free radical of kind more than 80 such as allergy, cancer, aging.Effect application: for calentura excessive thirst, lung-heat type cough, interior-heat is quenched one's thirst, sore swollen toxin, has promoting the production of body fluid to quench thirst, clearing away heat-fire, evacuation of pus detumescence, suppresses virus copying and breeding in vivo, improves body immunity effect.
The meridian distribution of property and flavor of above-mentioned Fructus Rubi extract: bitter, cool, mild toxicity; GUIXIN warp, Liver Channel, lung meridian, stomach warp, large intestine channel.Composition pharmacology: containing diosgenin-3-O-α-D-pyranglucoside etc. and alanine, the several amino acids such as agedoite.Effect application: the liver and the kidney tonifying, controlling nocturnal emission with astringent drugs reducing urination, can treat impotence and premature ejaculation, emission and spermatorrhea, cold womb is infertile, leukorrhagia is rare clearly, a little less than frequent micturition is lost, visual dim, early whitening of beard and hair, there is heat-clearing and toxic substances removing, reducing swelling and alleviating pain, the arresting convulsion of cool liver, there is anticancer, the reducing swelling and alleviating pain of relieving internal heat, heat clearing away arresting convulsion, antitussive and antiasthmatic effect, can strengthen liver function.
Above-mentioned Semen Vitis viniferae extract, Fructus Rubi extract extracting method can adopt the known method of this area to extract, and specifically respectively by Semen Vitis viniferae, the broken rear flooding that adopts respectively of Fructus Rubi, concrete extracting technology is with reference to well known in the art.Adopt flooding, can obtain functional component in Semen Vitis viniferae, Fructus Rubi, and its cost is low, nontoxic.
The meridian distribution of property and flavor of above-mentioned Margarita powder: cold, sweet, salty; GUIXIN, Liver Channel.Ming Dynasty's Li Shizhen (1518-1593 A.D.) is paid attention to the pharmacological action of Margarita more, thinks that the drug effect of Margarita is at skin Caring, thereby writes especially in Compendium of Material Medica: " Margarita salty in the mouth is sweet cold nontoxic, relieving palpitation point order; Margarita is coated with face, makes us moist good color; Be coated with brothers, peeling skin hangnail; Pendant expectorant, except speckle, antidiarrheal; Except children's's fever (of children) accompanied by fear, peace soul; The nebulousurine of only passing out semen, separates pox and treats poison.Composition pharmacology: protein (can obtain 18 seed amino acids after hydrolysis, wherein 7 kinds is essential amino acid), 20 various trace elements and vitamin B.Effect application: removing heat from blood, blood circulation promoting and blood stasis dispelling, removing toxic substances rash, there is heat-clearing and toxic substances removing, have the effect such as arresting convulsion, improving eyesight removing nebula of calming the nerves, modern study also shows that Margarita powder all has unique effect at aspects such as improving body immunity, slow down aging, freckle removing and whitening, supplement calcium.
Certainly, the each component in above-described embodiment treatment premature ovarian failure medicine can also be buied by commercially available.
As one embodiment of the present invention, the medicine that the present invention treats premature ovarian failure comprises the raw material of Chinese medicine extract components of following weight portion:
As another preferred embodiment of the present invention, the medicine that the present invention treats premature ovarian failure comprises the raw material of Chinese medicine extract components of following weight portion:
As the present invention's preferred embodiment again, the medicine that the present invention treats premature ovarian failure comprises the raw material of Chinese medicine extract components of following weight portion:
In three preferred embodiments of above-mentioned treatment premature ovarian failure medicine prescription, according to the treatment premature ovarian failure Drug therapy premature ovarian failure better effects if of this three preferred ingredients content preparation, can further transfer allomeric function, balance female incretion, improve the reactivity of ovary to promoting sexual gland hormone, more effective recovery and improve ovarian function, improves clinical effectiveness.The extracting method of the each extract in this three preferred embodiment and extraction crude drug as described above, in order to save length, do not repeat them here.
