CN105597020A - Pharmaceutical composition for treating polycystic ovarian syndrome combined with mammary gland hyperplasia - Google Patents
Pharmaceutical composition for treating polycystic ovarian syndrome combined with mammary gland hyperplasia Download PDFInfo
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- CN105597020A CN105597020A CN201610094452.XA CN201610094452A CN105597020A CN 105597020 A CN105597020 A CN 105597020A CN 201610094452 A CN201610094452 A CN 201610094452A CN 105597020 A CN105597020 A CN 105597020A
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Abstract
The invention belongs to the technical field of medicine, and relates to a pharmaceutical composition for treating a polycystic ovarian syndrome combined with mammary gland hyperplasia and a preparation method thereof. The pharmaceutical composition is meticulously prepared by taking stems and leaves of ficus formosana, radix caulophylli, glossy privet fruit, barbary wolfberry fruit, radix morindae officinalis, cortex magnoliae officinalis, radix curcumae longae, rhizoma cyperi, Indian iphigenia bulbs, fiveleaf akebia fruit, herba lysimachiae clethroids and caulis spatholobi as medicinal raw materials according to a certain weight ratio. All the materials jointly achieve the effects of regulating qi-flowing for activating stagnancy, promoting blood circulation to remove blood stasis, replenishing blood for tonifying qi, softening hardness to dissipate stagnation and tonifying the kidney to regulate menstruation and especially have the extremely high targeted treatment effect on the qi stagnation and blood stasis type polycystic ovarian syndrome combined with the mammary gland hyperplasia. Through clinical application verification, the pharmaceutical composition is exact in treatment effect, mild in medicinal property, free of toxic and side effects and obvious adverse reactions and high in safety coefficient.
Description
Technical field
The invention belongs to medical technical field, relate to a kind of treat Stein-Leventhal syndrome merge the proliferation of mammary gland pharmaceutical composition andIts preparation method.
Background technology
Cyclomastopathy is a kind of disease relevant with endocrine dysfunction, and clinical manifestation is breast periodicity or aperiodicityThe lump in breast of pain and different manifestations. The cell that histology shows as breast tissue essence composition increasing quantitatively,On tissue morphology, breast structure occurs that disorder is in various degree pathological change.
Stein-Leventhal syndrome (polycysticovarysyndrome, PCOS) be the common a kind of complexity of Women in menopause inDisease due to secretion and metabolic disorder, with chronic without ovulation (ovulation function disorderly or lose) and excessive androgen mass formed by blood stasis (in human femaleMale sex hormone produces superfluous) be feature, main clinical manifestation is irregular, infertile, crinosity of menstrual cycle and/or acne, isCommon female incretion disease.
Modern medicine thinks that the endocrinosity of the proliferation of mammary gland and ovary is closely related. Mammary gland is the target organ of sex hormone function,Being not only the most significant secondary sex characters of women, is also a part in broad sense reproductive system, its Hypothalamus-pituitary-Under the comprehensive function of hypothalamic pituitary ovarium axis and other endocrine hormones, occur progressively to grow from embryo, propagation replaces with restoration of old ways, finally moves backThe variation of the series of complex of changing. The physiological change of mammary gland is consistent with Menstrual cycle.
The traditional Chinese medical science thinks, the proliferation of mammary gland belongs to the traditional Chinese medical science " newborn addiction " category. How not smooth by feelings will, eating and drinking without temperance, overstrain internal injury causes punchingAppoint imbalance, stagnation of liver qi, the phlegm blood coagulation stasis of blood are sent out as this disease. Traditional Chinese medicine thinks that Stein-Leventhal syndrome belongs to " delayed menstrual cycle ", " closesThrough ", the category such as " infertile ". The traditional Chinese medical science thinks that wantonly two arteries and veins of punching arise from uterus, is all under the jurisdiction of kidney, behavior breast on its qi and blood, underBehavior warp, breast and uterus are maintained and are connected by wantonly two arteries and veins of punching, closely bound up on physiology, on pathology, influence each other.
The therapeutic purposes of cyclomastopathy will be removed pain on the one hand, are softening tubercle and elimination lump on the other hand. Treatment sideMethod has:
Hormone therapy: bromocriptine, the mechanism of action has the effect of blocking-up prolactin, but its side effect is large; DANAZOL, for anti-shortGonadal hormone medicine, blocks estrogenic generation, and side effect is easily to cause hypomenorrhea; TAM: antiestrogenSide effect is also easily to cause paramenia, and these Western medicine can be treated the proliferation of mammary gland, but Stein-Leventhal syndrome is not acted on.And having two kinds of medicine treatment and operative treatments for the treatment of PCOS, medicine treatment only limits to symptomatic treatment, as clomiphene is urgedOvulation treatment, female-progestational hormone alternative medicine, Diane 35 treatment excessive androgen mass formed by blood stasis, oral administration of metformin support to improve insulinAnti-state etc. And the illness rate of cyclomastopathy is higher in clomiphene decorporation treatment patient, patient's menstrual disorder and use classEstrogenic situation and cyclomastopathy are proportionate, and the medicine of these treatment Stein-Leventhal syndromes but can increase the weight of mammary gland and increaseRaw. Therefore merge the patient of the proliferation of mammary gland for Stein-Leventhal syndrome, Chinese traditional treatment be first-selection, and not yet have at present forThe medicine that Stein-Leventhal syndrome merges the proliferation of mammary gland emerges. This illness of Chinese traditional treatment has the advantage of multisystem conditioning. Therefore,The Chinese herbal compounds that a kind for the treatment of women polycystic ovary syndrome with better curative effect merges the proliferation of mammary gland need to be proposed.
