CN102274390B - Medicinal composition for high-androgen polycystic ovary syndrome - Google Patents
Medicinal composition for high-androgen polycystic ovary syndrome Download PDFInfo
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Abstract
The invention relates to a medicinal composition for a high-androgen polycystic ovary syndrome. The medicinal composition comprises a Chinese medicinal composition and a chemical medicament, wherein the Chinese medicinal composition comprises the following medicinal materials: epimedium, caladium, fructus psoraleae, sliced deerhorn, sea horse, tortoise plastron and the like, and does not contain rhubarb and Chinese angelica. The medicinal composition can reduce the level of androgen and androgen receptors of polycystic ovary syndrome (PCOS) patients, improve the level of sex hormone binding globulin, reduce the level of free testosterone, improve the level of in-vivo estrogen further, improve the growth and development of follicles, and improve the ovulation rate and pregnancy rate of the patients.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition that is used for the treatment of polycystic ovarian syndrome, relate in particular to a kind of by several kinds of Chinese medicinal materials by monarch, minister, help, make compatible Chinese medicine composition, and be used in conjunction with the pharmaceutical composition of chemicals, be used for the treatment of high-androgen polycystic ovary syndrome.
Background technology
Polycystic ovarian syndrome (Polycystic Ovary Syndrome, PCOS) proposed in nineteen thirty-five by Stein and Leventhal, refer to have menoxenia, amenorrhea, anovulation, hirsutism, obesity, infertile merging bilateral ovaries increase a class disease that is the performances such as polycystic change.This disease is the common endocrinopathy of women and mostly causes dysgenesia, and its sickness rate accounts for the women of child-bearing age's 5%-10%.Research in recent years recognizes that extensively there is insulin resistant in various degree in the women of PCOS, and the insulin resistant hyperinsulinemia that occurs together causes many clinical symptoms, as: androgen levels is too high, reproduction is disorderly, metabolism disorder, acne and hirsutism etc.Suffer from women's arteriosclerosis of PCOS and the risk factor increase of cardiovascular disease incidence owing to there being insulin resistant.Think that at present PCOS patient's insulin resistant (IR) mainly occurs in the classical target organ of insulin action---skeletal muscle, fat and liver etc., and reproduction abnormality mainly occurs in ovary tissue.
The syndromic genetics research of Stein-Leventhal was just proposed as far back as the thirties in last century, the foundation of diagnosis concentrates on the feature of polycystic ovary, it is polymorphism that the people such as Goldzicher in 1962 and Green have proposed clinical manifestation, and therapeutic effect is also polymorphic.Produced laboratory diagnosis standard along with radioimmunoassay technique carries out the seventies: lutropin/follicule-stimulating hormone (FSH) (LH/FSH)＞3 is emphasized in diagnosis, change into later on 〉=2.5.Rotterdam meeting U.S. reproductive medicine in 2003 can and the European mankind's reproductive medicine diagnostic criteria of PCOS can be proposed, possessing in following 32 can set up: (1) oligo-ovulation or do not ovulate; (2) clinical or biochemical excessive androgen performance; (3) ultrasonoscopy Ovarian Volume＞1Oml, or the follicle of visible 〉=12 diameter 2-9mm.The history of the existing last 100 years of the understanding of relevant polycystic ovarian syndrome, its diagnostic criteria changes with the epoch transition, and molecule genetics research has so far generally acknowledged that PCOS is a polygenic disease.2006 Nian Yujin professor combination Chinese and western medicine clinical practices for many years, around the too high core of PCOS androgen, proposed diagnostic point: (1) androgen is too high: have clinical or biochemical indicator (T or logT/E
2), can determine by the clinical manifestation performance the corresponding biochemical indicator of this mensuration; (2) anovular menstruation, infrequent menstruation, amenorrhea or anovulatory dysfunctional uterine hemorrhage: after menophania, can regular menstrual onset, but painless warp or menstrual period are uncomfortable, the basal body temperature individual event; Or infrequent menstruation, amenorrhea, small number of patients has the anovulatory dysfunctional uterine hemorrhage phenomenon; Sterile; (3) polycystic ovary is seen in ultrasonoscopy: Ovarian Volume＞6ml, the follicle of a visible diameter 2-10mm in plane＞10 is got rid of congenital adrenal cortical hyperplasia and the diseases such as ovary or adrenal gland neoplasms simultaneously.
