CN102846906A - 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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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, owing to persistence amenorrhea and sexual organ's atrophy appear in the ovarian function decline, rising and the estrogenic decline of Gonadotropin Level are often arranged, the sickness rate of premature ovarian failure is about 1% ~ 3% before 40 years old, and the sickness rate in 30 years old is about 0.1%.Clinical manifestation companion sees symptom before and after the menopause such as in various degree hectic fever hyperhidrosis, insomnia and dreamful sleep, irritated irritability, cardiopalmus, tired, nervous, vaginal dryness, sexual disorder, sterility and infertility, in advance amenorrhea, 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 the female life quality, have a strong impact on women's normal operation, bring very big misery for simultaneously its physical and mental health and love life.
Premature ovarian failure, its cause of disease it be unclear that so far, so the research of this disease has been become focus and the difficult point of domestic and international reproductive development circle.At present both at home and abroad research thinks that premature ovarian failure and hereditary, immune, metabolism and the factor such as iatrogenic are relevant more.Show chromosome mutation by research data; FSH (FSH) interstitialcellstimulating hormone (ICSH) (LH) and receptor variant thereof; Developmental and Metabolic Disorder or drug effect; the chemicotherapy damage; viral infection; immunity and other high risk factors such as the factors such as smoking, depression may be its reasons; these factors or make the congenital ovum decreased number of ovary; or its follicular atresia is accelerated; or directly destroyed; make the follicle premature depletion, generally adopt hormone replacement therapy for the treatment modern medicine of premature ovarian failure.
But the premature ovarian failure treatment is difficulty relatively, and doctor trained in Western medicine adopts Hormone Replacement Therapy clinically, need to use estrogen and progestogen under doctor's guidance.When studies show that this estrogen and progestogen therapy, have certain effect, can improve symptom, but unsatisfactory to the recovery of ovarian function, symptom reappears after the simultaneously drug withdrawal, makes ovary be in dependent status, and the worse possibility of the ovarian function of causing is arranged.That is to say that Hormone Replacement Therapy has only played the effect that takes stopgap measures, and this method side effect is large, the life-time service exogenous hormones has the danger that causes the endometrium canceration, and increases the sickness rate of coronary heart disease and cholecystopathy.Therefore the effect of this hormone therapy is undesirable, has simultaneously potential safety hazard.Aspect western medical treatment, except hormone replacement therapy, also there is induced ovulation, assist and give the ovum technology, from body or allosome ovary transplantation technology, immunosuppressant therapy replenishes 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 the premature ovarian failure cause of disease is complicated, the treatment difficulty is larger, and modern medicine not yet makes a breakthrough so far and carries out.
In recent years, along with the Chinese medicine development, the chemotherapy that substitutes in the doctor trained in Western medicine with the natural plant kind medicine more and more is concerned.Chinese medicine has the integrally-regulated effect of multisystem too many levels, can improve ovarian function, improves the ovarian reserve ability, promotes follicular development and ovulation, and regulating menstruation and assisting pregnancy is antiabortive, is confirmed in long-term clinical practice.The 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. all be 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 with two curative effect premature ovarian failure for the treatment of both the principal and secondary aspects of a disease is provided.
Another purpose 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 the foregoing invention purpose, technical scheme of the present invention is as follows:
A kind of medicine for the treatment of premature ovarian failure comprises the raw material of Chinese medicine extract components of following weight portion:
And, a kind of preparation method for the treatment of the medicine of premature ovarian failure, it comprises the steps:
Prescription by the medicine of above-mentioned treatment premature ovarian failure takes by weighing each raw material of Chinese medicine extract components;
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 each component of proportioning.As the principal agent for the treatment of, as monarch, nourish ovary with Radix Puerariae extract, soybean extract, Rhizoma Dioscoreae extract, the 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, the two-ways regulation incretion balance delays premature ovarian failure and the purpose of recovering ovarian function; Take Radix Angelicae Sinensis extract, Fructus Rubi extract two medicines mutually 5 for minister principal drug assistance altogether, take Semen Vitis viniferae extract, Semen Ziziphi Spinosae extract two flavor medicines as assistant, reach calm the nerves, antioxidation, the purpose 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, does not have untoward reaction, safety.
The preparation method of above-mentioned treatment premature ovarian failure medicine only need be mixed each component by prescription, adopts existing ripe peroral dosage form technique to prepare the medicine of this treatment premature ovarian failure.The method technique is simple, technology maturation, pharmaceutical properties is reliable and stable, Effective Raise production efficiency, reduced production cost.