Summary of the invention
Inventor is good at modern medical theory to combine with traditional medical theory, dialectically combines with the differentiation of disease, for polycystic ovarySyndrome merges the etiology and pathogenesis of the proliferation of mammary gland, based on clinical treatment experience for many years, learns wildly from other's strong points, and hammer away, in order to overcomeThe deficiencies in the prior art, the invention provides one can effectively treat Stein-Leventhal syndrome merge the proliferation of mammary gland and instant effect,Short treating period, the pharmaceutical composition that cure rate is high.
For realizing object of the present invention, existing according to following technical scheme:
Treat Stein-Leventhal syndrome and merge the pharmaceutical composition of the proliferation of mammary gland, its by beechey fig leaf, Radix Caulophylli, the fruit of glossy privet,The fruit of Chinese wolfberry, Morinda officinalis, the bark of official magnolia, turmeric, rhizoma cyperi, edible tulip, fiveleaf akebia fruit, loosestrife, reticulate millettia are that medicinal raw material is according to oneFixed weight portion proportioning elaborate.
Further preferably, a kind of pharmaceutical composition for the treatment of the Stein-Leventhal syndrome proliferation of mammary gland, is characterized in that by weighing belowThe medicinal raw material elaborate of amount part proportioning: beechey fig leaf 30-36 part, Radix Caulophylli 13-18 part, fruit of glossy privet 10-15 part, fruit of Chinese wolfberry 20-25Part, Morinda officinalis 7-12 part, bark of official magnolia 6-10 part, turmeric 4-6 part, rhizoma cyperi 8-13 part, edible tulip 15-20 part, fiveleaf akebia fruit 8-13 part,Loosestrife 10-15 part, reticulate millettia 10-15 part.
Further preferably, a kind of pharmaceutical composition for the treatment of the Stein-Leventhal syndrome proliferation of mammary gland, is characterized in that by weighing belowThe medicinal raw material elaborate of amount part proportioning: 35 parts of beechey fig leafs, 15 parts of Radix Caulophyllis, 10 parts of the fruit of glossy privets, 25 parts of the fruits of Chinese wolfberry, Ba JiThey 9 parts, 8 parts of the barks of official magnolia, 5 parts, turmeric, 12 parts of rhizoma cyperis, 16 parts of edible tulips, 10 parts of fiveleaf akebia fruits, 10 parts of loosestrives, reticulate millettia 15Part.
Inventor sums up and thinks: liver is lost bar and reaches, and QI-blood circulation is not smooth, and strongly fragrant in the heart, stagnation of QI and blood may bring about pain, is shown in swollen breasts, chestSide of body hardship is full etc.; Or the promotion of suffering from a deficiency of the kidney is unable, the stagnation of the circulation of vital energy is blood stasis, and not promoting circulation of blood of gas stops in extravasated blood, menalgia, and blockage of menstruation,The few look of amount is dark, has little clot; Tie in newborn network, occur lump in breast; Or asthenia of renal yang, spleen sun loses in warm, can not transporting waterWet and raw phlegm, or kidney qi do not fill, menses late extremely, appoint to lose and support by punching, and conception vessel is obstructed, can not moisten foster breast, uterus, causes this disease.Controlling should be promoting blood circulation and removing blood stasis, and regulating qi-flowing for activating stagnancy is adjusted liver kidney tonifying, and actual situation is taken into account. Therefore in side: the sweet light temperature tonifying middle-Jiao and Qi of beechey fig leaf, invigorating the spleenWet, strengthen muscles and bones, activating blood circulation and reducing swelling, removing toxic substances; The arduous temperature of Radix Caulophylli, promoting blood circulation to remove blood stasis, dispels rheumatism, promoting qi circulation and relieving pain, two medicines 5With the promoting flow of qi and blood circulation, loose stagnation resolvation is stagnant is monarch drug in a prescription. Fruit of glossy privet sweetness and bitterness is cool, replenishing vital essence to strengthen the kidney, and the tonifying Qi liver of relaxing, stimulates the menstrual flow and blood; The fruit of Chinese wolfberry is sweetProfit and nourishing liver and kidney kidney-KIN being deficient, tired interior heat; Morinda officinalis Xin Ganwen, subsidy Yuanyang, strengthens muscles and bones, dispels rheumatism, three medicines5 use liver-kidney tonifyings, coordinating yin and yang balance, is ministerial drug. Turmeric is broken blood gas, inducing meastruation to relieve menalgia; Loosestrife clearing heat and promoting diuresis, invigorates blood circulationThe loose stasis of blood, removing toxicity for eliminating carbuncles; Fiveleaf akebia fruit soothing liver and harmonizing stomach, promoting blood circulation and stopping pain, softening and resolving hard mass; Edible tulip is clearing heat and detoxicating, reducing phlegm and resolving masses; ThickPiao Hangqi disappears long-pending, and eliminating dampness is except full; Reticulate millettia is enriched blood and invigorates blood circulation; Rhizoma cyperi is fragrant and can alter, and how pungent its taste is can fall apart, and micro-hardship can be fallen, micro-sweetCan and, Nai Qibingzhi Directorate-General DG, the chief commander of female section, the regulation of qi and blood, is adjuvant. All medicines close 5, play altogether regulating qi-flowing for activating stagnancy, invigorate blood circulationStagnation resolvation, blood yiqi, softening and resolving hard mass, the effect of invigorating kidney for regulating menstruation.