The common western medicine therapy of PCOS mainly uses contraceptive or promoting ovulation drug, receives sweet smell, Marvelon and Da Ying etc. as: clomiphene, HMG, GnRH, fruit.These medicines not only can not be realized effectively treatment to all PCOS, also have the defectives such as low pregnancy rate and high abortion ratio.The surgery puncture technique also is applied to the treatment of PCOS, and these therapies may be to the ovary injury, or causes pelvic adhesion and fetus is had potential harm.
The traditional Chinese medical science is also treated PCOS from its peculiar understanding and medication angle, as: name is called the prescription of " growing the water Yishen Tang ", and its ingredients is: Radix Puerariae 30 grams, fresh Herba Dendrobii 12 grams, Radix Trichosanthis 10 grams, Endothelium Corneum Gigeriae Galli 15 grams, Semen Sinapis Albae 10 grams, Radix Cyathulae 15 grams, Fructus Schisandrae Chinensis 5 grams, Radix Angelicae Sinensis 10 grams, Radix Paeoniae Alba (parched) 10 grams, Radix Curcumae 10 grams, Radix Dipsaci 15 grams and Rhizoma Polygoni Cuspidati 15 grams.The people such as Yu Jin are using for reference theory of Chinese medical science, have obtained " Yu Shi temperature compensation ball " by practice, and the induced ovulation rate is 82.7% in treatment PCOS, pregnancy rate 50%.Further studies confirm that, " Yu Shi temperature compensation ball " has the PCOS patient of reduction androgen, thereby the secretion that has improved follicule-stimulating hormone (FSH) causes the effect of ovulating.
Summary of the invention
One object of the present invention is to provide a kind of pharmaceutical composition for high-androgen polycystic ovary syndrome, comprise Chinese medicine composition and chemicals, to reduce PCOS patient's androgen and Androgen Receptor Level, improve sex hormone binding globulin (Sex Hormone-Binding Globulin, SHBG) level reduces free testosterone level, further improves body inner estrogen level, improve the growth promoter of follicle, improve patient's ovulation rate and pregnancy rate.
" excessive androgen " that the present invention is alleged or " high androgen " refer to that the Serum Testosterone Levels compared with normal in the PCOS patient body is individual for high, and it is mainly extremely to be caused by the CYP17 expression of enzymes, can further be subdivided into Four types according to clinical manifestation:
I a type: patient has acne, nipple is other becomes mildewed; Testosterone (T) raises or blood logT/E
2〉=0.97, other androgen levels are all in normal range, and leptin and insulin level great majority are in normal range.
I b type: waist-to-hipratio (WHR) 〉=0.8, lower abdomen or large leg outer side have dermatoglyph, and nipple is less, nipple is other without coarse wool, acne is few, clitoris can slightly increase, and the levels such as T, hydrocortisone, 17 hydroxyprogesterones and androstenedione raise, and leptin and carbohydrate tolerance and insulin release test level slightly raise.
II a type: central obesity is obvious, and in infra-axillary region, nape section, waistline and the calm phenomenon of external genital visible black color element, often there are hypertension or diabetes family history in WHR 〉=0.8; T raises or logT/E
2〉=0.97, E
2Level is low, and fasting insulin and release test level raise, and the blood leptin level can raise, and androstenedione, 17 hydroxyprogesterone levels are not high
II b type: have the clinical manifestation of above-mentioned I b type and II a type, T, 17 hydroxyprogesterones, androstenedione, hydrocortisone raise, and insulin emission levels and leptin obviously raise.
" euglycemic agent " that the present invention is alleged, finger can improve in patient body insulin sensitivity, promote the material that insulin takes full advantage of, as: metformin class, sulphanylureas, insulin and analog thereof, modified insulin and analog thereof, GLUCAGON LIKE PEPTIDE (Glucogan-Like Peptide 1, GLP-1) and analog, modified GLP-1 and analog, Exendin-4 and analog thereof and modified Exendin-4 and analog thereof.
Alleged " analog " of the present invention refers to have with natural albumen or peptide sequence albumen or the polypeptide of 70% above homology.
Alleged " modification " of the present invention refer to by the methods such as chemistry, biology or genetic engineering on albumen or peptide sequence in conjunction with other material, with the attribute (as: stability, immunogenicity and Half-life in vivo etc.) that changes albumen or polypeptide.These materials as: but be not limited only to the materials such as straight or branched alkyl (as: palmitic acid or stearic acid-base), polymer (as: Polyethylene Glycol) and albumin.