In the various embodiments described above, the dosage form of this treatment premature ovarian failure medicine is peroral dosage form.Particularly, as any peroral dosage forms such as tablet, capsule, pill, granule dosage form or oral liquids.Wherein, capsule can be hard capsule.This treatment premature ovarian failure medicine is made to peroral dosage form, facilitate taking and the absorption of human body to medicine of patient.No matter adopt which kind of peroral dosage form, all can effectively ensure that the function ingredients of medicine is absorbed by the body, and reaches drug effect.
From the above, the medicine of above-described embodiment treatment premature ovarian failure is using Radix Puerariae extract, soybean extract, Rhizoma Dioscoreae extract as the principal agent for the treatment of, as monarch, nourish ovary, balance estrogen and progestogen, life lengthening, reach the economic benefits and social benefits for the treatment of both the principal and secondary aspects of a disease, reach female pregnant same benefit, two-ways regulation is supplemented incretion balance, delays premature ovarian failure and recovers ovarian function object; Taking Radix Angelicae Sinensis extract, Fructus Rubi extract two medicines mutually 5 for minister principal drug assistance altogether, taking Semen Vitis viniferae extract, Semen Ziziphi Spinosae extract two taste medicines as assistant, reach calm the nerves, antioxidation, the object of raising autoimmune function; Margarita powder energy convulsion, defying age.Therefore, the medicine of this treatment premature ovarian failure adopts warm palace to support nest, enriching yin and nourishing kidney, activating blood circulation to dissipate blood stasis, the principles of formulating prescriptions of adjusting meridian and stopping leukorrhea, inducing diuresis to remove edema are carried out the each component of proportioning, make this medicine there is the integrally-regulated effect of multisystem too many levels, can improve ovarian function, improve ovarian reserve ability, promote follicular development and ovulation.Can improve estrogen and progestogen level in premature ovarian failure human female, improve the interior environment of organism endocrine function and body, thereby improve, eliminate various clinical symptoms; Meanwhile, also can promote the absorption of body to calcium, prevent osteoporosis; This can reduce the sickness rate of atherosclerosis and coronary heart disease.Can promote gonad axis function normal activity, recover ovarian function, prevent that ovary tissue from occurring that pathologic changes; make gonadal hormone reach balance; can promote ovarian vessel to generate, suppress genitals's apoptosis, to follicular dysplasia granular cell, locking has protective effect.By conditioning hypothalamic-pituitary-ovarian axis function, can make ovarian function recovery.Chinese medicine composition of the present invention can impel shortage hormone symptom obviously to alleviate, even disappear, aedoeatrophia improves, can fundamentally recover the function that internal organs punching is appointed, thereby make body reach YIN and YANG in a relative equilibrium, QI and blood is vigorous, internal organs harmony, and then making gonad axis functional rehabilitation, premature ovarian failure phenomenon is improved.Adopt traditional Chinese medicine composition for treating premature ovarian failure of the present invention, by the integrally-regulated effect of multisystem, too many levels, can significantly transfer allomeric function, improve the reactivity of ovary to promoting sexual gland hormone, and then recover and improve ovarian function, clinical effectiveness is remarkable, and effective percentage is high, the intervening measure reducing for estrogen level than simple application Western medicine has clear superiority, and untoward reaction and the dependency that can avoid gonadal hormone to bring.Particularly, compared with the intervening measure reducing for estrogen level with simple application Western medicine, the medicine of above-described embodiment treatment premature ovarian failure has the following advantages: 1. substituting hormone therapy, avoid untoward reaction; 2. recover gonad s function, improve sexual hormone disturbance state; 3. improve the sensitivity of ovary to gonadal hormone; 4. directly excite ovary and other repair of damaged tissues.In addition, the medicine that the present invention treats premature ovarian failure is pure natural medical herbs, has no side effect, and without hepatic and renal function injure, there is no untoward reaction, safety.