The present Research of the related medicinal material of Chinese medicine of the present invention is as follows:
Beechey fig leaf: [nature and flavor] are sweet; Light; Warm in nature. [return through] lung; Spleen; Kidney channel. [function cures mainly] bowl spares invigorating the spleen; Dispel the windWet; Promoting blood circulation and removing obstruction in channels. The main deficiency of vital energy is weak; Four limbs are aching and limp; Arthralgia due to wind-dampness; Stiffness of muscle and joint; Traumatic injury; Through closing; Alactation.[usage and dosage] is for oral administration: decoct soup, 30-60g.
Radix Caulophylli: [nature and flavor] are pungent; Bitter; Warm in nature. [return through] liver; Stomach warp. [function cures mainly] promoting blood circulation to remove blood stasis; Dispel rheumatism;Promoting qi circulation and relieving pain. Main irregular menstruation; Dysmenorrhoea; Postpartum abdominal pain due to blood stasis; The cold pain of gastral cavity abdomen; Traumatic injury, arthralgia due to wind-dampness. [usage and dosage]For oral administration: to decoct soup, 3-15g; Or infusing drugs in wine; Or grind into powder.
The bark of official magnolia: [nature and flavor] hardship; Pungent; Warm in nature. [return through] spleen; Stomach; Large intestine channel. [function cures mainly] promoting the circulation of qi disappears long-pending;Eliminating dampness is except full; Relieving asthma. Main stagnation of QI due to dyspepsia; Abdominal distention constipation; Damp retention in middle-jiao, gastral cavity ruffian is vomited and diarrhoea; Phlegm is stopped up the circulation of vital energy in the wrong direction; Fullness sensation in chest is breathed heavilyCough. [usage and dosage] is for oral administration: decoct soup, 3-10g; Or enter ball, loose.
Turmeric: [nature and flavor] are pungent, bitter, temperature. [return through] returns spleen, Liver Channel. [function cures mainly] breaks blood gas, only stimulates the menstrual flowBitterly. Twinge amenorrhoea ， wei lump in the abdomen, rheumatism shoulder arm pain, tumbling and swelling for the chest side of body. " Japan hanako materia medica ": " control abdominal mass bloodPiece, carbuncle is swollen, and logical menstruation, controls to fall and flutters hemostasis, detumescence poison; Only storm wind pain cold air, lower food. "
Rhizoma cyperi: [nature and flavor] pungent, micro-hardship, micro-sweet, flat. [return through] returns liver, spleen, tri-jiao channel. [function cures mainly] promoting the circulation of qiXie Yu, menstruction regulating and pain relieving. For stagnation of QI due to depression of the liver, chest, the side of body, abdominal distention, indigestion, chest gastral cavity ruffian is vexed, cold hernia stomachache,Swollen breasts, irregular menstruation, through closing dysmenorrhoea. [usage and dosage] 6～9g.
Edible tulip: [nature and flavor] are sweet, micro-pungent, cool. [return through] liver, the spleen channel. [function cures mainly] is clearing heat and detoxicating, reducing phlegm and resolving masses.For the swollen serious case of furuncle of carbuncle, scrofula subcutaneous nodule, scrofula, snake bite and insect sting.
Fiveleaf akebia fruit: [nature and flavor] micro-hardship, flat. [return through] liver, stomach warp. [function cures mainly] soothing liver and harmonizing stomach, promoting blood circulation and stopping pain,Softening and resolving hard mass, diuresis. Main stagnation of liver-QI and stomach-QI, wrist abdomen, the side of body help distending pain, and diet does not disappear, and diarrhea just rushes down, hernia pain, pain in the back,Through closing dysmenorrhoea, goiter and tumor scrofula, malignant tumour.
Loosestrife: [nature and flavor] are bitter, pungent, property is flat. [return through] liver, the spleen channel. [function cures mainly] clearing heat and promoting diuresis, Huoxue San "The stasis of blood, removing toxicity for eliminating carbuncles. Main oedema; Heat is drenched; Jaundice; Dysentery; Rheumatic fever numbness; Under band; Through closing; Fall and beat; Fracture; WoundHemorrhage; Acute mastitis; Furunculosis; Snake bite. [usage and dosage] is for oral administration: decoct soup, 15-30g; Or steep in wine; Or fresh goods is smash juice.External application: appropriate, decoct washing; Or fresh goods is smash deposited.
The fruit of glossy privet: [nature and flavor] sweet, bitter, cold. [return through] returns liver, kidney channel. [function cures mainly] is nourishing liver and kidney, and crow sends out in improving eyesight.For dizzy tinnitus, soreness and weakness of waist and knees, poliosis, order is secretly not clear.
The fruit of Chinese wolfberry: [nature and flavor] are sweet is flat. [return through] returns liver, kidney channel. [function cures mainly] is nourishing liver and kidney, benefiting shrewd head. Be used forConsumptive disease essence is lost, soreness of waist and knee joint, and dizzy tinnitus, interior heat is quenched one's thirst, and the deficiency of blood is sallow, and blurred vision is not clear.
Morinda officinalis: [nature and flavor] Xin Gan; Temperature. [return through] liver; Kidney channel. [function cures mainly] tonifies the kidney and support yang; Strengthen muscles and bones;Dispel rheumatism. Main impotence due to deficiency of the kidney; Seminal emission premature ejaculation; Few abdomen crymodynia; Urinary incontinence; Palace is cold infertile; Wind-cold-dampness arthralgia; The acid of waist kneeSoft; Rheumatism limb gas.
Reticulate millettia: [nature and flavor] are bitter, sweet, temperature. [return through] returns liver, kidney channel. [function cures mainly] enriches blood, invigorate blood circulation, and dredging collateral.For irregular menstruation, the deficiency of blood is sallow, paralysis and numbness, arthralgia due to wind-dampness. [usage and dosage] 9～15g.