Alleged " patient " of the present invention refers to suffer from people, wild animal and the domestic animal (Livestock) of disease.Wild animal is without domestication's animal under naturalness.Domestic animal is the animal of the artificial breeding for food source is provided, as: monkey, ape, Canis familiaris L., Mus, hamster, pig, rabbit, milch cow, Babalus bubalis L., bull, sheep and goat etc." experimenter " that diagnose preferentially selects mammal, especially people.
Herba Epimedii, acrid in the mouth, sweet in the mouth are sweet, warm in nature, return liver, kidney two warps, the effect such as have kidney invigorating and YANG supporting, expelling wind and removing dampness, relieving cough and asthma, invigorate vital energy and reinforce the heart.Its chemical composition that mainly contains has flavonoid, icariin, icariine, 3,5,7-trihydroxy-2-(4-methoxy-phenyl)-8-(3-methyl-but-2-enyl)-chromen-4-one, and the volatile oil such as the acid of leaf fiber crops, oleic acid, Palmic acid, also contains the materials such as sterin, benzene, tannic acid, vitamin E and flavone.Herb or the leaf of XIAONIE section plant Herba Epimedii taken from its crude drug source, enters medicinal its stem and leaf, the preferential fresh leaf of selecting with cyan of medical material.
Bulbus Fritillariae Uninbracteatae, bitter, sweet, be slightly cold, return lung, the heart two warps.Its bulb hyoscine has the effect of relieving cough and resolving phlegm, heat clearing away eliminating stagnation.Can be divided into Bulbus Fritillariae Cirrhosae, Bulbus Fritillariae Thunbergii (Bulbus Fritillariae Thunbergii) and Rhizoma Bolbostematis three major types, different Bulbus Fritillariae Uninbracteatae effects also there are differences.Bulbus Fritillariae Cirrhosae is slightly cold, sweet in the mouth, and the relieving cough and resolving phlegm effect is stronger, and the effect of lung moistening is arranged, and abundant expectoration expectorant all can use less, is specially adapted to the cough due to the dryness of the lung or autumn-dryness disease.The patient shows as cough, and, difficulty few with expectorant coughed up, or the discomfort such as sputum mixed with blood, mouth and nose drying, dry throat and mouth.If the patient shows as cough chest pain, fever with aversion to cold, cough and tell stench purulent sputum, be hard and dry, during the symptom such as red tongue xerostomia, should select Bulbus Fritillariae Thunbergii, because the effect of Bulbus Fritillariae Thunbergii pathogenic fire purging is better than Bulbus Fritillariae Cirrhosae.And be good at the eliminating stagnation of relieving inflammation or internal heat, be the good medicine for the treatment of lung abscess.For take cough, unfavorable, the expectorant of expectoration yellow sticky, xerostomia is thirsty, the red cough due to pathogenic wind-heat patient as main manifestations of tongue fur, both can select Bulbus Fritillariae Cirrhosae, can select Bulbus Fritillariae Thunbergii again.Because of the Bulbus Fritillariae Cirrhosae this medicine is mild, abnormal smells from the patient is not dense, is more suitable for taking in the elderly and infirm.And for children's and adolescence that plain body heat is contained, preferably select Bulbus Fritillariae Thunbergii.Rhizoma Bolbostematis, cold in nature, bitter in the mouth has stronger antiinflammatory, antiviral and antineoplastic action, normal uses treatment breast disease, tuberculosis and the skin disease such as rotten that swells with other heat-clearing and toxic substances removing medicine compatibilities.The alleged Bulbus Fritillariae Uninbracteatae of the present invention is Bulbus Fritillariae Cirrhosae and Bulbus Fritillariae Thunbergii.
Fructus Psoraleae, hot, bitter, temperature.Return kidney, spleen two warps, warming the kidney to activate YANG, improving inspiration by invigorating kidney-QI and anti-diarrhea effect are arranged.Its main chemical compositions fruit contains 20% volatile oil of having an appointment, organic acid, a kind of methyl glucoside, alkali soluble resins, fixedness terpenoid oil and Saponin.It is the fruit of legumes psoraleae that its crude drug is originated.