Description of drawings
Fig. 1 is the flow chart of the preparation method of embodiment of the invention treatment premature ovarian failure medicine.
The specific embodiment
In order to make purpose 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 ".Institute says such as " boudoir treasure-married woman's Men-amenorrhea prove for the third time ": " married woman's taste prolonged deficiency, or shape wins menopause, by heat is glittered, wasting, the time see yearningly dry, name of disease day the blood depletion menopause ".The cause of disease of primary disease may be summarized to be: natural endowment is not enough, and kidney qi is not contained, and punching appoints QI and blood not fill and gradually extremely depletion; Internal injury caused by excess of seven emotions causes the stagnation of QI due to depression of the liver blood stasis, and retardance is appointed in punching, and QI and blood secretly consumes; Perhaps excessive thinking damage heart spleen, punching are appointed to decline and are caused less amenorrhea; Serious disease prolonged illness consumption impairment of YIN liquid, or the consumptions 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 was 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 the 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 is educated 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, suffering; Return spleen, stomach warp.The composition pharmacology: the underground tuber that Radix Puerariae is huge has been put aside " phytoestrogen " and derivant thereof, b-sitosterol, stigmasterol, coumestrol, puerarin, mirificoumestan, kwakhurin and the mirificin that includes isoflavone (different Huang, ketoside, daidzein, genistin, isoflavone wood alkali and puerarin).Effect is used: the 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, the 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 with Radix Puerariae, and concrete extracting technology is with reference to well known in the art getting final product.Adopting alcohol steep, mainly be in order to obtain fat-soluble functional component in the Radix Puerariae, and its cost is low, and is nontoxic, and can be effectively so that the fat-soluble functional component in the Radix Puerariae effectively leach, such as functional components such as Miroestrol. and the little female alcohol of deoxidation.Certainly functional component not only is the little 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: contain chlorogenic acid, inositol, dioscin and pure cellulose.Effect is used: the Rhizoma Dioscoreae dioscin has very strong progestogen action owing to similar to the progestogen molecular structure of ovarian secretion in the body; Have spleen reinforcing, support lung, reinforce the kidney, the 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 used for various febrile diseases, dispelling wind-heat, kind removing summer-heat blood poison also, have antibacterial, antiviral, antiinflammatory, analgesic, 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 with Rhizoma Dioscoreae, and concrete extracting technology is with reference to well known in the art getting final product.Adopting alcohol steep, mainly be in order to obtain fat-soluble functional component in the Rhizoma Dioscoreae, and its cost is low, and is nontoxic, and can be effectively so that the fat-soluble functional component in the Rhizoma Dioscoreae effectively leach, such as functional components such as Rhizoma Dioscoreae dioscins.Certainly functional component not only is the Rhizoma Dioscoreae dioscin, also has other functional components.
The meridian distribution of property and flavor of above-mentioned soybean extract: bitter, hot, 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 is used: the estrogen action that the isoflavone in the soybean extract has, the level of energy two-ways regulation women body inner estrogen; Simultaneously Semen sojae atricolor relieve inflammation or internal heat make eye bright, mass dissipating and swelling eliminating, have liver heat removing, blood pressure lowering, blood sugar lowering, antibiotic, antiinflammatory, antiallergic and antivirus action.As preferred embodiment, above-mentioned soybean extract is the bean cake of Semen sojae atricolor or the extract in the plumule.This bean cake is or/and the functional component content in the embryo extract is high, particularly isoflavone content.
This Semen sojae atricolor or bean cake or/and the concrete extracting method of embryo extract be: adopt alcohol steep after Semen sojae atricolor or plumule are pulverized or with bean cake, concrete extracting technology is with reference to well known in the art getting final product.Adopt alcohol steep, mainly be in order to obtain Semen sojae atricolor or bean cake or/and plumule extract in fat-soluble functional component, and its cost is low, and is nontoxic, and can be effectively so that Semen sojae atricolor or bean cake or/and the fat-soluble functional component in the plumule extraction effectively leach.