In order to express better pharmaceutical composition of the present invention, pharmaceutical composition of the present invention be by beechey fig leaf, Radix Caulophylli, the fruit of glossy privet,The fruit of Chinese wolfberry, Morinda officinalis, the bark of official magnolia, turmeric, rhizoma cyperi, edible tulip, fiveleaf akebia fruit, loosestrife, reticulate millettia or its water or it is organic moltenAgent extract is active component, can add medicine acceptable carrier, makes according to galenic pharmacy routine techniques.
Pharmaceutical composition of the present invention can be any pharmaceutically useful formulation, and these formulations comprise: tablet, sugar coated tablet, filmGarment piece agent, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, suck agent, granule, electuary, ballAgent, powder, paste, sublimed preparation, supensoid agent, pulvis, solution, injection, suppository, ointment, emplastrum, creme,Spray, drops, patch.
Preferably peroral dosage form of pharmaceutical composition described above, as: soft capsule, capsule, tablet, oral liquid,Granula, pill, powder, sublimed preparation, paste; More preferably tablet, capsule or granule; Most preferably be capsule.
Pharmaceutical composition of the present invention optionally adds applicable medicine acceptable carrier in the time being prepared into medicament, described inMedicine acceptable carrier is selected from and can be filler, adhesive, disintegrant, lubricant, diluent, the central one of flavor enhancementOr several, as: filler, the optional starch of diluent, Icing Sugar, dextrin, microcrystalline cellulose, lactose, pregelatinized starch, sweetReveal alcohol etc.; Selectable adhesive has sodium carboxymethylcellulose, PVP-K30, hydroxypropyl cellulose, starch slurry, methyl fiberElement, ethyl cellulose, Hydroxypropyl methylcellulose, gelling starch etc.; Selectable disintegrant has dried starch, PVPP, friendshipConnection sodium carboxymethylcellulose, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose etc.; Selectable lubricant has; Dolomol,Talcum powder, lauryl sodium sulfate, superfine silica gel powder etc.; Flavor enhancement is as sweetener, Aspartame etc.
The present invention also provides a kind of preparation method of pharmaceutical composition described above. The present inventor finds under study for action,By optimizing preparation method, can be in the situation that remaining valid medicine, remove impurity or the part without drug effect, reduce impurityTo the interference of result for the treatment of, make this Chinese medicine preparation more effective.
The preparation method of a kind of pharmaceutical composition for the treatment of the Stein-Leventhal syndrome proliferation of mammary gland provided by the invention comprises following stepRapid:
By prescription get beechey fig leaf, Radix Caulophylli, the fruit of glossy privet, the fruit of Chinese wolfberry, Morinda officinalis, the bark of official magnolia, turmeric, rhizoma cyperi, edible tulip,Fiveleaf akebia fruit, loosestrife, reticulate millettia, the water extraction that adds 4～7 times of medicinal material gross weights is got 2-3 time, and each 1～2 hour, merging was carriedGet liquid, filter, being evaporated to relative density is 1.05-1.10 (60 DEG C record), adds ethanol and makes to reach 40% (body containing alcohol amountLong-pending than), stir, hold over night, filters, filtrate decompression concentration and recovery ethanol, is condensed into thick paste, this thick paste separately and/orBe mixed into active component with medicine acceptable carrier, make according to galenic pharmacy routine techniques.
The present invention is inventor through research repeatedly, progressively improves, and last successful a kind of curative effect is treated polycystic ovary preferablyThe medicine of the syndrome proliferation of mammary gland, the patient that the present invention takes this medicine to 51 examples has carried out clinical observation, has obtained preferablyCurative effect, details are as follows:
1 data and method
1.1 physical data: observing go to a doctor year February in March, 2014 to 2015 in my institute's TCM Gynecology outpatient service be diagnosed as polycystic ovary combineSimulator sickness suffers from patient's 102 examples of cyclomastopathy simultaneously, is divided into observation group at random and control group is observed, every group of 51 examples. SeeExamine group age 22-36 year, 27.5 ± 3.6 years old mean age, the course of disease is the longest 1.3 years, the shortest 3 months, average 0.75 ± 0.53 year. RightAccording to group age 22-37 year, average 27.9 ± 3.5 years old; The course of disease is the longest 1.2 years, the shortest 3 months, average 0.86 ± 0.51 year. Two group oneAs relatively no difference of science of statistics (P > 0.05) of data, there is comparativity.
1.2 diagnostic criteria:
1.2.1PCOS diagnostic criteria: with reference to European human reproduction association (ESHRE) and reproductive medicine association of the U.S. (ASRM)The standard of formulating in Rotterdam's seminar in 2003: meet any 2 in following 3: (l) long-term without ovulation; (2)Clinical (as crinosity, acne) and (or) biochemical foundation that androgen levels raises; (3) ovary increases, one ovary volume > 10mlOr under ultrasonic, have the little ovarian follicle of diameter 2～9mm at least > 12. Except above 3, the hero that should get rid of due to other diseases swashsElement increase disease.
1.2.2 cyclomastopathy the diagnostic criteria: " traditional Chinese medical science disease diagnosis curative effect of promulgating for 1994 by State Administration of Traditional Chinese MedicineStandard " in the diagnosis basis of " newborn addiction ":
(1) most have a flat lump at the outside upper quadrant of breast, button have a big or small tough hard tubercle of beans, can have tenderness. Lump limitBoundary owes clearly, with surrounding tissue adhesion;
(2) breast can have distending pain, the anger of often joining in charitable and pious deeds and growth and decline, and month premenstrual the increasing the weight of of being everlasting, alleviates after menstruation;
(3) this disease is more common in 20-40 year women;
(4) mammography breast is taken the photograph the inspections such as sheet, cold light source strong illumination, liquid crystal thermography picture and is helped diagnosis. Organize if desiredPathological examination.