In order to improve curative effect, when using Chinese medicine to treat, PCOS patient also coordinate one or more with the chemicals of compound molecule as active component, these compounds as: but be not limited only to dexamethasone, spironolactone, ethinylestradiol, cyproterone and pharmaceutically acceptable salt.
Dexamethasone, chemical name: 16 Alpha-Methyls-11 β, 17 α, 21-trihydroxy-9 α-fuprednate-Isosorbide-5-Nitrae-diene-3, the 20-diketone acts on adrenal gland and ovary and plays the effect that reduces androgen levels.0.25-0.75mg, from the menstrual cycle first day, take 10-14 days altogether every night.
Spironolactone, chemical name: 17 beta-hydroxies-3-oxygen-7 α-(thioacetyl)-17 α-pregnant steroid-4-alkene-21-carboxylic acid gamma lactone, act on the adrenal gland and play the effect that reduces androgen levels, improve the hirsutism symptom.Consumption is generally 2-3 times/day, and each 20mg can take 3 months continuously.
The effect that ethinylestradiol not only has complementing estrogen and improves ovarian function can also improve sex hormone binding protein.Consumption is generally 0.0125mg-O.05mg/ days, from menstrual cycle the 6th day, takes altogether 20 days.
Conjugated estrogen hormone is that another kind has complementing estrogen and improves the medicine of ovarian function effect, also can improve sex hormone binding protein.Consumption is generally 0.625mg-2.5mg every day, from menstrual cycle the 6th day, takes altogether 20 days.
Estradiol valerate is that another kind has complementing estrogen and improves the medicine of ovarian function effect, also can improve sex hormone binding protein.Consumption is generally 1mg-4mg/ days, from menstrual cycle the 5th day, takes altogether 21 days.
A kind of pharmaceutical composition for high-androgen polycystic ovary syndrome provided by the invention is comprised of the chemicals take compound molecule as active component and Chinese medicine composition.Chinese medicine composition comprises,
Monarch drug: the Bulbus Fritillariae Uninbracteatae of the Herba Epimedii of weight portion 9-21 and weight portion 9-24; Ministerial drug: weight portion is that the Fructus Psoraleae of 9-21, Cornu Cervi tablet and the weight portion that weight portion is 3-15 are the Hippocampus of 0.3-15; Adjuvant drug: weight portion is the Carapax et Plastrum Testudinis of 9-21, and does not contain Radix Et Rhizoma Rhei and Radix Angelicae Sinensis two flavor medical materials.
The sweet little hot temperature of Herba Epimedii enters liver, kidney channel, reinforcing the kidney and supporting YANG, Chong and Ren Meridians regulating; The Bulbus Fritillariae Uninbracteatae bitter cold enters the heart, all warps of lung, and removing heat-phlegm is principal agent altogether; The sweet tepor of Fructus Psoraleae enters liver, kidney channel, and the kidney invigorating and essence nourishing is given birth to sun in the moon, help Herba Epimedii the kidney invigorating warming YANG; The sweet temperature of Cornu Cervi tablet enters kidney, liver, the heart and heart born of the same parents warp, the kidney warming tonify deficiency, and strong essence is invigorated blood circulation; Add the salty-cold Carapax et Plastrum Testudinis that enters liver, kidney channel, the marrow mind calming is mended in the YIN nourishing replenishing essence, and treating YANG within YIN can prevent that again warm drugs from robbing cloudy; The sweet temperature of Hippocampus enters the Liver and kidney warp, and the kidney warming tonify deficiency is mended with the Carapax et Plastrum Testudinis YIN YANG interdislocation syndrome, and helps vital essence rising.In addition, the hot temperature of Spina Gleditsiae enters lung, large intestine channel, phlegm reduction of blood circulation promoting, promoting blood circulation; The arduous temperature of Rhizoma Acori Graminei enters the heart, Liver Channel, reduces phlegm except stopping up, and refreshes oneself sensible.Chinese medicine composition of the present invention adds Spina Gleditsiae and Rhizoma Acori Graminei further to improve the therapeutic effect of compositions again.
Another kind provided by the invention is used for the pharmaceutical composition of high-androgen polycystic ovary syndrome, is comprised of the chemicals take compound molecule as active component and Chinese medicine composition.Chinese medicine composition comprises,
Monarch drug: the Bulbus Fritillariae Uninbracteatae of the Herba Epimedii of weight portion 12-21 and weight portion 9-24; Ministerial drug: weight portion is that the Fructus Psoraleae of 12-21, Cornu Cervi tablet and the weight portion that weight portion is 6-15 are the Hippocampus of 0.3-15; Adjuvant drug: weight portion is that the Carapax et Plastrum Testudinis of 9-21, Spina Gleditsiae and the weight portion that weight portion is 9-21 are the Rhizoma Acori Graminei of 9-21, and does not contain Radix Et Rhizoma Rhei and Radix Angelicae Sinensis two flavor medical materials.