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: contain multiple alkaloid and multiple flavone compound.Effect is used: heat clearing and damp drying, parasite killing, diuresis, have heat-clearing and toxic substances removing, loose carbuncle detumescence, and enrich blood and invigorate blood circulation, menstruction regulating and pain relieving, loosening bowel to relieve constipation.Be used 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: hot, sweet, temperature; 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 Lu ": main vexatious insomnia, umbilicus is pain up and down, and blood turns chronic diarrhea, the sweating due to debility excessive thirst, invigorating middle warmer, the liver benefiting gas, hard muscles and bones is helped cloudy gas, makes us fertile strong; 3. " property of medicine opinion ": main muscles and bones wind, fry the end and take it as soup; 4. supplement to the Herbal: give birth to of sleeping makes more, and must not sleep fries; 5. Wang Haogu: control milk-livered sleeplessness, cold also, fry clothes; Control somnolence due to gallbladder-excess, heat is also given birth to and is used; 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, and the warming middle-JIAO dampness removing, the astringing QI hidroschesis, beneficial will is breathed out surely, hearing-improing and eyesight improving.The composition pharmacology: Semen Ziziphi Spinosae contains the 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 is used: mind tranquilizing and the heart calming, nourishing the liver, arresting sweating, kidney-replenishing, bone and muscle strengthening, wind-damp dispelling, have raising hypophysis---the effect of interrenal system function, and can enhancing antibody the formation effect, suppress virus copying and breeding in vivo, improve the 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 the rear alcohol steep that adopts respectively, concrete extracting technology is with reference to well known in the art getting final product.
The meridian distribution of property and flavor of above-mentioned Semen Vitis viniferae extract: sweet, little hardship, be slightly cold; Attach to the lung and stomach meridians.The composition pharmacology: contain procyanidin (OPC) and the compositions such as trichosanthin and enzyme inhibitor class, wherein Procyanidin in Grape Seed Extracts is a kind of efficient free radical scavenger.The oxidative function of its free radical resisting is 50 times, ascorbic 20 times of vitamin E.Can remove poisonous free radical in the human body, the protection human cell tissue exempts to be prevented the diseases relevant with free radical of kind more than 80 such as allergy, cancer, aging by the oxidative damage of free radical.Effect is used: be used for calentura excessive thirst, lung-heat type cough, interior-heat is quenched one's thirst, and 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 the 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: contain diosgenin-3-O-α-D-pyranglucoside etc. and alanine, the several amino acids such as agedoite.Effect is used: the liver and the kidney tonifying, the controlling nocturnal emission with astringent drugs reducing urination can be treated impotence and premature ejaculation, emission and spermatorrhea, cold womb is infertile, leukorrhagia is rare clearly, and is a little less than frequent micturition is lost, visual dim, early whitening of beard and hair, have heat-clearing and toxic substances removing, reducing swelling and alleviating pain, the arresting convulsion of cool liver, have 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 with 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 getting final product.Adopt flooding, can obtain functional component in Semen Vitis viniferae, the 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 the drug effect of Margarita at skin Caring, thereby writes especially in Compendium of Material Medica: " the 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, the peace soul; The nebulousurine of only passing out semen is separated pox and is treated poison.Composition pharmacology: protein (can obtain 18 seed amino acids after the hydrolysis, wherein 7 kinds is essential amino acid), 20 various trace elements and vitamin B.Effect is used: removing heat from blood, blood circulation promoting and blood stasis dispelling, detoxifcation rash, has heat-clearing and toxic substances removing, have the effects such as the arresting convulsion of calming the nerves, the removing nebula that makes eye bright, modern study shows that also Margarita powder all has unique effect at aspects such as improving body immunity, slow down aging, freckle removing and whitening, supplement calcium.