Curative effect with reference to the 8th the relevant newborn addiction that meeting is passed through of Chinese Surgery of Chinese Medicine meeting mastosis Professional Committee in 2002 is commentedValency normative reference, formulate clinical manifestation score:
Breast pain: 0 grade (6 points) are without pain; 1 grade (12 points) are for pressing pain without spontaneous pain; 2 grades (18 points) are for spontaneous painParoxysmal; 3 grades (24 points) are continuation but do not affect life for spontaneous pain; 4 grades (30 points) are seriously continuation and shadow for painRing life;
Lump in breast hardness: 1 grade of (3 points) matter is soft as normal body of gland, and 2 grades of (6 points) matter are tough as nose; 3 grades of (9 points) matter are hard as volume;
Lump scope: 1 grade of (3 points) distribution is confined to 1-2 breast quadrant; 2 grades of (6 points) distributions reach 3-4 breastRoom quadrant; 3 grades of (9 points) distributions reach 5-6 breast quadrant; 4 grades of (12 points) distributions reach 7-8 breast quadrant;
The maximum lump diameter of breast: l level (3 points) is the following lump of 2.0cm; 2 grades (6 points) are 2.1～5cm lump; 3 grade (9Point) be the above lump of 5cm.
1.2.3 Syndrome Differentiation of Traditional Chinese Medicine standard: " the dialectical specification of tcm syndrome " of editing with reference to cold Fang Nan and Li Xiangyun chief editor's is " realBy gynaecology's traditional Chinese and western medicine diagnoses and treatment " middle related content formulation, the direct observational method of employing clinical case, to dissimilarPCOS classifies with cyclomastopathy patient's tcm syndrome, syndrome of qi stagnation and blood stasis type: delay through the cycle, and many or few through measuring,Drench drop menstrual period unclean, look dark red, and matter is thick or have clot, gradually to amenorrhoea; Companion's swollen breasts, lower abdominal distention pain tenderness, the chest side of body is swollenBitterly; Tongue is dim red or have petechia, tongue thin, arteries and veins string
1.3 enter group and exclusion standard
1.3.1 enter group standard: the diagnostic criteria that meets above-mentioned Stein-Leventhal syndrome and cyclomastopathy; Age 18-38 year itBetween women; Taking mammary gland symptom as main, not concurrent whole body serious symptoms, the medical medicine of not taking for first 1 month about the treatment proliferation of mammary glandThing; Informed consent is also ready partner treatment person.
1.3.2 Excluded cases standard: the women in gestation, lactation or climacteric; Be associated with tumor of breast, mammary gland fibroma, breastOther benign lesions such as adenositis; There is the serious primary disease such as cardiovascular, liver, kidney and hemopoietic system; Mental patient; Nearly 3Within individual month, use hormonal medicaments; Allergic constitution; Meet inclusive criteria, not medication in accordance with regulations; Participating in other drug clinical testingPerson; Cannot judge that curative effect or data are not congruent affects the treatment or security judgement person.
1.4 methods of treatments:
Treatment group: capsule prepared by the oral embodiment of the present invention 1, every day 2 times, each 2-4 grain, takes after meal half an hour. OneMenstrual cycle is a course for the treatment of, meets and subtracts clothes menstrual period or withdraw, and treats altogether 3 courses for the treatment of.
Control group: oral rupixiao tablets, rupixiao pian, every day 3 times, each 6, a menstrual cycle is a course for the treatment of, meets and subtracts clothes menstrual period or stopClothes, treat 3 courses for the treatment of altogether.
1.5 observation index:
1.5.1 select the lump of a maximum as target lump, observe treatment before, treatment 3 all after date situations.
1.5.2 observe the menstruation improvement situation of patient before treatment, after 3 cycles for the treatment of, measure ovarian size and many capsules situation (ovumNest volume=0.523* major diameter * anteroposterior diameter * transverse diameter, bilateral ovaries average external volume=0.5* left and right Ovarian Volume sum ovarian follicle total number is got coloured silkThe Follicle number sum of the each tangent plane of bilateral ovaries that the ovarian follicle of super lower diameter 2-9mm is maximum).
1.5.3 observe before treatment, the 3rd cycle patient's tcm symptom scoring situation after 3 all after dates for the treatment of and drug withdrawal.
1.5.4 detect liver function level, to observe the toxicity situation of two groups.
1.6 curative effect evaluation standards: with reference to Ministry of Health of the People's Republic of China's " new Chinese medicine guideline of clinical investigations " and " inCure the desease card Standardization of diagnosis and curative effect " in criterion of therapeutical effect judge: recovery from illness: menstruation recovery is normal, and clinical symptoms obviously alleviate,B ultrasonic prompting ovary recovers normal size; N > 90%; Effective: menstruation approaches normal cycle, clinical symptoms obviously alleviate, B ultrasonicPrompting ovary approaches normal size, 90% > n >=66.67%; Effective: the rear menstrual cycle for the treatment of is irregular, and clinical symptoms to some extentAlleviate, B ultrasonic prompting ovary dwindles before treating to some extent, 66.67% > n >=33.33%; Invalid: treat the rear menstrual cycle without change,Clinical symptoms are not improved, and ultrasound diagnosis is not improved, n < 33.33%. Total effective rate=(recovery from illness+effective+effectively)/Total case load X100%; Therapeutic index (n)=(the rear integration of integration-treatment before treating)/integration X100% before treating.