PCOS patient usually also be attended by such as: weak fatiguability, obesity, have expectorant, oral ulcer, insomnia, mammary swelling, merging pelvic inflammatory disease, endometriosis, hyperhidrosis, stomach upset and tongue that the clinical manifestations such as the stasis of blood are secretly arranged, therefore need to be in conjunction with actual state of an illness increase simply or the kinds of traditional Chinese medicines material.
Weak fatiguability, mostly take the deficiency of vital energy as main, the Chinese crude drug that need to re-use invigorating the spleen and benefiting QI as: but be not limited only to, Radix Codonopsis, the Radix Astragali, Radix Pseudostellariae and Rhizoma Dioscoreae, consumption is the 9-30 weight portion.
Obesity, how by the kidney yang deficiency of vital energy, can not rising body fluid, poly-ly wet into expectorant, overflow skin and cause, often need again Chinese crude drug that compatibility uses drying dampness to eliminate phlegm as: but be not limited only to, Rhizoma Pinelliae Preparata, Pericarpium Citri Reticulatae, Fructus Aurantii Immaturus, Poria, Rhizoma Alismatis and Folium Nelumbinis, consumption are the 6-24 weight portion.
Expectorant is arranged, how by blockage of qi mechanism by phlegm, disturbance of lung-QI and causing, the Chinese crude drug that often needs again the compatibility phlegm-eliminiating and qi-regulating as: but be not limited only to, Rhizoma Pinelliae Preparata, Pericarpium Citri Reticulatae, Pericarpium Trichosanthis and Bulbus Allii Macrostemonis, consumption are the 6-21 weight portion.
How oral ulcer damages the moon for a long time by disease, due to hyperactivity of deficient fire, the Chinese crude drug that often needs again the compatibility nourishing YIN and clearing away fire as: but be not limited only to, the Rhizoma Anemarrhenae and Cortex Phellodendri, consumption is the 6-24 weight portion.
Insomnia, how by imbalance of YIN and YANG, due to disarmony between the heart and kidney, often need again Chinese crude drug that compatibility calms the nerves as: but be not limited only to, Semen Ziziphi Spinosae, Semen Platycladi, Magnetitum, Concha Haliotidis, Cortex Albiziae and Caulis Polygoni Multiflori, consumption are the 6-30 weight portion.
Mammary swelling, how by the liver failing to maintain the normal flow of QI, due to newborn network is obstructed, the Chinese crude drug that often needs again compatibility depressed liver-energy dispersing and QI regulating collateral dredging as: but be not limited only to, Pericarpium Citri Reticulatae Viride, Radix Bupleuri, Cortex Moutan and Semen Vaccariae, consumption are the 6-24 weight portion.
Merge pelvic inflammatory disease person, the card that damp invasion of lower energizer is arranged more, the Chinese crude drug that often needs again the compatibility heat-clearing and toxic substances removing as: but be not limited only to, Pollen Typhae, Herba Taraxaci, Rhizoma Curcumae, Herba Patriniae, Herba Violae, Radix Sophorae Tonkinensis, Flos Lonicerae, Fructus Forsythiae, Herba Commelinae, Rhizoma Osmundae, Rhizoma Paridis, Rhizoma Smilacis Glabrae and Rhizoma Paridis, consumption are the 6-30 weight portion.
Merge the endometriosis person, the card that stops in blood stasis is arranged more, the Chinese crude drug that often needs again compatibility blood circulation promoting and blood stasis dispelling Xiao Disorder as: but be not limited only to, Hirudo, Rhizoma Curcumae, Olibanum, Myrrha, Eupolyphaga seu steleophaga, Pollen Typhae, Semen Persicae, rhizoma sparganic, Scolopendra and Pheretima, consumption is the 2-24 weight portion.
Hyperhidrosis, how by the deficiency of vital energy, can not astringency inducing due to, the Chinese crude drug that often needs again the astringent or styptic treatment for spontaneous sweating arresting sweating of compatibility as: but be not limited only to, Concha Ostreae, Fructus Tritici Levis and Radix Ephedrae, consumption are the 9-30 weight portion.