The present invention also provides the simple preparation method of a kind of technique of above-mentioned treatment premature ovarian failure medicine, and the preparation method technological process of this treatment premature ovarian failure medicine refers to Fig. 1.This treatment premature ovarian failure process for preparing medicine comprises the steps:
Step S01. takes each raw material of Chinese medicine extract components:
Take each raw material of Chinese medicine extract components by the formula of the medicine of above-mentioned treatment premature ovarian failure;
Step S02. adopts the medicine of peroral dosage form technique preparation treatment premature ovarian failure:
Each raw material of Chinese medicine extract components in step S01 is mixed, adopt peroral dosage form technique to make the medicine of described treatment premature ovarian failure.
Particularly, in above-mentioned steps S01 the extracting method of each raw material of Chinese medicine extract and extract crude drug used and preferred content as described above, in order to save length, do not repeat them here.
The method that in above-mentioned steps S02, each raw material of Chinese medicine extract components mixes can first first be ground every component, screening, and then the each component after grinding is carried out to mix homogeneously.
In this step S02, sterilization is preferably radiation sterilizing, and the environment of this radiation sterilizing is: 60Co radiation sterilization, and irradiation dose is greater than 0KGY, is less than or equal to 6KGY, and time irradiation is not less than 30 minutes.Employing radiation sterilizing is thorough, and efficiency is high, and technique is simple.
In this step S02, peroral dosage form technique can adopt the conventional peroral dosage form technique in this area to produce, as adopt the medicine of the treatment premature ovarian failure of tablet form explained hereafter tablet, adopt the medicine of the treatment premature ovarian failure of capsule formulation explained hereafter capsule, adopt the medicine of the treatment premature ovarian failure of oral liquid explained hereafter oral liquid formulation.In embodiments of the present invention, oral disposition dosage form technique does not have special requirement.
As one embodiment of the present invention, the dosage form of the medicine of above-mentioned treatment premature ovarian failure is hard capsule, and its preparation method is specific as follows:
(1) first take each component according to the prescription for the treatment of premature ovarian failure medicine mentioned above;
(2) raw material of Chinese medicine extract components step (1) being taken carries out respectively pulverizing, mix after sieving, and sterilization, granulates, and dry, granulate, makes Chinese medicine composition composition granule;
(3), by the mixture of step (2) Chinese medicine composition composition granule and pharmaceutically acceptable adjuvant or directly described Chinese medicine composition composition granule is incapsulated, obtain hard capsule.
Wherein, the pulverizing in step (2), sieve, granulate adopts method well known in the art.Preferred radiation sterilizing described above sterilizes.Method of granulating is preferably and in the mixture of the raw material of Chinese medicine extract after sterilization, adds the ethanol that the concentration of its weight 3～6% is 65～75%, makes to cross 10～16 mesh sieves after soft material and granulate; Wherein, the concentration of ethanol is preferably 70%, and consumption is preferably 5%.Dry temperature is preferably 50～70 DEG C, and the time is preferably 2～4h.
Adjuvant in step (3) can be selected starch.Certainly, adjuvant can also adopt the conventional adjuvant in this area, can select flexibly according to the dosage form difference for the treatment of premature ovarian failure medicine, and selecting of adjuvant do not affect this treatment premature ovarian failure medicine effect.
From the preparation method of above-mentioned treatment premature ovarian failure medicine, the method only need be mixed each component by formula, adopts the peroral dosage form technique of existing maturation to prepare the medicine of this treatment premature ovarian failure.The method technique is simple, technology maturation, and pharmaceutical properties is reliable and stable, has effectively improved production efficiency, has reduced production cost.
By the embodiment of concrete formula and preparation method, medicine of above-mentioned treatment premature ovarian failure and preparation method thereof and drug effect thereof etc. are described below.