1.7 statistical methods: adopt SPSS15.0 statistical software to calculate. Each numerical value withRepresent measurement dataAdopt t inspection, enumeration data adopts χ2Inspection, has statistical significance taking P < 0.05 as difference.
2 results
2.1 liang of group patient curative effects comparison: all patients all complete clinical testing, without coming off. Treatment group 21 examples of fully recovering after treatment,Effective 19 examples, effective 9 examples, invalid 2 examples, total effective rate 96.1%; Control group 8 examples of fully recovering, effective 14 examples, effectively18 examples, invalid 11 examples, total effective rate 78.4%, treatment group and the comparison of control group total effective rate, difference has statistical significance (P< 0.05), illustrate that treatment group can significantly improve compared with control group clinical the having that Stein-Leventhal syndrome merges proliferation of mammary gland patientEfficiency. In table 1.
Table 1 liang group patient curative effect comparison, example
Note: with control group comparison, * P < 0.05.
Proliferation of mammary gland sign comparisons before and after 2.2 liang of group treatments: after treatment, two groups of pain are obviously alleviated, lump in breast gradually deliquescing andDiminish gradually, before and after inspection treatment, pain situation and lump quality size have significant difference (P < 0.01), have statistics meaningJustice; After treatment, between two groups, compare, treatment group pain relief situation and lump size variation situation are better than control group difference statisticsMeaning (P < 0.05), but lump quality situation of change and control group comparison, difference not statistically significant (P > 0.05). In table 2.Visible, treatment group, compared with the significantly breast pain situation of reduction of patient of control group, reduces lump in breast.
Proliferation of mammary gland sign comparison before and after table 2 liang group treatment
Note: relatively front with treatment, * P < 0.05, * * P < 0.01; With the control group comparison same period,#P＜0.05。
Bilateral ovaries volume and the comparison of ovarian follicle total number before and after 2.3 liang of group treatments: before two groups of treatments the average external volume of bilateral ovaries andThe comparison of ovarian follicle total number, difference does not have statistical significance (P > 0.05), has comparativity; Bilateral ovaries after treatment group treatmentAverage external volume all have reduce, ovarian follicle total number all has minimizing, and before and after treatment, difference all has statistical significance (P < 0.05).Difference not statistically significant (P > 0.05) before and after treatment of control group. In table 3. Visible, treatment group can be obvious compared with control groupReduce patient's bilateral ovaries average external volume all, reduce ovarian follicle total number, and control group acts on without this.
Bilateral ovaries volume and the comparison of ovarian follicle total number before and after table 3 liang group treatment
Note: relatively front with treatment, * P < 0.05, with the control group comparison same period,#P＜0.05。
2.4 liang of group side reaction comparisons: all do not tell discomfort for two groups, two groups of comparing difference not statistically significants, two groups of equal well-tolerated.
In a word: treatment group of the present invention and the comparison of control group total effective rate, difference has statistical significance (P < 0.05), and the present invention controlsTreatment group total effective rate is higher; After treatment medicine of the present invention, patient's pain is obviously alleviated, and lump in breast is deliquescing and change gradually graduallyLittle, before and after inspection treatment, pain situation and lump quality size have significant difference (P < 0.05), have statistical significance; ControlTreatment group pain relief situation and lump size variation situation are better than control group, and difference has statistical significance (P < 0.05); Treatment groupAfter treatment bilateral ovaries average external volume all have reduce, ovarian follicle total number all has minimizing, and before and after treatment, difference all has statisticsMeaning (P < 0.05). Difference not statistically significant (P > 0.05) before and after treatment of control group. Visible medicine treatment of the present invention is manyIt is with the obvious advantage that capsule Ovary Syndrome merges the proliferation of mammary gland, has unexpected technique effect, because the present invention also asks protectionThe use of aforementioned pharmaceutical compositions in the medicine of the preparation treatment Stein-Leventhal syndrome merging proliferation of mammary gland especially qi stagnation and blood stasis typeWay and the aforementioned pharmaceutical compositions purposes in the medicine of the preparation treatment proliferation of mammary gland.
The present invention relatively and prior art, has following clear superiority: first, pharmaceutical composition prescription of the present invention is mainly according to manyThe pathogenic characteristic that capsule Ovary Syndrome merges the proliferation of mammary gland develops, and full side plays regulating qi-flowing for activating stagnancy altogether, promoting blood circulation and removing blood stasis, blood yiqi,Softening and resolving hard mass, the effect of invigorating kidney for regulating menstruation, especially qi stagnation and blood stasis type Stein-Leventhal syndrome being merged to the proliferation of mammary gland has extremely strong specific aimCurative effect, has the incomparable effect of Western medicine.
Prescription of the present invention is simplified, and dialectically combines with the differentiation of disease, and compatibility is reasonable, with low cost, through clinical practice checking, its curative effectDefinitely, the property of medicine is gentle, does not occur toxic and side effect and obvious adverse reaction, and safety coefficient is high.
Detailed description of the invention
Further describe the present invention by specific embodiment below, the present invention is not limited only to following examples. At model of the present inventionEnclose interior or not departing from content of the present invention, spirit and scope, change, combination or replacement that the present invention is carried out, forThose skilled in the art is apparent, and is included within the scope of the present invention.
Embodiment 1 capsule
Prescription: 35 parts of beechey fig leafs, 15 parts of Radix Caulophyllis, 10 parts of the fruit of glossy privets, 25 parts of the fruits of Chinese wolfberry, 9 parts of Morinda officinalis, 8 parts of the barks of official magnolia, ginger5 parts of Huangs, 12 parts of rhizoma cyperis, 16 parts of edible tulips, 10 parts of fiveleaf akebia fruits, 10 parts of loosestrives, 15 parts of reticulate millettias.