Stomach upset, how by due to disorder of stomach-QI, the Chinese crude drug that often needs again the compatibility regulating qi-flowing for harmonizing stomach as: but be not limited only to, Radix Aucklandiae (Radix Vladimiriae) and Fructus Amomi, consumption are the 3-15 weight portion.
Tongue secretly has the stasis of blood, how by caused by energy stagnation and blood stasis, the Chinese crude drug that often needs again the compatibility blood circulation promoting and blood stasis dispelling as: but be not limited only to, Semen Persicae, consumption are the 6-21 weight portion.
Development along with the state of an illness, PCOS patient also resists (Insulin Resistance) with insulin, and insulin sensitivity is descended, and blood glucose continues and significantly increases, then cause type ii diabetes (Non-insulin Dependent Diabetes Mellitus, NIDDM).For this reason, with the patient that insulin resists, also be used in conjunction with euglycemic agent for this class in pharmaceutical composition of the present invention.
Chinese medicine composition for high-androgen polycystic ovary syndrome provided by the invention is made decoction by decocting method, or makes unguentum by traditional Chinese medical science traditional method.
Chemicals or protein/polypeptide bio-pharmaceutical can be taken with the common per os of Chinese medicine composition of the present invention (Oral), or individually dosed by modes such as subcutaneous injection (Subcutaneous injection), intravenous injection (Intravenous injection), transdermal (Transdermal), oral cavity (Buccal) and nasal cavities (Nasal).The time of the administration of chemicals or protein/polypeptide bio-pharmaceutical and administering mode must not limit pharmaceutical composition of the present invention.
The beneficial effect that technical solution of the present invention realizes:
Pharmaceutical composition for high-androgen polycystic ovary syndrome provided by the invention comprises the medical materials such as Herba Epimedii, Bulbus Fritillariae Uninbracteatae, Fructus Psoraleae, Cornu Cervi tablet, Hippocampus and Carapax et Plastrum Testudinis; And do not contain Radix Et Rhizoma Rhei and Radix Angelicae Sinensis two flavor medical materials.Give to PCOS patient decoction or the unguentum that Chinese medicine composition of the present invention is made, and be used in conjunction with chemicals or protein/polypeptide bio-pharmaceutical, after taking a period of time, patient's androgen levels significantly reduces, the growth promoter of follicle improves, and has improved patient's ovulation rate and pregnancy rate.In addition, patient's weak fatiguability, obesity, have expectorant, oral ulcer, insomnia, mammary swelling, merging pelvic inflammatory disease, endometriosis, hyperhidrosis, stomach upset and tongue to have secretly that the symptom such as the stasis of blood is existing significantly to be improved.
The specific embodiment
Below describe technical scheme of the present invention in detail.The embodiment of the present invention is only unrestricted in order to technical scheme of the present invention to be described, although with reference to preferred embodiment, the present invention is had been described in detail, those of ordinary skill in the art is to be understood that, can modify or be equal to replacement the technical scheme of invention, and not breaking away from the spirit and scope of technical solution of the present invention, it all should be encompassed in claim scope of the present invention.
Embodiment of the present invention medical material used is dated except separately having, and all can obtain from Chinese crude drug sales company.The medical material that obtains is dated except separately having, and is tcm and herbal slice.Decoction pieces both can obtain from sales company, can be also to obtain by processing.
The preparation of embodiment 1 decoction
Get Hippocampus 0.6g, Herba Epimedii 15g, Bulbus Fritillariae Uninbracteatae 12g, Fructus Psoraleae 15g, Carapax et Plastrum Testudinis 12g, Cornu Cervi tablet 12g, Spina Gleditsiae 15g and Rhizoma Acori Graminei 15g, soak more than 2 hours in container after water rinses, then adopt and be decocted first and rear lower traditional fried technique, the normal pressure decoction leached medicinal liquid in 20 minutes.
The preparation of embodiment 2 unguentum
Get Hippocampus 6g, Herba Epimedii 150g, Bulbus Fritillariae Uninbracteatae 120g, Fructus Psoraleae 150g, Carapax et Plastrum Testudinis 120g, Cornu Cervi tablet 120g, Spina Gleditsiae 150g and Rhizoma Acori Graminei 150g, soak more than 2 hours in container after water rinses, then adopt be decocted first and rear under traditional fried technique, normal pressure leaches medicinal liquid and concentrating under reduced pressure medicinal liquid after decocting, in the medicinal liquid concentration process, add the required saccharide such as crystal sugar, maltose and yellow wine and necessary adjuvant, stir and receive cream.