Embodiment 1
By Radix Puerariae, Rhizoma Dioscoreae, plumula sojae atricolor, Radix Angelicae Sinensis, Semen Ziziphi Spinosae after crushed, extracts according to existing process conditions with ethanol respectively, then filter successively, concentrate, spray be dried, pulverizing, sieving obtains respectively Radix Puerariae extract, Rhizoma Dioscoreae extract, plumula sojae atricolor extract, Radix Angelicae Sinensis extract, Semen Ziziphi Spinosae extract;
After Semen Vitis viniferae, Fructus Rubi are pulverized, water extracts according to existing process conditions respectively, drier, the pulverizing of filtering successively, concentrate, spray, sieving obtains respectively Semen Vitis viniferae root extract and Fructus Rubi extract;
Take 10 grams of Radix Puerariae extracts, 10 grams of Rhizoma Dioscoreae extracts, 7 grams of Semen Vitis viniferae extracts, 6 grams of Radix Angelicae Sinensis extracts, 5 grams of plumula sojae atricolor extracts, 5 grams of Semen Ziziphi Spinosae extracts, 5 grams of Fructus Rubi extracts, 2 grams of Margarita powder, each extract is carried out to pulverizing, after sieving, mix, at 60Co radiation (irradiation dose 6KGY, time irradiation 60 minutes) sterilization, the ethanol that the concentration that adds mixture total weight amount 5% in gnotobasis is 70%, after making soft material, cross 10 ~ 16 mesh sieves granulations, dry 4h at 50 DEG C in gnotobasis, make Chinese medicine composition composition granule, in gnotobasis, press after existing technique granulate, and in gnotobasis, mixture after granulate is incapsulated, make hard capsule, obtain the medicine of the treatment premature ovarian failure of hard capsule dosage form.
Embodiment 2
The extracting method of Radix Puerariae extract, Rhizoma Dioscoreae extract, plumula sojae atricolor extract, Semen Vitis viniferae root extract, Radix Angelicae Sinensis extract, Semen Ziziphi Spinosae extract and Fructus Rubi extract is referring to the extracting method in embodiment 1.
Take 9 grams of Radix Puerariae extracts, 8 grams of Rhizoma Dioscoreae extracts, 3 grams of Semen Vitis viniferae extracts, 5 grams of Radix Angelicae Sinensis extracts, 4 grams of soybean meal extracts, 6 grams of Semen Ziziphi Spinosae extracts, 4 grams of Fructus Rubi extracts, 2 grams of Margarita powder, each extract is carried out to pulverizing, after sieving, mix, at 60Co radiation (irradiation dose 6KGY, time irradiation 80 minutes) sterilization, the ethanol that the concentration that adds mixture total weight amount 5% in gnotobasis is 70%, after making soft material, cross 10 ~ 16 mesh sieves granulations, dry 2h at 70 DEG C in gnotobasis, make Chinese medicine composition composition granule, in gnotobasis, press after existing technique granulate, and in gnotobasis, mixture after granulate is incapsulated, make capsule, obtain the medicine of the treatment premature ovarian failure of hard capsule dosage form.
Embodiment 3
The extracting method of Radix Puerariae extract, Rhizoma Dioscoreae extract, plumula sojae atricolor extract, Semen Vitis viniferae root extract, Radix Angelicae Sinensis extract, Semen Ziziphi Spinosae extract and Fructus Rubi extract is referring to the extracting method in embodiment 1.
Take 8 grams of Radix Puerariae extracts, 7 grams of Rhizoma Dioscoreae extracts, 5 grams of Semen Vitis viniferae extracts, 5 grams of Radix Angelicae Sinensis extracts, 4 grams of Semen sojae atricolor (bean cake or plumule) extracts, 4 grams of Semen Ziziphi Spinosae extracts, 6 grams of Fructus Rubi extracts, 3 grams of Margarita powder, each extract is carried out to pulverizing, after sieving, mix, at 60Co radiation (irradiation dose 6KGY, time irradiation 60 minutes) sterilization, the ethanol that the concentration that adds mixture total weight amount 5% in gnotobasis is 70%, after making soft material, cross 10 ~ 16 mesh sieves granulations, dry 3h at 60 DEG C in gnotobasis, make Chinese medicine composition composition granule, in gnotobasis, press after existing technique granulate, and will after granulate, incapsulate in gnotobasis, make capsule, obtain the medicine of the treatment premature ovarian failure of hard capsule dosage form.