Preparation method: by prescription get beechey fig leaf, Radix Caulophylli, the fruit of glossy privet, the fruit of Chinese wolfberry, Morinda officinalis, the bark of official magnolia, turmeric, rhizoma cyperi,Edible tulip, fiveleaf akebia fruit, loosestrife, reticulate millettia, the water extraction that adds 4～7 times of medicinal material gross weights is got 2-3 time, and each 1～2 hour,Merge extract, filter, being evaporated to relative density is 1.05-1.10 (60 DEG C record), adds ethanol and makes to reach 40% containing alcohol amount(volume ratio), stirs, and hold over night is filtered, and filtrate decompression concentration and recovery ethanol, is condensed into thick paste, according to galenic pharmacyRoutine techniques is made.
Every of the present embodiment capsule contains crude drug 0.85g.
Embodiment 2 capsules
Prescription: 30 parts of beechey fig leafs, 15 parts of Radix Caulophyllis, 15 parts of the fruit of glossy privets, 20 parts of the fruits of Chinese wolfberry, 8 parts of Morinda officinalis, 6 parts of the barks of official magnolia, ginger4 parts of Huangs, 10 parts of rhizoma cyperis, 15 parts of edible tulips, 12 parts of fiveleaf akebia fruits, 12 parts of loosestrives, 10 parts of reticulate millettias.
Preparation method: carry out with reference to embodiment 1.
Embodiment 3 capsules
Prescription: 30 parts of beechey fig leafs, 13 parts of Radix Caulophyllis, 12 parts of the fruit of glossy privets, 24 parts of the fruits of Chinese wolfberry, 12 parts of Morinda officinalis, 10 parts of the barks of official magnolia,4 parts, turmeric, 10 parts of rhizoma cyperis, 18 parts of edible tulips, 8 parts of fiveleaf akebia fruits, 12 parts of loosestrives, 15 parts of reticulate millettias.
Preparation method: carry out with reference to embodiment 1.
Embodiment 4 capsules
Prescription: 33 parts of beechey fig leafs, 13 parts of Radix Caulophyllis, 15 parts of the fruit of glossy privets, 20 parts of the fruits of Chinese wolfberry, 10 parts of Morinda officinalis, 10 parts of the barks of official magnolia,6 parts, turmeric, 8 parts of rhizoma cyperis, 15 parts of edible tulips, 12 parts of fiveleaf akebia fruits, 12 parts of loosestrives, 12 parts of reticulate millettias.
Preparation method: carry out with reference to embodiment 1.
Embodiment 5 capsules
Prescription: 35 parts of beechey fig leafs, 15 parts of Radix Caulophyllis, 15 parts of the fruit of glossy privets, 25 parts of the fruits of Chinese wolfberry, 12 parts of Morinda officinalis, 6 parts of the barks of official magnolia, ginger6 parts of Huangs, 10 parts of rhizoma cyperis, 15 parts of edible tulips, 12 parts of fiveleaf akebia fruits, 10 parts of loosestrives, 10 parts of reticulate millettias.
Preparation method: carry out with reference to embodiment 1.
Embodiment 6 capsules
Prescription: 30 parts of beechey fig leafs, 18 parts of Radix Caulophyllis, 15 parts of the fruit of glossy privets, 25 parts of the fruits of Chinese wolfberry, 8 parts of Morinda officinalis, 9 parts of the barks of official magnolia, ginger4 parts of Huangs, 10 parts of rhizoma cyperis, 20 parts of edible tulips, 10 parts of fiveleaf akebia fruits, 12 parts of loosestrives, 15 parts of reticulate millettias.
Preparation method: carry out with reference to embodiment 1.
Embodiment 7 tablets
Prescription: 35 parts of beechey fig leafs, 13 parts of Radix Caulophyllis, 12 parts of the fruit of glossy privets, 23 parts of the fruits of Chinese wolfberry, 9 parts of Morinda officinalis, 8 parts of the barks of official magnolia, ginger5 parts of Huangs, 10 parts of rhizoma cyperis, 18 parts of edible tulips, 10 parts of fiveleaf akebia fruits, 10 parts of loosestrives, 15 parts of reticulate millettias.
Preparation method: by prescription get beechey fig leaf, Radix Caulophylli, the fruit of glossy privet, the fruit of Chinese wolfberry, Morinda officinalis, the bark of official magnolia, turmeric, rhizoma cyperi,Edible tulip, fiveleaf akebia fruit, loosestrife, reticulate millettia, the water extraction that adds 4～7 times of medicinal material gross weights is got 2-3 time, and each 1～2 hour,Merge extract, filter, being evaporated to relative density is 1.05-1.10 (60 DEG C record), adds ethanol and makes to reach 40% containing alcohol amount(volume ratio), stirs, and hold over night is filtered, and filtrate decompression concentration and recovery ethanol, is condensed into thick paste, according to galenic pharmacyRoutine techniques is made.
Every, the present embodiment tablet contains crude drug 0.7g.
Embodiment 8 granules
Prescription: 30 parts of beechey fig leafs, 15 parts of Radix Caulophyllis, 12 parts of the fruit of glossy privets, 20 parts of the fruits of Chinese wolfberry, 12 parts of Morinda officinalis, 8 parts of the barks of official magnolia, ginger4 parts of Huangs, 8 parts of rhizoma cyperis, 18 parts of edible tulips, 8 parts of fiveleaf akebia fruits, 10 parts of loosestrives, 12 parts of reticulate millettias.