Certainly, 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, treatment premature ovarian failure Drug therapy premature ovarian failure better effects if according to this three preferred ingredients content preparation, can further transfer allomeric function, the balance female incretion, improve ovary to the reactivity of promoting sexual gland hormone, more effective recovery and improve ovarian function improves clinical effectiveness.The extracting method of each extract in this three preferred embodiment and extraction crude drug are as indicated 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, such as any peroral dosage forms such as tablet, capsule, pill, granule dosage form or oral liquids.Wherein, capsule can be hard capsule.Should treat the premature ovarian failure medicine and make peroral dosage form, make things convenient for taking and the absorption of human body to medicine of patient.No matter adopt which kind of peroral dosage form, can guarantee effectively that all 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 with Radix Puerariae extract, soybean extract, the Rhizoma Dioscoreae extract principal agent as treatment, 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 the benefit, two-ways regulation is replenished incretion balance, delays premature ovarian failure and recovers the ovarian function purpose; Take Radix Angelicae Sinensis extract, Fructus Rubi extract two medicines mutually 5 for minister principal drug assistance altogether, take Semen Vitis viniferae extract, Semen Ziziphi Spinosae extract two flavor medicines as assistant, reach calm the nerves, antioxidation, the purpose 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 each component of proportioning, so that this medicine has the integrally-regulated effect of multisystem too many levels, can improve ovarian function, improve the ovarian reserve ability, promote follicular development and ovulation.Can improve estrogen and progestogen level in the premature ovarian failure human female, improve the interior environment of organism endocrine function and body, thereby improve, eliminate various clinical symptoms; Simultaneously, also can promote body to the absorption of 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 pathologic occurring and changing; make gonadal hormone reach balance; can promote ovarian vessel to generate, suppress genitals's apoptosis, locking has protective effect to the follicular dysplasia granular cell.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 the internal organs punching is appointed, thereby make body reach YIN and YANG in a relative equilibrium, QI and blood is vigorous, and internal organs are harmonious, and then making the gonad axis functional rehabilitation, the premature ovarian failure phenomenon is improved.Adopt traditional Chinese medicine composition for treating premature ovarian failure of the present invention, integrally-regulated effect by multisystem, too many levels, can significantly transfer allomeric function, improve ovary to the reactivity of promoting sexual gland hormone, and then recover and improve ovarian function, clinical effectiveness is remarkable, and effective percentage is high, for the intervening measure that estrogen level reduces clear superiority is arranged than the simple Western medicine of using, and untoward reaction and the dependency that can avoid gonadal hormone to bring.Particularly, compare for the intervening measure that estrogen level reduces 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 the gonad s function, improve the sexual hormone disturbance state; 3. improve ovary to the sensitivity of 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, does not have 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 sees also Fig. 1.This treatment premature ovarian failure process for preparing medicine comprises the steps:
Step S01. takes by weighing each raw material of Chinese medicine extract components:
Prescription by the medicine of above-mentioned treatment premature ovarian failure takes by weighing each raw material of Chinese medicine extract components;
Step S02. adopts the medicine of peroral dosage form technique preparation treatment premature ovarian failure:
Each raw material of Chinese medicine extract components among the step S01 is mixed, adopt peroral dosage form technique to make the medicine of described treatment premature ovarian failure.
Particularly, the extracting method of each raw material of Chinese medicine extract and to extract used crude drug and preferred content as indicated above among the above-mentioned steps S01 in order to save length, does not repeat them here.
The method that each raw material of Chinese medicine extract components mixes among the above-mentioned steps S02 can be ground first every component first, screening, and then each component after will grinding is carried out mix homogeneously.
Among this step S02, sterilization is preferably radiation sterilizing, and the environment of this radiation sterilizing is: 60Co radiation sterilization, irradiation dose are greater than 0KGY, and less than or equal to 6KGY, time irradiation is not less than 30 minutes.The employing radiation sterilizing is thorough, and efficient is high, and technique is simple.
Among this step S02, peroral dosage form technique can adopt this area peroral dosage form technique commonly used to produce and get final product, 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) elder generation takes by weighing each component according to the prescription for the treatment of premature ovarian failure medicine mentioned above;
(2) the raw material of Chinese medicine extract components that step (1) is taken by weighing carries out respectively pulverizing, mix after sieving, and sterilization is granulated, drying, and granulate makes the Chinese medicine composition composition granule;
(3) with 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 the step (2), sieve, granulate adopts method well known in the art to get final product.Preferred radiation sterilizing described above sterilizes.It is 65～75% ethanol that method of granulating is preferably the concentration that adds its weight 3～6% in the mixture of the raw material of Chinese medicine extract after sterilization, makes to cross 10～16 mesh sieves behind the soft material and granulate; Wherein, the concentration of ethanol is preferably 70%, and consumption is preferably 5%.Dry temperature is preferably 50～70 ℃, and the time is preferably 2～4h.
Adjuvant in the step (3) can be selected starch.Certainly, adjuvant can also adopt this area adjuvant commonly used, can select flexibly according to the dosage form difference for the treatment of the premature ovarian failure medicine, and selecting of adjuvant do not affect this treatment premature ovarian failure medicine effect.