Embodiment 4
The extracting method of Radix Puerariae extract, Rhizoma Dioscoreae extract, plumula sojae atricolor extract, Semen Vitis viniferae root extract, Radix Angelicae Sinensis extract, Semen Ziziphi Spinosae extract and Fructus Rubi extract is referring to the extracting method in embodiment 1.
Take 10 grams of Radix Puerariae extracts, 6 grams of Rhizoma Dioscoreae extracts, 5 grams of Semen Vitis viniferae extracts, 8 grams of Radix Angelicae Sinensis extracts, 4 grams of Semen sojae atricolor (bean cake or plumule) extracts, 7 grams of Semen Ziziphi Spinosae extracts, 8 grams of Fructus Rubi extracts, 5 grams of Margarita powder, it is carried out respectively to pulverizing according to the method in embodiment 1, sieve and then mix, sterilize, granulate, granulate incapsulates, and obtains the medicine of the treatment premature ovarian failure of hard capsule dosage form.
Embodiment 5
The extracting method of Radix Puerariae extract, Rhizoma Dioscoreae extract, plumula sojae atricolor extract, Semen Vitis viniferae root extract, Radix Angelicae Sinensis extract, Semen Ziziphi Spinosae extract and Fructus Rubi extract is referring to the extracting method in embodiment 1.
Take 7 grams of Radix Puerariae extracts according to parts by weight; 6 grams of Rhizoma Dioscoreae extracts; 4 grams of Semen Vitis viniferae extracts; 5 grams of Radix Angelicae Sinensis extracts; 2.5 grams of soybean meal or embryo extract; 5 grams of Semen Ziziphi Spinosae extracts; 4.5 grams of Fructus Rubi extracts; 2 grams of Margarita powder, carry out respectively pulverizing according to the method in embodiment 1, after sieving, mix, and sterilization, granulates, and granulate incapsulates, and obtains the medicine of the treatment premature ovarian failure of hard capsule dosage form.
Toxicity test and clinical trial
One. acute toxicity test:
Entrust disease prevention and control center of Hunan Province to carry out acute toxicity test.
1, materials and methods
1.1 samples: An Meixin biological medicine Science and Technology Ltd. of Shenzhen provides, and sample is hard capsule prepared by above-described embodiment 1, gets capsule 's content and tests.
1.2 experimental situation conditions: 23 DEG C ~ 25 DEG C of temperature, humidity 52% ~ 60%.
1.3 laboratory animals: the clean level SD rat that grows up, body weight is 180 ~ 220g, each 10 of male and female.Provided by the experiment thing department of the Chinese Academy of Sciences of Central South University.
1.4 test methods: adopt maximum tolerated dose method.Take sample 105.5g adding distil water to 200ml, to 4 hours gavages in interval in rat one day 2 times, amount to dosage 21500mg/kgbw through 2ml/100gbw.Fasting 16 hours before gavage, after gavage, Continuous Observation 7 days, records poisoning manifestations and death condition.
2, result of the test
After gavage, rat, without obvious poisoning manifestations, is observed 7 days without dead.Within the 8th day, put to death all animals and carry out gross anatomy, the main organs smooth surfaces such as liver,kidney,spleen, stomach, intestinal, cardiopulmonary, size, form is normal, without hemorrhage, congestion.The macroscopic pathological change such as edema.SD rat acute LD50 of passing through mouth toxicity test be the results are shown in to following table 1.