Preparation method: by prescription get beechey fig leaf, Radix Caulophylli, the fruit of glossy privet, the fruit of Chinese wolfberry, Morinda officinalis, the bark of official magnolia, turmeric, rhizoma cyperi,Edible tulip, fiveleaf akebia fruit, loosestrife, reticulate millettia, the water extraction that adds 4～7 times of medicinal material gross weights is got 2-3 time, and each 1～2 hour,Merge extract, filter, being evaporated to relative density is 1.05-1.10 (60 DEG C record), adds ethanol and makes to reach 40% containing alcohol amount(volume ratio), stirs, and hold over night is filtered, and filtrate decompression concentration and recovery ethanol, is condensed into thick paste, according to galenic pharmacyRoutine techniques is made.
Every bag of the present embodiment granule contains crude drug 2.5g.
Claims (9)
1. treat Stein-Leventhal syndrome and merge the pharmaceutical composition of the proliferation of mammary gland, it is characterized in that by beechey fig leaf, Radix Caulophylli,The fruit of glossy privet, the fruit of Chinese wolfberry, Morinda officinalis, the bark of official magnolia, turmeric, rhizoma cyperi, edible tulip, fiveleaf akebia fruit, loosestrife, reticulate millettia are medicinal formerMaterial is made according to certain weight portion proportioning.
2. pharmaceutical composition as claimed in claim 1, is characterized in that being made up of the medicinal raw material of following weight portion proportioning: oxMilk bavin 30-36 part, Radix Caulophylli 13-18 part, fruit of glossy privet 10-15 part, fruit of Chinese wolfberry 20-25 part, Morinda officinalis 7-12 part, bark of official magnolia 6-10 part,Turmeric 4-6 part, rhizoma cyperi 8-13 part, edible tulip 15-20 part, fiveleaf akebia fruit 8-13 part, loosestrife 10-15 part, reticulate millettia 10-15 part.
3. pharmaceutical composition as claimed in claim 2, is characterized in that being made up of the medicinal raw material of following weight portion proportioning: ox35 parts of milk bavins, 15 parts of Radix Caulophyllis, 10 parts of the fruit of glossy privets, 25 parts of the fruits of Chinese wolfberry, 9 parts of Morinda officinalis, 8 parts of the barks of official magnolia, 5 parts, turmeric, rhizoma cyperi 12Part, 16 parts of edible tulips, 10 parts of fiveleaf akebia fruits, 10 parts of loosestrives, 15 parts of reticulate millettias.
4. the pharmaceutical composition as described in as arbitrary in claim 1-3, is characterized in that described pharmaceutical composition is preferably made for oral agentsType, as: soft capsule, capsule, tablet, oral liquid, granule, pill, powder, sublimed preparation, paste.
5. pharmaceutical composition as claimed in claim 4, it is characterized in that described peroral dosage form be preferably tablet, capsule orGranula.
6. pharmaceutical composition as claimed in claim 5, is characterized in that described peroral dosage form is preferably capsule.
7. the pharmaceutical composition as described in as arbitrary in claim 1-3, is characterized in that preparation method comprises the following steps: by placeSide get beechey fig leaf, Radix Caulophylli, the fruit of glossy privet, the fruit of Chinese wolfberry, Morinda officinalis, the bark of official magnolia, turmeric, rhizoma cyperi, edible tulip, fiveleaf akebia fruit,Loosestrife, reticulate millettia, the water extraction that adds 4～7 times of medicinal material gross weights is got 2-3 time, each 1～2 hour, merges extract, mistakeFilter, being evaporated to relative density is 1.05-1.10 (60 DEG C record), add ethanol and make to reach 40% (volume ratio) containing alcohol amount,Stir, hold over night, filters, and filtrate decompression concentration and recovery ethanol, is condensed into thick paste, this thick paste separately and/or with medicine canThe carrier of accepting is mixed into active component, makes according to galenic pharmacy routine techniques.
8. the pharmaceutical composition as described in as arbitrary in claim 1-3 merges the proliferation of mammary gland at preparation treatment Stein-Leventhal syndromePurposes in medicine.
9. the pharmaceutical composition as described in as arbitrary in claim 1-3 merges at preparation treatment qi stagnation and blood stasis type Stein-Leventhal syndromePurposes in the medicine of the proliferation of mammary gland.
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| CN117173092A (en) * | 2023-06-28 | 2023-12-05 | 中山大学肿瘤防治中心（中山大学附属肿瘤医院、中山大学肿瘤研究所） | Nasopharyngeal carcinoma radiotherapy method and system based on image processing |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103301391A (en) * | 2012-03-09 | 2013-09-18 | 刘炼武 | Traditional Chinese medicine for treating female infertility and preparation method thereof |
| CN103656067A (en) * | 2013-11-29 | 2014-03-26 | 周晨 | Traditional Chinese medicine formula for treating hyperplasia of mammary glands |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103301391A (en) * | 2012-03-09 | 2013-09-18 | 刘炼武 | Traditional Chinese medicine for treating female infertility and preparation method thereof |
| CN103656067A (en) * | 2013-11-29 | 2014-03-26 | 周晨 | Traditional Chinese medicine formula for treating hyperplasia of mammary glands |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN117173092A (en) * | 2023-06-28 | 2023-12-05 | 中山大学肿瘤防治中心（中山大学附属肿瘤医院、中山大学肿瘤研究所） | Nasopharyngeal carcinoma radiotherapy method and system based on image processing |
| CN117173092B (en) * | 2023-06-28 | 2024-04-09 | 中山大学肿瘤防治中心（中山大学附属肿瘤医院、中山大学肿瘤研究所） | Nasopharyngeal carcinoma radiotherapy method and system based on image processing |
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Application publication date: 20160525 |