Embodiment 3 clinical observations
Patient's typing standard: 1) menophania after 2 years basal body temperature (BBT) continue single-phase, infrequent menstruation or amenorrhea; 2) the blood androgen raises: testosterone (T) raises or testosterone/estradiol logarithm ratio (logT/E
2)＞0.97; (17 α-OHP), androstenedione increase can to merge 17 α-hydroxyprogesterone; 3) the ultrasound diagnosis Ovarian Volume increase (〉=6ml), the follicle number of diameter 2～9mm on plane in cortex＞10; 4) reactionless to the clomiphene treatment, more than hormone therapy used has stopped March; 5) get rid of the diseases such as congenital adrenal hyperproliferative disorder, ovule bubble syndrome, Cushing's syndrome, the ovary that secretes androgen and adrenal gland neoplasms; 6) 18～40 years old age.All patients all through in, western medical treatment is more than half a year, but all ovulation or gestation occurs.
hormone test: reach treatment before treatment and made blood follicule-stimulating hormone (FSH) (FSH) in rear 6 months in the 3rd day at 8 o'clock in the morning of withdrawal bleeding or menstrual onset, lutropin (LH), estradiol (E2), testosterone (T), 17 α-hydroxyprogesterone (17 α-OHP), hydrocortisone (F), sex hormone binding protein (SHBG), androstenedione, leptin (LEP), dehydroepiandrosterone sulfate (DHEAS), oral glucose tolerance test and insulin release test (OGTT, IRT) and the mensuration of free testosterone index (FAI=T/SHBG * 100%).
Physical examination: except gynecologial examination, record routinely that good size and spaced farapart, mammary areola otherly become mildewed, the situations such as pigmentation after hypogastric region and large leg outer side dermatoglyph, oxter and neck, glans of clitoris size, acne, hair are greasy, waist-to-hipratio (WHR); Treatment is checked to begin a project after half a year.
Just be divided into four types with the patient who enters group by above-mentioned standard:
I a type: become mildewed by acne, nipple are arranged; Testosterone (T) raises or blood logT/E
2〉=0.97, other androgen levels are all in normal range, and leptin and insulin level great majority are in normal range.
I b type: waist-to-hipratio (WHR) 〉=0.8, lower abdomen or large leg outer side have dermatoglyph, and nipple is less, other acne is few without coarse wool for nipple, and clitoris can slightly increase; The levels such as T, hydrocortisone, 17 α hydroxyprogesterones and androstenedione raise, and leptin and carbohydrate tolerance and insulin release test level slightly raise.
II a type: central obesity is obvious, and in infra-axillary region, nape section, waistline and the calm phenomenon of external genital visible black color element, often there are hypertension or diabetes family history in WHR 〉=0.8; T raises or logT/E
2〉=0.97, E
2Level is low, and fasting insulin and release test level raise, and the blood leptin level can raise, and androstenedione, 17 α hydroxyprogesterone levels are not high
II b type: have the clinical manifestation of above-mentioned I b type and II a type, T, 17 α hydroxyprogesterones, androstenedione, hydrocortisone raise; Insulin emission levels and leptin obviously raise.
Therapeutic Method: differential diagnosis of diseases with distinguish that disease combines and adopt respectively Chinese medicine composition decoction of the present invention to treat, in conjunction with patient performance or blood hormonal readiness, add with acupuncture, metformin (as: higher to leptin and carbohydrate tolerance and insulin release test level) and the periodically treatments such as estrogen and dexamethasone by the state of an illness is dialectical.Can give clomiphene 50mg/ days, totally 5 days in case of necessity.Before and after sufferer is treated, every lab index of patient detects, and observes (seeing Table 1) with regard to clinical symptoms, takes to treat the cross-reference mode and judges effects of clinic diagnosis.
Observe and find: after treatment in 2～3 months, when patient's menstruation and ovulation obviously improve, General Symptoms (as: xerostomia, vexed, leucorrhea reduce, hair is greasy and fat etc.), emotion, energy also are clearly better, most of pigmentation patient obviously disappear (seeing Table 2).