By the preparation method of above-mentioned treatment premature ovarian failure medicine as can be known, the method only need be mixed each component by prescription, adopts existing ripe peroral dosage form technique to prepare the medicine of this treatment premature ovarian failure.The method technique is simple, technology maturation, pharmaceutical properties is reliable and stable, Effective Raise production efficiency, reduced production cost.
Below embodiment by concrete prescription and preparation method the medicine and preparation method thereof of above-mentioned treatment premature ovarian failure and drug effect thereof etc. are described.
Embodiment 1
With Radix Puerariae, Rhizoma Dioscoreae, plumula sojae atricolor, Radix Angelicae Sinensis, Semen Ziziphi Spinosae after crushed, extract according to existing process conditions with ethanol respectively, filter successively again, concentrate, spray drying, 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 pulverized respectively water extract according to existing process conditions, filter successively again, concentrate, spray drying, pulverizing, sieving obtains respectively Semen Vitis viniferae root extract and Fructus Rubi extract;
Take by weighing Radix Puerariae extract 10 grams, Rhizoma Dioscoreae extract 10 grams, Semen Vitis viniferae extract 7 grams, Radix Angelicae Sinensis extract 6 grams, plumula sojae atricolor extract 5 grams, Semen Ziziphi Spinosae extract 5 grams, Fructus Rubi extract 5 grams, Margarita powder 2 grams, each extract is carried out pulverizing, mix after sieving, at 60Co radiation (irradiation dose 6KGY, time irradiation 60 minutes) sterilization, the concentration that adds mixture total weight amount 5% in gnotobasis is 70% ethanol, cross the granulation of 10 ~ 16 mesh sieves after making soft material, 50 ℃ of lower dry 4h in gnotobasis, make the Chinese medicine composition composition granule, after pressing existing technique granulate in the gnotobasis, and in gnotobasis, mixture behind the 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 among the embodiment 1.
Take by weighing Radix Puerariae extract 9 grams, Rhizoma Dioscoreae extract 8 grams, Semen Vitis viniferae extract 3 grams, Radix Angelicae Sinensis extract 5 grams, soybean meal extract 4 grams, Semen Ziziphi Spinosae extract 6 grams, Fructus Rubi extract 4 grams, Margarita powder 2 grams, each extract is carried out pulverizing, mix after sieving, at 60Co radiation (irradiation dose 6KGY, time irradiation 80 minutes) sterilization, the concentration that adds mixture total weight amount 5% in gnotobasis is 70% ethanol, cross the granulation of 10 ~ 16 mesh sieves after making soft material, 70 ℃ of lower dry 2h in gnotobasis, make the Chinese medicine composition composition granule, after pressing existing technique granulate in the gnotobasis, and in gnotobasis, mixture behind the 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 among the embodiment 1.
Take by weighing Radix Puerariae extract 8 grams, Rhizoma Dioscoreae extract 7 grams, Semen Vitis viniferae extract 5 grams, Radix Angelicae Sinensis extract 5 grams, Semen sojae atricolor (bean cake or plumule) extract 4 grams, Semen Ziziphi Spinosae extract 4 grams, Fructus Rubi extract 6 grams, Margarita powder 3 grams, each extract is carried out pulverizing, mix after sieving, at 60Co radiation (irradiation dose 6KGY, time irradiation 60 minutes) sterilization, the concentration that adds mixture total weight amount 5% in gnotobasis is 70% ethanol, cross the granulation of 10 ~ 16 mesh sieves after making soft material, 60 ℃ of lower dry 3h in gnotobasis, make the Chinese medicine composition composition granule, after pressing existing technique granulate in the gnotobasis, and in gnotobasis, will incapsulate behind the granulate, 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 among the embodiment 1.
Take by weighing Radix Puerariae extract 10 grams, Rhizoma Dioscoreae extract 6 grams, Semen Vitis viniferae extract 5 grams, Radix Angelicae Sinensis extract 8 grams, Semen sojae atricolor (bean cake or plumule) extract 4 grams, Semen Ziziphi Spinosae extract 7 grams, Fructus Rubi extract 8 grams, Margarita powder 5 grams, it is carried out respectively pulverizing according to the method among the 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 among the embodiment 1.
Take by weighing Radix Puerariae extract 7 grams according to parts by weight; Rhizoma Dioscoreae extract 6 grams; Semen Vitis viniferae extract 4 grams; Radix Angelicae Sinensis extract 5 grams; Soybean meal or embryo extract 2.5 grams; Semen Ziziphi Spinosae extract 5 grams; Fructus Rubi extract 4.5 grams; Margarita powder 2 grams carry out respectively pulverizing according to the method among the embodiment 1, mix after sieving, and sterilization is granulated, 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 the disease prevention and control center, Hunan Province to carry out acute toxicity test.