The acute oral toxicity test result of table 1 to SD rat
3, conclusion
As shown in Table 1, this sample is all greater than 21500mg/kgbw to the acute oral LD50 of male and female SD rat, according to the acute toxicity grading criteria in GB15193.3-94, belongs to non-poisonous material.Acute toxicity test shows, Chinese medicine composition of the present invention has no side effect.
The medicine of the treatment premature ovarian failure two, above-described embodiment 2 being made carries out clinical practice, and case is as follows:
Case 1: female, 28 years old, Shenzhen people, menstruation came once about half a year, through measuring rareness, with insomnia and dreamful sleep, tired, and agitation is nervous.Start to take this medicine, each serving with 3, every day 2 times, first week after date, menstruation is monthly risen, through measuring rareness, menstrual phase 2 days, take continuously after 26 months cycles, endocrine is recovered normal FSH:21IU/L, LH:13IU/L, menstruation recovery is normal, sleep improvement, the colour of skin is bright, energetic.
Case 2: female, 36 years old, Englishman, menstrual cycle does not have rule, and menoxenia, through measuring rareness, is married 10 years, fails pregnancy always.Tentative diagnosis is the anovular menstruation that causes of Ovarian factor or endocrine factors, without mature follicle, luteal phase dysfunction.Take after this medicine, every day twice, each 4, sooner or later service once half an hour after meal; After first 3 months cycles, menstrual onset strengthens through amount, and menstrual phase 4 days, takes after 26 months cycles, monthly about 4 ~ 6 days menstrual onset time phase difference time continuously; Take after three 9 months cycles, menstrual blood volume is tending towards normally, menstruation time advance 3 ~ 4 days; Take after 4 12 months cycles, all basic laws of menstrual blood volume and time, sexual life is normal, continues to take this medicine, and menstruation and time normal, follow up a case by regular visits to 3 months afterwards, adheres to all the time taking medicine, and menstrual cycle basic law, is the menstruation of ovulation property.Within 15th month, find of that month menstruation future, after several days, do detection paper and find conceivedly, do pregnant inspection check to hospital, confirm pregnancy, within 9 months 10 days, give birth to smoothly healthy boy baby, mother and sons' health.
Case 3: female, 38 years old, Nanjing Human, patient has normal menstrual and obstetrical histories, patient's tide 13 the beginning of the year, menstruation basic law after menophania, 30 ~ 35 days cycles, 5 days menstrual period, measure medium, pregnant 2 produce 1, artificial abortion 1 time, barrier contraception.Infrequent menstruation 2 years, half a year is accompanied Tidal fever with perspiration, vexed uneasiness in suddenly amenorrhea, and check result shows FSH>40IU/L, and with the symptom of perimenopausal syndrome, significantly premature ovarian failure symptom.Start to take this medicine, take every day 3 times, each 3, first week after date, sensation breast very rises, and vagina is moistening, in high spirits having rosy cheeks, takes after 5th month menstrual onset continuously, through measuring seldom, the 7th, August, the menstrual onset time was indefinite while starting, through measuring rareness, be maintained until 10 months through amount, after 12 months, start, menstrual onset time phase difference is few, through measuring rareness.Started to 13 months, through measuring rareness, the time of rising starts to be tending towards normal.
Case 4: female, 34 years old, Hong Kong native, vaginal dryness, dyspareunia, vulvismus (fear), irritability, hyperhidrosis, vagina estrogen level is measured low, and blood E2 is low, FSH>40IU/L, be diagnosed as endocrine disturbance, ovarian function decline, vaginal secretions reduces.Start to take this medicine, after 20 days, vaginal secretions increases, and vagina is moistening, in high spirits having rosy cheeks, dyspareunia sense alleviates, and continues to take 26 months cycles, and vagina is moistening, secretions showed increased, have the sensation of orgasm to occur, it is harmonious that sexual life is tending towards, and fear of sexual intercourse disappears, happy.