Blood androgen that lab testing is found patient after treatment is as 17 α-OHP, T, logT/E
2, F, androstenedione, free testosterone, leptin and fasting insulin, insulin emission levels obviously descend; Sex hormone binding protein and E
2All obviously risings of level (seeing Table 3-1, table 3-2 and table 3-3).
Table 1
In table 1, clinical cure refers to that gestation or menstruation monthly rise, and occurs continuously 3 ovulations in half a year; Weight loss simultaneously, the General Symptomies such as xerostomia, vexed, leucorrhea minimizing obviously improve; Produce effects refers to that menstruation rose once in 30～45 days, and 2 ovulations were arranged in half a year, and General Symptoms obviously improves; Effectively the finger menstruation is risen once for 1～February, and 1 ovulation was arranged in half a year, and General Symptoms improves; Invalid finger menstruation can be risen, the anovulation phenomenon, and General Symptoms improves.
Table 2
*Expression and front relatively P＜0.01 for the treatment of.
Table 3-1
Table 3-2
Table 3-3
Annotate: " ◇ " expression: compare P＜0.05 with the III type; " zero " expression: compare P＜0.01 with II type and IV type; " * " expression: compare P＜0.05 with II type and IV type; " ◎ " expression and other various relatively P＜0.05; " # " represents: compare P＜0.05 before and after treatment; " ## " expression: compare P＜0.01 before and after treatment.
After treatment, patient's blood estradiol, sex hormone binding protein level obviously rise (P＜0.05, P＜0.01), testosterone, log (T/E
2), hydrocortisone, 17a hydroxyprogesterone, androstenedione, free testosterone, leptin and insulin level obviously descend (P＜0.05, P＜0.01, P＜0.01, P＜0.01, P＜0.01, P＜0.01, P＜0.01, P＜0.01).Illustrate that patient body inner estrogen level rises, and excessive androgen hyperinsulinism state makes moderate progress.
Claims (2)
1. unite with the chemicals take compound molecule as active component the Chinese medicine composition that uses the treatment high-androgen polycystic ovary syndrome for one kind, wherein said compound molecule is selected from one or more of dexamethasone, spironolactone, ethinylestradiol, estradiol valerate, conjugated estrogen hormone and pharmaceutically acceptable salt, it is characterized in that described Chinese medicine composition is:
Monarch drug: the Bulbus Fritillariae Uninbracteatae of the Herba Epimedii of weight portion 12-21 and weight portion 9-24;
Ministerial drug: weight portion is that the Fructus Psoraleae of 12-21, Cornu Cervi tablet and the weight portion that weight portion is 6-15 are the Hippocampus of 0.3-15; With
Adjuvant drug: weight portion is that the Carapax et Plastrum Testudinis of 9-21, Spina Gleditsiae and the weight portion that weight portion is 9-21 are the Rhizoma Acori Graminei of 9-21.
2. unite with chemicals and euglycemic agent take compound molecule as active component the Chinese medicine composition that the use treatment is used for high-androgen polycystic ovary syndrome for one kind, wherein said compound molecule is selected from one or more of dexamethasone, spironolactone, ethinylestradiol, estradiol valerate, conjugated estrogen hormone and pharmaceutically acceptable salt, it is characterized in that described Chinese medicine composition is:
Monarch drug: the Bulbus Fritillariae Uninbracteatae of the Herba Epimedii of weight portion 12-21 and weight portion 9-24;
Ministerial drug: weight portion is that the Fructus Psoraleae of 12-21, Cornu Cervi tablet and the weight portion that weight portion is 6-15 are the Hippocampus of 0.3-15; With
Adjuvant drug: weight portion is that the Carapax et Plastrum Testudinis of 9-21, Spina Gleditsiae and the weight portion that weight portion is 9-21 are the Rhizoma Acori Graminei of 9-21.
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Non-Patent Citations (4)
| Title |
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| 中医药治疗闭经近况;周艳艳等;《河南中医》;20020630;第22卷(第03期);78-80 * |
| 周艳艳等.中医药治疗闭经近况.《河南中医》.2002,第22卷(第03期),78-80. |
| 多囊卵巢综合征67例治疗分析;李海燕等;《大理学院学报》;20040630;第03卷(第03期);20-22 * |
| 李海燕等.多囊卵巢综合征67例治疗分析.《大理学院学报》.2004,第03卷(第03期),20-22. |
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