1, materials and methods
1.1 sample: the U.S. letter of Shenzhen's peace biological medicine Science and Technology Ltd. provides, and sample is the hard capsule of above-described embodiment 1 preparation, gets capsule 's content and tests.
1.2 experimental situation condition: 23 ℃ ~ 25 ℃ of temperature, humidity 52% ~ 60%.
1.3 laboratory animal: the cleaning of growing up level SD rat, 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 method: adopt the maximum tolerated dose method.Take by weighing sample 105.5g adding distil water to 200ml, to 4 hours gavages in interval in the rat one day 2 times, amount to dosage 21500mg/kgbw through 2ml/100gbw.Fasting is 16 hours before the gavage, and Continuous Observation is 7 days after the gavage, record poisoning manifestations and death condition.
2, result of the test
Rat is observed 7 days without dead without obvious poisoning manifestations after the gavage.Put to death all animals on the 8th day and carry out gross anatomy, the main organs smooth surfaces such as liver,kidney,spleen, stomach, intestinal, cardiopulmonary, size, form are 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 following table 1.
The acute oral toxicity test result of table 1 pair SD rat
3, conclusion
As shown in Table 1, this sample all greater than 21500mg/kgbw, according to the acute toxicity grading criteria among the GB15193.3-94, belongs to non-poisonous material to the acute oral LD50 of male and female SD rat.Acute toxicity test shows, Chinese medicine composition of the present invention has no side effect.
The medicine of the treatment premature ovarian failure that two, above-described embodiment 2 is made carries out clinical practice, and case is as follows:
Case 1: the woman, 28 years old, Shenzhen people, menstruation came once about half a year, and is tired with insomnia and dreamful sleep through measuring rareness, and agitation is nervous.Begin to take this medicine, each serving with 3, every day 2 times, first all after date, menstruation is risen per month, through measuring rareness, menstrual phase 2 days, after taking continuously 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, and is energetic.
Case 2: the woman, 36 years old, the Englishman, menstrual cycle does not have rule, and menoxenia through measuring rareness, was married 10 years, failed pregnancy always.Tentative diagnosis is the anovular menstruation that causes of Ovarian factor or endocrine factors, without mature follicle, luteal phase dysfunction.After taking 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, menstrual phase 4 days, take continuously 26 months cycles after, per month about 4 ~ 6 days menstrual onset time phase difference time; After taking three 9 months cycles, menstrual blood volume is tending towards normally, menstruation time advance 3 ~ 4 days; After taking 4 12 months cycles, menstrual blood volume and time is basic law all, and sexual life is normal, continues to take this medicine, and menstruation and time normal were followed up a case by regular visits to 3 months afterwards, adheres to all the time taking medicine, and the menstrual cycle basic law is the menstruation of ovulation property.Find of that month menstruation future in 15th month, do detection paper after several days and find conceivedly, do pregnant inspection check to hospital, confirm conceivedly, gave birth to smoothly healthy boy baby, mother and sons' health in 9 months 10 days.
Case 3: the woman, 38 years old, Nanjing Human, the patient has normal menstrual and obstetrical histories, 13 the beginning of the year of patient tide, menstruation basic law after the menophania, 30 ~ 35 days cycles, 5 days menstrual period, measure medium, pregnant 2 products 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, check result shows FSH〉40IU/L, and with the symptom of perimenopausal syndrome, significantly premature ovarian failure symptom.Begin to take this medicine, take every day 3 times, each 3, first all after date, the sensation breast very rises, and vagina is moistening, in high spirits having rosy cheeks taken after 5th month menstrual onset continuously, through the amount seldom, the 7th, when begin August the menstrual onset time indefinite, through measuring rareness, be maintained until 10 months through amount, began after 12 months, the menstrual onset time phase difference is few, through measuring rareness.To beginning in 13 months, through measuring rareness, the time of rising began to be tending towards normal.