In addition, taking the medicine for the treatment of premature ovarian failure of preparation in above-described embodiment 1 as clinical medicine, since in December, 2004 to 2011 year December, under the famous physician of Chinese origin of Austrian nationality, professor doctor's Zhan Taisheng hosting, in He Huawei medical center, Rui Na medical center, through 165 routine women's clinical observations, the main patient taking China, Britain is as object.Most patient is the symptoms such as hectic fever hyperhidrosis, insomnia, irritated irritability, cardiopalmus, tired, nervous, vaginal dryness, sexual disorder, menoxenia, sterility and infertility, amenorrhea when medical, and symptom does not continue half a year to the several years not etc.Clinical data is reported as follows:
1. the infertile therapeutic effect that medicine of the present invention causes for premature ovarian failure
The clinical effectiveness of the sterility and infertility causing for premature ovarian failure is as follows: treatment premature ovarian failure barrenness case 13 examples, twice of patient every day, each 4, sooner or later service once half an hour after meal, within three months, be a course for the treatment of, take continuously 4 courses for the treatment of, observe the curative effect, recovery from illness 8 examples account for 61.54%, and (improvement refers to that menstruation recovery is normal) 1 example that takes a turn for the better accounts for 7.68%, more 4 examples do not account for 30.77%, and total effective rate reaches 69.23%.After 3 courses for the treatment of, follow up a case by regular visits to patient, patient has no adverse reaction, and three large routine tests and hepatic and renal function detect all no abnormal.
2, object: 165 ages were 25 years old ~ 45 years old women.Method: 165 women all take this medicine; The sings and symptoms that 165 routine women show and take this medicine after symptom and improvement situation see the following form 2:
Table 2
From above-mentioned case 1 to 4 and table 2, the medicine of embodiment of the present invention treatment premature ovarian failure is remarkable to treatment premature ovarian failure effect.The medicine of embodiment of the present invention treatment premature ovarian failure is pure natural medical herbs, has no side effect, and without hepatic and renal function injure, there is no untoward reaction, has significant therapeutic effect.
The foregoing is only preferred embodiment of the present invention, not in order to limit the present invention, all any amendments of doing within the spirit and principles in the present invention, be equal to and replace and improvement etc., within all should being included in protection scope of the present invention.
Claims (10)
1. treat a medicine for premature ovarian failure, made by the raw material of Chinese medicine extract components of following weight portion:
Wherein, Radix Puerariae extract must be to extract from Radix Puerariae, and Radix Puerariae is pulverized to rear employing alcohol steep acquisition; Described Rhizoma Dioscoreae extract extracting method is for to pulverize rear employing alcohol steep by Rhizoma Dioscoreae, described Radix Angelicae Sinensis extract, Semen Ziziphi Spinosae extract extracting method are Radix Angelicae Sinensis, Semen Ziziphi Spinosae crude drug to be pulverized to the rear alcohol steep that adopts respectively obtain, described soybean extract extracting method is for pulverizing Semen sojae atricolor or plumule rear or bean cake is adopted to alcohol steep, and described Semen Vitis viniferae extract, Fructus Rubi extract extracting method are by Semen Vitis viniferae, the broken rear flooding that adopts respectively of Fructus Rubi.
2. the medicine for the treatment of premature ovarian failure as claimed in claim 1, is characterized in that, is made up of the raw material of Chinese medicine extract components of following weight portion:
3. the medicine for the treatment of premature ovarian failure as claimed in claim 1, is characterized in that, is made up of the raw material of Chinese medicine extract components of following weight portion:
4. the medicine of the treatment premature ovarian failure as described in as arbitrary in claim 1～3, is characterized in that: the bean cake that described soybean extract is Semen sojae atricolor is or/and embryo extract.
5. the medicine of the treatment premature ovarian failure as described in as arbitrary in claim 1～3, is characterized in that: the dosage form of the medicine of described treatment premature ovarian failure is peroral dosage form.