Case 4: woman, 34 years old, Hong Kong native, vaginal dryness, dyspareunia, vulvismus (fear), irritability, hyperhidrosis, the vagina estrogen level is measured low, blood E2 is low, FSH 40IU/L, be diagnosed as the endocrine disturbance, the ovarian function decline, vaginal secretions reduces.Begin to take this medicine, after 20 days, vaginal secretions increases, and vagina is moistening, in high spirits having rosy cheeks, the dyspareunia sense alleviates, and continues to take 26 months cycles, and vagina is moistening, the 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, and is happy.
In addition, the medicine of the treatment premature ovarian failure of preparation is as clinical medicine in above-described embodiment 1, 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 Rui Na medical center and Hua Wei medical center, through 165 routine women's clinical observations, mainly take the patient of China, Britain 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 continues half a year to the several years and do not wait.Clinical data is reported as follows:
1. the infertile therapeutic effect that causes for premature ovarian failure of medicine of the present invention
The clinical effectiveness of the sterility and infertility that causes 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, three months is a course for the treatment of, take continuously 4 courses for the treatment of, observe the curative effect, 8 examples of fully recovering 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
By above-mentioned case 1 to 4 and table 2 as can be known, the medicine of embodiment of the invention treatment premature ovarian failure is remarkable to treatment premature ovarian failure effect.The medicine of embodiment of the invention treatment premature ovarian failure is pure natural medical herbs, has no side effect, and without hepatic and renal function injure, does not have untoward reaction, has significant therapeutic effect.
The above only is preferred embodiment of the present invention, not in order to limiting the present invention, all any modifications of doing within the spirit and principles in the present invention, is equal to and replaces and improvement etc., all should be included within protection scope of the present invention.
Claims (10)
1. medicine for the treatment of premature ovarian failure comprises the raw material of Chinese medicine extract components of following weight portion:
2. the medicine for the treatment of premature ovarian failure as claimed in claim 1 is characterized in that, comprises 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, comprises the raw material of Chinese medicine extract components of following weight portion:
4. such as the medicine of the described treatment premature ovarian failure of claim 1～3, it is characterized in that: described soybean extract is that the bean cake of Semen sojae atricolor is or/and embryo extract.
5. such as the medicine of the described treatment premature ovarian failure of claim 1～3, it 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, it is characterized in that: described peroral dosage form is tablet, capsule, pill, granule dosage form or oral liquid.
7. preparation method for the treatment of the medicine of premature ovarian failure, it comprises the steps:
Prescription by the medicine of the arbitrary described treatment premature ovarian failure of claim 1～6 takes by weighing each raw material of Chinese medicine extract components;
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, it is characterized in that: described peroral dosage form technique is hard capsule dosage form technique, described hard capsule dosage form technique is as follows:
After each described raw material of Chinese medicine extract components mixing, sterilization, granulation, dry, granulate make the Chinese medicine composition composition granule;
With 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 65～75% ethanol for the concentration that adds its weight 3～6% in the mixture of raw material of Chinese medicine extract after sterilization, makes to cross 10～16 mesh sieves behind the soft material and granulate;
The temperature of described drying is 50～70 ℃, and the time is 2～4h.
10. such as the preparation method of claim 7 or 8 described treatment premature ovarian failure medicines, it is characterized in that: described sterilization is radiation sterilizing, and the environment of described radiation sterilizing is: 60Co radiation sterilization, irradiation dose are greater than 0KGY, less than or equal to 6KGY.
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Cited By (7)
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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 |
| CN107441313A (en) * | 2017-09-28 | 2017-12-08 | 杭州市中医院 | Treat Chinese medicine composition, medicine of Ovary reserve decline and preparation method thereof |
| CN107836670A (en) * | 2017-09-01 | 2018-03-27 | 上海拜汶医药科技有限公司 | A kind of preparation method for the composite nutrient protected and improve women ovarian function |
| 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 |
| 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 | Composition for delaying ovarian senescence and preparation method and application thereof |
| CN116966138A (en) * | 2023-09-22 | 2023-10-31 | 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 |
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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 |
| CN107836670A (en) * | 2017-09-01 | 2018-03-27 | 上海拜汶医药科技有限公司 | A kind of preparation method for the composite nutrient protected and improve women ovarian function |
| 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 |
| CN107441313A (en) * | 2017-09-28 | 2017-12-08 | 杭州市中医院 | Treat Chinese medicine composition, medicine of Ovary reserve decline and preparation method thereof |
| 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 | Composition for delaying ovarian senescence and preparation method and application 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 |
| CN116966138A (en) * | 2023-09-22 | 2023-10-31 | 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 |
| 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 |
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