6. the medicine for the treatment of premature ovarian failure as claimed in claim 5, is characterized in that: described peroral dosage form is tablet, capsule, pill, granule dosage form or oral liquid.
7. a preparation method for the treatment of the medicine of premature ovarian failure, it comprises the steps:
Take each raw material of Chinese medicine extract components by the formula of the medicine of the arbitrary described treatment premature ovarian failure of claim 1～6;
Each described raw material of Chinese medicine extract components is mixed, and sterilization, adopts peroral dosage form technique to make the medicine of described treatment premature ovarian failure.
8. the preparation method for the treatment of premature ovarian failure medicine as claimed in claim 7, is characterized in that: described peroral dosage form technique is hard capsule dosage form technique, and described hard capsule dosage form technique is as follows:
After each described raw material of Chinese medicine extract components is mixed, sterilization, granulation, dry, granulate, make Chinese medicine composition composition granule;
By the mixture of described Chinese medicine composition composition granule and pharmaceutically acceptable adjuvant or directly described Chinese medicine composition composition granule is incapsulated, obtain hard capsule.
9. the preparation method for the treatment of premature ovarian failure medicine as claimed in claim 8, it is characterized in that: described method of granulating is in the mixture of the raw material of Chinese medicine extract after sterilization, to add the ethanol that the concentration of its weight 3～6% is 65～75%, make and cross 10～16 mesh sieves after soft material and granulate;
Described dry temperature is 50～70 DEG C, and the time is 2～4h.
10. the preparation method for the treatment of as claimed in claim 7 or 8 premature ovarian failure medicine, is characterized in that: described sterilization is radiation sterilizing, and the environment of described radiation sterilizing is: 60Co radiation sterilization, irradiation dose is greater than 0KGY, is less than or equal to 6KGY.
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| CN104906526A (en) * | 2015-07-14 | 2015-09-16 | 孙海玲 | Chinese medicine preparation for premature ovarian failure and preparation method of Chinese medicine preparation |
| CN107836670B (en) * | 2017-09-01 | 2021-03-16 | 上海拜汶医药科技有限公司 | Preparation method of compound nutrient for protecting and improving female ovarian function |
| CN107441313B (en) * | 2017-09-28 | 2021-07-13 | 杭州市中医院 | Traditional Chinese medicine composition, medicine and preparation method for treating decreased ovarian reserve |
| CN111346181A (en) * | 2018-12-21 | 2020-06-30 | 四川省中医药科学院 | Composition for treating iatrogenic premature ovarian failure and preparation method thereof |
| CN111419992A (en) * | 2019-01-10 | 2020-07-17 | 四川省中医药科学院 | A kind of composition for delaying ovarian aging and preparation method and use thereof |
| CN110897093A (en) * | 2019-12-11 | 2020-03-24 | 广州宏韵医药科技股份有限公司 | Composition with function of improving ovary and application thereof |
| CN120860047A (en) * | 2023-02-27 | 2025-10-31 | 无限极（中国）有限公司 | New application of raspberry extract |
| CN116966138B (en) * | 2023-09-22 | 2024-01-09 | 珠海远大美业生物科技有限公司 | Application of gel in preparation of medicine for improving AMH value |
| CN118743736B (en) * | 2024-07-19 | 2025-03-21 | 亚美利加(辽宁)药业有限公司 | An anti-premature ovarian failure nursing composition, an anti-premature ovarian failure nursing solution and a preparation method thereof |
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Inventor after: Wang Jianwei Inventor after: Yan Fuguo Inventor after: Zhan Taisheng Inventor after: Li Ying Inventor after: Kreyenborg.Kirk Inventor after: Christopher.Masterson Inventor after: Huang Zhaoling Inventor before: Wang Jianwei Inventor before: Yan Fuguo Inventor before: Zhan Taisheng Inventor before: Kreyenborg.Kirk Inventor before: Christopher.Masterson |
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